Dose recording device

Abstract

A dose recording device (100) for a drug delivery device (102) is disclosed, wherein the drug delivery device (102) comprises a housing (104), a cartridge holder (116) configured to receive a cartridge for holding a plurality of doses of a drug, and a dose setting member (118) connected to the housing (104) and configured to set a dose of the drug. The dose recording device (100) comprises a device housing (122) and a measuring system (130), the measuring system having an optical sensor (132) connected to a portion (134) of the device housing (122). The device housing (122) is configured to be mounted to the dose setting member (118). The measuring system (130) is configured to detect relative movement of the device housing (122) relative to the housing (104) by means of the optical sensor (132), and to store relative movement data in order to provide information about the delivery of the dose of the drug.

Description

Technical Field

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

[0002] Many liquids such as medicaments must be injected into the body. This is particularly applicable to medicaments that are inactivated or significantly less effective by oral administration, such as proteins (such as insulin, growth hormone, interferon), carbohydrates (such as heparin), antibodies and most vaccines. Such medicaments are mainly injected with the aid of delivery devices such as syringes, pens or pumps.

[0003] Users of such syringes, pens or pumps can range from health care professionals to the medication recipients themselves, the latter ranging from children to the elderly. Medication injections can include repeated or multiple injections of a specific dose (e.g., a vaccine in a multi-dose regimen) to a single injection of a single dose (e.g., a vaccine or emergency hydrocortisone).

[0004] For this purpose, several types of drug delivery devices are known, such as pen-type delivery devices. Using these delivery devices, it is possible to inject several doses of a liquid from a single cartridge that is input into the delivery device. For different reasons, it is necessary to obtain information about the delivered doses, such as the time point and dose of the last injection.

[0005] Despite the advantages of these delivery devices, there are some disadvantages. The measurement system is integrated in the pen-type injector delivery device, which complicates access to the system (e.g. for replacement or maintenance purposes). In addition, since the measurement system only detects the dialing operation, the measurement system does not obtain any information about the injection operation caused by the axial movement of the dose selector. Summary of the invention

[0006] A dose recording device and a delivery device are disclosed herein, which allow obtaining information not only about a dialing operation but also at least additionally about an injection operation.

[0007] Embodiments of the disclosed recording device and delivery device have the features of the independent claims. Specific embodiments which may be realized individually or in any arbitrary combination are listed in the dependent claims.

[0008] As used hereinafter, the terms "have", "comprise" or "include" or any of their arbitrary grammatical variations are used in a non-exclusive manner. Thus, these terms may refer to the case where no other features are present in the entity described in this context in addition to the features introduced by these terms as well as the case where one or more other features are present. For example, the expressions "A has B", "A comprises B" and "A includes B" may refer to the case where no other elements are present in A in addition to B (i.e., the case where A consists solely and exclusively of B) as well as the case where one or more other elements are present in entity A in addition to B (such as element C, elements C and D or even other elements).

[0009] In addition, it should be noted that the terms "at least one", "one or more" or similar expressions indicating that a feature or element may be present once or more than once will usually be used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" will not be repeated, despite the fact that the corresponding feature or element may be present once or more than once.

[0010] In addition, as used hereinafter, the terms "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the alternative possibilities. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the techniques described in this disclosure can be performed by using alternative features. Similarly, the features introduced by "in an embodiment" or similar expressions are intended to be optional features, without any limitation on alternative embodiments, without any limitation on the scope of this disclosure, and without any limitation on the possibility of combining the features introduced in such a manner with other optional or non-optional features.

[0011] The disclosed dose recording device is configured to be used in conjunction with a drug delivery device, wherein the drug delivery device comprises a housing, a cartridge holder configured to receive a cartridge for holding a plurality of doses of a drug, and a dose setting member connected to the housing and configured to set a dose of the drug. The dose recording device comprises a device housing and a measuring system having an optical sensor connected to a portion of the device housing. The device housing is configured to be mounted to the dose setting member. The measuring system is configured to detect relative movement of the device housing relative to the housing by means of the optical sensor and store relative movement data in order to provide information about the drug dose delivery.

