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

Abstract

The present disclosure is directed to an electronic add-on module (100) configured for attach- ment to a drug delivery device and to an assembly comprising a drug delivery device and an electronic add-on module (100). The electronic add-on module comprises a first portion (101) with a main housing (103) defining a first longitudinal axis (X). The first portion (101) may comprise 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) can be transferred from a radially outer position with respect to the first axis (X) to a radially inner position. The adjustment mechanism may comprise 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 that the portion (109) of the leg (108) is transferred from the radially outer position with respect to the first axis (X) to the radially inner position.

Description

[0001] Description

[0002] ELECTRONIC ADD-ON MODULE AND ASSEMBLY OF AN ELECTRONIC ADD-ON MODULE AND A DRUG DELIVERY DEVICE

[0003] The present disclosure is generally directed to an electronic add-on module and to an assembly of an electronic system, e.g. an electronic add-on module, which is configured to be, e.g. releasably, attached to a drug delivery device like.

[0004] Electronic add-on modules may be used attached on to a drug delivery device, e.g. a pen-type injection device. Such drug delivery devices often comprise a housing with a container configured to receive a drug or a cartridge filled with a drug, a dose setting unit comprising a dose dial user interface, e.g. a dial grip, at least rotationally moveable with respect to the housing during dose setting and an injection user interface, e.g. a dose button, at least axially moveable with respect to the housing for causing dose dispensing, and a dose delivery unit comprising a plunger at least axially moveable with respect to the housing during dose dispensing.

[0005] Electronic add-on modules for releasable attachment to drug delivery devices are generally known and often used to measure relevant data with respect to dose setting and / or dose dispensing. Due to the different dimensions and working principles of known injection devices, especially regarding dose dial user interfaces and injection user interfaces, such add-on modules are typically tailored to fit to one specific drug delivery device. This requires providing different modules for different devices.

[0006] An electronic add-on module is known from WO 2016 / 198516 A1 which comprises a sleevelike portion to be positioned over a dosage knob or dial grip of an injection device. A resilient padding is provided on the inner surface of the sleeve-like portion. The padding deforms to accommodate the dosage knob within the cavity of the sleeve-like portion. A further monitoring device with radially deflectable arms is known from US 2022 / 016352 A1.

[0007] Further, a monitoring device for attachment to an injection device is known from WO 2019 / 145415 A1. This add-on device comprises a coupling element adapted for accommodating the push button and the selector of an insulin pen. In order to adapt to the specific form of any dose selector, the coupling element comprises a gasket with an inner orifice, whose inner surface is similar to the external surface of the selector, such that it can slide along it and embrace it achieving a firm attachment thereto. By employing different designs for the gasket, the device can be used with any available model of drug pen. The gasket is a removable element which can be detached from the coupling element for example, to be interchanged with other gaskets for the adaptation of the device for its coupling to different models of drug pens.

[0008] It is an object of the present disclosure to provide an improved electronic add-on module suitable to be used with various different drug delivery devices and an improved assembly comprising a drug delivery device and such an electronic add-on module.

[0009] This object is essentially solved by an electronic add-on module according to claim 1.

[0010] The electronic add-on module typically comprises a first portion with a first longitudinal axis and may be attached to a portion of a drug delivery device, e.g. an injection pen. According to one aspect of the present disclosure, the dimension, for example the inner diameter, of the first portion can be adapted to fit to different dimensions and / or contours of different drug delivery devices, for example of the dose dial user interfaces of the devices. In other words, various inner diameters of the first portion can be set in a defined manner. This has the benefit of providing an add-on module which fits onto different drug delivery devices without requiring individual adapter parts.

[0011] The electronic add-on module may be, e.g. releasably, attached to the drug delivery device by releasably fastening means, for example, interacting mechanical coupling elements or by frictional or elastic engagement. An assembly comprises a drug delivery device and an electronic add-on module configured for releasable attachment to the drug delivery device.

[0012] Drug delivery devices may comprise at least a housing with a container configured to receive a drug or a cartridge filled with a drug. Further, the drug delivery device may comprise a dose setting unit and a dose delivery unit. Suitable drug delivery devices to be used with a module according to the present disclosure are described e.g. 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, the module may be used with spring driven devices as described in US 2008 / 306446 A1 or US 2009 / 054839 A1 . However, the present disclosure is not limited to these examples of drug delivery devices. Rather, other drug delivery devices with a stationary and / or operable portion having an e.g. substantially cylindrical shape may be used with the module. For example, the drug delivery devices may comprise a user interface for selecting and / or dispensing a fixed or variable dose of a drug.

