Magnetized molded device component of an injection device or add-on device

Abstract

The present disclosure relates to a device component (80) of at least one of an injection device (1) and an add-on device (20; 120; 240) configured for fastening to the injection device (1), the device component (80) comprising: - a molded body (81) permanently magnetized or permanently magnetizable, the molded body (81) comprises a polymeric carrier material (82) and magnetized or magnetizable particles (83) embedded in the polymeric carrier material (82).

Description

[0001] Magnetized Molded Device Component of an Injection Device or Add-on Device

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of injection devices, e.g. pen-type injection devices for self-medication and / or to the field of add-on devices suitable for such injection devices. The disclosure also relates to injection systems comprising an injection device and a corresponding add-on device as well as to a method of manufacturing a device component to be used in at least one of the injection device and the add-on device.

[0005] Background

[0006] Drug delivery devices allowing for multiple dosing of a required dosage of a liquid medicinal product and further providing administration of such liquid drug to a patient, are as such well known in the prior art. Generally, such devices have substantially the same purpose as that of an ordinary syringe. Typically, a medicinal product to be administered is provided in a cartridge having a moveable piston or bung mechanically interacting with a piston rod of a drive mechanism of the drug delivery device. By applying thrust to the piston, a certain and predefined amount of the medicinal fluid is expelled from the cartridge.

[0007] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0008] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up.

[0009] There further exist electronic units, e.g. either integrated into such delivery or injection devices or provided as a separate device, also denoted as an add-on device, supplementary device or data collecting device. Such add-on devices provide additional functionality to an all- mechanically implemented drug delivery device or injection device. By way of an add-on device, repeated setting and / or dispensing or injecting of doses of the medicament can be monitored and logged over time. Add-on devices offer a large variety of supplemental functions for the regular use of drug delivery or injection devices. Add-on devices may offer data analysis and further communication of such data to health care providers. Such data being indicative about the amount of a medicament administered at a particular point of time or at a particular date.

[0010] Some add-on devices comprise a sensor arrangement by way of which a movement of a dedicated component of the injection device to which the add-on device is attached to can be detected and / or quantitatively measured. The movement of the dedicated device component may be indicative of at least one of setting of a dose and / or injecting of a dose. By detecting and / or quantitatively measuring such movements, the add-on device can monitor a user- induced operation of the injection device.

[0011] In some devices the sensor arrangement is of magnetic type. Here, the sensor arrangement is configured to measure the movement of a magnetized or magnetic component of the injection device or of the add-on device itself. Typically, the injection device and / or the add-on device comprises a number of injection molded plastic components. In order to detect or to measure a movement of a magnetic component it is indispensable to either attach or to embed a magnet to or inside a plastic component of the injection device or add-on device. The attachment or integration of a permanent magnet to or into an injection molded plastic component does not only require supplemental installation space but also comes along with a respective installation effort.

[0012] In view of the above it is desirable to improve the overall design of injecting devices and / or addon devices and to simplify manufacturing and assembly thereof. It is further desirable to reduce the size of injection devices and respective add-on devices and to provide these devices with a rather compact design. Moreover, it would be beneficial to enhance a degree of functionality of injection devices and of respective add-on devices.

[0013] Summary

[0014] In one aspect there is provided a device component of at least one of an injection device and an add-on device, wherein the add-on device is configured for fastening of fixing to the injection device. The device component comprises a molded body permanently magnetized or permanently magnetizable. The molded body comprises a polymeric carrier material and magnetized or magnetizable particles embedded in the polymeric carrier material. In other words, the device component may comprise a kind of a molded plastic magnet, which may substitute a conventional plastic component used or implemented in the injection device or addon device.

[0015] The device component itself may be magnetized or may be magnetizable so as to provide a desired magnetic field that could be detected by a sensor arrangement. By embedding magnetized or magnetizable particles in a polymeric carrier material the molded body itself may become magnetic and may resemble or provide a permanent magnet, which could be used in connection with a magnetic sensor arrangement with the injection device and / or add-on device, respectively. Since the magnetized or magnetizable particles are embedded in the polymeric carrier material a separate installation or assembly of a magnet to a plastic component is no longer required. Moreover, insert molding of magnetic parts in a plastic component can be also circumvented or avoided. Rather, the molded body may comprise a homogeneous distribution of magnetized or magnetizable particles in the bulk of the polymeric carrier material. The polymeric carrier material may provide a mechanical bond and / or a matrix to fix the magnetized or magnetizable particles therein.

[0016] The device component may consist of the molded body. Hence, the entirety of the device component may be manufactured by molding of the molded body. The device component and / or the molded body provides a rather large freedom of design. Hence, the molded body may adapt any desirable shape that can be provided by way of molding, e.g. injection molding.

[0017] In some examples, the device component is a single pieced component. It may be a single part of an injection device or of an add-on device.

[0018] Attaching, e.g. gluing, welding or otherwise fastening of a magnetized part to an injection molded plastic component of at least one of the injection device and the add-on device can be avoided thus allowing to reduce installation space and / or to reduce manufacturing effort.

[0019] According to a further example the magnetized or magnetizable particles comprise at least one of hard ferrite particles and rare earth-based magnetizable particles. Both, hard ferrite particles and rare earth-based magnetizable particles can be permanently magnetized, e.g. by exposing the molded body with the magnetizable particles therein in an external magnetized ring magnetic field. The magnetic domains of the magnetized or magnetizable particles will be oriented in accordance to the externally applied magnetic field. The hard ferrite particles and / or rare earth-based magnetizable particles are configured to maintain their magnetization even in the absence of the magnetizing magnetic field. This way, the molded body may provide or constitute a kind of a molded plastic magnet.

[0020] According to a further example the magnetized or magnetizable particles comprise at least one of of neodymium-iron-boron (NdFeB) particles, samarium cobalt (SmCo) particles, aluminum- nickel-cobalt (AINiCo) particles, strontium-ferrite (SrFe) particles, powdered ferrite particles, iron (Fe) particles or combinations thereof. Use of these materials is well-established in producing permanent magnets. Some of these materials may be sintered. Here, the sintered material may be granulized or powdered in order to provide magnetized or magnetizable particles of a required size that are suitable for embedding in the polymeric carrier material.

[0021] According to a further example the magnetized or magnetizable particles comprise an average size between 1 pm and 100 pm in the molded body. The average particle size may be selected or chosen in accordance to the magnetic properties of the magnetizable or magnetized particles. Also, the density of the magnetized or magnetizable particles inside the molded body, i.e. inside the surrounding polymeric carrier material may be adapted in accordance to the magnetic demands that have to be fulfilled by the molded body or by the respective device component.

[0022] According to a further example the polymeric carrier material comprises a thermoplastic material. Thermoplastic materials allow a straightforward and easy embedding of magnetized or magnetizable particles in the body of the molded body. Typically, the molded body may be molded on the basis of a mixture or material mixture of raw materials including thermoplastic raw materials and including magnetized or magnetizable particles mixed in the raw material of the thermoplastic material. The process of molding the body may include application of heat or thermal energy and / or pressure, such that the thermoplastic material becomes plastically deformable.

[0023] According to another example the polymeric carrier material comprises at least one of a Polyamide (PA), a Polypropylene (PP), a Polyphenylene sulfide (PPS) and a Polyether ether ketone (PEEK) or mixtures thereof.

[0024] According to a further example the molded body comprises 5 - 90 wt.-% of the polymeric carrier material and 10 - 95 wt.-% of magnetized or magnetizable particles. Here, the weight percentage of the polymeric carrier material plus the wight percentage of the magnetized or magnetizable particles is smaller than or equal to 100 wt.-% of the molded body. In some examples the molded body may consist of the polymeric carrier material and the magnetized or magnetizable particles. Accordingly, the higher the percentage of the magnetized or magnetizable particles in the molded body, the lower will be the percentage of the polymeric carrier material in the molded body; and vice versa.

