Methods and apparatus for aspects of dose detection system

Abstract

To provide techniques for a dose sensing module that can be removably attached to a medication delivery device.SOLUTION: Techniques described herein relate to computerized methods and apparatus of at least one of for determining whether a dose sensing module is attached to a medication delivery device, such as, for example, with dose detection sensors, for detecting a color of a portion of a medication delivery device to determine a medication contained in the medication delivery device, such as, for example, with a set of LEDs and light sensor for different temperature conditions, and for monitoring a battery life of a battery in the dose sensing module, such as, for example, with current / voltage detection for different temperature conditions. At least some of the information obtained from these techniques may be communicated to a paired remote electronic device, such as a user's smartphone.SELECTED DRAWING: Figure 1B

Description

[Technical field]

[0001] The present disclosure relates to a technique for an electronic dose detection system for a drug delivery device, The present invention relates to a drug delivery device, a method for detecting a connection to the drug delivery device, determining the type of drug delivery device, and determining battery life. It relates to technologies for monitoring. [Background technology]

[0002] Patients suffering from various diseases often have to inject themselves with drugs. To allow humans to self-administer drugs conveniently and accurately, pen-type A variety of devices commonly known as syringes or injection pens have been developed. These pens include a piston and a cartridge that contains multiple doses of liquid medication. The drive member is movable forward and drives a piston in the cartridge. 2. The cartridge is then advanced to force the contained drug out of an outlet at the distal cartridge end, typically through a needle. Dispense. In disposable or prefilled pens, the pen dispenses the supply of medication in the cartridge. After the amount is depleted, the user discards the entire pen and purchases a new replacement pen. With a reusable pen, the pen uses up the supply of medication in the cartridge. After use, the pen is disassembled and the used cartridge is inserted into a new cartridge. The pen can then be reassembled for further use. can be.

[0003] Many pen injectors and other drug delivery devices deliver drugs by actuation of the device. A mechanical system in which the members rotate and / or translate relative to each other in a manner proportional to the displacement of the Thus, in the art, there are many methods for assessing the delivered dose, such as: To provide a reliable system for accurately measuring the relative motion of members of a drug delivery device. Efforts have been made to develop such a system. and a sensor for detecting relative motion of a sensed component fixed to a second member of the device. may include.

[0004] Administration of an appropriate amount of drug depends on the accuracy of the dose delivered by the drug delivery device. Many pen injectors and other drug delivery devices require device The device does not include functionality for automatically detecting and recording the amount of drug delivered by the device. Without a streamlined system, patients must manually track the amount and time of each injection. Thus, automatically detecting the dose delivered by the drug delivery device during an injection event. Moreover, such a dose detection device is required to be operable. It should be removable and reusable with multiple delivery devices. In some configurations, such a dose detection device needs to be integrated with the delivery device.

[0005] Delivering the right medication is also important. Patients may need different medications, or It may be necessary to choose between different forms of a given drug. If the wrong dose is placed in the wrong chair, the patient may not be properly administered and the dose administration may be inaccurately recorded. The possibility of this happening is due to the automatic checking of the type of drug contained in the drug delivery device. This is significantly reduced when a dose detection device is used. Summary of the Invention

[0006] The present disclosure relates to a dose sensing module that can be removably attached to a drug delivery device. The present invention relates to a dose sensing module attached to a drug delivery device. Such techniques may include, for example, determining whether the The dose sensing module only reports events detected when attached to a drug delivery device. It is possible to ensure that the dose is detected, processed, and / or reported (Dose Detection Module (as opposed to accidental actuation when not coupled to a drug delivery device), and the dose Use the sensing module to determine when to change to a new drug delivery device. This technology can also detect the color of a portion of the drug delivery device to determine the drug delivery device. Such techniques may include, for example, determining the drugs contained in the device. It can be ensured that patients are receiving the correct medication and which medication is being administered by the drug delivery device. This avoids mistakes about which chair is in the chair. The technology is Such techniques may further include monitoring the battery life of the battery. or to allow patients to plan ahead appropriately, for example by notifying them when the battery will run out. to allow the user or patient to know in a reliable manner and well in advance what allows the patient to monitor battery life. [Brief description of the drawings]

[0007] Further embodiments of the present disclosure, as well as features and advantages thereof, will now be described in conjunction with the accompanying drawings. This will become more apparent by reference to the detailed description. Moreover, in the drawings, like reference numbers correspond throughout different views. The corresponding part is shown.

[0008] [Figure 1A] FIG. 1 is a diagram of an exemplary system, according to some embodiments. [Figure 1B] FIG. 2 is a block diagram illustrating a controller and its components according to some embodiments. [Figure 1C] FIG. 1 is a diagram of an exemplary system, according to some embodiments. [Diagram 2] 1 is a flowchart of an example computerized method for determining a color associated with an object, according to some embodiments. [Diagram 3] 1 is a flowchart of an exemplary computerized method for generating calibration parameters, according to some embodiments. [Figure 4] 1 is a flowchart of an exemplary computerized method for determining a battery indication, according to some embodiments. [Diagram 5] FIG. 1 is a perspective view of an exemplary drug delivery device in which the dose detection system of the present disclosure is operable. [Figure 6] FIG. 6 is a cross-sectional perspective view of the exemplary drug delivery device of FIG. [Figure 7] FIG. 6 is a perspective view of a proximal portion of the exemplary drug delivery device of FIG. 5. [Figure 8] FIG. 6 is a partially exploded perspective view of a proximal portion of the exemplary drug delivery device of FIG. 5 together with a dose detection system of the present disclosure. [Figure 9] FIG. 13 is a side partial cross-sectional schematic view of a dose detection system module according to another exemplary embodiment mounted to a proximal portion of a drug delivery device. [Figure 10A] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 10B] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 11A] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 11B] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 12] FIG. 13 is an axial view of yet another exemplary embodiment of a dose delivery detection system utilizing magnetic sensing. [Figure 13] 1 illustrates an exemplary computerized method for determining whether an apparatus is removably coupled to a drug injection device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, in which: Certain language will be used to describe this, however it is understood that this does not limit the scope of the invention. It will be understood that it is not intended to

[0010] The present disclosure relates to a detection system for a drug delivery device. In one aspect, the detection system comprises: for determining whether a detection system is attached to a drug delivery device The inventors have removably coupled the dose sensing system to the drug delivery device. However, the inventors have discovered and recognized that it may be desirable to Various hardware, firmware, and other components that may be desirable to include in such a dose detection system are Consider hardware and / or software to make the dose sensing system small and easy to use. ,We want to limit the inclusion of only components that are unlikely to ,fail due to repeated use. We have discovered and recognized the need for a dose sensing system that is connected to a drug delivery device. Incorporate additional components (e.g., switches, latches, etc.) to detect when the The techniques described herein overcome the existing components of dose sensing devices. The present invention utilizes a dose sensing device to determine whether the dose sensing device is coupled to the drug delivery device. For example, the dose sensing device may include a sensor (such as a Hall effect sensor) and and associated hardware and / or software, by a drug delivery device. The size of the administered dose can be determined. This technique is used to perform dose detection. Utilizing such hardware and / or software used in It may also be possible to determine whether the system is coupled to a drug delivery device.

[0011] In a second aspect, the detection system determines the type of drug contained within the drug delivery device. As described herein, the present inventors have developed a drug delivery device We discovered and recognized that problems could occur due to the inability to determine the presence of drugs in the For example, the incorrect medication may be administered to a patient, which may result in inappropriate patient dosing. This may result in inaccurate recording of the dosage administered. The technology provides for detecting the color of the components of a drug being administered by a drug delivery device. In some embodiments, the technology includes one or more light emitting diodes. Utilizing a photodiode and a light sensor to illuminate the applicable color components and process the illumination data to ,matching the color to a stored set of colors and associated drugs.

[0012] In a third aspect, the detection system is for monitoring battery life of the detection system. The inventors have found that determining the remaining battery life of a battery is a matter of temperature, relaxation time, duration of use, The battery life may vary depending on various factors such as load fluctuation, battery brand, battery variation, and other parameters. Based on the structure of the dose sensing device, the inventors have discovered and recognized that They have developed technology to monitor batteries in a manner that incorporates other relevant data such as temperature. The technology avoids errors that can be caused by existing battery measurement techniques. can provide an estimate of battery life to calibrate the measurement process.

[0013] By way of example, the drug delivery device is described in the form of a pen-type injection device. The drug delivery device may be any suitable device, such as an infusion pump, a bolus injector, or an automatic injection device. The drug may be any device used to set and deliver a dose of a drug. It may be of any of the types that can be delivered by such a drug delivery device.

[0014] While various embodiments have been described, it is understood that many more embodiments and implementations are possible. It will be apparent to one skilled in the art that the embodiments described herein are illustrative and not restrictive. In addition, the advantages described above are not necessarily the only advantages. It is not necessarily expected that all of the described advantages will be achieved in each embodiment.

[0015] The devices described herein, such as device 10, may include, for example, a reservoir or cartridge. In another embodiment, the system may further include a drug, such as in device 20. The term "drug" may include one or more devices, including the chair 10, and a drug. However, insulin, insulin lispro or insulin glargine are not used. GLP-1 receptor antagonists such as phosphate analogues, insulin derivatives, dalaglutide or liraglutide Glucagon agonists, glucagon, glucagon analogues, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin The present invention includes any therapeutic agent capable of being delivered by the above-described devices, including thiamine derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered by the above-described devices. Drugs as used in the present device may include one or more therapeutic agents. The device may be formulated with excipients. The device may be used by patients, caregivers, or other personnel to deliver drugs to humans. or a medical professional in a manner generally as described above.

[0016] FIG. 1A is a diagram of an example system 120, according to some embodiments. 101 via a communication unit 106 (e.g., via a wired and / or wireless connection). ) a detection system 103 in communication with a remote computing device 104. The communication unit 106 may be, for example, a WiFi transceiver, a Bluetooth transceiver, , RFID transceivers, USB transceivers, Near Field Communication (NFC) transceivers , combination chips, etc.