[0013] The dose setting unit may comprise a dose dial user interface, e.g. a dose dial grip, which is, at least rotationally, e.g. helically, moveable with respect to the housing during dose setting and an injection user interface at least axially moveable with respect to the housing for causing dose dispensing. The injection user interface may be a separate component part, e.g. a dose button, which may be displaced relative to the dose dial user interface for causing dose dispensing. As an alternative, the dose dial user interface and the injection user interface may be portions of one single component part, e.g. a combined dose dial and injection knob.

[0014] The electronic add-on module may further comprise an optional second portion coupled to the first portion allowing relative axial movement parallel to the first longitudinal axis with respect to the first portion. The first portion may define an auxiliary dose dial user interface and may be configured to be releasably attached to the dose dial user interface of the drug delivery device such that the first portion follows the movement of the dose dial user interface and vice versa when attached to the drug delivery device. The second portion may define an auxiliary injection user interface configured to apply pressure onto the injection user interface of the drug delivery device when attached to the drug delivery device.

[0015] In one example of the present disclosure, the first portion comprises 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 transferred from a radially outer position with respect to the first axis to a radially inner position with respect to the first axis. In other words, the inner diameter may 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 add-on module may be narrowed and / or widened.

[0016] An independent aspect of the present disclosure is directed to the adjustment mechanism which may comprise at least a first adjustment element movably guided in 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 the portion of the leg is transferred from the radially outer position with respect to the first axis to the radially inner position with respect to the first axis and / or vice versa. The adjustment mechanism may be operable by a user in order to adapt the add-on module to the individual dimensions and / or contours of the dose dial user interfaces of different drug delivery devices.

[0017] According to a first example, the at least one leg may be pivot-mounted in the main housing such that a portion of the leg can be pivoted about a second longitudinal axis which is parallel to the first axis from a radially inner position with respect to the first axis to a radially outer position and / or vice versa. The at least one leg may comprise a pin extending along the second axis which is rotatably guided in a respective hole in the main housing. According to an alternative second example, the at least one leg may be fixed within the main housing and may comprise a deflectable arm such that a portion of the leg can be pivoted about a second longitudinal axis which is parallel to the first axis from a radially inner position with respect to the first axis to a radially outer position and / or vice versa. According to an alternative second example, the at least one leg may be pivotable and / or deflectable about an axis which may be substantially perpendicular to the first axis from a radially inner position with respect to the first axis to a radially outer position and / or vice versa.

[0018] For example, the first adjustment element may be an adjustment ring rotatably guided in the main housing and cooperating with the at least one leg such that rotation of the first adjustment element relative to the main housing causes that the portion of the leg is transferred from the radially outer position with respect to the first axis to the radially inner position. In an alternative example, the first adjustment element may be axially movable relative to the main housing for transferring the portion of the leg from the radially outer position with respect to the first axis to the radially inner position.

[0019] The first adjustment element may comprise at least one radially inwardly protruding boss, e.g. in the form of a rib extending substantially parallel to the first axis. The boss may be arranged and designed in order to act on the at least one leg upon movement of the first adjustment element relative to the main housing for transferring the portion of the leg from the radially outer position with respect to the first axis to the radially inner position.

[0020] There are several independent examples for causing the radial movement of the portion of the at least one leg. According to one exemplary embodiment of the present disclosure, the at least one leg comprises a wedge-shaped surface abutting the first adjustment element, e.g. the boss, at least during movement of the first adjustment element relative to the main housing. The wedge-shaped surface may extend substantially circumferentially such hat rotation of the protruding boss may cause the portion of the leg to move radially inwards. In addition or as an alternative, the first adjustment element comprises a wedge-shaped surface. For example, the boss may have an inclined surface such that movement of this inclined surface cause the portion of the leg to move radially inwards.

[0021] In order to securely attach the electronic add-on module onto the drug delivery device, the at least one leg may comprise an overmolded rubber portion. For example, the at least one leg may be partially overmolded with rubber having a 50 shore-A hardness.

