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

Abstract

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

Description

Technical Field

[0001] This disclosure relates to the field of injection devices (e.g., pen-type injection devices for self-administration) and / or the field of add-on devices suitable for such injection devices. This disclosure also relates to injection systems comprising an injection device and corresponding add-on devices, and a method of manufacturing device components for use in at least one of the injection device and the add-on device. Background Technology

[0002] Drug delivery devices that allow for the administration of multiple doses of liquid medicine and further provide the patient with the administration of such liquid medicine are well known in the prior art. Typically, such devices serve essentially the same purpose as ordinary syringes. Typically, the medicine to be administered is provided in a cartridge having a movable piston or stopper that mechanically interacts with a piston rod of the drive mechanism of the drug delivery device. By applying a thrust to the piston, a predetermined amount of pharmaceutical fluid is expelled from the cartridge.

[0003] Some drug delivery or injection devices allow for the selection of variable-sized drug doses and the injection of pre-set doses. Other injection devices offer fixed-dose settings and dispensing. In this case, the dose of drug that should be injected according to a given prescription schedule remains the same and does not change or cannot be changed over time.

[0004] Some injection devices are implemented as reusable injection devices, allowing users to replace the medication container (such as a cartridge). Other injection devices are implemented as single-use injection devices. For single-use injection devices, the design is to discard the entire injection device when the contents (i.e., the medication) have been used up.

[0005] In addition, there are electronic units, either integrated into such delivery or injection devices or provided as standalone devices, referred to as add-on devices, supplementary devices, or data collection devices. Such add-on devices provide additional functionality to fully mechanized drug delivery or injection devices. With these add-on devices, the repeated setting and / or dispensing or injection of drug dosages can be monitored and recorded over time. Add-on devices provide a wide variety of supplementary functions to the routine use of drug delivery or injection devices. They can provide data analysis and further communicate this data to healthcare providers. This data indicates the amount of drug administered at a specific time point or on a specific date.

[0006] Some add-on devices include a sensor arrangement that can detect and / or quantitatively measure movement of a dedicated component of the injection device to which the add-on device is attached. Movement of the dedicated device component can indicate at least one of dose setting and / or dose injection. By detecting and / or quantitatively measuring this movement, the add-on device can monitor user-induced actions of the injection device.

[0007] In some devices, the sensor arrangement is magnetic. Here, the sensor arrangement is configured to measure the movement of magnetized or magnetic components of the injection unit or the attachment itself. Typically, the injection unit and / or attachment comprises multiple injection-molded plastic parts. To detect or measure the movement of the magnetic components, magnets must be attached to or embedded within the plastic parts of the injection unit or attachment. Attaching permanent magnets to or integrating them into the injection-molded plastic parts requires not only additional installation space but also a corresponding amount of installation work.

[0008] In light of the foregoing, it is desirable to improve the overall design of the injection device and / or auxiliary devices and simplify their manufacture and assembly. Further, it is desirable to reduce the size of the injection device and corresponding auxiliary devices, and to provide these devices with a fairly compact design. In addition, enhancing the functionality of the injection device and corresponding auxiliary devices would be beneficial. Summary of the Invention

[0009] In one aspect, a device component is provided for at least one of an injection device and an attachment device, wherein the attachment device is configured for fastening or securing to the injection device. The device component includes a molded body that is permanently magnetized or can be permanently magnetized. The molded body includes a polymer carrier material and magnetized or magnetizable particles embedded in the polymer carrier material. In other words, the device component may include a molded plastic magnet that can replace conventional plastic components used or implemented in the injection device or the attachment device.

[0010] The device components themselves can be magnetized or magnetizable to provide a desired magnetic field that can be detected by a sensor arrangement. By embedding magnetized or magnetizable particles into a polymer carrier material, the molded body itself becomes magnetic and can resemble or provide a permanent magnet, which can be used in conjunction with an injection device and / or an additional device for use with a magnetic sensor arrangement. Because the magnetized or magnetizable particles are embedded in the polymer carrier material, it is no longer necessary to separately mount or assemble magnets into the plastic parts. Furthermore, insert molding of magnetic parts in the plastic parts can be avoided or prevented. More specifically, the molded body may include magnetized or magnetizable particles uniformly distributed within the polymer carrier material body. The polymer carrier material can provide mechanical bonding and / or a matrix to secure the magnetized or magnetizable particles therein.

[0011] Device components can be constructed from molded bodies. Therefore, the entire device component can be manufactured by molding the molded body. Device components and / or molded bodies offer considerable design freedom. Thus, the molded body can take any desired shape that can be provided by molding (e.g., injection molding).

[0012] In some examples, the device component is a single-piece component. It can be a single part of the injection device or an additional device.

[0013] This avoids attaching (e.g., gluing, welding, or otherwise fastening) magnetized parts to at least one of the injection unit and attachments in the injection-molded plastic parts, thereby allowing for reduced installation space and / or reduced manufacturing workload.

[0014] According to another example, the magnetized or magnetizable particles include 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, for example, by exposing a molded body having magnetizable particles therein to an external magnetizing toroidal magnetic field. The magnetic domains of the magnetized or magnetizable particles will be oriented according 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 a magnetizing magnetic field. In this way, the molded body can provide or constitute a molded plastic magnet.

[0015] According to another example, the magnetized or magnetizable particles include at least one of the following: neodymium iron boron (NdFeB) particles, samarium cobalt (SmCo) particles, aluminum nickel cobalt (AlNiCo) particles, strontium ferrite (SrFe) particles, powdered ferrite particles, iron (Fe) particles, or combinations thereof. The application of these materials in permanent magnet production is well-established. Some of these materials can be sintered. Here, the sintered material can be granulated or powdered to provide magnetized or magnetizable particles of the desired size suitable for embedding in a polymer carrier material.

[0016] According to another example, the average size of the magnetized or magnetizable particles in the molded body is between 1 μm and 100 μm. The average particle size can be selected or chosen based on the magnetic properties of the magnetizable or magnetizable particles. Moreover, the density of magnetized or magnetizable particles inside the molded body (i.e., inside the surrounding polymer carrier material) can be adjusted according to the magnetic requirements that the molded body or corresponding device components must meet.

[0017] According to another example, the polymer carrier material includes a thermoplastic material. Thermoplastic materials allow for the direct and easy embedding of magnetized or magnetizable particles into the body of the molded body. Typically, the molded body can be formed based on a mixture or blend of raw materials, including thermoplastic raw materials and including magnetized or magnetizable particles mixed within the raw materials of the thermoplastic material. The process of molding the body can include applying heat or thermal energy and / or pressure, causing the thermoplastic material to become plastically deformable.

[0018] According to another example, the polymer carrier material includes at least one of the following: polyamide (PA), polypropylene (PP), polyphenylene sulfide (PPS), and polyether ether ketone (PEEK), or a mixture thereof.

[0019] According to another example, the molded body comprises 5 wt.-% to 90 wt.-% of a polymer carrier material and 10 wt.-% to 95 wt.-% of magnetized or magnetizable particles. Here, the weight percentage of the polymer carrier material plus the weight percentage of the magnetized or magnetizable particles is less than or equal to 100 wt.-% of the molded body. In some examples, the molded body may consist of a polymer carrier material and magnetized or magnetizable particles. Accordingly, the higher the percentage of magnetized or magnetizable particles in the molded body, the lower the percentage of polymer carrier material in the molded body; and vice versa.