[0017] As described further herein, the sensing system 103 receives illumination data indicative of the color of the object. The detection system 103 may be configured to determine the optical sensor 110 and the control unit. The light sensor 110 includes a processing unit 108 (e.g., MCU) in communication with a processor 112. , in optical communication with an object 116 (e.g., a portion of a drug delivery device). In one embodiment, the light sensor 110 is, for example, an ambient light sensor (ALS) operating in a reflective mode. The LED driver 112 drives a light emitting diode (LED) in optical communication with the object 116. ) communicates with a set of LEDs 114A, 114B, and 114C (collectively LED114). For example, the LEDs 114 may include red LEDs, blue LEDs, and / or green LEDs. The light sensor 110, the LED 114, or both, can optionally be The object 116 is in optical communication with the object 116 via an optional light guide 118. The light guide 118 includes a It can be a transparent light guide such as the akrolon 2458 LightGuide. In some embodiments, the color sensor may be a separate LED, a single packaged RGB LED, or a combination of these.

[0018] FIG. 1B is a block diagram of a module 1400 that may be included in any of the modules described herein. FIG. 1 shows a detailed example of the electronics assembly of a sensing module, as shown in FIG. The MCU is programmed to implement the electronic functions of the drug delivery device. detecting a connection to the drug delivery device, determining a type of drug delivery device, and obtaining data used to determine a dose delivered by the drug device; and monitoring the battery life of the product delivery device. The MCU includes a control logic that can operate as follows: and operable to obtain data by detecting and / or determining an amount of The amount of rotation may be measured by a sensing element of a measurement sensor of the system, such as a Hall effect sensor. This is determined by detecting the magnetic field of the rotation sensor by

[0019] The assembly 1400 includes dosage sensors 1402A-E, a memory 1408, and an identification sensor 1409. 04, counter 1414, light driver 1411 and light indicator 1412, power on module 1406, communication module 1410, display unit driver / display unit 1416, power supply 1 418, as well as one or more of the presence modules 1420. The assembly 1400 includes, for example, five magnetic sensors 1402A to 1402E ( Any number of dose sensors may be included, such as 100, 150, 200, 250, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1400, 1600, 1800, 1900, 2000, 2100, 2200, 2300, 2400, 2500, 2600, 2700, 2800, 2900, 3000, 3100, 3200, 3300, 3400, 3500, 3600, 3700, 3800, 3900, 4000, 4100, 4200, 4300, 44 of components within the drug delivery device that can be used to determine the amount of a delivered dose. 5-12 in conjunction with the present specification to determine the total unit of rotation. (as further discussed in the document), and used to detect connection to a drug delivery device. The MCU detects whether the module is a device through a trigger of the presence switch system. In this embodiment, the dashed line is used to determine whether the button is connected to the The presence module 1420 may be configured as an optional component. is configured to determine the color of the dose button via the identification sensor 1404, In some cases, the device may be on-board or external (e.g., a remote computing device). The color data determined off-board by the device 104) is then correlated to the color corresponding to a specific drug. (e.g., using LED 114, as discussed further herein). U is an electronics assembly for use as a power-on module 1406. and determining whether a wake-up switch is triggered to power on the In one example, a full rotation can be performed by using a database, lookup table, or other data stored in memory. and communicating with an external device including a memory having a total rotation unit for a given identified drug. In another example, the MCU can be correlated to the amount of drug delivered. The MCU can be configured to store the detected dose in a local memory 14. 08 (e.g., in internal flash memory or on-board EEPROM) The MCU may further be operable to, for example, control a rotation unit (any one or more any combination of these), drug identification (e.g., color) data, timestamp, and date since last dose Time, battery charge status, module identification number, module insertion / removal time, inactivity time , and / or other errors (e.g., dose detection and / or transmission errors, drug identification errors, A signal representing device data (such as output and / or transmission errors) th Low Energy (BLE) or other suitable short-range or long-range wireless communication protocol Module 1410 (e.g., Near Field Communication (NFC), WiFi, or cellular) The data is then wirelessly transmitted to a companion remote electronic device, such as a user's smartphone, over the network. Illustratively, the BLE control logic and the MCU are implemented in the same circuit. In one example, any of the modules described herein may provide information to a user. In this embodiment, the dashed lines indicate that the A display module 1420 may be included. Such a display may be an LED, LCD, or other The display may be a digital or analog display of the M The CU receives and processes the sensed data, e.g., dose setting, dispensed dose, injection status, completion of injection, date and / or time, or time until next injection A display driver software module and a control module operable to display the In another example, the MCU may check whether the data was sent successfully, On / off sequences and notifications for high or low charge or other clinical communications and communicate with the patient by different colors, e.g. RGB LED, orange LED drivers coupled to one or more LED1412, such as a pink LED and a green LED. A counter 1414 is provided to track time, e.g., time of administration. The RTC is shown electronically coupled to the MCU. The counter 1414 can also be a time counter that tracks seconds from zero based on power up. The time or count value can be communicated to an external device.

[0020] In some embodiments, as will be further discussed in connection with FIGS. The system 103 is configured to be connected to a drug delivery device. The object 116 may be used to identify an aspect of the drug delivery device based on the color of the object 116. Parts of the drug delivery device that can be used (e.g., buttons, labels, outer compartments For example, the color of the object 116 may correspond to the type of drug in the drug delivery device. It can be shown that

[0021] FIG. 1C is a diagram of an example system 130, according to some embodiments. 130 via a communication unit 136 (e.g., via a wired and / or wireless connection). 132 in communication with a remote computing device 134. As described further herein, the sensing system 132 includes , can be configured to determine a battery indicator indicative of the remaining life of the battery 138 The device 132 communicates with a communication unit 136, a battery 138, and a temperature sensing unit 142. The system includes a processing unit 140 for receiving the

[0022] The exemplary embodiment of the dose detection system described in connection with FIGS. 1A-1C are shown for illustrative purposes to highlight various aspects of the system. The embodiment shown includes a single dose delivery detection system, such as the dose delivery detection system 80 described in connection with FIGS. For example, the various exemplary embodiments discussed in connection with those figures may be combined into one or more of the above-described devices. The present invention can be implemented using any suitable configuration.

[0023] Referring to FIG. 1A, in some embodiments, the detection system 103 detects an object (e.g., , a button of a pen-type drug delivery device. In this embodiment, the detection system sequentially switches on the LEDs 114 and detects a wide spectrum The reflected beam is read back through the ambient light sensor 110 to determine the object's The detection system 103 determines the color, e.g., three values ​​for each of the three LEDs 114. , various values ​​can be generated. The detection system 103 processes the generated values ​​to The detection system 103 can generate the final color values ​​for matching. Checks a specific color value against a set of predefined colors to determine if it matches It is possible.

[0024] FIG. 2 is an exemplary control for determining a color associated with an object, according to some embodiments. 2 is a flow chart of a computerized method 200. A processor, such as the processor 108, may include computer readable instructions that cause the processor to execute the method 200. In step 202, the detection system may execute a command to set an LED. The sensing system optionally includes a stage for acquiring illumination data of an object illuminated by the stage. The illumination data is processed in steps 204 and / or 206 to generate processed illumination data. In step 204, the detection system may optionally detect a temperature-based In step 206, the detection system optionally adjusts the illumination data according to: Normalize the illumination data. In step 208, the detection system detects whether the object is in the LED sensor. The light sensor captures illumination data of the object while it is illuminated by the step. At step 208, the sensing system transmits the processed illumination data to a remote device. (e.g., via a communication module that communicates with a processor of the device). The remote device determines whether the lighting metrics match a set of stored colors. If the remote device determines a match, then in step 212, the remote device The remote device will output the matching color (e.g. to a program, display, etc.). If the remote device does not determine a match, then in step 214 the remote device Outputs that no match was found (e.g., an error code, a mismatch code, etc.) (by returning the

[0025] Referring to step 202, the detection system detects whether an object is illuminated by a set of LEDs. The first illumination data when the object is not illuminated by each LED of the set of LEDs. can be configured to capture first illumination data, second illumination data when the For example, the device may detect when an object is illuminated by ambient light alone when the LEDs are not turned on. The camera can be configured to capture illumination data for an object when the camera is turned on. In some embodiments, the sensing system includes an exposure time for capturing low illumination data. It can include a space.

[0026] As another example, if a set of LEDs contains LEDs of different colors, the object will be illuminated by each LED. The device can be configured to capture illumination data for an object when illuminated with For example, as shown in FIG. 1A, in some embodiments, the device includes a red LED 1 14A, a blue LED 114B, and a green LED 114C. 0 and the LED driver 112 to illuminate the LED 114 and the illumination data. The optical sensor 110 may be configured to adjust the capture of the image data. Illumination data when an object is illuminated by the red LED114A (and not by other LEDs) data when the object is illuminated by blue LED114B, and illumination data when the object is illuminated by green LED114C. Capture lighting data when illuminated by LED114C. In an embodiment, the sensing system simultaneously detects the illumination of each LED while capturing the illumination data. The exposure times may be the same for one or more LEDs and / or may be different. It can be configured as follows.

[0027] Referring to step 204, the lighting data may be adjusted based on temperature. In some embodiments, the temperature is measured by the ambient air, the sensing system, and / or the drug delivery device. In some embodiments, the sensing system may include a plurality of temperature measurements taken from a device. Capture the temperature, average the values, determine the temperature, and use the averaged temperature to adjust the lighting data. In some embodiments, the sensing system can calculate the illumination data using Equation 1. You can adjust the value (X) of the rgbTempX=rgbX*(1-TempCoefficientX*(Temp- CalTemp))(Formula 1) During the ceremony, rgbTempX is the color, such as red value, green value, blue value, etc., depending on which color formula 1 is calculated. are the adjusted illumination data values ​​determined for each ·rgbX is the original lighting data value of each color, such as red, green, or blue. TempCoefficientX is the temperature coefficient for each value, using one coefficient Track different temperature measurements (e.g. performance drift with different temperature measurements) may occur). CalTemp is the temperature measured during the calibration of the sensing system, taking into account temperature changes. can be used to measure the relative position of the ·Temp is the measured (e.g., averaged) temperature.