[0022] In an example of the present disclosure, the first portion comprises the main housing, three legs which are each pivot-mounted in the main housing about different parallel second longitudinal axes and the adjustment mechanism. The provision of three legs has the benefit that a dose dial user interface of the respective drug delivery device may be securely gripped by the add-on module.

[0023] In the electronic add-on module, the adjustment mechanism may comprise the first adjustment ring and a second adjustment ring which are rotationally constrained to each other by a splined engagement permitting 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 free to rotate relative to the main housing, whereas the second adjustment ring can move axially and rotationally with respect to the main housing.

[0024] According to an independent example of the present disclosure, the electronic add-on module comprises an elastically deformable member, e.g. a spring member, for mechanically biasing components of the module into a home position or idle position. Such a deformable member may be acting on the second portion and / or on the second adjustment ring. For example, the first portion further comprises a spring element, like a spring plate, biasing the second adjustment ring axially towards the first adjustment ring. A spring plate is a substantially flat metal element which may be disc-shaped. A spring plate may have spring arms or elastically deformable protrusions. For example, the spring element, especially its spring arms, biases the second portion axially away from the first portion.

[0025] In the electronic add-on module, the components, e.g. the main housing and the second adjustment ring, are preferably releasably fixed in defined positions in relation to each other. The main housing and the second adjustment ring may be designed and arranged to be releasably fixed in relative positions corresponding to predetermined inner diameters of the first portion, e.g. between about 14.5mm and 19mm, adapted to specific dimensions and contours of drug delivery devices. For example, the main housing may comprise at least two recesses at circumferentially spaced positions and the second adjustment ring may comprise at least one peg adapted to engage one of the recesses. In other words, the main housing and the second adjustment ring may assume different predetermined angular positions for adapting the module to different drug delivery devices. In an example, the main housing and the second adjustment ring may assume three different positions corresponding to different clamping geometries of different drug delivery devices. In an example, the legs can form a clamping diameter between 14.6mm and 17.8mm in 3 discrete positions, for example 17.8mm , 16.2mm and 14.6mm.

[0026] The second portion may be at least partially encased by and retained in the first portion. For example, the first portion has a cavity receiving at least partially the second portion. The second portion may be axially movable relative to the first portion in a restricted manner preventing full disassembly of the first and second portions. In other words, they can be moved a limited distance relative to each other for operating the drug delivery device. According to an independent aspect of the present disclosure, the second portion may comprise an electrical power source, e.g. a battery or a rechargeable cell, a printed circuit board assembly (PCBA), e.g. comprising and / or forming a control unit, a sensor arrangement, a communication unit for communicating with another device, e.g. for wireless transfer of data, and / or a switch arrangement, e.g. for turning the electronic module on and off and / or for waking the module or its components from a sleeping mode or a low power consumption mode.

[0027] The sensor arrangement may comprise an acoustic sensor and / or a vibrational (acceleration) sensor. For example, an acoustic sensor arrangement comprises at least one microphone. According to an aspect of the present disclosure, the sensor arrangement is configured to detect an acoustic and / or vibration feedback generated by the drug delivery device during dose setting and / or dose dispensing, wherein the feedback is indicative of the selected dose amount and / or dispensed dose amount. In other words, the sensor arrangement may at least indirectly permit detection of relative movements, e.g. a relative rotational movement, between at least two component parts of the drug delivery device which typically move in a predetermined manner during a dose setting operation and / or a dose dispensing operation. An example of such a movement may be a clicker mechanism which generates an acoustic and / or vibration feedback during a dose setting operation and / or a dose dispensing operation.

[0028] An assembly according to the present disclosure comprises a drug delivery device and an electronic add-on module configured for releasable attachment to the drug delivery device.

[0029] Preferably, the drug delivery device comprises: device housing with a container configured to receive a drug or a cartridge filled with a drug, a dose setting unit comprising a dose dial user interface at least rotationally moveable with respect to the device housing during dose setting and an injection user interface at least axially moveable with respect to the device housing for causing dose dispensing, and a dose delivery unit comprising a plunger at least axially moveable with respect to the device housing during dose dispensing.

