Methods and apparatus for aspects of a dosage detection system

Abstract

The technology described herein relates to computerized methods and apparatus for at least one of determining whether a dose detection module is attached to a drug delivery device, e.g., using a dose detection sensor, detecting the color of a portion of the drug delivery device to determine the drug contained in the drug delivery device, e.g., using an LED and a light sensor for different temperature conditions, and monitoring the battery life of a battery in the dose detection module, e.g., using current / voltage detection for different temperature conditions, etc. At least a portion of the information obtained from these techniques can be communicated to a paired remote electronic device, such as a user's smartphone.

Description

Technical Field

[0001] The present disclosure relates to a technology for an electronic dosage detection system for a drug delivery device, and more particularly to a technology for detecting a connection to a drug delivery device, determining the type of the drug delivery device, and monitoring the battery life.

Background Art

[0002] Patients suffering from various diseases often have to inject themselves with drugs. To enable humans to conveniently and accurately self-administer drugs, various devices widely known as pen-type syringes or injection pens have been developed. Generally, these pens contain a piston and are loaded with a cartridge containing a plurality of doses of liquid drug. The drive member is movable forward to advance the piston in the cartridge and dispense the contained drug from the outlet at the distal end of the cartridge, typically through a needle. In disposable or pre-filled pens, after the pen has been used up the supply of drug in the cartridge, the user discards the entire pen and begins using a new replacement pen. In reusable pens, after the pen has been used up the supply of drug in the cartridge, the pen can be disassembled to replace the used cartridge with a new cartridge, and then the pen is reassembled for subsequent use.

[0003] Many pen-type syringes and other drug delivery devices utilize a mechanical system in which members rotate and / or translate relative to each other in a manner proportional to the dose delivered by the operation of the device. Thus, in the art, efforts have been made to provide a reliable system for accurately measuring the relative movement of the members of a drug delivery device in order to evaluate the dose delivered. Such a system may include a sensor fixed to a first member of the drug delivery device and detecting the relative movement of a detected component fixed to a second member of the device.

[0004] The administration of an appropriate amount of a drug requires that the dosage delivered by a drug delivery device be accurate. Many pen-type syringes and other drug delivery devices do not include a feature for automatically detecting and recording the amount of drug delivered by the device during an injection event. In the absence of an automated system, the patient must manually track the amount and time of each injection. Accordingly, there is a need for a device operable to automatically detect the dosage delivered by a drug delivery device during an injection event. Further, such a dosage detection device should be removable and reusable with multiple delivery devices. In other embodiments, such a dosage detection device should be integrated with the delivery device.

[0005] It is also important to deliver the correct drug. A patient may need to select either a different drug or a different form of a given drug, depending on the situation. Mistaking which drug is in a drug delivery device can result in the patient not being properly dosed and the recording of the dosage administration being inaccurate. The likelihood of this occurring is significantly reduced when a dosage detection device that automatically identifies the type of drug contained in the drug delivery device is used. SUMMARY OF THE INVENTION

[0006] The present disclosure relates to techniques for a dosage detection module that can be removably attached to a drug delivery device. The techniques can include determining whether the dosage detection module is attached to the drug delivery device. Such techniques can ensure, for example, that the dosage detection module only detects, processes, and / or reports events detected when attached to the drug delivery device (as opposed to spurious activations when the dosage detection module is not coupled to the drug delivery device), and can be used to determine when the dosage detection module is changed to a new drug delivery device. The techniques can also include detecting the color of a portion of the drug delivery device to determine the drug contained in the drug delivery device. Such techniques can ensure, for example, that the patient is administering the correct drug and can avoid mistakes about which drug is in the drug delivery device. The techniques can further include monitoring the battery life of a battery within the dosage detection module. Such techniques enable the user or patient to monitor the battery life in a reliable manner, such that, for example, the user or patient can know well in advance when the battery will run out, allowing the user or patient to plan appropriately ahead of time. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Further embodiments of the present disclosure, as well as their features and advantages, will become more apparent by reference to the description herein in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. Further, in the drawings, like reference numerals designate corresponding parts throughout the different views.

[0008]

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DETAILED DESCRIPTION OF THE INVENTION

[0009] To facilitate understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and this will be described using specific language. However, it will be understood that this is not intended to limit the scope of the present invention.

[0010] The present disclosure relates to a detection system for a drug delivery device. In one aspect, the detection system is for determining whether the detection system is attached to a drug delivery device. The inventors have discovered and recognized that it may be desirable to removably couple a dosage detection system to a drug delivery device. However, the inventors have also discovered and recognized a desire to limit the dosage detection system to small, easy-to-use components with a low likelihood of failure due to repeated use, considering the various hardware, firmware, and / or software that would be desirable to include in such a dosage detection system. However, it can also be difficult to incorporate additional components (e.g., switches, latches, etc.) to detect that the dosage detection system is connected to the drug delivery device. The techniques described herein utilize existing components of the dosage detection device to provide a determination as to whether the dosage detection device is coupled to a drug delivery device. For example, the dosage detection device includes a sensor (such as a Hall effect sensor) and associated hardware and / or software and can determine the size of the dosage administered by the drug delivery device. This technique can also utilize such hardware and / or software used to perform dosage detection to determine whether the dosage detection system is coupled to the drug delivery device.

[0011] In a second aspect, the detection system is for determining the type of drug contained within a drug delivery device. As described herein, the inventors have discovered and recognized that there can be problems in being unable to determine the drug within a drug delivery device. For example, there is a possibility that an incorrect drug may be administered to a patient, which can lead to inappropriate dosing of the patient and inaccurate dosing records. The techniques described herein provide for detecting the color of the components of the drug being administered by the drug delivery device, where the color indicates the type of drug. In some embodiments, the technique utilizes one or more light-emitting diodes and light sensors to illuminate the applicable coloring components and process the illumination data to match the color to a stored set of colors and associated drugs.

[0012] In a third aspect, the detection system is for monitoring the battery life of the detection system. The inventors have discovered and recognized that determining the remaining battery life of a battery is complicated by various factors such as temperature, relaxation time, usage period, load fluctuations, battery brand, battery variations, and other parameters. The inventors have developed a technique for monitoring the battery in a manner that incorporates other relevant data such as temperature based on the structure of the dose detection device. This technique can provide an estimate of the battery life that adjusts the measurement process in a specification that avoids errors that may be caused by existing battery measurement techniques.

[0013] As an example, the drug delivery device is described in the form of a pen-type syringe. However, the drug delivery device can be any device used to set and deliver a dose of a drug, such as an infusion pump, a bolus syringe, or an auto-injector device. The drug can be any of the types that can be delivered by such a drug delivery device.

[0014] Although various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and not the only possible embodiments and implementations. Further, the above advantages are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages will be achieved in each embodiment.

[0015] Devices described herein, such as device 10, can further include a drug, for example, within a reservoir or cartridge 20. In another embodiment, the system can include one or more devices including device 10 and a drug. The term "drug" refers to one or more therapeutic agents including, but not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent that can be delivered by the devices described above. Drugs as used in this device can be formulated with one or more excipients. The device is generally operated in the manner described above by a patient, caregiver, or healthcare professional for delivering a drug to a human.

[0016] Figure 1A is a diagram of an exemplary system 120 according to some embodiments. System 101 includes a detection system 103 that communicates with a remote computing device 104 via a communication unit 106 (e.g., via a wired and / or wireless connection). The communication unit 106 can be, for example, a WiFi transceiver, a Bluetooth transceiver, an RFID transceiver, a USB transceiver, a near field communication (NFC) transceiver, a combination chip, and the like.

