Improvements in the usability of drug delivery devices

Abstract

A system is described, comprising: a pen-shaped drug injection device (10) having a distal end and a proximal end (12, 14), the proximal end (14) including a syringe (16) for injecting a drug into a patient; an electronic module (18) for wirelessly exchanging (20) data relating to the use of the drug injection device (10) with a device paired with the electronic module, the electronic module (18) being attached to or integrated into the distal end (12) of the drug injection device (10); and a computing device (22) configurable to pair with the electronic module (18) for use in... The wireless exchange (20) includes data relating to the use of the drug injection device (10) and includes a touch interface (24); a touch input device (26) attached to the drug injection device (10) and configured to perform input (28) on the touch interface (24) of the computing device (22); and a computer program including instructions for execution by the processor of the computing device (22) to configure the computing device (22) for pairing with the electronic module (18) based on the input (28) received via the touch interface (24).

Description

Technical Field

[0001] This disclosure relates to improvements in the usability of drug delivery devices. Background Technology

[0002] Many diseases require regular treatment through the delivery or injection of medications or drugs. These injections can be administered using an injection device, either by a healthcare professional or by the patient themselves.

[0003] Injection devices for patient self-use are, for example, disposable Solostar. TM Injection pens and reusable Allstar TM Both are injection pens from Sanofi. Allstar is described in detail in International Patent Application WO 2014 / 033195 A1. TM Injection pens. Such as Solostar. TM and Allstar TM Injection pens, such as pen-like syringes, include a distal and a proximal end, wherein, in the context of this disclosure, the term "proximal" refers to the direction in which the injection is directed towards the patient, while the term "distal" refers to the opposite direction away from the patient.

[0004] Self-administered drug delivery devices for patients may be equipped with electronics for measuring and storing usage-related data. This usage-related data may also be transmitted wirelessly or via a wired connection to an external device (such as a smartphone, tablet, or laptop) or to the cloud. For example, US 2019 / 0134305 A1 discloses a drug delivery device (e.g., an injection pen or wearable pump) that can be paired with an external device to provide data collected from a flow sensor associated with the medication being delivered to the patient. The device may have features for proximity-based pairing and connectivity with the external device. Communication circuitry and / or near-field communication (NFC) circuitry are used to transmit the acquired data to the external device in real time or with a delay. Summary of the Invention

[0005] This disclosure describes improvements to the usability of drug delivery devices, particularly injection pens equipped with electronics for transmitting data related to pen use to an external device via a wireless communication connection requiring pairing with the external device.

[0006] On one hand, this disclosure provides a system comprising: a pen-shaped drug delivery device having a distal end and a proximal end, the proximal end including a syringe for injecting a drug into a patient; an electronic module for wirelessly exchanging data relating to the use of the drug delivery device with a device paired with the electronic module, the electronic module being attached to or integrated into the distal end of the drug delivery device; a computing device configured to pair with the electronic module for wirelessly exchanging the data relating to the use of the drug delivery device, and including a touch interface; a touch input device attached to the drug delivery device and configured to perform input on the touch interface of the computing device; and a computer program including instructions executable by a processor of the computing device for configuring the computing device to pair with the electronic module based on the input received via the touch interface. The touch input device may, for example, be attached to the proximal end of the drug delivery device. This system can improve the usability of the drug delivery device by making the pairing of the drug delivery device with the computing device more comfortable, particularly for the user of the drug delivery device. Studies have shown that users typically tend to use the drug delivery device as an input device for computing devices, especially if the computing device includes a touchscreen. Users apparently assume that pen-shaped drug delivery devices should be used with a touch interface, but note that this is incompatible with conventional pen-shaped drug delivery devices. However, using the system disclosed herein, users can now use a drug delivery device, including an attached touch input device, as an input device for computing devices with touch interfaces.

[0007] In an implementation of the system, the touch interface may be a touchscreen, and the pairing includes touching a pairing button configured by the computer program displayed on the touchscreen using the touch input device. For example, the computing device may be a mobile computing device, such as a smartphone, tablet computer, or laptop computer with a touchscreen, and the computer program may be a dedicated program for processing data related to the use of the drug injection device, such as an application downloadable from an app store.

[0008] In a further embodiment of the system, touching the pairing button with the touch input device may include receiving and processing the touch via a computer program to switch the wireless communication module of the computing device to a scanning mode for detecting the electronic module within a predetermined neighborhood area of ​​the computing device over a certain time span, and for detecting pairing with the electronic module over the certain time span. Therefore, the user may not consciously activate the wireless communication module of the computing device, as this can be performed by the computer program once the user touches the pairing button with the touch input device. This can further improve the usability of the system for the user.

