Electronic add-on module and assembly of an electronic add-on module and a drug delivery device

Abstract

This disclosure relates to an electronic add-on module (100) configured for attachment to a drug delivery device and an assembly including the drug delivery device and the electronic add-on module (100). The electronic add-on module includes a first portion (101) having a main housing (103) defining a first longitudinal axis (X). The first portion (101) may include at least one leg (108) and at least one adjustment mechanism. The at least one leg (108) is mounted in the main housing (103) such that a portion (109) of the leg (108) is movable from a radially outer position relative to the first axis (X) to a radially inner position. The adjustment mechanism may include at least a first adjustment element (105) movably guided in the main housing (103) and cooperating with the at least one leg (108) such that movement of the first adjustment element (105) relative to the main housing (103) causes the portion (109) of the leg (108) to move from the radially outer position relative to the first axis (X) to the radially inner position.

Description

[0001] This disclosure generally relates to an electronic add-on module and components of an electronic system (e.g., the electronic add-on module) configured, for example, releasably attachable to a drug delivery device, etc.

[0002] Electronic add-on modules can be used attached to a drug delivery device (e.g., a pen-type injection device). Such a drug delivery device typically includes: a housing having a container configured to receive a drug or a cartridge filled with a drug; a dosage setting unit including a dosage selection user interface (e.g., a selection grip) and an injection user interface (e.g., a dosage button), the dosage selection user interface being at least rotatably movable relative to the housing during dosage setting, and the injection user interface being at least axially movable relative to the housing to induce dose dispensing; and a dosage delivery unit including a plunger being at least axially movable relative to the housing during dose dispensing.

[0003] Electronic add-on modules for releasable attachment to drug delivery devices are generally known and are often used to measure data related to dose setting and / or dose dispensing. Because injection devices vary in size and operating principle, particularly regarding dose selection and injection user interfaces, these add-on modules are typically customized to work with a specific drug delivery device. This necessitates providing different modules for different devices.

[0004] An electronic add-on module is known from WO 2016 / 198516 A1, comprising a sleeve-shaped portion to be positioned over a dose knob or selector handle of an injection device. An elastic pad is provided on the inner surface of the sleeve-shaped portion. The pad deforms to accommodate the dose knob within a cavity of the sleeve-shaped portion. Another monitoring device is known from US 2022 / 016352 A1, which has a radially deflectable arm.

[0005] Furthermore, a monitoring device for attachment to an injection device is known from WO 2019 / 145415 A1. This attachment includes a connecting element adapted to accommodate the push button and selector of an insulin pen. To accommodate any particular form of dose selector, the connecting element includes a washer with an inner surface similar to the outer surface of the selector, allowing the washer to slide along and wrap around the selector, thereby achieving a secure attachment. By employing different designs for the washer, the device can be used with any available model of medication pen. The washer is a removable element that can be detached from the connecting element, for example, to allow interchangeability with other washeres, thus adapting the device for attachment to different models of medication pens.

[0006] The purpose of this disclosure is to provide an improved electronic add-on module suitable for use with a variety of different drug delivery devices, as well as an improved component comprising a drug delivery device and such electronic add-on module.

[0007] This objective is essentially achieved by the electronic add-on module as described in claim 1.

[0008] Electronic add-on modules typically include a first portion having a first longitudinal axis and can be attached to a portion of a drug delivery device (e.g., an injection pen). According to one aspect of this disclosure, the dimensions (e.g., inner diameter) of the first portion can be adapted to accommodate different sizes and / or profiles of different drug delivery devices (e.g., a dose-selection user interface for the device). In other words, various inner diameters of the first portion can be defined in a specific manner. This has the advantage of providing add-on modules that fit on different drug delivery devices without requiring a separate adapter portion.

[0009] The electronic attachment module can be releasably attached to a drug delivery device via, for example, a releasably fastened component (e.g., an interacting mechanical coupling element) or by friction or resilient engagement. One component includes a drug delivery device and an electronic attachment module configured for releasable attachment to the drug delivery device.

[0010] A drug delivery device may include at least a housing having a container configured to receive a drug or a cartridge filled with a drug. Further, the drug delivery device may include a dose setting unit and a dose delivery unit. Suitable drug delivery devices to be used with modules according to this disclosure are described, for example, in WO 2004 / 078239 A1, EP 1 570 876 B1, EP 2 814 547 B1, EP 2 890 434 B1, WO 2005 / 018721 A1, WO 2009 / 132777 A1, WO 2014 / 033195 A1, US 5,693,027 A, US 6,663,602 B2, US 7,241,278 B2, or US 9,937,294 B2. In addition to manually driven devices, this module can also be used with spring-driven devices, as described in US 2008 / 306446 A1 or US 2009 / 054839 A1. However, this disclosure is not limited to these examples of drug delivery devices. Instead, other drug delivery devices having stationary and / or operable portions, such as those with a substantially cylindrical shape, can be used with this module. For example, a drug delivery device may include a user interface for selecting and / or dispensing a fixed or variable dose of drug.