[0017] As further described herein, the detection system 103 can be configured to determine illumination data indicative of the color of an object. The detection system 103 includes a processing unit 108 (e.g., an MCU) that communicates with an optical sensor 110 and a control unit 112. The optical sensor 110 is in optical communication with an object 116 (e.g., a part of a drug delivery device). In some embodiments, the optical sensor 110 is, for example, an ambient light sensor (ALS) operating in reflection mode. The LED driver 112 communicates with a set of light emitting diodes (LEDs) 114A, 114B, and 114C (collectively referred to as LEDs 114) in optical communication with the object 116. For example, the LEDs 114 can include red LEDs, blue LEDs, and / or green LEDs. The optical sensor 110, the LEDs 114, or both are optionally in optical communication with the object 116 via an optional optical waveguide 118. The optical waveguide 118 can be a transparent optical waveguide such as Makrolon 2458 LightGuide. In some embodiments, the color sensor is made up of separate LEDs, an RGB LED in a single package, or a combination thereof.

[0018] FIG. 1B shows a detailed example of an electronic device assembly of a detection module, referred to as 1400, which can be included in any of the modules described herein. The MCU is programmed to implement the electronic functions of the module. The MCU includes control logic operable to perform the operations described herein, including detecting a connection to a drug delivery device, determining the type of drug delivery device, obtaining data used to determine the dosage delivered by the drug delivery device, and monitoring the battery life of the drug delivery device. The MCU can be operable to obtain data by detecting and / or determining the amount of rotation of a rotary sensor fixed to a flange, the amount of rotation being determined by detecting the magnetic field of the rotary sensor by a sensing element of a measurement sensor of the system, such as a Hall effect sensor.

[0019] Assembly 1400 includes an MCU that can be operably coupled to one or more of dosing sensors 1402A - E, memory 1408, identification sensor 1404, counter 1414, light drive unit 1411 and light indicator 1412, power - on module 1406, communication module 1410, display unit drive unit / display unit 1416, power supply 1418, and presence module 1420. Assembly 1400 can include any number of dosing sensors, such as, for example, five magnetic sensors 1402A - E (shown) or six sensors. The dosing sensors can be used to determine the total number of units of rotation of components within a drug delivery device that can be used to determine the amount of the administered dose (as further discussed herein in conjunction with FIGS. 5 - 12), and are used to detect a connection to the drug delivery device. The MCU can be configured via presence module 1420, shown as optional in dashed lines in this embodiment, to determine whether a module is coupled to a button of the device via a trigger of a presence switch system. The MCU is configured to determine the color of the dosing button via identification sensor 1404 and, in some examples, associate color data determined on - board or off - board at an external device (e.g., remote computing device 104) with the color corresponding to a particular drug (e.g., using LED 114 as further discussed herein). The MCU is configured to determine a trigger of a wake - up switch to power on the electronic device assembly for use, shown as power - on module 1406. In one example, the total rotation can communicate with an external device including memory having a database, look - up table, or other data stored therein to correlate the total number of rotation units to the amount of drug delivered for a given drug specified. In another example, the MCU can be configured to determine the amount of drug delivered. The MCU can be operable to store the detected dose in local memory 1408 (e.g., internal flash memory or on - board EEPROM).The MCU is further operable to wirelessly transmit signals representing device data, such as, for example, a rotation unit (any one or any combination thereof), drug identification (such as color) data, a timestamp, time since last administration, battery charge state, module identification number, module attachment / detachment time, inactive time, and / or other errors (such as dose detection and / or transmission errors, drug identification detection and / or transmission errors, etc.), to a Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocol module 1410, such as to a paired remote electronic device like a Near Field Communication (NFC), WiFi, or the user's smartphone on a cellular network. Exemplarily, the BLE control logic and the MCU are integrated on the same circuit. In one example, any of the modules described herein may include a display module 1420, shown as optional in this embodiment by a dashed line, for indication of information to the user. Such a display may be an LED, LCD, or other digital or analog display, and may be integrated with the finger pad of the proximal portion. The MCU includes a display driver software module and control logic operable to receive and process the sensed data and display information, such as, for example, dose setting, dispensed dose, injection status, injection completion, date and / or time, or time until next injection, on the display. In another example, the MCU is coupled to an LED driver 1411 for one or more LEDs 1412, such as RGB LEDs, orange LEDs, and green LEDs, used to communicate with the patient by on / off sequences and different colors for, for example, whether data was successfully transmitted, whether the battery charge is high or low, or other clinical communications. A counter 1414 is shown as a real-time clock (RTC) electronically coupled to the MCU to track time, such as administration time. The counter 1414 may also be a time counter that tracks seconds from zero based on power-on. The time or count value can be communicated to an external device.

[0020] In some embodiments, as further discussed in connection with FIGS. 8 - 12, the sensing system 103 is configured to be connected to a drug delivery device. In some embodiments, the object 116 can be part of a drug delivery device (e.g., a button, label, color of an external compartment, etc.) that can be used to identify an aspect of the drug delivery device based on the color of the object 116. For example, the color of the object 116 can indicate the type of drug of the drug delivery device.

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

[0022] The exemplary aspects of the dosage detection system described in connection with FIGS. 1A - 1C are shown for exemplary purposes to highlight various aspects of the dosage detection system. The aspects shown in FIGS. 1A - 1C can be combined in a single device such as the dosage delivery detection system 80 described in connection with FIGS. 8 - 12 and can be implemented using various exemplary configurations discussed in connection with those figures.

[0023] Referring to FIG. 1A, in some embodiments, the detection system 103 is configured to determine the color of an object (e.g., the button of a pen-type drug delivery device). In some embodiments, the detection system switches on the LEDs 114 in sequence and reads the reflected beam back through the broad-spectrum ambient light sensor 110 to determine the color of the object. The detection system 103 can generate various values, such as three values for each of the three LEDs 114. The detection system 103 can process the generated values to generate a final color value for matching. The detection system 103 can check the final color value against a predefined set of colors to determine if there is a match.

[0024] Figure 2 is a flowchart of an exemplary computerized method 200 for determining a color associated with an object according to some embodiments. A processor, such as the processing unit 108 of the detection system 103, can execute computer-readable instructions that cause the processor to execute method 200. In step 202, the detection system obtains illumination data of an object illuminated by a set of LEDs. Optionally, the detection system can process the illumination data in steps 204 and / or 206 to generate processed illumination data. In step 204, the detection system optionally adjusts the illumination data based on temperature. In step 206, the detection system optionally normalizes the illumination data. In step 208, while the object is illuminated by the set of LEDs, the detection system causes the light sensor to capture the illumination data of the object. In step 208, the detection system transmits the processed illumination data to a remote device (e.g., via a communication module that communicates with the processor of the device). In step 210, the remote device determines whether the illumination metric matches a set of stored colors. If the remote device determines a match, in step 212, the remote device outputs the matched color (e.g., to a program, display, etc.). If the remote device does not determine a match, in step 214, the remote device outputs that no color match was found (e.g., by returning an error code, a non-matching code, etc.).

[0025] Referring to step 202, the detection system can be configured to capture first illumination data when the object is not illuminated by the set of LEDs, second illumination data when the object is illuminated by each LED of the set of LEDs, or both. For example, the device can be configured to capture the illumination data of the object when the object is illuminated only by ambient light when the LEDs are off. In some embodiments, the detection system can include an exposure time for capturing dark illumination data.

[0026] As another example, if a set of LEDs includes LEDs of different colors, the apparatus can be configured to capture illumination data of an object when the object is illuminated by each LED. For example, as shown in FIG. 1A, in some embodiments, the apparatus includes a red LED 114A, a blue LED 114B, and a green LED 114C. The apparatus can be configured to adjust the light sensor 110 and the LED driver 112 to illuminate the LEDs 114 and to adjust to capture illumination data, whereby the light sensor 110 captures illumination data when the object is illuminated by the red LED 114A (and not by other LEDs), illumination data when the object is illuminated by the blue LED 114B, and illumination data when the object is illuminated by the green LED 114C. In some embodiments, the detection system can be configured to use exposure times that are the same for each LED and / or can be different for one or more LEDs during capturing of the illumination data.