[0012] Thus, an external dose recording device is disclosed which is configured to be mounted onto an existing pen-type drug delivery device. An advantage of this dose recording device is that the measurement system is able to distinguish between dialing and injection. Furthermore, the dose recording device does not require any movable parts.

[0013] As used herein, the term "drug delivery device" refers to any device configured to deliver or apply liquid from a corresponding cartridge. In particular, a drug delivery device is configured to deliver or apply a predetermined dose of liquid medicine. The term "drug delivery device" should encompass any type of device or system, which is configured to distribute a certain volume of medicine to a human or animal body. The volume range can typically be from about 0.5ml to about 10ml. In a non-limiting manner, a drug delivery device may include a syringe, a needle safety system, a pen injector, an automatic injector, a large volume device (LVD), a pump, an infusion system, or other devices configured for subcutaneous, intramuscular or intravascular delivery of a drug. Such devices typically include a needle, wherein the needle may include a small gauge needle (e.g., greater than about 24 gauges, and including 27, 29 or 31 gauges).

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

[0015] As used herein, the term "drug" refers to a pharmaceutical preparation containing at least one pharmaceutically active compound. The term "drug" or "medicament" is used herein to describe one or more pharmaceutically active compounds. As described below, a drug or medicament may include at least one small molecule or macromolecule or a combination thereof in various types of preparations for the treatment of one or more diseases. Exemplary pharmaceutically active compounds may include small molecules; 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. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids or liposomes). Mixtures of one or more of these drugs may also be encompassed.

[0016] The presently described devices may also be customized to operate within desired parameters in conjunction with a particular drug, for example, within a certain time period (e.g., about 3 seconds to about 20 seconds for an autoinjector, about 5 minutes to about 60 minutes for a LVD), with low or minimal discomfort, or within certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental factors, etc. Such variations may result from various factors (e.g., the viscosity of the drug ranges from about 3 cP to about 50 cP).

[0017] The drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more pharmaceutically active compounds. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components of a drug preparation (e.g., a drug and a diluent, or two different types of drugs) separately, one of which is stored in each chamber. In such a case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of the drug or medicament before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers) and allow the two components to be mixed by the user when desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are being dispensed into a human or animal body.

[0018] The drug delivery devices and drugs described herein can be used to treat and / or prevent many different types of conditions. Exemplary conditions include, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic conditions (such as deep vein or pulmonary thromboembolism). Other exemplary conditions are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0019] Exemplary drugs for treating and / or preventing diabetes or complications associated with diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the term "derivative" refers to any substance that is sufficiently similar in structure to the original substance to have substantially similar function or activity (e.g., therapeutic effectiveness).

[0020] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human 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 in which at position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0021] Exemplary insulin derivatives are, 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-Thr B29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-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 are, for example: lixisenatide / AVE0010 / ZP10 / Lyxumia, exenatide / exendin-4 / Byetta / Bydureon / ITCA650 / AC-2993 (derived from Gila monster monster), liraglutide / Victoza, semaglutide, taspoglutide, Syncria / albiglutide, dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-090 1. NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, 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, mipomersen / Kynamro, a cholesterol-lowering antisense therapeutic used to treat familial hypercholesterolemia.

[0023] Exemplary DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0024] Exemplary hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropines (Follitropin, Lutropin, Choriongonadotropin, Menotropin), somatropines (Somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0025] Exemplary polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. The example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. The example of a hyaluronic acid derivative is Hylan GF 20 / Synvisc, which is a sodium hyaluronate.

[0026] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind to antigens. 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 can fix complement. In some embodiments, the antibody has reduced or no ability to bind 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, for example, it has a mutagenized or deleted Fc receptor binding region.

