Method and apparatus for embodiments of a dose detection system module for a drug delivery device

Abstract

To provide at least one computerized method and system for generating a single light indication pattern via LEDs for a dose detection system, such as for example, based on a use case type and a battery life status type.SOLUTION: The use case types may include pairing, manual synchronization, and / or dose injection, and the battery life status types may include 1 to 3 different states. Another method and system are for reducing drainage of a battery for a dose detection system 103 by monitoring the continuous activation of the power-on module, and / or alerting the user in a manner for the user to take action. At least some of the information obtained from these techniques may be communicated to a paired remote electronic device 104, such as a user's smartphone.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present disclosure relates to techniques for electronic dose detection systems for drug delivery devices, and in particular to techniques for detecting connection to a drug delivery device, determining the type of drug delivery device, and monitoring battery life. [Background technology]

[0002] Patients suffering from various diseases frequently must inject themselves with medication. To enable people to conveniently and accurately self-administer medication, various devices, commonly known as pen-type injectors or injection pens, have been developed. Generally, these pens are loaded with a cartridge that includes a piston and contains multiple doses of liquid medication. A drive member is movable forward, advancing the piston within the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle. In disposable or pre-filled pens, after the pen has been used to exhaust the supply of medication 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 to exhaust the supply of medication in the cartridge, the pen can be disassembled to allow the used cartridge to be replaced with a new cartridge, and the pen is then reassembled for subsequent use.

[0003] Many pen injectors and other drug delivery devices utilize mechanical systems in which members rotate and / or translate relative to one another in a manner proportional to the dose delivered by actuation of the device. Accordingly, efforts have been made in the art to provide reliable systems for accurately measuring the relative motion of members of a drug delivery device to assess the delivered dose. Such systems may include a sensor secured to a first member of the drug delivery device that detects the relative motion of a sensed component secured to a second member of the device.

[0004] Administration of an appropriate amount of medication requires that the dose delivered by a drug delivery device be accurate. Many pen injectors and other drug delivery devices do not include functionality for automatically detecting and recording the amount of medication delivered by the device during an injection event. Without an automated system, patients must manually track the amount and time of each injection. Therefore, a device operable to automatically detect the dose delivered by a drug delivery device during an injection event is needed. Furthermore, such a dose detection device should be removable and reusable with multiple delivery devices. In other embodiments, such a dose detection device should be integrated with the delivery device. Summary of the Invention

[0005] In one embodiment, disclosed are systems and methods configured to generate a light indication pattern for a dose detection system. For example, the system can include one or more light-emitting diodes (LEDs), one or more batteries, and a processing circuit. The processing circuit can be configured, or the method steps can be, to determine a use case type from a plurality of use case types for the dose detection system, determine a battery life status of one or more batteries from a plurality of battery life statuses, and provide the light indication pattern via the one or more LEDs. The light indication pattern can include (i) a first light indication segment based on the determined use case type and (ii) a second light indication segment based on the battery life status determined a delay period after completion of the first light indication segment.

[0006] In another embodiment, disclosed are systems and methods configured to reduce battery drain for a dose detection system. For example, the system may include a power-on module switchable between an active state and an inactive state, a battery, and a processing circuit. The processing circuit may be configured, or the method steps may include, increasing the power drawn from the battery by the system to an increased power state when the power-on module is switched from the inactive state to the active state and measuring how long the power-on module is continuously maintained in the active state. If the power-on module is continuously in the active state for a first period of time, the power drawn from the battery by the system is reduced to a low power state. Thereafter, if the power-on module is continuously in the active state for a second period of time in addition to the first period of time, the power drawn from the battery by the system is increased from the low power state to an increased power state, an event is generated, and data indicative of the event is stored in a memory of the dose detection system.

[0007] Further embodiments of the present disclosure, and its features and advantages, will become more apparent by reference to the description herein in conjunction with the accompanying drawings, in which elements are not necessarily drawn to scale. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the different views. [Brief explanation of the drawings]

[0008] [Figure 1A] FIG. 1 is a diagram of an exemplary system, according to some embodiments. [Figure 1B] FIG. 1 shows 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. [Figure 2] 1 is a flowchart of an exemplary computerized method for determining a color associated with an object, according to some embodiments. [Figure 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. [Figure 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. 5. [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 along with a dose detection system of the present disclosure. [Figure 9] FIG. 10 is a side, partially 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] 10 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 10B] 10 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 11A] 10 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 11B] 10 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 12] FIG. 10 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. [Figure 14] FIG. 1 illustrates an exemplary system and a remote computing system according to some embodiments. [Figure 15]1 illustrates an exemplary computerized method for generating an indication signal of a single light indication pattern to a user of a system, according to some embodiments. [Figure 16] 1 illustrates an exemplary computerized method for determining a use case type of a dose delivery detection system from a plurality of use case type configurations, according to some embodiments. [Figure 17] 1 illustrates an exemplary computerized method for determining a light indication pattern based on remaining battery state life, according to some embodiments. [Figure 18] 1 illustrates an exemplary computerized method for generating an indication to a user if a power-on module of a dose detection system has been continuously activated for a period of time, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[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 and specific language will be used to describe the same, it being understood, however, that no limitation on the scope of the invention is intended.

[0010] Delivering the correct medication is important. Patients may need to choose between different medications or different forms of a given medication depending on the situation. Mistaking which medication is in the medication delivery device could result in the patient not being properly administered and the administration of the dose being inaccurately recorded. The likelihood of this occurring is greatly reduced when a dose detection device is used that automatically verifies the type of medication contained in the medication delivery device.

[0011] The present disclosure relates to a sensing system for a medication delivery device. In one aspect, the sensing system is for generating a single light indication pattern for a dose detection system. The inventors have discovered and realized that it may be desirable to have a light indication strategy when the dose detection system does not have a display, but they recognize that a light indication strategy may still have advantages in a dose detection system that has a display. However, given the various hardware, firmware, and / or software that may be desired to be included in such a dose detection system, as well as the desire to limit the dose detection system to include only components that are small, easy to use, and unlikely to fail due to repeated use, the inventors have discovered and recognized that incorporating additional components (e.g., switches, latches, etc.) to indicate to a user when the dose detection system is connected to a remote computing device or whether an injection was successful may also be difficult. The technology described herein provides for leveraging existing components of a dose detection device to determine whether the dose detection device is coupled to a drug delivery device, whether the sensing element is moving, and how long the power-on module has been operating to determine different use case types. For example, the dose sensing device may include a sensor (such as a Hall Effect sensor) and associated hardware and / or software to determine the size of the dose administered by the drug delivery device. This technique may also utilize such hardware and / or software used to perform dose detection to determine whether a dose sensing system is coupled to the drug delivery device.