[0011] The dosage setting unit may include a dosage selection user interface (e.g., a dosage selection grip) and an injection user interface, the dosage selection user interface being at least rotatably (e.g., helically) movable relative to the housing during dosage setting, and the injection user interface being at least axially movable relative to the housing to induce dosage dispensing. The injection user interface may be a separate component, such as a dosage button, that can be displaced relative to the dosage selection user interface to induce dosage dispensing. Alternatively, the dosage selection user interface and the injection user interface may be part of a single component (e.g., a combined dosage selection and injection knob).

[0012] The electronic add-on module may further include an optional second portion coupled to the first portion, thereby allowing relative axial movement parallel to the first longitudinal axis relative to the first portion. The first portion may define an auxiliary dose-selection user interface and may be configured to releasably attach to the dose-selection user interface of the drug delivery device such that when attached to the drug delivery device, the first portion follows the movement of the dose-selection user interface, and vice versa. The second portion may define an auxiliary injection user interface configured to apply pressure to the injection user interface of the drug delivery device when attached to the drug delivery device.

[0013] In one example of this disclosure, the first part includes a main housing, at least one adjustable leg, and at least one adjustment mechanism. The at least one adjustable leg may be movable and / or deflectable. For example, the at least one leg may be mounted in the main housing such that a portion of the leg can be moved from a radially external position relative to a first axis to a radially internal position relative to the first axis. In other words, the inner diameter can be adjusted or adapted by such radial movement of a portion of the at least one leg. This radial movement may be reversible, i.e., the inner diameter of the additional module may be narrowed and / or widened.

[0014] An independent aspect of this disclosure relates to an adjustment mechanism that may include at least a first adjustment element movably guided within the main housing and cooperating with the at least one leg, such that movement of the first adjustment element relative to the main housing causes that portion of the leg to shift from a radially external position relative to a first axis to a radially internal position relative to the first axis, and / or vice versa. The adjustment mechanism may be user-operable to adapt the additional module to the individual dimensions and / or profiles of the dose-selection user interface for different drug delivery devices.

[0015] According to a first example, the at least one leg can be pivotally mounted in the main housing such that a portion of the leg can pivot about a second longitudinal axis parallel to the first axis from a radially inward position relative to the first axis to a radially outward position, and / or vice versa. The at least one leg may include a pin extending along the second axis, the pin being rotatably guided in a corresponding hole in the main housing. According to an alternative second example, the at least one leg can be fixed within the main housing and may include a deflectable arm such that a portion of the leg can pivot about a second longitudinal axis parallel to the first axis from a radially inward position relative to the first axis to a radially outward position, and / or vice versa. According to an alternative second example, the at least one leg can pivot and / or deflect about an axis that may be substantially perpendicular to the first axis from a radially inward position relative to the first axis to a radially outward position, and / or vice versa.

[0016] For example, the first adjusting element may be an adjusting ring, which is rotatably guided within the main housing and cooperates with the at least one leg, such that rotation of the first adjusting element relative to the main housing causes that portion of the leg to move from a radially outer position relative to the first axis to a radially inner position. In an alternative example, the first adjusting element may be axially movable relative to the main housing to move that portion of the leg from a radially outer position relative to the first axis to a radially inner position.

[0017] The first adjusting element may include at least one radially inwardly projecting boss, which may be, for example, in the form of a rib extending substantially parallel to the first axis. The boss may be arranged and designed to act on the at least one leg as the first adjusting element moves relative to the main housing to transfer that portion of the leg from a radially outer position relative to the first axis to a radially inner position.

[0018] Several independent examples exist for causing radial movement of that portion of the at least one leg. According to one exemplary embodiment of this disclosure, the at least one leg includes a wedge-shaped surface that abuts a first adjusting element (e.g., a boss) at least during movement of the first adjusting element relative to the main housing. The wedge-shaped surface may extend substantially circumferentially such that rotation of the protruding boss can cause radial inward movement of that portion of the leg. Alternatively, the first adjusting element may include a wedge-shaped surface. For example, the boss may have an inclined surface such that movement of the inclined surface causes radial inward movement of that portion of the leg.

[0019] To securely attach the electronic add-on module to the drug delivery device, the at least one leg may include a molded rubber portion. For example, the at least one leg may be partially molded with a rubber portion having a Shore A hardness of 50.