[0027] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide) that does not contain a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used 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., double-chain antibodies, three-chain antibodies, four-chain antibodies)), mini antibodies, chelated recombinant antibodies, three antibodies or double antibodies, intracellular antibodies, nano antibodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and antibodies containing VHH. 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 within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is generally not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies 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 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0030] The compounds described herein can be used in pharmaceutical preparations comprising (a) one or more compounds or pharmaceutically acceptable salts thereof, and (b) a pharmaceutically acceptable carrier. The compounds can also be used in pharmaceutical preparations including one or more other active pharmaceutical ingredients or in pharmaceutical preparations in which the compounds of the present invention or pharmaceutically acceptable salts thereof are the only active ingredients. Therefore, the pharmaceutical preparations of the present disclosure encompass any preparation prepared by mixing the compounds described herein and a pharmaceutically acceptable carrier.

[0031] Pharmaceutically acceptable salts of any drug described herein are also contemplated for use in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, salts with cations selected from alkali metals or alkaline earth metals, for example, Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 represent, independently of one another: hydrogen, optionally substituted C1-C6-alkyl, optionally substituted C2-C6-alkenyl, optionally substituted C6-C10-aryl, or optionally substituted C6-C10-heteroaryl. Other examples of pharmaceutically 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 appreciate that the various components / components of the materials, formulations, devices, methods, systems, apparatuses and embodiments described herein may be modified (e.g., adjusted, added or removed) without departing from the overall scope and spirit of the inventive concept, and the present invention covers 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 the housing. The cartridge holder may be removable from the housing to enable exchange of the cartridge. Thus, the device may be a reusable device.

[0035] As used herein, the term "optical sensor" refers to any optoelectronic sensor, such as a miniature low-resolution video camera, that is configured to capture continuous images of a surface relative to which the sensor operates and moves.

[0036] The information may include the dose amount and time of delivery of the drug dose. Thus, useful information about the delivered drug dose may be obtained.

[0037] Said part of the device housing may be made of a transparent material.Therefore, the device housing does not cover a dose display (eg a dose window of a dose delivery device), and a user can read the displayed dose.

[0038] The device housing may comprise a front end configured to be mounted to the dose setting member and a rear end opposite the front end, wherein the portion is located at the front end.Thus, the measuring system is arranged close to the dose setting member, which facilitates detecting any movement thereof.

[0039] The dose register device may further comprise a grip feature at the rear end.Thus, a user may rotate the dose register device together with the dose setting member.

[0040] The dose recording device may further comprise a power supply configured to supply power to the measurement system. Thus, the measurement system may be powered.

[0041] The power supply can be arranged in the device housing. Thus, a relatively compact power supply arrangement is provided.

[0042] The power source may be a battery or a secondary battery. Thus, a mature power source may be used with the dose recording device, which reduces manufacturing costs.

[0043] The device housing may be configured to be rotationally and axially movable relative to the housing. Thus, the dose recording device can reliably distinguish between dialing and injection.

[0044] The measuring system may be configured to be calibrated by detecting a rotation and / or axial movement of the housing of the device. Thus, the measuring system may be calibrated in a relatively simple manner.

[0045] The dose recording device may further comprise a force sensor configured to detect an axial force applied to the device housing.Thereby, the detection quality may be improved.

[0046] The force sensor may be arranged between the dose setting member and the device housing. Thus, before an injection starts, it is possible to detect movement of the dose setting member without injection.

[0047] The measurement system may be configured to be calibrated by detecting rotational and / or axial movement of the device housing corresponding to at least two different settings and delivered doses. Thus, calibration may be performed with only a few process steps.

[0048] The measurement system can be configured to wirelessly transmit information about the delivery of the drug dose to a remote electronic device. Thus, the information can be transmitted using a mature device that reduces manufacturing costs. In addition, since the information can be transmitted wirelessly, the dose recording device does not need to be connected to another connection device, such as an adapter or a socket.

[0049] The device housing may be designed as a sleeve. Thus, the device housing may be mounted on the dose setting member by pressing the sleeve thereon.

[0050] The device housing may have a length corresponding at least to the dimension of the dose setting member extendable axially from the housing. Thus, the device housing is relatively small or compact.

[0051] The device housing may be configured to be removably mounted to the dose setting member. Thus, the dose recording device may be easily replaced or removed from the delivery device.

[0052] The optical sensor can be configured to detect relative movement based on the structure of the outer surface of the housing. Therefore, the optical sensor does not require a coded surface to perform its measurement. Instead, in order for the optical sensor to work well, only the outer surface of the housing needs to be slightly structured, as is the case with the outer surface of the pen-type body of the drug delivery device.