[0030] Although not required in the context of the present disclosure, the drug delivery device may optionally comprise further components such as a drive sleeve, a number sleeve, a clutch, a cap, a needle, a spring, a lead screw or the like, interacting with the dose button, the dose dial grip, the drive sleeve, the plunger and / or the housing, for example as disclosed in WO 2004 / 078239 A1. However, the present disclosure is not limited to the drug delivery device of WO 2004 / 078239 A1. Other suitable drug delivery devices to be used with such a module may comprise a dial grip for selecting a variable dose and a separate dose button for initiating or performing dose dispensing, e.g. 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. In addition, other suitable drug delivery devices to be used with such a module may comprise a single knob forming a dial grip for selecting a variable dose and a dose button for initiating or performing dose dispensing, e.g. as described in WO 2005 / 018721 A1 or WO 2014 / 033195 A1. Still further, the drug delivery device may be a spring driven device as described in US 2008 / 306446 A1 or US 2009 / 054839 A1 .

[0031] If the drug delivery device has a similar working principle as in the example of WO 2004 / 078239 A1 , during dose setting components of the drug delivery device may perform the following movements. A housing may be stationary and may be used as a reference system for the further movements of other components. A plunger may be stationary and may be guided in a housing thread. A drive sleeve may be provided rotationally coupled to the dose dial grip during dose setting and rotationally constrained to the housing during dose dispensing. In other words, the drive sleeve may be guided in the housing to perform a purely axial movement during dose dispensing. The drive sleeve may perform a helical movement, i.e. a combined axial and rotational movement, and may be in threaded engagement with the plunger. A dial grip may perform a helical movement. A dose button may be free to rotate but axially constrained to the drive sleeve. For example, the dose button may be axially retained to the drive sleeve by a clutch. An optional clutch may perform a helical movement and may couple a number sleeve to the drive sleeve. An optional clutch spring may perform an axial movement and may be guided in housing splines and may click over clutch teeth. An optional number sleeve may be permanently fixed on the dial grip and may perform a helical movement and may be guided in a housing thread. An optional last dose nut may perform a helical movement on a drive sleeve track of the drive sleeve and may be rotationally constrained to the housing. Hence, the last dose nut may perform axial movement relative to the housing and a helical movement with respect to the drive sleeve.

[0032] During dose dispensing components of the drug delivery device may perform the following movements. The housing may remain stationary as a reference system for the further movements of other components. The plunger may perform a helical movement and may be guided in the housing thread. The drive sleeve may perform a pure axial movement and may be in threaded engagement with the plunger. The dose dial grip may perform a helical movement and may be permanently fixed on the number sleeve. The dose button may perform an axial movement if coupled to the drive sleeve and / or the clutch. The optional clutch may perform pure axial movement and may de-couple the number sleeve from the drive sleeve. The optional clutch spring may perform pure axial movement and may be rotationally constrained to the clutch due to a pressure applied to the dose button. The optional number sleeve may perform a helical movement and may be guided in the housing thread. The optional last dose nut may maintain its axial position on the drive sleeve track and may be rotationally constrained to the housing.

[0033] In an assembly according to the present disclosure, the position of the portion of the at least one leg may be adapted to the outer diameter the dose dial user interface of the respective drug delivery device. Preferably, the first portion of the electronic add-on module is adapted to be rotationally constrained to the dose dial user interface of the drug-delivery device by means of the portion of the at least one leg.

[0034] According to an independent aspect of the present disclosure, the assembly comprises a drug delivery device having a clicker mechanism generating an acoustic and / or vibrational feedback signal during specific use conditions, e.g. at least during dose setting. Such a feedback signal may be detected by the electronic module and the module may determine an amount of dose selected and / or dispensed. For example, the clicker mechanism may generate one clicking sound for every III dispensed, like e.g. in WO 2004 / 078239 A1 , WO 2014 / 033195 A1 , WO 2005 / 018721 A1 or EP 1 570 876 B1.

[0035] The electronic add-on module may be an electronic dose recording system for determining, storing and / or transmitting data indicative of at least a condition of the drug delivery device or its use. For example, the system may detect if the drug delivery device is switched between a dose setting mode and a dose dispensing mode and vice versa. In addition or as an alternative, the system may detect if a dose is set and / or if a dose is dispensed. Still further, the system may detect the amount of dose selected and / or the amount of dose dispensed. Preferably, the electronic add-on module is configured such that it may be switched from a first state having lower energy consumption into a second state having higher energy consumption. This may be achieved by operation of the electronic add-on module, especially by actuating the microswitch. The first state may be a sleeping mode and the second mode may be a detection and / or communication mode. As an alternative, an electronic control unit may issue a command, e.g. a signal, to another unit of the electronic dose recording system such that this unit is switched on or rendered operational.