[0027] Referring to step 204, the illumination data can be adjusted based on temperature. In some embodiments, the temperature is obtained from the ambient air, the detection system, and / or the drug delivery device. In some embodiments, the detection system can capture a plurality of temperature measurements, average the values to make a determination, and use the averaged temperature to adjust the illumination data. In some embodiments, the detection system can adjust each illumination data value (X) using Equation 1. rgbTempX = rgbX * (1 - TempCoefficientX * (Temp - CalTemp)) (Equation 1) Wherein, · rgbTempX is an adjusted illumination data value determined for each color, such as a red value, a green value, a blue value, etc., depending on the color for which Equation 1 is calculated. · rgbX is each original illumination data value, such as a red value, a green value, a blue value, etc. ·TempCoefficientX is the temperature coefficient of each value, and a single coefficient can be used to track various temperature measurement values (e.g., because performance drift may occur at different temperature measurement values). ·CalTemp is the temperature measured during calibration of the detection system and can be used to account for temperature changes (e.g., in the case of uncalibrated measurements). ·Temp is the measured (e.g., averaged) temperature.

[0028] Referring to step 206, the detection system can normalize (temperature-adjusted) illumination data based on dark illumination data captured without illumination of the LED. In some embodiments, the detection system can normalize the illumination data based on one or more illumination measurement values determined during calibration. For example, Equation 2 can be used to normalize each illumination data value (X).

Equation

[0029] Referring to step 210, the remote device can be configured to determine the lightness AB (LABc) value. The system can determine the LABc value based on any of the lighting values, whether the lighting data is raw lighting data or temperature-adjusted and / or normalized lighting data. For purposes of explanation, in the following examples, normalized lighting data is referred to for simplicity. The A value can be calculated according to the normalized lighting value. For example, depending on whether rgbNormRed determined using Equation 2 is greater than rgbNormGreen, the A value is determined using either Equation 3 or 4.

Number

Number

[0030] The B value can also be calculated according to the normalized lighting value. For example, depending on whether rgbNormBlue determined using Equation 2 is greater than rgbNormGreen, either Equation 5 or 6 is used to determine the B value. In the case of Equations 3-6, Kn is a coefficient used for the conversion from RGB to LABc, the A and B values range from -100 to 100, and the L value ranges from 0 to 100 (e.g., 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 can include a table of metrics used to determine whether lighting data meets a color. The remote device can include a set of colors (e.g., gray, blue, navy, red, and / or other colors) where each color has an associated set of data. The data associated with each color can include average data and / or sigma variation data determined during calibration and / or design of the system. In some embodiments, each color can include the average of the respective A, B, and L values, and the sigma variation values of the respective A, B, and L values. The remote device can determine the sigma distance between the lighting data and each color within the stored set of colors. For example, Equation 8 can be used to determine the sigma distance of each color within the set of colors.

Number

[0033] The remote device can determine whether the lighting data matches the color in the set of colors using the Sigma distance. For example, the remote device can select the minimum value as the most likely color from among the Sigma distance values (Min1). The second smallest value (Min2) can be used for checking the matching color, as will be further considered here.

[0034] The detection system and / or the remote device can be configured to perform one or more checks on the lighting data. For example, the dim lighting data can be checked to determine whether subsequent measurements under LED lighting are being interfered with by ambient light. As another example, the lighting data obtained for the LED can be checked to confirm that the lighting data is within the expected threshold between the minimum black value and the maximum white value. As a further example, the LABc values can be checked to determine whether they are within an acceptable range (e.g., -100 to 100 for A or B, 0 to 100 for L). As another example, a matching color check can be performed to confirm that Min1 and / or Min2 are within acceptable values. For example, Min1 can be checked to confirm that Min1 is below the maximum Sigma distance for the expected color match, and / or the ratio of Min2 / Min1 can be compared to the minimum ratio between the two smallest values of an acceptable match.

[0035] During calibration, the detection device can take various measurements that can be used to calibrate the real-time measurements of an object. The calibration measurements can include temperature and various light measurements such as measurements using a white target, a black target, and dark lighting with no LEDs turned on. FIG. 3 is a flowchart of an exemplary computerized method 300 for generating calibration parameters according to some embodiments. In step 302, the device measures the temperature. In step 304, the device captures the illumination data of a white target object (e.g., a white object). In step 306, the device captures the illumination data of a black target (e.g., a black object). In step 308, the device captures the illumination data of dark light with no LEDs turned on. In step 310, the device generates a set of calibration parameters. The calibration parameters can include dark measurements and / or exposure times (or maximum / minimum exposure times) used for each LED (e.g., red, green, and blue LEDs), the counts read during calibration for each LED for each of the white and / or black objects, temperature, temperature margin, and / or other calibration parameters.

[0036] As described herein, the dosage detection system includes a detection module having various components including, among other components, a processor / MCU, sensors, and LEDs. In some embodiments, the detection module can be powered by a battery. Referring to FIG. 1C, for example, the detection system 132 includes a battery 138 that powers the dosage detection system, including the exemplary components shown in FIG. 1C. The techniques described herein can be used to monitor the battery life of the dosage detection system. By monitoring the battery life, information such as a battery status indicator that tracks the life of the battery, warnings related to the battery (e.g., warning the user that the battery life is short, when to replace the battery, etc.) can be provided to the user. For example, the dosage detection system can warn the user that the battery is about to run out (e.g., 1 or 2 weeks before the battery life expires) so that sufficient time can be provided to the user to replace the battery, whether using the detection module or a remote computing device.

[0037] The inventors have discovered and recognized that estimating battery life by using battery voltage measurements can be complicated due to the fact that the behavior of the battery can depend on many variables such as temperature, relaxation time from measurement to measurement, duration of injection of the attached drug delivery device, load variations, battery brand, battery variations, and other parameters. To address such problems, which are often not controllable by the device provider, the inventors have developed techniques for monitoring the battery based on the device architecture in a manner that provides a sufficient margin for battery life to compensate for potential errors and variability that the inventors have recognized can occur during battery measurements.

[0038] Figure 4 is a flowchart of an exemplary computerized method 400 for determining battery indication according to some embodiments. A processor, such as the processing unit 140 of the apparatus 132 in FIG. 1B, can be configured to execute computer-readable instructions that cause the processor to execute method 400. In step 402, the apparatus obtains a set of battery voltage measurements. In step 404, the apparatus obtains temperature measurements (e.g., via a temperature sensing module). In step 406, the apparatus determines a set of temperature-adjusted battery indications based on the temperature measurements. In step 408, the apparatus determines a battery indicator indicating the remaining life of the battery based on the set of temperature-adjusted battery indications and the set of voltage measurements.

[0039] Referring to step 402, the apparatus (e.g., an MCU) can obtain various voltage measurements when the battery is under different loads and / or when the apparatus is in different operating states. In some embodiments, the apparatus obtains (a) the startup battery voltage when the apparatus is powered on, (b) the high-current battery voltage when the processor is operating at maximum speed, (c) the low-current battery voltage when the processor is operating in a low-power mode, or a combination thereof. The startup battery voltage can be determined, for example, by obtaining the high-current battery voltage from a power-on detection module within a certain time. For example, when the apparatus is started (e.g., after a button is pressed), the apparatus can increase the consumption from the battery. In some embodiments, when started, the apparatus can initiate a startup process. The startup process can increase the consumption from the battery, for example, for various self-tests, startup operations, etc. In some embodiments, when started, the apparatus can perform magnetic measurements (e.g., to determine the starting positions of one or more components). Thus, such a startup process and / or magnetic sensing can provide the high-current battery voltage for measurement as the startup battery voltage.

[0040] The high-current battery voltage can capture a high (e.g., maximum) current peak that can be used, for example, to measure the voltage drop at that point in time. The high-current battery voltage can be determined, for example, by running a microcontroller at maximum speed, running all other loads in low-power mode for a predetermined time (e.g., in milliseconds), and measuring the high-current battery voltage. In some embodiments, the high-current battery voltage is an average voltage calculated based on a set of measured values. In some embodiments, the high-current battery voltage can be calculated at the start and / or end of magnetic sensor activity. For example, the maximum voltage drop of the system can be obtained when the magnetic sensor has completed the measurement.