[0025] According to a further example the molded body comprises 5 - 20 wt.-% of polymeric carrier material and 80 - 95 wt.-% of magnetized or magnetizable particles. Generally, and with a comparatively large degree of magnetized or magnetizable particles in the molded body, the magnetic properties of the molded body may be optimized and the molded body may more and more resemble a conventional sintered permanent magnet.

[0026] According to a further example the molded body is an injection molded body. Here, the raw materials, i.e. the polymeric carrier material and the magnetized or magnetizable particles may be mixed as a raw material mixture and may then be injected into a respective cavity of an injection mold or molding tool. The injection molding process may be accompanied by the application of heat, which may be required to plasticize the thermoplastic injection moldable polymeric carrier material.

[0027] In some examples the molded body is in-mold magnetized. Hence, the manufacturing of the molded body by way of injection molding may also provide and enable a magnetizing of the molded body while the molded body is molded or after the molded body has been molded but still remains in the injection mold.

[0028] Magnetizing the molded body may apply to the entirety of the molded body or only to selected parts or portions thereof. The degree and the specific configuration of a magnetization of the molded body may depend on and may be controlled by an externally applied magnetic field configured to magnetize the magnetizable particles inside the molded body.

[0029] According to a further example the molded body of the device component comprises one of a dipole magnet and a multipole magnet. Dipole magnets or multipole magnets may be implemented by applying a respective external magnetizing magnetic field to the molded body, which is provided with the magnetizable particles embedded in the polymeric carrier material. By way of a multipole magnet, and in particular by way of increasing a number of multipole magnets in the molded body the magnitude of the magnetic field emanating or generated by the molded body can be precisely defined and e.g. increased compared to a magnetic field emanating from a dipole magnet.

[0030] Compared to a conventional sintered permanent magnet the molded body may exhibit or provide a magnetic field of reduced magnetic remanence since the polymeric carrier material surrounding or embedding the magnetized or magnetizable particles may not contribute to the generation of the permanent magnetic field. However, by increasing the number of multipoles in the molded body the magnetic remanence may be increased and may even overcompensate a magnetic remanence deficit, which is caused by the contribution of the polymeric carrier material in the molded body compared to a conventional sintered magnet.

[0031] According to another example the device component and / or its molded body forms or constitutes at least one of a housing, an injection button, a dosage knob and a number sleeve of the injection device. Typically, the device component with its molded and permanently magnetized or permanently magnetizable body may be configured to substitute any conventional plastic component of an existing injection device, e.g. of a hand held pen-type injector. The molded body may be of the same size and may perfectly match the geometric dimensions of a substituted device component. Here and by way of embedding the magnetized or magnetizable particles in the polymeric carrier material of the molded body the device component can be magnetized and can provide a permanent magnetic field, which can be used for detecting or identifying the type of injection device and / or to detect a movement of a movable device component, e.g. in the course of one of setting of a dose and dispensing or injecting of a those.

[0032] According to another example the molded body or the device component itself forms or constitutes at least one of a first portion and a second portion of an add-on device. Here, the first portion is movable relative to the second portion. In this way, a movement of the first portion relative to the second portion can be magnetically detected.

[0033] In a further example the first portion of the add-on device is fixable to a first device portion of the injection device. The second portion of the add-on device is fixable to a second device portion of the injection device. The first device portion is movable relative to the second device portion during at least one of setting of a dose and injecting of a dose of a medicament. By fixing the first and second portions of the add-on device to respective first and second device portions of the injection device the first portion of the add-on device will be subject to a movement relative to the second portion of the add-on device during at least one of setting of the dose and injecting of the dose.

[0034] When at least one of the first portion and the second portion is magnetized, e.g. because it is implemented as a device component as described above, a magnetic sensor arrangement provided on the other one of the first portion and the second portion may be operable to detect and / or to quantitatively measure the degree of movement of the first component relative to the second component of the add-on device.

[0035] In some examples the first portion of the add-on device is rotatable relative to the second portion of the add-on device. In other examples the first portion of the add-on device is longitudinally displaceable relative to the second portion of the add-on device. In further examples the first portion of the add-on device is movable according to a screw motion relative to the second portion. Hence, it may be longitudinally displaceable and rotatable relative to the second portion.

[0036] There is no general restriction on the type of ferrite particles to be used for the molded body. Both, so-called low-energy and high-energy ferrites can be used. In particular, high-energy ferrite particles with a density of 5.0 to 5.2 g / cm3and an average particle size of 1.5 to 2.5 pm can be used, which may have a magnetic remanence of 155 to 180 mT and an intrinsic coercivity of 155 to 250 kA / m. In further examples, high-energy ferrites whose remanence is 165 to 180 mT and whose intrinsic coercivity is 180 to 250 kA / m can be used.

[0037] In further examples, the magnetized or magnetizable particles comprises soft magnetic particles based on iron powder, magnetite powder or also so-called soft ferrites, for example a manganese-zinc-ferrite powder or mixtures thereof, whereby iron powder provides a high saturation remanence.

[0038] When using iron powder, its average particle size may be smaller than 160 pm and its bulk density may range between 6.9 and 6.95 g / cm3. If magnetite powder is used, this can have, for example, a density of 5.1 g / cm3, a bulk density of approx. 2.5 g / cm3and typical particle sizes in the range between 5 and 25 pm with a Mohs hardness between 5.5 and 6.

[0039] Provided a Mn-Zn ferrite powder is used, its density may be, for example, 4.7 g / cm3with a bulk density of 1.8 g / cm3and an average grain size of between 1 and 100 pm.

[0040] According to a further example, the molded body is provided with or comprises a magnetic encoding, which is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device. Here, an injection device comprising the device component of the molded body may be magnetically encoded accordingly. The magnetic encoding may be readable or recognizable, e.g., by a magnetic sensor of an external electronic device, e.g., by a magnetic sensor of an add-on device configured for attachment to the injection device. In this way, the injection device may be permanently magnetically encoded by the device component and the respective magnetic encoding may be readable or recognizable by an add-on device, e.g., in the course of mutual assembly of the injection device and the addon device.

[0041] Here, different injection devices, e.g., equipped with different medicaments, may be differently magnetically encoded and can be hence magnetically distinguished by their magnetic encoding. According to another aspect the present disclosure also relates to an injection device for injecting a dose of a medicament. The injection device comprises a housing configured to accommodate a medicament container containing an injectable medicament. The injection device further comprises a drive mechanism to operably engage with the medicament container in order to expel or to withdraw the dose of the medicament from the medicament container and to inject the dose of the medicament into biological tissue, e.g. underneath the skin of a patient. At least one of the housing and a component of the drive mechanism is configured and implemented as a device component as described above.

[0042] When the housing of the injection device is implemented as a magnetized or magnetizable device component the housing itself may be provided with a magnetic encoding allowing to magnetically encode the housing and hence the entire injection device. By implementing the housing of the injection device as a molded body as described above allows to provide a magnetic encoding to the housing of the injection device, which may then be magnetically detected, e.g. by an add-on device, which is provided with a respective magnetic sensor arrangement. Here, the add-on device and / or its magnetic sensor arrangement may be configured to detect the magnetic encoding as provided by the housing of the injection device.

