Dose Recording Device

Abstract

Disclosed is a dose recording device (100) for a drug delivery device (102), the drug delivery device (102) including a housing (104), a cartridge holder (116) configured to receive a cartridge for holding multiple doses of a drug, and a dose setting member (118) coupled to the housing (104) and configured to set a dose of the drug. The dose recording device (100) includes a device housing (122) and a measurement system (130) having an optical sensor (132) coupled to a portion (134) of the device housing (122). The device housing (122) is configured to be attached to the dose setting member (118). The measurement system (130) is configured to detect relative movement of the device housing (122) with respect to the housing (104) with the optical sensor (132) and to store the relative movement data to provide information about the delivery of a dose of the drug. [Selected Figure] Figure 2

Description

[Technical field]

[0001] The present disclosure relates to a dose recording device. [Background technology]

[0002] Many liquids, including drugs, must be injected into the body. Injection applies especially to drugs that are inactivated or have a significantly reduced effect when administered orally, such as proteins (insulin, growth hormone, interferon, etc.), carbohydrates (e.g., heparin), antibodies, and most vaccines. Such drugs are mostly injected by a delivery device such as a syringe, drug pen, or drug pump.

[0003] Users of such syringes, drug pens or drug pumps range from medical professionals to drug recipients themselves, the latter ranging from children to the elderly. Pharmaceutical injections can include repeated or multiple injections of a specific dose (e.g., vaccines in multiple dose regimens) to a single injection of a single dose (e.g., vaccines, or emergency hydrocortisone).

[0004] For this purpose, there are several types of pharmaceutical delivery devices known, such as pen-type delivery devices. With these delivery devices, it is possible to inject several doses of liquid from a single cartridge contained in the delivery device. For various reasons, it is necessary to obtain information about the delivered dose, such as the time and dose of the last injection. Summary of the Invention [Problem to be solved by the invention]

[0005] Despite the advantages offered by these delivery devices, there are still some drawbacks: the measurement system is integrated into the pen injection delivery device, making it difficult to access the system, such as for replacement or maintenance purposes. Furthermore, the measurement system only detects the dial setting operation. Thus, the measurement system does not obtain any information about the injection action caused by the axial movement of the dose selector. [Means for solving the problem]

[0006] Disclosed herein is a dose recording and delivery device that allows for capture of information not only about the dialing operation, but also at least additionally about the injection operation.

[0007] Embodiments of the disclosed recording device and delivery device have the structure of the independent claims. Specific embodiments, which may be realized in a separate manner or in any combination, are recited in the dependent claims.

[0008] As used below, the terms "have", "comprise", "include" or any grammatical variants thereof are used non-exclusively. Thus, these terms may refer both to a situation where no other configuration exists in the entity described herein other than the configuration introduced by these terms, and to a situation where one or more other configurations exist. As an example, the expressions "A has B", "A comprises B", and "A includes B" may refer both to a situation where no other elements exist in A other than B (i.e., a situation where A is solely and exclusively composed of B), and to a situation where one or more other elements exist in the entity A other than B, such as element C, elements C and D, and even other elements.

[0009] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a component or element may be present once or more than once are typically used only once when introducing each component or element. In the following, in most cases, the expressions "at least one" or "one or more" will not be repeated when referring to each component or element, but the irrefutable fact is that each component or element may be present once or more than once.

[0010] Furthermore, as used below, the terms "particularly", "more particularly", "particularly", "more particularly", or similar terms are used in conjunction with optional configurations without limiting alternative feasibility. Thus, the configurations introduced by these terms are optional configurations and do not limit the scope of the claims in any way. The techniques described in this disclosure are implemented by using alternative configurations, as will be understood by those skilled in the art. Similarly, the configurations introduced by "in one embodiment" or similar expressions are intended to be optional configurations, with no limitations on alternative embodiments, no limitations on the scope of the disclosure, and no limitations on the possibility of combining the configurations introduced in this way with other optional or non-optional configurations.

[0011] The dose recording device of the present disclosure is configured for use with a drug delivery device including a housing, a cartridge holder configured to receive a cartridge for holding a plurality of doses of the drug, and a dose setting member coupled to the housing and configured to set a dose of the drug. The dose recording device includes a device housing and a measurement system having an optical sensor coupled to a portion of the device housing. The device housing is configured to be attached to the dose setting member. The measurement system is configured to detect relative movement of the device housing with respect to the housing by the optical sensor and to store the relative movement data to provide information about the delivery of the dose of the drug.