[0053] The disclosed drug delivery device comprises a housing, a cartridge holder configured to receive a cartridge for holding a plurality of doses of a drug, a dose setting member connected to the housing and configured to set a dose of the drug, and a dose recording device as previously described, wherein the device housing is mounted to the dose setting member.

[0054] The housing may include an uncoded outer surface facing the optical sensor.The term "uncoded" as used herein refers to a generally uniform surface that is only slightly textured and does not include a code printed or otherwise disposed thereon.

[0055] Summarizing the findings of the present disclosure, the following embodiments are preferred:

[0056] Embodiment 1: A dose recording device for a drug delivery device, wherein the drug delivery device comprises a housing, a cartridge holder configured to receive a cartridge for holding multiple doses of a drug, and a dose setting member connected to the housing and configured to set a dose of the drug, wherein the dose recording device comprises a device housing and a measuring system having an optical sensor connected to a portion of the device housing, wherein the device housing is configured to be mounted to the dose setting member, wherein the measuring system is configured to detect relative movement of the device housing relative to the housing by means of the optical sensor, and store relative movement data to provide information about the delivery of the dose of the drug.

[0057] Embodiment 2: The dosage recording device according to embodiment 1, wherein the information includes a dosage amount and a time of the delivery of the dose of the drug.

[0058] Embodiment 3: A dose recording device according to embodiment 1 or 2, wherein the portion of the device housing is made of a transparent material.

[0059] Embodiment 4: A dose recording device according to embodiment 3, wherein the device housing comprises a front end configured to be mounted to the dose setting member and a rear end opposite the front end, wherein the portion is located at the front end.

[0060] Embodiment 5: A dose recording device according to Embodiment 4, further comprising a grip feature located at the rear end.

[0061] Embodiment 6: The dose recording device according to any one of Embodiments 1 to 5, further comprising a power supply configured to supply power to the measurement system.

[0062] Embodiment 7: A dose recording device according to embodiment 6, wherein the power supply is arranged within the device housing.

[0063] Embodiment 8: The dose recording device according to embodiment 6 or 7, wherein the power source is a battery or a secondary battery.

[0064] Embodiment 9: A dose recording device according to any one of Embodiments 1 to 8, wherein the device housing is configured to be rotationally and axially movable relative to the housing.

[0065] Embodiment 10: A dose recording device according to embodiment 9, wherein the measurement system is configured to be calibrated by detecting rotational and / or axial movement of the device housing.

[0066] Embodiment 11: A dose recording device according to embodiment 9 or 10, further comprising a force sensor configured to detect an axial force applied to the device housing.

[0067] Embodiment 12: A dose recording device according to embodiment 11, wherein the force sensor is arranged between the dose setting member and the device housing.

[0068] Embodiment 13: A dose recording device according to 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 and delivered doses.

[0069] Embodiment 14: The dose recording device according to any one of Embodiments 1 to 13, wherein the measurement system is configured to wirelessly transmit the information about the delivery of the dose of the drug to a remote electronic device.

[0070] Embodiment 15: A dose recording device according to any one of Embodiments 1 to 14, wherein the device housing is designed as a sleeve.

[0071] Embodiment 16: A dose recording device according to any one of Embodiments 1 to 15, wherein the device housing has a length corresponding at least to a dimension by which the dose setting member is axially extendable from the housing.

[0072] Embodiment 17: A dose recording device according to any one of Embodiments 1 to 16, wherein the device housing is configured to be removably mounted to the dose setting member.

[0073] Embodiment 18: A dose recording device according to any one of Embodiments 1 to 17, wherein the optical sensor is configured to detect relative movement based on the outer surface structure of the housing.

[0074] 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 connected to the housing and configured to set a dose of the drug, and a dose recording device according to any one of Embodiments 1 to 17, wherein the device housing is mounted to the dose setting member.