[0028] Referring to step 206, the detection system detects the captured image without illumination by the LED. The (temperature adjusted) illumination data can be normalized based on the dark illumination data. In some embodiments, the sensing system is adapted to detect one or more illumination measurements determined during calibration. For example, each illumination data can be normalized based on the following equation: The data value (X) can be normalized.

number

[0029] Referring to step 210, the remote device determines the lightness AB (LABc) value. The system can be configured to provide either raw lighting data or temperature adjusted and / or normalized lighting data, whether the lighting values ​​are For illustration purposes, the following example uses a simple The A value is based on the normalized illumination value. For example, if rgbNormRed determined using Equation 2 is Depending on whether the A value is greater than ormGreen, use either Equation 3 or 4. is determined.

number

number

[0030] The B value can also be calculated according to the normalized illumination value. For example, using Equation 2 Depending on whether the determined rgbNormBlue is greater than rgbNormGreen, Depending on the formula, either formula 5 or 6 is used to determine the B value. For formulas 3 to 6, Kn is the sum of RG A and B are coefficients used to convert B to LABc. A and B values ​​range from -100 to 100. and L ranges from 0 to 100 (for example, 20, 21.5, 23, etc.).

number

number

[0031] The L value can be calculated using Equation 7.

number

[0032] In some embodiments, the remote device determines whether the lighting data satisfies the color. The remote device may include a table of metrics that are used to determine ,A set of colors (e.g., gray, blue, navy blue, ... The data associated with each color may include, for example, red, red, and / or other colors. Mean data and / or sigma variation data determined during calibration and / or design of In some embodiments, each color can include a respective A, B, and L value. It can include the average and sigma variation of each of the A, B, and L values. The device can determine the illumination data and sigma distance for each color in a set of stored colors. For example, Equation 8 can be used to determine the sigma distance for each color in a set of colors.

number

[0033] The remote device uses the sigma distance to determine whether the lighting data matches a color in the set of colors. For example, the remote device can determine whether the sigma distance value ( The second smallest value (M in2) can be used to check for matching colors, as discussed further herein. .

[0034] The sensing system and / or remote device may perform one or more checks on the lighting data. For example, it can be configured to check the low light data and It is possible to determine whether subsequent measurements under LED illumination are obstructed by ambient light. As another example, you can check the lighting data captured for LEDs to see if the lighting data It can be seen that the data is within the expected threshold between the minimum black value and the maximum white value. As an example, checking LABc values ​​to determine if they are within acceptable limits. (For example, -100 to 100 for A or B, 0 to 10 for L) 0). As another example, a match color check can be performed to check if Min1 and / or Min2 are allowed. For example, you can check Min1 to see if it is within the expected range. Ensure that the color match is below the maximum sigma distance for the color match and / or Min2 / Mi The ratio of n1 may be compared to the minimum ratio between the two minimum values ​​of an acceptable match.

[0035] During calibration, the sensing device is calibrated so that it can be used to calibrate real-time measurements of the object. Calibration measurements include temperature, white target, black target, and The measurements are taken in various lighting conditions, including low light without any LEDs turned on, and low light without any LEDs turned on. FIG. 3 illustrates a method for generating calibration parameters according to some embodiments. 3 is a flowchart of an exemplary computerized method 300 for In step 304, the device measures the temperature. In step 306, the illumination data of the target object (e.g., a white object) is captured. The device captures illumination data for a black target (e.g., a black object). At step 308, the device captures illumination data for a dim light where the LED is not turned on. In step 310, the device generates a set of calibration parameters. The meter includes a dark measurement and / or individual LEDs (e.g. red, green and blue LEDs) ), the exposure time (or maximum / minimum exposure time) used for Calibration of each LED for each temperature, temperature margin, and / or other calibration parameters It may contain a count of what was read.

[0036] As described herein, the dose sensing system includes, among other components, a Includes a sensing module with various components including a processor / MCU, sensors, and LEDs In some embodiments, the sensing module may be powered by a battery. For example, the detection system 132 may include the exemplary components shown in FIG. 1C. The dose detection system includes a battery 138 that powers the dose detection system. It can be used to monitor the battery life of the detection system. This allows you to see battery status indicators that track battery life, battery-related warnings (e.g. For example, to warn the user that the battery life is short and when to change the battery. For example, the dose detection system may provide a user with Regardless of which computing device you are using, you should be able to get users to replace the battery. It can warn users when the battery is running low so that they can get a reasonable amount of time (for example, (For example, one or two weeks before the battery expires).

[0037] The inventors have demonstrated that the behavior of the battery depends on the temperature, the relaxation time between measurements, the attached drug, Delivery device injection duration, load variation, battery brand, battery variation, and other parameters Due to the fact that battery voltage measurements can depend on many variables such as We have discovered and recognized that estimating battery life using To address these issues, which are often beyond the control of device providers, To this end, the inventors have designed the device architecture in a manner that provides sufficient margin for battery life. We developed a technology to monitor batteries based on the This compensates for potential errors and variability that the authors have recognized.

[0038] FIG. 4 illustrates an exemplary method for determining a battery indication, according to some embodiments. 1 is a flow chart of a computerized method 400. A processor, such as unit 140, may be a computer-implemented device that causes the processor to perform method 400. In step 402, the device may be configured to execute a read command. In step 404, the device takes a set of temperature measurements. In step 406, the device detects the temperature A set of temperature regulated battery indications is determined based on the measurements. At 408, the device generates a set of temperature conditioned battery indications and voltage measurements. Based on the battery status, a battery indicator is determined that indicates the remaining life of the battery.

[0039] Referring to step 402, the device (e.g., MCU) determines whether the battery is under different loads. Take various voltage measurements when the device is in a standby state and / or during different operating conditions. In some embodiments, the device may: (a) detect a current state of the device when the device is powered on; (b) the high-current battery voltage when the processor is running at full speed, c) Low current battery voltage when the processor is operating in a low power mode, or any combination thereof. The start-up battery voltage is obtained, for example, from the powered-on detection module. This can be determined by obtaining a high current battery voltage within a certain period of time. When the device is activated (e.g. after pressing a button), the device may increase the drain from the battery. In some embodiments, when woken up, the device may begin a wake-up process. The operating process may consume more power from the battery, for example for various self-tests, start-up operations, etc. In some embodiments, when activated, the device can take magnetic measurements. (e.g., to determine the start position of one or more components). Such starting processes and / or magnetic sensing may require high current to be measured as starting battery voltage. The battery voltage may be provided.

[0040] The high current battery voltage can be used to measure the voltage drop at that point, for example. The high current battery voltage is For example, you can run a microcontroller at full speed and run all other loads in low-power mode. Run for a given amount of time (e.g., in milliseconds) and determine by measuring the high current battery voltage In some embodiments, the high current battery voltage can be calculated based on a set of measurements. In some embodiments, the high current battery voltage is the average voltage measured during the magnetic sensor activation. It can be calculated at the beginning and / or end of a system activity. A large voltage drop may be obtained when the magnetic sensor completes a measurement.

[0041] Use the low current battery voltage to measure the voltage drop at minimal current load to determine e.g. An open circuit voltage check can be simulated. The low current battery voltage is, for example, The firmware running on the U must be able to run all loads (including the MCU) at a given time. This may be determined by putting the device into a low power mode for a certain period of time (e.g., a specified inactive period in milliseconds). , the low current battery voltage is measured. In some embodiments, the low current battery voltage is The average voltage is calculated by averaging the set. The low current battery voltage is determined after determining the high current battery voltage measurement.

[0042] As described herein, one or more voltage measurements may be used in step 402. For example, in some embodiments, the voltage may be high and / or at maximum power dissipation. voltage reading at the current (e.g., point with maximum voltage drop) and low / lowest current draw The measurements may be taken in a manner designed to obtain representative open circuit voltage measurements for As described herein, the voltage can be used to determine the remaining energy in the battery. In some embodiments, the technique can estimate, for example, the maximum voltage drop. A single voltage drop can be used to estimate the remaining battery energy (e.g., The large voltage drop is more dependent on the battery condition compared to other voltage drops that may be more capacitively driven. For example, the voltage drop at power-on / start-up may be greater than the maximum voltage drop. It can easily be used for comparison. For example, the voltage drop during power-up is the maximum measured drop in the system. If it is greater than the lower limit, the comparison indicates that there is a risk that the component may be reset. can be.

[0043] Referring to step 406, the device may generate a battery indication table at various temperatures. For example, the device may store a battery of inductors, each of which has a voltage associated with a low temperature. A set of low battery indications can be stored, including a set of low battery indications. Table 1 is an example set of low temperature battery indications (e.g., 0° C.). [Table 1]

[0044] As another example, the device may include high temperature battery indicators, each having a voltage associated with a high temperature. A set of hot battery indications including a set of hot battery indications can be stored. Table 2 shows , is an example of a set of high temperature battery indications (e.g., 22-24°C). [Table 2]

[0045] The detection system consists of a set of low-temperature battery indications and a set of high-temperature battery indications. and a temperature adjusted set of temperature measurements obtained in step 402. A set of battery indications may be determined. The system (e.g., via firmware running on the MCU) may then proceed to step 404. A correction factor can be determined based on the temperature measured by the sensing system. The system determines the correction factor based on the measured temperature and one or more correction factors. Logarithmic (as shown below) and / or linear relationships can be developed to determine the correction factor. For example, the detection system can determine the correction factor using Equation 9: Cut. corrFactor=A*log2(Temp+LogOffset)+Temp*B +C (Formula 9) During the ceremony, ·corrFactor is the correction factor. A, B, C are coefficients (e.g., providing the desired degrees of freedom for determining the correction factor) (based on data collected to provide LogOffset is a coefficient (e.g., the desired correction factor for determining (based on data collected to provide degrees of freedom).