[0012] That is, an external dose recording device is disclosed that is configured to be attached to an existing pen-type drug delivery device. The advantage of this dose recording device is that its measurement system can distinguish between dialing and injection. Furthermore, this dose recording device does not require any moving parts.

[0013] As used herein, the term "drug delivery device" refers to any device configured to deliver or administer a liquid from a respective cartridge. In particular, the drug delivery device is configured to deliver or administer a predetermined dose of a liquid drug. The term "drug delivery device" encompasses any type of device or system configured to administer a quantity of a drug into the human or animal body. This quantity can typically range from about 0.5 mL to about 10 mL. Drug delivery devices can include, but are not limited to, syringes, needle-safe systems, pen injectors, auto-injectors, large volume devices (LVDs), pumps, perfusion systems, or other devices configured for subcutaneous, intramuscular, or intravascular delivery of drugs. Such devices often include a needle, which can include a small gauge needle (e.g., greater than about 24 gauge, including 27, 29, or 31 gauge).

[0014] As used herein, the term "liquid" refers to any liquid provided in the single dose medication cartridge. The liquid may be a medical liquid or a nutritional supplement, such as a vitamin solution.

[0015] The term "drug" as used herein refers to a pharmaceutical formulation that contains at least one pharma- ceutical active compound. The terms "drug" or "medicament" are used herein to describe one or more pharma- ceutical active compounds. As described below, a drug or medicament may include at least one small molecule or macromolecule or combinations thereof in various types of formulations for the treatment of one or more diseases. Exemplary pharma-ceutical active compounds may include small molecules, 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. Nucleic acids may be incorporated into vectors, plasmids, or molecular delivery systems such as liposomes. Mixtures of one or more of these drugs are also contemplated.

[0016] In combination with a particular drug, the devices of the present disclosure are also customized to operate within required parameters, for example, within a particular time period (e.g., from about 3 seconds to about 20 seconds for a syringe and from about 5 minutes to about 60 minutes for an LVD), with low or minimal levels of discomfort, or within particular conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations may arise due to a variety of factors, such as, for example, a drug with a viscosity ranging from about 3 cp to about 50 cp.

[0017] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharma- ceutically active compounds. For example, in some cases, the chamber can 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 can be designed to store the drug for about one month to about two years. Storage can 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 can be or include a dual-chamber cartridge configured to separately store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of a drug or agent prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0018] The drug delivery devices and drugs according to the present invention can be used for the treatment and / or prevention of many different types of disorders. Exemplary disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0019] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or 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 term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to have substantially the same functionality or activity (e.g., therapeutic effect).

[0020] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0021] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; 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-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; 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. Exemplary GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide / AVE0010 / ZP10 / Lyxumia, exenatide / exendin-4 / Byetta / Bydureon / ITCA650 / AC-2993 (a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide / Victoza, semaglutide, taspoglutide, synclear / albiglutide, dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langrena These include: cefotide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, 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, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN and glucagon-Xten.

[0022] An exemplary oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen / quinamro for the treatment of familial hypercholesterolemia.

[0023] Exemplary DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0024] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropins, menotropins), somatropins (somatropins), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0025] Exemplary 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 above-mentioned polysaccharides in polysulfated form, and / or their pharmaceutically acceptable salts.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 G-F20 / Synvisc, sodium hyaluronate.

[0026] 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 can 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 function and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., has a mutation or deletion of the Fc receptor binding region.

[0027] 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 includes at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can 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 disclosure 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, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), 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.

[0028] 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 and 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.

[0029] Exemplary antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0030] The compounds described herein can be used in pharmaceutical preparations that include (a) the compounds or their pharmaceutically acceptable salts, and (b) pharmaceutically acceptable carriers.The compounds can also be used in pharmaceutical preparations that include one or more other active pharmaceutical ingredients, or in pharmaceutical preparations in which the compounds or their pharmaceutically acceptable salts are the only active ingredient.Thus, the pharmaceutical preparations of the present disclosure encompass any preparation made by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0031] Pharmaceutically acceptable salts of any of the drugs described herein are contemplated for use in the drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. Acid addition salts are, for example, HCl or HBr salts. Base salts are, for example, salts with a cation selected from an alkali or alkaline earth metal, for example, Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), where R1 to R4 are each independently: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharma-ceutically acceptable salts are known to those skilled in the art.