[0020] In the example disclosed herein, the first part includes a main housing, three legs, and an adjustment mechanism, each of the three legs being pivotally mounted within the main housing about a different parallel second longitudinal axis. The advantage of providing three legs is that the dose selection user interface of the corresponding drug delivery device can be securely gripped via an additional module.

[0021] In the electronic add-on module, the adjustment mechanism may include a first adjustment ring and a second adjustment ring, which are rotatably constrained to each other by a spline engagement that allows axial movement of the second adjustment ring relative to the first adjustment ring. For example, the first adjustment ring may be axially constrained in the main housing but rotatably free relative to the main housing, while the second adjustment ring may move axially and rotatably relative to the main housing.

[0022] According to an independent example of this disclosure, the electronic add-on module includes a resiliently deformable member, such as a spring member, for mechanically biasing a component of the module into a starting or idle position. This deformable member can act on a second portion and / or a second adjusting ring. For example, the first portion further includes a spring element, such as a spring plate, that axially biases the second adjusting ring toward the first adjusting ring. The spring plate is a substantially flat metal element, which may be disc-shaped. The spring plate may have a spring arm or a resiliently deformable protrusion. For example, the spring element (especially its spring arm) axially biases the second portion away from the first portion.

[0023] In the electronic add-on module, components (e.g., the main housing and the second adjustment ring) are preferably releasably secured in defined positions relative to each other. The main housing and the second adjustment ring can be designed and arranged to be releasably secured in relative positions corresponding to a predetermined inner diameter of the first portion (e.g., between about 14.5 mm and 19 mm), adapted to the specific size and profile of the drug delivery device. For example, the main housing may include at least two recesses located at circumferentially spaced positions, and the second adjustment ring may include at least one stud adapted to engage one of these recesses. In other words, the main housing and the second adjustment ring can take different predetermined angular positions to adapt the module to different drug delivery devices. In an example, the main housing and the second adjustment ring can take three different positions corresponding to different clamping geometries of different drug delivery devices. In an example, the legs can form clamping diameters between 14.6 mm and 17.8 mm (e.g., 17.8 mm, 16.2 mm, and 14.6 mm) in three discrete positions.

[0024] The second part may be at least partially enclosed and held within the first part. For example, the first part has a cavity that at least partially receives the second part. The second part may be axially movable relative to the first part in a restricted manner, thereby preventing complete disassembly of the first and second parts. In other words, they may be moved a limited distance relative to each other to operate the drug delivery device. According to an independent aspect of this disclosure, the second part may include: an electrical power source, such as a battery or rechargeable battery cell; a printed circuit board assembly (PCBA) that includes and / or forms a control unit, for example; a sensor arrangement; a communication unit for communicating with another device, for example, for wireless data transmission; and / or a switch arrangement for, for example, turning an electronic module on and off, and / or for waking the module or its components from a sleep mode or a low-power consumption mode.

[0025] The sensor arrangement may include acoustic sensors and / or vibration (accelerometer) sensors. For example, the acoustic sensor arrangement includes at least one microphone. According to one aspect of this disclosure, the sensor arrangement is configured to detect acoustic and / or vibrational feedback generated by the drug delivery device during dose setting and / or dose dispensing, wherein the feedback indicates the amount of the selected dose and / or the amount of the dispensed dose. In other words, the sensor arrangement may at least indirectly allow the detection of relative movement, such as relative rotational movement, between at least two components of the drug delivery device, which typically move in a predetermined manner during dose setting and / or dose dispensing operations. An example of such movement may be a clicker mechanism that generates acoustic and / or vibrational feedback during dose setting and / or dose dispensing operations.

[0026] The components according to this disclosure include a drug delivery device and an electronic add-on module configured for releasable attachment to the drug delivery device.

[0027] Preferably, the drug delivery device includes: a device housing having a container configured to receive a drug or a cartridge filled with the drug; a dosage setting unit including a dosage selection user interface and an injection user interface, the dosage selection user interface being at least rotatably movable relative to the device housing during dosage setting, and the injection user interface being at least axially movable relative to the device housing to induce dosage dispensing; and a dosage delivery unit including a plunger being at least axially movable relative to the device housing during dosage dispensing.