[0012] In a second aspect, the detection system may be for reducing drain from the detection system's battery. The inventors have discovered and recognized that when a power-on module is operated for an extended period of time, complete battery depletion can occur much sooner than expected. The inventors have developed techniques that monitor the continued operation of the power-on module and provide techniques for storing the event and / or communicating with a remote computing system configured to provide some indication to a user of the event. As used herein, the term "event" is defined to include any one or more of the following: (i) a processor interrupt; (ii) the generation of an electrical signal that propagates along a circuit; (iii) the setting or unsetting of one or more bits in a register; and (iv) the changing of the value of a programming variable.

[0013] By way of example, the drug delivery device is described in the form of a pen-type injector. However, the drug delivery device may be any device used to set and deliver a dose of drug, such as an infusion pump, a bolus injector, or an automatic injection device. The drug 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 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 are not intended to be the only possible embodiments and implementations. Furthermore, the advantages described above 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, in reservoir or cartridge 20. In another embodiment, a 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 dalaglutide 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 capable of being delivered by the above-described devices. Drugs such as those used in the present devices can be formulated with one or more excipients. The device is operated by a patient, caregiver, or medical professional to deliver the drug to a human, generally in the manner described above.

[0016] 1A is a diagram of an example system 120, according to some embodiments. The system 101 includes a sensing 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, etc.

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

[0018] FIG. 1B, with further reference to FIG. 14, shows a detailed example of an electronics assembly of a sensing module, designated 1400, that may be included in any of the modules described herein. The electronics assembly includes a microcontroller (referred to in FIG. 1B as an MCU). The MCU of sensing system 1400 includes a processing unit that may be or include a processing circuit. A "processing circuit" may include one or more application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or combinations thereof. 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 connection to a drug delivery device, determining the type of drug delivery device, acquiring data used to determine the dose delivered by the drug delivery device, and monitoring battery life of the drug delivery device. The MCU may be operable to acquire data by detecting and / or determining the amount of rotation of a rotation sensor fixed to the flange, the amount of rotation being determined by detecting the magnetic field of the rotation sensor with a sensing element of a measurement sensor of the system, such as a Hall effect sensor.

[0019] The sensing module 1400 includes an MCU that can be operably coupled to one or more of the dose sensing elements 1402A-E, memory 1408, identification sensor 1404, counter 1414, light driver 1411 and light indicator 1412, power-on module 1406, communications module 1410, display driver / display 1416, power supply 1418, and presence module 1420. The sensing module 1400 can include any number of sensing elements, such as five magnetic sensors 1402A-E (as shown) or six sensors. The dose sensor can be used to determine the gross unit of rotation of a component within the drug delivery device, which can be used to determine the amount of a dose administered (e.g., as discussed further herein in conjunction with FIGS. 5-12), and is used to detect connection to the drug delivery device. The MCU can be configured via the presence module 1420, shown optional in dashed lines in this embodiment, to determine whether the module is coupled to the dose knob of the device via triggering a presence switch system. The MCU is configured to determine the color of the dose knob via the identification sensor 1404 and, in some examples, associate the determined color with a particular medication using logic onboard the detection module 1400 or with the assistance of logic implemented on an external device (e.g., remote computing device 104). In some embodiments, the detection module 1400 can be configured to provide an external indication to the user of the color of the dose knob or the type of medication associated with a particular medication (e.g., using LED 114, as discussed further herein). The MCU is configured to determine the triggering of a power-on switch (shown as reference 137, activated by button 139 shown in FIG. 9) to increase the power drawn from the power source to the electronic assembly for use, collectively shown in FIG. 14 as power-on module 1406. In one example, the total rotations can be communicated to an external device including a database, look-up table, or memory with other data stored in memory to correlate the total rotation unit to the amount of medication delivered for a given identified medication.In another example, the MCU may be configured to determine the amount of drug delivered, and the MCU may 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, the rotation unit (any one or any combination thereof), drug identification (e.g., color) data, timestamp, time since last dose, battery charge state, module identification number, module insertion / removal time, inactivity time, and / or other errors (e.g., dose detection and / or transmission errors, drug identification detection and / or transmission errors, etc.) to a paired remote electronic device such as a Bluetooth Low Energy (BLE) or other suitable short- or long-range wireless communication protocol module 1410 (e.g., near field communication (NFC), WiFi, or cellular network) to a user's smartphone. Illustratively, 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 1416, shown in dashed lines in this embodiment as optional, 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 sensed data and display information on the display, such as, for example, dose setting, dispensed dose, injection status, injection completion, date and / or time, or time until the next injection. In another example, the MCU includes an LED driver 1411 coupled to one or more LEDs 1412, e.g., an amber LED and a green LED, used to communicate with the patient through on / off sequences and different colors whether data was successfully transmitted, whether battery charge is high or low, or other clinical communications. Counter 1414 is shown as a real-time clock (RTC) electronically coupled to the MCU to track time, such as administration time. 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] 14 , the remote computing device / smartphone 104 includes a user interface 1461 in communication with a processor 1463 (which may also be referred to herein as a processing circuit) having memory 1465 (which may be any suitable computer-readable medium accessible by the processor 1463, including both volatile and non-volatile memory), and a communication device 1467 configured to communicate with a communication protocol module 1410 via wired or wireless signals 1475 and operable to provide user input data to the system and receive and display data, information, and prompts generated by the system. The wireless signals 1475 may be configured according to one or more of the communication protocols previously described with respect to module 1410. The user interface includes at least one input device for receiving user input and providing the user input to the system. In the illustrated embodiment, the user interface 1461 is a graphical user interface (GUI) including a touchscreen display operable to display data and receive user input. The touchscreen display allows a user to interact with presented information, menus, buttons, and other data to receive information from and provide user input to the system. Alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

[0021] In some embodiments, as further discussed in connection with Figures 8-12, the sensing system 103 is configured to be connected to a drug delivery device. In some embodiments, the object 116 is a part of the drug delivery device (e.g., the color of a knob, a label, an exterior compartment, etc.) that can be used to identify aspects 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 in the drug delivery device.

[0022] 1C is a diagram of an exemplary system 130, according to some embodiments. System 130 includes aspects of a dose detection system, including a sensing system 132 that communicates with a remote computing device 134 via a communication unit 136 (e.g., via a wired and / or wireless connection). As described further herein, sensing system 132 can be configured to determine a battery indicator indicative of the remaining life of battery 138. Device 132 includes a processing unit 140 that communicates with communication unit 136, battery 138, and a temperature sensing unit 142.

[0023] The exemplary embodiment of the dose detection system described in connection with Figures 1A-1C is shown for illustrative purposes to highlight various aspects of the dose detection system. The embodiments shown in Figures 1A-1C may be combined into a single device, such as dose delivery detection system 80 described in connection with Figures 8-12, and may be implemented, for example, using the various exemplary configurations discussed in connection with those figures. While a battery is described as an exemplary power source, the teachings described herein may be applied to power sources other than batteries.