[0032] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0033] Those skilled in the art will understand that modifications (e.g., adjustments, additions, or removals, etc.) of the substances, formulations, apparatus, methods, systems, devices, and various components of the embodiments described herein may be made without departing from the full scope and spirit of the inventive concept, which encompasses such modifications and any equivalents thereof.

[0034] The term "cartridge holder" as used herein refers to any device configured to receive a cartridge. The cartridge holder may be connectable, e.g., screwable, to a housing. The cartridge holder may be removable from the housing to enable replacement of the cartridge. Thus, the device may be a reusable device.

[0035] As used herein, the term "optical sensor" refers to any optoelectronic sensor configured to take successive images of a surface of interest as the sensor operates and moves relative to one another, such as a very small, low-resolution video camera.

[0036] The information may include the dose and the time of delivery of the drug dose, thus providing useful information about the drug dose delivered.

[0037] Parts of the device housing are made of a transparent material, so that the device housing does not obscure a dose display, such as a dose window, of the dose delivery device and the user can read the displayed dose.

[0038] The device housing may include a front end configured to be attached to the dose setting member and a rear end opposite the front end, with a portion located at the front end, such that the measurement system is configured to be in close proximity to the dose setting member, facilitating detection of any movement of the dose setting member.

[0039] The dose recording device may further include a grip feature located at the rear end, so that a user can rotate the dose recording device together with the dose setting member.

[0040] The dose recording device may further include a power source configured to power the measurement system, such that the measurement system is powered.

[0041] The power supply is disposed within the device housing, thus resulting in a fairly compact arrangement of the power supply.

[0042] The power source can be a battery or a secondary battery, thus allowing a well-established power source to be used with the dose recording device, thus reducing manufacturing costs.

[0043] The device housing is configured to be rotatably and axially movable relative to the housing, such that the dose recording device can reliably distinguish between a dial setting and an injection.

[0044] The measurement system is configured to be calibrated by detecting rotational and / or axial movements of the device housing, and is therefore calibrated in a fairly simple manner.

[0045] The dose recording device may further include a force sensor configured to detect an axial force applied to the device housing, thus improving detection quality.

[0046] The force sensor is arranged between the dose setting member and the device housing, so that it is possible to detect the movement of the dose setting member even in the absence of an injection until the injection starts.

[0047] The measurement system is configured to be calibrated by detecting rotational and / or axial movements of the device housing corresponding to at least two different set doses and delivered doses. Thus, calibration is performed in just a few processing steps.

[0048] The measurement system is configured to wirelessly transfer information about the delivery of the drug dose to a remote electronic device. Thus, the information is transferred by well-established means, thereby reducing manufacturing costs. Furthermore, because the information is transferred wirelessly, the dose recording device does not need to be connected to a separate connection device, such as an adapter or slot.

[0049] The device housing is designed as a sleeve, and is therefore attached by pressing the sleeve onto the dose setting member.

[0050] The device housing may include a length at least corresponding to the dimension by which the dose setting member can be axially extended from the housing, and thus the device housing is fairly small or compact.

[0051] The device housing is configured to be removably attached to the dose setting member such that the dose recording device is easily replaced or removed from the delivery device.

[0052] The optical sensor is configured to detect relative motion based on the exterior structure of the housing. Thus, the optical sensor does not require a coded surface to make its measurements. Rather, the exterior of the housing only needs to be slightly structured for the optical sensor to operate properly, which is indeed the case for the exterior of the pen-shaped body of the drug delivery device.

[0053] The disclosed drug delivery device includes a housing, a cartridge holder configured to receive a cartridge for holding multiple doses of the drug, a dose setting member coupled to the housing and configured to set a dose of the drug, and the aforementioned dose recording device, wherein the device housing is attached to the dose setting member.

[0054] The housing may include a non-coded exterior surface facing the optical sensor. As used herein, the term "non-coded" refers to a substantially uniform surface that is only lightly structured and does not include printed or otherwise disposed markings.