[0043] The magnetic sensor arrangement of the add-on device may be operable to distinguish between different the magnetically encoded housings of different injection devices, e.g. equipped with different types, different concentrations or different amounts of a medicament. This way, the housing of the injection device, in particular the at least partial magnetization of the housing of the injection device may provide a magnetic encoding, which can be detected and / or decoded by a magnetic sensor arrangement of an add-on device. In this way, a magnetically encoded drug delivery device or injection device can be automatically detected by attaching an add-on device to the respective injection device when the add-on device is equipped with a corresponding sensor arrangement capable to distinguish between differently magnetically encoded housings of such injection devices.

[0044] It may not only be the housing of the injection device but also any other component of the injection device, such as a dosage knob, an injection button or a number sleeve that may be magnetically encoded thus allowing to identify the type of injection device through a magnetic sensor arrangement of an add-on device to be attached to the respective injection device.

[0045] In some examples, the injection device may comprise numerous components that are implemented as magnetized molded plastic components with embedded magnetic particles. Hence, the injection device may comprise numerous device components as described above, each of which comprising specific magnetic properties.

[0046] In other examples the drive mechanism of the injection device is equipped with at least one device component as described above. Here, a movable part of the drive mechanism may comprise the molded body, which is magnetized and which can be therefore magnetically detected by the magnetic sensor arrangement of the add-on device. In further examples, the movable component of the drive mechanism is subject to a movement during at least one of setting of a dose and dispensing or injecting of a dose. Here, the magnetic sensor arrangement of the add-on device may be capable not only to detect a respective movement but also to quantitatively measure the degree of movement of the movable component of the drive mechanism during at least one of setting of the dose and dispensing or injecting of the dose. This way and by measuring the degree of movement the size of a dose actually set or injected can be precisely measured by the add-on device.

[0047] In another example the injection device is readily equipped with a medicament container arranged inside the housing of the injection device. The medicament container may be preinstalled inside the housing of the injection device. Here, the injection device may be implemented as a disposable injection device intended to become discarded in its entirety when the content of the medicament container has been used up or when the medicament container is empty. In other examples the medicament container may be interchangeably or replaceably arranged inside the housing of the injection device thus allowing to replace an empty medicament container.

[0048] According to a further example of the injection device, at least one of housing and the device component of the drive mechanism is provided with a magnetic encoding, which is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device. Here, for a first medicament there be provided a first magnetic encoding and for a second medicament, that distinguishes from the first medicament by at least one of the above-mentioned parameters, namely by at least one of a my concentration and an amount located inside the injection device, there may be provided a second magnetic encoding, which magnetically distinguishes from the first magnetic encoding. This way, different injection devices, e.g., equipped with different medicaments, can be differently magnetically encoded by suitably magnetically encoding at least device component of the injection device, e.g., by magnetically encoding the housing of the injection device.

[0049] According to another aspect the present disclosure also relates to an add-on device for attaching to an injection device. The injection device is configured for injecting a dose of a medicament. The injection device comprises a housing configured to accommodate a medicament container, wherein the medicament container contains an injectable medicament. The injection device further comprises a drive mechanism operably engaged or operably engageable with the medicament container in order to expel or to withdraw the dose of the medicament from the medicament container and to inject the dose of the medicament into biological tissue. The drive mechanism comprises a first device portion and a second device portion movable relative to the first device portion during at least one of setting of the dose and injecting of the dose.

[0050] The add-on device comprises a first portion fixable to the first device portion and a second portion fixable to the second device portion. The add-on device further comprises a device component as described above, which is fixed to or which is integrated into at least one of the first portion and the second portion. In some examples the other one of the first portion and the second portion comprises a magnetic sensor arrangement, which is capable to measure and / or to detect the presence of the magnetic field provided by the molded body of the device component as described above and / or to measure or to detect a movement of the device component or molded body.

[0051] In some examples the first device portion may be implemented as a dosage knob or dose dial rotationally provided at a proximal end of the injection device. The second device portion may be implemented as an injection button, protruding proximally from the rotatable dosage knob or dose dial. Here, and with further examples the first and the second device portion may be subject to a combined helical or rotational movement during the process of dose setting. During dose injection, it may be only the first device portion that is rotatable whereas the second device portion is prevented from rotating.

[0052] Then and due to the fixing of the first and second portions of the add-on device to respective first and second device portions of the injection device there will arise a rotation of the first portion relative to the second portion, e.g. during the process of dose injection or dose dispensing. By having one of the first portion and the second portion implemented as a device component as described above, which may be magnetically encoded there can be provided a magnetic sensor arrangement on the other of the first and the second portions of the add-on device to detect and / or to quantitatively measure a movement, e.g. a rotation between the first and the second portion of the add-on device.

[0053] In some examples, the add-on device may comprise numerous components that are implemented as magnetized molded plastic components with embedded magnetic particles. Hence, the add-on device may comprise numerous device components as described above, each of which comprising specific magnetic properties.

[0054] According to a further example the add-on device may be void of a device component as described above. Rather, the add-on device may comprise a magnetic sensor arrangement, which is configured to detect and / or to distinguish between differently magnetically encoded device components of the injection device, e.g., when attached to or engaged with the injection device.

[0055] According to a further aspect there is provided an injection system to inject a dose of a medicament and to record the dose injection. The injection system comprises an injection device. The injection device comprises a housing, which is configured to accommodate a medicament container containing an injectable medicament. In some examples the injection device may be provided with a respective medicament container, e.g. readily assembled inside the housing of the injection device. The injection device further comprises a drive mechanism to operably engage with the medicament container in order to expel or to withdraw the dose of the medicament from the medicament container and to inject the dose of the medicament into biological tissue. The injection system further comprises an add-on device for attaching, e.g. for a releasably attaching to the injection device. The add-on device comprises a magnetic sensor arrangement. At least one of the injection device and the add-on device comprises a device component as described above featuring a molded body which is permanently magnetized or which is permanently magnetizable and which comprises a polymeric carrier material and magnetized or magnetizable particles embedded in the polymeric carrier material.

[0056] Typically, the add-on device is an add-on device as described above. The add-on device may comprise a first portion fixable to a first device portion and may further comprise a second portion fixable to a second device portion of the injection device, wherein first and second device portions are subject to a relative movement during at least one of setting and injecting of the dose of the medicament. This way, and when duly attached to the injection device the first portion and the second portion of the add-on device are subject to a movement relative to each other, which movement can be detected and / or measured by the magnetic sensor arrangement of the add-on device when at least one of the first portion and the second portion is implemented as a device component as described above.

[0057] In other examples, wherein the injection device of the injection system is provided with a magnetized plastic component as described above, the add-on device may comprise a magnetic sensor arrangement, which is suitable or configured to detect and / or to quantitatively measure a movement of the magnetized or magnetic device component of the injection device.

[0058] In a further example, the injection system comprises a device component as described above. The device component is provided with a magnetic encoding, which magnetic encoding is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device or configured for or intended to be stored inside the injection device. The add-on device further comprises a magnetic sensor arrangement, which is capable to distinguish between differently magnetically encoded device components of the injection device. In this way, there can be provided numerous and differently configured injection devices, each of which being equipped with a different type, different concentration and / or a different amount of a particular medicament. According to the type, the concentration and / or the amount of medicament the respective injection device may be magnetically encoded, respectively. Here, the magnetic encoding may be indicative of at least one of the type, the concentration and the amount of the medicament located inside the injection device.

[0059] Here, the add-on device configured for attaching to the injection device, may be equipped with a magnetic sensor arrangement, which is capable to read the magnetic encoding and / or which is capable to distinguish between differently magnetically encoded device components of the injection device. In this way, it is possible to almost automatically detect a particular type of a medicament simply by reading or by recognizing the magnetic encoding of a device component of the injection device, e.g., in the course of a mutual assembly of the injection device and the add-on device.