[0024] 1A , in some embodiments, the detection system 103 is configured to determine the color of an object (e.g., the knob of a pen-type drug delivery device). In some embodiments, the detection system determines the color of the object by sequentially switching on the LEDs 114 and reading the reflected beam back through the wide-spectrum ambient light sensor 110. 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 set of predefined colors to determine if there is a match.

[0025] 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 perform the method 200. In step 202, the detection system acquires illumination data of an object illuminated by a set of LEDs. The detection system can optionally 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, the detection system causes a light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs. In step 208, the detection system transmits the processed illumination data to a remote device (e.g., via a communications module that communicates with the device's processor). In step 210, the remote device determines whether the illumination metrics match a set of stored colors. If the remote device determines a match, then 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, then in step 214 the remote device outputs that a color match was not found (e.g., by returning an error code, no match code, etc.).

[0026] 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 illumination data of the object when the object is illuminated by ambient light alone when no LEDs are turned on. In some embodiments, the detection system can include an exposure time for capturing dark illumination data.

[0027] As another example, if the set of LEDs includes LEDs of different colors, the device can be configured to capture illumination data of the object when the object is illuminated by each LED. For example, as shown in FIG. 1A , in some embodiments, the device includes red LEDs 114A, blue LEDs 114B, and green LEDs 114C. The device can be configured to adjust the light sensor 110 and the LED driver 112 to coordinate illuminating the LEDs 114 and capturing illumination data such that the light sensor 110 captures illumination data when the object is illuminated by red LED 114A (and not the other LEDs), illumination data when the object is illuminated by blue LED 114B (and not the other LEDs), and illumination data when the object is illuminated by green LED 114C (and not the other LEDs). In some embodiments, the sensing system can be configured to use an exposure time while capturing illumination data that is the same for each LED and / or can be different for one or more LEDs.

[0028] Referring to step 204, the illumination data may be adjusted based on temperature. In some embodiments, the temperature is obtained from the ambient air, the sensing system, and / or the drug delivery device. In some embodiments, the sensing system may capture multiple temperature measurements, average the value, and adjust the illumination data using the averaged temperature. In some embodiments, the sensing system may adjust each illumination data value (X) using Equation 1:

[0029]

number

[0030] During the ceremony, rgbTempX is the adjusted lighting data value determined for each color, such as red value, green value, blue value, etc., depending on the color for which Equation 1 is calculated. rgbX is the original lighting data value, such as red, green, or blue. TempCoefficientX is the temperature coefficient for each value, allowing one coefficient to track different temperature measurements (e.g., because performance drift may occur with different temperature measurements). CalTemp is the temperature measured during calibration of the sensing system and can be used to account for temperature changes (e.g. in the case of non-calibrated measurements). ·Temp is the measured (e.g., averaged) temperature.

[0031] Referring to step 206, the sensing system may normalize the (temperature adjusted) illumination data based on dark illumination data captured without LED illumination. In some embodiments, the sensing system may normalize the illumination data based on one or more illumination measurements determined during calibration. For example, each illumination data value (X) may be normalized using Equation 2:

[0032]

number

[0033] During the ceremony, bNormX is the normalized lighting value (in percent, multiplied by 100), such as the red, green, or blue normalized value, depending on the color for which formula 2 is calculated. ·whiteX represents illumination values ​​such as red, green and blue values ​​obtained during the calibration phase when using a white target object (further explained in conjunction with FIG. 3). ·blackX represents illumination values ​​such as red, green and blue values ​​obtained during the calibration phase when using a black target object (further explained in conjunction with FIG. 3). · calDark is the dark illumination value (when LEDs are off) determined during the calibration phase (further explained in conjunction with Figure 3). darkValue is the dark illumination value determined during step 202.

[0034] Referring to step 210, the remote device can be configured to determine a lightness AB (LABc) value. The system can determine the LABc value based on either the illumination values, whether raw illumination data or temperature-adjusted and / or normalized illumination data. For illustrative purposes, the following examples refer to normalized illumination data for simplicity. The A value can be calculated depending on the normalized illumination value. For example, depending on whether rgbNormRed is greater than rgbNormGreen, as determined using Equation 2, the A value is determined using either Equation 3 or 4.

[0035]

number

[0036] The B value can also be calculated depending on the normalized illumination value. For example, depending on whether rgbNormBlue is greater than rgbNormGreen, as determined using Equation 2, either Equation 5 or 6 is used to determine the B value. For Equations 3-6, Kn is a coefficient used in the RGB to LABc conversion, the A and B values ​​range from -100 to 100, and L ranges from 0 to 100 (e.g., 20, 21.5, 23, etc.).

[0037]

number

[0038] The L value can be calculated using Equation 7.

[0039]

number

[0040] In some embodiments, the remote device can include a table of metrics used to determine whether the lighting data satisfies a color. The remote device can include a set of colors (e.g., gray, blue, navy blue, red, and / or other colors), each color having an associated set of data. The data associated with each color can include mean data and / or sigma variation data determined during system calibration and / or design. In some embodiments, each color can include a mean for each of the A, B, and L values, and a sigma variation value for each of the A, B, and L values. The remote device can determine a sigma distance between the lighting data and each color in the stored set of colors. For example, Equation 8 can be used to determine the sigma distance for each color in the set of colors.

[0041]

number

[0042] During the ceremony, SigmaDistanceX is the sigma distance of the color under consideration (X) from the set of colors. For real-time measurements, ·L is calculated using Equation 7. ·A is calculated using either Equation 3 or 4. ·B is calculated using either Equation 5 or 6. For the color under consideration (X), μLX is the average L value for color (X). ·σLX is the sigma variation of the L value for color (X). μAX is the average A value for color (X). ·σAX is the sigma variation of the A value for color (X). μBX is the average B value for color (X). ·σBX is the sigma variation of the B value for color (X).

[0043] The remote device can use the sigma distance to determine whether the lighting data matches a color in the set of colors. For example, the remote device can select the smallest sigma distance value (Min1) as the most likely color. The next smallest value (Min2) can be used to check for matching colors, as discussed further herein.

[0044] The sensing system and / or remote device can be configured to perform one or more checks on the lighting data. For example, dark lighting data can be checked to determine whether subsequent measurements under LED illumination are being obstructed by ambient light. As another example, lighting data acquired for an LED can be checked to ensure that the lighting data is within an expected threshold between a minimum black value and a maximum white value. As a further example, 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 match color check can be performed to ensure Min1 and / or Min2 are within acceptable values. For example, Min1 can be checked to ensure that Min1 is below the maximum sigma distance for an expected color match, and / or the ratio of Min2 / Min1 can be compared to the minimum ratio between the two minimum values ​​for an acceptable match.