[0020] According to another example, the molded body comprises 5 wt.-% to 20 wt.-% of a polymer carrier material and 80 wt.-% to 95 wt.-% of magnetized or magnetizable particles. Typically, with a relatively high proportion of magnetized or magnetizable particles in the molded body, the magnetic properties of the molded body can be optimized, and the molded body can become increasingly similar to conventional sintered permanent magnets.

[0021] According to another example, the molding body is an injection molding body. Here, raw materials (i.e., polymer carrier material and magnetized or magnetizable particles) can be mixed as a raw material mixture and then injected into the appropriate 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 injection-moldable thermoplastic polymer carrier material.

[0022] In some examples, the molded body is magnetized within the mold. Therefore, manufacturing the molded body by injection molding can also provide and achieve magnetization of the molded body during molding or after molding but while still remaining in the injection mold.

[0023] Magnetization of the molded body can be applied to the entire molded body or only to selected parts or sections thereof. The degree and specific configuration of the magnetization of the molded body can depend on and be controlled by an externally applied magnetic field configured to magnetize the magnetizable particles inside the molded body.

[0024] According to another example, the molded body of the device component includes one of a dipole magnet and a multipole magnet. The dipole magnet or multipole magnet can be implemented by applying a corresponding external magnetizing magnetic field to the molded body, which is provided with magnetizable particles embedded in a polymer carrier material. With the multipole magnet, particularly by increasing the number of multipole magnets in the molded body, the magnitude of the magnetic field emitted or generated by the molded body can be precisely defined, and, for example, it can be made higher than the magnitude of the magnetic field emitted by the dipole magnet.

[0025] Compared to conventional sintered permanent magnets, molded bodies may exhibit or provide a magnetic field with reduced remanence because the polymer carrier material surrounding or embedding magnetized or magnetizable particles may not participate in the generation of the permanent magnetic field. However, by increasing the number of multipoles in the molded body, remanence can be improved, and even the insufficient remanence (relative to conventional sintered magnets) due to the presence of polymer carrier material in the molded body can be overcompensated.

[0026] According to another example, the device component and / or its molded body forms or constitutes at least one of the following: the housing, injection button, dosage knob, and digital sleeve of the injection device. Typically, a device component having a molded and permanently magnetized or permanently magnetizable body can be configured to replace any conventional plastic part of an existing injection device (e.g., a handheld pen-type syringe). The molded body can have the same size as the device component being replaced and can perfectly match its geometry. Here, by embedding magnetized or magnetizable particles in the polymer carrier material of the molded body, the device component can be magnetized and can provide a permanent magnetic field that can be used to detect or identify the type of injection device and / or, for example, detect movement of a movable device component during dose setting and dispensing or injection.

[0027] According to another example, the molded body or device component itself forms or constitutes at least one of a first part and a second part of the additional device. Here, the first part is movable relative to the second part. In this way, the movement of the first part relative to the second part can be detected magnetically.

[0028] In another example, a first portion of the attachment may be fixed to a first device portion of the injection device. A second portion of the attachment may be fixed to a second device portion of the injection device. During at least one of setting a dose and injecting a dose of the drug, the first device portion may move relative to the second device portion. By fixing the first and second portions of the attachment to the corresponding first and second device portions of the injection device, the first portion of the attachment will undergo movement relative to the second portion of the attachment during at least one of setting a dose and injecting a dose.

[0029] When at least one of the first and second parts is magnetized (e.g., because it is implemented as a device component as described above), the arrangement of magnetic sensors disposed on the other of the first and second parts can be operable to detect and / or quantitatively measure the degree of movement of the first component of the auxiliary device relative to the second component.

[0030] In some examples, the first part of the attachment may rotate relative to the second part of the attachment. In other examples, the first part of the attachment may be longitudinally displaced relative to the second part of the attachment. In still other examples, the first part of the attachment may move relative to the second part according to a helical motion. Therefore, the first part may be longitudinally displaced and rotated relative to the second part.

[0031] There are no general restrictions on the type of ferrite particles used to form the bulk material. Both low-energy and high-energy ferrites can be used. In particular, ferrites with a density of 5.0 g / cm³ can be used. 3 Up to 5.2 g / cm 3 High-energy ferrite particles with an average particle size of 1.5 μm to 2.5 μm can be used, which may have a remanence of 155 mT to 180 mT and an intrinsic coercivity of 155 kA / m to 250 kA / m. In another example, high-energy ferrites with a remanence of 165 mT to 180 mT and an intrinsic coercivity of 180 kA / m to 250 kA / m can be used.

[0032] In another example, magnetized or magnetizable particles include soft magnetic particles based on iron powder, magnetite powder, or so-called soft ferrites (such as manganese zinc ferrite powder) or mixtures thereof, wherein the iron powder provides high saturation remanence.

[0033] When using iron powder, its average particle size can be less than 160 μm, and its tap density can be 6.9 g / cm³. 3 Up to 6.95 g / cm 3 Within the range between [specific values]. If magnetite powder is used, its density can be, for example, 5.1 g / cm³. 3The tap density is approximately 2.5 g / cm³. 3 Typical particle sizes range from 5 μm to 25 μm, and Mohs hardness is between 5.5 and 6.

[0034] Assuming the use of manganese-zinc ferrite powder, its density can be, for example, 4.7 g / cm³. 3 The tap density is 1.8 g / cm³. 3 The average grain size ranges from 1 μm to 100 μm.

[0035] According to another example, the molded body is provided with or includes a magnetic code indicating at least one of the type, concentration, and amount of a drug located inside the injection device. Here, the injection device, including the device component of the molded body, can be correspondingly magnetically encoded. The magnetic code can be readable or identifiable, for example, by a magnetic sensor of an external electronic device, or by a magnetic sensor of an additional device configured to attach to the injection device. In this way, the injection device can be permanently magnetically encoded by the device component, and the corresponding magnetic code can be read or identified by the additional device, for example, during the mutual assembly of the injection device and the additional device.

[0036] Here, different injection devices (e.g., equipped with different medications) can be encoded differently by geomagnetic codes, and thus can be magnetically distinguished by their magnetic codes. According to another aspect, this disclosure also relates to an injection device for injecting a dose of medication. The injection device includes a housing configured to house a medication container containing an injectable medication. The injection device further includes a drive mechanism for operatively engaging with the medication container to dispensing or withdrawing a dose of medication from the medication container and injecting the dose of medication into biological tissue (e.g., under the patient's skin). Components of the drive mechanism and at least one of the housing are configured and implemented as device components as described above.

[0037] When the housing of the injection device is implemented as a magnetizable or magnetizable component, the housing itself can be provided with a magnetic code, which allows for magnetic coding of the housing and thus the entire injection device. By implementing the housing of the injection device as a molded body as described above, it is possible to provide a magnetic code to the housing of the injection device, which can then be detected magnetically, for example, by an additional device provided with a corresponding magnetic sensor arrangement. Here, the additional device and / or its magnetic sensor arrangement can be configured to detect the magnetic code provided by the housing of the injection device.