[0060] According to another aspect there is also provided a method of manufacturing a device component as described above. The method comprises the step of providing a molding tool, e.g. an injection molding tool. The method further comprises the step of preparing a moldable material mixture comprising a polymeric carrier material and magnetized or magnetizable particles as described above. In a further step the molded body of the device component is molded. Here, the moldable material mixture is molded in the molding tool to form the molded body with the magnetized or magnetizable particles embedded in the polymeric carrier material. Optionally, the molded body may be magnetized during the molding procedure and / or after completion of the molding procedure while remaining in the molding tool. This way there can be provided an in-mold magnetization. Generally, magnetization can be provided by applying a magnetic field inside the cavity of the molding tool.

[0061] Such an in-mold magnetizing procedure is beneficial in that the molded body can be directly magnetized while being in the mold. Opening the mold and demolding the molded body may then inherently provide the device component, which is readily magnetized to a desired degree and / or in accordance to a desired magnetic design or structure.

[0062] The molded plastic device component as described herein provides the advantage that installation space or geometric dimensions required so far for a respective component plus a separate magnet can be reduced. Moreover, existing plastic components can be substituted by an identically shaped magnetic molded plastic component, which has no effect on the overall function or constitution of the respective component in an injection device or add-on device. The resulting compact design is therefore beneficial for a user of the injection device or add-on device. The molded magnetized or magnetizable plastic component may also have a significant impact on a reduction of the manufacturing costs and manufacturing effort.

[0063] Generally, the scope of the present disclosure is defined by the content of the claims. The injection device, the add-on device and the device component are not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0064] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

[0065] 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.

[0066] 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.

[0067] 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., shorter 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 dualchamber 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 dual-chamber 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.

[0068] 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 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0069] 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 dipeptidyl 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.

[0070] 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.

[0071] 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- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; 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- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0072] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, 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, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0073] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0074] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0075] 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.

[0076] 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).

[0077] 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.

[0078] 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.

[0079] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0080] 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. 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.

[0081] 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), needlebased 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.

[0082] 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).

[0083] 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).

[0084] Brief description of the drawings

[0085] In the following, numerous examples of the device component, of an injection device and an add-on or data collecting device will be described in greater detail by making reference to the drawings, in which:

[0086] Fig. 1 is a principal illustration of a device component comprising a dipole magnetic structure, Fig. 2 shows another example of a device component featuring a multipolar magnetic structure,

[0087] Fig. 3 shows another example of a molded magnetic component,

[0088] Fig. 4 shows a further example of a molded magnetic device component,

[0089] Fig. 5 shows another example of a molded magnetic device component,

[0090] Fig. 6 schematically illustrates a measurement of a movement of the magnetized device component relative to a magnetic sensor arrangement,

[0091] Fig. 7 shows a further example of a magnetic sensor arrangement in combination with a multipole magnet,

[0092] Fig. 8 shows a further example of a magnetic sensor arrangement in combination with a dipole magnetic component,

[0093] Fig. 9 schematically shows an injection system comprising an injection device and an add-on device,

[0094] Fig. 10 shows a schematic example of an add-on device for fastening to a body or housing of an injection device,

[0095] Fig. 11 shows a further schematic example of an add-on device configured for fastening to a proximal end of the injection device,

[0096] Fig. 12 shows an example of an injection device,

[0097] Fig. 13 shows the process of assembly, attaching or fixing the add-on device to the proximal end of the injection device,

[0098] Fig. 14 shows another example of the add-on device attached to the proximal end of the injection device,

[0099] Fig. 15 shows a cross-section through a proximal portion of an injection system, wherein the add-on device is attached to the proximal end of the injection device,

[0100] Fig. 16 shows a perspective and partially cut view of another example of an add-on device attached to the injection device,

[0101] Fig. 17 shows a further example of an add-on device attached to the proximal end of an injection device,

[0102] Fig. 18 is a block diagram of numerous components of an example of an add-on device,

[0103] Fig. 19 schematically illustrates a molding tool for producing or manufacturing a magnetized plastic device component and

[0104] Fig. 20 is a flowchart of a method of manufacturing a device component as described herein.

[0105] Detailed description.

[0106] In Figs. 1-5 numerous examples of a device component 80 of one of an injection device 1 and an add-on device 20 for fastening to the injection device 1 are schematically illustrated. The device component 80 as illustrated comprises a molded body 81, which is permanently magnetized or permanently magnetizable. The molded body 81 comprises a polymeric carrier material 82 and magnetized or magnetizable particles 83 that are embedded in the polymeric carrier material 82. In some examples the magnetized or magnetizable particles 83 comprise at least one of hard ferrite particles and rare earth-based magnetized or magnetizable particles. The magnetized or magnetizable particles may comprise at least one of neodymium-iron-boron (NdFeB) particles, samarium cobalt (SmCo) particles, aluminum-nickel-cobalt (AINiCo) particles, strontium-ferrite (SrFe) particles, powdered ferrite particles and iron (Fe) particles and mixtures thereof.

[0107] In some examples the magnetized or magnetizable particles comprise an average size between 1 pm - 100 pm in the molded body 81.

[0108] In some examples the polymeric carrier material 82 comprises a thermoplastic material. The carrier material 82 may comprise at least one of a polyamide, a polypropylene, a polyphenylene sulfide and a polyether ether ketone or mixtures thereof.

[0109] According to some examples the molded body 81 comprises 5 - 20 wt.-% of polymeric carrier material and 80 - 95 wt.-% of magnetized or magnetizable particles. This way and by increasing the percentage of the magnetized or magnetizable particles above 50 wt.-% in the molded body a comparatively strong magnetic field may be provided or generated by the molded body.

[0110] As indicated in the examples of Figs. 1 and 3 the molded body 81 comprises a dipole magnet 84 with a magnetic south pole S and a magnetic north pole N. The molded body 81 according to Fig. 1 is of cuboid or cubic shape and comprises or constitutes a cuboid 86. The device component 80 and hence the molded body 81 according to Fig. 3 is of cylindrical or disc-like shape and comprises or constitutes a cylinder or disc 88. In the example according to Fig. 2 the molded body 81 is of elongated shape and comprises a multipole magnet 85. It may comprise a longitudinal rod 87. Here, consecutive portions of the molded body 81 located adjacently next to each other along a longitudinal direction of the molded body 81 are alternatively magnetically poled.

[0111] In the example of Fig. 4 the molded body 81 comprises a tubular - shaped sleeve 89 comprising an outside surface, which is alternately magnetically encoded in circumferential and / or longitudinal directions. Here, a multipole magnetic structure, e.g. an alternating sequence of magnetic north poles N and magnetic south poles S is arranged along the circumference of the outside surface of the sleeve 89. In the example of Fig. 5, the device component 80 comprises an annular ring 89a, which is implemented as a multipole magnet 85. Here, the multipole magnet 85 comprises four individual dipole magnets 84, 84’, 84”, 84”’, each arranged at an offset of 90° as seen along a circumferential direction of the ring 89a. The individual dipole magnets 84, 84’, 84”, 84’” comprise north and south poles separated in radial direction. Also, and as seen in circumferential direction the dipole magnets 84 are oppositely poled with regard to the radial direction compared to the neighboring dipole magnet 84', 84"'. Likewise, the dipole magnet 84" is oppositely poled compared to the polarization of the dipole magnets 84', 84'" that are located adjacently as seen in circumferential direction.

[0112] In principle, the device component 80 may adapt any conceivable geometric shape, that is producible by injection molding. For producing the device component 80 as schematically illustrated in any of the Figs. 1-5, there may be provided a molding tool 90 as shown in Fig. 19. The molding tool 90 comprises a lower mold part 92 and an upper mold part 93. There may be provided a cavity 94 in at least one of the upper and the lower mold parts 92, 93 that serves to receive a material mixture 91. The material mixture may comprise raw materials including a polymeric carrier material 82 and further including magnetized or magnetizable particles 93.

