Drive mechanism for a drug delivery device - Patent application

Abstract

The present disclosure relates to a drive mechanism (11) for moving a stopper (24) of a medicament container (22), the stopper (24) being movably disposed within a longitudinally extending barrel (23) of the medicament container (22), the drive mechanism (11) comprising: a drive member (30) movable along a longitudinal direction (z) parallel to the longitudinal extent of the barrel (23); a magnetic coupling (36) including an outer coupling member (40) and an inner coupling member (50), the outer coupling member (40) being mechanically engaged with the drive member (30) and configured to move along an outer surface (25) of the barrel (23), the inner coupling member (50) being mechanically engageable with the stopper (24) and configured for insertion into the barrel (23); At least one of the outer coupling member (40) and the inner coupling member (50) includes a first magnet (41) and a second magnet (42) separated from each other in the longitudinal direction (z) and configured to magnetically couple with a third magnet (53) of the other of the outer coupling member (40) and the inner coupling member (50), in relation to a drive mechanism (11).

Description

[Technical field]

[0001] The present disclosure relates to the field of drug delivery devices, in particular for the delivery of liquid medicaments, for example by infusion or injection. In one aspect, the present disclosure relates to a drive mechanism for moving a stopper of a cartridge filled with a liquid medicament. [Background technology]

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are well known per se in the art. Generally, such devices have a purpose substantially similar to that of a conventional syringe.

[0003] Drug delivery devices such as pen injectors must meet several user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically debilitated and may also have impaired eyesight. Therefore, a suitable drug delivery device, especially for home drug treatment, needs to be robust in construction and should be easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such an injection device should provide for the setting and subsequent dispensing of variable sized doses of the drug. Furthermore, the dose setting as well as dose dispensing procedures must be easy to perform and unambiguous.

[0004] Patients suffering from certain diseases may need to have certain amounts of medication injected via a pen syringe or infused via a pump.

[0005] In a drug delivery or injection device, the liquid medicament is typically provided in a medicament container, such as a cartridge, syringe or carpule. Such a medicament container is typically proximally closed or sealed by a stopper movably disposed on the barrel of such a medicament container. The liquid medicament can be expelled or dispensed from the medicament container, for example, by displacing, e.g., urging, the stopper distally relative to the barrel of the container. A distal outlet of the medicament container can be fluidly connected to an injection needle or an infusion line.

[0006] To introduce or transmit a driving force into or onto the stopper, there is a mechanically implemented drive mechanism, for example including an elongated piston rod that abuts longitudinally against a proximal end face of the stopper. Previously known drive mechanisms are typically operable to advance the piston rod distally to apply a dosing pressure to the stopper of the drug container.

[0007] With the increasing digitalization and availability of electrically implemented drive mechanisms, i.e. drive mechanisms in which the force for moving the stopper in the distal direction is provided or generated by an electrical or electromechanical drive, there is an increasing demand for new solutions and approaches of how to provide a mechanical coupling between the drive or drive member of the drive mechanism and the stopper of the drug container, e.g. the stopper of a cartridge. Furthermore, miniaturization of such drive mechanisms and drug delivery devices is also desired. The engagement or mating of the drive mechanism, and in particular the components of the drive mechanism and the stopper of the drug container moved by the drive mechanism, should be fairly fail-safe, robust and efficient in terms of longitudinal force transmission. Summary of the Invention [Means for solving the problem]

[0008] In one aspect, the present disclosure relates to a drive mechanism for moving a stopper of a drug container, and in particular for moving a stopper of a cartridge. The stopper is movably disposed within a longitudinally extending barrel of the drug container or cartridge. The drive mechanism includes a longitudinally movable drive member parallel to the longitudinal extent of the barrel. The drive mechanism further includes a magnetic coupling. The magnetic coupling includes an outer coupling member and an inner coupling member. The outer coupling member is mechanically engaged with the drive member. The drive mechanism is configured to move along an outer surface of the barrel.

[0009] The inner coupling member is mechanically engagable with the stopper. In some examples, the inner coupling member is mechanically engaged, e.g., mechanically fastened or secured to the stopper, either temporarily or permanently. The inner coupling member is sized and configured to be inserted into the barrel. Additionally, at least one of the outer coupling member and the inner coupling member includes a first magnet and a second magnet. The first magnet and the second magnet are longitudinally separated from one another. The first magnet and the second magnet are further configured to magnetically couple or magnetically interact with a third magnet of the other of the outer coupling member and the inner coupling member.

[0010] The first and second magnets, which are longitudinally separated from one another, can provide a fairly accurate, strong and well-defined magnetic coupling between the outer and inner coupling members.

[0011] The outer coupling member is mechanically connected or secured to the drive member of the drive mechanism and is movable along the outer surface of the barrel. Typically, the drive member is longitudinally movable toward the distal end of the barrel of the drug container to expel the drug from the barrel. The inner coupling member is located at or near the stopper of the cartridge. When mechanically engaged, i.e., connected to or abutting the stopper, and when the outer coupling member comes into proximity with the inner coupling member, a magnetic interaction begins to occur between the outer coupling member and the inner coupling member.

[0012] When viewed in the longitudinal direction, as the outer coupling member approaches the inner coupling member, the magnetic interaction continuously increases until the mechanical force effect transmitted through the magnetic coupling between the outer and inner coupling members is effective and sufficient to move the inner coupling member, and thus the stopper of the drug container, along the same direction as the outer coupling member moved by the drive member.

[0013] With two magnets separated along the direction of movement, for example along the longitudinal direction, the magnetic interaction with the third magnet can be improved. The mechanical or magnetic force of the arrangement of the first and second magnets relative to the third magnet can be increased. In this way, a fairly accurate and strong magnetic, and therefore quasi-mechanical, coupling can be provided between the outer and inner coupling members.