[0055] To summarize the findings of the present disclosure, the following embodiments are preferred: Embodiment 1: A dose recording device for a drug delivery device, the drug delivery device comprising a housing, a cartridge holder configured to receive a cartridge for holding multiple doses of a drug, and a dose setting member coupled to the housing and configured to set a dose of the drug, the dose recording device comprising a device housing and a measurement system having an optical sensor coupled to a portion of the device housing, the device housing configured to be attached to the dose setting member, the measurement system configured to detect relative movement of the device housing with respect to the housing by the optical sensor and to store the relative movement data to provide information about the delivery of the dose of the drug. Embodiment 2: The dose recording device of embodiment 1, wherein the information includes the dose and the delivery time of the drug dose. Embodiment 3: A dose recording device as described in embodiment 1 or 2, wherein a portion of the device housing is made of a transparent material. Embodiment 4: A dose recording device as described in embodiment 3, wherein the device housing includes a front end configured to be attached to the dose setting member and a rear end opposite the front end, with a portion located at the front end. Embodiment 5: The dose recording device of embodiment 4, further comprising a grip feature located at the rear end. Embodiment 6: The dose recording device of any one of embodiments 1 to 5, further comprising a power source configured to power the measurement system. Embodiment 7: A dose recording device as described in embodiment 6, wherein the power source is disposed within the device housing. Embodiment 8: The dose recording device of embodiment 6 or 7, wherein the power source is a battery or a secondary battery. Embodiment 9: A dose recording device as described in any one of embodiments 1 to 8, wherein the device housing is configured to be rotatably and axially movable relative to the housing. Embodiment 10: A dose recording device as described in embodiment 9, wherein the measurement system is configured to be calibrated by detecting rotational and / or axial movement of the device housing. Embodiment 11: A dose recording device as described in embodiment 9 or 10, further comprising a force sensor configured to detect an axial force applied to the device housing. Embodiment 12: A dose recording device as described in embodiment 11, wherein the force sensor is positioned between the dose setting member and the device housing. Embodiment 13: A dose recording device described in any one of embodiments 10 to 12, wherein the measurement system is configured to be calibrated by detecting rotational and / or axial movement of the device housing corresponding to at least two different set doses and delivered doses. Embodiment 14: A dose recording device as described in any one of embodiments 1 to 13, wherein the measurement system is configured to wirelessly transfer information about the delivery of the drug dose to a remote electronic device. Embodiment 15: A dose recording device according to any one of embodiments 1 to 14, wherein the device housing is designed as a sleeve. Embodiment 16: A dose recording device according to any one of embodiments 1 to 15, wherein the device housing comprises a length at least corresponding to a dimension by which the dose setting member can be axially extended from the housing. Embodiment 17: A dose recording device according to any one of embodiments 1 to 16, wherein the device housing is configured to be removably attached to the dose setting member. Embodiment 18: A dose recording device according to any one of embodiments 1 to 17, wherein the optical sensor is configured to detect relative motion based on an outer surface structure of the housing. Embodiment 19: A drug delivery device comprising a housing, a cartridge holder configured to receive a cartridge for holding multiple doses of a drug, a dose setting member coupled to the housing and configured to set a dose of the drug, and a dose recording device described in any one of embodiments 1 to 17, wherein the device housing is attached to the dose setting member. Embodiment 20: A drug delivery device as described in embodiment 19, wherein the housing includes a non-encoded outer surface facing the optical sensor.

[0056] Further configurations and embodiments are disclosed in more detail in the following description of the embodiments, especially in relation to the dependent claims. In the embodiments, each configuration is realized separately as well as in any possible combination, as will be understood by those skilled in the art. The scope of the present disclosure is not limited by the embodiments. The embodiments are illustrated diagrammatically in the figures, in which the same reference numbers in the figures refer to the same or functionally equivalent elements. [Brief description of the drawings]