[0113] The magnetized or magnetizable particles 93 are typically homogeneously mixed or homogeneously distributed in the raw polymeric carrier material 82. Once the material mixture 91 is duly prepared it may be filled or injected into the cavity 94, e.g. by applying heat and / or pressure. This way, the molded body 81 can be produced, e.g. by way of injection molding. During and / or after completion of the molding procedure there may be applied an external magnetizing magnetic field to the molding tool 90 by way of which the magnetizable particles 83 embedded in the molded body 81 can be magnetized in accordance to the magnitude or geometry of the externally applied magnetic field. In this way, the device component 80, in particular the molded body 81, can be magnetized to a desired degree. Finally, the molding tool 90 can be opened, e.g. by lifting the upper mold part 93 thereby providing access to the cavity 94. The molded body 81 can then be demolded or removed from the molding tool 90.

[0114] The process of manufacturing and producing the device component 80 is further illustrated in the flowchart according to Fig. 20. In a first step 300 there is provided the molding tool 90. In step 302 the material mixture 91 to be inserted into the molding tool 94 is prepared. Here, the magnetized or magnetizable particles 83 are mixed with the raw polymeric carrier material 82. The so-prepared material mixture 91 is then filled into the cavity 94 of the molding tool 90 in step 304. Optionally, in step 304 there is applied thermal energy to the molding tool 90 in order to enable a respective molding, e.g. injection molding of the material mixture 91. Optionally and in step 306 the molded body 81 located inside the molding tool 90 can be magnetized, e.g. by applying a suitable magnetizing magnetic field, which may penetrate the material of the molding tool 90. Thereafter and in step 308 the molded body 81 is removed from the molding tool 90.

[0115] The device component 80 may be regarded as a molded permanently magnetized plastic component. It is generally suitable to replace any injection moldable component of the injection device 1 and / or of an add-on device 20 as will be described below. Generally, the device component 80 may be implemented in any conceivable or suitable geometric form and may replace or substitute any injection molded component or part of the injection device 1 and / or of the add-on device 20. In some examples the device component 80 with its molded body 81 may comprise a permanent magnetic encoding as e.g. illustrated in the example of Fig. 7. Here, the device component 80 as implemented in the injection device 1 or as implemented in the add-on device 20 may cooperate with at least one magnetic sensor arrangement 51 located in close vicinity to the movable device component 80.

[0116] The magnetic sensor arrangement may comprise a magnetometer. It may comprise one of a Hall sensor, a microelectromechanical systems (MEMS) device for detecting and measuring magnetic fields, a magneto-diode, a magneto-transistor, an AMR magnetometer, a GMR magnetometer, a magnetic tunnel junction magnetometer, a magneto-optical sensor, a Lorentz force based MEMS sensor, an Electron Tunneling based MEMS sensor, a MEMS compass, a fluxgate magnetometer, a search coil magnetic field sensor and a SQUID magnetometer

[0117] In this way and when the device component 80 is subject to a movement, e.g. subject to a rotation, there will arise a varying magnetic field at the sensor arrangement 51, 5T, which can be then evaluated by electronic components connected to the sensor arrangement 51 in order to quantitatively measure a degree of rotation of the device component 80 relative to the sensor arrangement 51. Generally, the sensor arrangement may comprise one or more individual sensors as indicated by the references 51 and 5T in Figs 7 and 8.

[0118] In Fig. 8 the device component 80 comprises a dipole magnet 84. Here, the magnetic sensor arrangement 51 may be configured to detect such a dipole magnet or may be also configured to detect other, characteristic multipole magnetic encodings of the device component 80. Here, the device component 80 may be implemented as a tubular - shaped housing 10 of the injection device 1. The housing 10 may be provided with a respective magnetic encoding as defined by the permanent magnetization of the respective device component 80. The magnetic sensor arrangement 51 may be still provided or integrated into the add-on device 20. By attaching the add-on device 20 to the injection device 1 the magnetic sensor arrangement 51, 5T may be capable to distinguish between different types of magnetic encodings, as e.g. indicated in Fig. 8 in form of a dipole 84 type magnetic encoding 78 and as indicated in Fig. 7 in form of a magnetic multipole 85 encoding 78.

[0119] This way, e.g. the housing 10 or any other injection moldable plastic component of the injection device 1 may be magnetically encoded, the magnetic encoding may be associated with a specific medicament or injecting device and may thus characterize a specific medicament or injection device, thus allowing to automatically detect the type of medicament or type of injection device when connected with the add-on device 20.

[0120] In the example of Fig. 9, the injection device 1 comprises a drive mechanism 8 comprising at least one movable component, e.g. a number sleeve 70. The number sleeve 70 may be subject to at least one of a rotational, a longitudinal or helical movement during at least one of setting of a dose and injecting of a dose of the medicament from the injection device 1. The number sleeve 70 may be implemented as a magnetized device component 80' as described herein. The add-on device 20, which is configured for fastening or fixing to a proximal end of the injection device 1, e.g. to a dosage knob 12 or injection button 11, is equipped with the magnetic sensor arrangement 51 , which is suitable to detect or to quantitatively measure a movement of the device component 80'.

[0121] In addition or alternative to the magnetic implementation of a number sleeve 70 it is also conceivable that at least one of the dosage knob 12 and the injection button 11 is implemented as a device component 80 as described herein comprising a molded body 81 with a polymeric carrier material 82 and magnetized or magnetizable particles 83 embedded in the polymeric material 82. Here and as described above, by attaching or fixing the add-on device 20 to at least one of the dosage knob 12 and the injection button 11 the magnetic sensor arrangement 51 may become suitable to either detect a magnetic structure of the magnetized device component 80 and / or to detect or to quantitatively measure a movement of e.g. the dosage knob 12 relative to at least one of the injection button 11 and the housing 10.

[0122] In the example of Fig. 10 the add-on device 20' may be equipped with a magnetic sensor arrangement 51. The add-on device 20' may be configured or may be suitable for an attachment to a sidewall of the housing 10 of the injection device 1. Here, the magnetic sensor arrangement 51 may be located in close vicinity of a magnetized device component 80', e.g. the number sleeve 70 or any other movable component of the dosing or drive mechanism 8 of the injection device 1. This way and as long as the add-on device 20' is duly attached to the sidewall of the housing 10 of the injection device 1 as shown in Fig. 9 the magnetic sensor arrangement 51 may be capable to detect and / or to quantitatively measure a movement of the magnetic device component 80', e.g. relative to the housing 10.

[0123] In the example of Fig. 11 there is shown another example of an add-on device 20 comprising a first portion 23 and further comprising a second portion 24. Here, the second portion 24 is equipped with a magnetic sensor arrangement 51. The first portion 23 is movable relative to the second portion 24. In some examples the first portion 23 may be fixable to a dosage knob 12 provided at the proximal end of the injection device 1 and the second portion 24 may be fixable to the injection button 11. Typically, and during setting of a dose the dosage knob 12 and the injection button 11 may be subject to a common rotation or helical motion. During dispensing or injecting of the dose the injection button 11 may be rotationally locked to the housing 10 of the injection device 1 while the dosage knob 12 may be subject to a helical motion or rotational motion relative to the injection button 11 or housing 10.

