Carrying case for drug delivery device and drug delivery device

Abstract

The present invention refers to a drug delivery device (10) having a carry case (1) for storing the drug delivery device (10) and a rotatable dose dial member (11). The case (1) includes an outer shell (2) and a support recess (3) for receiving and holding the drug delivery device (10). In addition, the case (1) further includes a coupling member (5) for mechanically engaging the dose dial member (11) of the drug delivery device (10), an electric motor (4), a battery, and a processor connected to the motor (4) and the battery. The coupling member (5) is configured to be driven by said motor (4) to rotate the dose dial member (11) when engaged with the coupling member (5).

Description

[Technical field]

[0001] The present invention is generally directed to a carry case for a drug delivery device. The present invention further relates to a drug delivery device and a system of such a carry case and a corresponding drug delivery device. [Background technology]

[0002] Pen-type drug delivery devices have applications where regular injections occur by people without formal medical training. This is becoming more common for patients suffering from diabetes, where self-medication allows such patients to effectively manage their disease. In practice, such drug delivery devices allow a user to individually select and dispense several user-variable doses of medication. However, setting the correct dosage can be difficult or burdensome for patients with, for example, visual and / or hand impairments.

[0003] There are essentially two types of drug delivery devices: resettable (i.e. reusable) and non-resettable (i.e. disposable). For example, disposable pen delivery devices are supplied as stand-alone devices. Such stand-alone devices do not have a removable pre-filled cartridge. Rather, the pre-filled cartridge may not be removable and replaceable from these devices without destroying the device itself. Thus, such disposable devices do not need to have a resettable dose setting mechanism. The present invention is applicable to disposable and reusable devices.

[0004] It is commonly known to store drug delivery devices in a carry case to prevent damage to or contamination of the device. Such a carry case may include an outer shell and a support recess for receiving and holding the drug delivery device. DE 42 08 677 A1 discloses an injection device for visually impaired patients, comprising a case having a receiving section for a pen-type drug delivery device, a dose setting wheel and a gear coupled to the dose setting wheel. The dose setting wheel is configured to engage with an annular gear on the drug delivery device when the drug delivery device is held in the case. Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present disclosure is to facilitate dose titration, especially for patients with visual and / or hand impairments. [Means for solving the problem]

[0006] This object is solved, for example, by the subject matter defined in the independent claims. Advantageous embodiments and refinements are the subject of the dependent claims. It should be noted, however, that the present disclosure is not limited to the subject matter defined in the appended claims. Rather, the present disclosure may include refinements in addition to or instead of those defined in the independent claims, as will become apparent from the following description.

[0007] One aspect of the present disclosure relates to a carry case having an outer shell and a support recess for receiving and holding a drug delivery device. In addition, the case includes a coupling member for mechanically engaging a rotatable dose dial member of the drug delivery device. The coupling member may include and / or be part of a gearbox mechanism. Furthermore, the case may include an electric motor, a power supply, for example one or more batteries, such as a coin cell battery or a cylindrical battery, and a processor connected to the motor and the battery. The processor may be provided with or may include a memory for storing data. Preferably, the coupling member is configured to be driven by said motor to rotate the dose dial member when engaged with the coupling member. In other words, the case is configured and adapted to perform a dose setting operation by actuating the dose dial member of the drug delivery device. This dose setting operation may be the only possibility of dose setting of the drug delivery device or may be an additional function as an alternative to the known manual dose setting operation. Thus, in addition to storing and protecting the drug delivery device, the case has an additional function that allows setting the dose to be administered by the drug delivery device.

[0008] The case may generally be suitable for storing and holding any kind of, e.g., pen-type drug delivery device and its accessories such as injection needles, whereas the case according to the present disclosure is adapted to mate and interact with a specific kind of drug delivery device, i.e., the drug delivery device includes a rotatable dose dial member for setting the dose to be administered by the drug delivery device, which engages with a coupling member of the case to transmit torque from the coupling member to the dose dial member.

[0009] According to one example, the coupling member may be a gear, in particular a gear with serial or radially outward gear teeth. The motor may be a micro gear motor, i.e. a motor and gearbox combination, which may include or be engageable by the coupling member.