[0036] The electronic add-on module may further comprise a communication unit for communicating with another device, e.g. a wireless communications interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector. Preferably, the electronic add-on module comprises an RF, Wi-Fi and / or Bluetooth unit as the communication unit. The communication unit may be provided as a communication interface between the electronic add-on module and the exterior, such as other electronic devices, e.g. mobile phones, personal computers, laptops and so on. For example, dose data may be transmitted by the communication unit to the external device. The dose data may be used for a dose log or dose history established in the external device.

[0037] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0038] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API 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 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. The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dualchamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0039] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0040] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipep- tidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0041] 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, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0042] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-pal- mitoyl-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; 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-(w-carbox- yheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0043] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lix- isenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semag- lutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134- PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP- 1 Eligen, GRMD-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, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten. An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cho- lesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0044] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0045] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0046] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0047] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0048] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are 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 (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0049] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0050] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sari- lumab), and anti IL-4 mAb (e.g., Dupilumab).

[0051] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0052] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof. An example drug delivery device may involve a needle-based injection system 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 distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0053] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0054] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0055] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a first longitudinal axis of the electronic add-on module, the first portion, the second portion, the drug delivery device, the cartridge, the housing, the cartridge holder or the assembly of the drug delivery device and the electronic add-on module, e.g. the axis which extends through the proximal and distal ends of the cartridge.

[0056] "Distal" is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the electronic add-on module or the drug delivery device or components thereof and / or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the electronic add-on module or the drug delivery device or components thereof. The distal end may be the end closest to the dispensing and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example. Similarly, a distal element compared to a proximal element is located closer to the dispensing end than to the proximal end. Furthermore, when the electronic add-on module is considered alone, the term "distal" may be used with regard to the more distal end of the electronic add-on module, which is located closer to the dispensing end of the drug delivery device when attached to the drug delivery device, and the term "proximal" may be used with regard to the proximal end of the electronic add-on module, which is located further away from the dispensing end of the drug delivery device when attached to the drug delivery device. In the following, non-limiting, examples of the electronic add-on module, the drug delivery device and the assembly of the drug delivery device and the electronic add-on module are described in more detail by making reference to the drawings, in which:

[0057] Figure 1 is a perspective view of a module according to a first embodiment of the present disclosure;

[0058] Figure 2 is a sectional view of the module of Figure 1 ;

[0059] Figure 3 is an exploded view of the module of Figure 1 ;

[0060] Figures 4a, b show a detail of the module of Figure 1 ;

[0061] Figures 5a, b show a further detail of the module of Figure 1 ;

[0062] Figures 6a-c show different positions of an adjustment ring of the module of Figure 1 ;

[0063] Figure 7 is a sectional view of the module of Figure 1 in a home position;

[0064] Figure 8 is a sectional view of the module of Figure 1 with a lifted adjustment ring;

[0065] Figure 9 is a sectional view of the module of Figure 1 with a depressed second portion;

[0066] Figures 10a-c show different positions of the legs of the module of Figure 1 ; and

[0067] Figure 11 shows an exploded view of a module according to a second embodiment of the present disclosure.

[0068] In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs.

[0069] Figures 1 to 3 show an exemplary embodiment of an electronic add-on module 100 suitable for releasable attachment to a user interface of a drug delivery device (not shown). The module 100 substantially comprises a first portion 101 and a second portion 102 which are coaxially arranged on a first longitudinal axis X. The first portion 101 comprises 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 having a rubber portion 109. The second portion 102 comprises a button housing 110, a printed circuit board assembly (PCBA) 111 , a battery 112 and a bumper 113.

[0070] The main housing 103 is a sleeve-like component with an inwardly protruding, ring-shaped web 114. The outer surface of the main housing 103 may be structured, e.g. by ribs and / or grooves as depicted, to facilitate gripping and rotating the main housing 103. When attached to a drug delivery device, the main housing 103 forms an auxiliary dose dial user interface replicating a dose dial user interface, e.g. a dose dial grip, of the drug delivery device. The main housing 103 has three bearing holes 115 on its inner side, each defining a second axis Y parallel to the main longitudinal axis X. These bearing holes 115 receive bearing pins of the respective legs 108 such that the legs 108 are free to swivel about the respective axes Y. The end ring 104 may be snapped onto the distal side of the main housing 103 facing towards the drug delivery device after mounting the legs 108 into the main housing 103. The end ring 104 may comprise three bearing holes for receiving the distal ends of bearing pins of the legs 108.