[0124] The first portion 23 of the add-on device 20 may be rotationally fixed to the dosage knob 12 and the second portion 24 of the add-on device 20 may be rotationally fixed to the injection button 11. In this way and at least during dispensing or injecting of a dose of the medicament the first portion 23 may rotate relative to the second portion 24. Here, it may be of particular benefit that the first portion 23 comprises a device component 80 as described above with a molded body 81 comprising magnetized or magnetizable particles 83 embedded in a polymeric carrier material 82. Then, the rotation of the first portion 23 relative to the second portion 24 can be detected and / or quantitatively measured by the magnetic sensor arrangement 51 as provided in or on the second portion 24 of the add-on device 20.

[0125] The injection device 1 of Fig. 12 is a pre-filled, disposable injection pen that comprises a housing 10 and contains a medicament container 14, to which a needle 15 can be affixed. The needle 15 is protected by an inner needle cap 16 and either an outer needle cap 17 and / or a protective cap 18. An dose to be ejected from injection device 1 can be programmed, or 'dialed in' by turning a dosage knob 12, and a currently programmed dose is then displayed via dosage window 13, for instance in multiples of units. For example, where the injection device 1 is configured to administer human insulin, the dosage may be displayed in so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units may be employed in injection devices for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window 13 in Fig. 12. The dosage window 13 may be in the form of an aperture in the housing 10, which permits a user to view a limited portion of a number sleeve 70 that is configured to move when the dosage knob 12 is turned, to provide a visual indication of a currently programmed dose. The dosage knob 12 is rotated on a helical path with respect to the housing 10 when turned during programming.

[0126] In this example, the dosage knob 12 includes one or more formations 71a, 71b, 71c to facilitate attachment of an add-on device 20 or data collection device. The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 70 mechanically interacts with a piston in the medicament container 14. When the needle 15 is stuck into a skin portion of a patient, and then injection button 11 is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1. In this example, during delivery of the dose, the dosage knob 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 70 is rotated to return to its initial position, e.g. to display a dose of zero units.

[0127] Further details of such an example of an injection device 1 are apparent from one of the following documents WO 2004 / 078239 A1, WO 2004 / 078240 A1 or WO 2004 / 078241 A1, the entirety of which being incorporated herein by reference.

[0128] Figs. 13 and 14 are perspective views of one end of the injection device 1 when a add-on device 20 is attached. The add-on device 20 includes a housing 21 and an end plate 22 with an optional display 22a. The add-on device 20 may take one of a number of different forms or configurations as described below in connection with Figs 13 - 17.

[0129] Figure 15 is a cross-sectional view of the add-on or add-on device 20 when attached to the injection device 1. The add-on device 20 includes a first portion 23 and a second portion 24, where the first portion 23 is capable of rotational movement relative to the second portion 24. Further details of such an add-on device 20 or data collection device will be immediately apparent from document WO 2016 / 198516 A1 , the entirety of which being incorporated herein by reference.

[0130] In this particular example, the first portion 23 is a sleeve that is positioned over the dosage knob 12. The first portion may have formations 19 that co-operate with the formations 71a, 71b, 71c on the dosage knob 12. Whether or not the formations 19a-c are provided on the first portion 23, the arrangement is such that, when the first portion 23 is rotated by a user during programming of the dosage, the dosage knob 12 also rotates and such that, when the dosage knob 12 rotates during expulsion of medicament, the first portion 23 also rotates. Resilient padding, such as a foam rubber pad 44, may be provided within the formations 19 on the first portion 23, to allow for tolerances in the dimensions of the formations 19 on the first portion 23 and the formations 71a, 71b, 71c on the dosage knob 12 and / or to provide an engagement between the first portion 23 and the dosage knob 12 so that rotation of the first portion 23 causes rotation of the dosage knob 12 and vice versa.

[0131] Once the add-on device 20 is installed fully, further movement is prevented. This can be detected by the user through tactile feedback by providing the user with a step change from some relative movement to no relative movement as the proximal end of the dosage knob 12 abuts an abutting surface at the proximal end of the cavity in the first section 23 (see Fig. 16 for instance). The friction between the data collection device 20 and the dosage knob 12 causes the add-on device 20 to remain installed on the injection device 1. This can be achieved without any further mechanism to secure the add-on device 20 to the injection device, although the use of a further mechanism is not precluded. To uninstall the add-on device 20 from the injection device, the friction force needs to be overcome. This can be achieved by applying a strong pulling force, for instance of 30N or more, to the data collection device in the proximal direction.

[0132] To set a medicament dosage amount to be administered, the user may grip and rotate the first portion 23, since this will cause the dosage knob 12 of the injection device 1 to turn and, thereby, program the dosage amount. Also, in this particular example, the second portion 24 is a body located within the first portion 23, to which it is rotatably attached using bearings 25. The second portion 24 includes an outer portion 26, which includes the endplate 22 and optionally a display 22a. The second portion 24 also includes an inner portion 27. When the add-on device 20 is attached to the injection device 1 , the inner portion 27 overlies the injection button 11. The outer portion 26 and the inner portion 27 are attached by a fixture 28 that prevents rotation relative to each other. However, in this embodiment, the outer portion 26 can be moved axially relative to the inner portion 27 and one or more resilient members, such as springs 29, may be provided to bias the outer portion 26 away from the inner portion 27. The add-on device 20 is configured to detect axial movement of the outer portion 26 relative to the inner portion 27. Movement greater than a predetermined amount may be detected using a switch 53.

[0133] In this particular arrangement, first electrical contacts 30 are provided on the outer portion 26, while corresponding second electrical contacts 31 are provided on the inner portion 27. When a user presses the endplate 22, the outer portion 26 moves axially towards the inner portion, establishing a connection between the first and second electrical contacts 30, 31. Further pressure on the endplate 22 causes the inner portion 27 to press against, and activate, the injection button 11. The first and second electrical contacts 30, 31 provide a data connection between the processor arrangement 50 and display 22a when engaged.

[0134] Optionally, the add-on device 20 may be arranged to have a first configuration, in which rotation of the first portion 23 relative to the second portion 24 is prevented, and a second configuration, in which such rotation is unimpeded.

[0135] Figure 16 is an isometric cutaway view of a first alternative data collection device 240, which is a variation of the add-on device 20. The data collection device 240 of Fig. 16 includes a capsule 244, which is contained within the body of the data collection device 240. The capsule 244 itself contains a power source 54 or battery, in the form of a coin cell in this example, and a printed circuit board (PCB) 242. Mounted on the PCB are a number of electronic components including a communications interface 243, for instance a Bluetooth Low Energy chip or a Near Field Communications (NFC) chip. It also supports a switch 53 for detecting axial movement of the second portion 24. The PCB 242 further supports a sensor arrangement 51, which is configured to detect rotation of the first portion 23 relative to the second portion 24. In particular, the capsule 244 is fixed in rotation relative to the second portion 24 and rotates with the second portion 24 relative to the first portion 23 when the dose is being delivered.

[0136] The power source 54 provides power to the electronic components of the data collection device 240. The power source 54 is located distally to the PCB 242. The power source 54 is abutted by the distal end of the capsule 244 and by the PCB 242. The first portion 23 has three key structural elements. The first portion 23 may be formed as one part, or it may be formed of multiple parts that are connected together. A first element 246 of the first portion 23 is configured to engage with the dialing knob 12. A second element 247 is configured to engage with the dose delivery button 11. In particular, the second element 247 is configured to fit closely around the dose delivery button 11. The second element 247 helps to ensure correct axial alignment of the data collection device 240 on the injection device 1. The second element 247 may take the form of a ring. The second element 247 may have a low friction inner surface, so as not to impede movement of the dose delivery button 11 in the distal direction. The third element 248 is located at the proximal end of the first portion 23. The third element 248 extends radially inwardly. It also surrounds the second portion 24 in the radial direction.