[0038] The magnetic sensor arrangement of the add-on device can be operable to distinguish the housings of different injection devices (e.g., those equipped with different types, concentrations, or amounts of medication) with different geomagnetic codes. Thus, the magnetization of at least a portion of the injection device's housing can provide a magnetic code that can be detected and / or decoded by the magnetic sensor arrangement of the add-on device. In this way, when the add-on device is equipped with a corresponding sensor arrangement capable of distinguishing the housings with different geomagnetic codes of such injection devices, the magnetically coded drug delivery or injection device can be automatically detected by attaching the add-on device to the corresponding injection device.

[0039] Not only the housing of the injection device can be magnetically encoded, but also any other component of the injection device (such as a dosage knob, injection button, or digital sleeve), thus allowing the type of injection device to be identified by magnetic sensor arrangements of the attachments to the corresponding injection device.

[0040] In some examples, the injection device may include multiple components implemented as magnetized molded plastic parts with embedded magnetic particles. Therefore, the injection device may include multiple device components as described above, each of which has specific magnetic properties.

[0041] In other examples, the drive mechanism of the injection device is equipped with at least one device component as described above. Here, the movable part of the drive mechanism may include a molding body that is magnetized and thus can be detected magnetically by a magnetic sensor arrangement of the auxiliary device. In another example, the movable part of the drive mechanism is moved during at least one of setting the dose and dispensing or injecting the dose. Here, during at least one of setting the dose and dispensing or injecting the dose, the magnetic sensor arrangement of the auxiliary device is not only able to detect the corresponding movement but also able to quantitatively measure the degree of movement of the movable part of the drive mechanism. Thus, by measuring the degree of movement, the auxiliary device can accurately measure the actual set or injected dose.

[0042] In another example, the injection device is equipped with a medication container disposed inside the housing of the injection device. The medication container may be pre-installed inside the housing of the injection device. Here, the injection device can be implemented as a disposable injection device, designed to be discarded entirely when the contents of the medication container are used up or when the medication container is empty. In other examples, the medication container may be interchangeably or replaceably disposed inside the housing of the injection device, thereby allowing for the replacement of empty medication containers.

[0043] According to another example of an injection device, at least one of the device components of the drive mechanism and the housing is provided with a magnetic code indicating at least one of the type, concentration, and amount of the agent located inside the injection device. Here, a first magnetic code is provided for a first agent, and a second magnetic code can be provided for a second agent that differs from the first agent in at least one of the aforementioned parameters (i.e., at least one of the concentration and amount located inside the injection device), the second magnetic code being magnetically different from the first magnetic code. Thus, different injection devices, for example, equipped with different agents, can be magnetically encoded differently by appropriately magnetically encoding at least the device components of the injection device (e.g., by magnetically encoding the housing of the injection device).

[0044] According to another aspect, this disclosure also relates to an auxiliary device for attachment to an injection device. The injection device is configured to inject a dose of a drug. The injection device includes a housing configured to receive a drug container, wherein the drug container contains an injectable drug. The injection device further includes a drive mechanism operatively engaged with or operable to the drug container to dispensing or withdrawing a dose of the drug from the drug container and injecting a dose of the drug into biological tissue. The drive mechanism includes a first device portion and a second device portion, the second device portion being movable relative to the first device portion during at least one of a set dose and an injection dose.

[0045] The additional device includes a first portion that can be fixed to a first device portion and a second portion that can be fixed to a second device portion. The additional device further includes a device component as described above, which is fixed to or integrated into at least one of the first and second portions. In some examples, the other of the first and second portions includes a magnetic sensor arrangement capable of measuring and / or detecting the presence of a magnetic field provided by the molded body of the device component as described above, and / or measuring or detecting movement of the device component or the molded body.

[0046] In some examples, the first device portion may be implemented as a dose knob or dose dial rotatably disposed proximally on the injection device. The second device portion may be implemented as an injection button proximal to the rotatable dose knob or dose dial. Here, for another example, the first and second device portions may undergo combined helical or rotational movement during the dose setting process. During dose injection, only the first device portion may be rotatable, while the second device portion is prevented from rotating.

[0047] Then, since the first and second parts of the attachment are fixed to the corresponding first and second parts of the injection device, rotation of the first part relative to the second part will occur, for example, during the dose injection or dose dispensing process. By making one of the first and second parts a magnetically coded device component as described above, a magnetic sensor arrangement can be provided on the other of the first and second parts of the attachment to detect and / or quantitatively measure movement (e.g., rotation between the first and second parts of the attachment).

[0048] In some examples, the attachment may include multiple components implemented as magnetized molded plastic parts with embedded magnetic particles. Therefore, the attachment may include multiple device components as described above, each of which has specific magnetic properties.

[0049] According to another example, the attachment may not have the device components described above. More specifically, the attachment may include a magnetic sensor arrangement configured to detect and / or distinguish device components of the injection device, for example, when the attachment is attached to or engaged with the injection device.

[0050] According to another aspect, an injection system is provided for injecting a dose of a drug and recording the dose injection. The injection system includes an injection device. The injection device includes a housing configured to house a drug container containing an injectable drug. In some examples, the injection device may be provided with a corresponding drug container, which is, for example, pre-assembled inside the housing of the injection device. The injection device further includes a drive mechanism for operatively engaging with the drug container to dispensing or withdrawing a dose of the drug from the drug container and injecting the dose of the drug into biological tissue. The injection system further includes an auxiliary device for attachment (e.g., for releasable attachment) to the injection device. The auxiliary device includes a magnetic sensor arrangement. At least one of the injection device and the auxiliary device includes a device component as described above, characterized by a molded body that is permanently magnetized or can be permanently magnetized and includes a polymer carrier material and magnetized or magnetizable particles embedded in the polymer carrier material.

[0051] Typically, the attachment is as described above. The attachment may include a first portion that can be fixed to a first device portion, and may further include a second portion that can be fixed to a second device portion of the injection device, wherein the first device portion and the second device portion undergo relative movement during at least one of setting a dosage and injecting a dose of the drug. Thus, when properly attached to the injection device, the first and second portions of the attachment undergo movement relative to each other, and when at least one of the first and second portions is implemented as a device component as described above, a magnetic sensor arrangement of the attachment can detect and / or measure this movement.

[0052] In other examples where the injection device of the injection system is provided with the magnetized plastic component as described above, the additional device may include a magnetic sensor arrangement adapted to or configured to detect and / or quantitatively measure the movement of the magnetized or magnetic device component of the injection device.

[0053] In another example, the injection system includes device components as described above. The device components are provided with magnetic codes indicating at least one of the type, concentration, and amount of a drug located inside the injection device or configured for or intended to be stored inside the injection device. Additional devices further include a magnetic sensor arrangement capable of distinguishing device components with different magnetic codes from the injection device. In this way, multiple differently configured injection devices can be provided, each equipped with a specific drug of a different type, concentration, and / or amount. Depending on the type, concentration, and / or amount of the drug, the respective injection device can be magnetically coded. Here, the magnetic code can indicate at least one of the type, concentration, and amount of the drug located inside the injection device.

