Recognition of drug delivery devices

Abstract

A system is provided that comprises a drug delivery device, a user device, and a case for the user device, wherein the case includes a first wall, a second wall, and at least two side walls that define a space configured to receive the user device, and the case further includes a slot adapted to receive the drug delivery device; the user device includes at least one camera; and the case is configured to align the camera of the user device and the drug delivery device such that when the user device and the drug delivery device are inserted into the case, the camera is able to capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation.

Description

Technical Field

[0001] The present disclosure relates to the recognition of drug delivery devices, as well as devices and systems used for the recognition of drug delivery devices.

Background Art

[0002] As an application of a pen-type drug delivery device, there is a case where regular injections are performed by the user (patient) himself / herself. This is becoming increasingly common among diabetic patients, and self-treatment enables such patients to effectively manage their diabetes.

[0003] The drug delivery device can be, for example, a pre-filled disposable insulin pen. Alternatively, a reusable pen can also be used. With a reusable pen, it is possible to replace an empty drug cartridge with a new one. A set of needles is attached to both pens, and the needles are replaced before each use. Then, for example, in an insulin pen, the injection dose of insulin can be manually selected by turning the dose dial and observing the actual dose through the dose window of the insulin pen. Next, the needle is inserted into a suitable skin site, and the dose is injected by pressing the injection button of the insulin pen.

Summary of the Invention

Problems to be Solved by the Invention

[0004] It may be desirable to provide additional or continuous assistance to the user regarding the use of the drug delivery device. For example, the user may need to use two or more drug delivery devices and may have difficulty recognizing or remembering which device to use when.

[0005] It may also be advantageous to monitor the state of the device and / or the correct use of the device by the user permanently or temporarily (for example, when the user is not yet familiar with the device).

[0006] In certain situations, it may be advantageous to verify a device and confirm that the device is genuine (i.e., not a counterfeit device, for example).

Means for Solving the Problem

[0007] According to a first aspect, a system is provided that includes a drug delivery device, a user device, and a case for the user device. The case includes a first wall, a second wall, and at least two side walls that define a space configured to receive the user device, and the case further includes a slot adapted to receive the drug delivery device; the user device includes at least one camera; and when the user device and the drug delivery device are inserted into the case, the case is configured to align the camera of the user device and the drug delivery device such that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation.

[0008] In a second aspect, a case for a user device is provided, the case including a first wall, a second wall, and at least two side walls that define a space configured to receive the user device; and a slot adapted to receive the drug delivery device; and when the user device and the drug delivery device are inserted into the case, the case is applied so as to align the camera of the user device and the drug delivery device such that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation.

[0009] In a third aspect, a method for recognizing a drug delivery device is provided, the drug delivery device including at least one characteristic configuration, the method including: inserting the drug delivery device into a case; inserting a user device into the case; the case being configured to align a camera of the user device and the drug delivery device such that the camera can capture an image of the drug delivery device from a predetermined distance and / or orientation; the method further including: using the camera of the user device to capture an image of the drug delivery device; using a processor of the user device to identify one or more characteristic configurations of the drug delivery device based on the captured image; using the processor of the user device to compare the identified characteristic configuration with a predetermined characteristic configuration stored in a memory of the user device; identifying the drug delivery device based on the comparison; and outputting a result of the identification using a screen of the user device.

[0010] In a fourth aspect, a method for calculating a dosage of a medicament administered by a drug delivery device is provided, the drug delivery device including a container for the medicament, the container including a stopper for displacing the medicament, the method including: inserting the drug delivery device into a case; inserting a user device into the case; the case being configured to align a camera of the user device and the drug delivery device such that the camera can capture an image of the drug delivery device from a predetermined distance and / or orientation; the method further including: using the camera of the user device to capture a first image of the container; using a processor of the user device to determine a first position of the stopper corresponding to a position of the stopper before the dosage of the medicament is administered from the first image; using the camera of the user device to capture a second image of the container; using a processor of the user device to determine a second position of the stopper corresponding to a position of the stopper after the dosage of the medicament is administered from the second image; and determining the administered dosage based on the first and second positions.

[0011] Embodiments of the first, second, third, and fourth aspects are provided in the dependent claims and the detailed description.

[0012] Specific embodiments of the present invention will now be described with reference to the accompanying drawings for illustrative purposes only.