[0014] In some instances, it is the outer coupling member that includes the first and second magnets, and therefore it is the inner coupling member that includes the third magnet. In other instances, it is the inner coupling member that includes the first and second magnets, while the outer coupling member includes the third magnet. Providing the first and second magnets on one of the outer and inner coupling members and only one third magnet on the other of the outer and inner coupling members is generally sufficient to obtain the currently intended or desired magnetic interaction between the outer and inner coupling members.

[0015] In effect, the magnetic field of the first practice interacts with the magnetic field of the second practice, thus providing a resulting magnetic field of the first and second magnets, which interacts with the magnetic field of the third magnet.

[0016] According to a further example, the first and second magnets are separated by a gap of predefined longitudinal size. The gap may include a circumferential gap. It may include a free annular space located between the first and second magnets. A spacer may be provided in the gap located longitudinally between the first and second magnets. The spacer may entirely or at least partially fill the gap so as to keep the first and second magnets at a well-defined non-overlapping longitudinal distance from each other. The spacer or mount allows for precise control of the relative position of the first and second magnets.

[0017] In some examples, the gap between the first magnet and the second magnet is realized as an air gap. Thus, the gap between the first magnet and the second magnet is a void or an empty space. It may not be filled or occupied by a material. In other examples, a component or object may be placed in the gap between the first magnet and the second magnet. The component or object located inside or projecting into the gap may be of non-ferromagnetic and paramagnetic type. In particular, the component or object located inside or projecting into the gap between the first magnet and the second magnet may be of diamagnetic type. Effectively, the space or gap between the first magnet and the second magnet may be magnetically inactive.

[0018] According to a further example, at least one of the first magnet and the second magnet includes a magnetic pole of a first type and another magnetic pole of a second type. The magnetic poles of the first and second types are separated in a longitudinal direction. Thus, for example, the north pole of the third magnet may face in a proximal direction and the corresponding south pole of each magnet may face in a distal direction. Typically, the magnetic orientations of the first magnet and the second magnet are substantially parallel. Thus, the different poles of the first and second magnets are separated in a longitudinal direction. In some examples, the magnetic poles of the third magnet are also separated in a longitudinal direction.

[0019] In fact, by way of further example, the magnetic poles of all magnets of a magnetic coupling may be separated longitudinally, such that the north pole of the magnet may face in one of the proximal or distal directions and the south pole may face in the other of the proximal and distal directions as defined by the elongation of the longitudinally extending barrel.

[0020] According to a further example, the first magnet and the second magnet respectively comprise a first type and a second type of magnetic pole. The longitudinal end of the first magnet facing the second magnet as well as the longitudinal end of the second magnet facing the first magnet comprise a common type of magnetic pole. In this way, when the first and second magnets are aligned, for example coaxially, they are in a repelling configuration. Thus, the poles of the first magnet facing the second magnet are of the same type as the poles of the second magnet facing the first magnet. Thus, when the first and second magnets are brought together longitudinally, a respective repelling force is established between the first and second magnets. Typically, the first and second magnets are fixed to each other, for example they are fixed to the carrier of the drive member, or in another example, when the first and second magnets are provided on or in the inner coupling member, the two magnets can be fixed on or in the stopper of the cartridge.

[0021] The repulsive arrangement of the first and second magnets generates a respective repulsive magnetic field, for example in the longitudinal direction, between the first and second magnets, which separates them from each other. Such a magnetic field is used in particular for a rather strong and / or precise magnetic interaction with a third magnet.

[0022] In another example, the first and second magnets may be arranged in different orientations such that they attract each other. Thus, the longitudinal end of the first magnet facing the second magnet and the longitudinal end of the second magnet facing the first magnet include different types of magnetic poles. Here, for example, the north pole of the first magnet may face the south pole of the second magnet or vice versa, and the south pole of the first magnet may face the north pole of the second magnet. Thus, such an arrangement may increase the magnetic field of the arrangement of the first and second magnets, resulting in an increase in the resulting mechanical force that occurs when the third magnet magnetically interacts with the magnetic fields of the first and second magnets.

[0023] According to a further example, the longitudinal size of the gap between the first and second magnets is equal to or smaller than the longitudinal extent of the third magnet. By varying the longitudinal size of the gap between the first and second magnets, the magnetic response or magnetic interaction with the third magnet can be precisely tuned. This may be especially true when the first and second magnets are arranged in a repelling configuration, i.e., when the north pole of the first magnet faces the north pole of the second magnet, or when the south pole of the first magnet faces the south pole of the second magnet. Typically, a smaller longitudinal size of the gap between the repelling first and second magnets can increase the amplitude of the magnetic force between the outer and inner coupling members. An increased longitudinal size of the gap between the first and second magnets can provide a fairly uniform magnetic force over a relatively large range of relative distances between the outer and inner coupling members.

[0024] Depending on the particular use of the drive mechanism, for example whether configured to provide a bolus injection or a continuous flow of drug, the longitudinal size of the gap between the first and second magnets can be adjusted or regulated appropriately. If the longitudinal gap size between the first and second magnets is the longitudinal extent of the third magnet, a fairly uniform or even damped longitudinal force transmission can be provided between the outer and inner coupling members.

[0025] According to another example, the longitudinal size of the gap between the first and second magnets is equal to or greater than the longitudinal extent of the third magnet. By further increasing the longitudinal size of the gap, a more uniform force transmission can be provided between the outer and inner coupling members.