[0041] The low-current battery voltage can be used to measure the voltage drop at the minimum current load to simulate, for example, an open-circuit voltage check of the battery. The low-current battery voltage can be determined, for example, by putting all loads (e.g., including the MCU) in low-power mode for a predetermined time (e.g., a pause period specified in milliseconds) in the firmware running on the MCU, and then measuring the low-current battery voltage. In some embodiments, the low-current battery voltage is an average voltage calculated by averaging a set of measured values. In some embodiments, the low-current battery voltage is determined after determining the high-current battery voltage measurement value.

[0042] As described herein, one or more voltage measurements can be used at step 402. For example, in some embodiments, the voltage can be taken in a manner designed to obtain voltage readings at high and / or maximum current consumption (e.g., the point with the maximum voltage drop) and representative open circuit voltage measurements for low / minimum current consumption. As described herein, the voltage can be used to estimate the remaining energy of the battery. In some embodiments, the technique can estimate the remaining battery energy using, for example, a single voltage drop such as the maximum voltage drop (e.g., the maximum voltage drop may be more dependent on the state of the battery as compared to other voltage drops that may be more capacitive-driven). For example, the voltage drop at power-on / startup can be easily used for comparison with the maximum voltage drop. For example, if the voltage drop during power-on is greater than the measured maximum drop of the system, comparison indicates that there may be a risk that components can be reset.

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

Table 1

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

Table 2

[0045] The detection system can determine a set of temperature-adjusted battery indications based on a set of low-temperature battery indications, a set of high-temperature battery indications, and a set of temperature measurements obtained in step 402. In some embodiments, the detection system can determine a correction factor based on the temperature measured in step 404 (e.g., via firmware executed on an MCU). For example, the detection system can determine a correction factor based on the measured temperature and one or more correction factors. Logarithmic (shown below) and / or linear relationships can be developed to characterize the correction factor. For example, the detection system can use Equation 9 to determine the correction factor. corrFactor = A * log2(Temp + LogOffset) + Temp * B + C (Equation 9) Wherein, · corrFactor is the correction factor. · A, B, and C are coefficients (e.g., determined based on data collected to provide a desired degree of freedom for determining the correction factor). · LogOffset is a coefficient (e.g., determined based on data collected to provide a desired degree of freedom for determining the correction factor).

[0046] The detection system can determine a set of corrected battery indications (e.g., a corrected battery table) based on the temperature correction factor. In some embodiments, the detection system can determine the corrected battery indication based on both low-temperature and high-temperature battery tables. For example, the detection system can use Equation 10 to determine each corrected battery voltage associated with each indicator. corrBatCurve x ={(Voltage TEMPHIx - Voltage TEMPLOx ) / (TEMPHI - TEMPLO)} * (corrFactor - TEMPHI) + Voltage TEMPHIx (Equation 10) Wherein, ·corrBatCurve x is the corrected battery curve voltage of 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 obtained by Equation 9.

[0047] Referring to step 408, the device can determine the battery indicator based on the previous battery indicator. For example, the device can obtain the previous battery indicator for the battery, determine the current battery indicator for the battery based on the temperature-adjusted battery indication with the corrected battery table and the set of voltage measurements, and determine the battery indicator based on the previous battery indicator and the current battery indicator.

[0048] In some embodiments, the detection system can determine the current battery indicator based on the stored battery table and / or the corrected battery table. For example, the detection system can interpolate the point in the corrected battery table with the high current battery voltage (e.g., measured in step 402 of FIG. 4). For example, if the high current battery voltage is equal to the voltage value of the table, the detection system can determine that the battery indicator is the indicator associated with that row of the table. As another example, if the high current battery voltage is between two voltage values in the table, the detection system can interpolate the two relevant battery indicators to determine the relevant battery indication.

[0049] In some embodiments, the detection system can determine a new battery indicator based on a previous battery indicator (e.g., can be stored in storage on the detection system such as an EEPROM). For example, the detection system can use Equation 11 to determine the new battery indicator. newBatInd=(FILTER*batInd+curBatInd) / (FILTER+1) (Equation 11) Wherein, · newBatInd is the new battery indicator. · batInd is the previous battery indicator (e.g., obtained from the EEPROM). · curBatInd is the currently determined battery indicator. · FILTER is the filter value. FILTER can be determined based on the last operation related to the detection system (e.g., communication synchronization with a remote computing device such as remote computing device 104), a bonding event with a remote computing device, and / or the time elapsed since the detection of the dose administered by the associated drug delivery device.

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

[0051] The device can send a battery indicator to a remote device (e.g., remote computing device 104). The remote device can process the new battery indicator. For example, the remote device can be set to determine the battery state based on the battery indicator. As an example, Table 3 below shows battery indicators associated with exemplary battery states. [Table 3]

[0052] In some embodiments, when the sensing device first sets the low battery flag, the sensing device can enter the low battery state (e.g., when the device is unlikely to be able to provide more than a certain number of injections, such as 120 injections). Once the sensing device enters the low battery state, it can avoid changes that would take it out of the low battery state for that battery (e.g., to avoid moving back and forth between the low battery state and the non - low battery state). In some embodiments, the sensing device can be set to decrement the battery indicator by one for each new operation (e.g., synchronization, bonding, or dosing event) of the sensing device once it enters the low power state. In some embodiments, the sensing device can be set to decrement the number of remaining injections by one for each new operation of the sensing device once it enters the low power state. When the battery indicator equals zero, the sensing system may enter an end - of - life state. In some embodiments, the battery can be replaced, and when a new battery is detected, the sensing system can be reset. In some embodiments, the sensing system is disposable and can be discarded when it reaches the end - of - life state and its lifespan is exhausted.

[0053] In some embodiments, the detection system can perform one or more checks on the data obtained during the battery monitoring process and / or the measurements obtained. For example, the MCU can issue a warning of battery depletion when the new battery indicator falls below a predetermined threshold. As another example, the detection system can check whether the detected voltage is within a predetermined tolerance range, whether the temperature measurement is within a predetermined tolerance range, and the like.

[0054] As described herein, this technology can be used in various types of drug delivery devices, including drug delivery devices incorporating aspects described herein, as well as add-on components that can be attached to drug delivery devices. For illustrative purposes, FIGS. 5-12 illustrate exemplary drug delivery devices and dose detection systems that can incorporate the technology. Such technology is further discussed in PCT Application No. PCT / US19 / 18780, filed Feb. 20, 2019, which is incorporated herein by reference.

[0055] Figures 5-6 show an exemplary drug delivery device 10 according to several examples. The drug delivery device 10 is a pen-type syringe configured to inject a drug into a patient through a needle. The pen-type syringe 10 includes a body 11 having an elongated pen-type housing 12 that includes a distal portion 14 and a proximal portion 16. The distal portion 14 is received within a pen cap 18. Referring to FIG. 6, the distal portion 14 includes a reservoir or cartridge 20 configured to hold a drug solution to be dispensed through its distal outlet end during a dispensing operation. The outlet end of the distal portion 14 is equipped with a removable needle assembly 22 that includes an injection needle 24 surrounded by a removable cover 25. A piston 26 is positioned within the reservoir 20. An injection mechanism positioned within the proximal portion 16 is operable to advance the piston 26 toward the outlet of the reservoir 20 during a dose dispensing operation to force the contained drug through the needle tip. The injection mechanism includes, by way of example, a drive member 28 in the form of a screw that is axially movable relative to the housing 12 to advance the piston 26 through the reservoir 20.

[0056] A dose setting member 30 is coupled to the housing 12 to set the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a screw element operable to move helically (i.e., move both axially and rotationally simultaneously) relative to the housing 12 during dose setting and dose dispensing. FIGS. 5 and 6 show the dose setting member 30 fully screwed into the housing 12 in its home or zero dose position. The dose setting member 30 is operable to screw proximally from the housing 12 until it reaches a fully extended position corresponding to the maximum dose deliverable by the device 10 in a single injection.