[0045] During calibration, the sensing device can take various measurements that can be used to calibrate real-time measurements of an object. Calibration measurements can include temperature and measurements of various lights, such as measurements using a white target, a black target, and dim lighting without any 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 temperature. In step 304, the device captures illumination data for a white target object (e.g., a white object). In step 306, the device captures illumination data for a black target (e.g., a black object). In step 308, the device captures illumination data for dim lighting without any LEDs turned on. In step 310, the device generates a set of calibration parameters. The calibration parameters can include dark measurements and / or counts read during calibration for each LED for each of the white and / or black objects, temperature, temperature margins, and / or other calibration parameters.

[0046] As described herein, the dose detection system includes a detection module having various components including a processor / MCU, sensors, and LEDs, among other components. In some embodiments, the detection module can be powered by a power source, such as, for example, one or more batteries. With reference to FIG. 1C , for example, detection system 132 includes battery 138, which powers the dose detection system, including the exemplary components shown in FIG. 1C . The techniques described herein can be used to monitor the battery life of the dose detection system. By monitoring battery life, information can be provided to the user, such as a battery status indicator that tracks battery life, battery-related warnings (e.g., alerting the user that battery life is short, when to replace the battery, etc.). For example, the dose detection system, whether using the detection module or a remote computing device, can warn the user that the battery is running low (e.g., one or two weeks before the battery life expires), providing the user with sufficient time to replace the battery.

[0047] The inventors have discovered and recognized that estimating battery life by using battery voltage measurements can be complicated due to the fact that battery behavior can depend on many variables such as temperature, relaxation time between measurements, duration of injection of the attached drug delivery device, load fluctuations, battery brand, battery fluctuations, and other parameters. To address such issues, which are often not controllable by the device provider, the inventors have developed a technique to monitor the battery based on the device architecture in a manner that provides sufficient margin for battery life to compensate for potential errors and variability that the inventors recognized may occur during battery measurements.

[0048] 4 is a flowchart of an exemplary computerized method 400 for determining battery indications, according to some embodiments. A processor, such as processing unit 140 of device 132 of FIG. 1B, can be configured to execute computer-readable instructions that cause the processor to perform method 400. In step 402, the device obtains a set of voltage measurements of the battery. In step 404, the device obtains temperature measurements (e.g., via a temperature sensing module). In step 406, the device determines a set of temperature-adjusted battery indications based on the temperature measurements. In step 408, the device determines a battery indicator indicative of the remaining life of the battery based on the temperature-adjusted battery indications and the set of voltage measurements.

[0049] Referring to step 402, the device (e.g., MCU) can obtain various voltage measurements when the battery is under different loads and / or in different operating states of the device. The power drawn from the battery is lower in a low-power state (which may be referred to as a sleep state) compared to an increased-power state (which may be referred to as an awake state). The low-power state may be implemented by (a) operating some or all components in the system at a slower clock speed than they would operate in the increased-power state, (b) shutting down some or all components that would operate and consume power in the increased-power state, or (c) both. In some embodiments, the device obtains (a) a startup battery voltage when the device is powered on, (b) a high-current battery voltage when the processor is operating at maximum speed, (c) a 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 within a certain period of time from a powered-on sensing module. For example, when the device is activated (e.g., following depression of a button (see reference number 139 in FIG. 9 )), the device may increase the draw from the battery for the electronics to an increased power state. Button 139 is configured to be more axially opposed to dose body 88 when depressed to activate switch 137 (shown having a spring-loaded arm that contacts the sensor pad for activation and removes from the sensor pad for deactivation). In some embodiments, when activated, the device may begin a startup process. The startup process may increase the draw from the battery to place the electronics in an increased power state, for example, for various self-tests, startup operations, and / or the like. In some embodiments, when activated, the device may take magnetic measurements (e.g., to determine the starting position of one or more components). Accordingly, such startup process and / or magnetic sensing may provide a high-current battery voltage to measure as a starting battery voltage.

[0050] The high-current battery voltage may, for example, capture a high (e.g., maximum) current peak, which may be used to measure the voltage drop at that time. The high-current battery voltage may, for example, be determined by running the microcontroller at maximum speed and all other loads in low-power mode for a predetermined time (e.g., in ms) 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 measurements. In some embodiments, the high-current battery voltage may be calculated at the beginning and / or end of magnetic sensor activity. For example, the maximum voltage drop of the system may be obtained when the magnetic sensor completes a measurement.

[0051] The low-current battery voltage can be used to measure the voltage drop at a 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 firmware running on the MCU placing all loads (e.g., including the MCU) in a low-power mode for a predetermined period of time (e.g., a sleep time specified in ms) and measuring the low-current battery voltage. In some embodiments, the low-current battery voltage is an average voltage calculated by averaging a set of measurements. In some embodiments, the low-current battery voltage is determined after determining the high-current battery voltage measurement.

[0052] As described herein, one or more voltage measurements can be used in step 402. For example, in some embodiments, voltages can be taken in a manner designed to obtain voltage readings at high and / or maximum current draw (e.g., points with the largest voltage drop) and representative open-circuit voltage measurements for low / lowest current draw. As described herein, the voltages can be used to estimate the remaining energy of the battery. In some embodiments, techniques can estimate the remaining battery energy using a single voltage drop, such as the maximum voltage drop (e.g., because the maximum voltage drop may be more dependent on the battery's condition compared to other voltage drops that may be more capacitively driven). For example, the voltage drop at power-on / start-up can be easily used for comparison with the maximum voltage drop. For example, if the voltage drop during power-on is greater than the system's measured maximum drop, the comparison indicates that there is a risk that a component may be reset.

[0053] Referring to step 406, the device may store a battery indication table at various temperatures. For example, the device may store a set of low temperature battery indications that includes 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., at 0°C).

[0054] [Table 1]

[0055] As another example, the device may 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., at 22-24°C).

[0056] [Table 2]

[0057] The detection system may determine a set of temperature adjusted battery indications based on the set of low temperature battery indications, the set of high temperature battery indications, and the set of temperature measurements obtained in step 402. In some embodiments, the detection system (e.g., via firmware executing on the MCU) may determine a correction factor based on the temperature measured in step 404. For example, the detection system may determine the correction factor based on the measured temperature and one or more correction factors. Logarithmic (as shown below) and / or linear relationships may be developed to characterize the correction factor. For example, the detection system may determine the correction factor using Equation 9.

[0058]

number

[0059] During the ceremony, ·corrFactor is the correction factor. A, B, and C are coefficients (e.g., determined based on data collected to provide the desired degrees of freedom for determining the correction factors). LogOffset is a coefficient (eg, determined based on collected data to provide the desired degrees of freedom for determining the correction factor).

[0060] 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 modified battery indications based on both the 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.

[0061]

number

[0062] During the ceremony, corrBatCurve x is 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 to determine 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.