[0026] According to another example, the distance between the longitudinal center of the first magnet and the longitudinal center of the second magnet is equal to or smaller than the longitudinal extent of the third magnet. In this example, the longitudinal extent of the third magnet may further be at least slightly larger than the longitudinal extent of at least one of the first and second magnets. In this way, depending on the longitudinal size or extent of the first and / or second magnet, a gap of rather small longitudinal size between the first and second magnets may be realized. By adjusting or modifying the longitudinal distance between the first and second magnets and / or the distance between the longitudinal centers of the first and second magnets taking into account the longitudinal extent of the third magnet, the magnetic coupling between the outer coupling member and the inner coupling member may be adjusted according to predefined demands.

[0027] According to a further example, the distance between the longitudinal centre of the first magnet and the longitudinal centre of the second magnet is equal to or greater than the longitudinal extent of the third magnet, so that the entire third magnet can be located between the longitudinal centres of the first and second magnets, thus enabling a well-defined interaction and thus a respective force transmission between the outer and inner coupling members to be realised when the outer coupling member is moved relative to the barrel of the drug container or cartridge.

[0028] According to another example, at least one magnet of the outer coupling member comprises a ring magnet. The ring magnet is configured and / or sized to surround the barrel in a circumferential direction. The inner circumference, diameter or cross section of the ring magnet is therefore only slightly larger than the corresponding outer circumference, outer diameter or cross section of the barrel of the cartridge or drug container. Typically, the barrel is tubular and comprises a constant outer diameter when viewed in the longitudinal direction. This allows for a sliding displacement of the ring magnet relative to the barrel. This is particularly beneficial when the remaining annular gap between the inside of the ring magnet and the outside of the side wall of the barrel is rather small, for example less than 2 mm, less than 1 mm, or less than 0.5 mm. In this way, the radial distance between the ring magnet and the inner coupling member can be reduced to a minimum, thus providing a good magnetic coupling between the outer and inner coupling members.

[0029] Typically, when the first and second magnets are provided on the outer coupling member, the first and second magnets are both realized as ring magnets, so that they may be arranged coaxially or concentrically when viewed in the longitudinal direction.

[0030] According to a further example, the at least one magnet of the inner coupling member comprises a rod magnet. The rod magnet may comprise a tubular or any other geometric shape. The rod magnet is sized for insertion into the barrel of a drug container or cartridge.

[0031] According to a further example, the inner coupling member includes a third magnet, which includes a rod magnet. Here, the outer coupling member includes a first magnet and a second magnet. The first magnet and the second magnet are thus realized as ring magnets, respectively. The ring magnet and the rod magnet are arranged concentrically. Thus, when the outer coupling member is moved longitudinally relative to the barrel and thus relative to the stopper by the movement of the drive member, the magnetic field generated by the arrangement of the first and second magnets starts to electrically couple or magnetically interact with the magnetic field of the rod magnet, thereby transmitting a respective driving force to the connected lock and thus to the physician, for example to move it in a distal direction.

[0032] According to another example, the inner coupling member abuts longitudinally against the proximal face of the stopper. Alternatively or additionally, the inner coupling member is fastened or fixed to the stopper or the inner coupling member is integrated into the stopper. Since at least one of the magnets mentioned above is a component of the inner coupling member, this also applies correspondingly to the respective magnet, e.g. the third magnet. In some examples, the inner coupling member is provided with only a single magnet, e.g. the third magnet. The third magnet may abut longitudinally directly or indirectly against the proximal face of the stopper. Such an arrangement is sufficient to exert a distally directed thrust or pressure on the stopper. In other examples, the inner coupling member is fastened to the stopper or even integrated, e.g. embedded, into the stopper. Fastening or integration of the inner coupling member to the stopper is particularly useful for implementing a directional movement of the body of the stopper, e.g. in the distal as well as in the proximal direction by magnetic coupling between the outer and inner coupling members.

[0033] According to a further example, the inner coupling member comprises a first magnet and a second magnet. The first magnet and the second magnet each comprise a rod magnet coaxially arranged and fastened on the inner coupling member. Again, the first magnet and the second magnet are arranged longitudinally apart from each other, i.e. to form a gap of predefined longitudinal size between the first magnet and the second magnet. In this example, the third magnet may be provided on the outer coupling member and may comprise a ring magnet. Thus, the ring magnet and the first and second rod magnets are arranged coaxially and / or concentrically with respect to the axis of symmetry of the tubular barrel of the drug container or cartridge. In this example, the outer coupling member may comprise only one magnet, typically realized as a ring magnet.

[0034] According to another example, the outer coupling member includes a first magnet and a second magnet, each of which includes a ring magnet that is coaxially arranged with respect to one another and fastened onto a carrier or connected or embedded in a drive member and movable relative to the barrel. In such an implementation, the third magnet may be realized as a rod magnet and may be disposed within the barrel to mechanically engage with the stopper.

[0035] According to another example, it is the outer coupling member and the other of the coupling members that includes a third magnet and a fourth magnet separated from each other in the longitudinal direction by a gap of a predefined longitudinal size. Here, the outer coupling member may include the first magnet and the second magnet, and the inner coupling member may include the third magnet and the fourth magnet. In this example, the first magnet and the second magnet may be realized as ring magnets. The third magnet and the fourth magnet may each be realized as a rod magnet. The first magnet and the second magnet are fixed to each other to define a longitudinal gap between them. The same may apply to the third magnet and the fourth magnet. Also, the third magnet and the fourth magnet may be arranged and fixed to each other with a predefined gap of a predefined longitudinal size. In this example, the magnetic interaction between the outer coupling member and the inner coupling member may be precisely adjusted and defined, in particular by the longitudinal size, as well as by the mutual longitudinal arrangement and distance between the first magnet and the second magnet and between the third magnet and the fourth magnet.