[0057] Referring to FIGS. 6 - 8, the dose setting member 30 includes a cylindrical dose dial member 32 having a helical threaded outer surface that engages the corresponding threaded inner surface of the housing 12 so as to allow the dose setting member 30 to move helically relative to the housing 12. The dose dial member 32 further includes a helical threaded inner surface that engages the threaded outer surface of the sleeve 34 (FIG. 6) of the device 10. The outer surface of the dial member 32 includes dose indicator markings such as numbers that are visible through the dose window 36 to indicate the set dose to the user. The dose setting member 30 further includes a tubular flange 38 that is connected to the open proximal end of the dial member 32 and is axially and rotationally locked to the dial member 32 by a detent 40 received within the opening 41 of the dial member 32. The dose setting member 30 can further include a collar or skirt 42 that is positioned around the outer periphery of the dial member 32 at its proximal end. The skirt 42 is axially and rotationally locked to the dial member 32 by a tab 44 received within a slot 46. Further embodiments described below show examples of devices without a skirt.

[0058] Thus, since the dose dial member 32, the flange 38, and the skirt 42 are all rotationally and axially fixed together, the dose setting member 30 can be considered to include any or all of them. The dose dial member 32 is directly involved in setting the dose and advancing the delivery of the drug. The flange 38 is attached to the dose dial member 32 and, as will be described later, cooperates with a clutch to selectively connect the dial member 32 to the dose button 56. The skirt 42 provides a surface external to the body 11 so that the user can rotate the dial member 32 to set the dose. In embodiments without a skirt, the applicator dose button 56 includes an outer wall that extends distally to form a surface for the user to rotate.

[0059] The skirt 42 includes, illustratively, a plurality of surface features 48 and an annular ridge 49 formed on the outer surface of the skirt 42. The surface features 48 are, illustratively, longitudinally extending ribs and grooves circumferentially spaced around the outer surface of the skirt 42 to facilitate gripping and rotation of the skirt by the user. In an alternative embodiment, the skirt 42 is removable or integrated with the dial member 32, and the user can grip and rotate the dose button 56 and / or the dose dial member 32 for dose setting. In the embodiment of FIG. 8, the user can similarly grip and rotate the radially outer surface of the integral dose button 56, which also includes a plurality of surface features, for dose setting.

[0060] The delivery device 10 includes an actuator 50 having a clutch 52 received within the dial member 32. The clutch 52 includes a stem 54 extending axially at its proximal end. The actuator 50 further includes a dose button 56 positioned proximal to the skirt 42 of the dose setting member 30. The dose button 56 includes a mounting collar 58 (FIG. 6) located at the center of the distal face of the dose button 56. The collar 58 is attached to the stem 54 of the clutch 52, such as by interference fit or ultrasonic welding, to axially and rotationally fix the dose button 56 and the clutch 52 together.

[0061] The dose button 56 includes a disc-shaped proximal end surface or face 60 and an annular wall portion 62 extending distally and spaced radially inwardly from the outer peripheral edge of the face 60, with an annular lip 64 formed therebetween. The proximal face 60 of the dose button 56 functions as a pressing surface that can be manually, i.e., directly by the user, forced to push the actuator 50 in the distal direction. The dose button 56 illustratively includes a concave portion 66 located at the center of the proximal face 60, although the proximal face 60 may alternatively be a flat surface. A biasing member 68, illustratively a spring, is disposed between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to bias the actuator 50 and the dose setting member 30 axially apart from each other. The dose button 56 is depressible 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 operation of the dose setting mode, to set the desired dose to be delivered by the device 10, the dose setting member 30 is dialed (rotated) relative to the housing 12. Dialing in the proximal direction functions to increase the set dose, and dialing in the distal direction functions to decrease the set dose. The dose setting member 30 is adjustable in rotational increments (e.g., clicks) corresponding to the minimum incremental increase or decrease of the set dose during the dose setting operation. For example, one increment or “click” can be equal to one-half or one unit of the drug. The set dose is visible to the user via the dial indicator markings shown through the dosing window 36. The actuator 50 including the dose button 56 and the clutch 52 moves axially and rotationally with the dose setting member 30 during dialing in the dose setting mode.

[0063] The dose dial member 32, the flange 38, and the skirt 42 are all rotationally fixed to each other and rotate during dose setting and extend proximally of the drug delivery device 10 due to the threaded connection between the dose dial member 32 and the housing 12. During this dose setting operation, the dose button 56 is rotationally fixed relative to the skirt 42 by complementary splines 74 (FIG. 6) of the flange 38 and the clutch 52 that are biased together by the biasing member 68. During the process of dose setting, the skirt 42 and the dose button 56 move spirally from a “start” position to an “end” position relative to the housing 12. This rotation relative to the housing is proportional to the dose to be administered set by the operation of the drug delivery device 10.

[0064] After the desired dose is set, the device 10 is operated so that the injection needle 24 penetrates the user's skin appropriately, for example. The operation of the dose dispensing mode is initiated in response to an axial distal force applied to the proximal face 60 of the dose button 56. The axial force is applied directly to the dose button 56 by the user. This moves the actuator 50 axially distally relative to the housing 12.

[0065] The axial movement of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dose button 56 and the tubular flange 38. This relative axial movement disengages the clutch 52 and the complementary splines 74 on the flange 38, thereby releasing the actuator 50, e.g., the dose button 56, from being rotationally fixed to the dose setting member 30. Specifically, the dose setting member 30 is rotationally disconnected from the actuator 50, allowing for rearward driving rotation of the dose setting member 30 relative to the actuator 50 and the housing 12. The operation of the dose dispensing mode can also be initiated by activating a separate switch or trigger mechanism.

[0066] If the actuator 50 continues to be axially pushed in while not rotating relative to the housing 12, as the dial member 32 rotates relative to the dose button 56, the dial member 32 is screwed back into the housing 12. The dose markings indicating that an amount of drug remains to be injected are visible through the window 36. When the dose setting member 30 is screwed distally, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and release the drug through the needle 24 (FIG. 6).

[0067] During the dose dispensing operation, the amount of drug released from the drug delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50 as the dial member 32 is screwed back into the housing 12. The injection is completed when the female threads of the dial member 32 reach the distal end of the corresponding male threads of the sleeve 34 (FIG. 6). The device 10 is then repositioned to the ready state or zero dose position as shown in FIGS. 6 and 7.

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

[0069] A variety of sensor systems are contemplated herein. Generally, a sensor system includes a sensing component and a sensed component. The term "sensing component" refers to any component capable of detecting the relative position of a sensed component. A sensing component includes a sensing element or "sensor" together with associated electrical components for operating the sensing element. A "sensed component" is any component such that a sensing component can detect the position and / or movement 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, whereby the angular position and / or rotational movement of the sensed component can be detected. In the case of a dose type detection system, the sensing component detects the relative angular position of the sensed component. A sensing component can include one or more sensing elements, and a sensed component can include one or more sensed elements. A sensor system can detect the position or movement of a sensed component and provide an output representative of the position or movement of the sensed component.

[0070] A sensor system typically detects the characteristics of a sensed parameter that vary in relation to the position of one or more sensed elements within a sensed region. The sensed elements extend into or otherwise affect the sensed region in a manner that directly or indirectly affects the characteristics of the sensed parameter. The relative position of the sensor and the sensed elements affects the characteristics of the sensed parameter and enables the microcontroller unit (MCU) of the sensor system to determine the different rotational positions of the sensed elements.

[0071] A suitable sensor system may include a combination of active components and passive components. When the sensing component operates as an active component, neither component needs to be connected to a power source or other system elements such as an MCU.

[0072] Any of a variety of sensing techniques capable of detecting the relative position of two members can be incorporated. Such techniques can include, for example, techniques based on tactile, optical, inductive, or electrical measurements. Such techniques can include measurements of sensed parameters related to a field such as a magnetic field. In one form, when a magnetic component is moved relative to the sensor, the magnetic sensor detects a change in the sensed magnetic field. In another embodiment, the sensor system can detect the characteristics of the magnetic field and / or changes to the magnetic field when an object is placed within and / or moved through the magnetic field. The fluctuations of the field change the characteristics of the sensed parameters detected in relation to the position of the sensed element within the sensed region. In such embodiments, the sensed parameters can be capacitance, conductance, resistance, impedance, voltage, inductance, etc. For example, a magnetoresistive sensor detects the strain of an applied magnetic field that causes a change in the resistance of the sensor's element. As another example, a Hall effect sensor detects a change in voltage resulting from the strain of an applied magnetic field.