[0046] The sensing system provides a compensated battery indication based on a temperature compensation factor. In some embodiments, the detection table (e.g., a corrected battery table) can be determined. The system will display modified battery indicators based on both low and high temperature battery tables. For example, the detection system can use Equation 10 to determine each indicator. Each corrected battery voltage associated with the data can be determined. corrBatCurve x ={(Voltage TEMPHIx -Voltage TE MPLOx ) / (TEMPHI-TEMPLO)}*(corrFactor-TEMP HI)+Voltage TEMPHIx (Formula 10) During the ceremony, ·corrBatCurve xis the corrected battery curve voltage for row X. Voltage TEMPHIx is the voltage of row X of the high temperature battery table. Voltage TEMPLOx is the voltage of row X of the low temperature battery table. ·TEMPHI is the temperature used when determining the high temperature battery table. ·TEMPLO is the temperature used when determining the low temperature battery table. ·corrFactor is the correction factor calculated using Equation 9.

[0047] Referring to step 408, the device may update the battery indicator based on the previous battery indicator. For example, the device can determine the previous battery indicator for the battery. The battery data is then taken and the temperature adjusted battery indicator is generated with a corrected set of battery tables and voltage measurements. determining a current battery indicator for the battery based on the indication and determining a previous battery indicator for the battery based on the indication; determining a battery indicator based on the indicator and a current battery indicator; can be done.

[0048] In some embodiments, the detection system includes a stored battery table and / or a repair Based on the corrected battery table, the current battery indicator can be determined. For example, the detection system may map a point in the modified battery table to a high current battery voltage (e.g. , measured in step 402 of FIG. 4). For example, If the battery voltage is equal to the voltage value in the table, the detection system will As another example, a high voltage If the current cell voltage is between two voltage values ​​in the table, the detection system detects the two associated The battery indicators can be interpolated to determine the relevant battery indication. .

[0049] In some embodiments, the detection system detects a new battery indicator based on a previous battery indicator. The battery indicator can be determined (e.g., on a detection system such as an EEPROM). (The new storage can be stored in the storage). For example, the detection system can use Equation 11 to A new battery indicator can be determined. newBatInd=(FILTER*batInd+curBatInd) / (FIL TER+1) (Equation 11) During the ceremony, -newBatInd is the new battery indicator. batInd is the previous battery indicator (e.g. obtained from EEPROM). be. · curBatInd is the currently determined battery indicator. FILTER is the filter value. FILTER is the final filter associated with the detection system. Operation (e.g., at a remote computing device, such as remote computing device 104) Synchronization with a remote computing device), bonding with a remote computing device The time lapse from detection of an event and / or a dose administered by an associated drug delivery device. The time period may be determined based on the time that the

[0050] The detection system stores (e.g., in an EEPROM) the determined new battery indicator. In some embodiments, additional data such as a timestamp, number of remaining injections, etc. For example, the initial injection number can be stored with the new battery indicator. The new detection system and / or the system associated with the new battery and the detection system detects a number of injections for each detected injection through the drug delivery device. can be set to decrease.

[0051] The device may transmit the battery indicator to a remote device (e.g., a remote computing The remote device may transmit a new battery indicator to the device 104. For example, the remote device may process the battery status based on a battery indicator. The battery status can be determined by the following table 3. 1 shows an associated battery indicator. [Table 3]

[0052] In some embodiments, the first time the sensing device raises a low battery flag, the sensing device The device can enter a low battery state (e.g., the device is in a low-battery state after a certain period of time, such as 120 injections). (When it is unlikely that the device can provide more than one injection.) Entering a low battery state can prevent a transition out of the low battery state for that battery. (e.g., to avoid going back and forth between low and non-low battery states) In some embodiments, the sensing device may be configured to power down the sensing device when it enters a low power state. The battery indicator will be updated with each new device operation (e.g., synchronization, bonding, or charge event). In some embodiments, the sensing device may be configured to decrement the number of When the enters a low power state, each new motion of the sensing device reduces the number of remaining injections by one. When the battery indicator is equal to zero, the detection system is at end of life. In some embodiments, the battery can be replaced and a new Upon detecting a battery, the detection system may be reset. The sensing system is disposable and will be discarded when it reaches an end of life condition. can be done.

[0053] In some embodiments, the detection system comprises a processor that detects data obtained during the battery monitoring process and and / or one or more checks may be performed on the measurements obtained, e.g. The MCU will issue a low battery warning when the new battery indicator falls below a predefined threshold. As another example, the detection system may detect whether the detected voltage is within a predetermined tolerance. You can check whether the temperature measurements are within a given tolerance range, etc. Cut.

[0054] As described herein, this technology includes drug delivery systems incorporating aspects described herein. The present invention includes a drug delivery device, as well as add-on components that can be attached to the drug delivery device. The present invention can be used in various types of drug delivery devices, including those shown in Figs. 2 illustrates exemplary drug delivery devices and dose sensing systems that can incorporate the technology. Such technology is described in PCT application PCT Ser. No. PCT / US2019 / 023366, filed on February 20, 2019. This is further discussed in US Pat. No. 6,219,333, which is incorporated herein by reference. To be incorporated.

[0055] 5-6 show an exemplary drug delivery device 10, according to some examples. The drug delivery device 10 is a pen-type injector configured to inject a drug into a patient through a needle. The pen injection device 10 is an elongated pen-type handpiece including a distal portion 14 and a proximal portion 16. The pen includes a body 11 having a housing 12. The distal portion 14 is received within a pen cap 18. 6, the distal portion 14 is configured to receive a dispenser through its distal outlet end during a dispensing operation. It includes a reservoir or cartridge 20 configured to hold the medical fluid to be dispensed. The outlet end of the distal portion 14 includes a needle 24 surrounded by a removable cover 25. The reservoir 20 is equipped with a removable needle assembly 22 that includes a piston 26. An injection mechanism positioned within the proximal portion 16 is inserted into the piston during a dose dispensing operation. The needle 26 is advanced toward the outlet of the reservoir 20 to force the contained drug through the needle end. The injection mechanism is operable to advance a piston 26 through the reservoir 20. To this end, a drive member, illustratively in the form of a screw, is axially movable relative to the housing 12. Includes 28.

[0056] The dose setting member 30 is housed in a housing for setting the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is coupled to the housing 12 during dose setting. and moves helically (i.e., axially and rotationally) relative to the housing 12 during dose dispensing. 5 and 6 are views of the embodiment of the present invention. 1 shows the dose setting member 30 fully threaded into the housing 12 in the dose or zero dose position. The dose setting member 30 corresponds to the maximum dose that can be delivered by the device 10 in a single injection. Thread the housing 12 proximally until it reaches its fully extended position. It is operable.

[0057] 6 to 8, the dose setting member 30 moves in a spiral manner relative to the housing 12. The dose setting member 30 is adapted to engage with a correspondingly threaded inner surface of the housing 12 so as to enable The dose dial member 32 includes a cylindrical dose dial member 32 having a helically threaded outer surface that engages the dose die 32. The threaded member 32 is a helical thread that engages with the threaded exterior surface of a sleeve 34 (FIG. 6) of the device 10. The outer surface of the dial member 32 further includes a threaded inner surface. To facilitate this, the dosage window 36 includes dose indicator markings, such as numbers, viewable through the dosage window 36. The dose setting member 30 is coupled to the open proximal end of the dial member 32 and axially and axially relative to the dial member 32 by a detent 40 received within an opening 41 in the The dose setting member 30 further includes a tubular flange 38 that is rotationally locked to the dose setting member 30 at its proximal end. The dial member 32 further includes a collar or skirt 42 positioned around the outer periphery thereof. The skirt 42 is dialed by tabs 44 received in slots 46. The scallop is axially and rotationally locked to member 32. Further embodiments described below are An example of a device without a port is given.

[0058] Thus, the dose dial member 32, the flange 38, and the skirt 42 all rotate. Since the dose setting member 30 is fixed together radially and axially, The dose dial member 32 controls the setting of the dose and the administration of the drug. The flange 38 is attached to the dose dial member 32 and is directly involved in driving the delivery. , which cooperates with a clutch to selectively couple dial member 32 to dose button 56, as described below. The skirt 42 allows the user to rotate the dial member 32 to set the dose. In an embodiment without a skirt, a surface is provided on the exterior of the body 11 so that the The dosage button 56 includes an outer wall that extends distally to form a surface for the user to rotate. nothing.

[0059] The skirt 42 illustratively includes a plurality of surface features 48 formed on an exterior surface of the skirt 42. and an annular ridge 49. The surface features 48 illustratively extend around the outer surface of the skirt 42. The skirt is provided with circumferentially spaced longitudinally extending ribs and grooves that allow a user to grip the skirt. In an alternative embodiment, the skirt 42 may be removed or are integrated with the dial member 32, and the user presses the dose button 56 and and / or the dose dial member 32 can be grasped and rotated. To set a dose, the user presses the integrated dose button 56, which also includes a number of surface features. The radially outer surface can be grasped and rotated.

[0060] The delivery device 10 includes an actuator having a clutch 52 received within the dial member 32. The clutch 52 includes an axially extending stem 54 at its proximal end. The actuator 50 engages a dose bore positioned proximal to the skirt 42 of the dose setting member 30. The dose button 56 further includes a mounting tab 56 located at the center of the distal face of the dose button 56. The dose button 56 and the clutch 52 are attached to a bearing collar 58 (FIG. 6). The collar 58 supports the dose button 56 and the clutch 52 together. The clutch 5 is secured to the bearing 1 by, for example, an interference fit or ultrasonic welding so as to be axially and rotationally fixed. 2 is attached to stem 54.

[0061] The dose button 56 has a disk-shaped proximal end surface or face 60 and a distally extending and an annular wall portion 62 spaced radially inwardly of the outer periphery thereof with an annular lip 64 therebetween. The proximal surface 60 of the dose button 56 defines a proximal surface 62 for pushing the actuator 50 distally. Acts as a pressure surface to which force can be applied manually, i.e. directly by the user Dose button 56 illustratively includes a recessed portion 66 centrally located on proximal face 60, but may be recessed at any position within proximal face 60. The biasing member 68, illustratively a spring, biases the button. 56 and a proximal surface 72 of the tubular flange 38. The dose button 56 biases the actuator 50 and the dose setting member 30 axially away from each other. , which can be pressed by the user to initiate a dose dispensing operation.