[0036] According to a further example, the third magnet and the fourth magnet respectively comprise magnetic poles of the first type and the second type. The longitudinal end of the third magnet facing the fourth magnet and the longitudinal end of the fourth magnet facing the third magnet comprise magnetic poles of a common type or different types. When the opposing and mutually facing magnetic poles are of a common type, the third and fourth magnets can be arranged in a repulsive mode. Thus, the third and fourth magnets tend to repel each other. In the other configuration, where the longitudinal end faces of the third and fourth magnets facing each other comprise magnetic poles of different types, an attractive interaction is obtained between the third and fourth magnets. In the repulsive mode, two extra poles are formed with a strong magnetic field in the center or in the area between the third and fourth magnets.

[0037] Typically, when the respective magnetic poles facing each other are of different types, spacers are used between the respective magnets to prevent mutually induced movement towards each other.

[0038] According to another example, the drive mechanism includes an electric drive mechanically engaged with a spindle gear. The spindle gear includes an elongated rod extending in a longitudinal direction. By activating the electric drive, either the electric drive or the spindle gear is moved along the extension of the elongated rod. Here, the elongated rod may be fixed to a housing of the drive member or to a housing of the respective drug delivery device. In this example, the drive member may be mechanically fixed to the electric drive or to the spindle gear. Activating the drive leads to a respective movement of the drive member relative to the elongated rod in the longitudinal direction of the elongated rod. Typically, the elongated rod is a threaded rod.

[0039] In other examples, the drive member may be mechanically connected to the elongated rod, which may include a nut that threadably engages with the elongated rod, such that rotation of the elongated rod induced by activation of, for example, an electric drive, may result in longitudinal displacement of the drive member due to the threaded engagement between the drive member and the elongated rod.

[0040] Here, the drive member is splined to the drive mechanism or to the housing of the drug delivery device such that the drive member is allowed to move longitudinally but is prevented from rotating relative to the rotation axis of the elongate rod.

[0041] In another example, the drive mechanism includes an array or conventional arrangement of electromagnets. A number of electromagnets may be provided that are longitudinally adjacently arranged such that the array of electromagnets extends longitudinally, where the electromagnets are controlled by an electronic control and can be individually activated to magnetically interact with at least one magnet of the outer coupling member to move the outer coupling member longitudinally.

[0042] In practice, an array of electromagnets may surround the outer coupling member and provide a type of linear drive for the outer coupling member. By appropriately energizing the electromagnets, the resulting magnetic field is operable to move the outer coupling member longitudinally.

[0043] In another aspect, the present disclosure relates to a drug delivery device for dispensing a liquid medicament. The drug delivery device includes a housing configured to hold and / or receive a cartridge. Typically, the cartridge is filled with a liquid medicament and sealed by a stopper. Typically, the stopper seals a proximal longitudinal end of the cartridge and is movable relative to the cartridge or relative to the tubular barrel of the cartridge. The drug delivery device further includes a drive mechanism as described above. The drive mechanism may be integrated in the drug delivery device. It may be arranged and fixed in the housing of the drug delivery device. Here, the drive member of the drive mechanism may be arranged to move along a receiving space configured to hold or receive the cartridge in the housing of the drug delivery device. In this way, when the cartridge is properly assembled or placed in the housing, the drive member, in particular the outer coupling member, can slide along the outer circumference of the tubular cartridge in the longitudinal direction of the cartridge.

[0044] According to a further example, the drug delivery device further includes a cartridge filled with a liquid medicament and disposed within or fastened to the housing of the drug delivery device.

[0045] In some examples, the drug delivery device includes an injection device, such as a handheld injection device. In other examples, the drug delivery device includes an infusion device, such as an infusion pump. In other examples, the drug delivery device may include an inhaler.

[0046] Generally, in the drive mechanisms described above, the magnetic coupling between the outer and inner coupling members provides a fairly constant force that can be maintained over a relatively large relative distance between the outer and inner coupling members as the outer coupling member is moved longitudinally relative to the inner coupling member.

[0047] By having at least a first magnet and a second magnet on one of the outer and inner coupling members and keeping the two magnets at a predefined longitudinal distance from each other, a relatively high magnetic force can be transferred between the arrangement of the first and second magnets and the third magnet.

[0048] Due to the magnetic coupling between the outer and inner coupling members, a relatively short overall longitudinal extension of the drive mechanism can be realized. Thus, an elongated piston rod extending into the proximal extension of the longitudinally extending cartridge is no longer required. In practice, the longitudinal size of the housing of the drive mechanism or the housing of the drug delivery device may be defined primarily by the longitudinal extent of the cartridge.

[0049] Furthermore, mounting the first and second magnets on one of the outer and inner coupling members is of particular use in reusable drug delivery devices, where a third magnet, particularly when positioned longitudinally between or longitudinally overlapping the first and second magnets, can provide repulsive and attractive forces between the magnets to enable bidirectional force transmission, for example, in the proximal direction from the outer coupling member towards the inner coupling member as well as in the distal direction.

[0050] Further, it can provide maximum force in both opposing longitudinal directions.Further, in addition to and in comparison to preload force generation solutions, the magnetic coupling can be transferred to a fairly force-free initial or stored configuration in which there is substantially no magnetic interaction between the outer and inner coupling members.

[0051] The magnets described herein may be embodied as permanent magnets. They may, for example, comprise or consist of at least one of the following materials, including sintered neodymium-iron-boron (NdFeB), preferably with a medical grade coating, samarium-cobalt (SmCo) and aluminum-nickel-cobalt (AlNiCo).

[0052] Generally, the scope of the present disclosure is defined by the content of the claims. The infusion device is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. To that extent, the present disclosure covers any combination of the claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0053] In the present context, the term "distal" or "distal end" refers to the end of the injection device that points towards the injection site of a person or animal, whereas the term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest from the injection site of a person or animal.