[0063] Referring to step 408, the device may determine a battery indicator based on a previous battery indicator. For example, the device may obtain a previous battery indicator for the battery, determine a current battery indicator for the battery based on the battery indications temperature adjusted with a modified battery table and set of voltage measurements, and determine the battery indicator based on the previous battery indicator and the current battery indicator.

[0064] In some embodiments, the detection system can determine a current battery indicator based on the stored battery table and / or the revised battery table. For example, the detection system can interpolate a point in the revised 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 a voltage value in the table, the detection system can determine that the battery indicator is the indicator associated with that table row. As another example, if the high-current battery voltage is between two voltage values ​​in the table, the detection system can interpolate between the two associated battery indicators to determine the associated battery indication.

[0065] In some embodiments, the detection system can determine a new battery indicator based on a previous battery indicator (e.g., 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.

[0066]

number

[0067] During the ceremony, newBatInd is the new battery indicator. batInd is the previous battery indicator (e.g., retrieved from EEPROM). · curBatInd is the currently determined battery indicator. FILTER is a filter value. FILTER may be determined based on the time elapsed since the last operation associated with the sensing system (e.g., a communication synchronization with a remote computing device, such as remote computing device 104), a bonding event with a remote computing device, and / or detection of a dose administered by an associated drug delivery device.

[0068] The detection system can store (e.g., in EEPROM) the determined new battery indicator. In some embodiments, additional data, such as a timestamp, number of remaining injections, etc., can be stored along with the new battery indicator. For example, the initial number of injections can be set by a system associated with the new detection system and / or the new battery, and the detection system can be configured to reduce the number of injections for each detected injection via the drug delivery device.

[0069] The device can transmit the 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 configured to determine the battery status based on the battery indicator. By way of example, Table 3 below shows exemplary battery statuses and associated battery indicators (as a percentage of the design capacity for delivering the maximum number of injections).

[0070] [Table 3]

[0071] In some embodiments, the sensing device may enter a low battery state when the sensing device first sets a low battery flag (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 may avoid transitioning out of the low battery state for that battery (e.g., to avoid moving back and forth between a low battery state and a non-low battery state). In some embodiments, the sensing device may be configured to decrement the battery indicator by one for each new sensing device operation (e.g., synchronization, bonding, or dose event) once it is in the low power state. In some embodiments, the sensing device may be configured to decrement the number of remaining injections by one for each new sensing device operation once it is in 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 may be replaced, and the sensing system may be reset upon detecting a new battery. In some embodiments, the sensing system is disposable and may be discarded when it reaches its end-of-life state and has reached the end of its life.

[0072] In some embodiments, the detection system may perform one or more checks on the data obtained and / or measurements obtained during the battery monitoring process. For example, the MCU may issue a low battery warning if the new battery indicator falls below a predetermined threshold. As another example, the detection system may check whether the detected voltage is within a predetermined tolerance, whether the temperature measurement is within a predetermined tolerance, etc.

[0073] 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, Figures 5-12 depict exemplary drug delivery devices and dose sensing systems that can incorporate the technology. Such technology is further discussed in PCT Publication No. WO2019 / 164955, filed February 20, 2019, and incorporated herein by reference.

[0074] 5-6 illustrate an exemplary drug delivery device 10, according to some examples. The drug delivery device 10 is a pen injector configured to inject a medication into a patient through a needle. The pen injector 10 includes a body 11 with an elongated pen housing 12, including 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 medication 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 including 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, forcing the contained medication through the needle end. The injection mechanism includes a drive member 28 , illustratively in the form of a screw axially movable relative to the housing 12 , for advancing a piston 26 through the reservoir 20 .

[0075] The dose setting member 30 is coupled to the housing 12 for setting the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a threaded element operable to helically move (i.e., move axially and rotationally simultaneously) relative to the housing 12 during dose setting and dose dispensing. Figures 5 and 6 show the dose setting member 30 fully threaded into the housing 12 in its home or zero dose position. The dose setting member 30 is operable to thread 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.

[0076] 6-8 , the dose setting member 30 includes a cylindrical dose dial member 32 having a helically threaded outer surface that engages a correspondingly threaded inner surface of the housing 12 to enable the dose setting member 30 to move helically relative to the housing 12. The dose dial member 32 further includes a helically threaded inner surface that engages a threaded outer surface of a sleeve 34 ( FIG. 6 ) of the device 10. The outer surface of the dial member 32 includes dose indicator markings, such as numbers, viewable through a dose window 36 to indicate the set dose to the user. The dose setting member 30 further includes a tubular flange 38 coupled to the open proximal end of the dial member 32 and axially and rotationally locked to the dial member 32 by a detent 40 received within an opening 41 of the dial member 32. The dose setting member 30 may further include a collar or skirt 42 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 tabs 44 received in slots 46. Further embodiments described below illustrate skirtless devices.

[0077] Thus, the dose setting member 30 can be considered to include any or all of the dose dial member 32, flange 38, and skirt 42, as they are all rotationally and axially fixed together. The dose dial member 32 is directly involved in setting the dose and driving the delivery of the medication. The flange 38 is attached to the dose dial member 32 and cooperates with a clutch to selectively couple the dial member 32 to the dose knob 56, as described below. The skirt 42 provides a surface on the exterior of the body 11 so that a user can rotate the dial member 32 to set the dose. In embodiments without a skirt, the dose knob 56 includes an outer wall that extends distally to form a surface for the user to rotate.

[0078] The skirt 42 illustratively includes a plurality of surface features 48 and annular ridges 49 formed on the outer surface of the skirt 42. The surface features 48 are illustratively longitudinally extending ribs and grooves spaced circumferentially around the outer surface of the skirt 42 to facilitate a user's gripping and rotating the skirt. In alternative embodiments, the skirt 42 is removed or integrated with the dial member 32, and the user can grip and rotate the dose knob 56 and / or the dose dial member 32 for dose setting. In the embodiment of FIG. 8, the user can grip and rotate the radially outer surface of the integrated dose knob 56, which also includes a plurality of surface features, for dose setting.

[0079] The delivery device 10 includes an actuator 50 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 further includes a dose knob 56 positioned proximal to the skirt 42 of the dose setting member 30. The dose knob 56 includes a mounting collar 58 ( FIG. 6 ) centrally located on the distal face of the dose knob 56. The collar 58 is attached to the stem 54 of the clutch 52, such as by an interference fit or ultrasonic welding, to axially and rotationally secure the dose knob 56 and clutch 52 together.

[0080] The dose knob 56 includes a disc-shaped proximal end surface or face 60 and a distally extending, radially inwardly spaced-apart annular wall portion 62 at the outer periphery of the face 60, forming an annular lip 64 therebetween. The proximal face 60 of the dose knob 56 serves as a pressing surface to which a force can be applied manually, i.e., directly by a user, to push the actuator 50 distally. The dose knob 56 illustratively includes a concave portion 66 centrally located on 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 a distal surface 70 of the knob 56 and a proximal surface 72 of the tubular flange 38 to bias the actuator 50 and the dose setting member 30 axially away from each other. The dose knob 56 is depressible by a user to initiate a dose dispensing operation.