[0137] The capsule 244 is movable in the axial direction within the cavity formed in the first portion 23. The capsule 244 is restrained in the proximal direction at the periphery of the capsule 244 by the third element 248 of the first portion 23. In the distal direction, the capsule 244 abuts the dose button 11. The second portion 24 is connected at its periphery to a proximal end of the capsule 244. A pillar 245 is provided at the center of the second portion 24 and extends axially. The pillar 245 is coincident with the switch 53, and may or may not contact it when no force in the distal direction is applied to the second portion 24. The center of the second portion 24 is slightly deformable in the distal direction. The switch 53 is configured to be operated upon movement of at least part of the second portion 24 relative to the first portion 23. A force required to operate the switch 53 is lower than a force required to cause medicament delivery from the injection device 1. By using operation of the switch 53 to trigger powering of components of the data collection device, the components of the data collection device will thus be powered before dose delivery commences.

[0138] Operation of the data collection device 240 will now be described. First, a user dials a dose into the injection device 1. This is achieved by the user rotating the first portion 23 of the data collection device 240. The rotational force is communicated to the dosage knob 12, which rotates also. The second portion 24 also rotates along with the first portion when the dose is being dialed. During dialing, the electronics on the PCB 242 are not powered.

[0139] Once the user has dialed the desired dose, they press the second portion 24 in order to start delivery of the dose, i.e. to cause injection. Initially, the second portion 24 deforms slightly and the center of the second portion 24 moves in the distal direction more than the periphery of the second portion 24, or put another way the center of the second portion 24 moves axially relative to the periphery of the second portion and axially relative to the first portion. This causes the pillar 245 to activate the switch 53. This causes the electronics on the PCB 242 to be powered and thus activated. Further movement of the second portion 24 is communicated into movement of the capsule 244 within the first portion 23. This is communicated to movement of the dose button 11 in the distal direction.

[0140] Once the dose button 11 has moved enough to permit dose delivery (which occurs by causing disengagement of a clutch, not shown, within the injection device 1), the dosage knob 12 begins to rotate relative to the dose button 11 as the dose delivery button is moved in the distal direction by action of the user. In particular, the dose delivery button 11 does not rotate relative to the housing 10 of the injection device 1, but the dosage button and the number sleeve 70 move helically (i.e. they move axially and rotate simultaneously). The first portion 23 thus rotates relative to the second portion 24. When the user ceases to press on the second portion 24, or when all of the dose is delivered, rotation of the first portion 23 relative to the second portion 24 ceases. The amount of rotation that occurred indicates the delivered dose. The amount of rotation is detected by the sensor 51 , and this is used to calculate the delivered dose. The delivered dose is then stored in memory, as is described below. Figure 17 is view of a third alternative data collection device 120, which is a variation of the add- one device 20. Here, reference numerals are retained from Figures 12, 15 and 16 for like elements unless otherwise stated.

[0141] In the Figure 17 data collection device 120, the second portion 24 is relatively large. Within the second portion 24, a spring 121 biases the power source (e.g. batteries) 54 against the proximal face of the PCB 242. A first collar 124 is directed in a distal direction from the distal end of the capsule 244. A second collar 125 extends distally from the distal end of the capsule 244. The second collar 125 is outside of the first collar 124, and they are concentric.

[0142] The second collar 125 and the second portion 24 have interoperating features that limit axial movement of the components relative to each other. In particular, one or more protrusions 228 fit into one or more indents 229. The movement of the second portion 24 relative to the capsule 244 is limited by the ends of the one or more indents 229 as regards the one or more protrusions 228. In this example, the protrusions 228 are provided on the second collar 125, and thus the capsule 244, and the indents 229 are provided on the second portion 24.

[0143] The first collar 124 snugly fits the dose button 11 , to assist in axial alignment between the data collection device 120 and the injection device 1 during delivery. A washer (not shown) may be provided between the first collar 124 and the dose button 11 , to improve contact between the components. The first collar 124 does not contact the first portion 23 during installation of the data collection device 120 nor during dose delivery.

[0144] The first portion 23 is provided with grip features 123. These allow a user to grip the first portion so as to provide torque and thus rotate the first portion when setting a dose. The grip features 123 provide surfaces that extend generally radially, to which the user can provide force to cause rotation of the first portion 23.

[0145] As can be seen from Figure 17, the first portion 23 is coupled to the second portion 24 by a connector arrangement 230, 231 , 228. In particular, the first portion 23 includes a first L section component 231 , which has an abutting surface facing in the distal direction. This is formed as part of the first portion 23. A second L section component 230, forming part of the second portion 24, is coupled to a support 232, which is coupled to the PCB 242, the first collar 124 and other components of the second portion 24. The second L section component 230 has an abutting surface facing in the proximal direction. The second L section component 230, and the other components that are coupled to it, are attached to the first section 23 during manufacture by application of a force to cause a snap fit such that the abutting surfaces of the first and second L section components 231, 230 are located together. The snap fitting of the second L section component 230 over the first L section component 231 is facilitated by a sloping face of the first L section component 231 , which faces slightly in the proximal direction.

[0146] During installation of the data collection device 120 on the injection device 1 , force is applied in an axial direction. During installation, the user is likely to apply force to the second portion 24. In this case, the force is communicated to the first portion, to result in fitting of the first portion 23 over the dosage knob 12, by the distal end of the third L section component 228, or more generally a main body 234, against a proximally facing surface 235 of the first portion 23. A spring force provided by the data collection device 120 forces the second portion 24 in the proximal direction relative to the first portion 23, after installation. This spring force is greater than a reaction force that is provided by the injection device 1 during dose delivery (the reaction force results primarily from friction from movement of internal components and hydrodynamic force resulting from medicament expulsion through the needle). Thus, the distal end of the third L section component 228, or more generally the main body 234, does not contact the proximally facing surface 235 of the first portion 23 during dose delivery.

[0147] Figure 18 is a block diagram of the add-on devices 20, 120, 240. The add-on device 20 includes a processor arrangement 50 including one or more processors, such as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like, together with memory units 52a, 52b, including program memory 52a and main memory 52b, which can store software for execution by the processor arrangement 50 and data generated during use of the data collection device such as counted pulses, derived dose size, time stamp, etc.. The switch 53 connects the power source 54 to the electronic components of the device, including the sensor arrangement 51 , when operated. The display 22a may or may not be present.

[0148] The first and second electrical contacts 30, 31 may provide a data connection between the processor arrangement 50 and display 22a when engaged.

[0149] A timer 55 is also provided. In addition to, or instead of, switching the add-on device 20 on and off, the switch 53 or the first and second electrical contacts 30, 31 may be arranged to trigger the timer 55 when engaged and / or disengaged. For example, if the timer 55 is triggered on both engagement or disengagement of the first and second electrical contacts 30, 31 ,, or both operation and ceasing of operation of the switch 53, then the processor arrangement 50 may use the output from the timer to determine a length of time during which the injection button 11 was pressed, for example to determine the duration of an injection. A sensor arrangement 51, comprising one or more sensors, is provided for detecting rotational movement between the first portion 23 and the second portion 24. The resolution of the sensing arrangement 51 is determined by the design of the injection device 1. A suitable angular resolution of the sensing arrangement 51 may be determined by an equation resolution = 360° I units_per_rotation.

[0150] For instance, if one full rotation of the dosage knob 12 corresponds to a medicament dosage amount of 24 units, then a suitable resolution for the sensing arrangement 51 would be not more than 15°.

[0151] In the example of Fig. 15, one or more first magnets 56a are provided on or along a circumference of the inner surface of the first portion 23 and one or more second magnets 56b are provided around a circumference of the outer surface of the second portion 24. The sensor arrangement 51 is a transducer that varies its output due to variations in the magnetic field, based on the Hall effect, as the first portion 23 and first magnets 56a rotate relative to the second portion 24 and second magnets 56b.