[0054] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and, optionally, a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose disease, or to otherwise improve physical or mental health. Drugs or medicines may be used for a limited duration, or periodically for chronic diseases.

[0055] As described below, the drug or agent may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. The nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0056] The drug or agent may be placed in a primary package or "drug container" adapted for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing of two or more components prior to and / or during administration into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with one another (e.g., by a conduit between the two chambers), allowing the two components to be mixed if desired by a user prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0057] The drugs or agents contained in the drug delivery device as described herein may be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, such as, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index 15th Edition.

[0058] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g. human insulin, or insulin analogs or derivatives, glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharma-ceutically acceptable salts or solvates thereof, or any mixtures thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally obtained from the structure of a naturally occurring peptide, e.g. the structure of human insulin, by deleting and / or replacing at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0059] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0060] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0061] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, GilaMonster (Gila 39 amino acid peptide produced by the salivary glands of the pancreatic monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-exendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN -9926, NN-9927, nodexene, Viadol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0062] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0063] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0064] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0065] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the above polysaccharides, and / or pharmaceutically acceptable salts thereof.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0066] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody may be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.

[0067] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0068] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences, but are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen. Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0069] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0070] It will be understood by those skilled in the art that modifications (addition and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0071] Furthermore, it will be apparent to those skilled in the art that various modifications and changes can be made to the present disclosure without departing from the scope of the present disclosure. Furthermore, it should be noted that any reference signs used in the appended claims should not be construed as limiting the scope of the present disclosure.

[0072] In the following, a number of examples of infusion device usage and data logging devices for monitoring the respective infusion devices are described in detail with reference to the drawings. [Brief description of the drawings]

[0073] [Figure 1] 1 shows a perspective cross-sectional view of an example of a drive mechanism of a drug delivery device for delivering a liquid medicament. [Diagram 2] FIG. 2 is a schematic diagram of a magnetic coupling according to a first embodiment. [Diagram 3] 3 shows a schematic representation of the magnetic coupling of FIG. 2 in another form; [Figure 4] 1 shows an example of first and second magnets separated longitudinally. [Diagram 5] 13 illustrates a further example of first and second magnets positioned longitudinally apart from one another. [Figure 6] 13 illustrates a sequence of five positions of the outer coupling member relative to the inner coupling member during movement of the outer coupling member in a distal direction relative to the inner coupling member. [Figure 7] 7 shows multiple views of the magnetic force between the outer and inner coupling members according to the five positions of FIG. 6 for three different longitudinal spacings between the first and second magnets. [Figure 8] 2 shows two further examples of third and fourth rod magnet arrangements. [Figure 9] 13 illustrates another implementation of a drive mechanism featuring multiple electromagnets for inducing longitudinal movement of the outer coupling member. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] The drug delivery device 10 as shown in FIG. 1 includes a drive mechanism 11 and a housing 12. The drive mechanism 11 is integrated into or disposed within the housing 12. The housing 12 includes a compartment 14 sized and configured to receive and / or hold, i.e., secure, a drug container 22, which in this case is realized as a tubular cartridge. The cartridge may include a glass body. The drug container 22 includes a tubular barrel 23, e.g., a vitreous material. The container 22 is sealed in a longitudinal proximal direction by a stopper 24. The stopper 24, typically made of an elastomeric material, is longitudinally movable within the tubular barrel 23. The internal volume of the cartridge is limited by the barrel 23, the stopper 24, and an outlet 27 provided at the distal end of the cartridge. The cartridge is fillable or filled with a liquid drug 21. The outlet 27 of the cartridge is typically covered or closed with a seal 28. The seal 28 may comprise a rubber disc pierceable by an injection needle 29 to displace or urge the stopper 24 towards the outlet 27, thereby expelling a dose of the liquid medicament 21 from within the cartridge.

[0075] The outlet 27 of the drug container 22 may be connected to an injection needle 29, which is shown only diagrammatically in Figure 1. In other examples, the outlet 27 may include a standardized connector, such as a Luer connector, that can connect an infusion line in fluid communication with the interior of the drug container 22.

[0076] In the currently illustrated example, the drug container 22 is fixed within the housing 12. It may be removably fixed within the housing. Thus, the housing may include some sort of removable fastener or movable closure that can provide access to the interior of the compartment 14 for replacing the drug container 22 when empty.

[0077] The drive mechanism 11 further includes an elongated rod 20. The elongated rod 20 extends substantially parallel to the longitudinal direction of the tubular drug container 22. The elongated rod 20 may include a threaded rod, which may include an external thread. The rod 20 may be threadedly engaged with a spindle gear 18, which in turn is operably engaged with the electric drive 16. As shown in FIG. 1, the spindle gear 80 may be located inside a gear box, for example, which may also surround the electric drive 16. By activating the electric drive 16, the spindle gear 18 also rotates to advance along the longitudinal extent of the elongated rod 20. It is clear that the arrangement of the electric drive 16 and the spindle gear 18 is prevented from rotating inside the housing 12. Thus, activation of the electric drive 16, and therefore the spindle gear 80, leads to longitudinal movement of the electric drive 16 along the elongated rod due to the threaded engagement between the spindle gear 18 and the threaded rod 20.

[0078] The drive mechanism 11 further includes a drive member 30. As shown in FIG. 1, the drive member 30 projects radially from the elongated rod 24 and is fixedly attached to the electric drive 16 or spindle gear 18. Activation of the electric drive 16 results in longitudinal sliding motion of the drive member 30. As shown, the drive member 30 includes a type of tubular or sleeve-like shape. The inner diameter or cross-section of the drive member 30 is sized to surround the outer circumference or outer surface 25 of the barrel 23 of the drug container 22. The drive member 30 further includes an outer coupling member 40 of a magnetic coupling 36. The magnetic coupling 36 further includes an inner coupling member 50. The inner coupling member 50 may include at least a magnet 53 attached to or at least longitudinally abutting the proximal surface 26 of the stopper 24.