[0009] In a further embodiment of the system, pairing may require touching the pairing button with the touch input device until the electronic module is paired with the computing device. For example, when a user touches the pairing button with the touch input device of the drug delivery device, the computer program may instruct the user to continue touching the pairing button until the pairing process is successfully terminated when both devices are paired. This can help the user better follow the pairing process, as the user may notice that pairing only successfully terminates when touching can stop.

[0010] In a further embodiment of the system, the drug injection device may include a visual indicator for signaling the availability of pairing with the computing device. The visual indicator may be, for example, embodied in an LED (light-emitting diode) for visually signaling the pairing process, for example by flashing during the pairing process. In embodiments, the visual indicator may specifically include one or more of the following features: it may be located at a distal end of the drug injection device, particularly making it easily visible to the user when the user holds the pen in their hand; it may be controlled by an electronic module such that when the electronic module switches to pairing mode, the visual indicator is controlled to signal the pairing mode; it may signal pairing availability via a predetermined light sequence, for example by flashing at a relatively slow frequency during the pairing process and by flashing at a higher frequency at the end of a successful pairing process.

[0011] Another aspect of this disclosure provides a drug injection device with a pen-shaped form, having a distal end and a proximal end, the proximal end including a syringe for injecting a drug into a patient. The drug injection device is configured for use with the system described herein and includes a touch input device attached to the drug injection device and configured for touch input on a touch interface of a computing device. The touch input device may, for example, be attached to the proximal end of the drug injection device. The drug injection device may be, for example, a Solostar. TMOr Allstar TM The pen, with its improvements, has an attached touch input device for better utilization of the system as described herein.

[0012] In embodiments of the drug injection device, the touch input device may be attached to the proximal end of the drug injection device. This is particularly useful when a visual indicator for pairing the drug injection device with a computing device is located at the distal end of the drug injection device, allowing a user holding the drug injection device like a pen to easily see the visual indicator without rotating the drug injection device.

[0013] Another aspect of this disclosure provides a cap configured to attach to the proximal end of a drug injection device for a syringe, wherein a touch input device configured for touch input on a touch interface of a computing device is attached to the cap, particularly located at the tip of the cap. The cap can be, for example, shaped like a ballpoint pen cap, allowing a user to input on the touch interface in a conventional manner using an injection pen with a ballpoint pen-like attached cap.

[0014] In embodiments of the drug injection device or cap, the touch input device may include a stylus tip. This allows users to perform touch input more comfortably, for example, on smaller touch interfaces such as the touch display of a smartphone. In particular, this allows users to perform handwriting input on a touchscreen.

[0015] In a further embodiment of the drug injection device or cap, the stylus tip may be shaped as a ballpoint pen tip, a pencil tip, or a spherical tip, and in particular, the stylus tip may at least partially include a resilient surface configured for touch input. Ballpoint pen tips and pencil tips are particularly useful for inputting handwritten data into a computing device, while spherical tips may be more useful for activating larger buttons shown on a touchscreen. The resilient surface is particularly useful for preventing damage such as scratches on touch interface surfaces such as touchscreens.

[0016] In a further embodiment of the drug injection device or the cap, the touch input device may be configured for use with a capacitive touchscreen. Compared to resistive touchscreens, capacitive touchscreens require a conductive touch input device. Therefore, the touch input device may be at least partially conductive to allow input on the capacitive touchscreen.

[0017] In a further embodiment, the drug injection device may include an electronic module for wirelessly exchanging data related to the use of the drug injection device with a device paired with the electronic module, the electronic module being attached to or integrated in a remote part of the drug injection device.

[0018] Another aspect of this disclosure provides a computing device capable of being configured to pair with an electronic module for wirelessly exchanging data relating to the use of a drug injection device. The computing device includes a touch interface and a computer program comprising instructions executable by a processor of the computing device, the instructions being used to configure the computing device to pair with the electronic module based on one or more touch inputs received via the touch interface from a touch input device of a drug injection device as disclosed herein.

[0019] In an embodiment of the computing device, the touch interface may be a touchscreen, and the computer program may include instructions for execution by the processor of the computing device, the instructions being for displaying a pairing button on the touchscreen, for detecting a touch of the pairing button using the touch input device of the drug injection device, and for configuring the computing device to pair with the electronic module when the touch of the pairing button using the touch input device of the drug injection device is detected.