[0010] The case may further comprise a communication unit for communicating with another device, e.g. a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), mini-USB or micro-USB connector. Preferably, the case comprises an RF, WiFi and / or Bluetooth unit as a communication unit. The communication unit may be provided as a communication interface between the case and the outside, e.g. another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, dosage data may be transmitted by the communication unit to the external device. The dosage data may be used for a dosage log or dosage history established in the external device. Additionally or alternatively, the communication unit may receive data from the external device, e.g. data regarding the health status of the user and / or dosage data regarding the amount of drug delivered by the drug delivery device.

[0011] In addition to or as an alternative to the communication unit, the case may include at least one data input member and / or at least one data output member. For example, dosage data may be input by the at least one data input member. The data output member may include an LCD display connected to the processor and may display, for example, a history of the last administered dose or a dosage recommendation.

[0012] To facilitate setting a dose in a drug delivery device using the case of the present disclosure, the processor may be configured to calculate, receive and / or store data corresponding to a dosage to be administered by the drug delivery device. More specifically, the processor may be configured to operate the motor to rotate the coupling member a prescribed number of revolutions corresponding to the dosage to be administered by the drug delivery device. This may include rotating the coupling member in a dose-decreasing direction until any previously set dose is cancelled, and then rotating the coupling member in a dose-increasing direction until the intended dose is set. To more accurately perform the prescribed number of revolutions with a motor, for example a small DC motor with a gearbox, the motor or mechanism may include a position sensor and / or encoder that allows the motor to operate in a closed-loop positioning mode. Such a position sensor and / or encoder may be coupled or connected to the processor.

[0013] According to yet another aspect of the present disclosure, a drug delivery device for setting and dispensing a liquid drug, for example in variable or fixed doses, may include a cartridge containing the liquid drug, and a dose setting and drive mechanism configured to perform a dose dial setting operation to select a dose to be delivered by the drug delivery device and a dose delivery operation to deliver the set dose, the dose setting and drive mechanism including, for example, a rotatable dose dial member configured to be mechanically engaged by a driven coupling member, preferably a case coupling member as described above. In one example, the dose dial member includes a ring of radially inwardly directed gear teeth.

[0014] The drug delivery device may be a reusable device that allows replacement of an empty cartridge, for example the cartridge may be received in a releasably attached cartridge holder.

[0015] In one embodiment, the drug delivery device includes a dial sleeve, e.g. a number sleeve, rotatable relative to the housing, e.g. along a helical path, at least in the dose setting motion. Additionally, a manually operable injection trigger, e.g. a dose and / or injection button or a member axially and / or rotationally locked thereto, may be axially displaceable relative to the dial sleeve and rotationally constrained relative to the housing, at least in the dose delivery motion.

[0016] The present disclosure is applicable to devices that are manually actuated, for example by the user applying force to an injection button, devices actuated by springs or the like, and devices that combine these two concepts, i.e., spring-assisted devices that still require the user to apply an injection force. Spring-type devices include preloaded springs and springs that are loaded by the user during dose selection. Some stored energy devices use a combination of spring preload and additional energy provided by the user, for example during dose setting.

[0017] According to one aspect of the present disclosure, the dose dial member may be located at a proximal end portion of the drug delivery device. To prevent unintentional modification of the set dose, at least a radially outer surface and / or a proximally facing annular surface of the dose dial member may be shielded by a cover member of the drug delivery device.

[0018] Additionally or alternatively, the drug delivery device may further include a locking mechanism that may be switched between a locked state that prevents dose setting and an unlocked state that allows dose setting. For example, the locking mechanism prevents rotation of the dose dial member when in its locked state and allows rotation of the dose dial member when in its unlocked state. Optionally, the locking mechanism may be biased to its locked state and switched to its unlocked state by placing the drug delivery device in the case, in particular by mechanical engagement of the dose dial member with the coupling member. In an alternative example, an axially shiftable portion that matches the internal geometry of the dial member may lock the rotation and then be pushed by the coupling member, thereby unlocking the rotation. As yet another alternative, an inwardly facing gear may be used as the axially movable locking member and a gear with outwardly facing teeth may be used as the dial member. In this case, the coupling member may have an annular shape that matches the inwardly facing teeth. Furthermore, the drug delivery device may include, for example, an annular slot under the cover, into which a matching geometry of the case may enter when the device is placed in the case, thereby unlocking the mechanism.