[0028] Although not required in the context of this disclosure, the drug delivery device may optionally include additional components, such as the drive sleeve, digital sleeve, clutch, cap, needle, spring, lead screw, etc., that interact with the dose button, dose selector grip, drive sleeve, plunger, and / or housing, as disclosed, for example, in WO 2004 / 078239 A1. However, this disclosure is not limited to the drug delivery device of WO 2004 / 078239 A1. Other suitable drug delivery devices to be used with this module may include a selector grip for selecting a variable dose and a separate dose button for initiating or performing dose dispensing, for example, as described in EP 1 570 876 B1, EP 2 814 547 B1, EP 2 890 434 B1, WO 2009 / 132777 A1, US 6,663,602 B2, US 7,241,278 B2, or US 9,937,294 B2. Additionally, other suitable drug delivery devices to be used with this module may include a single knob forming a selector grip for selecting a variable dose and a dose button for initiating or performing dose dispensing, for example, as described in WO 2005 / 018721 A1 or WO2014 / 033195 A1. Furthermore, the drug delivery device may be a spring-driven device as described in US 2008 / 306446 A1 or US2009 / 054839 A1.

[0029] If the drug delivery device operates on a similar principle to the example in WO 2004 / 078239 A1, the components of the drug delivery device can perform the following movements during dose setting: The housing can be stationary and can serve as a reference system for further movement of other components. The plunger can be stationary and can be guided in the housing threads. The drive sleeve can be configured to be rotatably coupled to the dose selector grip during dose setting and rotatably constrained to the housing during dose dispensing. In other words, during dose dispensing, the drive sleeve can be guided in the housing to perform purely axial movement. The drive sleeve can perform helical movement, i.e., a combination of axial and rotational movement, and can engage with the plunger threads. The selector grip can perform helical movement. The dose button can rotate freely but is axially constrained to the drive sleeve. For example, the dose button can be axially held to the drive sleeve by a clutch. An optional clutch can perform helical movement and can be coupled to the drive sleeve by a digital sleeve. An optional clutch spring can perform axial movement and can be guided in the housing splines and can click on the clutch teeth. An optional digital sleeve can be permanently fixed to the selector grip and can perform helical movement, guided within the housing threads. An optional final dose nut can perform helical movement on the drive sleeve track of the drive sleeve and can be rotatably constrained to the housing. Therefore, the final dose nut can perform axial movement relative to the housing and helical movement relative to the drive sleeve.

[0030] During dosing, the components of the drug delivery device can perform the following movements: The housing can remain stationary, serving as a reference system for further movement of other components. The plunger can perform helical movement and can be guided in the housing threads. The drive sleeve can perform purely axial movement and can engage with the plunger threads. The dose selector grip can perform helical movement and can be permanently fixed to the digital sleeve. When coupled to the drive sleeve and / or clutch, the dose button can perform axial movement. An optional clutch can perform purely axial movement and can disengage the digital sleeve from the drive sleeve. An optional clutch spring can perform purely axial movement and can be rotationally constrained to the clutch due to pressure applied to the dose button. An optional digital sleeve can perform helical movement and can be guided in the housing threads. An optional final dose nut can maintain its axial position on the drive sleeve track and can be rotationally constrained to the housing.

[0031] In the components according to this disclosure, the position of that portion of the at least one leg can be adapted to the outer diameter of the dose selection user interface of the corresponding drug delivery device. Preferably, a first portion of the electronic add-on module is adapted to be rotatably constrained to the dose selection user interface of the drug delivery device by means of that portion of the at least one leg.

[0032] According to an independent aspect of this disclosure, the component includes a drug delivery device having a click-emitting mechanism that generates acoustic and / or vibratory feedback signals during specific use conditions, such as at least during dose setting. This feedback signal can be detected by an electronic module that can determine the amount of the selected and / or dispensed dose. For example, the click-emitting mechanism can generate a click once per IU dispensed, as described, for example, in WO 2004 / 078239 A1, WO 2014 / 033195 A1, WO 2005 / 018721 A1, or EP 1 570 876 B1.

[0033] The electronic add-in module can be an electronic dosing recording system for determining, storing, and / or transmitting data that at least indicates the status of a drug delivery device or its use. For example, the system can detect whether the drug delivery device is switching between a dose setting mode and a dose dispensing mode, and vice versa. Alternatively, the system can detect whether a dose has been set and / or dispensed. Further, the system can detect the amount of the selected dose and / or the amount of the dispensed dose. Preferably, the electronic add-in module is configured to switch from a first state with lower energy consumption to a second state with higher energy consumption. This can be achieved by operating the electronic add-in module, particularly by actuating a microswitch. The first state can be a sleep mode, and the second state can be a detection and / or communication mode. Alternatively, the electronic control unit can issue commands, such as signals, to another unit of the electronic dosing recording system, causing that unit to be turned on or become operable.

[0034] The electronic add-on module may further include a communication unit for communicating with another device, such as a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. Preferably, the electronic add-on module includes an RF, Wi-Fi, and / or Bluetooth unit as the communication unit. The communication unit can be configured as a communication interface between the electronic add-on module and external devices (e.g., other electronic devices, such as mobile phones, personal computers, laptops, etc.). For example, dose data can be transmitted from the communication unit to the external device. The dose data can be used for dose recording or dose history established in the external device.