[0062] The delivery device 10 is operable in both a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, a desired dose to be delivered by the device 10 is set. To do so, the dose setting member 30 is dialed (rotated) relative to the housing 12. Dialing in the direction of the inlet works to increase the set dose, while dialing in the distal direction works to decrease the set dose. The dose setting member 30 functions to reduce the set dose during the dose setting operation. It is adjustable in rotational increments (e.g., clicks) that correspond to a minimum incremental increase or decrease. For example, one increment or "click" can be equal to one-half or one unit of drug. The set dose is indicated to the user via a dial indicator marking shown through a dosing window 36. The actuator 50, including the dose button 56 and the clutch 52, is visible to the user. axially and rotationally moving with the dose setting member 30 during dialing in the dose setting mode. do.

[0063] The dose dial member 32, the flange 38, and the skirt 42 are all rotationally fixed to one another. Due to the threaded connection between the dose dial member 32 and the housing 12, 2. Rotate to extend proximally of the drug delivery device 10. During this dose setting operation, the dose button 56 The complementary springs of flange 38 and clutch 52 are biased together by biasing member 68. It is rotationally fixed to the skirt 42 by splines 74 (FIG. 6). During this process, the skirt 42 and the dose button 56 move from the "start" position relative to the housing 12. This rotation relative to the housing causes the drug delivery device to spiral to the "end" position. It is proportional to the dosage set by the 10 operation.

[0064] Once the desired dose is set, the needle 24 is adjusted, for example, to properly penetrate the user's skin. The device 10 is operated in the dose dispense mode as follows. The axial force is initiated in response to a distal axial force applied to the directly onto the button 56. This allows the actuator 50 to be attached to the housing 12. and move it axially distally.

[0065] The axial translational movement of the actuator 50 compresses the biasing member 68, causing the dose button 56 to engage. and the tubular flange 38. This relative axial The movement separates the clutch 52 and the complementary splines 74 on the flange 38, thereby The actuator 50, e.g. the dose button 56, is fixed to the dose setting member 30 by a rotational mechanism. Specifically, the dose setting member 30 is released from the actuator 50 in a rotational manner. After the dose setting member 30 is decoupled from the actuator 50 and the housing 12 Operation in dose dispense mode is also controlled by a separate switch or trigger. It may also be initiated by activating a mechanism.

[0066] The actuator 50 is continuously pushed axially without rotating relative to the housing 12. 5. When the dose button 56 is pressed against the dial member 32, the dose button 56 rotates relative to the dial member 32. 2 is screwed back into the housing 12. The quantity markings are visible through a window 36. The dose setting member 30 is screwed distally. Once inserted, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20. The drug enters the blood vessel and is expelled through needle 24 (FIG. 6).

[0067] During a dose dispensing operation, the amount of drug released from the drug delivery device is controlled by the dial member 32. Rotation of the dose setting member 30 relative to the actuator 50 as it is screwed back into the housing 12 The injection, which is proportional to the amount of rotational movement, is performed by threading the dial member 32 with a corresponding male thread on the sleeve 34. The process is complete when the device 10 reaches the distal end of the same catheter (FIG. 6). 7, is placed back into the ready or zero dose position.

[0068] The thus rotationally fixed flange of the dose dial member 32 to the dose button 56 38 and the start and end angular positions of the skirt 42 define the "absolute" angular position during dose delivery. There are several ways to determine whether the relative rotation has exceeded 360°. By way of example, a full rotation can be measured by a sensing system in any number of ways. This can also be determined by taking into account the incremental movement of the dose setting member 30 that can be achieved.

[0069] A variety of sensor systems are contemplated herein. In general, a sensor system detects The term "sensing component" includes the sensed component. The term "sensing component" refers to any component capable of detecting the relative position of a sensor or a detector. The term "sensor" includes a sensing element together with associated electrical components for operating the sensing element. The "sensing component" refers to the sensing component's position and / or location of the sensed component relative to the sensing component. In the case of a dose delivery detection system, The sensed component rotates relative to the sensing component, thereby changing the angular position of the sensed component. and / or rotational motion. In the case of a dose-type detection system, the detection The component detects the relative angular position of the sensed component. The sensing component comprises one or more sensing elements. A sensor may include a sensor element, and a sensed component may include one or more sensed elements. The system detects the position or movement of the sensed component and An output representative of the movement can be provided.

[0070] A sensor system typically involves the position of one or more sensed elements within a sensed area. The sensed element detects a characteristic of the sensed parameter that varies with the sensed parameter. The sensor may extend or otherwise enter the sensed area in a manner that directly or indirectly affects the characteristics of the sensor. The relative position of the sensor and the sensed element affects the characteristics of the sensed parameter. The microcontroller unit (MCU) of the sensor system detects different This allows the rotational position to be determined.

[0071] A suitable sensor system may include a combination of active and passive components. When the sensing component is operating as the active component, both components must be powered or It does not need to be connected to other system elements such as a CU.

[0072] Any of a variety of sensing technologies capable of detecting the relative position of two members may be incorporated. Such techniques may be, for example, techniques based on tactile, optical, inductive or electrical measurements. Such techniques may include measurements of sensed parameters related to fields such as magnetic fields. In one form, when the magnetic component is moved relative to the sensor, the magnetic sensor In another embodiment, an object is placed in the magnetic field and a change in the sensed magnetic field is detected. The sensor system measures and detects the characteristics of the magnetic field when the sensor is moved through the magnetic field. The field variation can be detected by the sensing element within the sensing region. In such an embodiment, the characteristic of the sensed parameter is changed in relation to the position. The parameters known are capacitance, conductance, resistance, impedance, voltage, and inductance. For example, a magnetoresistive sensor has a characteristic change in the resistance of the sensor element. As another example, Hall effect sensors detect distortions in an applied magnetic field that result in a change in the magnetic field. It detects the change in voltage resulting from distortion of the

[0073] In one aspect, the sensor system comprises a sensing element and, therefore, an associated The sensor system detects the relative position or movement of a component. For example, the sensor system may generate an output representative of the amount of movement of the dose setting member during dose delivery. The apparatus may be operable to generate an output from which the rotation can be determined. In one embodiment, the MCU is operatively connected to each sensor for controlling the drug delivery device. The dose delivered by operation of the device is configured to be determined from the output.

[0074] The dose delivery detection system involves detecting relative rotational motion between the two members. The degree of rotation, which has a known relationship to the amount of dose administered, determines whether the sensor system is capable of detecting the start of dose injection. The device operates to detect the amount of angular movement from the end of the dose injection to the end of the dose injection. A typical relationship is that an angular displacement of the dose setting member of 18° is equal to one unit dose. However, other angular relationships are also suitable. The sensor system detects the position of the dose setting member during dose delivery. Operable to determine the total angular displacement. Thus, if the angular displacement is 90°, then 5 A unit dose has been delivered.

[0075] One approach to detect angular displacement is to count dose increments as the injection progresses. For example, the sensor system may provide an indication of a rotation angle of a predefined degree for each iteration. A repeating pattern of sensed elements can be used to provide a uniform distribution. Advantageously, the pattern is such that each repetition is a dose that can be set using the drug delivery device. It can be established to correspond to a minimum increment.

[0076] An alternative approach is to detect the start and stop positions of the relatively moving members and then calculate those positions. The approach is to determine the delivered dose as the difference between the dose Part of the determination can be to detect the number of full revolutions of the setting member. Various methods for this are sufficient. It is within the skill of the art to "count" the increments to assess the total number of revolutions. It may include.

[0077] The sensor system components are attached, either permanently or removably, to the drug delivery device. In an exemplary embodiment, at least some of the components of the dose detection system may be Some are provided in the form of modules that can be removably attached to the drug delivery device. This allows these sensor components to be used in more than one pen-injector. This has the advantage of making it

[0078] In some embodiments, the sensing component is attached to the actuator and the sensed configuration The element is attached to the dose setting member. The sensed component may also be attached to the dose setting member or The sensor system may include any of the following components during dose delivery: detecting a relative rotation of the dose setting member and then determining a dose to be delivered by the drug delivery device; In an exemplary embodiment, a rotation sensor is attached to the actuator and The actuator rotates relative to the body of the drug delivery device during dose delivery. In this embodiment, the sensed component is connected to the actuator and device during dose delivery. The component to be sensed is attached to and fixed in rotation to a dose setting member which rotates relative to the sensor body. The rotary sensor may also include a dose setting member or any portion thereof. The sensor is not directly attached to the dose setting member which rotates relative to it during dose delivery.

[0079] With reference to FIG. 9, a device useful in combination with a drug delivery device such as device 10 A dose delivery detection system 80 including an example of such a module 82 is shown in schematic form. The module 82 includes a rotation sensor 86 (or more than one rotation sensor) and a processor. The sensor system is shown in schematic form along with other associated components such as a power supply, memory, battery, etc. The module 82 is a separate component that can be removably attached to the actuator. It is provided as a component of.

[0080] The dose detection module 82 comprises a body 88 attached to the dose button 56 (shown in dashed lines). The body 88 illustratively includes a cylindrical sidewall 90 and a and a sealing top wall 92. The dose detection module 82 may alternatively be a snap or press fit. , attached to the dose button 56 via any suitable fastening means, such as a threaded interface. However, in one embodiment, the module 82 may be removed from the first drug delivery device. and then can be attached to a second drug delivery device. It may be anywhere on the dose button 56, provided that, as discussed herein, The dose button 56 can be moved axially relative to the dose setting member 30 by any desired amount. It is possible.

[0081] During dose delivery, the dose setting member 30 is free to move relative to the dose button 56 and the module 82. In an exemplary embodiment, the module 82 is rotationally secured to the dose button 56. and does not rotate during dose delivery. This can be done, for example, by using a tab or by pressing the dose button 56. A module body 88 and a dosage body 56 engage during axial movement of the module 82 relative to the dosage body 56. By having opposing splines or other surface features on the tongue 56, In another embodiment, pushing the module distally may provide a 2 and the dose button 56 during dose delivery. and dose button 56 remain functionally rotationally fixed together.