[0081] The delivery device 10 is operable in both a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, the dose setting member 30 is dialed (rotated) relative to the housing 12 to set the desired dose to be delivered by the device 10. Dialing proximally functions to increase the set dose, and dialing distally functions to decrease the set dose. The dose setting member 30 is adjustable in rotational increments (e.g., clicks) corresponding to the smallest incremental increase or decrease in the set dose during the dose setting operation. For example, one increment or "click" may be equal to one-half or one unit of medication. The set dose is visible to the user via dial indicator markings shown through the dosing window 36. The actuator 50, including the dose knob 56 and clutch 52, moves axially and rotationally with the dose setting member 30 during dialing in the dose setting mode.

[0082] The dose dial member 32, flange 38, and skirt 42 are all rotationally fixed to one another and rotate to extend proximally of the drug delivery device 10 during dose setting due to the threaded connection between the dose dial member 32 and the housing 12. During this dose setting operation, the dose knob 56 is rotationally fixed relative to the skirt 42 by complementary splines 74 ( FIG. 6 ) on the flange 38 and clutch 52, which are biased together by a biasing member 68. During the dose setting process, the skirt 42 and dose knob 56 helically move relative to the housing 12 from a “start” position to an “end” position. This rotation relative to the housing is proportional to the dose being set by operation of the drug delivery device 10.

[0083] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 properly penetrates, for example, the user's skin. The dose-dispensing mode of operation is initiated in response to a distal axial force applied to the proximal face 60 of the dose knob 56. The axial force is applied directly to the dose knob 56 by the user, which moves the actuator 50 axially distally relative to the housing 12.

[0084] The axial movement of the actuator 50 compresses the biasing member 68, reducing or closing the gap between the dose knob 56 and the tubular flange 38. This relative axial movement separates the clutch 52 and the complementary splines 74 on the flange 38, thereby releasing the actuator 50, e.g., the dose knob 56, from its rotationally fixed relationship to the dose setting member 30. Specifically, the dose setting member 30 is rotationally decoupled from the actuator 50, allowing rearward drive rotation of the dose setting member 30 relative to the actuator 50 and housing 12. Operation in the dose dispensing mode may also be initiated by activating a separate switch or trigger mechanism.

[0085] As the actuator 50 continues to be pushed axially without rotating relative to the housing 12, the dial member 32 screws back into the housing 12 as it rotates relative to the dose knob 56. Dose markings indicating the amount remaining to be injected are visible through the window 36. As the dose setting member 30 is screwed distally, the drive member 28 is advanced distally to force the piston 26 through the reservoir 20 and expel the medication through the needle 24 (FIG. 6).

[0086] During a 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. Injection is completed when the internal threads of the dial member 32 reach the distal end of the corresponding external threads of the sleeve 34 (FIG. 6). The device 10 is then repositioned in the ready or zero-dose position as shown in FIGS. 6 and 7.

[0087] The start and end angular positions of the dose dial member 32, and therefore the rotationally fixed flange 38 and skirt 42, relative to the dose knob 56 provide an "absolute" change in angular position during dose delivery. Determining whether the relative rotation has exceeded 360° may be determined in several ways. By way of example, a full rotation may be determined by also taking into account the incremental movement of the dose setting member 30, which may be measured in any number of ways by a sensing system.

[0088] Various sensor systems are contemplated herein. Generally, a sensor system includes a sensing element and a sensed element. The term "sensing element" refers to any component capable of detecting the relative position of the sensed element. A sensing element includes a sensing element or "sensor" along with associated electrical components for operating the sensing element. A "sensed element" is any component capable of detecting the position and / or movement of the sensed element relative to the sensing element. In the case of a dose delivery detection system, the sensed element rotates relative to the sensing element, thereby detecting the angular position and / or rotational movement of the sensed element. In the case of a dose-type detection system, the sensing element detects the relative angular position of the sensed element. A sensing element may include one or more sensing elements, and a sensed element may include one or more sensed elements. A sensor system can detect the position or movement of the sensed element and provide an output representative of the position or movement of the sensed element.

[0089] A sensor system typically detects a characteristic of a sensed parameter that varies in relation to the position of one or more sensed elements within a sensed region. The sensed elements extend into or otherwise influence the sensed region in a manner that directly or indirectly affects the characteristic of the sensed parameter. The relative positions of the sensor and sensed elements affect the characteristic of the sensed parameter, allowing a microcontroller unit (MCU) of the sensor system to determine different rotational positions of the sensed elements.

[0090] A suitable sensor system may include a combination of active and passive components. If the sensing element is operating as an active component, both components do not need to be connected to a power source or other system elements such as an MCU.

[0091] Any of a variety of sensing technologies capable of detecting the relative position of two members may be incorporated. Such technologies may include, for example, technologies based on tactile, optical, inductive, or electrical measurements. Such technologies may include measuring a sensed parameter related to a field, such as a magnetic field. In one form, a magnetic sensor detects changes in the sensed magnetic field when a magnetic component is moved relative to the sensor. In another embodiment, a sensor system may detect changes to the characteristics of and / or to the magnetic field when an object is placed in and / or moved through the magnetic field. The field variations change the characteristics of the sensed parameter related to the position of the sensed element within the sensed region. In such embodiments, the sensed parameter may be capacitance, conductance, resistance, impedance, voltage, inductance, or the like. For example, a magnetoresistive sensor detects distortions in an applied magnetic field that result in a characteristic change in the resistance of the sensor element. As another example, a Hall effect sensor detects changes in voltage resulting from distortions in an applied magnetic field.

[0092] In one aspect, the sensor system detects the relative position or movement of the sensed element and therefore the associated member of the drug delivery device. The sensor system produces an output representative of the position or amount of movement of the sensed element. For example, the sensor system may be operable to generate an output from which rotation of the dose setting member during dose delivery can be determined. An MCU is operatively connected to each sensor to receive the output. In one aspect, the MCU is configured to determine the dose delivered by operation of the drug delivery device from the output.

[0093] The dose delivery detection system involves detecting relative rotational movement between the two members. The sensor system operates to detect the amount of angular movement from the start of dose injection to the end of dose injection, with the degree of rotation having a known relationship to the dose delivered. For example, a typical relationship for a pen injector is that an 18° angular displacement of the dose setting member equals one unit dose, although other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, an angular displacement of 90° would result in five unit doses being delivered.

[0094] One approach to detecting angular displacement is to count dose increments as the injection progresses. For example, the sensor system can use a repeating pattern of sensed elements, with each repetition being an indication of a predetermined degree of rotation angle. Advantageously, the pattern can be established so that each repetition corresponds to the smallest dose increment that can be set using the medication delivery device.

