Data collection apparatus to be attached to injection device

Abstract

To provide a data collection device to be attached to an injection device for collecting medicament dosage information therefrom.SOLUTION: A data collection device comprises an attachment assembly 23 for attaching the data collection device to a dose setting dial 12 of a medicament administration device, and a sensor configured to detect an identifier provided on a surface of an internal component of the medicament administration device, the sensor comprising an ultrasound sensor 34 configured to detect a geometric identifier formed on the surface of the internal component of the medicament administration device.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] The present disclosure relates to a data collection device that is attached to an injection device and collects drug dosage information therefrom.

Background Art

[0002] There are various diseases that require regular treatment by injection of drugs. Such injections can be performed by using an injection device, which can be applied by either a medical practitioner or the patient himself / herself. As an example, type 1 and type 2 diabetes can be treated by the patient himself / herself injecting, for example, one or several insulin doses per day. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can also be used. The reusable pen allows an empty drug cartridge to be replaced with a new one. Both pens are equipped with a set of one-way needles that are replaced before each use. Here, for example, the insulin dose to be injected can be manually selected in the insulin pen by turning a dose knob and observing the actual dose from the dose window or display of the insulin pen. Then, the needle is inserted into the appropriate skin area, and the dose is injected by pressing the dose knob or injection button of the insulin pen. In order to be able to monitor insulin injections, for example, to prevent incorrect handling of the insulin pen or to track the doses already applied, it is desirable to measure information regarding the state and / or use of the injection device, such as information regarding the insulin dose injected.

[0003] Patent Document 1 relates to a data collection device for attachment to an injection device, the data collection device including a sensor configuration for detecting the moment of a movable component of the injection device during drug delivery.

[0004] Patent Document 2 relates to a dosage monitoring device for use with a liquid dispenser, which includes a dispensing sensor for sensing when a dose has been dispensed and a quantity sensor for determining the dispensed dose. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] European Patent No. 3,058,970 [Patent Document 2] International Publication No. 2012 / 046199 [Overview of the project] [Means for solving the problem]

[0006] Generally, in one embodiment, the data acquisition device includes a mounting assembly for attaching the data acquisition device to a dose setting dial of a drug delivery device, and a sensor configured to detect identifiers provided on the surface of an internal component of the drug delivery device; wherein the sensor includes an ultrasonic sensor configured to detect geometric identifiers formed on the surface of an internal component of the drug delivery device.

[0007] In some examples, the sensor is supported on the side of the data acquisition device, in contact with the dose setting dial of the drug administration device.

[0008] In some examples, the mounting assembly is configured such that the dose setting dial of the drug administration device is positioned between the sensor and the surface of the internal components, thereby enabling the data acquisition device to access the drug administration device. It is configured to be releasably attached to the chair's dosage setting dial.

[0009] In some examples, the data acquisition device includes a processor configured to receive signals from sensors and determine the identity of a drug delivered from a drug delivery device based on the detected identifier.

[0010] In some examples, the processor device is further configured to detect when drug delivery has occurred from the drug delivery device.

[0011] In some examples, the processor device is configured to determine a timestamp indicating that a detected drug delivery has taken place, and to store the determined drug dosage and the aforementioned timestamp.

[0012] In some examples, identifiers are provided on the surface of internal components that rotate during drug delivery, and the processor device is configured to determine the amount of rotation of the internal components from signals received from optical sensors.

[0013] In general, in another embodiment, the system includes a drug delivery device which includes a dose setting dial and an internal component which rotates around the longitudinal axis of the device when a certain dose of drug is delivered from the device, and which includes an identifier formed on its surface, and the data acquisition device is configured as described above.

[0014] In general, in another embodiment, the system includes a drug delivery device comprising a dose setting dial and an internal component that rotates around the longitudinal axis of the device when a certain dose of drug is delivered from the device. The internal component includes an identifier formed on its surface. The system also includes a data acquisition device comprising a mounting assembly for attaching the data acquisition device to the dose setting dial and a sensor configured to detect an identifier provided on the surface of the internal component of the drug delivery device, the sensor including an ultrasonic sensor configured to detect a geometric identifier formed on the surface of the internal component of the drug delivery device.

[0015] In some examples, the sensor is supported on the side of the data acquisition device, in contact with the dose setting dial of the drug administration device.

[0016] In some examples, the attachment assembly is configured to releasably attach the data collection device to the dose setting dial of the drug delivery device such that the dose setting dial of the drug delivery device is disposed between the sensor and the surface of the internal component.