[0020] In a further embodiment of the computing device, the computer program may include instructions for execution by the processor of the computing device, wherein, upon detection of a touch of the pairing button using the touch input device of the drug injection device, the instructions are used to switch a radio communication module to a scanning mode for detecting the electronic module within a predetermined neighborhood area around the computing device over a certain time span, and for detecting pairing with the electronic module over the certain time span, wherein pairing specifically requires touching the pairing button until the electronic module is paired with the computing device. Attached Figure Description

[0021] Figure 1 An example of the system is shown;

[0022] Figure 2 Examples of drug injection devices are shown; and

[0023] Figure 3 It shows Figure 1 An example of a block diagram of the electronic components of a system. Detailed Implementation

[0024] In the following description, embodiments of this disclosure will be referred to in the context of injection devices, particularly those in the form of a pen. However, this disclosure is not limited to such applications and can be equally well applied to other types of drug delivery devices, particularly those in a different shape from a pen.

[0025] Figure 1A drug injection device 10 in the form of a pen is shown, along with a computing device, which is a smartphone 22 with a capacitive touchscreen 24. The pen 10 can be, for example, a reusable device (such as Allstar). TM Injection pen) or disposable device (such as Solostar) TM (Injection pen). The smartphone 22 can be a standard smartphone, such as Apple's iPhone. TM or Android TM A smartphone powered by a touchscreen. However, device 22 can be any kind of mobile or fixed computing device with a touchscreen interface, such as a tablet computer, laptop computer, PDA (personal digital assistant), desktop computer, or a dedicated computing device configured for use with a drug injection device.

[0026] Injection pen 10 includes a body 100 configured to hold a cartridge (not shown) and house a dose selection and dispensing mechanism. Figure 1 Only the scale 102 for dose selection is shown in the diagram. The pen body 100 has a distal end 12 and a proximal end 14. A syringe 16, which can be protected by a cap 34, is provided at the proximal end 14 of the body 100, and a selector grip 104, which can be used to select the dose and dispense the dose into the patient via the syringe 16, is provided at the distal end 12 of the body 100.

[0027] The selector grip 104 may include an electronic module 18 for wirelessly exchanging data related to the use of the pen 10 with a device paired with the electronic module 18 (such as a smartphone 22). The electronic module 18 may also be configured to record and store doses, and / or read stored doses from memory, the doses being selected and dispensed via the pen 10. The recorded and stored doses may include data related to the use of the pen 10. This data may include additional data such as time, date, and / or the amount of dose dispensed, drug-related data (such as drug type, manufacturing date, expiration date), and / or the last date of use of the pen, the patient's identifier, the pen's serial number, and any other data relating to the use of the pen 10 in any way. Therefore, the term "data related to the use of the pen" as used herein must be understood to have a broad meaning within the context of this disclosure.

[0028] Electronic module 18 can, for example, enable some form of wireless connectivity for wireless data exchange 20, such as... Connectivity, Near Field Communication (NFC) connectivity and / or WiFi TMConnectivity. Achieving connectivity may require pairing of the electronic module 18 with the device (i.e., smartphone 22), through which data exchange must be completed at least once before data exchange can be established. This means that wireless data exchange between the electronic module 18 and smartphone 22 may not be possible, for example, in an "ad-hoc" manner without any pairing. Therefore, the term "pairing," as used herein, can be understood as requiring some user interaction to establish a dedicated wireless data connection between the electronic module 18 and smartphone 22. Specifically, pairing may include user input 28 at the touchscreen 24 of smartphone 22 (particularly with a touch tip 26 disposed at the tip of cap 34) and / or at the electronic device 18. User input 28 may include touching a button 28 with the touch tip 26 displayed on the touchscreen 24. User input may also be required at the pen 10, for example by pressing a button or rotating the dial grip 104, through which the electronic module 18 is activated (i.e., powered). Specifically, user input 10 at the injection pen can switch the electronic module 18 to pairing mode, for example, by interacting with a user on the selector grip 104, such as by slightly pulling the selector grip 104 out of the body 100 of the injection pen 10 or slightly pushing the selector grip 104 into the body 100, to switch the electronic module 18 to pairing mode.

[0029] A visual indicator 32, such as an LED (light-emitting diode), may be positioned at the end of the selector grip 104. The visual indicator 32 may be controlled by an electronic module 18 to indicate a pairing mode, i.e., the electronic module 18 is available for pairing. This indication of pairing mode may include a specific color (e.g., blue) and / or a specific light sequence (e.g., rapid flashing). The pairing availability signal emitted by the visual indicator 32 should be easily visible to the user holding the syringe 10.