[0082] The top wall 92 is spaced from the face 60 of the dose button 56 to allow for easy access to the rotation sensor and other The cavity 96 may include some or all of the components of the cavity. 96 may be open at the bottom or may be surrounded by a bottom wall 98 or the like. The bottom wall 98 may be positioned to directly abut the face of the dose button 56. Alternatively, the bottom wall 98 may If present, it may be spaced apart from the dose button 56, and the module 82 and the dose button 56 The other contact between the module 82 and the dose button 56 ensures that axial forces applied to the module 82 are transmitted to the dose button 56. In another embodiment, the module 82 may be used in an integrated dose button configuration. It may be rotationally fixed.

[0083] In an alternative embodiment, the dose setting module 82 is instead connected to the dose setting member 30. For example, side wall 90 may be provided with a link arm 102 in the form of a link arm that engages the side wall of the button. In this approach, the module 8 may include a lower wall portion 100 having an inward protrusion of 2 effectively engages the proximal face 60 of the dose button 56 and the distal side of the annular ridge 49. In this configuration, the lower wall portion 100 is provided with surface features that engage with surface features of the dose button. The housing 82 is fitted with a screw to rotationally secure the module 82 to the dose button during dose setting. The applied rotational force is applied to the dose button by the force of the coupling between the bottom wall portion 100 and the side walls of the dose button. The light guide 118 is disposed between the LEDs 114A to 114C and the light sensor 110. collectively and when present at a single location on an electronics assembly, The battery 138 is shown on the face of the button 56. The battery 138 is connected to the lighting system 89 and electronics assembly. It is shown disposed on a portion of yellowtail.

[0084] The exemplary electronics assembly 120 is a flexible printed circuit board having multiple electronic components. The FPCB includes an electronics assembly that transmits a signal representative of the sensed relative rotation. one or more rotation sensors 86 in operative communication with the processor for receiving signals from the sensors; The electronics assembly includes a sensor system including at least one processing core and The electronics assembly further includes an MCU having an internal memory. A schematic example of the electronics assembly is shown in FIG. As shown.

[0085] 10A, 10B, 11A, and 11B, the north pole 154 and the south pole An exemplary magnetic sensor includes an annular ring-shaped dipole magnet 152 having a diameter of 156 as a sensed element. The sensor system 150 is shown. The magnets described herein are diametrically magnetized. The magnet 152 is attached to the flange 38 and is also called a ring. The magnet 152 may alternatively be attached to the dose dial 32. Or it may be attached to another member that is rotationally fixed to the dose setting member. The magnets may be constructed from a variety of materials, such as rare earth magnets, such as neodymium.

[0086] The sensor system 150 includes sensor electronics (not shown) contained within a module 82. It further includes a measurement sensor 158 that includes one or more sensing elements 160 operably connected thereto. The sensing element 160 of the sensor 158 is mounted on a printed circuit board 162 in FIG. 1, the circuit board 162 is shown attached to the module 82. The module 82 is rotationally secured to the dose button 56. As a result, during dose delivery, the magnet The magnet 152 rotates relative to the sensing element 160. The sensing element 160 detects the relative angular position of the magnet 152. The sensing element 160 is operable to detect the position of the ring 152 when the ring 152 is a metal ring. When used in conjunction with a sensor, the sensor may include an inductive, capacitive, or other non-contact sensor. Thus, the magnetic sensor system 150 detects the full rotation of the flange 38 relative to the dose button 56, and Thus, it operates to detect rotation relative to the housing 12 during dose delivery. , a magnetic sensor system 15 including a sensor 158 having a magnet 152 and a sensing element 160 0 may be disposed within the module.

[0087] In one embodiment, the magnetic sensor system 150 may be configured to generate a ring pattern as shown. The module 82 includes four detector elements 160 spaced at equal radiuses. Alternative numbers and locations of sensing elements may be used. For example, the alternative embodiment shown in FIG. In this embodiment, a single sensing element 160 is used. Furthermore, the sensing element 160 in FIG. Although shown as being centered within module 82, other locations may be used. In another embodiment shown in FIG. 1, for example, five sensing elements 906 are arranged equicircularly within the module. In the embodiment described above, the sensing elements 160 are modular. 82. Alternatively, the components may be mounted within the housing 1 during dose delivery. The sensing element 160 is rotationally fixed to the dose button 56 so as not to rotate relative to the dose button 56. It may be attached to any part of the element.

[0088] For purposes of illustration, magnet 152 may be considered as a single annular bipolar magnet attached to flange 38. However, alternative configurations and locations of magnets 152 are contemplated. For example, the magnet may have multiple poles, such as alternating north and south poles. In one embodiment, the magnet is , which includes a number of pole pairs equal to the number of distinct rotational dose setting positions of the flange 38. 2 may also include several separate magnet members. In addition, the magnet components are 2 or the dose dial member 32, which is rotationally fixed to the flange 38 during dose delivery. It can be attached to any part of the

[0089] Alternatively, the sensor system may be an inductive or capacitive sensor system. This type of sensor system can be used in conjunction with the magnetic ring attachment described herein. The sensor system utilizes a sensed element that includes a metal strip attached to a flange. Four, five, or more equiangularly spaced apart along the distal wall of the ball or pen housing. One or more sensing elements, such as six or more independent antennas or armatures These antennas may be spaced apart by 180 degrees or other angles. The tensor pairs are paired to provide a ratiometric measurement of the angular position of the metal rings proportional to the delivered dose. Provide a definition.

[0090] The metal band ring can detect one or more different rotational positions of the metal ring relative to the module. The metal band is shaped so that it can be rotated relative to the antenna. The antenna is operatively connected to the electronics assembly. , so that the antenna is in contact with the sensor, and therefore the housing of the pen 10, during dose delivery. 12. The metal band is attached to the outside of the flange. However, alternative configurations of metal bands may be used. For example, the metal band may include multiple different metal elements. In the form, the metal band has a number of elements equal to the number of distinct rotational dose setting positions of the flange. An alternative metal band, such as dial member 32, may be rotationally coupled to flange 38 during dose delivery. The metal band can be attached to any part of the fixed component. It may include a metal element attached to the rotating member at its exterior or may be incorporated into the component. by overmolding components with metal particles or with a metal strip. Therefore, it can be incorporated into such a component. The MCU determines the position of the metal ring with the sensor. The device is operable to:

[0091] The MCU samples 160 sensing elements at the maximum sampling rate according to standard quadrature differential signal calculations. The starting position of the magnet 152 is determined by averaging a number of (e.g., four) During dose delivery mode, the MCU is configured to detect the number of rotations of the magnet 152. At the end of dose delivery, the MCU The number of sensing elements 160 (e.g. 4) to determine the final position of the magnet 152. The MCU calculates the total rotation angle from the determined starting position, the number of rotations, and the final position. The MCU is operable to determine the total rotation angle in relation to the device design and the drug. The dosage schedule is calculated by dividing by a predetermined number related to the The step or unit number is operable to determine the number of steps or units.

[0092] With further reference to FIG. 12, FIG. 12 shows a diametrical FIG. 9 illustrates another example of a magnetic sensor system 900 that includes a uniformly magnetized ring 902 as a sensing element. The magnetized ring 902 is attached to a dose setting, e.g., a flange, as previously described. A magnetized ring 902 is attached to the member, e.g., a Hall effect sensor. The radial arrangement of the magnetic sensors 906 may be at equal angles to each other in a ring pattern. In one example, the magnetic sensor 906 is a ring 902 in which a portion of the magnetic sensor 906 is magnetized. 902 , and the remainder is outside the magnetized ring 902 . The outer circumferential edge 902A of the ring 902 is disposed radially in overlapping relationship with the outer circumferential edge 902A of the ring 902.

[0093] In some embodiments, the sensing system is coupled to the drug delivery device. FIG. 13 illustrates a block diagram of a system according to some embodiments. 1. An example for determining whether an apparatus is removably coupled to a drug injection device An exemplary computerized method 1300 is shown. The sensing system may include a plurality of sensing elements. For example, the sensing system may be arranged in a uniform circumferential direction and a uniform and a number of detector elements, such as four or five detector elements, spaced equally radially. As described herein, the plurality of sensing elements may include a plurality of Hall effect sensors. In some embodiments, five Hall effect sensors are provided to measure the drug delivery being detected. Equally spaced at 72 degrees around a circle with a diameter designed based on the magnetic components of the device For example, when a magnet rotates around its axis, the sensor detects the Z component of the magnetic field. A diameter of approximately 14 mm was used to show the envelope described by the maximum value of The sensing system may also include a processor (e.g., a processor for CU).

[0094] The sensing system (through its processor, such as the MCU) 13. The method of claim 13, further comprising: In step 1302, the sensing system receives a voltage measurement from each of a plurality of sensing elements. In step 1304, the detection system detects the magnetic field of the drug injection device. In step 1306, the sensing system determines two-dimensional data representative of the magnetic field of the air component. The system determines the one-dimensional data based on the two-dimensional data. The detection system determines, based on the one-dimensional data, that a set of voltage measurements is Determine if it represents a bound device.

[0095] Referring to step 1302, a power button to the detection system is pressed by a user. When this happens, the detection system is activated and firmware running on the processor: A sensing element (e.g., a magnetic sensor) is provided to detect the starting position of the magnetic component of the drug delivery device. ) is switched on (e.g. before rotation occurs). During this phase, measurements are taken during rotation. It is important to take sensor readings immediately after power-up to avoid taking too many measurements. In some embodiments, the sensing system may, for example, sample each sensor to reduce noise. A number of samples (e.g., 5, 10, 15, etc. from each sensor) can be averaged.

[0096] Referring to step 1304, in some embodiments, the detection system includes an in-phase (I The system determines a quadrature signal that includes a quadrature (Q) portion and a quadrature (Q) portion. In some embodiments, the sensing system may determine I and Q values ​​based on the For example, the system uses a coefficient when summing the sensor values. In some embodiments, the detection system determines the I value by storing the coefficients. One coefficient for each sensor that the sensor value is multiplied by during the summation to determine the value Stores a second coefficient for each sensor by which the sensor value is multiplied during the summation to obtain the In one embodiment, the coefficients are used to calculate I and Q using multiple sensors (e.g., You can combine the results of a single sensor (e.g., five sensors spaced equally at 72 degrees from each other). In some embodiments, the coefficients are determined by the fact that the result of the quadrature calculation is a function of the offset of the measured signal. compared to the nominal angle in the presence of distortion, second harmonic distortion, third harmonic distortion and / or the like. can be obtained by solving the simultaneous equations do.