[0035] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0036] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked DNA and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0037] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about 1 month to about 2 years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0038] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and the Merck Index (15th edition).

[0039] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0040] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0041] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0042] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0043] Examples of oligonucleotides include, for example, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0044] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0045] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0046] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0047] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0048] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0049] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0050] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0051] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0052] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0053] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0054] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0055] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0056] As used herein, the terms “axial,” “radial,” or “circumferential” may be used relative to a first longitudinal axis (e.g., an axis extending through the proximal and distal ends of the cartridge) of the electronic add-on module, the first part, the second part, the drug delivery device, the cartridge, the housing, the cartridge holder, or the drug delivery device and the electronic add-on module assembly.

[0057] The term "distal" herein is used to specify a direction, end, or surface that is arranged or is to be arranged facing or toward the dispensing end of the electronic add-in module or drug delivery device or its components and / or away from, or to be arranged away from, or away from the proximal end. Conversely, the term "proximal" is used to specify a direction, end, or surface that is arranged or is to be arranged away from or away from the dispensing end and / or distal end of the electronic add-in module or drug delivery device or its components. The distal end can be the end closest to the dispensing end and / or furthest from the proximal end, and the proximal end can be the end furthest from the dispensing end. The proximal surface can be away from the distal end and / or face the proximal end. The distal surface can face the distal end and / or be away from the proximal end. For example, the dispensing end can be the tip of a needle at which a needle unit is mounted or to be mounted onto the device. Similarly, distal elements are positioned closer to the dispensing end than to the proximal end compared to proximal elements. Furthermore, when considering the electronic add-on module in isolation, the term "distal" can be used with respect to the more distal end of the electronic add-on module, which, when attached to a drug delivery device, is located closer to the dispensing end of the drug delivery device, and the term "proximal" can be used with respect to the proximal end of the electronic add-on module, which, when attached to a drug delivery device, is located further away from the dispensing end of the drug delivery device.

[0058] In the following description, non-limiting examples of the electronic add-on module, the drug delivery device, and components thereof are described in more detail with reference to the accompanying drawings, in which:

[0059] Figure 1 This is a perspective view of a module according to a first embodiment of the present disclosure;

[0060] Figure 2 yes Figure 1 A cross-sectional view of the module;

[0061] Figure 3 yes Figure 1 The exploded view of the module;

[0062] Figure 4a , Figure 4b It shows Figure 1 Details of the module;

[0063] Figure 5a , Figure 5b It shows Figure 1 Further details of the module;

[0064] Figures 6a to 6c It shows Figure 1 The different positions of the adjustment ring of the module;

[0065] Figure 7 It is in the starting position. Figure 1 A cross-sectional view of the module;

[0066] Figure 8 The adjustment ring was raised. Figure 1 A cross-sectional view of the module;

[0067] Figure 9 The second part was pressed down. Figure 1 A cross-sectional view of the module;

[0068] Figures 10a to 10c It shows Figure 1 The different positions of the module's legs; and

[0069] Figure 11 An exploded view of a module according to a second embodiment of this disclosure is shown.

[0070] In the accompanying drawings, identical elements and components, as well as identical elements and components in different examples or embodiments (i.e., elements and components that function exactly the same or are provided for the same purpose but belong to different examples), are given the same reference numerals.

[0071] Figures 1 to 3 An exemplary embodiment of an electronic add-on module 100 suitable for releasably attaching to a drug delivery device (not shown) is illustrated. Module 100 substantially includes a first portion 101 and a second portion 102 arranged coaxially on a first longitudinal axis X.

[0072] The first part 101 includes a main housing 103, an end ring 104, a first adjustment ring 105, a second adjustment ring 106, a spring 107, and three legs 108, each leg having a rubber portion 109. The second part 102 includes a button housing 110, a printed circuit board assembly (PCBA) 111, a battery 112, and a buffer 113.

[0073] The main housing 103 is a sleeve-like component with an inwardly projecting annular web 114. The outer surface of the main housing 103 may be structured, for example, by ribs and / or grooves as depicted, to facilitate gripping and rotation of the main housing 103. When attached to a drug delivery device, the main housing 103 forms an auxiliary dose-selection user interface that replicates the dose-selection user interface of the drug delivery device (e.g., a dose-selection grip). The main housing 103 has three bearing holes 115 on its inner side, each bearing hole defining a second axis Y parallel to the main longitudinal axis X. These bearing holes 115 receive bearing pins of corresponding legs 108, allowing the legs 108 to rotate freely about the corresponding axis Y. An end ring 104 can snap onto the distal side of the main housing 103 facing the drug delivery device after the legs 108 are installed into the main housing 103. The end ring 104 may include three bearing holes for receiving the distal ends of the bearing pins of the legs 108.