[0057] [Figure 1] FIG. 2 is a perspective view of the dose recording device and the drug delivery device in disassembled state. [Diagram 2] FIG. 2 is a perspective view of the dose recording device and the drug delivery device in an assembled state. [Diagram 3] FIG. 1 is a perspective view of a dose recording device. [Figure 4] FIG. 2 is a perspective view of the dose recording device and the drug delivery device in operation. [Diagram 5] 1 is a graph illustrating the calibration process of a dose recording device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] FIG. 1 shows a perspective view of the dose recording device 100 and the drug delivery device 102 in a disassembled state. The drug delivery device 102 includes a housing 104. The housing 104 is adapted and arranged to protect the components of the drug delivery device 102 disposed therein from environmental influences. The housing 104 has a distal end 106 and a proximal end 108. The term "distal end" refers to the end of the housing 104 that is closest to, or should be disposed closest to, the dosing end of the drug delivery device 102. The term "proximal end" refers to the end of the housing 104 that is furthest from, or should be disposed furthest from, the dosing end of the drug delivery device 102. The distal end 106 and the proximal end 108 are spaced apart from each other and arranged in the direction of an axis 110. The axis 110 can be a longitudinal axis and / or a rotatable axis of the drug delivery device 102. The housing 104 includes a dose window 112 made of a transparent material. The housing 104 includes an uncoded exterior surface 114. Thus, the exterior surface 114 is only slightly structured. attitude Just in, It does not include any patterns, printed or separately attached.

[0059] The drug delivery device 102 further includes a cartridge holder 116. The cartridge holder 116 is configured to receive a cartridge (not shown in detail) for holding multiple doses of a drug. In the exemplary embodiment shown in FIG. 1, the cartridge holder 116 includes a cartridge. The cartridge includes a drug, preferably multiple doses of the drug. The cartridge is held in the cartridge holder 116. The cartridge holder 116 mechanically stabilizes the position of the cartridge. The cartridge holder 116 is connectable at its distal end 106 to the housing 104, for example by a threaded engagement or by a bayonet connection. The cartridge holder 116 and the housing 104 are releasably connected to each other. In an alternative embodiment, the cartridge is directly connected to the housing 104. In this case, the cartridge holder 116 may be redundant.

[0060] The drug delivery device 102 may be a pen-type device, in particular a pen-type injector. The drug delivery device 102 may be a reusable device, meaning that the cartridge is replaced with a replacement cartridge, in particular during a reset operation, and multiple doses are dispensed from the replacement cartridge.

[0061] A bung (not shown in detail) is slidably held in the cartridge. The bung proximally seals the cartridge. When the bung moves distally relative to the cartridge, the drug is dispensed from the cartridge. A needle assembly (not shown in detail) is disposed at the distal end of the cartridge holder 116, for example by means of an engagement means (e.g. a screw thread). A cap is fixed to the cartridge holder 116 to protect the drug delivery device 102, and in particular the cartridge holder 116, from environmental influences, for example when the drug delivery device 102 is not in use.

[0062] The drug delivery device 102 further includes a dose setting member 118 and a dose button 120 that are operated to set and dispense a dose of the drug. The dose button 120 is located at a proximal end of the dose setting member 118. The drug delivery device 102 includes a piston rod (not shown in detail). The piston rod is configured to transmit motion through the housing 104 to expel a dose of the drug from the cartridge. The piston rod is movable between an initial position relative to the housing 104 and an end position relative to the housing 104. The initial position may be the position of the piston rod when the drug delivery device 102 is supplied from the manufacturer. Furthermore, the initial position may also be the position of the piston after a reset operation has been performed. The initial position may be the proximal most position of the piston rod. The end position may be the position of the piston rod after the entire amount of the drug has been dispensed from the cartridge. The end position may be the distal most position of the piston rod. During operation of the drug delivery device 102, specifically during dispensing of the drug, the piston rod moves towards the end position.

[0063] The piston rod has a distal end disposed closest to the dosing end of the drug delivery device 102. The distal end of the piston rod includes a bearing member. The bearing member is disposed between the bung and the piston rod. The bearing member is configured to reduce damage that may occur due to friction. The bearing member may be part of the piston rod. The bearing member is coupled to the piston rod. Alternatively, the bearing member and the piston rod are integrally formed. The bearing member and the bung are in mechanical contact, specifically abutting, throughout the operation of the device. The bearing member and the bung are in mechanical contact as long as a cartridge or a replacement cartridge is loaded into the device. In other words, the bearing member and the bung are in mechanical contact as long as the cartridge holder 116 is at least partially coupled to the housing 104.