[0095] An alternative approach is to detect the start and stop positions of the relatively moving members and determine the delivered dose as the difference between those positions. In this approach, part of the determination may involve a sensor system detecting the number of full rotations of the dose setting member. Various methods for this are well within the purview of those skilled in the art and may include "counting" the number of increments to assess the number of full rotations.

[0096] The sensor system components can be permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dose detection system are provided in the form of modules that are removably attached to the drug delivery device. This has the advantage that these sensor components can be used with more than one pen injector.

[0097] In some embodiments, the sensing element is attached to the actuator and the sensed element is attached to the dose setting member. The sensed element may also include the dose setting member or any part thereof. The sensor system detects relative rotation of the sensed element, and therefore the dose setting member, during dose delivery, from which the dose delivered by the drug delivery device is determined. In an exemplary embodiment, a rotation sensor is attached to and rotationally fixed with the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the sensed element is attached to and rotationally fixed with the dose setting member, which rotates relative to the actuator and the device body during dose delivery. The sensed element may also include the dose setting member or any part thereof. In an exemplary embodiment, the rotation sensor is not directly attached to the dose setting member, which rotates relative to the actuator and the device body during dose delivery.

[0098] 9, there is shown in schematic form a dose delivery detection system 80 including one example of a module 82 useful in combination with a drug delivery device such as device 10. Module 82 carries a sensor system shown schematically as a rotation sensor 86 (or more than one rotation sensor) and other associated components such as a processor, memory, battery, etc. Module 82 is provided as a separate component that can be removably attached to the actuator.

[0099] The dose detection module 82 includes a body 88 attached to the dose knob 56 (shown in dashed lines). The body 88 illustratively includes a cylindrical sidewall 90 and a top wall 92 that extends over and seals the sidewall 90. The dose detection module 82 may alternatively be attached to the dose knob 56 via any suitable fastening means, such as a snap or press fit, a threaded interface, or the like, provided that in one aspect the module 82 can be removed from a first drug delivery device and subsequently attached to a second drug delivery device. Attachment may be anywhere on the dose knob 56, provided that the dose knob 56 can move axially any desired amount relative to the dose setting member 30, as discussed herein.

[0100] During dose delivery, the dose setting member 30 is free to rotate relative to the dose knob 56 and the module 82. In an exemplary embodiment, the module 82 is rotationally fixed with the dose knob 56 and does not rotate during dose delivery. This may be provided structurally, for example, with tabs, or by having opposing splines or other surface features on the module body 88 and dose knob 56 that engage upon axial movement of the module 82 relative to the dose knob 56. In another embodiment, pushing the module distally creates sufficient frictional engagement between the module 82 and the dose knob 56 to keep the module 82 and dose knob 56 functionally rotationally fixed together during dose delivery.

[0101] The top wall 92 is spaced from the face 60 of the dose knob 56, thereby providing a cavity 96 in which some or all of the rotation sensor and other components may be contained. 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 knob 56. Alternatively, the bottom wall 98, if present, may be spaced from the dose knob 56, and other contact between the module 82 and the dose knob 56 may be used so that axial forces applied to the module 82 are transmitted to the dose knob 56. In another embodiment, the module 82 may be rotationally fixed to the one-piece dose knob arrangement.

[0102] In an alternative embodiment, the module 82 during dose setting is instead attached to the dose setting member 30. For example, the sidewall 90 may include a lower wall portion 100 having inward protrusions in the form of coupling arms 102 that engage the knob sidewalls. In this manner, the module 82 may effectively engage the proximal face 60 of the dose knob 56 and the distal side of the annular ridge 49. In this configuration, the lower wall portion 100 may be provided with surface features that engage with surface features of the dose knob to rotationally secure the module 82 to the dose knob. Rotational forces applied to the housing 82 during dose setting are thereby transmitted to the dose knob by virtue of the coupling between the lower wall portion 100 and the sidewalls of the dose knob. A light guide 118 is shown disposed between the LEDs 114A-C and light sensor 110, when present, and the face of the dose knob 56, which are collectively shown at a single location on the electronics assembly. A battery 138 is shown disposed on the illumination system 89 and part of the electronics assembly.

[0103] An exemplary electronics assembly 120 includes a flexible printed circuit board (FPCB) having multiple electronic components. The electronics assembly includes a sensor system including one or more rotation sensors 86 in operative communication with a processor for receiving signals from the sensors representative of sensed relative rotation. The electronics assembly further includes an MCU having at least one processing core and internal memory. An example schematic of an electronics assembly is shown in FIG. 1B.

[0104] 10A, 10B, 11A, and 11B, an exemplary magnetic sensor system 150 is shown that includes an annular ring-shaped bipolar magnet 152 having a north pole 154 and a south pole 156 as the sensed element. The magnets described herein are sometimes referred to as diametrically magnetized rings. The magnet 152 is attached to the flange 38 and therefore rotates with the flange during dose delivery. The magnet 152 may alternatively be attached to the dose dial 32 or other member that is rotationally fixed to the dose setting member. The magnet 152 may be constructed from a rare earth magnet, such as neodymium, and a variety of other materials.

[0105] The sensor system 150 further includes a measurement sensor 158 including one or more sensing elements 160 operatively connected to sensor electronics (not shown) contained within the module 82. The sensing element 160 of the sensor 158 is shown in FIG. 11A mounted on a printed circuit board 162 that is rotationally mounted to the module 82, which is rotationally fixed to the dose knob 56. As a result, the magnet 152 rotates relative to the sensing element 160 during dose delivery. The sensing element 160 is operable to detect the relative angular position of the magnet 152. The sensing element 160 may include an inductive sensor, a capacitive sensor, or other non-contact sensor if the ring 152 is a metal ring. This allows the magnetic sensor system 150 to detect the full rotation of the flange 38 relative to the dose knob 56, and thus relative to the housing 12, during dose delivery. In one example, the magnetic sensor system 150 including the sensor 158 having the magnet 152 and the sensing element 160 may be disposed within a module.

[0106] In one embodiment, the magnetic sensor system 150 includes four sensing elements 160 spaced equiradially within the module 82 to define a ring pattern, as shown. Alternative numbers and locations of sensing elements may be used. For example, in another embodiment shown in FIG. 11B, a single sensing element 160 is used. Furthermore, while the sensing element 160 in FIG. 11B is shown as being centered within the module 82, other locations may be used. In another embodiment shown in FIG. 12, for example, five sensing elements 906 are spaced equicircumferentially and equiradially within the module. In the foregoing embodiment, the sensing element 160 is shown mounted within the module 82. Alternatively, the sensing element 160 may be mounted on any portion of a component that is rotationally fixed to the dose knob 56 to prevent the component from rotating relative to the housing 12 during dose delivery.