[0097] Referring to step 1306, in some embodiments, the detection system includes steps Determine a scale factor based on the two-dimensional signal (e.g., the orthogonal signal) determined in 1304. In some embodiments, the detection system detects the quadrature signals and the predetermined offset and and a predetermined gain. The processor can determine the scale factor based on the following Equation 12:

number

[0098] When I and Q are balanced, such as when the offset is equal to zero and the gain is equal to one, Since quadrature works well when A calibration process can be used to calibrate the measured I and Q baluns. to achieve sufficient values, to eliminate the skew between I and Q, etc. In some embodiments, the detection system may determine the offset / gain. , normalize the I and Q values, and use the I and Q values ​​to calculate the normalized angle of the Z component of the magnetic field. After the dose is administered, the detection system can then be configured to determine: Monitoring the end position of the magnetic component of the drug delivery device to determine the amount of the injected dose. (e.g., using techniques similar to those described herein to monitor magnet rotation. using the technique and / or determining the end position of the magnet).

[0099] Referring to step 1308, the detection system detects whether the one-dimensional data is a drug. Whether or not it is shown coupled to a delivery device The detection system can use the scale factor to determine whether the detection system It is possible to determine whether the drug is attached or coupled to a drug delivery device. For example, if the scale factor is between certain thresholds, the detection system It can be determined that the stem is attached to the drug delivery device. If the detector is not between the predetermined thresholds, the detection system detects the drug delivery device. In some embodiments, it may be determined that the device is not likely to be attached. The detection system checks the scale factor for low and high amplitude margins. Check the magnet status to determine if the magnet the module is monitoring is the expected magnet. (e.g., about + / - 25% of the nominal value is acceptable), which allows the required Only the width is accepted by the module.

[0100] The dose detection system uses the specific design of the drug delivery device, e.g., a pen-type injector. However, exemplary dose detection systems may also be used as described herein. and for use with alternative drug delivery devices and with other sensing configurations operable in the manner of For example, any one or more of a variety of sensing and switching systems may be used. may be omitted from the rules.

[0101] The various methods or processes outlined herein may be implemented in a variety of operating systems. or platforms. Moreover, such software may be coded as a number of A suitable programming language and / or programming or scripting tool It can be written using either the IDE or the IDE itself, and can run on a virtual machine or any suitable framework. It may be compiled into executable machine code or intermediate code that is executed.

[0102] In this regard, various inventive concepts may be implemented using one or more computers or other processors. One or more programmatically encoded small objects that, when implemented, implement various embodiments of the present invention. At least one non-transitory computer-readable storage medium (e.g., computer memory, The above floppy disks, compact disks, optical disks, magnetic tapes, flash in memory, field programmable gate arrays or other semiconductor devices A non-transitory computer-readable medium or media may be embodied in the non-transitory computer-readable medium or media. The body may be mobile so that the program(s) stored therein may be Any computer resources for implementing the various aspects of the present invention as discussed. It can be loaded.

[0103] The terms "program," "software," and / or "application" is used herein in a general sense and applies to various embodiments as discussed above. The present invention may be adapted to program a computer or other processor to implement various aspects. Any type of computer code or set of computer executable instructions used in Further, according to one embodiment, there is provided one or more components which, when executed, perform the method of the present invention. A computer program need not reside on a single computer or processor, To implement various aspects of the present invention, modules may be used between different computers or processors. It should be understood that the present invention may be distributed in a software or software package.

[0104] Computer-executable instructions may be implemented by one or more computer programs, such as program modules. The program modules may take many forms, each of which may be executed by a computer or other device. A tool contains routines that perform a particular task or implement a particular abstract data type. , programs, objects, components, data structures, etc. Typically, The functions of the program modules may be combined as desired in various embodiments. or distributed.

[0105] Also, the data structures may be stored in any suitable form on a non-transitory computer-readable storage medium. A data structure may have fields that are related by their location within the data structure. Such relationships may also include non-transient relationships that convey relationships between fields. By allocating storage to a field having a location in a computer readable medium However, any suitable mechanism can be used to associate the data elements including through the use of pointers, tags, or other mechanisms that establish relationships between Relationships can be established between information in fields of a data structure.

[0106] Various inventive concepts can be embodied in one or more methods, examples of which are provided. The actions performed as part of the methods may be ordered in any suitable way. Thus, although shown in the exemplary embodiment as sequential operations, some operations may be performed simultaneously. Embodiments may be implemented in which operations are performed in a different order than illustrated, including performing It can be built.

[0107] As used herein in the specification and claims, the indefinite articles "a" and " "an" shall be understood to mean "at least one" unless expressly indicated to the contrary. As used herein in the specification and claims, one or more The phrase "at least one" in relation to a list of elements of means at least one selected from any one or more of the elements in the list of elements. It should be understood that each and every element specifically listed within the list of elements is included. It does not have to contain at least one of all the elements, but any combination of elements in the list of elements. This does not exclude the list of elements to which the phrase "at least one" refers. Any elements other than those specifically identified in the list shall have no bearing on those elements specifically identified. It may be optionally present, whether or not it is related to the

[0108] As used herein in the specification and claims, "and / or" refers to The phrase "d / or" refers to the elements so combined, i.e., in some cases, conjunctively "either or both" of elements that are otherwise disjunctively present "and / or" should be understood to mean "or both." Multiple elements listed must be interpreted in the same way, i.e. "one or more" of the specified elements. Therefore, other elements than those specifically identified shall not be construed as being related to those elements specifically identified. These may be present optionally, whether or not they are associated with each other. Thus, as non-limiting examples, Therefore, references to "A and / or B" are not intended to be limiting unless expressly stated in the specification or elsewhere in this document. When used in combination with a language without A, in one embodiment, A alone (optionally with B or more) In another embodiment, only B (optionally including elements other than A) is mentioned. In yet another embodiment, both A and B (optionally including other The term may refer to a particular aspect of a technology (including elements thereof).

[0109] As used in this specification and claims, "or" means any of the elements defined above. and / or." For example, items in a list When separating terms, "or" or "and / or" shall be construed as inclusive. That is, at least one but not two of the elements or lists of elements and, optionally, additional unlisted items. "Only one of" or "One of" shall be interpreted as "one of" or "one of". "exactly one of," or as used in the claims. If the term is "consisting of," a clearly indicated term to the contrary will be used. Only contains exactly one element of a set of elements or a list of elements. Additionally, as used herein, the term "or" means "either ", "one of", "only one of", or "exactly one of" When followed by an exclusive term such as "one of," it means an exclusive choice (i.e., "one or the other"). "one or the other but not both." "Consisting essentially of" should be interpreted as meaning "consisting essentially of" "essentially of" is used in patent law when used in the claims. "contract" has the ordinary meaning ascribed to it.

[0110] In the claims, the use of prefixes such as "first," "second," and "third" to modify claim elements The use of numerical terms does not, in and of itself, imply any priority, precedence, or order of any claim element. The order or timing (the order in which method actions are performed) relative to other claim elements Such terms do not imply a chronological order or a specific order to a particular named claim element. is used only as a label to distinguish it from other elements of the same name (except , through the use of ordinal terminology).

[0111] The phraseology and terminology used herein is for the purpose of description and not of limitation. "Including," "comprising" "having," "containing," "in The use of "Volving" and variations thereof is subject to the terms and conditions set forth therein and in the appended claims. This means that additional items are included.

[0112] Although several embodiments of the present invention have been described in detail, those skilled in the art will recognize various modifications and variations. Modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are within the spirit and scope of the present invention. Accordingly, the foregoing description is by way of example only and is not intended to be limiting. It is not intended to

Claims

1. 1. An apparatus configured to determine illumination data indicative of a color of an object, the apparatus comprising: a set of light emitting diodes (LEDs) in optical communication with the object; an optical sensor in optical communication with the object; 1. A processor configured to execute computer readable instructions, the instructions comprising: The processor, While the object is illuminated by a set of LEDs, the light sensor detects the illumination of the object. Capturing data; processing the illumination data to generate processed illumination data, adjusting the illumination data based on a temperature associated with the object; normalizing the set of illumination data based on a set of normalization parameters; and processing the sample, the processing comprising one or more of: A communication module in communication with the processor is used to remotely process the processed lighting data. and a processor configured to cause the device to:

2. The apparatus of claim 1 , wherein the light sensor is an ambient light sensor.

3. The object may be used to identify an aspect of a drug delivery device based on the color of the object.

3. The device according to claim 1 or 2, which is part of the drug delivery device that can be used in Place.

4. (a) between the set of LEDs, the light sensor, or both, and (b) the object. The apparatus of any one of claims 1 to 3, further comprising a light guide disposed on the

5. While the object is illuminated by the set of LEDs, the light sensor detects the object. The capturing of illumination data includes causing the light sensor to: a first illumination data when the object is not illuminated by the set of LEDs; A second illumination data when the object is illuminated by each LED of the set of LEDs. The apparatus according to any one of claims 1 to 4, further comprising:

6. the set of LEDs includes a red LED, a blue LED, and a green LED; causing the light sensor to capture the second illumination data; The light sensor detects: (a) a first light emitted from the object when the object is illuminated by the red LED; (b) the illumination data of the third object when the object is illuminated by the green LED; (c) the illumination data of the fourth image when the object is illuminated by the green LED; 6. The apparatus of claim 5, further comprising: causing a camera to capture five illumination data points.

7. 1. A method for determining illumination data indicative of a color of an object, comprising: an apparatus in optical communication with the object; a set of light emitting diodes (LEDs) for detecting a position of the object; and a light sensor in optical communication with the object; While the object is illuminated by the set of LEDs, the light sensor detects the Capturing lighting data; and processing the illumination data to generate processed illumination data, adjusting the illumination data based on a temperature associated with the object; normalizing the set of illumination data based on a set of normalization parameters; and processing the sample, the processing comprising one or more of: A communication module in communication with the processor is used to remotely process the processed lighting data. and causing the host device to transmit the

8. While the object is illuminated by the set of LEDs, the light sensor detects the object. The capturing of illumination data includes causing the light sensor to: a first illumination data when the object is not illuminated by the set of LEDs; A second illumination data when the object is illuminated by each LED of the set of LEDs. and capturing the data.