[0019] The present disclosure is further directed to a combination or system including a carry case and a drug delivery device as described above.

[0020] The present disclosure further relates to a drug delivery device having an electronic system as described above, the drug delivery device including a cartridge containing a medicament.

[0021] As used herein, the terms "drug" or "medicament" are used interchangeably 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 has a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease or otherwise enhance physical or mental comfort. Drugs or agents may be used for a limited period of time or on a regular basis for chronic conditions.

[0022] As described below, the drug or medicament 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 a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked DNA and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes and oligonucleotides. The nucleic acid may be incorporated into a molecular delivery system such as a vector, a plasmid or a liposome. Mixtures of one or more drugs are also contemplated.

[0023] The drug or agent may be placed in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber 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 between the 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 each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired 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.

[0024] 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 include 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, for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs) and the Merck Index, 15th edition.

[0025] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g. human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or a GLP-1 receptor agonist or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor or a pharma-ceutically acceptable salt or solvate thereof or any mixture thereof. As used herein, the terms "analog" and "derivative" refer 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, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or addition of 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 referred to as "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, such as 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 substituted 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.

[0026] 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.

[0027] 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.

[0028] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, C M-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, Z P-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.

[0029] 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.

[0030] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0031] 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.

[0032] 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 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.

[0033] 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. The 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, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the 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 with crossover binding region orientation (CODV).

[0034] 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 a full-length antibody polypeptide but comprises at least a portion of a 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.

[0035] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within 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 within 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 within 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 within the CDR to interact with the antigen.

[0036] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0037] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or pharmaceutical preparation in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0038] It will be understood by those skilled in the art that modifications (additions 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 any and all equivalents thereof.

[0039] Exemplary drug delivery devices may include 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 may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or may be an integrated non-exchangeable container.

[0040] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0041] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an exchangeable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable volume to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable volume to be expelled (partial expulsion). As also described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable volume to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable volume to be expelled (partial expulsion).

[0042] As used herein, the terms "axial", "radial" or "circumferential" may be used with respect to the main longitudinal axis of a device, cartridge, housing or cartridge holder, e.g., an axis extending through the proximal and distal ends of a cartridge, cartridge holder or drug delivery device.

[0043] Non-limiting exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0044] [Figure 1] FIG. 1 is a perspective view of one embodiment of a carry case and a corresponding drug delivery device. [Diagram 2] 1 shows details of the case and the drug delivery device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] In the figures, identical elements, identically functioning elements or elements of the same type may be labeled with the same reference numbers.

[0046] In the following, some embodiments are described with reference to an insulin infusion device, however, the present disclosure is not limited to such application and may be equally deployed with infusion devices configured to deliver other medicaments or drug delivery devices in general, preferably pen devices and / or infusion devices.

[0047] Some embodiments of the present disclosure are indicated as suitable for use with injection devices as described in WO 2014 / 033195 or WO 2014 / 033197, in which an injection button and a grip (dose setting member or dose setter) are combined. The injection button may provide a user interface member for initiating and / or executing a dose delivery operation of the drug delivery device. The grip or knob may provide a user interface member for initiating and / or executing a dose setting operation. Both devices are of the dial-extension type, i.e. the length of these devices increases during dose setting. Other injection devices having the same kinematic behavior of the dial extension and button during dose setting and dose ejection operating modes are known, for example the Kwikpen® device marketed by Eli Lilly (also described in WO 2005 / 018721) and the Novopen® 4 device marketed by Novo Nordisk (also described in US Pat. No. 6,663,602). Therefore, the application of the general principles to these devices is clearly straightforward and will not be described further. However, the general principles of the present disclosure are not limited to their kinematic behavior. Some other embodiments can be devised for application to injection devices such as those described in WO 2004 / 078239 or WO 2009 / 132777, where there is a separate injection button and grip component / dose setting member. There can therefore be two separate user interface members, one for the dose setting action and one for the dose delivery action.

[0048] In this specification, "distal" is used to designate a direction, end or surface that is or will be positioned to face or face toward the dosing end of the drug delivery device or a component thereof and / or faces away from the proximal end. On the other hand, "proximal" is used to designate a direction, end or surface that is or will be positioned to face away from the dosing end and / or the distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dosing end and / or furthest from the proximal end, and the proximal end may be the end furthest from the dosing end. The proximal face may face away from the distal end and / or towards the proximal end. The distal face may face towards the distal end and / or away from the proximal end. The dosing end may be, for example, the needle end where the needle unit is or will be attached to the device.