[0079] The inner coupling member 50 is sized and configured for insertion into the proximal end of the barrel 23 of the drug container 22. The outer coupling member 40 includes a first magnet 41 and a second magnet 42. Both the first magnet 41 and the second magnet 42 are realized as ring magnets 45. Although not specifically shown in FIG. 1, the first magnet 41 and the second magnet 42 are separated in a longitudinal direction' (z) by a gap 43 of a predefined size. The gap 43 is specifically shown in FIGS. 4 and 5.

[0080] Additionally, the ring magnet 45, and therefore the first and second magnets 41, 42, are sized and configured to surround the outer periphery 25 of the barrel 23. In this manner, the outer coupling member 40, with its first and second magnets 41, 42, is configured to slide along the sidewall of the barrel 23.

[0081] 1, the drive member 30 provides or includes a carrier 31 for the first magnet 41 and the second magnet 42, respectively. Thus, the first magnet 41 and the second magnet 42 are mounted and / or disposed on or within the carrier 31 and thus on or within the drive member 30. The drive member 30 and the carrier 31 may be formed unitarily. In some examples, the carrier 31 may be provided by the drive member 30.

[0082] The inner coupling member 50 may include a respective carrier (not shown). However, as currently illustrated, the inner coupling member 50 may also be generally represented or provided by a single magnet 53. In another example, the inner coupling member may be equipped with a third magnet 53 and an optional fourth magnet 54, as shown in FIG. 8, where the coupling member 50 includes a type of carrier to which the third and fourth magnets 34, 54 are mechanically attached or fixed. As a further example, the carrier of the inner coupling member 50 may be provided by the stopper 24 of the medicament container 22.

[0083] In the examples of Figures 1-6, the magnet 53 is a third magnet. It may be the only magnet of the inner coupling member 50. As shown in particular in Figure 2, the outer coupling member 40 is slidable relative to the barrel 23 of the drug container 22, while the third magnet 53, for example realized as a rod magnet 55, is attached or fixed to the stopper 24 of the drug container 22. In the configuration of Figure 2, the outer coupling member 40 has moved a certain distance from the proximal end of the drug container 22 towards the distal end of the drug container 22. In the configuration as shown in Figure 2, the first magnet 41 is somewhat longitudinally aligned or longitudinally overlapped with the third magnet 53. Here, the respective facing poles of the first magnet 41 and the third magnet 53 may initially repel. As soon as the configuration as shown in Figure 2 is reached, the respective different pole sections of the first magnet 41 and the third magnet 53 may attract each other.

[0084] As the outer coupling member 40 is moved further in the distal direction, and therefore closer to the outlet port 27, as shown in FIG. 3, the interaction between the outer coupling member 40 and the inner coupling member 50 may be further influenced by the magnetic field of the second magnet 42 of the outer coupling member 40. The south pole S of the third magnet 53 may be in a repulsive interaction with the south pole S of the first magnet 41. The north pole N of the third magnet 53 is in an attractive interaction with the south pole P of the second magnet 42.

[0085] Experiments have revealed that the configuration according to Figure 2 is a fairly neutral configuration, with minimal longitudinal force effects as transmitted from the outer coupling member 40 to the inner coupling member 50. In the configuration of Figure 3, longitudinal force transmission between the outer coupling member 40 and the inner coupling member 50 is maximum.

[0086] In FIG. 4, the longitudinal distance LS between the longitudinal centre of the first magnet 41 and the longitudinal centre of the second magnet 42 is substantially equal to the longitudinal extent or longitudinal size LS of the third magnet 53 .

[0087] In Fig. 5, gaps 43 of different sizes are provided, where the longitudinal size LS of the gap 43 between the first magnet 41 and the second magnet 42 is substantially equal to the longitudinal size or longitudinal extent of the third magnet 53. Here, by adjusting the longitudinal size of the individual magnets 41, 42, 53 and also by changing the longitudinal distance between the first magnet 41 and the second magnet 42, the force transmission between the outer coupling member 40 and the inner coupling member 50 can be appropriately modified, for example, according to the relevant application scenario.

[0088] In the examples of Figures 2-7, the first magnet 41 and the second magnet 42 are arranged in a repelling configuration. Thus, the longitudinal end 44 of the first magnet 41 facing towards the second magnet 42 and the longitudinal end 46 of the second magnet 42 facing towards the first magnet 41 have the same polarity or contain the same magnetic pole. In the examples of Figures 2 and 3, the south poles of the first magnet 41 and the second magnet 42 face towards each other.

[0089] As a result, a relatively strong magnetic field is provided with two extra magnetic poles at the center or in the region between the first magnet 41 and the second magnet 42. These supplementary magnetic poles, as shown for example in FIG. 8, are particularly beneficial in achieving a relatively strong longitudinal force transmission between the outer coupling member 40 and the inner coupling member 50.

[0090] In the diagram of Fig. 6, the outer coupling member 40 is shown in five different positions Pos.1, Pos.2, Pos.3, Pos.4 and Pos.5 as it is moved by the drive member 30 from a proximal end position as shown in position Pos.1 to a distal end position Pos.5. The respective positions are also reflected in the graph of Fig. 7. Furthermore, in Fig. 7, three different measurement curves 100, 102, 104 of magnetic force transmission versus displacement of the outer coupling member 40 relative to the drug container 22 are shown. Here, curve 104 is a comparative example showing force transmission versus longitudinal displacement when the outer coupling member 40 includes only a single ring magnet 45.