[0017] In some examples, the data collection device includes a processor device configured to receive a signal from the sensor and determine the identity of the drug delivered from the drug delivery device based on the detected identifier.

[0018] In some examples, the processor device is further configured to detect that drug delivery from the drug delivery device has occurred.

[0019] In some examples, the processor device is configured to determine a timestamp for the detected drug delivery and store the determined drug dose and the timestamp.

[0020] In some examples, the identifier is provided on the surface of an internal component that rotates during drug delivery, and the processor device is configured to determine the amount of rotation of the internal component from the signal received from the optical sensor.

[0021] These and other aspects of the present disclosure will become apparent and elucidated with reference to the embodiments described below.

[0022] Exemplary embodiments will be described below with reference to the accompanying drawings.

Brief Description of the Drawings

[0023] [Figure 1] It is an exploded view of an injection device for use with a data collection device. [Figure 2] It is a view showing a data collection device attached to the injection device of FIG. 1. [Figure 3] It is a cross-sectional view of a data collection device when attached to a first type of injection device. [Figure 4] An internal view of an injection device for use with a first type of data collection device. [Figure 5] A diagram illustrating a further alternative configuration of components of the data collection device. [Figure 6] A block diagram of the data collection device. [Figure 7] A diagram showing a system in which the data collection device is connected to another device such as a personal computer.

Best Mode for Carrying Out the Invention

[0024] In the following disclosure, embodiments are described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and may be used with injection devices that discharge other drugs.

[0025] FIG. 1 is an exploded view of a drug administration device. In this example, the drug administration device is an injection device 1 such as the Sanofi AllStar (registered trademark) insulin injection pen, but the present disclosure is also compatible with other types and manufacturers of injection pens as described below.

[0026] The injection device 1 in Figure 1 is a pre-filled injection pen including a housing 10, an insulin container 14, and a needle 15 can be attached to the insulin container 14. The injection device 1 may be disposable or reusable. The needle is protected by an inner needle cap 16 and either an outer needle cap 17 or an alternative cap 18. The insulin dose dispensed from the injection device 1 can be programmed or “dialed in” by turning a dose knob 12 (also referred herein as dose selection element 12), and the currently programmed dose is then displayed through a dose window 13, for example, in multiple units. For example, if the injection device 1 is configured to administer human insulin, the dose is expressed in so-called international units (IU), where 1 IU is a bioequation of approximately 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. Other units are used for injection devices to deliver analog insulin or other drugs. Note that the selected dose can also be preferably displayed in a form different from that shown in the dose window 13 in Figure 1.

[0027] The dosage window 13 may also be in the form of an aperture in the housing 10, allowing the user to see a limited portion of a numeric sleeve 70 configured to move when the dosage knob 12 is turned to provide a visual display of the currently programmed dose. Alternatively, the numeric sleeve 70 may remain stationary during the dose dial setting phase, and the dosage window 13 may move when the dose is dialed in to display the numeric number corresponding to the dialed dose. In either case, the numeric sleeve 70 is the component that rotates when the dose is being administered from the injection device 1.

[0028] In this example, the dosage knob 12 includes one or more formations 71a, 71b, 71c that improve the grip the user feels when holding the dosage knob 12, thereby facilitating programming. In another example (not shown), the dosage knob does not include any formations.

[0029] The mounting of the data acquisition device does not require a dosage knob with a molded object. Having a close fit at the contact surface between the data acquisition device and the injection device and / or using a rubber-like material provides a mounting that, on the one hand, facilitates a stable connection in the sense that the two devices remain attached to each other, and on the other hand, allows the two devices to be separated when intended. The rubber-like material ensures a proper fit even on smooth surfaces, such as a dosage knob with a smooth surface where rotation of the data acquisition device causes rotation of the dosage knob, and vice versa.

[0030] The injection device 1 is configured to provide acoustic feedback to the user by producing a mechanical click sound when the dosage knob 12 is turned. A numeral sleeve 70 mechanically interacts with the piston of the insulin container 14. When the needle 15 is inserted into the patient's skin and then the injection button 11 is pressed, the insulin dose displayed in the display window 13 is dispensed from the injection device 1. After the injection button 11 is pressed, if the needle 15 of the injection device 1 remains in the skin for a certain period of time, a high percentage of the dose is actually injected into the patient's body. A mechanical click sound may also be produced by the dispensing of the insulin dose, but this is different from the sound produced when using the dosage knob 12. In some other embodiments, the injection device 1 does not have a separate injection button 11, and the user presses down the entire dosage knob 12, which moves longitudinally relative to the housing 10 so that the drug is dispensed.