Brief Description of the Drawings

[0013]

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Mode for Carrying Out the Invention

[0014] As shown in FIG. 1, an exemplary system according to the present invention includes a drug delivery device 1, a user device 2, and a case 5 for housing the user device 2 and the drug delivery device 1.

[0015] The drug delivery device 1 can be, for example, an insulin pen. The drug delivery device can be any other pen-type injection device. The user device 2 can be, for example, a mobile phone 2 or a tablet. The user device 2 has a camera 21 and a display 23 attached to the user device 2. The user device 2 also has at least one rear camera (not shown). The user device 2 can further include a flashlight (not shown) located near (e.g., adjacent to) at least one rear camera.

[0016] FIG. 2 is a diagram of an exemplary drug delivery device 1. An example of such a device is the Sanofi's Solostar (trademark) insulin injection pen. The drug delivery device 1 can be any suitable pen-type or auto-injector type drug delivery device.

[0017] The drug delivery device 1 includes a housing 10. Generally, the housing 10 includes an injection mechanism, such as an injection button 11, a dose dial 12, a dose window 13, and a container region 14. A needle (not shown) can be attached to the container region 14. The housing further includes a cap 18 that covers the container region 14 when the device 1 is not in use (and when the needle is not attached). Until the needle is attached to the housing 10, the needle is protected by an inner needle cap (not shown) and an outer needle cap (not shown).

[0018] The housing 10 includes a container region 14 to which a needle can be attached. The container region 14 houses a container. The container contains the drug to be injected. The drug can be, for example, insulin. The container can be, for example, an insulin container.

[0019] The container region 14 can include a drug window 14a. The drug window 14a is, for example, an opening covered with glass, transparent plastic, or other transparent material (so that the user can see the container and / or the contents of the container).

[0020] By turning the dosage dial 12, an appropriate dosage of the drug can be selected. By turning the dosage dial 12, the dosage dial 12 can be spirally extended along the longitudinal axis of the main body 10 away from the main body 10 of the drug delivery device 1. The extension can correspond to the dial-set dosage (described below).

[0021] By turning the dosage dial 12, tactile and acoustic feedback can be provided to the user by a mechanical clicker. The numbers displayed within the dosage window 13 are present on the sleeve by printing, and the sleeve is housed within the housing 10 and mechanically interacts with the piston within the insulin container located within the container region 14. When the needle pierces the patient's skin site and then the injection button 11 is pressed, the insulin dosage displayed within the dosage window 13 is discharged from the injection device 1. After the injection button 11 is pressed, if the needle of the injection device 1 remains at the skin site for a specific time, most of the dosage is injected into the patient's body. The discharge of the insulin dosage also causes a mechanical click sound, which is different from the sound generated when using the dosage dial 12.

[0022] The selected dosage, for example, a multiple of the so-called international unit (IU) of insulin dosage, is displayed via the dosage window 13, and 1 IU is biologically equivalent to approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). An example of the selected dosage displayed within the dosage window 13 can be, for example, 30 IU as shown in FIGS. 1 to 4.

[0023] The user device 2 can include suitable software (e.g., a suitable application) to assist the user regarding the handling of the drug delivery device 1. For example, the user device 2 can accommodate suitable software that can recognize a specific drug delivery device 1 and then provide assistance to the user based on the recognition of the drug delivery device 1. The recognition of the drug delivery device 1 will be described below. Alternatively or in addition, the software can recognize a configuration (described later) related to the administered dose and can assist the user regarding providing feedback on drug administration, logging the administered dose, and the like.

[0024] For example, the user device 2 can provide or enable one or more of the following: a function to indicate to the user whether the user has selected the correct drug delivery device 1; a function to advise the user regarding the state of the drug delivery device 1 (e.g., advise the user if a component of the drug delivery device 1 is not functioning or not fully functioning); a function to advise the user regarding the state of the drug in the drug delivery device 1 (e.g., if the expiration date of the drug has passed or is considered to have passed, if the drug is cloudy when it should be clear, etc.); a function to indicate whether the drug delivery device 1 is genuine (i.e., not a counterfeit device); a function to verify the dose administered by the drug delivery device 1; and the like.

[0025] The drug delivery device 1 has one or more characteristic configurations. The user device 2 stores suitable software that enables the user device 2 to identify the characteristic configurations and compare them to a set of predetermined characteristic configurations associated with a specific device. Thus, the user device 2 enables the recognition of the drug delivery device 1. The characteristic configurations can enable the user device 2 to identify the state of the drug delivery device 1.