[0054] Here, the auxiliary device configured to attach to the injection device may be equipped with a magnetic sensor arrangement capable of reading magnetic codes and / or distinguishing different geomagnetic codes of the injection device components. In this way, for example during the mutual assembly of the injection device and the auxiliary device, a specific type of drug can be detected almost automatically simply by reading or identifying the magnetic codes of the injection device components.

[0055] According to another aspect, a method for manufacturing the device component as described above is also provided. The method includes the step of providing a molding tool (e.g., an injection molding tool). The method further includes the step of preparing a moldable material mixture comprising the polymer carrier material as described above and magnetized or magnetizable particles. In a further step, a molded body of the device component is formed. Here, the moldable material mixture is formed in the molding tool to form the molded body, wherein the magnetized or magnetizable particles are embedded in the polymer carrier material.

[0056] Optionally, the molding body can be magnetized during the molding process and / or after the molding process but while still remaining in the molding tool. This allows for magnetization within the mold. Typically, magnetization can be provided by applying a magnetic field within the mold cavity of the molding tool.

[0057] This in-mold magnetization process is advantageous because the molded body can be directly magnetized while still in the mold. Then, by opening the mold and demolding the molded body, the device component is directly obtained, which can be easily magnetized to the desired degree and / or according to the desired magnetic design or structure.

[0058] The advantages offered by the molded plastic assembly components described herein include a reduction in the mounting space or geometry required to add separate magnets to the corresponding components in the past. Furthermore, existing plastic components can be replaced by magnetically molded plastic components of the same shape without affecting the overall function or configuration of the corresponding components in the injection unit or add-on. Therefore, the resulting compact design is beneficial to users of the injection unit or add-on. Molded magnetized or magnetizable plastic components can also have a significant impact on reducing manufacturing costs and workload.

[0059] Generally, the scope of this disclosure is defined by the content of the claims. Injection devices, additional devices, and device components are not limited to specific embodiments or examples, but include any combination of elements from different embodiments or examples. To a certain extent, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in different examples or embodiments.

[0060] In this context, the term "distal" or "far end" refers to the end of the injection device facing the injection site in a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0061] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0062] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0063] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about 1 month to about 2 years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0064] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and the Merck Index (15th edition).

[0065] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0066] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0067] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0068] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0069] Examples of oligonucleotides are, for example, mirtrimazole sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome. Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0070] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0071] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0072] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0073] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0074] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0075] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0076] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0077] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0078] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0079] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0080] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Attached Figure Description

[0081] In the following description, numerous examples of device components, injection devices, and additional devices or data collection devices will be described in more detail with reference to the accompanying drawings, in which:

[0082] Figure 1 It is a schematic diagram of the device components including a dipole magnetic structure.

[0083] Figure 2 Another example of a device component characterized by a multipole magnetic structure is shown.

[0084] Figure 3 Another example of a molded magnetic component is shown.

[0085] Figure 4 Another example of a molded magnetic device component is shown.

[0086] Figure 5 Another example of a molded magnetic device component is shown.

[0087] Figure 6 The diagram schematically illustrates the measurement results of the movement of the magnetization device components relative to the arrangement of magnetic sensors.

[0088] Figure 7 Another example of a magnetic sensor arrangement combined with a multipole magnet is shown.

[0089] Figure 8 Another example of a magnetic sensor arrangement combined with a dipole magnetic component is shown.

[0090] Figure 9 An injection system including an injection device and additional devices is schematically shown.

[0091] Figure 10 A schematic example of an attachment for fastening to the body or housing of the injection device is shown.

[0092] Figure 11 Another schematic example of an attachment configured for fastening to the proximal end of an injection device is shown.

[0093] Figure 12 An example of an injection device is shown.

[0094] Figure 13 The process of assembling, attaching, or securing the additional device to the proximal end of the injection device is illustrated.

[0095] Figure 14 Another example of an attachment device that is attached to the proximal end of the injection device is shown.

[0096] Figure 15 A cross-section through the proximal portion of the injection system is shown, wherein the additional device is attached to the proximal end of the injection device.

[0097] Figure 16 A partial sectional view of a three-dimensional structure is shown as another example of an attachment to the injection device.

[0098] Figure 17 Another example of an attachment device that is attached to the proximal end of the injection device is shown.

[0099] Figure 18 This is a block diagram of many components of an example of an additional device.

[0100] Figure 19 The diagram schematically illustrates molding tools used for producing or manufacturing parts for magnetized plastic devices, and

[0101] Figure 20 This is a flowchart of a method for manufacturing a device component as described herein. Detailed Implementation

[0102] exist Figures 1 to 5 The diagram schematically illustrates several examples of a device component 80 for fastening one of an injection device 1 and an auxiliary device 20 to the injection device 1. The device component 80, as shown, includes a molded body 81 that is permanently magnetized or can be permanently magnetized. The molded body 81 includes a polymer carrier material 82 and magnetized or magnetizable particles 83 embedded in the polymer carrier material 82. In some examples, the magnetized or magnetizable particles 83 include at least one of hard ferrite particles and rare-earth-based magnetized or magnetizable particles. The magnetized or magnetizable particles may include at least one of neodymium iron boron (NdFeB) particles, samarium cobalt (SmCo) particles, alnicotinic nickel cobalt (AlNiCo) particles, strontium ferrite (SrFe) particles, powdered ferrite particles, and iron (Fe) particles, and mixtures thereof.

[0103] In some examples, the average size of the magnetized or magnetizable particles in the molded body 81 ranges from 1 µm to 100 µm.

[0104] In some examples, the polymer carrier material 82 includes a thermoplastic material. The carrier material 82 may include at least one of the following: polyamide, polypropylene, polyphenylene sulfide, and polyetheretherketone, or a mixture thereof.

[0105] According to some examples, the molded body 81 comprises 5 wt.-% to 20 wt.-% of a polymer carrier material and 80 wt.-% to 95 wt.-% of magnetized or magnetizable particles. In this way, by increasing the percentage of magnetized or magnetizable particles in the molded body to more than 50 wt.-%, the molded body can provide or generate a relatively strong magnetic field.

[0106] like Figure 1 and Figure 3 As shown in the example, the molded body 81 includes a dipole magnet 84 having a magnetic south pole S and a magnetic north pole N. According to... Figure 1 The molded body 81 has a cuboid or cubic shape and includes or constitutes a cuboid 86. According to Figure 3 The device component 80 and thus the molded body 81 have a cylindrical or disc-shaped form, and include or constitute a cylinder or disc 88. According to Figure 2 In the example, the molding body 81 has an elongated shape and includes a multipole magnet 85. The molding body may include a longitudinal rod 87. Here, continuous portions of the molding body 81 positioned adjacent to each other along the longitudinal direction of the molding body 81 are alternately magnetized.

[0107] exist Figure 4 In one example, the molded body 81 includes a tubular sleeve 89, which has an outer surface that is alternately magnetically encoded in the 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 circumferentially along the outer surface of the sleeve 89.