[0031] In various embodiments, during insulin dose delivery, the dose knob 12 is directed to its initial position by axial motion, i.e., without rotation, while the numeral sleeve 70 is rotated back to its initial position to display, for example, a dose of zero units.

[0032] The injection device 1 can be used for several injection processes until either the insulin container 14 is empty or the expiration date of the medication in the injection device 1 is reached (for example, 28 days from the first use).

[0033] Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" to remove air from the insulin container 14 and needle 15 by selecting, for example, 2 units of insulin and pressing the injection button 11 while holding injection device 1 with the needle 15 facing upwards. For the sake of simplicity, we will assume below that the amount dispensed substantially corresponds to the dose injected, and therefore, for example, that the amount of drug dispensed from injection device 1 is equal to the dose received by the user. Nevertheless, it may be necessary to take into account the difference (e.g., loss) between the amount dispensed and the dose injected.

[0034] Figure 2 is a perspective view of one end of the injection device 1 with a data acquisition device 20 attached according to an exemplary embodiment. The data acquisition device 20 includes a housing 21 having an end plate 22 that forms a user interaction surface. The housing 21 supports optical user feedback, such as one or more LEDs (not shown). In some embodiments that may be adopted, the data acquisition device 20 includes a display (not shown).

[0035] The data acquisition device 20 is compatible with several existing injection devices 1. The data acquisition device 20 is compatible with injection devices that have a separate dose delivery button or an integrated dial. The data acquisition device 20 is compatible with injection devices that have a dose setting dial that rotates during dose administration. However, it is compatible with injection devices in which an internal component near the dose setting dial rotates during dose administration. The data acquisition device 20 enables the detection and measurement of this internal component's rotation.

[0036] Figure 3 is a cross-sectional view of a data acquisition device 20 according to several embodiments when attached to a first type injection device 1.

[0037] In these embodiments, the injection device 1 is of a type that includes a dose setting dial 12 with a pressable dose delivery button 11, which the user typically presses down to activate the drug delivery mechanism. The dose setting dial 12 is configured to rotate to set the dose. In some injection devices, the rotation of the dose setting dial 12 tensions an internal spring, or the device has a pre-tensioned spring. The dose setting dial 12 does not move longitudinally during dose setting. The dose setting dial 12 is stationary during dose delivery. In some other injection devices, the rotation of the dose setting dial 12 causes the dose setting dial to move proximal out of the housing 10. Once the dose is delivered from the injection device 1, the dose setting dial returns to the housing (distally) but does not rotate. In any case, internal components 70, such as a numeral sleeve 70, rotate during dose delivery. The data acquisition device 20, when attached to the injection device 1, is configured to detect and measure the rotation of these internal components 70.

[0038] The data acquisition device 20 includes a housing 21, an electronic equipment assembly 24 disposed inside the housing 21, and a button 26 protruding from the proximal end of the housing 21 and movable longitudinally relative to the housing 21. The housing 21 includes a mounting assembly 23 configured to secure the data acquisition device 20 to the dose setting dial 12. Formations 71a, 71b, and 71c of the dose setting dial 12 are used to facilitate the mounting of the data acquisition device 20.

[0039] In this particular example, the mounting assembly 23 is a sleeve that covers and positions the dose setting dial 12 via a molded part (not shown) that cooperates with the molded parts 71a, 71b, 71c of the dose setting dial 12, so that the data acquisition device 20 also rotates when the dose setting dial 12 is rotated during dose programming. Alternatively, or additionally, an elastic pad such as a foamed rubber pad 44 may be provided within the molded parts of the mounting assembly 23 to allow dimensional tolerances between the molded parts of the mounting assembly 23 and the molded parts 71a, 71b, 71c of the dose setting dial 12, and / or so that rotation of the mounting assembly 23 causes rotation of the dose setting dial 12, and vice versa. Further alternatively, the mounting assembly 23 may include an elastic pad of sufficient thickness to provide a molded part that cooperates with the molded parts 71a, 71b, 71c of the dose setting dial. The pad is soft enough to conform to the surface of the dose setting dial 12. For example, the pad is soft enough to conform to the surface formations of the dose setting dial 12.