[0074] Each support leg 108 is basically arched, with a bearing pin at one end and a free end at the opposite end, such as... Figure 4a and Figure 4b As shown. The radially inward-facing side of each support leg 108 may have a molded rubber portion 109, for example, with a hardness of 50 Shore A. The radially outward-facing side of each support leg 108 is wedge-shaped, i.e., inclined, such that the side facing the bearing pin is thinner than the side facing the free end. The distal-facing bead of the support leg 108 may have a uniform thickness, i.e., only a portion of the support leg may be wedge-shaped.

[0075] First (in) Figure 3 The middle and lower adjustment ring 105 includes three radially inwardly projecting bosses 116 extending distally. In the depicted example, the first adjustment ring 105 is substantially disc-shaped. However, in an alternative example, the first adjustment ring 105 may have a sleeve-like configuration, wherein the bosses 116 are formed as internal ribs. Figure 5a and Figure 5b A (partially transparent) main housing 103 is depicted, having only one leg 108 and a first adjusting ring 105. A boss 116 extends in the radial space between the leg 108 and the main housing 103, thereby abutting the wedge-shaped outer side of the leg 108. Thus, the first adjusting ring 105 is positioned relative to the main housing 103 and the leg 108 from... Figure 5a The depicted position rotates to Figure 5bThe depicted position forces the free end of the outrigger 108, with its overmolded rubber portion 109, to pivot radially inward as the boss 116 slides along the wedge-shaped outer side of the outrigger 108. The opposite rotation will allow the outrigger 108 to pivot back. Figure 5a In the position. For example... Figure 10a , Figure 10b and Figure 10c As depicted, this radial movement of the free end of the leg 108 widens or narrows the inner diameter of the module 100. In other words, by pivoting the free end of the leg 108 inward or outward, the module 100 can be adapted to different sized user interfaces for different drug delivery devices. Typically, the inner diameter can be adjusted from about 14.5 mm to about 19 mm.

[0076] Furthermore, the first adjusting ring 105 includes proximal teeth 117 for mating and engaging with distally facing recesses 118 in the second (upper) adjusting ring 106. The teeth 117 and recesses 118 are always engaged, thereby rotatably constraining the first adjusting ring 105 and the second adjusting ring 106 while allowing small relative axial movements, such as... Figure 6a As shown. In other words, the second adjustment ring 106 can be adjusted from... Figure 6c The position shown is raised to Figure 6b The spring 107 is in the form of a plate and is clamped between the web 114 of the main housing 103 and the second portion 102. The lateral protrusions of the spring 107 are fixed in the second adjusting ring 106. Therefore, when the second adjusting ring 106 is in the starting position (see...), Figure 7 ) Improvement (see Figure 8 When the spring 107 is engaged, the spring 107 deflects elastically. In other words, the spring 107 biases the second adjusting ring 106 back to its initial position where the teeth 117 and the recess 118 are fully engaged.

[0077] The second adjusting ring 106 has a proximal convex edge projecting radially over the main housing 103 to allow a user to grip and lift the second adjusting ring 106. A stud 119 is provided on the distal side of the convex edge of the second adjusting ring 106, and the main housing 103 includes three proximal recesses 120 adapted to each receive the stud 119. In other words, the stud 119 and the recesses 120 define three dedicated relative rotational positions between the second adjusting ring 106 and the main housing 103. These three dedicated positions correspond to three predefined inner diameters of the module defined by the legs 108, such as 17.8 mm, 16.2 mm, and 14.6 mm.

[0078] The second portion 102 is partially held within the cavity of the first portion 101, specifically by means of the cavity of the second adjusting ring 106. The button housing 110 of the second portion 102 has an enlarged upper portion enclosing the PCBA 111 and the battery 112, and a smaller lower portion extending toward the web 114 of the main housing 103. A buffer 113 extends through the web 114 and includes a snap-fit ​​arm for attachment into the button housing 110, thereby limiting relative axial movement of the second portion 102 relative to the first portion 101.

[0079] A spring arm disposed on spring 107 abuts button housing 110, such that the second portion 102 is biased relative to the first portion 101. Figure 7 In the depicted starting position, the second part 102 can be pressed into the first part 101 by the user against the force of the spring arm, as shown. Figure 9 As shown. Therefore, the button housing 110 forms an auxiliary injection user interface. By pressing the second portion 102 into the first portion 101, the buffer 113 moves distally relative to the main housing 103. Thus, when the module 100 is attached to the drug delivery device, the buffer 113 can apply pressure to the user interface of the drug delivery device (e.g., the dosage button).