[0026] The user device 2 can memorize two or more characteristic configurations of a given drug delivery device 1. When the user device 2 memorizes two or more characteristic configurations of a given drug delivery device 1, the drug delivery device 1 can be more accurately identified by the user device 2. When the user device 2 memorizes two or more characteristic configurations of a given drug delivery device 1, it can be made possible to recognize one or more of the position of the drug delivery device 1, the orientation of the drug delivery device 1 with respect to the user device 2, the distance from the user device 2 to the drug delivery device 1, etc. Alternatively or in addition, when the user device 2 is used for the user to capture video rather than a still image, it can be made possible to identify the movement of the drug delivery device 1, the change in its position, orientation, distance from the user device 2, etc.

[0027] Exemplary characteristic configurations that can serve as characteristic configurations are shown in FIG. 3. For example, the following can be cited as characteristic configurations: - The outer shapes 101c, 101d of the main body 10 of the container region 14 (i.e., the cap 18 is removed); - The color of the main body 10 of the drug delivery device 1; - The shape and / or color 105 of the dosage window 13; - The shape and / or color 106 of the dosage dial 12; - The shape and / or color 108 of the drug window 14a; - The distance L6 between the dosage dial 12 and the main body 10 of the drug delivery device 1; - The number and / or position of the notches 112 on the dosage dial 12; - The diameter D1 of the main body 10 of the drug delivery device 1 (see FIG. 3); - The diameter D2 of the injection button 11; - The diameter D3 of the dosage dial 12 (see FIG. 4); - The ratio of any combination of the length L6 and the diameters D1 to D3 (generally, either the ratio Dx / Dy or L6 / Dy, where x and y represent the numerical values of the respective lengths or diameters); - The distance (not shown) between any two of the characteristic configurations listed above, and / or the ratio of any two of these distances.

[0028] The characteristic configurations can be used alone or in combination. The user device 2 can recognize one or more of the characteristic configurations within a given drug delivery device 1. Any one of the characteristic configurations listed above can be combined with any other one of the characteristic configurations for use in recognizing the drug delivery device. The user device 2 can memorize any part of the characteristic configurations listed above, including all of the characteristic configurations. The recognition by the user device 2 of any one of the characteristic configurations listed above can be combined with the recognition by the user device 2 of any other one of the characteristic configurations. The drug delivery device 1 can include any part of the characteristic configurations listed above, including all of the characteristic configurations. The drug delivery device 1 can include any one of the characteristic configurations listed above in combination with any other one of the characteristic configurations.

[0029] The user device 2 memorizes a predetermined characteristic configuration (such as any one of the characteristic configurations listed above, a part of the characteristic configurations, or all of the characteristic configurations listed above) of a given drug delivery device 1. The user device 2 can compare the characteristic configuration measured from the image or video captured by the camera 21 with the predetermined characteristic configuration memorized in the memory 25 of the user device 2 to identify which drug delivery device 1 is presented to the camera 21.

[0030] For example, a user may own two different drug delivery devices. Each of these drug delivery devices has a set of characteristic configurations. The first set of characteristic configurations of the first drug delivery device is different from the second set of characteristic configurations of the second drug delivery device with respect to at least one, preferably two or more, of these characteristic configurations. The user device 2 stores the first and second sets of characteristic configurations of the first and second drug delivery devices, respectively. When the user presents one of the drug delivery devices to the camera (front camera 21 or rear camera) of the user device 2, the user device 2 captures an image of the drug delivery device presented to the camera. Based on the characteristic configurations, the user device 2 uses the captured image to derive the characteristic configurations of the drug delivery device 1 shown in the camera 21. The drug delivery device 1 compares the characteristic configurations derived from the image with the stored first and second sets of characteristic configurations. Then the user device 2 identifies which of the first and second sets matches the characteristic configurations derived from the image and determines which of the drug delivery devices owned by the user was presented to the camera.

[0031] The diameter D1 of the body 10 of the drug delivery device 1 can be measured at the widest point of the drug delivery device 1. Alternatively, the diameter D1 can be measured at a predetermined location, for example, along the contact line between the body 10 and the cap 18, along the line where the dose dial 12 is located, or at any other suitable location.

[0032] The diameter D2 of the injection button 11 can be measured in the outermost region of the injection button 11. Alternatively, the diameter D2 can be measured at the widest point of the injection button 11.