[0152] Specifically, each one the magnets 56a and 56b can be implemented by a device component 80 as described above. Hence, any one of the first portion 23 and the second portion 24 may be implemented as a molded body 81, which is at least in sections permanently magnetized. In this way, there is no need to attach or to assemble a separate magnet component to an injection molded plastic part.

[0153] Reference Numbers

[0154] I injection device

[0155] 3 device portion

[0156] 4 device portion

[0157] 5 injection system

[0158] 8 drive mechanism

[0159] 10 housing

[0160] I I injection button,

[0161] 12 dosage knob

[0162] 13 window

[0163] 14 container

[0164] 15 needle

[0165] 16 needle cap

[0166] 17 needle cap

[0167] 18 protective cap

[0168] 20 add-on device

[0169] 21 housing

[0170] 22 endplate

[0171] 22a display

[0172] 23 first portion

[0173] 24 second portion

[0174] 25 bearings

[0175] 26 outer portion

[0176] 27 inner portion

[0177] 28 fixture

[0178] 29 spring

[0179] 30 contact

[0180] 31 contact

[0181] 51 sensor arrangement

[0182] 52a memory

[0183] 52b memory

[0184] 53 switch

[0185] 54 power source

[0186] 55 timer

[0187] 78 magnetic encoding

[0188] 80 device component 81 molded body

[0189] 82 carrier material

[0190] 83 particle

[0191] 84 dipole magnet

[0192] 85 multipole magnet

[0193] 86 cuboid

[0194] 87 rod

[0195] 88 disc

[0196] 89 sleeve

[0197] 89a ring

[0198] 90 molding tool

[0199] 91 material mixture

[0200] 92 mold part

[0201] 93 mold part

[0202] 94 cavity

[0203] 120 data collection device

[0204] 121 spring

[0205] 124 collar

[0206] 125 collar

[0207] 228 component

[0208] 230 component

[0209] 231 component

[0210] 232 support

[0211] 234 main body

[0212] 235 surface

[0213] 240 data collection device

[0214] 242 PCB

[0215] 243 communications interface

[0216] 244 capsule

[0217] 245 pillar

[0218] 246 element

[0219] 247 element

[0220] 248 element

Claims

PAT23283-WO-PCTClaims1. A device component (80) of at least one of an injection device (1) and an add-on device (20; 120; 240) configured for fastening to the injection device (1), the device component (80) comprising: a molded body (81) permanently magnetized or permanently magnetizable, the molded body (81) comprises a polymeric carrier material (82) and magnetized or magnetizable particles (83) embedded in the polymeric carrier material (82).

2. The device component (80) according to claim 1, wherein the magnetized or magnetizable particles (83) comprise at least one of hard ferrite particles and rare earth-based magnetizable particles.

3. The device component (80) according to any one of the preceding claims, wherein the magnetized or magnetizable particles (83) comprise an average size between 1 pm - 100 pm in the molded body (81).

4. The device component (80) according to any one of the preceding claims, wherein the polymeric carrier material (82) comprises a thermoplastic material.

5. The device component (80) according to any one of the preceding claims, wherein the polymeric carrier material (82) comprises at least one of a Polyamide, a Polypropylene, a Polyphenylene sulfide and a Polyether ether ketone or mixtures thereof.

6. The device component (80) according to any one of the preceding claims, wherein the molded body (81) comprises 5 - 90 wt. % of polymeric carrier material (82) and 10 - 95 wt.% of magnetized or magnetizable particles (83).

7. The device component (80) according to any one of the preceding claims, wherein the molded body (81) comprises 5 - 20 wt. % of polymeric carrier material (82) and 80 - 95 wt.% of magnetized or magnetizable particles (83).

8. The device component (80) according to any one of the preceding claims, wherein the molded body (81) is an injection molded body.

9. The device component (80) according to claim 7, wherein the molded body (81) is inmold magnetized.

10. The device component (80) according to any one of the preceding claims, wherein the molded body (81) comprises one of a dipole magnet (84) and a multipole magnet (85).

11. The device component (80) according to any one of the preceding claims, wherein the molded body (81) forms or constitutes at least one of a housing (10), an injection button (11), a dosage knob (12) and a number sleeve (70) of the injection device (1).

12. The device component (80) according to any one of the preceding claims, wherein the molded body (81) forms or constitutes at least one of a first portion (23) and a second portion (24) of an add-on device (20; 120; 240), wherein the first portion (23) is movable relative to the second portion (24).

13. The device component (80) according to any one of the preceding claims, wherein the molded body (80) is provided with a magnetic encoding, which is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device (1).

14. An injection device (1) for injecting a dose of a medicament, the injection device comprising: a housing (10) configured to accommodate a medicament container (14) containing an injectable medicament, a drive mechanism (8) to operably engage with the medicament container (14) to expel or to withdraw the dose of the medicament from the medicament container (14) and to inject the dose of the medicament into biological tissue, wherein at least one of the housing (10) and a component (11 , 12, 70) of the drive mechanism (8) is a device component (80) according to any one of the preceding claims.

15. The injection device (1) according to claim 14, wherein at least one of the housing (10) and the device component (11, 12, 70) of the drive mechanism (8) is provided with a magnetic encoding, which is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device (1).

16. An add-on device (20; 120; 240) for attaching to an injection device (1), wherein the injection device (1) is configured for injecting a dose of a medicament, the injection device (1) comprising:a housing (10) configured to accommodate a medicament container (14) containing an injectable medicament, a drive mechanism (8) to operably engage with the medicament container (14) to expel or to withdraw the dose of the medicament from the medicament container (14) and to inject the dose of the medicament into biological tissue, wherein the drive mechanism (8) comprises a first device portion (3) and a second device portion (4) movable relative to the first device portion (3) during at least one of setting of the dose and injecting of the dose, the add-on device (20; 120; 240) comprising: a first portion (23) fixable to the first device portion (3), a second portion (24) fixable to the second device portion (4), and the device component (80) according to any one of the preceding claims 1-13 fixed to or integrated to at least one of the first portion (23) and the second portion (24).

17. An injection system (5) to inject a dose of a medicament and to record the dose injection, the injection system (5) comprising: an injection device (1) comprising: a housing (10) configured to accommodate a medicament container (14) containing an injectable medicament, a drive mechanism (8) to operably engage with the medicament container (14) to expel or to withdraw the dose of the medicament from the medicament container (14) and to inject the dose of the medicament into biological tissue; and an add-on device (20; 120; 240) for attaching to the injection device (1), the add-on device (20; 120; 240) comprising a magnetic sensor arrangement (51), and wherein at least one of the injection device (1) and the add-on device (20; 120; 240) comprises a device component (80) according to any one of the preceding claims 1-13.

18. The injection system (5) according to claim 16, wherein the injection device (1) comprises a device component (80) according to any one of the preceding claims 1-13, wherein the device component (80) is provided with a magnetic encoding, which magnetic encoding is indicative of at least one of a type, a concentration and an amount of a medicament located inside the injection device (1), and wherein the add-on device (20; 120; 240) comprises a magnetic sensor arrangement, which is capable to distinguish between differently magnetically encoded device components (80) of the injection device (1).

19. A method of manufacturing a device component (80) according to any one of the preceding claims 1-13, the method comprising the steps of:providing a molding tool (90), preparing a moldable material mixture (91) comprising: a polymeric carrier material (82) and magnetized or magnetizable particles (83), and molding the moldable material mixture (91) to form the molded body (81) with the magnetized or magnetizable particles (83) embedded in the polymeric carrier material (82).

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