[0040] The electronics assembly 24 is retained within the housing 21 so that it can move longitudinally relative to the housing. The distal end of the electronics assembly 24 is configured to abut against the dose delivery button 11 when the data acquisition device 20 is attached to the injection device. The proximal end of the electronics assembly 24 abuts against or is integral with the button 26. The button 26 and the electronics assembly 24 form a single subassembly. The mounting assembly 23 forms another subassembly. In this embodiment, the two subassemblies can move longitudinally relative to each other but cannot rotate relative to each other. The button 26 has a finger rest for the user. The device provides a rest (r) and a push surface for transmitting pressing force to the dose delivery button 11 of the injection device. As a result of this configuration, when the button 26 of the data acquisition device 20 is pressed down, force is transferred to the dose delivery button 11 via the electronic equipment assembly 24, causing the dose delivery button 11 to be pressed down.

[0041] The electronic equipment assembly 24 includes a PCB 28 and a battery 30, for example, in the form of a coin cell. The PCB 28 supports several components, including a processor unit 50, an ultrasonic source 32, and an ultrasonic detector 34. As shown in Figure 3, in some embodiments, the ultrasonic source 32 and the ultrasonic detector 34 are supported on the side of the PCB that abuts the dose delivery button 11. The dose delivery button 11 is transparent or substantially transparent to ultrasonic waves. Thus, the sound emitted by the ultrasonic source 32 passes through the dose delivery button 11 and is reflected by the internal components. In particular, the numeral sleeve 70 is a hollow cylindrical body that extends to the proximal end of the housing 10 and is releasably fixed to the dose setting dial 12. Thus, the annular end face of the numeral sleeve 70 is located below the dose delivery button 11 and is in the path of the emitted ultrasonic waves. The numeral sleeve 70 is provided with a three-dimensional geometric pattern on its annular end face. For example, raised and non-raised sections are arranged alternately. Alternatively, a pattern of holes is provided at intervals around the annular end face.

[0042] During the dose-delivery operation, the ultrasonic source 32 emits ultrasonic sounds to portions of the digit sleeve 70 that include patterns of relatively raised and non-raised areas; the ultrasonic detector 34 receives the sounds reflected by the patterns. The output of the ultrasonic detector 34 is relayed to the processor 50, which determines the pattern on the annular end face of the digit sleeve 70.

[0043] Figure 4A shows a first example of a pattern formed on the annular end face of the numeral sleeve 70. The end face of the numeral sleeve 70 is provided with a pattern of relatively raised and non-raised regions. In one example, the raised regions are shapes or a group of teeth arranged to extend axially from the end face of the numeral sleeve to the device. The group of teeth are formed with a specific shape or contour. The shape or contour of the teeth can be used to identify the drug.

[0044] Figure 4B shows a second example of a pattern formed on the annular end face of the numeral sleeve 70. The end face of the numeral sleeve 70 is provided with a pattern of holes spaced apart around the annular end face. The holes are formed with a specific shape and size. The shape and / or size of the holes can be used to identify the drug. The edge of the annular end face is provided with a plurality of teeth that extend radially from the end face of the numeral sleeve to the device. The plurality of teeth are formed with a specific shape or contour. The shape or contour of the teeth can be used to identify the drug.

[0045] To improve detection accuracy, any combination of radial and / or axial teeth and / or holes formed on the annular end face can be provided.

[0046] The processor 50 calculates the amount of rotation of the numeral sleeve 70 during the dose dispensing operation. From the amount of rotation, the delivered dose can be calculated. This is done by the data acquisition device 20 or another calculating device. Generally, any component located near the dose setting dial and that rotates when a dose is dispensed from the injection device 1 can be used as an internal component having a pattern of relatively reflective and non-reflective areas formed on its surface.

[0047] The data acquisition device disclosed herein is directly attached to the dose setting dial of a drug administration device. Conventional data acquisition devices are attached to the main housing of the drug administration device. This can interfere with the user's use of the drug administration device. Such devices are mounted above the dose display window on the drug delivery device housing. This can make the dose display window difficult to see, and the user may rely entirely on the data acquisition device for displaying the dialed dose, reducing the user's confidence in the drug delivery device. Such devices do not allow the type of drug delivery by the drug delivery device to be determined solely from the dose display window. Some other such devices require an additional notch or aperture in the drug delivery device housing to view or connect to internal moving components. Cutting out a portion of the drug delivery device housing makes it easier for dust and dirt to enter the delivery mechanism. This can also lead to problems with the sterility of the drug delivery device.