[0049] Figure 1 is a perspective view of a carry case 1 for storing at least one drug delivery device 10. The case 1, in the illustrated exemplary embodiment, includes an outer shell 2 consisting of two hinged half shells. The half shells can be opened to provide access to the interior of the shell 2, as shown in Figure 1, or closed to enclose at least one drug delivery device 10.

[0050] At least one support recess 3 is provided in the shell 2 shaped to receive the pen-type drug delivery device 10. To this end, the support recess has a shape for closely receiving at least a part of the drug delivery device 10. For example, the drug delivery device 10 can be held in the support recess 3 by snap-fitting.

[0051] Furthermore, the case 1 includes an electric motor 4, a coupling member in the form of a gear 5 connected to the motor 4, data input means, e.g. an LCD display 6, a battery (not shown), and a processor (not shown) connected to the motor 4, the display 6 and the battery. The case may optionally include data input means (not shown), e.g. a Bluetooth® communication interface, and / or a keyboard, and / or a socket for connecting the processor or the battery of the case 1 with an external device.

[0052] As shown in more detail in Figure 2, the coupling member is a gear 5 with a series of gear teeth facing radially outward. The gear 5 may be part of a gear box that is rotationally connected to the motor 4, which drives the gear 5 when it is operated. The gear 5 meshes and engages with a rotatable dose dial member 11 of the drug delivery device 10 when the drug delivery device 10 is received in the support recess 3 of the case 1.

[0053] The dose dial member 11 is located at the proximal end of the drug delivery device 10 and in the illustrated example includes radially inward gear teeth. Alternatively, the dose dial member 11 may include a geometry, e.g., teeth or holes, on the distal face that allows axial coupling with outward gear teeth or a corresponding pin as a coupling member. A cover 12 is provided as part of the drug delivery device 10 to at least partially shield the dose dial member 11. In the illustrated example, the cover 12 shields the radially outer face of the dose dial member 11 and the annular proximal face of the dose dial member 11, thereby preventing access to the dose dial member 11 from the lateral and proximal sides. As shown in the example of FIG. 2, if the distal face of the dose dial member 11 is shielded by an adjacent component of the drug delivery device 10, the gear teeth of the dose dial member 11 are only accessible from the radially inner side, e.g., by the gear 5 as illustrated. This arrangement prevents unintended or undesired manipulation of the dose dial member 11.

[0054] Additionally or alternatively, the drug delivery device 10 may be provided with a locking mechanism (not shown) that may be switched between a locked state that prevents dose setting and an released state that allows dose setting. More specifically, such a locking mechanism, when in its locked state, may prevent undesired rotation of the dose dial member and, when in its released state, may allow rotation of the dose dial member, particularly during dose setting.

[0055] In an exemplary embodiment, the locking mechanism may be biased to its locked state. This means that the locking mechanism is in its locked state in the idle state of the drug delivery device 10, i.e. when the user is not applying any force or torque to the device. This may be by a spring that holds the locking mechanism in its locked state, or by the locking member being snap-fitted into the locked state. On the other hand, the locking mechanism may be switched to its released state by automatic and / or user actuation, for example, by placing the drug delivery device in the carry case 1. In one example, the locking mechanism may be switched to its released state by mechanical engagement of the dose dial member 11 with the coupling member, i.e. gear 5. Alternatively, when the drug delivery device 10 is received in the support recess 3 of the carry case 1, a clamping feature that holds the drug delivery device 10 in the case 1 may switch the locking mechanism to its released state.

[0056] The battery-powered case 1 may be configured to set a dose in the drug delivery device 10 automatically, i.e. without manual user interaction and / or autonomously, i.e. without the use of an external device such as a smartphone. This allows for high dose accuracy during dose setting and facilitates use by patients with hand and / or visual impairments. In addition, the drug delivery device 10 may be a fully mechanical device and may be simple, for example without a dose display.