[0080] PCBA 111 may include or form a control unit, sensor arrangement, and / or communication unit. Preferably, PCBA 111 includes an acoustic sensor for detecting a clicking sound generated when the drug delivery device is attached to module 100. Further, the control unit preferably determines the amount of medication dispensed from the drug delivery device based on the clicking sound detected by the sensor. This data can be transmitted to an external device via the communication unit.

[0081] To adjust the clamping diameter of module 100, the support leg 108 is rotated a small angle about the corresponding axis Y. This moves the rubberized part 109 of the support leg 108 closer to or further away from the centerline X of module 100. This movement is driven by a first (lower) adjustment ring 105 that is movable + / 30° (i.e., approximately 60° in total). The first adjustment ring 105 is actuated by a second (upper) adjustment ring 106. The second adjustment ring 106 must be turned manually. To set the correct clamping diameter for the dedicated insulin pen, recesses 120 form three indentations in the main housing 103, in which the second adjustment ring 106 is locked. The second adjustment ring 106 must be lifted manually, then rotated, and then forced back into the indentations upon release. The force that returns the second adjustment ring 106 is provided by a spring plate 107. The same spring plate 107 generates resistance when the button housing 110 is pressed down. The button housing 110 is pressed to trigger injection. The button housing 110 also serves as the housing for the electronic components. The buffer 113 ensures the correct distance between the button housing 110 and the second adjusting ring 106 to maintain the spring plate 107 under a certain preload. The buffer 113 also ensures that the components remain within the main housing 103.

[0082] Figure 11 Another example of module 100 according to this disclosure is shown. The first part 101 and the second part 102 operate substantially the same as described above with respect to the first example. However, the module further includes a switch or wake-up mechanism.

[0083] To extend the lifespan of battery 112, the electronics can be set to sleep mode. Module 100 can measure a preset dose volume for injection. One possible measurement technique could be achieved using a microphone in the button housing 110 of the electronics and counting the clicks produced when the dose volume is selected upwards. For the microphone to operate, a wake-up function must be installed to set the electronics to recording mode before the insulin pen mechanism produces the first click.

[0084] The wake-up mechanism consists of a spring-loaded clutch 121 surrounding the main housing 103, a segmented magnetized ring 122, and a small magnetic sensor 123 (e.g., a Hall sensor) located inside the electronic button housing 110. The clutch comprises two parts attached to the main housing 103 by a spring 124 and guided by a ball bearing 125. When no momentum is applied by the user, the spring-loaded clutch 121 is always forced into the idle or starting position. When the user begins the up-selection process, the clutch 121 and the magnetized ring 122 rotate approximately 30° to 60° relative to the main housing 103 without transferring momentum to the main housing 103 of the module.

[0085] The movement of the magnetized ring 122 will be detected by the magnetic sensor 123, and this will initiate the recording process of the electronic device. This arrangement of the components allows the magnetic sensor 123 in the button housing 110 to remain at any position within 360° around the central axis X of the module.

[0086] After the clutch 121 rotates 30° to 60° for the first time, momentum is transferred from the main housing 103 to the selector grip of the drug delivery device (not shown), and it begins to select upwards and produces a clicking sound.

[0087] Figure Labels

[0088] 100 Electronic Add-on Module

[0089] 101 Part 1

[0090] Part 2 of 102

[0091] 103 main shell

[0092] 104 end ring

[0093] 105 First (Lower) Adjustment Ring

[0094] 106 Second (Upper) Adjustment Ring

[0095] 107 Spring Plate

[0096] 108 legs

[0097] 109 Rubber Part

[0098] 110 button housing

[0099] 111PCBA

[0100] 112 battery

[0101] 113 Buffer

[0102] 114 web

[0103] 115 bearing bore

[0104] 116 boss

[0105] 117 teeth

[0106] 118 Depression

[0107] 119 bolts

[0108] 120 recessed area

[0109] 121 Clutch

[0110] 122 magnetized ring

[0111] 123 Sensors

[0112] 124 springs

[0113] 125 ball bearing

[0114] X (first part) first longitudinal axis

[0115] Y is the second longitudinal axis.

Claims

1. An electronic add-on module (100) configured to be attached to a drug delivery device, the electronic add-on module including a first portion (101) having a main housing (103) defining a first longitudinal axis (X). Its features are, The first part (101) includes at least one leg (108) and at least one adjustment mechanism, wherein the at least one leg (108) is mounted in the main housing (103) such that a portion (109) of the leg (108) is movable from a radially outer position relative to the first axis (X) to a radially inner position, and wherein the adjustment mechanism includes at least a first adjustment element (105) movably guided in the main housing (103) and cooperating with the at least one leg (108) such that movement of the first adjustment element (105) relative to the main housing (103) causes the portion (109) of the leg (108) to move from the radially outer position relative to the first axis (X) to the radially inner position.