[0108] exist Figure 5In the example, device component 80 includes an annular ring 89a, which is implemented as a multipole magnet 85. Here, the multipole magnet 85 includes four individual dipole magnets 84, 84', 84'', and 84''', each arranged offset from each other by 90° as seen along the circumferential direction of the ring 89a. The individual dipole magnets 84, 84', 84'', and 84''' include a north pole and a south pole separated in the radial direction. Moreover, as seen in the circumferential direction, dipole magnet 84 is polarized in the opposite direction in the radial direction compared to its adjacent dipole magnets 84' and 84'''. Similarly, dipole magnet 84'' is polarized in the opposite direction compared to the polarization of its adjacently positioned dipole magnets 84' and 84''' as seen in the circumferential direction.

[0109] In principle, device component 80 can adopt any conceivable geometry that can be produced by injection molding. For production such as Figures 1 to 5 Any of the schematically shown device components 80 can provide, for example Figure 19 The molding tool 90 is shown. The molding tool 90 includes a lower mold portion 92 and an upper mold portion 93. A mold cavity 94 may be provided in at least one of the upper mold portion 93 and the lower mold portion 92 for receiving a material mixture 91. The material mixture may include raw materials, which include a polymer carrier material 82 and further include magnetized or magnetizable particles 93.

[0110] Magnetized or magnetizable particles 93 are typically uniformly mixed or distributed in the original polymer carrier material 82. Once the material mixture 91 is prepared, it can be filled or injected into the mold cavity 94, for example, by applying heat and / or pressure. This produces the molded body 81, for example, by injection molding. During and / or after the molding process, an external magnetizing magnetic field can be applied to the molding tool 90, which magnetizes the magnetizable particles 83 embedded in the molded body 81 according to the magnitude or geometry of the externally applied magnetic field. In this way, the device component 80, particularly the molded body 81, can be magnetized to a desired degree. Finally, the molding tool 90 can be opened, for example, by lifting the upper mold portion 93, thereby providing access to the mold cavity 94. The molded body 81 can then be demolded or removed from the molding tool 90.

[0111] According to Figure 20The flowchart further illustrates a method for manufacturing and producing device component 80. In a first step 300, a molding tool 90 is provided. In step 302, a material mixture 91 to be inserted into the molding tool 94 is prepared. Here, magnetized or magnetizable particles 83 are mixed with the original polymer carrier material 82. Then, in step 304, the material mixture 91 thus prepared is filled into the mold cavity 94 of the molding tool 90. Optionally, in step 304, heat energy is applied to the molding tool 90 to enable the material mixture 91 to be molded accordingly, such as by injection molding. Optionally, in step 306, the molding body 81 located inside the molding tool 90 can be magnetized, for example by applying a suitable magnetizing magnetic field that can penetrate the material of the molding tool 90. Subsequently, in step 308, the molding body 81 is removed from the molding tool 90.

[0112] Device component 80 can be considered as a molded, permanently magnetized plastic component. This component is generally suitable for replacing any injection-molded component of injection device 1 and / or auxiliary device 20, as described below. Typically, device component 80 can be implemented in any conceivable or suitable geometry and can replace or substitute any injection-molded component or portion of injection device 1 and / or auxiliary device 20. In some examples, device component 80 having its molded body 81 may include permanent magnet encoding, such as, for example... Figure 7 As illustrated in the example, the device component 80, as implemented in the injection device 1 or as implemented in the auxiliary device 20, may cooperate with at least one magnetic sensor arrangement 51 positioned adjacent to the movable device component 80.

[0113] The magnetic sensor arrangement may include a magnetometer. It may include one of the following: Hall sensor, microelectromechanical system (MEMS) device for detecting and measuring magnetic fields, magnetic diode, magnetic transistor, AMR magnetometer, GMR magnetometer, magnetic tunnel junction magnetometer, magneto-optical sensor, Lorentz force-based MEMS sensor, electron tunneling effect-based MEMS sensor, MEMS compass, fluxgate magnetometer, search coil magnetic field sensor, and SQUID magnetometer.

[0114] In this way, when the device component 80 is moved (e.g., rotated), a changing magnetic field is generated at the sensor arrangement 51, 51'. This changing magnetic field can then be evaluated by electronic components connected to the sensor arrangement 51 to quantitatively measure the degree of rotation of the device component 80 relative to the sensor arrangement 51. Typically, the sensor arrangement may include one or more individual sensors, such as... Figure 7 and Figure 8 As indicated by reference numerals 51 and 51' in the accompanying drawings.

[0115] exist Figure 8 In this embodiment, device component 80 includes a dipole magnet 84. Here, the magnetic sensor arrangement 51 can be configured to detect this dipole magnet, or it can be configured to detect other characteristic multipole magnetic codes of device component 80. Here, device component 80 can be implemented as a tubular housing 10 of injection device 1. Housing 10 can be provided with a corresponding magnetic code defined by the permanent magnetization of the respective device component 80. Magnetic sensor arrangement 51 can also be provided or integrated into an auxiliary device 20. By attaching the auxiliary device 20 to injection device 1, magnetic sensor arrangements 51, 51' can be able to distinguish different types of magnetic codes, for example, such as... Figure 8 The format indicated by the dipole 84 type magnetic code 78 and such Figure 7 It is indicated in the form of magnetic multipole 85 code 78.

[0116] Thus, any other injection-moldable plastic component, such as housing 10 or injection device 1, can be magnetically encoded. The magnetic encoding can be associated with a specific drug or injection device, thus characterizing that particular drug or injection device and allowing for automatic detection of the drug type or injection device type when connected to the attachment 20.

[0117] exist Figure 9 In the example, the injection device 1 includes a drive mechanism 8 comprising at least one movable component, such as a digital sleeve 70. During at least one of setting the dosage and injecting a dose of medication from the injection device 1, the digital sleeve 70 may undergo at least one of rotational movement, longitudinal movement, or helical movement. The digital sleeve 70 may be implemented as a magnetized device component 80' as described herein. An auxiliary device 20 configured for fastening or securing to the proximal end of the injection device 1 (e.g., the dosage knob 12 or injection button 11) is equipped with a magnetic sensor arrangement 51 adapted to detect or quantitatively measure the movement of the device component 80'.

[0118] In addition to or alternative to the magnetic implementation of the digital sleeve 70, it is conceivable that at least one of the dosage knob 12 and injection button 11 may be implemented as a device component 80 as described herein, comprising a molded body 81 having a polymer carrier material 82 and magnetized or magnetizable particles 83 embedded in the polymer material 82. Hereinafter and as described above, by attaching or securing the additional device 20 to at least one of the dosage knob 12 and injection button 11, the magnetic sensor arrangement 51 may become suitable for detecting the magnetic structure of the magnetized device component 80 and / or detecting or quantitatively measuring, for example, the movement of the dosage knob 12 relative to at least one of the injection button 11 and housing 10.

[0119] exist Figure 10In this example, the attachment 20' may be equipped with a magnetic sensor arrangement 51. The attachment 20' may be configured or adapted to be attached to the sidewall of the housing 10 of the injection device 1. Here, the magnetic sensor arrangement 51 may be positioned adjacent to the magnetization device component 80' (e.g., the digital sleeve 70 or any other movable component of the drug delivery or actuation mechanism 8 of the injection device 1). Thus, as long as the attachment 20' is properly attached to the sidewall of the housing 10 of the injection device 1, such as... Figure 9 As shown, the magnetic sensor arrangement 51 can detect and / or quantitatively measure, for example, the movement of the magnetic device component 80' relative to the housing 10.