[0071] Each leg 108 is substantially arch-shaped with the bearing pin on one end and a free opposite end as shown in Figures 4a and 4b. The radially inwards facing side of each leg 108 may have an overmolded rubber portion 109, e.g. with a hardness of 50 shore-A. The radially outwards facing side of each leg 108 is wedge-shaped, i.e. inclined such that the side facing towards the bearing pin is thinner than the side of the free end. A distally facing bead of the leg 108 may have a uniform thickness, i.e. only a portion of the leg may be wedge-shaped.

[0072] The first (lower in Figure 3) adjustment ring 105 comprises three radially inwardly protruding 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 with the bosses 116 formed as internal ribs. Figures 5a and 5b depict the main housing 103 (partially transparent) with only one leg 108 and the first adjustment ring 105. A boss 116 extends in the radial space between leg 108 and main housing 103 thereby abutting the wedge-shaped outer side of leg 108. Rotating the first adjustment ring 105 with respect to the main housing 103 and the leg 108 from the position depicted in Figure 5a to the position depicted in Figure 5b thus forces the free end of the leg 108 with the overmolded rubber portion 109 to pivot radially inwards as the boss 116 slides along the wedge- shaped outer side of the leg 108. An opposite rotation would allow the leg 108 to pivot back into the position of Figure 5a. As depicted in Figures 10a, 10b and 10c this radial movement of the free ends of the legs 108 widens or narrows the inner diameter of the module 100. In other words, by pivoting the free ends of the legs 108 inwardly or outwardly, the module 100 can be adapted to different dimensions of user interfaces of different drug delivery devices. Typically, the inner diameter may be adjusted in a range between about 14.5mm to about 19mm.

[0073] Further, the first adjustment ring 105 comprises proximally facing teeth 117 for mating engagement with distally facing recesses 118 in the second (upper) adjustment ring 106. Teeth 117 and recesses 118 are always in engagement, thereby rotationally constraining the first and second adjustment rings 105, 106 while permitting small relative axial movement as shown in Figure 6a. In other words, the second adjustment ring 106 may be lifted from the position shown in Figure 6c to the position shown in Figure 6b. Spring 107 has a plate-like form and is clamped between the web 114 of the main housing 103 and the second portion 102. Lateral protrusions of spring 107 are fixed in the second adjustment ring 106. Thus, spring 107 is elastically deflected when second adjustment ring 106 is lifted (see Figure 8) from a home position (see Figure 7). In other words, spring 107 biases second adjustment ring 106 back into the home position where teeth 117 fully engage with recesses 118.

[0074] The second adjustment ring 106 has a proximal bead radially protruding over main housing 103 in order to allow a user to grip and lift the second adjustment ring 106. A peg 119 is provided on the distal face of the bead of second adjustment ring 106 and the main housing 103 comprises three proximally facing recesses 120 adapted to each receive peg 119. In other words, peg 119 and recesses 120 define three dedicated relative rotational positions between the second adjustment ring 106 and the main housing 103. These three dedicated positions correspond to three predefined inner diameters of the module, e.g. 17.8mm, 16.2mm and 14.6mm, defined by legs 108.

[0075] The second portion 102 is partially retained in the cavity of the first portion 101 , specifically by the cavity of the second adjustment ring 106. The button housing 110 of the second portion 102 has an enlarged upper portion which encases the PCBA 111 and the battery 112 and a smaller lower portion which extends towards the web 114 of the main housing 103. The bumper 113 extends through the web 114 an comprises snap arms for attaching into the button housing 110, thereby restricting the relative axial movement of the second portion 102 relative to the first portion 101.