[0075] Embodiment 20: The drug delivery device of Embodiment 19, wherein the housing comprises an uncoded outer surface facing the optical sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Other features and embodiments will be disclosed in more detail in the subsequent description of the embodiments, in particular in conjunction with the dependent claims. Wherein, as the skilled person will recognize, the corresponding features can be implemented in an independent manner and in any arbitrary feasible combination. The scope of the present disclosure is not limited by the embodiments. The embodiments are schematically depicted in the accompanying drawings. Wherein, the same reference numerals in these figures refer to the same or functionally equivalent elements.

[0077] Figure 1 a perspective view showing the dose recording device and the drug delivery device in a disassembled state;

[0078] Figure 2 a perspective view showing a dose recording device and a drug delivery device in an assembled state;

[0079] Figure 3 showing a perspective view of a dose recording device;

[0080] Figure 4 a perspective view showing the dose recording device and the drug delivery device during operation; and

[0081] Figure 5 A graph is shown for explaining the calibration process of a dose recording device. DETAILED DESCRIPTION

[0082] Figure 1A perspective view of a dose recording device 100 and a drug delivery device 102 in a disassembled state is shown. The drug delivery device 102 comprises a housing 104. The housing 104 is adapted and arranged to protect the components of the drug delivery device 102 arranged in the housing 104 from environmental influences. The housing 104 has a distal end 106 and a proximal end 108. The term "distal end" means that the end of the housing 104 is arranged or will be arranged closest to the dispensing end of the drug delivery device 102. The term "proximal end" means that the end of the housing 104 is arranged or will be arranged farthest from the dispensing end of the drug delivery device 102. The distal end 106 and the proximal end 108 are spaced from each other in the direction of an axis 110. The axis 110 may be a longitudinal axis and / or a rotational axis of the drug delivery device 102. The housing 104 comprises a dose window 112 made of a transparent material. The housing 104 comprises an uncoded outer surface 114. Thus, the outer surface 114 is only lightly textured but does not include graphics or the like printed or otherwise adhered thereto.

[0083] The drug delivery device 102 also includes a cartridge holder 116. The cartridge holder 116 is configured to receive a cartridge (not shown in detail) for holding a plurality of doses of a drug. Figure 1 In the exemplary embodiment shown in , the cartridge holder 116 comprises a cartridge. The cartridge contains a drug, preferably a plurality of doses of the drug. The cartridge is retained in the cartridge holder 116. The cartridge holder 116 mechanically stabilizes the position of the cartridge. The cartridge holder 116 may be connected to the housing 104 at its distal end 106, for example, by threaded engagement or by a bayonet coupling. The cartridge holder 116 and the housing 104 are releasably connected to each other. In an alternative embodiment, the cartridge may be directly connected to the housing 104. In this case, the cartridge holder 116 may be redundant.

[0084] 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, which means that the cartridge may be replaced by a replacement cartridge for dispensing a plurality of doses from the replacement cartridge, in particular during a resetting operation.

[0085] A stopper (not shown in detail) is slidably retained in the cartridge. The stopper seals the cartridge proximally. Movement of the stopper relative to the cartridge in a distal direction causes the drug to be dispensed from the cartridge. A needle assembly (not shown in detail) may be arranged at a distal end section of the cartridge holder 116, for example, by means of an engagement means (e.g., a thread). A cap may be fastened to the cartridge holder 116, for example, to protect the drug delivery device 102, in particular the cartridge holder 116, from environmental influences when the drug delivery device 102 is not in use.

[0086] The drug delivery device 102 further comprises a dose setting member 118 and a dose button 120, which are operated to set and dispense a dose of the drug. The dose button 120 is located at a proximal section of the dose setting member 118. The drug delivery device 102 comprises a piston rod (not shown in detail). The piston rod is configured to transmit movement through the housing 104 for discharging a dose of the drug from the cartridge. The piston rod can move 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 by the manufacturer. In addition, the initial position may be the position of the piston rod after performing a reset operation. The initial position may be the most proximal position of the piston rod. The end position may be the position of the piston rod after dispensing the entire amount of drug from the cartridge. The end position may be the most distal position of the piston rod. During operation of the drug delivery device 102, in particular during dispensing of a dose of the drug, the piston rod moves toward the end position.