[0033] The diameter D3 of the dose dial 12 can be measured at one of the ends (outermost regions) of the dose dial 12. The diameter D3 can be measured along the color 109a. Alternatively, the diameter D2 can be measured at the widest point of the dose dial 12.

[0034] Recognition of the drug delivery device 1 based on the recognition of the shapes of various other components (such as the dosage window 13, the dosage dial 12, the injection button 11, or the drug window 14a) can depend on the distance from the camera of the user device 2 to the drug delivery device 1.

[0035] Recognition of the drug delivery device 1 based on the recognition of the dimensions (such as the length L6 and the diameters D1 - D3, etc.) of the members of the drug delivery device 1 can depend on the distance from the user device 2 to the drug delivery device 1.

[0036] Figures 5 and 6 show an example of a container 113 that can be used with the drug delivery device 1. It will be understood that the container 113 can be replaced with any suitable alternative. For example, a pen - type drug delivery device that can be used only once can use an integrated container instead of the container shown in Figures 5 and 6. The container 113 can be made replaceable within the drug delivery device 1.

[0037] Regardless of the type of container used, the container 113 can include a stopper 114 and a closure 115. The closure engages with the needle via a needle interface (not shown). The stopper 114 closes the first or distal end of the container 113. The closure 115 closes the second or proximal end of the container 113.

[0038] The stopper 114 is movable within the container 113. Due to the movement of the stopper 114, the drug contained within the container 113 is pushed out into the needle and exits the drug delivery device 1. Figure 5 shows an exemplary configuration of the container 113 before a dose is administered. Figure 6 shows an exemplary configuration of the container 113 after a dose is administered. Figures 5 and 6 show that after a dose is administered, the stopper 114 is moved from a first position closer to the distal end of the container 113 to a second position away from the distal end and closer to the proximal end of the container 113.

[0039] During use of the drug delivery device 1, the container is housed within the container region 14. Through the drug window 14a, the container 113 and the stopper 114 can be observed. Through the drug window 14a, the position of the stopper 114 and / or a change in the position of the stopper 114 can be observed.

[0040] One way to establish a known distance between the user device 2 and the drug delivery device 1 and a known orientation of the drug delivery device 1 relative to the user device 2 is to use a specially designed case 5 (shown in detail in FIGS. 11-13). The case 5 has a first wall 502, a second wall 504, and at least two side walls 503. The first wall 502, the second wall 504, and the side walls 503 define a space 501 for housing the user device 2. The second wall 504 of the case 5 includes a slot 505. The slot 505 can be, for example, a tube as shown in FIGS. 11 and 12, but other shapes are possible. The slot 505 has an inner space 506 adapted to house the drug delivery device 1. The slot 505 can further include an extension 507. The extension 507 can be adapted to house the needle mount 14b. The extension 507 can be adapted to house the dose dial 12 and the button 11.

[0041] The second wall 504 of the case 5 includes a lens system 508. The lens system 508 is positioned to be aligned with the camera of the user device 2. The lens system 508 can enhance the measurement of the configuration of the drug delivery device 1. Preferably, the lens system compensates for the short distance between the camera and the drug delivery device 1 when the drug delivery device 1 is positioned within the slot 505 of the case 5.

[0042] In one embodiment, the lens system 508 also includes a light guide (not shown). Preferably, the light guide is configured to direct light from the flashlight to the drug delivery device 1, thus improving the resolution of the captured image and / or the recognition of characteristic configurations. In one embodiment, the light guide can assist in recognizing the stopper 114 and / or its position. Thus, the light guide can improve the accuracy of recognizing the administered dose.

[0043] In one embodiment, the case 5 can be configured such that the user device 2 can be positioned within the case 5 facing the first wall 502. The front wall 502 can be adapted to enable the user to observe and / or operate the screen 23 (e.g., a touch screen) of the user device 2. In this case, the lens system 508 is positioned to be aligned with the rear camera of the user device 2.

[0044] In one embodiment, the user device 2 can be positioned within the case 5 facing the second wall 504. In this case, the lens system 508 is positioned to be aligned with the front camera 21 of the user device 2. The user device 2 can be housed such that the user does not have access to the display 21 when the user device 2 is inserted into the case 5. Alternatively, the case 5 can include a lid (not shown). At this time, the slot 505 can be positioned on or in the lid. The lid can be adapted to be opened and closed. When the lid is open, the user can access the display screen 23 of the user device 2. When the lid is closed, the slot 505 is aligned with the front camera 21 of the user device. After the drug delivery device 1 is housed in the slot 505, the drug delivery device 1 is also aligned with the front camera 21 of the user device 2.