[0064] The piston rod is configured as a lead screw. The piston rod includes two threaded sections. These threaded sections have opposite rotational directions. A first threaded section is located at the distal portion of the piston rod and a second threaded section is located at the proximal portion of the piston rod. The piston rod, specifically the first threaded section, is threadedly engaged with a guide member (not shown in detail), for example a guide nut. The guide member includes a central bore. In the central bore, a screw thread is designed. The screw thread is used to bias the piston in a predetermined helical movement through the housing 104 towards an end position, as it is connected to the piston rod. The piston rod is axially and rotatably movable towards an end position by mechanical cooperation with the guide member. Furthermore, the piston rod, specifically the second threaded section, is threadedly engaged with a drive member (not shown in detail). The drive member exerts a force on the piston rod when the user presses the dose button 120, resulting in a movement of the piston rod to deliver a dose of the drug. The dose set by the dose setting member 118 is visible through the dose window 112. For example, the numeric units of the medication set by the user are visible through the dose window 112.

[0065] The dose recording device 100 comprises a device housing 122. The device housing 122 is configured to be attached to the dose setting member 118. The device housing 122 comprises a front end 124 configured to be attached to the dose setting member 118 and a rear end 126 opposite the front end 124. The device housing 122 is configured to be removably attached to the dose setting member 118. The device housing 122 is designed as a sleeve. The device housing 122 comprises a length 128 that corresponds at least to a dimension by which the dose setting member 118 can be axially extended from the housing 104. The device housing 122 is configured to be rotatably and axially movable relative to the housing 104.

[0066] The dose recording device 100 further includes a measurement system 130 having an optical sensor 132 coupled to a portion 134 of the device housing 122. The portion 134 is located at the front end 124. The portion 134 of the device housing 122 is made of a transparent material. The measurement system 130 is configured to detect a relative movement of the device housing 122 with respect to the housing 104 by means of the optical sensor 132, and to store the relative movement data to provide information about the delivery of the dose of the drug. To this end, the measurement system 130 includes a storage or memory device and an interface configured to transmit the data. The optical sensor 132 is configured to detect the relative movement based on an outer surface structure of the housing 104. In particular, the optical sensor 132 faces the non-coded outer surface 114.

[0067] 2 shows a perspective view of the dose recording device 100 and the drug delivery device 102 in an assembled state. The dose recording device 100 is attached by pressing it onto the dose setting member 118, whereby the dose button 120 is located within the device housing 122. The dose recording device 102 further includes a grip feature 136 located at the rear end 126.

[0068] FIG. 3 shows a perspective view of the dose recording device 100. The dose recording device 100 further includes a power source 138 configured to power the measurement system 130. The power source 138 is disposed in the device housing 122. As shown in FIG. 3, the power source 138 is a battery. Alternatively, the power source 138 can be a secondary battery. The measurement system 130 is configured to be calibrated by detecting rotational and / or axial movements of the device housing 122. In this embodiment, the measurement system 130 is configured to be calibrated by detecting rotational and axial movements of the device housing 122. The dose recording device 100 further includes a force sensor (not shown in detail) configured to detect an axial force applied to the device housing 122. The force sensor is disposed between the dose setting member 118 and the device housing 122. The measurement system 130 is configured to wirelessly transfer information about the delivery of the drug dose to a remote electronic device (not shown in detail), such as a smartphone of the user. For example, the interface can be a wireless transmission interface, such as Bluetooth or WLAN.

[0069] Further details of the operation of the dose recording device 100 and its calibration will now be described below.

[0070] FIG. 4 shows a perspective view of the dose recording device 100 and the drug delivery device 102 during operation. For operation purposes, the dose recording device 100 is attached to the drug delivery device 102 as described above. When the user dials in a dose, the user rotates the dose setting member 118 by rotating the device housing 122. While dialing, a helical movement indicated by the arrow 140, consisting of the axial and rotational movements of the device housing 122 of the dose recording device 100 relative to the housing 104 of the drug delivery device 102 along and around the axis 110, respectively, is measured by the measurement system 130. This movement is detected by the optical sensor 132. FIG. 4 shows the movement of the optical sensor 132 when 72 units of the drug are dialed in. That is, the initial position of the dose recording device 100 and the position of the dose recording device 100 after dialing are shown in FIG. 4. When the user injects a drug, the user presses the dose button 120 by pressing it against the device housing 122. The dose recording device 100 is now moved axially to a starting position and the measurement system 130 detects the movement corresponding to the dialed dose by means of an optical sensor 132 monitoring the outer surface 114 .