[0073] In one aspect, the sensor system detects the relative position or movement of the sensed element and thus the associated members of the drug delivery device. The sensor system generates an output representing the position or amount of movement of the sensed component. For example, the sensor system can be operable to generate an output that can determine the rotation of a dose setting member during dose delivery. The MCU is operably connected to each sensor to receive the output. In one aspect, the MCU is configured to determine the dose delivered by the operation of the drug delivery device from the output.

[0074] The dosage delivery detection system includes detecting relative rotational movement between two members. Based on the degree of rotation having a known relationship with the dosage being delivered, the sensor system operates to detect the amount of angular movement from the start to the end of the dosage injection. For example, a typical relationship for a pen-type syringe is that an 18° angular displacement of the dosage setting member is equal to 1 unit dosage, although other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of the dosage setting member during dosage delivery. Thus, if the angular displacement is 90°, it means that 5 units of dosage have been delivered.

[0075] One technique for detecting angular displacement is to count increments of dosage as the injection progresses. For example, the sensor system can use a repeating pattern of the element to be detected such that each repetition indicates a predefined degree of rotational angle. Conveniently, the pattern can be established such that each repetition corresponds to the minimum increment of dosage that can be set using the drug delivery device.

[0076] An alternative technique is to detect the starting and stopping positions of the relatively moving members and determine the delivered dosage as the difference between those positions. In this technique, it may be part of the determination for the sensor system to detect the total number of rotations of the dosage setting member. Various methods for this are well within the scope of those skilled in the art and may include "counting" increments to evaluate the total number of rotations.

[0077] The sensor system components can be attached to the drug delivery device either permanently or removably. In an exemplary embodiment, at least some of the components of the dosage detection system are provided in the form of modules that are removably attached to the drug delivery device. This has the advantage of allowing these sensor components to be used with more than one pen-type syringe.

[0078] In some embodiments, the sensing component is attached to the actuator and the sensed component is attached to the dose setting member. The sensed component may also include the dose setting member or any portion thereof. The sensor system detects the relative rotation of the sensed component, and thus the dose setting member, during dose delivery, and then determines the dose administered by the drug delivery device. In an exemplary embodiment, a rotational sensor is attached to and rotationally fixed to the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the sensed component is attached to and rotationally fixed to a dose setting member that rotates relative to the actuator and the device body during dose delivery. The sensed component may also include the dose setting member or any portion thereof. In an exemplary embodiment, the rotational sensor is not directly attached to the relatively rotating dose setting member during dose delivery.

[0079] Referring to FIG. 9, a dose delivery detection system 80 is shown in schematic form, including an example of a module 82 useful in combination with a drug delivery device such as device 10. Module 82 carries a sensor system schematically shown with a rotational sensor 86 (or more than one rotational sensor) and other associated components such as a processor, memory, battery. Module 82 is provided as a separate component that can be removably attached to the actuator.

[0080] The dose detection module 82 includes a body 88 attached to a dose button 56 (shown in dashed lines). The body 88 illustratively includes a cylindrical side wall 90 and a top wall 92 that extends across and seals the side wall 90. The dose detection module 82 may alternatively be attached to the dose button 56 via any suitable fastening means such as snap or press-fit, screw interface, etc., provided that in one aspect, the module 82 can be removed from a first drug delivery device and then attached to a second drug delivery device. The attachment can be at any position on the dose button 56, provided that as contemplated herein, the dose button 56 can be axially moved any required amount relative to the dose setting member 30.

[0081] During dose delivery, the dose setting member 30 can rotate freely relative to the dose button 56 and the module 82. In an exemplary embodiment, the module 82 is rotationally fixed to the dose button 56 and does not rotate during dose delivery. This can be structurally provided, for example, by using tabs or by having mating splines or other surface features on the module body 88 and the dose button 56 that engage during axial movement of the module 82 relative to the dose button 56. In another embodiment, pressing the module distally provides sufficient frictional engagement between the module 82 and the dose button 56 to functionally rotationally fix the module 82 and the dose button 56 together during dose delivery.

[0082] The top wall 92 is spaced from the face 60 of the dose button 56, thereby providing a cavity 96 that can include a rotation sensor and some or all of the other components. The cavity 96 can open at the bottom or can be enclosed by a bottom wall 98 or the like. The bottom wall 98 can be positioned to directly abut the face of the dose button 56. Alternatively, if a bottom wall 98 is present, it can be spaced from the dose button 56, and other contacts between the module 82 and the dose button 56 can be used such that the axial force applied to the module 82 is transmitted to the dose button 56. In another embodiment, the module 82 can be rotationally fixed to an integral dose button configuration.

[0083] In an alternative embodiment, the module 82 during dose setting is instead attached to the dose setting member 30. For example, the side wall 90 can include a lower wall portion 100 having inward projections in the form of coupling arms 102 that engage the side walls of the button. In this approach, the module 82 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 the surface features of the dose button to rotationally fix the module 82 to the dose button. The rotational force applied to the housing 82 during dose setting is transmitted to the dose button by the force of the coupling between the lower wall portion 100 and the side wall of the dose button. The light guide 118 is shown disposed between the LEDs 114A - C and the light sensor 110, and is shown collectively at a single location of the electronic device assembly and, if present, on the face of the applicable dose button 56. The battery 138 is shown disposed over the illumination system 89 and part of the electronic device assembly.

[0084] An exemplary electronic device assembly 120 includes a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronic device assembly comprises a sensor system including one or more rotation sensors 86 that are operably communicable with a processor to receive signals representative of the detected relative rotation from the sensors. The electronic device assembly further includes an MCU having at least one processing core and internal memory. An example schematic of the electronic device assembly is shown in FIG. 1B.

[0085] Referring to FIGS. 10A, 10B, 11A, and 11B, an exemplary magnetic sensor system 150 is shown that includes an annular ring-shaped bipolar magnet 152 having an N pole 154 and an S pole 156 as a sensing element. The magnets described herein may also be referred to as rings magnetized in the diametrical direction. Magnet 152 is attached to flange 38 and thus rotates with the flange during dose delivery. Magnet 152 may alternatively be attached to dose dial 32 or other member rotationally fixed to the dose setting member. Magnet 152 may be composed of various materials such as rare earth magnets such as neodymium, for example.

[0086] Sensor system 150 further includes a measurement sensor 158 that includes one or more sensing elements 160 operably connected to sensor electronics (not shown) included within module 82. The sensing element 160 of sensor 158 is shown attached to a printed circuit board 162 in FIG. 11A, and the circuit board 162 is in turn attached to module 82, which is rotationally fixed to dose button 56. As a result, during dose delivery, magnet 152 rotates relative to sensing element 160. Sensing element 160 is operable to detect the relative angular position of magnet 152. Sensing element 160 can include an inductive sensor, a capacitive sensor, or other non-contact sensor if ring 152 is a metal ring. Thereby, magnetic sensor system 150 operates to detect the full rotation of flange 38 relative to dose button 56 and thus the rotation of housing 12 during dose delivery. In one example, magnetic sensor system 150 including sensor 158 having magnet 152 and sensing element 160 may be disposed within the module.

[0087] In one embodiment, as shown, the magnetic sensor system 150 includes four sensing elements 160 equally spaced radially within a module 82 for defining a ring pattern. Alternative numbers and positions of sensing elements may be used. For example, in another embodiment shown in FIG. 11B, a single sensing element 160 is used. Further, although the sensing element 160 in FIG. 11B is shown to be at the center within the module 82, other positions may be used. In another embodiment shown in FIG. 12, for example, five sensing elements 906 are equally circumferentially and radially spaced within the module. In the foregoing embodiments, the sensing elements 160 are shown mounted within the module 82. Alternatively, the sensing elements 160 may be attached to any part of a component rotationally fixed to the dose button 56 so that the components do not rotate relative to the housing 12 during dose delivery.