[0045] The slot 505 can be positioned to align the lens system 508, the drug window 14a, the stopper 114, and the camera of the user device 2.

[0046] When the drug delivery device 1 is inserted into the inner space 506 of the slot 505, the drug delivery device 1 is positioned at a specific position and orientation relative to the user device 2. In particular, the slot 505 positions the drug delivery device 1 at a specific position (distance, orientation) relative to the front camera 21 or the rear camera of the user device 2. This then enables the user device 2 to capture an image of the drug delivery device 1 from a known distance and angle.

[0047] Using the known distance and orientation of the drug delivery device 1 relative to the user device 2, the user device 2 can process the captured image and measure the characteristic configuration described above. Alternatively or in addition, using the known distance and orientation of the drug delivery device 1 relative to the user device 2, the user device 2 can process the captured image, measure the positions of the stopper 114 before and after the dose is administered respectively, and derive the administered dose from this measurement.

[0048] By using the port 5, the known position (distance, orientation) of the drug delivery device 1 from the camera of the user device 2 can make the measurement of the characteristic configuration and / or the administered dose more precise.

[0049] The user device 2 (schematically shown in FIG. 8) includes a processor 24, a memory 25, at least one camera 21, a display 23, and a power supply 26. The memory 25 stores suitable software (e.g., a software application) for the recognition of the drug delivery device 1 as described above. The processor 24 executes the software according to the above-described content.

[0050] In use, the user uses the camera 21 of the user device 2 to capture an image of the drug delivery device 1 (Figure 9, step S1). The captured image is then processed by the user device 2, and one or more characteristic configurations within the captured image are identified (step S2). The identified characteristic configurations are compared with the characteristic configurations stored in the user device 2 (step S3). Then, the drug delivery device is identified (step S4), and the result is output (step S5).

[0051] For example, in the method shown in Figure 10, the above-described devices and methods can be used (described later).

[0052] The drug delivery device 1 is first located within the slot 505 of the case 5. The user device 2 is also located within the space 501 within the case 5. Preferably, the user device 2 stores a set of parameters of the drug delivery device 1 in its memory.

[0053] After the user device 2 and the drug delivery device 1 are located within the case 5, the user device 2 can capture a first photograph of the container 113 of the drug delivery device 1 (step S10).

[0054] From the first photograph of the drug delivery device 1 and / or the first photograph of the container 113, the first position of the stopper 114 can be determined (step S11). The first position of the stopper 114 typically corresponds to the position of the stopper 114 before the dose is administered.

[0055] The user device 2 stores the first stopper position (step S12).

[0056] The user device 2 can instruct the user to inject the dose (step S13). The user device 2 can optionally require confirmation from the user that the dose has been injected.

[0057] The user device 2 can capture a second photograph of the container 113 (step S14).

[0058] From the second photograph of the drug delivery device 1 and / or the second photograph of the container 113, the second position of the stopper 114 can be determined (step S15).

[0059] The second position of the stopper 114 typically corresponds to the position of the stopper 114 after the dose has been administered. From the known (pre-stored) parameters of the cartridge 113 and the known first and second positions of the stopper 114, the administered dose can be calculated (step S16).

[0060] Optionally, the administered dose can be displayed on the display 23 of the user device 2 (step S17). As an alternative or addition, information regarding whether the correct dose has been administered can be displayed. For example, if it is determined that the dose corresponds to the user's recommended dose (pre-stored or pre-selected), a confirmation that the correct dose has been administered can be displayed.

[0061] To assist in recognizing the stopper position, the container 113 and / or the stopper 114 and / or the drug window 14a can include at least one contrast function. For example, the inner surface of the stopper 114 can be provided with a contrasting color and / or a contrasting backing. Similarly, at least one of the boundaries 116 (shown in FIG. 7) of the drug window 14a can be provided with a contrasting color.