[0071] It is important to detect the movement of the dose button 120 until an injection begins, even without an injection. This movement is measured using a force sensor between the dose button 120 and the device housing 122. To attach the dose recording device 100 to the dose button 120, the user must press the dose recording device 100 firmly onto the dose button 120. Using this process, the axial movement of the dose button 120 can be measured until a clutch (not shown in detail) in the housing 104 switches from dial setting, i.e., rotational movement, to injection, i.e., axial movement, thereby calibrating the measurement system 130.

[0072] FIG. 5 shows a graph illustrating the calibration process, which is another method of calibrating the dose recording device 100. In the method shown in FIG. 5, a simulated injection is made without a cartridge. The user must dial 10 units (D1), detect the first dial extension E1, and inject. Then the user must dial 20 units (D2), detect the second dial extension E2, and inject. Due to the axial movement of the dose button 120, the "offset" of the dose button 120 is calculated as offset=(E1D2-E2D1) / (D1-D2) obtained from the resulting calibration curve 142. [Explanation of symbols]

[0073] 100 Dose Recording Device 102 Drug delivery devices 104 Housing 106 Distal end 108 Proximal end 110 Axis 112 Dosage window 114 Exterior 116 Cartridge holder 118 Dose setting member 120 Dose Button 122 Device Housing 124 Front end 126 Rear end 128 Length 130 Measurement System 132 Optical Sensor 134 part 136 Grip Function 138 Power supply 140 Arrow 142 Constituent curve

Claims

1. A dose recording device (100) for a drug delivery device (102), comprising: The drug delivery device (102) comprises: a housing (104) and a cartridge holder (116) configured to receive a cartridge for holding multiple doses of a medication; a dose setting member (118) coupled to the housing (104) and configured to set a dose of the drug; wherein the dose recording device (100) comprises: A device housing (122); a measurement system (130) having an optical sensor (132) coupled to a portion (134) of the device housing (122); wherein the device housing (122) is configured to be attached to the dose setting member (118), and the measurement system (130) is configured to detect relative movement of the device housing (122) with respect to the housing (104) by an optical sensor (132) and to store the relative movement data to provide information about the delivery of a dose of drug, the optical sensor (132) being configured to detect the relative movement based on an outer surface structure of the housing (104).

2. The dose recording device (100) of claim 1, wherein the information includes a dose and a delivery time of the drug dose.

3. The dose recording device (100) of claim 1 or 2, wherein a portion (134) of the device housing (122) is made of a transparent material.

4. The dose recording device (100) of claim 3, wherein the device housing (122) includes a front end (124) configured to be attached to the dose setting member (118) and a rear end (126) opposite the front end (124), and the portion (134) is located at the front end (124).

5. The dose recording device (100) of claim 4, further comprising a gripping feature (136) located at the rear end (126).

6. The dose recording device (100) of any one of claims 1 to 5, further comprising a power source (138) configured to power the measurement system (130).

7. The dose recording device (100) of claim 6, wherein the power source (138) is disposed within the device housing (122).

8. The dose recording device (100) of claim 6 or 7, wherein the power source (138) is a battery or a secondary battery.

9. The dose recording device (100) of any one of claims 1 to 8, wherein the device housing (122) is configured to be rotatably and axially movable relative to the housing (104).

10. The dose recording device (100) of claim 9, wherein the measurement system (130) is configured to be calibrated by detecting rotational and / or axial movements of the device housing (122).

11. The dose recording device (100) of claim 9 or 10, further comprising a force sensor configured to detect an axial force applied to the device housing (122).

12. The dose recording device (100) of claim 11, wherein the force sensor is disposed between the dose setting member (118) and the device housing (122).

13. The dose recording device (100) of any one of claims 10 to 12, wherein the measurement system (130) is configured to be calibrated by detecting rotational and axial movements of the device housing (122) corresponding to at least two different set doses and delivered doses.

14. The dose recording device (100) of any one of claims 1 to 13, wherein the measurement system (130) is configured for wirelessly transferring information about the delivery of the drug dose to a remote electronic device.

15. The dose recording device (100) according to any of the preceding claims, wherein the device housing (122) is designed as a sleeve.

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