[0088] For illustration purposes, the magnet 152 is shown as a single annular bipolar magnet attached to the flange 38. However, alternative configurations and positions of the magnet 152 are also contemplated. For example, the magnet may comprise multiple poles such as alternating N and S poles. In one embodiment, the magnet includes several pole pairs equal in number to the number of individual rotational dose setting positions of the flange 38. The magnet 152 may also include several separate magnet members. Additionally, the magnet component can be attached to any part of a member rotationally fixed to the flange 38 during dose delivery, such as the skirt 42 or the dose dial member 32.

[0089] Alternatively, the sensor system may be an inductive sensor system or a capacitive sensor system. This type of sensor system utilizes a sensed element including a metal strip attached to the flange, similar to the attachment of the magnetic rings described herein. The sensor system further includes one or more sensing elements, such as four, five, six, or more independent antennas or armatures equally angularly spaced along the distal wall of the module housing or pen housing. Those antennas form antenna pairs at positions separated by 180 degrees or other angles and provide a rheometric measurement of the angular position of the metal ring proportional to the dose delivered.

[0090] The metal band ring is shaped such that it can detect one or more different rotational positions of the metal ring relative to the module. The metal band has a shape that generates a signal that changes as the metal ring rotates relative to the antenna. The antenna is operably connected to the electronic device assembly, and thus the antenna functions to detect the position of the metal ring relative to the sensor and thus relative to the housing 12 of the pen 10 during dose delivery. The metal band may be a single cylindrical band attached to the outside of the flange. However, alternative configurations and positions of the metal band are also contemplated. For example, the metal band may include a plurality of different metal elements. In one embodiment, the metal band includes several elements equal in number to the number of individual rotational dose setting positions of the flange. Alternative metal bands can be attached to any part of a component that is rotationally fixed to the flange 38 during dose delivery, such as the dial member 32. The metal band may include metal elements attached to the rotating member inside or outside the member, or may be incorporated into such a member by metal particles incorporated into the component or by overmolding the component with the metal band. The MCU is operable to determine the position of the metal ring with the sensor.

[0091] The MCU is operable to determine the starting position of the magnet 152 by averaging the number (e.g., 4) of sensing elements 160 at the maximum sampling rate according to standard quadrature differential signal calculations. During the dose delivery mode, sampling at the target frequency is performed by the MCU to detect the rotational speed of the magnet 152. At the end of dose delivery, the MCU is operable to determine the final position of the magnet 152 by averaging the number (e.g., 4) of sensing elements 160 at the maximum sampling rate according to standard quadrature differential signal calculations. The MCU is operable to determine from the calculation of the total rotation angle from the determined starting position, rotational speed, and final position. The MCU is operable to determine the number of dosing steps or units by dividing the total rotation angle by a predetermined number (10, 15, 18, 20, 24, etc.) that correlates with the design of the device and the drug.

[0092] Referring further to FIG. 12, FIG. 12 shows another example of a magnetic sensor system 900 that includes a diametrically magnetized ring 902 having an N pole 903 and an S pole 905 as a sensing element. The magnetized ring 902 is attached to a dosing setting member such as a flange, for example, as described above. The radial arrangement of a magnetic sensor 906, such as a Hall effect sensor, relative to the magnetized ring 902 can be equiangular with respect to each other in a ring pattern. In one example, the magnetic sensor 906 is radially disposed in an overlapping relationship with the outer peripheral edge 902A of the magnetized ring 902 such that a portion of the magnetic sensor 906 exists across the magnetized ring 902 and the remaining portion exists outside the magnetized ring 902.

[0093] In some embodiments, the detection system is configured to determine whether the detection system is coupled to a drug delivery device. FIG. 13 shows an exemplary computerized method 1300 for determining whether a device is removably coupled to a drug injection device, according to some embodiments. A detection system, such as a dosing delivery detection system, includes a plurality of sensing elements. For example, the detection system includes several sensing elements, such as four or five sensing elements spaced equiangularly and equi-radially within the device. As described herein, the plurality of sensing elements can include a plurality of Hall effect sensors. In some embodiments, five Hall effect sensors are spaced 72 degrees apart around a circle having a diameter designed based on the magnetic components of the drug delivery device being detected. For example, a diameter of about 14 mm can be used such that the sensors exhibit an envelope described by the maximum value of the Z component of the magnetic field when the magnet rotates about its axis. The detection system also includes a processor (e.g., an MCU) that communicates with the set of sensing elements.

[0094] The detection system (such as an MCU, via its processor) is configured to execute computer-readable instructions that cause the processor to execute a computerized method 1300. In step 1302, the detection system obtains a set of voltage measurements from each of a plurality of detection elements. In step 1304, the detection system determines two-dimensional data representing the magnetic field of the magnetic component of the drug injection device. In step 1306, the detection system determines one-dimensional data based on the two-dimensional data. In step 1308, the detection system determines, based on the one-dimensional data, whether the set of voltage measurements indicates a device coupled to the drug injection device.

[0095] Referring to step 1302, when the power-on button to the detection system is pressed by the user, the detection system is activated and the firmware running on the processor switches on the detection elements (e.g., magnetic sensors) to take the starting position of the magnetic component of the drug delivery device (e.g., before rotation occurs). In this phase, it is important to take sensor readings immediately after startup to avoid taking measurements during rotation. In some embodiments, the detection system can average the number of samples (e.g., 5, 10, 15, etc. for each sensor) of each sensor, for example, to reduce noise.

[0096] Referring to step 1304, in some embodiments, the detection system determines a quadrature signal that includes an in-phase (I) component and a quadrature (Q) component. The system can determine the I and Q values based on the sum of each sensor value. In some embodiments, the detection system uses coefficients when summing the sensor values. For example, the system can store one or more coefficients for each sensor. In some embodiments, the detection system stores one coefficient for each sensor whose sensor value is multiplied during addition to determine the I value, and a second coefficient for each sensor whose sensor value is multiplied during addition to determine the value. In some embodiments, the coefficients can be used to combine the results of multiple sensors (e.g., five sensors spaced equally apart at 72 degrees from each other, etc.) for the calculation of I and Q. In some embodiments, the coefficients are obtained by solving a system of simultaneous equations that forces the result of the quadrature calculation to have a zero error compared to the nominal angle, before offsets, second harmonic distortion, third harmonic distortion, and / or the like of the measured signal.

[0097] Referring to step 1306, in some embodiments, the detection system determines a scale factor based on the two-dimensional signal (e.g., quadrature signal) determined in step 1304. In some embodiments, the detection system determines the scale factor based on the quadrature signal and one or more of a predetermined offset and a predetermined gain. For example, the processor can determine the scale factor based on Equation 12 below.

Equation

[0098] In cases where the balance between I and Q is achieved, such as when the offset is equal to zero and the gain is equal to 1, the quadrature phase functions properly, so such exemplary I and Q offsets and gains can be used. The offset / gain can be determined to balance the measured I and Q and achieve sufficient values, remove skew between I and Q, etc. using a calibration process. In some embodiments, the sensing system can be configured to normalize the I and Q values and use the I and Q values to determine a normalized angle of the Z component of the magnetic field. After the dose is administered, the sensing system can then monitor the end position of the magnetic component of the drug delivery device to determine the amount of the injected dose (e.g., using a technique similar to that described herein to monitor the rotation of the magnet and / or determine the end position of the magnet).

[0099] Referring to step 1308, the sensing system can determine whether the one-dimensional data indicates that the sensing system is (or is not) coupled to the drug delivery device. The sensing system can use a scale factor to determine whether the sensing system is attached or coupled to the drug delivery device. For example, if the scale factor is within a predetermined threshold, the sensing system can determine that the sensing system is attached to the drug delivery device. If the scale factor is not within the predetermined threshold, the sensing system can determine that it is likely not attached to the drug delivery device. In some embodiments, the sensing system can check the scale factor against a low amplitude margin and a high amplitude margin to determine whether the magnet being monitored by the module is the expected magnet (e.g., a tolerance of about + / - 25% of the nominal value is acceptable), thereby allowing only the required amplitude to be accepted by the module.