[0048] The data acquisition device of this disclosure can remotely identify the drug being administered from the drug administration device and monitor the amount of drug being administered without contacting or fixing it to the main housing of the drug administration device. The data acquisition device is mounted on the part of the drug administration device that the user normally interacts with and is configured to effectively replace that part. When the user wants to dial a dose, they grasp and rotate the housing 21 of the data acquisition device 20, thereby rotating the dose setting dial 12. The user can continue to observe the mechanical dose display window 13 of the drug administration device. When the user wants to inject a dose, they apply force to the proximal end of the data acquisition device. This transmits force to the dose setting dial. If the drug administration device has a dose delivery button 11, the button 26 of the data acquisition device is configured to press down the housing 21, and therefore press down the dose delivery button 11. Thus, the user will not notice any substantial difference in the way the drug administration device is operated due to the addition of the data acquisition device according to this disclosure.

[0049] The data acquisition device can record the number of administrations and the amount of medication administered for multiple types of drug delivery devices, and can monitor each identified drug individually.

[0050] The data acquisition device of this disclosure uses ultrasonic sound to identify patterns. This allows the external components of the drug delivery device to be made from plastic or other materials that are opaque to light but transparent to ultrasound. No additional notches or apertures are required for the ultrasonic detector to detect the pattern provided to the numeral sleeve 70.

[0051] Alternatively, the data acquisition device uses light as an illumination source. The external components of the drug delivery device are formed from plastic or other materials that are transparent or partially transparent to light. Only appropriate areas of the drug delivery device are made from transparent material to effectively form a window, or alternatively, an opening or aperture.

[0052] In this embodiment, the pattern of the numeral sleeve 70 is formed as a pattern of relatively reflective and non-reflective regions on the annular end face. For example, reflective sections and non-reflective sections are arranged alternately. During the dose-dispensing operation, a light source illuminates a portion of the numeral sleeve 70 that includes the pattern of relatively reflective and non-reflective regions; an optical sensor receives the light reflected by at least the relatively reflective regions. The relatively reflective and non-reflective regions are different colors, such as black and white.

[0053] Alternatively, the data acquisition device uses infrared light as the illumination source. This allows the external components of the drug delivery device to be made from plastic or other materials that are opaque to light wavelengths but transparent or partially transparent to infrared wavelengths. No additional notches or apertures are needed; only the appropriate areas of the drug delivery device are made of infrared-transparent material, effectively forming an infrared "window."

[0054] The relatively reflective and non-reflective areas of the pattern are created during the manufacturing of the component by directly printing, depositing, etching, or otherwise fabricating them onto the numeral sleeve 70 or other suitable internal component. The drug delivery device is then assembled in the same manner as before using the same assembly method and tools. Thus, only minimal changes to the design and fabrication of the drug delivery device are required to implement this disclosure.

[0055] Referring to Figure 5, alternative embodiments are shown. In some embodiments, instead of having an ultrasonic source or light source and a detector / sensor, the electronic assembly includes only passive sensors. In this embodiment, the electronic assembly includes a non-contact magnetic sensor 80, such as a Hall sensor. In this embodiment, the rotatable component 70 includes a series of magnetic regions 82 and non-magnetic regions 84 spaced apart and alternately arranged along the circumference of the rotatable component 70. The magnetic regions 82 are permanent magnets, such as regions containing magnetic particles or magnetic ink. As the magnetic and non-magnetic regions 82, 84 rotate past the magnetic sensor 80 during dose delivery, the magnetic sensor 80 detects patterns of change in magnetic field strength and, optionally, direction. This information can then be used to identify the drug and determine the amount (angle) of rotation of the rotatable component 70.

[0056] In this embodiment, the magnetic sensor 80 is supported in a recess between the dose setting dial 12 and the inner surface of the mounting assembly 23. For example, the magnetic sensor 80 is supported on a projection of the electronic equipment assembly 24. The mounting assembly 23 has a recess to provide space for this projection. In this embodiment, a series of magnetic regions 82 and non-magnetic regions 84 are arranged along the circumference on the outer surface of the numeral sleeve 70. Such arrangement makes more space available on this surface of the numeral sleeve 70, so that the series of magnetic regions 82 and non-magnetic regions 84 can be made larger or spaced further apart.

[0057] The dose setting dial 12 is permeable or partially permeable to the magnetic field generated by the magnetic region 82, allowing the magnetic sensor 80 to remotely detect the rotation of the rotatable component 70 without the need for a notch or aperture on the dose setting dial 12. This embodiment minimizes the distance between the magnetic sensor 80 and the series of magnetic and non-magnetic regions 84 so as not to change when the dose delivery button 11 is pressed down. This further improves the reliability of dose detection. This embodiment also has a simple mechanical design and structure. The mounting assembly 23 of this embodiment has a wider diameter compared to the diameter in Figure 3, providing space for the magnetic sensor 80. This reduces the force required for the user to rotate the dose setting dial 12 during dose setting, and thus makes it easier to use even for less dexterous users.