[0062] It will be apparent to those skilled in the art that a similar contrast function can be provided in the container (e.g., at a position close to the proximal end, a position where this contrast function can be seen through the drug window 14a after insertion of the container into the container region). In this context, a contrasting color is a color that is visible relative to other functions and / or the drug contained within the container. For example, the container region 14 can be provided in a dark color (such as black, gray, dark green, or brown), the stopper 114 can also be provided in a dark color (the same or different from the color of the container region 14), and the contrast function can be provided in a transparent color (such as yellow, orange) or a light color (such as white, beige, yellow, or red).

[0063] As described above, in Case 5, the image captured by the user device 2 during the method of FIG. 10 is associated with the known position of the drug delivery device 1 relative to the user device 2. Thus, the identification of the drug delivery device 1 and / or the measurement of the administered dose do not require an additional step of positioning the drug delivery device 1 relative to the user device to derive the precise position (distance and orientation) of the drug delivery device 1 relative to the user device. Thus, each method is simplified. In addition, the identification of the drug delivery device 1 and / or the measurement of the administered dose can be made more precise than in the absence of Case 5.

[0064] The terms “drug” or “agent” are used synonymously herein and describe a pharmaceutical formulation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, optionally together with a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”) is, in the broadest sense, a chemical structure having a biological effect on a human or animal. In pharmacology, a drug or medicine is used for the treatment, cure, prevention, or diagnosis of a disease or, alternatively, for improving physical or mental well-being. A drug or agent can be used for a limited duration or, in the case of a chronic disorder, periodically.

[0065] As described below, a drug or medicament can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0066] A drug or medicament 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 rigid or flexible vessel configured to provide a chamber suitable for containing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber can be designed to contain a 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 contain a drug for about one month to about two years. Storage can be carried out at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately contain in each chamber two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a 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 allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing upon dosing of the components into a human or animal body.

[0067] The drugs or agents included in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic agents) or 86 (oncological agents)) or the Merck Index, 15th edition.

[0068] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms "analog" and "derivative" refer to polypeptide molecules having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the molecular structure of human insulin in which one or more organic substituents (such as fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids including non-codable amino acids, or amino acids are added including those non-codable for the naturally occurring peptide.

[0069] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and the 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.

[0070] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, Levemir®); B29 - N - palmitoyl - des(B30) human insulin; B29 - N - myristoyl human insulin; B29 - N - palmitoyl human insulin; B28 - N - myristoyl LysB28ProB29 human insulin; B28 - N - palmitoyl - LysB28ProB29 human insulin; B30 - N - myristoyl - ThrB29LysB30 human insulin; B30 - N - palmitoyl - ThrB29LysB30 human insulin; B29 - N - (N - palmitoyl - gamma - glutamyl) - des(B30) human insulin, B29 - N - omega - carboxypentadecanoyl - gamma - L - glutamyl - des(B30) human insulin (insulin degludec, Tresiba®); B29 - N - (N - lithocholyl - gamma - glutamyl) - des(B30) human insulin; B29 - N - (ω - carboxyheptadecanoyl) - des(B30) human insulin and B29 - N - (ω - carboxyheptadecanoyl) human insulin.

[0071] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia (registered trademark)), exenatide (exendin-4, Byetta (registered trademark), Bydureon (registered trademark), a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza (registered trademark)), semaglutide, taspoglutide, albiglutide (Syncria (registered trademark)), dulaglutide (Trulicity (registered trademark)), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0072] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro (registered trademark)), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0073] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0074] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0075] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in poly-sulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hyaluron G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0076] 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 that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has a reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to an Fc receptor, for example, having a mutation or deletion in the Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0077] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may include a cleaved portion of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific, and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or polyvalent antibody fragments, such as divalent, trivalent, tetravalent, and polyvalent antibodies, minibodies, chelated 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.

[0078] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of the CDR sequences to enable antigen binding. The framework region itself typically does not directly participate in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody may directly participate in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0079] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0080] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use in a drug or agent in a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0081] Without departing from the full scope and spirit of the invention, modifications (additions and / or deletions) can be made to the various components of the APIs, manufacturing methods, devices, methods, systems, and embodiments described herein, and it will be understood by those skilled in the art that the invention encompasses such modifications and any equivalents thereof.

[0082] An exemplary drug delivery device can be accompanied by a needle-based injection system as described in Table 1 of Chapter 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly classified into multi-dose container systems and single-dose (partial or full discharge) container systems. The container can be an exchangeable container or an integrated non-exchangeable container.