[0087] The piston rod has a distal end, which is arranged closest to the dispensing end of the drug delivery device 102. The distal section of the piston rod includes a bearing member. The bearing member is arranged between the stopper and the piston rod. The bearing member is configured to reduce damage that may be caused by friction. The bearing member can be part of the piston rod. The bearing member can be connected to the piston rod. Alternatively, the bearing member and the piston rod can be formed integrally. During the entire operation of the device, the bearing member and the stopper are in mechanical contact, in particular adjacent. As long as the cartridge or replacement cartridge is loaded in the device, the bearing member and the stopper are in mechanical contact. In other words, as long as the cartridge holder 116 is at least partially connected to the housing 104, the bearing member and the stopper are in mechanical contact.

[0088] The piston rod is configured as a lead screw. The piston rod includes two threaded sections. The threaded sections have opposite rotational directions. The first threaded section is located at the distal portion of the piston rod, while the threaded section is located at the proximal portion of the piston rod. The piston rod and in particular the first threaded section are threadedly engaged with a guide member (e.g., a guide nut, not shown in detail). The guide member includes a central hole. In the central hole, a thread is designed. The thread is used to be connected to the piston rod so as to push the piston rod through the housing 104 and to the end position with a predetermined spiral movement. Due to the mechanical cooperation with the guide member, the piston rod can be moved axially and rotationally toward the end position. In addition, the piston rod and in particular the second threaded section are threadedly engaged with a drive member (not shown in detail). When the user pushes the dose button 120, the drive member applies a force on the piston rod to cause the movement of the piston rod for delivering a dose of the drug. The dose set by means of the dose setting member 118 can be seen through the dose window 112. For example, the number of units of the drug set by the user can be seen through the dose window 112.

[0089] The dose recording device 100 comprises a device housing 122. The device housing 122 is configured to be mounted to a dose setting member 118. The device housing 122 comprises a front end 124 configured to be mounted 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 mounted to the dose setting member 118. The device housing 122 is designed as a sleeve. The device housing 122 has a length 128 that at least corresponds to a dimension that the dose setting member 118 can extend axially from the housing 104. The device housing 122 is configured to be rotationally and axially movable relative to the housing 104.

[0090] The dose recording device 100 further comprises a measuring system 130 having an optical sensor 132 connected 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 measuring system 130 is configured to detect a relative movement of the device housing 122 relative to the housing 104 by means of the optical sensor 132 and store relative movement data in order to provide information about the delivery of the dose of the drug. For this purpose, the measuring system 130 comprises a memory or a memory device and an interface configured to transmit data. The optical sensor 132 is configured to detect the relative movement based on the outer surface structure of the housing 104. In particular, the optical sensor 132 faces the uncoded outer surface 114.

[0091] Figure 2 A perspective view of the dose recording device 100 and the drug delivery device 102 in an assembled state is shown. The dose recording device 100 can be mounted to the dose setting member 118 by pressing thereon. Thus, the dose button 120 is arranged within the device housing 122. The dose recording device 102 further comprises a grip feature 136 at the rear end 126.

[0092] Figure 3 1 shows a perspective view of the dose recording device 100. The dose recording device 100 also includes a power supply 138 configured to supply power to the measurement system 130. The power supply 138 is arranged in the device housing 122. Figure 3As shown, 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 the rotation and / or axial movement of the device housing 122. In the present embodiment, the measurement system 130 is configured to be calibrated by detecting the rotation and axial movement of the device housing 122. The dose recording device 100 also includes a force sensor (not shown in detail), which is configured to detect the axial force applied to the device housing 122. The force sensor is arranged between the dose setting member 118 and the device housing 122. The measurement system 130 is configured to wirelessly transmit information about the drug dose delivery to a remote electronic device (not shown in detail), such as a user's smart phone. For example, the interface can be a wireless transmission interface, such as Bluetooth or WLAN.

[0093] In the following, further details of the operation of the dose recording device 102 and its calibration will be described below.