[0091] Curve 100 represents an example in which a relatively large longitudinal spacing between the first magnet 41 and the second magnet 42 is realized. Here, the longitudinal size of the gap 43 between the first magnet 41 and the second magnet 42 was about 8 millimeters. The longitudinal size of the gap 43 can therefore be in the region of the longitudinal extent of the third magnet 53.

[0092] As is immediately evident from the curve 100, the peaks below associated with Pos.3 and Pos.4 are significantly flattened. Thus, a fairly constant force is provided over a relatively long relative distance. This is particularly beneficial in providing a constant longitudinal force transmission, regardless of the longitudinal displacement of the outer coupling member 40 relative to the drug container 22. In a further curve 102, the distance between the first magnet 41 and the second magnet 42, and therefore the gap size, is reduced, for example, to a size of about 2 mm. The longitudinal size of the gap may be less than 50%, less than 30% or less than 20% of the longitudinal extent of the third magnet 53.

[0093] As can be seen immediately, the amplitude of the magnetic force transmission is substantially increased compared to that of the comparison curve 104. Thus, in this configuration, at the relative position Pos. 3, also reflected in FIG. 3, it is possible to provide a longitudinal force effect or force transmission that is approximately twice as large as the solution using only one ring magnet 45.

[0094] When the outer coupling member 40 is moved towards Pos.1 as shown in Figures 6 and 7, initially a distal repelling force is exerted on the third magnet 53, thus urging the third magnet 53 in the distal direction.

[0095] At Pos.2, there is no net longitudinal force effect. As the outer coupling member 40 is moved further distally, a distally directed force is exerted on the magnet 53. Here, maximum force transfer is provided between the outer coupling member 30 and the inner coupling member 50 to move the inner coupling member 50 and thus the stopper 24.

[0096] In the configuration of FIG. 3, due to the fairly symmetrical arrangement of the first and second magnets 41, 42 as viewed in the longitudinal direction (z), it is also possible to move the third magnet 53 in the opposite direction, and thus towards the proximal end, i.e. by moving the outer coupling member 40 in the opposite, and therefore proximal, direction, i.e. away from the outlet 27.

[0097] In Fig. 8 two further examples of the inner coupling member 50 are shown, which not only include a third magnet 53 but also a fourth magnet 54. Here, the third magnet 53 and the fourth magnet 54 are both realized as rod magnets 55. They are coaxially arranged and separated along the longitudinal direction (z) by a gap 56 of a predefined longitudinal size.

[0098] In the example shown on the left side of Fig. 8, the third magnet 53 and the fourth magnet are co-aligned in an attractive manner, where the longitudinal end 57 of the third magnet 53 facing towards the fourth magnet 54 and the longitudinal end 58 of the fourth magnet 54 facing towards the third magnet 53 comprise different types of magnetic poles. Thus, the third magnet 53 and the fourth magnet 54 attract each other.

[0099] The resulting magnetic field is therefore lower than that of a rod magnet oriented in the opposite direction as shown in the example on the right side of Figure 8. Here, the longitudinal end 57 of the third magnet 53 facing towards the fourth magnet 54 and the longitudinal end 58 of the fourth magnet 54 facing towards the third magnet 53 comprise a common type of magnetic pole.

[0100] Thus, two extractor poles are created with a strong magnetic field in the center, which can interact with the resulting magnetic fields of the first and second magnets 41, 42 respectively.

[0101] In Figure 9, another example of the drive mechanism 11 is shown. Instead of an electric drive 16 and spindle gear 18 as shown in Figure 1, the drive mechanism 11 includes several individual electromagnets 71, 72, 73. Each electromagnet 71, 72, 73 typically includes a coil and generates a magnetic field when a respective electric current is passed through it. The individual electromagnets 71, 72, 73 form or configure an array 70 of electromagnets extending in a longitudinal direction (z) and thus parallel to the elongation of the drug container 22.

[0102] The outer coupling member 40 comprises a first ring magnet 41 and a second ring magnet 42, which are arranged concentrically at a longitudinal distance from each other. The electromagnets 71, 72, 73 may be realized as so-called air-core coils and may be covered with a sheet of so-called μ-metal to ensure sufficient magnetic flux. By means of a controller (not shown), the individual coils and therefore the electromagnets 71, 72, 73 may be excited to induce a longitudinal movement of the outer coupling member 40 relative to the barrel 23. Here, the first and second magnets 41, 42 of the outer coupling member 40 provide and fulfil a dual function.

[0103] A first magnetic coupling comprising an array 70 of electromagnets 71, 72, 73 allows the outer coupling member 40 to move in a longitudinal direction (z) relative to the medicament container 22. A magnetic coupling 36 between the third magnet 53 of the inner coupling member 50 and the first and second magnets 41, 42 of the outer coupling member 40 allows the longitudinal movement of the outer coupling member 40 to be transferred to a respective longitudinal advancement or displacement of the stopper 24. [Explanation of symbols]

[0104] 10 Drug Delivery Devices 11 Drive mechanism 12. Housing 14 Plots 16 Electric Drive Unit 18 Spindle gear 20 Rod 21 Drugs 22 Drug containers 23 Barrel 24 Stopper 25 Exterior 26 Proximal aspect 27 Outlet 28 Seal 29 Syringe needle 30 Driving member 31 Career 36 Magnetic Coupling 40 Outer coupling member 41 Magnet 42 Magnet 43 Gap 44 Longitudinal end 45 Ring Magnet 46 Longitudinal end 50 Inner coupling member 53 Magnet 54 Magnet 55 Rod Magnet 56 Gap 57 Longitudinal end 58 Longitudinal end 70 Array 71 Electromagnet 72 Electromagnet 73 Electromagnet