[0120] exist Figure 11 In the example shown, another example of the attachment 20 is illustrated, which includes a first portion 23 and further includes 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 fixed to a dose knob 12 located proximally at the injection device 1, and the second portion 24 may be fixed to an injection button 11. Typically, during dose setting, the dose knob 12 and the injection button 11 may undergo common rotational or helical movement. During dose dispensing or injection, the injection button 11 may be locked in a rotational sense relative to the housing 10 of the injection device 1, while the dose knob 12 may undergo helical or rotational movement relative to the injection button 11 or the housing 10.

[0121] The first portion 23 of the auxiliary device 20 can be fixed in a rotational sense relative to the dosage knob 12, and the second portion 24 of the auxiliary device 20 can be fixed in a rotational sense relative to the injection button 11. In this way, the first portion 23 can be rotated relative to the second portion 24, at least during the dispensing or injection of a certain dose of the agent. Here, it may be particularly advantageous that the first portion 23 includes a device component 80 as described above, which has a molded body 81 comprising magnetized or magnetizable particles 83 embedded in a polymer carrier material 82. The rotation of the first portion 23 relative to the second portion 24 can then be detected and / or quantitatively measured by a magnetic sensor arrangement 51 disposed in or on the second portion 24 of the auxiliary device 20.

[0122] Figure 12The injection device 1 is a pre-filled disposable pen comprising a housing 10 and housing a drug container 14 to which a needle 15 can be attached. The needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 and / or a protective cap 18. By rotating the dosage knob 12, the dose to be dispensed from the injection device 1 can be programmed or “dialed in,” and the currently programmed dose is then displayed via a dosage window 13, for example, in various units. For example, when the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), where one IU is the bioequivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units may be used in injection devices used to deliver analog insulin or other medications. It should be noted that the selected dose can also be... Figure 12 The dose window 13 is shown differently and is well displayed. The dose window 13 may be in the form of an aperture in the housing 10, which allows the user to observe a limited portion of the digital sleeve 70, which is configured to move as the dose knob 12 is turned to provide a visual indication of the currently programmed dose. When turned during programming, the dose knob 12 rotates in a helical path relative to the housing 10.

[0123] In this example, the dosage knob 12 includes one or more shaped structures 71a, 71b, 71c to facilitate the attachment of the attachment device 20 or data collection device. The injection device 1 can be configured such that turning the dosage knob 12 produces a mechanical click to provide acoustic feedback to the user. The digital sleeve 70 interacts mechanically with a piston in the medication container 14. When the needle 15 is inserted into the patient's skin and the injection button 11 is subsequently pushed, the insulin dose displayed in the display window 13 is ejected from the injection device 1. In this example, during dose delivery, the dosage knob 12 rotates axially (i.e., without rotation) to its initial position, while the digital sleeve 70 rotates to return to its initial position, for example, to display a dose of zero units.

[0124] Further details of this example of injection device 1 can be found in one of the following documents: WO 2004 / 078239 A1, WO 2004 / 078240 A1 or WO 2004 / 078241 A1, the entire contents of which are incorporated herein by reference.

[0125] Figure 13 and Figure 14 This is a perspective view of one end of the injection device 1 with the attachment device 20 attached. The attachment device 20 includes a housing 21 and an end plate 22 having an optional display 22a. The attachment device 20 can be in the following combination: Figures 13 to 17 One of the many different forms or configurations described.

[0126] Figure 15This is a cross-sectional view of the attachment or auxiliary device 20 when attached to the injection device 1. The attachment 20 includes a first portion 23 and a second portion 24, wherein the first portion 23 is rotatably movable relative to the second portion 24. Further details of this attachment 20 or data collection device will immediately become apparent from document WO 2016 / 198516 A1, the entire contents of which are incorporated herein by reference.

[0127] In this particular example, the first portion 23 is a sleeve positioned above the dosage knob 12. The first portion may have a forming structure 19 that cooperates with the forming structures 71a, 71b, 71c on the dosage knob 12. Regardless of whether the first portion 23 is provided with forming structures 19a-c, this arrangement ensures that when the user rotates the first portion 23 during programmed dosage, the dosage knob 12 also rotates, and that when the dosage knob 12 is rotated during drug dispensing, the first portion 23 also rotates.

[0128] An elastic pad (such as a foam rubber pad 44) ​​may be provided within the molding structure 19 on the first part 23 to allow for dimensional tolerances between the molding structure 19 on the first part 23 and the molding structures 71a, 71b, 71c on the dose knob 12, and / or to provide engagement between the first part 23 and the dose knob 12 such that rotation of the first part 23 causes rotation of the dose knob 12, and vice versa.

[0129] Once the attachment 20 is fully installed, further movement is prevented. This can be detected by the user through tactile feedback, i.e., when the proximal end of the dosage knob 12 abuts against the abutment surface at the proximal end of the cavity in the first section 23 (see, for example, [reference needed]). Figure 16 This provides the user with a step change from some relative movement to no relative movement. Friction between the data collection device 20 and the dosage knob 12 causes the attachment 20 to remain mounted on the injection device 1. This can be achieved without using any additional mechanism to secure the attachment 20 to the injection device, although the use of an additional mechanism is not excluded. To unload the attachment 20 from the injection device, the frictional force needs to be overcome. This can be achieved by applying a strong pulling force, for example, 30 N or greater, to the data collection device in the proximal direction.

[0130] To set the dosage of the medication to be administered, the user can grasp and rotate the first portion 23, which will cause the dosage knob 12 of the injection device 1 to turn, thereby programming the dosage. Moreover, in this particular example, the second portion 24 is a body located within the first portion 23, rotatably attached to the first portion using a bearing 25. The second portion 24 includes an outer portion 26, which includes an end plate 22 and optionally a display 22a. The second portion 24 also includes an inner portion 27. When the attachment 20 is attached to the injection device 1, the inner portion 27 covers the injection button 11. The outer portion 26 and the inner portion 27 are attached by a fixing device 28 that prevents rotation relative to each other. However, in this embodiment, the outer portion 26 can be axially moved relative to the inner portion 27, and one or more elastic members (such as springs 29) can be provided to bias the outer portion 26 away from the inner portion 27. The attachment 20 is configured to detect axial movement of the outer portion 26 relative to the inner portion 27. A switch 53 can be used to detect movement greater than a predetermined amount.

[0131] In this particular arrangement, a first electrical contact 30 is provided on the outer portion 26, and a corresponding second electrical contact 31 is provided on the inner portion 27. When the user presses the end plate 22, the outer portion 26 moves axially toward the inner portion, thereby establishing a connection between the first electrical contact 30 and the second electrical contact 31. Further pressure applied to the end plate 22 causes the inner portion 27 to press against the injection button 11 and activate the injection button. The first electrical contact 30 and the second electrical contact 31, when engaged, provide a data connection between the processor arrangement 50 and the display 22a.