[0094] Figure 4 A perspective view of the dose recording device 100 and the drug delivery device 102 during operation is shown. For operational purposes, the dose recording device 100 is mounted on the drug delivery device 102 as described above. If the user dials a dose, he turns the dose setting member 118 by turning the device housing 122. Upon dialing, the helical movement indicated by the arrow 140 consists of an axial movement and a rotational movement 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, which will be measured by the measuring system 130. This movement will be detected by the optical sensor 132. Figure 4 The movement of the optical sensor 132 is shown when 72 units of medication have been dialed. Figure 4 1 and 2 show the initial position of the dose recording device 100 and the position of the dose recording device 100 after dialing. If the user injects the drug, he presses the dose button 120 by pressing the device housing 122. Now, the dose recording device 100 is moved axially to the starting position and the measuring system 130 detects the movement corresponding to the dialed dose by means of the optical sensor 132 monitoring the outer surface 114.

[0095] Before an injection is started, it is important to detect the movement of the dose button 120 without injection. This can be measured with a force sensor between the dose button 120 and the device housing 122. In order to mount the dose recording device 100 onto the dose button 120, the user must press the dose recording device 100 firmly onto the dose button 120. This process can be used to measure the axial movement of the dose button 120 until the clutch (not shown in detail) within the housing 104 switches from dialing (i.e. rotational movement) to injection (i.e. axial movement), and thus calibrate the measurement system 130.

[0096] Figure 5 A graph for explaining the calibration process of the dose recording device 100 is shown, which is another calibration method. Figure 5 The method shown is a simulated injection without a cartridge. The user must dial 10 units (D1), detect the first dial extension E1 and inject. Then he must dial 20 units (D2), detect the second dial extension E2 and inject. As the dose button 120 moves axially, the "offset" of the dose button 120 can be calculated as Offset = (E1D2-E2D1) / (D1-D2), which can be obtained from the resulting calibration curve 142.

[0097] Reference numerals list

[0098] 100 Dose Recording Device

[0099] 102 Drug delivery devices

[0100] 104 Housing

[0101] 106 Remote

[0102] 108 Proximal

[0103] 110 Axis

[0104] 112 Dosage Window

[0105] 114 External surface

[0106] 116 Cartridge Holder

[0107] 118 dose setting member

[0108] 120 Dose Button

[0109] 122 Device housing

[0110] 124 Front End

[0111] 126 Backend

[0112] 128 Length

[0113] 130 Measurement system

[0114] 132 Optical Sensor

[0115] 134 Parts

[0116] 136 Grip Features

[0117] 138 Power Supply

[0118] 140 Arrow

[0119] 142 Calibration curve

Claims

1. A dose recording device (100) for a drug delivery device (102), wherein the drug delivery device (102) comprises a housing (104), a cartridge holder (116) configured to receive a cartridge for holding a plurality of doses of a drug, and a dose setting member (118) connected to the housing (104) and configured to set a dose of the drug, wherein the dose recording device (100) comprises a device housing (122) and a measuring system (130), the measuring system having a portion connected to the device housing (122) (134) wherein the device housing (122) is configured to be mounted to the dose setting member (118), wherein the measurement system (130) is configured to detect relative movement of the device housing (122) relative to the housing (104) by means of the optical sensor (132) and store relative movement data to provide information about the delivery of the dose of the drug, wherein the optical sensor (132) is configured to detect the relative movement based on an outer surface structure of the housing (104).

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

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

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

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

6. The dose recording device (100) according to claim 1 or 2, further comprising a power supply (138) configured to supply power to the measurement system (130).

7. The dose recording device (100) according to claim 6, wherein the power supply (138) is arranged within the device housing (122).

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

9. The dose recording device (100) according to claim 1 or 2, wherein the device housing (122) is configured to be rotationally and axially movable relative to the housing (104).

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

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

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

13. The dose recording device (100) according to claim 10, 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 and delivered doses.

14. The dose recording device (100) according to claim 1 or 2, wherein the measurement system (130) is configured to wirelessly transmit the information regarding the delivery of the dose of the drug to a remote electronic device.

15. The dose recording device (100) according to claim 1 or 2, wherein the device housing (122) is designed as a sleeve.

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