[0057] For example, case 1 may be configured to set a dose based on dose information stored and / or calculated in case 1. The dose is set by operating motor 4 such that gear 5 is rotated a pre-determined number of revolutions corresponding to the intended dose to be set. To more accurately perform a prescribed number of revolutions with a motor of the kind shown in FIG. 2, i.e. a small DC motor with a gearbox, the motor or mechanism may include a position sensor, i.e. an encoder (not shown), to operate the motor in a closed-loop positioning mode. In such a scenario, it may be desirable that gear 5 is not accessible to the patient and / or that the set dose is locked after removing drug delivery device 10 from case 1. As an example, drug delivery device 10 may be designed to have no accessible moving parts at all, except for an injection trigger (not shown).

[0058] The processor of case 1 may be further configured to calculate, receive and / or store data corresponding to the dosage to be administered by the drug delivery device 10. This may include the functionality of a dose coach that selects the required dose based on health or other patient data received and / or stored in case 1 and / or transmitted to case 1 by an external device. [Explanation of symbols]

[0059] 1 Carry Case 2 Outer shell 3 Support recess 4 Motors 5 Coupling parts (gears) 6 Display 10 Drug Delivery Devices 11 Dose dial member 12 Cover

Claims

1. A carry case for storing a drug delivery device (10) having a rotatable dose dial member, comprising: - an outer shell (2), a support recess (3) for receiving and holding said drug delivery device (10); Including, - a coupling member (5) for mechanically engaging said dose dial member (11) of said drug delivery device (10); an electric motor (4), - a battery; a processor connected to said motor (4) and to said battery; wherein the coupling member (5) is configured to be driven by the motor (4) to rotate the dose dial member (11) when engaged with the coupling member (5).

2. 2. A case according to claim 1, wherein the coupling member (5) is a gear.

3. A case according to claim 1 or 2, wherein the motor (4) is optionally a micro gear motor including a position sensor and / or an encoder connected to the processor such that the motor (4) can operate in a closed loop positioning mode.

4. The case according to any one of claims 1 to 3, further comprising a communication unit connected to the processor for communicating with another device.

5. The case according to claim 4, wherein the communication unit includes a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth.

6. A case according to any one of claims 1 to 5, further comprising an LCD display (6) connected to the processor.

7. A case according to any one of claims 1 to 6, wherein the processor is configured to calculate, receive and / or store data corresponding to a dosage administered by the drug delivery device (10).

8. The case according to claim 7, wherein the processor is configured to operate the motor (4) in a closed-loop positioning mode, e.g. based on signals from a positioning sensor and / or an encoder, to rotate the coupling member (5) a predetermined number of rotations corresponding to a dosage to be administered by the drug delivery device (10).

9. A drug delivery device for setting and dispensing a dose of a liquid drug, comprising a cartridge containing the liquid drug and a dose setting and drive mechanism configured to perform a dose dial setting operation to select a dose to be delivered by the drug delivery device and a dose delivery operation to deliver the set dose, the dose setting and drive mechanism comprising a rotatable dose dial member (11) configured to be mechanically engaged by a driven coupling member (5), preferably the coupling member (5) of a case (1) as described in any one of claims 1 to 8.

10. 10. A drug delivery device as claimed in claim 9, wherein the dose dial member (11) comprises a ring of radially inwardly facing gear teeth.

11. A drug delivery device as described in claim 9 or 10, wherein the dose dial member (11) is located at a proximal end portion of the drug delivery device (10), and at least the radially outer surface and / or the proximally facing annular surface of the dose dial member (11) is shielded by a cover member (12) of the drug delivery device.

12. A drug delivery device according to any one of claims 9 to 11, wherein the dose setting and driving mechanism comprises a manually operable injection trigger.

13. A drug delivery device according to any one of claims 9 to 12, further comprising a locking mechanism which can be switched between a locked state which prevents dose setting and an released state which allows dose setting.

14. 14. The drug delivery device of claim 13, wherein the locking mechanism prevents rotation of the dose dial member (11) when in its locked state and allows rotation of the dose dial member (11) when in its released state.

15. A drug delivery device as described in claim 13 or 14, wherein the locking mechanism is biased to its locked state and switched to its released state by placing the drug delivery device in a case as described in any one of claims 1 to 9, in particular by mechanical engagement of the dose dial member (11) and the coupling member (5).

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