[0076] Spring arms provided on spring 107 abut the button housing 110 such that the second portion 102 is biased into the home position depicted in Figure 7 relative to the first portion 101. The second portion 102 may be pressed by a user into the first portion 101 against the force of the spring arms as shown in Figure 9. Thus, the button housing 110 forms an auxiliary injection user interface. By pressing the second portion 102 into the first portion 101 , the bumper 113 is moved distally with respect to the main housing 103. Thus, bumper 113 may exert pressure on a user interface, e.g. a dose button, of a drug delivery device when the module 100 is attached to a drug delivery device.

[0077] The PCBA 111 may comprise or form a control unit, a sensor arrangement and / or a communication unit. Preferably, the PCBA 111 comprises an acoustic sensor for detecting clicking sounds generated by a drug delivery device when attached to the module 100. Further, the control unit preferably determines the amount of medicament dispensed from the drug delivery device on the basis of the clicking sounds detected by the sensor. This data may be transmitted to an external device by means of the communication unit.

[0078] To adjust the clamping diameter of the module 100, the legs 108 are turned around the respective axes Y by a small angle. This moves the rubberized part 109 of the legs 108 nearer to or farer from the center line X of the module 100. The movement is forced by the first (lower) adjustment ring 105 which is movable + / 30°, i.e. in total about 60°. The first adjustment ring 105 is actuated by the second (upper) adjustment ring 106. This second adjustment ring 106 must be turned by hand. To set the correct clamping mechanism diameter for dedicated insulin pens the recesses 120 form three idents in the main housing 103 where the second adjustment ring 106 is locked. The second adjustment ring 106 must be lifted by hand, afterwards turned and is then forced back into the idents when released. The force to set the second adjustment ring 106 back is provided by the spring-plate 107. The same spring plate 107 generates a resistance when pressing the button housing 110 down. This button housing 110 is pressed to trigger the injection. The button housing 110 also serves as housing for the electronics. The bumper 113 assures the correct distance between button housing 110 and the second adjustment ring 106 to hold the spring plate 107 at a certain preload. The bumper 113 also ensures that the parts stay in the main housing 103.

[0079] Figure 11 shows a further example of a module 100 according to the present disclosure. The working principle of the first portion 101 and the second portion 102 is substantially the same as described above for the first example. However, this module further comprises a switch or wake-up mechanism.

[0080] To extend the battery 112 lifetime the status of the electronics may be set into a sleep mode. The module 100 may be able to measure the dose volume preset for injection. One possible measurement technology could be realized with a microphone in the electronics button housing 110 and counting the generated clicks when up dialing the dose volume. To make the microphone operational a wake-up functionality has to be installed to set the electronics into recording mode before the first click is generated by the insulin pen mechanics.

[0081] The wake-up mechanism consists of a spring-loaded clutch 121 surrounding the main housing 103, a sectional magnetized ring 122 and a small magnetic sensor 123, e.g. a hall sensor, inside the electronics button housing 110. The clutch comprises two parts attached to the main housing 103 by a spring 124 and guided by ball bearings 125. The spring-loaded clutch 121 is always forced into an idle or home position when no momentum is applied by the user. When the user starts the dialing up process the clutch 121 and the magnetized ring 122 are rotated for about 30°- 60° relative to the main housing 103 without transforming the momentum to the main housing 103 of the module.

[0082] The movement of the magnetized ring 122 will be detected by the magnetic sensor 123 and this starts the recording process of the electronics. This arrangement of the elements allows that the magnetic sensor 123 in the button housing 110 to stay anywhere within 360° around the middle axis X of the module.

[0083] After the first rotation of 30°- 60° of the clutch 121 the momentum is transferred by the main housing 103 to the dial grip of the drug delivery device (not shown) and the up dialing and click generation starts.

[0084] Reference Numerals

[0085] 100 electronic add-on module

[0086] 101 first portion

[0087] 102 second portion

[0088] 103 main housing

[0089] 104 end ring

[0090] 105 first (lower) adjustment ring

[0091] 106 second (upper) adjustment ring

[0092] 107 spring plate

[0093] 108 leg

[0094] 109 rubber portion

[0095] 110 button housing

[0096] 111 PC BA

[0097] 112 battery

[0098] 113 bumper

[0099] 114 web

[0100] 115 bearing hole

[0101] 116 boss

[0102] 117 tooth

[0103] 118 recess

[0104] 119 peg

[0105] 120 recess

[0106] 121 clutch

[0107] 122 magnetized ring

[0108] 123 sensor

[0109] 124 spring

[0110] 125 ball bearing

[0111] X first Longitudinal axis (of the first portion)