Claims

1. A drive mechanism (11) for moving a stopper (24) of a drug container (22), the stopper (24) being movably disposed within a longitudinally extending barrel (23) of the drug container (22), the drive mechanism (11) comprising: a drive member (30) movable along a longitudinal direction (z) parallel to the longitudinal extent of said barrel (23); a magnetic coupling (36) including an outer coupling member (40) and an inner coupling member (50), the outer coupling member (40) being mechanically engaged with the drive member (30) and configured to move along the outer surface (25) of the barrel (23), and the inner coupling member (50) being mechanically engageable with the stopper (24) and configured for insertion into the barrel (23); Including, a drive mechanism (11), wherein at least one of the outer coupling member (40) and the inner coupling member (50) comprises a first magnet (41) and a second magnet (42) separated from each other in the longitudinal direction (z) and configured to magnetically couple with a third magnet (53) of the other of the outer coupling member (40) and the inner coupling member (50).

2. 2. The drive mechanism (11) of claim 1, wherein the first magnet (41) and the second magnet (42) are separated by a gap (43) of a predefined longitudinal size.

3. 3. The drive mechanism (11) of claim 1 or 2, wherein at least one of the first magnet (41) and the second magnet (42) comprises a magnetic pole (N) of a first type and another magnetic pole (S) of a second type, the magnetic poles (N, S) of the first and second types being separated in a longitudinal direction (z).

4. 4. The drive mechanism (11) according to claim 3, wherein the first magnet (41) and the second magnet (42) respectively comprise magnetic poles of the first type (N) and the second type (S), wherein a longitudinal end (44) of the first magnet (41) facing towards the second magnet (42) and a longitudinal end (46) of the second magnet (42) facing towards the first magnet (41) comprise magnetic poles of a common type (N, S).

5. A drive mechanism (11) as described in any one of claims 2 to 4, wherein the longitudinal size of the gap (43) between the first magnet (41) and the second magnet (42) is less than or equal to the longitudinal extent of the third magnet (53).

6. The drive mechanism (11) according to any one of claims 2 to 5, wherein the distance between the longitudinal center of the first magnet (41) and the longitudinal center of the second magnet (42) is less than or equal to the longitudinal extent of the third magnet (53).

7. The drive mechanism (11) of any one of claims 1 to 6, wherein the at least one magnet (41, 42, 53) of the outer coupling member (40) comprises a ring magnet (45) configured and / or sized to circumferentially surround the barrel (23).

8. The drive mechanism (11) according to any one of the preceding claims, wherein the at least one magnet (41, 42, 53) of the inner coupling member (50) comprises a rod magnet (55).

9. The drive mechanism (11) according to any one of the preceding claims, wherein the inner coupling member (50) comprises the third magnet (53), the third magnet (53) comprising a rod magnet (55).

10. The inner coupling member (50) - in longitudinal abutment with the proximal face (26) of said stopper (24), - fastened to said stopper (24), or - is it integrated into said stopper (24)? The drive mechanism (11) according to any one of claims 1 to 9, wherein the drive mechanism (11) is one of the following:

11. The drive mechanism (11) according to any one of claims 1 to 10, wherein the inner coupling member (50) comprises the first magnet (41) and the second magnet (42), each of the first magnet (41) and the second magnet (42) comprising a rod magnet (45) arranged coaxially and fastened to the inner coupling member (50).

12. The drive mechanism (11) according to any one of claims 1 to 10, wherein the outer coupling member (40) comprises the first magnet (41) and the second magnet (42), each of the first magnet (41) and the second magnet (42) comprising a ring magnet (45) fastened on a carrier (31) connected to or embedded in the drive member (30) arranged coaxially and movable relative to the barrel (23).

13. The drive mechanism (11) according to any one of claims 1 to 12, wherein the other of the outer coupling member (40) and the inner coupling member (50) comprises the third magnet (53) and the fourth magnet (54) separated from each other in the longitudinal direction (z) by a gap (56) of a predefined longitudinal size.

14. The drive mechanism (11) according to any one of claims 1 to 13, wherein the third magnet (53) and the fourth magnet (54) respectively comprise magnetic poles of the first type (N) and the second type (S), wherein a longitudinal end (57) of the third magnet (53) facing towards the fourth magnet (54) and a longitudinal end (57) of the fourth magnet (54) facing towards the third magnet (53) comprise magnetic poles of a common type or different types (N, S).

15. The drive mechanism (11) according to any one of claims 1 to 14, wherein the drive member (30) includes an electric drive (16) mechanically engaged with a spindle gear (18), the spindle gear (18) including an elongated rod (20) extending in an elongated longitudinal direction (z).

16. The drive mechanism (11) according to any one of claims 1 to 14, further comprising an array (70) of electromagnets (71, 72, 73) extending in the longitudinal direction (z) and operable to magnetically interact with the at least one magnet (41, 42, 53) of the outer coupling member (40) to move the outer coupling member (40) in the longitudinal direction (z).

17. The drive mechanism (11) of any one of claims 1 to 16, wherein the outer coupling member (40) is mechanically connected or fixed to the drive member (30) and is movable along the outer surface (25) of the barrel (23).

18. 1. A drug delivery device for dispensing a liquid medicament, comprising: a housing (12) configured to hold and / or receive a drug container (22) filled with a liquid drug and sealed by a stopper (24); and A drive mechanism (11) according to any one of claims 1 to 17.

13. A drug delivery device comprising:

19. 20. The drug delivery device (10) of claim 18, further comprising a drug container (22) disposed within or fastened to the housing (12).

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