9. the set of LEDs includes a red LED, a blue LED, and a green LED; causing the light sensor to capture the second illumination data; The light sensor detects: (a) a first light emitted from the object when the object is illuminated by the red LED; (b) the illumination data of the third object when the object is illuminated by the green LED; (c) the illumination data of the fourth image when the object is illuminated by the green LED; 9. The method of claim 8, further comprising: capturing five illumination data points.

10. The light sensor is an ambient light sensor, and the object is detected by a drug delivery system based on the color of the object. A portion of the drug delivery device that can be used to identify an aspect of the drug delivery device. a light guide including: (a) the set of LEDs, the light sensor, or both; and (b) 10. The method according to claim 7, wherein the object is disposed between the object and the sensor.

11. 1. An apparatus configured to process illumination data to determine a color associated with the illumination data. the apparatus comprising a processor configured to execute computer readable instructions. The instructions further include: Based on the captured illumination data of the object under the illumination of the set of LEDs, an illumination metric is calculated. Generate a set of blocks, The set of illumination metrics is compared to a set of stored representative illumination metrics. and comparing the representative illumination metrics, each of the set of representative illumination metrics being a representative illumination metric. The tricks are compared to determine the closest matching set of colors. To do so, The lighting data is then calculated based on a closest matching set of representative lighting metrics. The representative lighting metric is associated with the color associated with the set of representative lighting metrics. A device for determining whether or not a person has a medical condition.

12. The computer readable instructions are then transmitted to the processor. The apparatus of claim 11 , further comprising: a module for receiving the lighting data.

13. Generating the set of illumination metrics includes a brightness metric, a red / green metric, generating a color metric, and a yellow / blue metric; Each of the stored set of representative lighting metrics has an associated lightness metric.

13. The method of claim 11 or 12, further comprising: The apparatus described in

14. comparing said set of illumination metrics to said set of representative illumination metrics; 、 A system of the set of illumination metrics for each of the set of representative illumination metrics. determining a set of sigma distances, including determining a sigma distance; Based on the smallest sigma distance and the second smallest sigma distance in the set of sigma distances, determining that the smallest sigma distance is the closest matching sigma distance.

14. An apparatus according to any one of claims 11 to 13.

15. receiving a new set of representative lighting metrics; updating the set of stored representative metrics to the representative illumination metrics; and including a new set of blocks in the device according to any one of claims 11 to 14. Place.

16. 1. A method for processing illumination data to determine a color associated with said illumination data, comprising: The method further comprising: Based on the captured illumination data of the object under the illumination of the set of LEDs, an illumination metric is calculated. generating a set of blocks; The set of illumination metrics is compared to a set of stored representative illumination metrics. and comparing each of the set of representative illumination metrics. The color associated with the image is used to determine the closest matching set of images. and, Based on a closest matching set of the representative lighting metrics, The data is associated with the colors associated with the set of representative lighting metrics. and determining that the

17. receiving the lighting data from a communication module in communication with a processor. The method of claim 16 .

18. Generating the set of illumination metrics includes a brightness metric, a red / green metric, generating a color metric, and a yellow / blue metric; Each of the stored set of representative lighting metrics has an associated lightness metric.

17. The method according to claim 16, further comprising: The method described above.

19. comparing said set of illumination metrics to said set of representative illumination metrics; 、 A system of the set of illumination metrics for each of the set of representative illumination metrics. determining a set of sigma distances, including determining a sigma distance; Based on the smallest sigma distance and the second smallest sigma distance in the set of sigma distances, determining that the smallest sigma distance is the closest matching sigma distance. The method according to any one of claims 16 to 18.

20. receiving a new set of representative lighting metrics; updating the set of stored representative metrics to the representative illumination metrics; and including a new set of blocks according to any one of claims 16 to 19. Law.

21. 1. An apparatus configured to determine a battery indicator indicative of a remaining battery life, comprising: The device, Batteries and A temperature sensing module; a processor in communication with the battery and the temperature sensing module, the processor a processor configured to execute computer readable instructions, the instructions To the processor, obtaining a set of voltage measurements of the battery; obtaining a temperature measurement via the temperature sensing module; determining a set of temperature adjusted battery indications based on the temperature measurements; 、 based on the temperature conditioned battery indication and the set of voltage measurements. and a processor for determining a battery indicator indicative of a remaining life of the battery. 。

22. causing said set of voltage measurements to be obtained, obtaining a start-up battery voltage when the device is powered on; obtaining a high current battery voltage when said processor is operating at maximum speed; obtaining a low current battery voltage when the processor is operating in a low power mode; 22. The apparatus of claim 21 , comprising:

23. determining a set of temperature conditioned battery indications based on the temperature measurements; To be able to, A set of low temperature battery indications, each low temperature battery indication indicating a low temperature battery A set of low temperature battery indications, including indications and associated voltages for low temperatures. To, A set of hot battery indications, each hot battery indication indicating a hot battery A set of high temperature battery indications, including indications and associated voltages for high temperatures. storing the the set of low temperature battery indications, the set of high temperature battery indications, and and determining the set of temperature conditioned battery indications based on the temperature measurements. and a.

24. Determining the battery indicator indicative of remaining life of the battery obtaining a previous battery indicator for the battery; based on the temperature conditioned battery indication and the set of voltage measurements. determining a current battery indicator for the battery; The battery indicator is determined based on the previous battery indicator and the current battery indicator. and determining an indicator.

25. 21 to 25, further comprising transmitting the battery indicator to a remote device.

24. The apparatus according to any one of claims 23.

26. 1. A method for determining a battery indicator indicative of remaining battery life, comprising: a temperature sensing module; a processor in communication with the battery and the temperature sensing module; The method further comprises: obtaining a set of voltage measurements for the battery; obtaining a temperature measurement via the temperature sensing module; determining a set of temperature adjusted battery indications based on the temperature measurements; And, based on the temperature conditioned battery indication and the set of voltage measurements. and determining a battery indicator indicative of a remaining life of the battery.

27. obtaining the set of voltage measurements; obtaining a start-up battery voltage when the device is powered on; obtaining a high current battery voltage when said processor is operating at maximum speed; obtaining a low current battery voltage when the processor is operating in a low power mode; 27. The method of claim 26, comprising:

28. determining a set of temperature conditioned battery indications based on the temperature measurements; To be able to, A set of low temperature battery indications, each low temperature battery indication indicating a low temperature battery A set of low temperature battery indications, including indications and associated voltages for low temperatures. To, A set of hot battery indications, each hot battery indication indicating a hot battery A set of high temperature battery indications, including indications and associated voltages for high temperatures. storing the the set of low temperature battery indications, the set of high temperature battery indications, and and determining the set of temperature conditioned battery indications based on the temperature measurements.

28. The method of claim 26 or 27, comprising:

29. Determining the battery indicator indicative of remaining life of the battery obtaining a previous battery indicator for the battery; based on the temperature conditioned battery indication and the set of voltage measurements. determining a current battery indicator for the battery; The battery indicator is determined based on the previous battery indicator and the current battery indicator. and determining an indicator.

30. 26 - 28, further comprising transmitting the battery indicator to a remote device.

30. The method of any one of claims 29 to 30.

31. A device, whether said device is removably coupled to a drug injection device.

11. An apparatus configured to determine A plurality of sensing elements; a processor in communication with the set of sensing elements, the processor comprising: and configured to execute computer-readable instructions that cause the processor to: obtaining a set of voltage measurements from each of the plurality of sensing elements; determining two-dimensional data representative of a magnetic field of a magnetic component of the drug injection device; determining one-dimensional data based on the two-dimensional data; Based on the one-dimensional data, the set of voltage measurements is coupled to the drug injection device. and a processor for determining whether the device is indicative of an associated device. Place.

32. Determining the two-dimensional data includes determining a quadrature signal including an in-phase portion and a quadrature portion. The apparatus of claim 31 , further comprising:

33. Determining the one-dimensional data includes determining a scale factor based on the quadrature signal. The apparatus of claim 32, further comprising:

34. Determining the scale factor includes determining the quadrature signal, a predetermined offset, and determining the scale factor based on one or more of the predetermined gains; 34. The apparatus of claim 33.

35. The plurality of sensing elements are spaced equally circumferentially and radially within the device.

35. Apparatus according to any one of claims 31 to 34, comprising five sensing elements arranged in a matrix.

36. 36. Any of claims 31 to 35, wherein the plurality of sensing elements comprises a plurality of Hall effect sensors.

13. The apparatus described in claim 1.

37. Method for determining whether an apparatus is removably coupled to a drug injection device - Patent Application 20070229333 The method includes the apparatus comprising: a plurality of sensing elements; and a processor in communication with the set of sensing elements. and a gas supplying means for supplying the gas to the gas supplying means, obtaining a set of voltage measurements from each of the plurality of sensing elements; determining two-dimensional data representative of a magnetic field of a magnetic component of the drug injection device; determining one-dimensional data based on the two-dimensional data; Based on the one-dimensional data, the set of voltage measurements is coupled to the drug injection device. and determining whether the device is indicative of a mated device.

38. Determining the two-dimensional data includes determining a quadrature signal including an in-phase portion and a quadrature portion.

40. The method of claim 37, comprising:

39. Determining the one-dimensional data includes determining a scale factor based on the quadrature signals.

40. The method of claim 38, comprising:

40. Determining the scale factor includes determining a scale factor for the quadrature signal and a predetermined offset and a predetermined determining the scale factor based on one or more of the constant gains; 40. The method of claim 39.

41. The plurality of sensing elements are spaced equally circumferentially and radially within the device.

41. The method of any one of claims 37 to 40, comprising five sensing elements arranged in a matrix.

42. The method of claim 41 , wherein the plurality of sensing elements comprises a plurality of Hall effect sensors.

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