[0112] Y second longitudinal axis

Claims

Claims1. An electronic add-on module (100) configured for attachment to a drug delivery device, the electronic add-on module comprising a first portion (101) with a main housing (103) defining a first longitudinal axis (X), characterized in that, the first portion (101) comprises 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) can be transferred from a radially outer position with respect to the first axis (X) to a radially inner position, and wherein the adjustment mechanism comprises 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 that the portion (109) of the leg (108) is transferred from the radially outer position with respect 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 pivot-mounted in the main housing (103) such that a portion (109) of the leg (108) can be pivoted about a second longitudinal axis (Y) which is parallel to the first axis (X) from a radially inner position with respect to the first axis (X) to a radially outer position and vice versa.

3. The electronic add-on module (100) according to claim 1 or 2, wherein the first adjustment element (105) is an adjustment ring rotatably guided in the main housing (103) and cooperating with the at least one leg (108) such that rotation of the first adjustment element (105) relative to the main housing (103) causes that the portion (109) of the leg (108) is transferred from the radially outer position with respect 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 adjustment element (105) comprises at least one radially inwardly protruding boss (116) which acts on the at least one leg (108) upon movement of the first adjustment element (105) 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) comprises a wedge-shaped surface abutting the first adjustment element (105) at least during movement of the first adjustment 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) comprises an overmolded rubber portion (109).

7. The electronic add-on module (100) according to any one of the preceding claims, wherein the first portion (101) comprises the main housing (103), three legs (108) each pivotmounted in the main housing (103) about different second longitudinal axes (Y) and the adjustment mechanism.

8. The electronic add-on module (100) according to any one of claims 3 to 7, wherein the adjustment mechanism comprises the first adjustment ring (105) and a second adjustment ring (106) which are rotationally constrained to each other by a splined engagement permitting axial movement of the second adjustment ring (106) relative to the first adjustment ring (105).

9. The electronic add-on module (100) according to claim 8, wherein the first portion (101) further comprises a spring element, for example a spring plate (107), biasing the second adjustment ring (106) axially towards the first adjustment ring (105).

10. The electronic add-on module (100) according to any one of claims 8 to 9, wherein the main housing (103) comprises at least two recesses (120) at circumferentially spaced positions, and wherein the second adjustment ring (106) comprises at least one peg (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 dial user interface (103; 121) configured to be attached to a dose dial user interface of the drug delivery device, such that the first portion (101) follows the movement of the dose dial user interface and vice versa when attached to the drug delivery device, and wherein the module (100) further comprises a second portion (102) coupled to the first portion (101) allowing relative axial movement parallel to the first longitudinal axis (X) with respect to the first portion (101), wherein the second portion (102) defines an auxiliary injection user interface (110) configured to apply pressure onto an injection user interface of the drug delivery device.

12. The electronic add-on module (100) according to claim 11 , wherein second portion (102) is at least partially encased by and retained in the first portion (101) and comprises an electrical power source (112), a printed circuit board assembly (111), a sensor arrangement, for example an acoustic sensor arrangement and / or a and / or a vibrational sensorarrangement, configured to detect a feedback of 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 claims 9 and 11 or 12, wherein the spring element (107) biases the second portion (102) axially away from the first portion (101).

14. An assembly comprising a drug delivery device and an electronic add-on module (100) according to any one of the preceding claims configured for releasable attachment to the drug delivery device, wherein the drug delivery device comprises:• a device housing with a container configured to receive a drug or a cartridge filled with a drug,• a dose setting unit comprising a dose dial user interface at least rotationally moveable with respect to the device housing during dose setting and an injection user interface at least axially moveable with respect to the device housing for causing dose dispensing, and• a dose delivery unit comprising a plunger at least axially moveable with respect to the device housing during dose dispensing, characterized in that the position of the portion (109) of the at least one leg (108) is adapted to the outer the dose dial user interface of the drug-delivery device and in that the first portion (101) of the electronic add-on module (100) is adapted to be rotationally constrained to the dose dial user interface of the drug-delivery device by means of the portion (109) of the at least one leg (108).

15. The assembly according to claim 14, wherein the drug delivery device (1) further comprises a clicker mechanism generating an acoustic and / or vibrational feedback signal at least during dose setting.

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