[0030] Figure 2 Injection pens with different caps 34, 34', 34" are shown, which are attached to the distal end 14 of the injection pen 10 to cover the syringe 16. The particular difference between the caps 34, 34', 34" is the touch input device 26, 26', 26" disposed at its tip.

[0031] Cap 34 includes a touch input device 26 having a stylus tip shaped like a ballpoint pen tip 260, particularly suitable for use on touchscreens (such as...). Figure 1The pen tip 260 is used for writing and tapping input on the touchscreen 24 of the smartphone 22 shown. The shape of the pen tip 260 reduces the need for touch input on user interfaces with particularly small touch areas (such as small buttons, text fields, etc.). The pen tip 260 may at least partially include an elastic surface 262. Specifically, the tip of the pen tip 260 may form the elastic surface portion 262, which may be made of an elastic material such as rubber. The elastic surface 262 should be made of a specially selected material to avoid any damage to the touchscreen 24, such as scratches.

[0032] Cap 34' includes a touch input device 26' having a stylus tip shaped like a pencil tip 260', particularly suitable for use on touchscreens (such as...). Figure 1 The touchscreen 24 of the smartphone 22 shown is used for both tapping and writing input. The shape of the pencil tip 260' reduces the burden of touch input on user interfaces with particularly large and medium-sized touch areas (such as large and medium-sized buttons, text fields, etc.). The pencil tip 260' may at least partially include an elastic surface 262'. In particular, the tip of the pencil tip 260' may form the elastic surface portion 262', for example, it may be made of an elastic material such as rubber. The elastic surface 262' should be made of a material of choice to avoid any damage to the touchscreen 24, such as scratches.

[0033] "Cap 34" includes a touch input device 26 having a stylus tip shaped like a spherical tip 260", particularly suitable for use on touchscreens (such as... Figure 1 Touch input is performed on the touchscreen 24 of the smartphone 22 shown. The shape of the "spherical tip 260" reduces the burden of touch input on user interfaces with large touch areas (such as large buttons). The "spherical tip 260" may at least partially include an elastic surface 262". In particular, the tip of the "spherical tip 260" may be formed as an elastic surface 262", for example, it may be made of an elastic material such as rubber. The elastic surface 262" may be made of a material of choice to avoid any damage to the touchscreen 24, such as scratches.

[0034] Figure 2 All three examples of the injection pen 10 shown make it easier for users to use the pen 10 more naturally and in touch interfaces (such as...) Figure 1 Touch input is performed on the touchscreen 24 of the smartphone 22 shown. Users tend to use the tip of the distal end 15 of the pen 10 to perform touch input on the touchscreen 24, and therefore, touch input devices 26, 26', 26" of different shapes improve the usability of the pen 10.

[0035] Figure 3 It shows Figure 1A block diagram of the electronic components of the system. The smartphone 22 includes a processor 220 and a storage device 222 accessible by the processor 220 for read / write access. The processor 220 is connected to a touchscreen 24 and controls the display on the touchscreen 24 (such as buttons, e.g., pairing button 30), and receives touch input made on the touchscreen 24, such as touching the pairing button 30 with the touch tip 26 of the pen 10. The processor 220 is also connected to a radio communication (wireless) module 224, which is configured to establish a radio or wireless communication connection with other devices such as the electronic module 18 of the pen 10. The electronic module 224 may, for example, enable some form of wireless connectivity for wireless data exchange 20 with another device such as the electronic module 18, such as… Connectivity, Near Field Communication (NFC) connectivity and / or WiFi TM Connected.

[0036] The injection pen 10 includes an electronics module 18 and may also include one or more sensors 106 for acquiring drug-related data, such as the selected dose of drug dispensed by the injection pen 10. The electronics 18 may be powered by a battery 108 (such as a button battery, specifically integrated into the selector grip 104). A visual indicator 32 is controlled by the electronics 18 and is specifically activated to indicate the pairing mode of the electronics 18. The electronics 18, battery 108, and visual indicator 32 may be integrated into a compact module, such as on a PCB (printed circuit board) designed to be housed by the selector grip 104. The compact module may also include at least a portion of one or more sensors 106, such as one or more optical detectors if an optical coding system is applied in the injection pen 10 to detect dose selection.