[0100] Dosage detection systems have been described by way of example using a particular design of a drug delivery device such as a pen-type syringe. However, the exemplary dosage detection systems may also be used with alternative drug delivery devices and with other sensing configurations that are operable in the manner described herein. For example, one or more of various sensing and switch systems may be omitted from the module.

[0101] The various methods or processes outlined herein may be encoded as software executable on one or more processors using any one of various operating systems or platforms. Further, such software may be written using any one of a number of suitable programming languages and / or programming tools or scripting tools, and may be compiled as executable machine language code or intermediate code to be executed on a virtual machine or a suitable framework.

[0102] In this regard, various inventive concepts may be embodied as one or more non-transitory computer-readable storage media (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memories, circuit configurations in a field programmable gate array or other semiconductor device, etc.) encoded with one or more programs that, when executed on one or more computers or other processors, implement various embodiments of the present invention. The non-transitory computer-readable medium or media may be removable, such that the program(s) stored thereon may be loaded onto any computer resource for implementing various aspects of the present invention as discussed above.

[0103] The terms "program," "software," and / or "application" are used herein in their general sense and refer to any type of computer code or set of computer-executable instructions employed to program a computer or other processor to implement the various aspects of the embodiments as discussed above. Further, according to one aspect, it should be understood that one or more computer programs that, when executed, implement the methods of the present invention need not be present on a single computer or processor, but may be distributed in a modular fashion among different computers or processors to implement the various aspects of the present invention.

[0104] Computer-executable instructions can be in many forms, such as by one or more computers or other devices, like program modules. Generally, program modules include routines, programs, objects, components, data structures, etc., which perform specific tasks or implement specific abstract data types. Typically, the functions of program modules can be combined or distributed as desired in various embodiments.

[0105] Also, data structures can be stored in a non-transitory computer-readable storage medium in any suitable form. A data structure may include fields that are associated by their location within the data structure. Such relationships can likewise be achieved by allocating storage areas to fields that have locations within the non-transitory computer-readable medium that convey the relationships between the fields. However, relationships between the information within the fields of a data structure can be established, including through the use of pointers, tags, or other mechanisms that use any suitable mechanism to establish relationships between data elements.

[0106] Various inventive concepts can be embodied in one or more ways, and examples are provided. The operations performed as part of a method can be ordered in any suitable way. Thus, although shown as sequential operations in the exemplary embodiments, embodiments can be constructed in which the operations are performed in a different order than that shown, including performing some operations simultaneously.

[0107] As used herein in the specification and claims of this specification, the indefinite articles "a" and "an" should be understood to mean "at least one" unless clearly indicated to the contrary. When used in the specification and claims of this specification, the phrase "at least one" in connection with a list of one or more elements should be understood to mean at least one selected from any one or more of the elements in the list of elements, and need not include at least one of each and every element specifically listed within the list of elements, nor does it exclude any combination of elements within the list of elements. Thus, elements other than those specifically identified within the list of elements referred to by the phrase "at least one" can optionally be present, whether or not related to these specifically identified elements.

[0108] As used herein in the specification and claims, the phrase "and / or" shall be understood to mean "either or both" of the elements so joined, i.e., elements that may be present conjunctively in some cases and disjunctively in other cases. Multiple elements listed using "and / or" shall be construed in the same fashion, i.e., "one or more" of the elements so joined. Elements other than those specifically identified by the "and / or" clause may optionally be present, whether or not they are related to those specifically identified. Thus, by way of non-limiting example, reference to "A and / or B", when used in combination with open-ended language such as "comprising", may refer in one embodiment to only A (optionally including elements other than B), in another embodiment to only B (optionally including elements other than A), and in yet another embodiment to both A and B (optionally including other elements).

[0109] As used in this specification and the claims, "or" shall be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted as inclusive. That is, it shall be interpreted as including at least one, but also two or more, of the plurality of elements or list of elements, and optionally also including additional unlisted items. Terms such as "only one of", "exactly one of", or "consisting of" when used in the claims, indicate that only the terms explicitly indicated to the contrary refer to exactly one element of the plurality of elements or list of elements. In general, as used in this specification, the term "or" shall be interpreted to indicate an exclusive choice (i.e., "one or the other but not both") when followed by exclusive terms such as "either", "one of", "only one of", or "exactly one of". "Consisting essentially of" shall have its ordinary meaning as used in the field of patent law when used in the claims.

[0110] The use of ordinal terms such as "first", "second", "third", etc. in the claims to modify claim elements does not in itself mean any order of precedence, precedence, or order of one claim element over another claim element, or (where the operations of a method are performed in this order) chronological order. Such terms are used only as labels to distinguish one claim element having a particular name from another element having the same name (except by the use of ordinal terms).

[0111] The syntax and terminology used in this specification are for the purpose of explanation and should not be regarded as limiting. The use of "including", "comprising", "having", "containing", "involving", and variations thereof means including the items listed thereafter and additional items.

[0112] Although some embodiments of the present invention have been described in detail, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to be within the spirit and scope of the present invention. Accordingly, the foregoing description is merely illustrative and not intended to be limiting.

Claims

1. An apparatus configured to determine illumination data indicative of the color of an object, wherein the object is a component of a drug included in a drug delivery device, the apparatus comprising: a set of light-emitting diodes (LEDs) including a red LED, a green LED, and a blue LED; a light sensor; a temperature sensor; and a processor configured to execute computer-readable instructions, wherein the instructions cause the processor to: cause the light sensor to capture, (a) first illumination data when the object is illuminated by the red LED, (b) second illumination data when the object is illuminated by the green LED, and (c) third illumination data when the object is illuminated by the blue LED; determine a temperature associated with the object using the temperature sensor; process the first through third illumination data to generate processed illumination data, including adjusting the first through third illumination data based on the determined temperature associated with the object to generate temperature-adjusted first through third illumination data; and normalize each of the temperature-adjusted first through third illumination data based on a set of normalization parameters including dark illumination data captured when the red LED, the green LED, and the blue LED are off; and transmit the processed illumination data to a remote device using a communication module in communication with the processor. An apparatus as claimed in claim 1, wherein the light sensor is an ambient light sensor.

3. The apparatus according to any one of claims 1 to 2, further comprising an optical guide disposed between (a) the set of LEDs, the light sensor, or both, and (b) the object.

4. The apparatus according to any one of claims 1 to 3, wherein prior to causing the light sensor to capture the first through third illumination data of the object, the instructions cause the processor to cause the light sensor to capture fourth illumination data when the object is not illuminated by the set of LEDs.

5. A method of operating an apparatus to determine illumination data indicative of the color of an object, the apparatus including a set of light-emitting diodes (LEDs) including a red LED, a green LED, and a blue LED, a light sensor, and a temperature sensor, ​ ​ ​ ​ ​ The object is a component of a drug contained in a drug delivery device, The method is such that the apparatus causes the optical sensor to capture (a) first illumination data when the object is illuminated by the red LED, (b) second illumination data when the object is illuminated by the green LED, and (c) third illumination data when the object is illuminated by the blue LED; determining a temperature associated with the object using the temperature sensor; processing the first to third illumination data to generate processed illumination data, adjusting the first to third illumination data based on the determined temperature associated with the object to generate temperature-adjusted first to third illumination data; normalizing each of the temperature-adjusted first to third illumination data based on a set of normalization parameters including dark illumination data captured when the red LED, the green LED, and the blue LED are off; transmitting the processed illumination data to a remote device using a communication module that communicates with the processor A method comprising. **Claim 6** The method according to claim 5, further comprising causing the optical sensor to capture fourth illumination data when the object is not illuminated by the set of LEDs, prior to causing the optical sensor to capture the first to third illumination data of the object. **Claim 7** The method according to claim 5 or 6, wherein the optical sensor is an ambient light sensor and an optical guide is disposed between (a) the set of LEDs, the optical sensor, or both, and (b) the object.

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