[0132] Optionally, the auxiliary device 20 can be arranged to have a first configuration and a second configuration, in which rotation of the first part 23 relative to the second part 24 is prevented, and in the second configuration, such rotation is unimpeded.

[0133] Figure 16 This is an isometric sectional view of the first alternative data collection device 240, which is a variant of the additional device 20. Figure 16The data collection device 240 includes a sealed chamber 244 housed within its main body. The sealed chamber 244 itself houses a power source 54 or battery (in the form of a coin cell in this example) and a printed circuit board (PCB) 242. Multiple electronic components are mounted on the PCB, including a communication interface 243, such as a Bluetooth Low Energy chip or a Near Field Communication (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 configured to detect rotation of the first portion 23 relative to the second portion 24. Specifically, the sealed chamber 244 is rotationally fixed relative to the second portion 24 and rotates together with the second portion 24 relative to the first portion 23 when a dose is delivered.

[0134] Power supply 54 provides power to the electronic components of data collection device 240. Power supply 54 is located on the distal side of PCB 242. Power supply 54 is abutted by the distal ends of PCB 242 and sealing chamber 244. First part 23 has three key structural elements. First part 23 can be formed as a single section or as multiple sections joined together. First element 246 of first part 23 is configured to engage with selector knob 12. Second element 247 is configured to engage with dose delivery button 11. Specifically, second element 247 is configured to fit snugly around dose delivery button 11. Second element 247 helps ensure proper axial alignment of data collection device 240 on injection device 1. Second element 247 can take the form of a ring. Second element 247 can have a low-friction inner surface so as not to impede movement of dose delivery button 11 in the distal direction. Third element 248 is located at the proximal end of first part 23. Third element 248 extends radially inward. This third element also surrounds second part 24 in the radial direction.

[0135] The sealed chamber 244 is axially movable within the cavity formed in the first portion 23. The sealed chamber 244 is proximally constrained at its periphery by a third element 248 of the first portion 23. Distally, the sealed chamber 244 abuts against the dosing button 11. The second portion 24 is connected to the proximal end of the sealed chamber 244 at its periphery. A support 245, extending axially, is provided at the center of the second portion 24. The support 245 coincides with the switch 53 and may or may not contact the switch when no force is applied to the second portion 24 in the distal direction. The center of the second portion 24 may deform slightly in the distal direction. The switch 53 is configured to operate when at least a portion of the second portion 24 moves relative to the first portion 23. The force required to operate the switch 53 is less than the force required to deliver the drug from the injection device 1. Power is supplied to components of the data collection device by operating the switch 53, thus ensuring that the components are powered before the start of dose delivery.

[0136] The operation of the data collection device 240 will now be described. First, the user selects a dose into the injection device 1. This is achieved by the user rotating the first part 23 of the data collection device 240. The rotational force is transmitted to the dose knob 12, which also rotates. When the dose is selected, the second part 24 also rotates together with the first part. During the selection, the electronics on the PCB 242 are not powered.

[0137] Once the user selects the desired dose, they press the second part 24 to initiate dose delivery, i.e., to induce an injection. Initially, the second part 24 deforms slightly, and the center of the second part 24 moves more distally than its periphery; in other words, the center of the second part 24 moves axially relative to its periphery and axially relative to the first part. This causes the support 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 part 24 is transmitted as movement of the sealed chamber 244 within the first part 23. This is transmitted as movement of the dosage button 11 distally.

[0138] Once the dose button 11 has been moved sufficiently to allow dose delivery (this occurs by disengaging a clutch (not shown) within the injection device 1), the dose knob 12 begins to rotate relative to the dose button 11 as the dose delivery button moves distally by the user's action. Specifically, the dose delivery button 11 does not rotate relative to the housing 10 of the injection device 1, but the dose button and the digital sleeve 70 move helically (i.e., they move axially and rotate simultaneously). Therefore, the first portion 23 rotates relative to the second portion 24. Rotation of the first portion 23 relative to the second portion 24 ceases when the user stops pressing the second portion 24, or when all doses have been delivered. The amount of rotation indicates the dose delivered. The amount of rotation is detected by sensor 51 and used to calculate the delivered dose. The delivered dose is then stored in memory, as described below.

[0139] Figure 17 This is a view of the third alternative data collection device 120, which is a variation of the additional device 20. Unless otherwise stated, the reference numerals for the same elements are used herein. Figure 12 , Figure 15 and Figure 16 The accompanying figure labels.

[0140] exist Figure 17 In the data collection device 120, the second part 24 is relatively large. Within the second part 24, a spring 121 biases a power source (e.g., a battery) 54 against the proximal side of the PCB 242. A first ring 124 extends distally from the distal end of the sealed chamber 244. A second ring 125 extends distally from the distal end of the sealed chamber 244. The second ring 125 is outside the first ring 124, and they are concentric.

[0141] The second collar 125 and the second portion 24 have interoperability features that restrict axial movement of the components relative to each other. Specifically, one or more protrusions 228 are fitted into one or more recesses 229. Movement of the second portion 24 relative to the sealing chamber 244 is restricted, with respect to the one or more protrusions 228, by the ends of the one or more recesses 229. In this example, the protrusions 228 are disposed on the second collar 125 and thus on the sealing chamber 244, and the recesses 229 are disposed on the second portion 24.

[0142] The first collar 124 fits snugly against the dosing button 11 to aid in axial alignment between the data collection device 120 and the injection device 1 during delivery. A gasket (not shown) may be provided between the first collar 124 and the dosing 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 or during dosing delivery.

[0143] The first part 23 is provided with gripping features 123. These gripping features allow a user to grip the first part to provide torque, and thus rotate the first part when a dose is set. The gripping features 123 provide generally radially extending surfaces to which the user can apply force to cause rotation of the first part 23.

[0144] As from Figure 17 As can be seen, the first part 23 is connected to the second part 24 via connector arrangements 230, 231, and 228. Specifically, the first part 23 includes a first L-shaped component 231 having an abutment surface facing the distal direction. This is formed as part of the first part 23. A second L-shaped component 230, forming part of the second part 24, is connected to a support 232, which is connected to the PCB 242, the first collar 124, and other components of the second part 24. The second L-shaped component 230 has an abutment surface facing the proximal direction. The second L-shaped component 230 and other components connected to it are attached to the first section 23 during manufacturing by applying force to induce a snap-fit ​​engagement, such that the abutment surfaces of the first L-shaped component 231 and the second L-shaped component 230 are positioned together. The inclined surface of the first L-shaped component 231, slightly facing the proximal direction, facilitates the snap-fit ​​engagement of the second L-shaped component 230 onto the first L-shaped component 231.

[0145] During the installation of the data collection device 120 onto the injection device 1, a force is applied in the axial direction. During installation, the user may apply force to the second part 24. In this case, the force is transmitted to the first part, causing the first part 23 to be fitted onto the dosage knob 12 by abutting against the proximal surface 235 of the first part 23 via the distal end of the third L-shaped component 228 or more generally the body 234. After installation, the spring force provided by the data collection device 120 forces the second part 24 to move proximally relative to the first part 23. This spring force is greater than the reaction force provided by the injection device 1 during dosage delivery (the reaction force primarily originates from frictional forces generated by the movement of internal components and hydrodynamic forces generated by the expulsion of the drug through the needle). Therefore, the distal end of the third L-shaped component 228 or more generally the body 234 does not contact the proximal surface 235 of the first part 23 during dosage delivery.