[0058] Figure 5 shows a magnetic sensor 80 positioned radially relative to the dose setting dial 12, but instead, the magnetic sensor 80 is positioned proximal to the dose setting dial 12 in the same manner as shown in Figure 3.

[0059] In an alternative embodiment, the electronic assembly includes an acoustic detector, such as a microphone, and the rotatable component 70 includes one or more piezoelectric transducers spaced apart along the circumference of the rotatable component 70. Each piezoelectric transducer is configured to emit sound, for example, at a specific intensity, tone, or pitch. As the piezoelectric transducers rotate past the microphone during dose delivery, the microphone can detect changes in the intensity, tone, or pitch of the emitted sound. This information can then be used to identify the drug and determine the amount (angle) of rotation of the rotatable component 70. Alternatively, each piezoelectric transducer emits a time-varying acoustic signal, which can be detected by the microphone and identified by the processor device 50.

[0060] Figure 6 is a block diagram of the data acquisition device 20. The data acquisition device 20 includes a processor unit 50 which includes one or more processors such as a microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), or a field-programmable gate array (FPGA), and further includes memory units 52a and 52b which include program memory 52a and main memory 52b that can store software to be executed by the processor unit 50. The data acquisition device includes an ultrasonic source 32 and an ultrasonic detector 34. The processor unit 50 controls the operation of the ultrasonic source 32 and receives signals from the ultrasonic detector 34.

[0061] The data acquisition device 20 has a power supply 54, which is a battery, such as a coin cell. The data acquisition device 20 optionally includes a switch 53 configured to be triggered at or immediately before the time when a dose is administered. For this purpose, the switch 53 includes a pressure or touch-sensitive area, such as a piezoelectric switch, on the end plate 22 or button 26 of the data acquisition device 20. The switch 53 controls the application of power from the power supply 54 to the processor unit 50 and other components of the data acquisition device 20. In embodiments where the electronics assembly 24 and the mounting assembly 23 are configured to move longitudinally relative to each other, the switch 53 is mechanically mounted. For example, electrodes are disposed on the inner surface of the mounting assembly 23, and the corresponding electrodes of the electronics assembly 24 make contact (and thus complete the circuit) when the button 26 is pressed down. This triggers the wake-up of other electronics, including a light source and optical sensors.

[0062] A timer 55 is also included. The processor device 50 uses the timer 55 to monitor the length of time elapsed since the completion of an injection, which is determined using the switch 53. The processor device 50 may also compare the elapsed time to a predetermined threshold to determine whether the user is attempting to administer the next injection prematurely after the previous injection, and if so, generate a warning such as an audible signal and / or a light signal such as flashing one or more LEDs. The data acquisition device 20 includes several LEDs or other light sources to provide the user with light feedback. For example, the LEDs may use different colors and / or illumination patterns such as flashing with a constant or changing periodicity. On the other hand, if the elapsed time is very short, it indicates that the user is administering the drug amount as a “split dose,” and the processor device 50 stores information indicating that the dose was delivered in this manner. In such a scenario, the elapsed time is compared to a predetermined threshold ranging from a few seconds (e.g., 10 seconds) to a few minutes (e.g., 5 minutes). In one example, the predetermined threshold is set to 2 minutes. If the time elapsed since the last injection is 2 minutes or less, the processor device 50 stores information indicating that the dose was delivered as a "divided dose". Another optional purpose of monitoring the elapsed time by the processor device 50, which may occur in some cases, is to determine when the elapsed time exceeds a predetermined threshold, which suggests that the user may have forgotten to administer a further injection, and if so, a warning is issued.

[0063] Furthermore, the processor is configured to store data relating to date and / or time information, data relating to information from the ultrasonic detector 34, or a combination thereof. In particular, the memory is configured to store a combination of date and / or time information, drug identification information, and internal component rotation information retrieved from the output data of the ultrasonic detector 34. In this way, the memory can store a log that provides a history of information regarding the rotation of the numeral sleeve 70 (or other internal components). The data may be stored, for example, in the main memory 52b. Alternatively, the data may be stored in a separate data storage section of the memory (not shown).

[0064] When the drug is discharged from injection device 1, the number sleeve or other internal components rotate Therefore, the rotation angle measured by the ultrasonic detector 34 is proportional to the amount of drug being discharged. There is no need to determine the zero level or absolute amount of drug contained in the injection device 1. In this way, the sensor configuration is less complex than a sensor configuration configured to detect an absolute position. Furthermore, since there is no need to monitor the numbers or scales of the numeric sleeve 70 displayed through the dosage window 13, the data acquisition device 20 is designed not to obstruct the view of the dosage window 13.