[0037] The processor 220 executes a computer program stored in the storage device 222. The computer program may include the operating system of the smartphone 22, such as Apple's iOS. TM Or Google LLC's Android TM The computer program may include instructions for configuring pairing between the smartphone 22 and the electronic module 18. This pairing may be based on one or more touch inputs 28 received via the touch tip 26 of the pen 10 from the touchscreen 24.

[0038] Pairing can be performed using operating system features, such as general-purpose... Pairing or WiFi TMDirect connection. Alternatively or additionally, the pairing can also be performed via an application. For example, a user can launch an application stored in storage device 222 on smartphone 22, and the application is set to pair with the electronic module 18 of injection pen 10 and, after pairing, receive drug-related data acquired using one or more sensors 106 via wireless connection 20. Processor 220 can execute instructions from the application to display the application's graphical user interface (GUI) on touchscreen 24. The GUI may show one or more buttons, including pairing button 30. Processor 220 can detect touch input 28 made on touchscreen 24 using the touch tip 26 of injection pen 10. Upon detecting touch input, processor 220 can identify the touched button. If processor 220 detects a touch of pairing button 30, it can activate wireless module 224 (if not already activated) and switch it to scanning mode, for example... or WiFi TM A scanning mode is used to detect active wireless modules, such as electronic module 18, in a predetermined neighborhood. This neighborhood can be predetermined by the wireless range of wireless module 224. For example, if wireless module 224 includes... If connected, it can be configured to detect active wireless modules within a few centimeters of the smartphone 22 by broadcasting a pairing request and receiving a response to the pairing request. The scanning mode can be active for a certain time span, limited to, for example, approximately 30 to 60 seconds. When the wireless module 224 receives a response to its broadcast pairing request from the electronic module 18 within the time span, pairing can be performed between the wireless module 224 and the electronic module 18. This pairing may require touching the pairing button 30 until pairing is complete (i.e., the electronic module 18 and wireless module 224 are paired), for example, requiring the user to hold the touch tip 26 of the pen 10 throughout the pairing process on the pairing button 30.

[0039] The electronic module 18 can be switched to pairing mode via a switch (not shown). The switch can be integrated into the toggle grip 104, allowing it to be switched by slightly pushing the toggle grip 104 into the pen body 100, pulling it slightly out of the pen body 100, or by rotating the toggle grip 104. When the electronic module 18 is switched to pairing mode, it can control the visual indicator 32 to display visual indications of the pairing mode, such as a flashing sequence. The user can thus recognize that the pen 10 or the electronic module 18 is ready for pairing and can launch the aforementioned application on the smartphone 22 to display a GUI with a pairing button 20. The user can then touch the pairing button 30 with the touch tip 26 of the pen 10, and the control processor 220 establishes pairing with the electronic module 18 of the pen 10 via the wireless module 224.

[0040] After pairing, pairing-related data (such as the unique IDs of electronic module 18 and wireless module 224) can be stored in the storage device 222 and internal storage of electronic module 18. Subsequently, processor 220 can update the GUI to no longer display the pairing button 30, and electronic module 18 can control visual indicator 32 to indicate successful pairing, for example, through continuous activation. On both device 22 and pen 10, pairing mode can be terminated, and wireless connection 20 can be established for data exchange.

[0041] The processor 220 can then display additional buttons on the GUI shown on the touchscreen 24, which the user can use to initiate data transmission, for example. For instance, the user can then touch a data request button on the GUI with the touch tip 26 of the syringe pen 10, which can cause the processor 220 to control the wireless module 224 to transmit a data request command to the electronic module 18 via link 20. The electronic module 18 can then transmit internally stored dose-related data, obtained, for example, through sensors(s) 106, upon receiving the request.

[0042] After receiving the requested data, the user can then instruct the processor to update the GUI to display the received data by touching the data display button on the GUI with the touch tip 26 of the injection pen 10.

[0043] All the functions described above are merely examples of the intuitive handling of the entire system, which includes the device 22 with a touch interface 24 and the injection pen 10 with a touch tip 26. As stated above, the system allows the user to comfortably use the injection pen 10 for touch input on the touch interface 24 of the external computing device 22. In particular, the pairing of the injection pen 10 with the device 22 for data exchange can be made more intuitive for the user.

[0044] The terms “drug” or “pharmaceutical preparation” are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical preparation may be used for a limited duration or periodically for chronic disorders.