[0146] Figure 18This is a block diagram of auxiliary devices 20, 120, and 240. Auxiliary device 20 includes: a processor arrangement 50 comprising one or more processors (such as a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc.); and memory units 52a and 52b (including program memory 52a and main memory 52b) that can store software executed by the processor arrangement 50 and data generated during use of the data collection device, such as counting pulses, derived dose magnitudes, timestamps, etc. Switch 53 connects power supply 54 to the device's electronic components, including sensor arrangement 51, during operation. Display 22a may or may not be present.

[0147] The first electrical contact 30 and the second electrical contact 31 can provide a data connection between the processor arrangement 50 and the display 22a when engaged.

[0148] A timer 55 is also provided. In addition to or replacing the connection and disconnection of the auxiliary device 20, the switch 53 or the first electrical contact 30 and the second electrical contact 31 can be arranged to trigger the timer 55 upon engagement and / or disengagement. For example, if the timer 55 is triggered when the first electrical contact 30 and the second electrical contact 31 are engaged or disengaged, or when the switch 53 is operated and stopped, the processor arrangement 50 can use the output from the timer to determine the duration of pressing the injection button 11, for example, to determine the duration of the injection.

[0149] 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 sensor arrangement 51 is determined by the design of the injection device 1. A suitable angular resolution for the sensor arrangement 51 can be determined by the following equation:

[0150] Resolution = 360° / number of units per rotation.

[0151] For example, if each full rotation of the dosage knob 12 corresponds to a dose of 24 units of medication, then the appropriate resolution of the sensing arrangement 51 will not exceed 15°.

[0152] exist Figure 15 In the example, one or more first magnets 56a are arranged on or along the circumference of the inner surface of the first portion 23, and one or more second magnets 56b are arranged around the circumference of the outer surface of the second portion 24. The sensor arrangement 51 is a transducer that changes its output based on the Hall effect due to the change in the magnetic field when the first portion 23 and the first magnets 56a are rotated relative to the second portion 24 and the second magnets 56b.

[0153] Specifically, each of magnets 56a and 56b can be implemented by device component 80 as described above. Therefore, either the first portion 23 or the second portion 24 can be implemented as a molded body 81, which is permanently magnetized at least segmentally. In this way, it is not necessary to attach or assemble individual magnet components to the injection-molded plastic part.

[0154] Figure Labels

[0155]

[0156]

[0157] .

Claims

1. An injection device (1) and a device component (80) configured for fastening to at least one of an auxiliary device (20; 120; 240) of the injection device (1), the device component (80) comprising: - A molded body (81) is permanently magnetized or can be permanently magnetized, the molded body (81) comprising a polymer carrier material (82) and magnetized or magnetizable particles (83) embedded in the polymer carrier material (82).

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

3. The device component (80) according to any of the preceding claims, wherein The average size of these magnetized or magnetizable particles (83) in the molded body (81) is between 1 μm and 100 μm.

4. The device component (80) according to any of the preceding claims, wherein The polymer carrier material (82) includes thermoplastic materials.

5. The device component (80) according to any one of the preceding claims, wherein, The polymer carrier material (82) includes at least one of the following: polyamide, polypropylene, polyphenylene sulfide and polyether ether ketone, or a mixture thereof.

6. The device component (80) according to any one of the preceding claims, wherein, The molded body (81) comprises 5 wt.% to 90 wt.% of polymer carrier material (82) and 10 wt.% to 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 wt.% to 20 wt.% of polymer carrier material (82) and 80 wt.% to 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 magnetized inside the mold.

10. The device component (80) according to any one of the preceding claims, wherein, The molded body (81) includes 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 the housing (10), injection button (11), dosage knob (12), and digital 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 part (23) and a second part (24) of an auxiliary device (20; 120; 240), wherein the first part (23) is movable relative to the second part (24).

13. The device component (80) according to any one of the preceding claims, wherein, The molded body (80) is provided with a magnetic code that indicates at least one of the type, concentration and amount of the agent located inside the injection device (1).

14. An injection device (1) for injecting a certain dose of a drug, the injection device comprising: - A housing (10) configured to contain a pharmaceutical container (14) containing an injectable pharmaceutical agent. - A drive mechanism (8) is operatively engaged with the drug container (14) to discharge or extract a given dose of drug from the drug container (14) and inject the given dose of drug into biological tissue. - wherein at least one of the components (11, 12, 70) of the drive mechanism (8) and the housing (10) 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 device components (11, 12, 70) of the drive mechanism (8) and the housing (10) is provided with a magnetic code indicating at least one of the type, concentration and amount of the drug located inside the injection device (1).

16. An auxiliary device (20; 120; 240) for attachment to an injection device (1), wherein, The injection device (1) is configured to inject a certain dose of medicine, and the injection device (1) includes: - A housing (10) configured to contain a pharmaceutical container (14) containing an injectable pharmaceutical agent. A drive mechanism (8) is configured to operatively engage with the drug container (14) to dispense or extract a dose of drug from the drug container (14) and inject the dose of drug into biological tissue, wherein the drive mechanism (8) includes a first device portion (3) and a second device portion (4), the second device portion being movable relative to the first device portion (3) during at least one of setting the dose and injecting the dose. The additional device (20; 120; 240) includes: - First part (23), which can be fixed to the first device part (3). - The second part (24), which can be fixed to the second device part (4), and The device component (80) according to any one of claims 1 to 13 is fixed to or integrated into at least one of the first part (23) and the second part (24).

17. An injection system (5) for injecting a dose of a drug and recording the dose injection, the injection system (5) comprising: - Injection device (1), the injection device comprising: - A housing (10) configured to contain a pharmaceutical container (14) containing an injectable pharmaceutical agent. - A drive mechanism (8) operably engages with the drug container (14) to discharge or extract a dose of drug from the drug container (14) and inject the dose of drug into biological tissue; and - An attachment device (20; 120; 240) for attaching to the injection device (1), the attachment device (20; 120; 240) including a magnetic sensor arrangement (51), and The injection device (1) and the auxiliary device (20; 120; 240) include at least one of the device components (80) according to any one of claims 1 to 13.

18. The injection system (5) according to claim 16, wherein, The injection device (1) includes a device component (80) according to any one of claims 1 to 13. -The device component (80) is provided with a magnetic code indicating at least one of the type, concentration, and amount of the drug located inside the injection device (1), and -The additional device (20; 120; 240) includes a magnetic sensor arrangement that is capable of distinguishing different geomagnetic encoded device components (80) of the injection device (1).

19. A method for manufacturing a device component (80) according to any one of claims 1 to 13, the method comprising the following steps: - Provide molding tools (90). - Prepare a formable material mixture (91) comprising: a polymer carrier material (82) and magnetized or magnetizable particles (83), and - The formable material mixture (91) is molded to form the molded body (81), wherein the magnetized or magnetizable particles (83) are embedded in the polymer carrier material (82).

Images