[0065] Output 57 is provided, which is a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi, Bluetooth (trademark), or NFC, or an interface for a wired communication link such as a socket for receiving USB (Universal Series Bus), mini-USB, or micro-USB connectors. Figure 7 shows an example of a system in which the data acquisition device 20 is connected to another device such as a personal computer 60 via a wireless connection 61 for data transfer. Alternatively or additionally, the data acquisition device 20 may be connected to another device via a wired connection. For example, when injections are administered by a user, the processor unit 50 stores the rotation angle and timestamp (including date and / or time) of the determined numeric sleeve 70 with respect to those injections, and then transfers the stored data to the computer 60. The computer 60 is configured to calculate the administered dose based on further information entered by the user or medical professional regarding the type of injection device and the type of drug. The computer 60 maintains a treatment log and / or transfers treatment history information to a remote location, for example, for review by a medical professional.

[0066] According to some embodiments, the data acquisition device 20 is configured to store data such as drug identification, the rotation angle of the number sleeve 70, and timestamps for up to 35 injection events. Following a once-daily injection therapy, this is sufficient to store approximately one month's treatment history. The data storage is organized in a first-in, first-out manner to ensure that the most recent injection event is always present in the memory of the data acquisition device 20. When transferred to the computer 60, the injection event history in the data acquisition device 20 is deleted. Alternatively, the data remains in the data acquisition device 20, and when new data is stored, the oldest data is automatically deleted. In this way, the log of the data acquisition device accumulates over time during use and always includes the most recent injection events. Alternatively, other configurations may include storage capacity for 70 injection events (twice daily), 100 injection events (3 months), or any other appropriate number depending on the user's therapy requirements and / or preferences.

[0067] In another embodiment, output 57 is configured to transmit information using a wireless communication link, and / or processor device 23 is configured to periodically transmit such information to computer 60.

[0068] The specific embodiments described in detail above are intended only as examples of how this disclosure may be implemented. Many variations are possible in the configuration of the data acquisition device 20 and / or the injection device 1.

[0069] In particular, while the embodiments described above have been related to collecting data from an insulin syringe pen, it should be noted that embodiments of this disclosure can be used for other purposes, such as monitoring the injection of other drugs or multiple different drugs.

[0070] The data acquisition device 20 may optionally include a display (not shown) which may occupy, for example, the end plate 22 of the data acquisition device 20. The data includes the length of time elapsed since the completion of the injection, and whether the user is attempting to administer the next injection prematurely after the previous injection. It can display various information, such as warning messages in certain situations.

[0071] The terms “drug” or “pharmaceutical” are used synonymously herein to describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical is used to treat, cure, prevent or diagnose a disease, or otherwise improve physical or mental well-being. Drugs or pharmaceuticals may be used for a limited duration or, in the case of chronic disorders, regularly.

[0072] As described below, drugs or pharmaceuticals may contain 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, polypeptides, peptides, and proteins with molecular weights of 500 Da or less (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (e.g., 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 intended.

[0073] Drugs or pharmaceuticals can be contained in a primary package or “drug container” adapted for use in a drug delivery device. A drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide chambers suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chambers may be designed to store drugs for at least one day (e.g., one day to at least 30 days). In some cases, the chambers may be designed to store drugs for about one month to about two years. Storage may 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, a drug container may be or include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to 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, optionally, to allow the user to mix the two components before administration. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are administered to a human or animal body.

[0074] The drugs or agents contained 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, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), anguina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in handbooks such as Rote Liste 2014 (e.g., main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0075] 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, e.g., human insulin, or human insulin analogs or derivatives; glucagon-like peptides (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 thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by the deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or the addition of at least one amino acid residue. The added and / or replaced amino acid residue may be any of the coding amino acid residues, other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called “insulin receptor ligands.” In particular, the term “derivative” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, for example, a polypeptide having the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. In some cases, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-coding amino acids, or amino acids are added to the naturally occurring peptide, including non-coding ones.

[0076] Examples of insulin analogs include 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 proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28~B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0077] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29LysB30 human insulin. These are 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 (registered trademark)); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0078] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (Exsendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of Hiramonster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), and Dulag. Lutide (Trulicity (registered trademark)), r Exenzine-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexene, Biador-GLP-1, CVX- These are 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.

[0079] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense agent used to treat familial hypercholesterolemia.