2. The electronic add-on module (100) according to claim 1, wherein, The at least one leg (108) is pivotally mounted in the main housing (103) such that a portion (109) of the leg (108) is pivotable about a second longitudinal axis (Y) parallel to the first axis (X) from a radially inward position relative to the first axis (X) to a radially outward position, and vice versa.

3. The electronic add-on module (100) according to claim 1 or 2, wherein, The first adjusting element (105) is an adjusting ring that is rotatably guided in the main housing (103) and cooperates with the at least one leg (108) such that rotation of the first adjusting element (105) relative to the main housing (103) causes the portion (109) of the leg (108) to move from the radially outer position relative to the first axis (X) to the radially inner position.

4. The electronic add-on module (100) according to any one of the preceding claims, wherein, The first adjusting element (105) includes at least one radially inwardly projecting boss (116) that acts on the at least one leg (108) when the first adjusting element (105) moves relative to the main housing (103).

5. The electronic add-on module (100) according to any one of the preceding claims, wherein, The at least one leg (108) includes a wedge-shaped surface that abuts the first adjusting element (105) at least during movement of the first adjusting element (105) relative to the main housing (103).

6. The electronic add-on module (100) according to any one of the preceding claims, wherein, The at least one leg (108) includes a molded rubber portion (109).

7. The electronic add-on module (100) according to any one of the preceding claims, wherein, The first part (101) includes the main housing (103), three legs (108) and the adjustment mechanism, each of the three legs being pivotally mounted in the main housing (103) about a different second longitudinal axis (Y).

8. The electronic add-on module (100) according to any one of claims 3 to 7, wherein, The adjustment mechanism includes a first adjustment ring (105) and a second adjustment ring (106), which are rotatably constrained to each other by a spline engagement that allows the second adjustment ring (106) to move axially relative to the first adjustment ring (105).

9. The electronic add-on module (100) according to claim 8, wherein, The first part (101) further includes a spring element, such as a spring plate (107), which axially biases the second adjusting ring (106) toward the first adjusting ring (105).

10. The electronic add-on module (100) according to any one of claims 8 to 9, wherein, The main housing (103) includes at least two recesses (120) located at circumferentially spaced positions, and wherein the second adjusting ring (106) includes at least one stud (119) adapted to engage one of the recesses (120).

11. The electronic add-on module (100) according to any one of the preceding claims, wherein, The first portion (101) defines an auxiliary dose selection user interface (103; 121) configured to be attached to the dose selection user interface of the drug delivery device such that when attached to the drug delivery device, the first portion (101) follows the movement of the dose selection user interface and vice versa, and wherein the module (100) further includes a second portion (102) coupled to the first portion (101) to allow relative axial movement of the first portion (101) parallel to the first longitudinal axis (X), wherein the second portion (102) defines an auxiliary injection user interface (110) configured to apply pressure to the injection user interface of the drug delivery device.

12. The electronic add-on module (100) according to claim 11, wherein, The second part (102) is at least partially enclosed and held within the first part (101) and includes: an electrical power source (112); a printed circuit board assembly (111); a sensor arrangement, such as an acoustic sensor arrangement and / or a vibration sensor arrangement, configured to detect feedback from the drug delivery device; a communication unit for communicating with another device; and / or a switch arrangement (122, 123).

13. The electronic add-on module (100) according to claim 9 and 11 or 12, wherein, The spring element (107) axially biases the second part (102) away from the first part (101).

14. A component comprising a drug delivery device and an electronic attachment module (100) according to any one of the preceding claims, the electronic attachment module being configured for releasable attachment to the drug delivery device, wherein, The drug delivery device includes: • Device housing having a container configured to receive a drug or a cartridge filled with a drug. • A dose setting unit, comprising a dose selection user interface and an injection user interface, the dose selection user interface being at least rotatably movable relative to the device housing during dose setting, and the injection user interface being at least axially movable relative to the device housing to induce dose dispensing. • A dose delivery unit, comprising a plunger capable of moving at least axially relative to the device housing during dose dispensing. The feature is that the position of the portion (109) of the at least one leg (108) is adapted to be outside the dose selection user interface of the drug delivery device, and the first portion (101) of the electronic add-on module (100) is adapted to be rotatably constrained to the dose selection user interface of the drug delivery device by means of the portion (109) of the at least one leg (108).

15. The component of claim 14, wherein, The drug delivery device (1) further includes a clicking mechanism that generates acoustic and / or vibrational feedback signals at least during dose setting.

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