[0083] As further described in ISO11608-1:2014(E), a multi-dose container system can be accompanied by a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses, and the dose size can be fixed or variable (pre-set by the user). Another multi-dose container system can be accompanied by a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses, and the dose size can be fixed or variable (pre-set by the user).

[0084] As further described in ISO11608-1:2014(E), a single-dose container system can be accompanied by a needle-based injection device with an exchangeable container. In one example for such a system, each container holds a single dose, and the entire volume deliverable thereby is discharged (total discharge). In a further example, each container holds a single dose, and a portion of the volume deliverable thereby is discharged (partial discharge). As also described in ISO11608-1:2014(E), a single-dose container system can be accompanied by a needle-based injection device with an integrated non-exchangeable container. In one example for such a system, each container holds a single dose, and the entire volume deliverable thereby is discharged (total discharge). In a further example, each container holds a single dose, and a portion of the volume deliverable thereby is discharged (partial discharge).

Claims

1. A system comprising a drug delivery device (1), a user device (2), and a case (5) for the user device, wherein: The case includes a first wall (502), a second wall (504), and at least two side walls (503) defining a space (501) configured to receive the user device (2) removably therein, and the case further includes a slot (505) adapted to receive the drug delivery device (1) removably therein; The user device includes at least one camera; When the user device and the drug delivery device are both received removably in the case, the case is configured to align the camera of the user device and the drug delivery device such that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation. The said system.

2. The system according to claim 1, wherein the case further includes a lens system (508) located between the camera and the drug delivery device when the user device and the drug delivery device are inserted into the case.

3. The system according to claim 1 or 2, wherein the user device further includes a flashlight, and the case further includes a light guide configured to guide light from the flashlight towards the drug delivery device.

4. The drug delivery device includes a container for containing a medicament, the container includes a stopper for displacing the medicament, and the case is configured to align the camera of the user device and the container of the drug delivery device such that the camera comes to a position for capturing at least one image of the stopper. The system according to any one of claims 1 to 3.

5. The user device: Uses the camera to capture a first image of the container; From the first image, uses a processor to determine a first position of the stopper corresponding to the position of the stopper before the dose of the medicament is administered; Uses the camera to capture a second image of the container; From the second image, uses a processor to determine a second position of the stopper corresponding to the position of the stopper after the dose of the medicament is administered; The system according to claim 4, configured to determine the administered dose based on the first and second positions.

6. The user device includes a rear camera, and the case is configured to align the rear camera of the user device and the drug delivery device so that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation. The system according to any one of claims 1 to 5.

7. The user device includes a front camera, and the case is configured to align the front camera of the user device and the drug delivery device so that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation. The system according to any one of claims 1 to 6.

8. The case includes a lid, and the slot is provided in the lid. The system according to any one of claims 1 to 7.

9. A case (5) for a user device (2), a first wall (502), a second wall (504), and at least two side walls (503) defining a space (501) configured to receive the user device (2) removably within the case; a slot (505) applied to receive the drug delivery device removably within the case; when the user device and the drug delivery device are received within the case so that both are removable, the case is applied to align the camera of the user device and the drug delivery device so that the camera can capture an image of at least one configuration of the drug delivery device from a predetermined distance and / or orientation. Said case.

10. The case according to claim 9, further comprising a lens system (508) positioned between the camera of the user device and the drug delivery device when the user device and the drug delivery device are inserted into the case.

11. The case according to claim 9 or 10, further comprising a light guide configured to guide light from the flash light of the user device towards the drug delivery device when the user device and the drug delivery device are inserted into the case.

12. The case according to any one of claims 9 to 11, wherein the camera of the user device and the container for accommodating the drug are configured to be aligned such that the camera comes to a position for capturing at least one image of the stopper configured to displace the drug.

13. A method for recognizing a drug delivery device, the drug delivery device including at least one characteristic configuration, the method comprising: inserting the drug delivery device removably into the case; inserting the user device removably into the case; the case being configured to align the camera of the user device and the drug delivery device such that the camera can capture an image of the drug delivery device from a predetermined distance and / or orientation; the method comprising: using the camera of the user device to capture an image of the drug delivery device; using the processor of the user device to identify one or more characteristic configurations of the drug delivery device based on the captured image; using the processor of the user device to compare the identified characteristic configuration with a predetermined characteristic configuration stored in the memory of the user device; identifying the drug delivery device based on the comparison; further comprising outputting the result of the identification using the screen of the user device.

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