[0080] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0081] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0082] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or their derivatives, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0083] 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 to antigens. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be complement-immobilized. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant having mutations or deletions in the Fc receptor-binding region that do not support binding to the Fc receptor. The term “antibody” also includes antigen-binding molecules based on quadrivalent bispecific tandem immunoglobulins (TBTIs) and / or bivariable region antibody-like binding proteins (CODVs) having crossover binding region orientation.

[0084] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy chain and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of the full-length antibody polypeptide, but the term is not limited to such cleavage fragments. Antibody fragments useful in this disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-stranded Fv) fragments, linear antibodies, and monospecific or multispecific antibodies. Examples include fragments, such as bispecific, tripspecific, quadrspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module 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.

[0085] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light polypeptides that primarily mediates specific antigen recognition. The term "framework region" refers to an amino acid sequence within the variable region of both heavy and light polypeptides that is not a CDR sequence and primarily maintains the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself is typically not directly involved in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0086] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0087] Any pharmaceutically acceptable salt of any API described herein is intended for use in drug delivery devices with drugs or pharmaceuticals. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0088] Modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems, and embodiments described herein will be made without departing from the full scope and spirit of the disclosure, and it will be understood by those skilled in the art that the full scope and spirit of the disclosure includes such modifications and all equivalents thereof.

Claims

1. 1. A data collection device comprising: a mounting assembly for mounting the data collection device to a dose setting dial of a medication delivery device; a magnetic sensor configured to detect an identifier provided on an internal component of the medication delivery device; wherein the processor unit is configured to receive one or more signals from the magnetic sensor and determine a type of medication delivered from the medication administration device based on the detected identifier.

2. 2. The data collection device of claim 1, wherein the sensor is supported on a side of the data collection device that abuts a dose setting dial of the medication delivery device.

3. The data collection device of claim 1 , wherein the magnetic sensor is a Hall sensor.

4. The data collection device of claim 1 , wherein the internal component is a rotatable component.

5. The data collection device of claim 1 , wherein the identifiers are disposed along a circumference of the internal component.

6. The data collection device of claim 1 , wherein the identifier is located at a proximal end of the internal component.

7. The data collection device of claim 1 , wherein the identifier comprises at least one magnetic region.

8. The data collection device of claim 1 , wherein the identifier comprises a permanent magnet.

9. 2. The data collection device of claim 1, wherein the internal component is a rotatable component that rotates during drug delivery, the identifier is disposed at a proximal end of the internal component, and the identifier includes at least one magnetic region disposed along a circumference of the rotatable component.

10. The data collection device of claim 1 , wherein the processor unit is configured to determine the type of medication based at least on a change in strength of the magnetic field detected by the magnetic sensor.

11. The data collection device of claim 1 , wherein the magnetic sensor is supported within a recess in the mounting assembly.

12. The data collection device of claim 1 , wherein the magnetic sensor is positioned to detect movement of an internal component relative to the magnetic sensor.

13. The data collection device of claim 1 , wherein the magnetic sensor is positioned to detect movement of an internal component relative to the magnetic sensor during drug delivery.

14. The data collection device of claim 1 , wherein the processor unit is further configured to detect when drug delivery from the drug administration device has occurred.

15. The data collection device of claim 1 , wherein the drug delivery device includes a drug.

16. 13. A system comprising:

1. A medication delivery device comprising: Dose setting dial; and An internal component that rotates about a longitudinal axis of the drug delivery device when a dose of drug is delivered from the drug delivery device. A medication delivery device comprising:

1. A data collection device comprising: a mounting assembly for mounting the data collection device to a dose setting dial of a medication delivery device; and A magnetic sensor configured to detect an identifier provided on an internal component of a medication delivery device. Data collection devices including and wherein the processor unit is configured to receive one or more signals from the magnetic sensor and determine a type of medication to be delivered from the medication administration device based on the detected identifier.

17. 17. The system of claim 16, wherein when the data collection device is attached to the dose setting dial, the magnetic sensor is located proximal to the dose setting dial.

18. The system of claim 16 , wherein the drug delivery device comprises a drug.

19. 1. A medication delivery device comprising: Dose setting dial; and an internal component that rotates about a longitudinal axis of the medication delivery device when a dose of medication is delivered from the medication delivery device, the internal component including a magnetic identifier positioned to be detected by a magnetic sensor of the data collection device, the magnetic identifier being indicative of a type of medication delivered from the medication delivery device. The drug delivery device.

20. 20. The drug delivery device of claim 19, wherein the drug delivery device contains a drug.

Images