[0045] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may 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, namely double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0046] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components of the drug formulation to be administered (e.g., API and diluent, or two different drugs), one component in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0047] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: for example, Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0048] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (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 terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0049] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0050] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0051] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, 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.

[0052] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0053] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0054] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0055] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0056] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. 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 function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, antibody fragment, or mutant that does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0057] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Additional examples of antigen-binding antibody fragments are known in the art.

[0058] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0059] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0060] Pharmaceutically acceptable salts of any API described herein are also intended for use in “medicines” or “pharmaceuticals” in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0061] Those skilled in the art will understand that various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

Claims

1. A system comprising - A pen-shaped drug injection device (10) having a distal end and a proximal end (12, 14), the proximal end (14) including an injection tube (16) for injecting drugs into a patient. - An electronic module (18) for wirelessly exchanging (20) data related to the use of the drug injection device (10) with a device paired with the electronic module, the electronic module (18) being attached to or integrated into the distal end (12) of the drug injection device (10). - A computing device (22) that can be configured to pair with the electronic module (18) for wireless exchange (20) of data relating to the use of the drug injection device (10), and includes a touch interface (24). - A touch input device (26) is attached to the proximal end (14) of the drug injection device (10) and is configured to input (28) on the touch interface (24) of the computing device (22). - A visual indicator (32) for emitting a signal indicating availability in conjunction with the computing device (22), wherein the visual indicator (32) is located at the distal end (12) of the drug injection device (10), and - A computer program comprising instructions for execution by the processor of the computing device (22), the instructions being configured to pair the computing device (22) with the electronic module (18) based on the input (28) received via the touch interface (24).

2. The system according to claim 1, wherein, The touch interface is a touch screen (24), and the pairing includes touching a pairing button (30) configured by the computer program displayed on the touch screen (24) with the touch input device (26).

3. The system according to claim 2, wherein, The act of touching the pairing button (30) with the touch input device (26) includes receiving and processing the touch through the computer program to switch the radio communication module of the computing device (22) to a scanning mode for detecting the electronic module (18) in a predetermined neighborhood area of ​​the computing device (22) within a certain time span, and the pairing with the electronic module (18) within the certain time span is detected.

4. The system according to claim 2 or 3, wherein, The pairing requirement is to touch the pairing button (30) with the touch input device (26) until the electronic module (18) is paired with the computing device (22).

5. The system according to claim 1, wherein, The visual indicator (32) further includes one or more of the following features: it is controlled by the electronic module (18) such that when the electronic module (18) switches to the pairing mode, the visual indicator (32) is controlled to emit a signal of the pairing mode; it emits a signal of pairing availability through a predetermined light sequence.

6. The system of claim 1, comprising a cap (34; 34'; 34'') configured to attach to the proximal end (14) of the drug injection device (10) to cover the syringe (16), wherein, The touch input device (26; 26'; 26'') is attached to the cap (34; 34'; 34'').

7. The system according to claim 6, wherein, The touch input device is located at the tip of the cap (34).

8. The system according to claim 6 or 7, wherein, The touch input device (26; 26'; 26'') includes a stylus tip (260; 260'; 260'').

9. The system according to claim 8, wherein, The tip of the stylus is shaped like a ballpoint pen tip (260), a pencil tip (260'), or a spherical tip (260'').

10. The system of claim 9, wherein the stylus tip at least partially comprises an elastic surface (262; 262'; 262'') configured for touch input (28).

11. The system according to claim 1, wherein, The touch input device (26; 26'; 26'') is configured for use with a capacitive touchscreen (24).

12. The system according to claim 1, wherein, The touch interface is a touch screen (24), and the computer program includes instructions for execution by the processor (220) of the computing device (22), the instructions for displaying a pairing button (30) on the touch screen (24), for detecting a touch (28) of the pairing button (30) by the touch input device (26) of the drug injection device (10), and for configuring the computing device (22) to pair with the electronic module (18) when the touch (28) of the pairing button (30) by the touch input device (26) of the drug injection device (10) is detected.

13. The system according to claim 12, wherein, The computer program includes instructions for execution by the processor (220) of the computing device (22), which, upon detection of a touch (28) of the pairing button (30) using the touch input device (26) of the drug injection device (10), switch the radio communication module (224) to a scanning mode for detecting the electronic module (18) within a predetermined neighborhood area around the computing device (22) over a certain time span, and for detecting pairing with the electronic module (18) over the certain time span.

14. The system according to claim 13, wherein, The pairing requirement is to touch (28) the pairing button (30) until the electronic module (18) is paired with the computing device (22).

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