[0107] For purposes of illustration, magnet 152 is shown as a single, annular, bipolar magnet attached to flange 38. However, alternative configurations and locations of magnet 152 are contemplated. For example, the magnet may include multiple poles, such as alternating north and south poles. In one embodiment, the magnet includes a number of pole pairs equal to the number of distinct rotational dose setting positions of flange 38. Magnet 152 may also include several separate magnetic members. Additionally, the magnetic components may be attached to any portion of a member that is rotationally secured to flange 38 during dose delivery, such as skirt 42 or dose dial member 32.

[0108] Alternatively, the sensor system may be an inductive or capacitive sensor system. This type of sensor system utilizes a sensed element that includes a metal strip attached to a flange, similar to the magnetic ring attachment described herein. The sensor system may further include one or more sensing elements, such as four, five, six, or more independent antennas or armatures, equiangularly spaced along the distal wall of the module or pen housing. The antennas form antenna pairs spaced 180 degrees or other angles apart to provide a ratiometric measurement of the angular position of the metal ring proportional to the delivered dose.

[0109] The metal band ring is shaped to 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 electronics assembly, such that the antenna functions to detect the position of the metal ring relative to the sensor, and therefore 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 multiple different metal elements. In one embodiment, the metal band includes a number of elements equal to the number of distinct rotational dose setting positions of the flange. Alternative metal bands can be attached to any portion 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 a rotating member on the inside or outside of 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.

[0110] The MCU is operable to determine the starting position of the magnet 152 by averaging a number (e.g., four) of sensing elements 160 at a maximum sampling rate according to standard quadrature differential signal calculations. During dose delivery mode, sampling at a target frequency is performed by the MCU to detect the number of rotations 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 a number (e.g., four) of sensing elements 160 at a maximum sampling rate according to standard quadrature differential signal calculations. The MCU is operable to determine from the determined starting position, number of rotations, and calculation of the total angle of rotation from the final position. The MCU is operable to determine the number of administration steps or units by dividing the total angle of rotation by a predetermined number (e.g., 10, 15, 18, 20, 24, etc.) that correlates to the device design and drug.

[0111] 12, which illustrates another example of a magnetic sensor system 900 including a diametrically magnetized ring 902 having a north pole 903 and a south pole 905 as a sensing element. The magnetized ring 902 is attached to a dose setting member, such as a flange, as previously described. The radial placement of magnetic sensors 906, such as Hall effect sensors, relative to the magnetized ring 902 can be equiangular with respect to each other in a ring pattern. In one example, the magnetic sensors 906 are radially disposed in overlapping relationship with the outer periphery 902A of the magnetized ring 902, such that a portion of the magnetic sensor 906 lies across the magnetized ring 902 and a remaining portion lies outside the magnetized ring 902.

[0112] 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 an apparatus is removably coupled to a drug injection device, according to some embodiments. A detection system, such as a dose delivery detection system, includes multiple detection elements. For example, the detection system includes several detection elements, such as four or five detection elements, spaced equally circumferentially and equally radially within the apparatus. As described herein, the multiple detection elements can include multiple Hall effect sensors. In some embodiments, five Hall effect sensors are equally spaced at 72 degrees around a circle with a diameter designed based on the magnetic components of the drug delivery device being detected. For example, a diameter of approximately 14 mm can be used so that the sensors indicate an envelope described by the maximum value of the Z component of the magnetic field as the magnet rotates around its axis. The detection system also includes a processor (e.g., MCU) in communication with the set of detection elements.

[0113] The sensing system (via its processor, such as an MCU) is configured to execute computer-readable instructions that cause the processor to perform computerized method 1300. In step 1302, the sensing system obtains a set of voltage measurements from each of a plurality of sensing elements. In step 1304, the sensing system determines two-dimensional data representative of the magnetic fields of the magnetic components of the drug injection device. In step 1306, the sensing system determines one-dimensional data based on the two-dimensional data. In step 1308, the sensing system determines, based on the one-dimensional data, whether the set of voltage measurements is indicative of an apparatus coupled to the drug injection device.

[0114] Referring to step 1302, when the power-on button to the detection system (see button 139 and switch 137 in FIG. 9 ) is pressed by the user, switch 137 is actuated to start the detection system, and firmware running on the processor switches on the sensing elements (e.g., magnetic sensors) to assume a starting position of the magnetic components of the drug delivery device (e.g., before rotation occurs). During this phase, it is important to take sensor readings immediately after start-up to avoid taking measurements during rotation. In some embodiments, the detection system can average a number of samples from each sensor (e.g., 5, 10, 15, etc. from each sensor), for example, to reduce noise.

[0115] Referring to step 1304, in some embodiments, the sensing system determines a quadrature signal including an in-phase (I) portion and a quadrature (Q) portion. The system can determine the I and Q values ​​based on a sum of each sensor value. In some embodiments, the sensing 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 sensing system stores one coefficient for each sensor by which the sensor values ​​are multiplied during summation to determine the I value, and a second coefficient for each sensor by which the sensor values ​​are multiplied during summation to determine the I value. In some embodiments, the coefficients can be used to combine the results of multiple sensors (e.g., five sensors equally spaced 72 degrees from each other) for the I and Q calculations. In some embodiments, the coefficients can be obtained by solving a system of equations that forces the results of the quadrature calculation to have zero error compared to the nominal angle of the measured signal, prior to offset, second harmonic distortion, third harmonic distortion, and / or the like.

[0116] Referring to step 1306, in some embodiments, the detection system determines the scale factor based on the two-dimensional signal (e.g., the 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 may determine the scale factor based on the following Equation 12:

[0117]

number

[0118] During the ceremony, ·ScaleFactor is the scale factor. ·I is the in-phase part of the quadrature signal. ·Q is the quadrature part of the quadrature signal. ·OI is the offset measured on the I signal during calibration. OQ is the offset measured in the Q signal during calibration. GI is the gain measured on the I signal during calibration. GQ is the gain measured on the Q signal during calibration.

[0119] Such exemplary I and Q offsets and gains can be used because quadrature works properly when I and Q are balanced, such as when the offset is equal to zero and the gain is equal to one. A calibration process can be used to determine the offset / gain that balances the measured I and Q to achieve sufficient values, removes skew between I and Q, etc. In some embodiments, the detection system can be configured to normalize the I and Q values ​​and use them to determine the normalized angle of the Z component of the magnetic field. After the dose is administered, the detection 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 techniques similar to those described herein to monitor magnet rotation and / or by determining the end position of the magnet).

[0120] Referring to step 1308, the detection system can determine whether the one-dimensional data indicates that the detection system is coupled (or not coupled) to the drug delivery device. The detection system can use the scale factor to determine whether the detection system is attached to or coupled to the drug delivery device. For example, if the scale factor is between predetermined thresholds, the detection system can determine that the detection system is attached to the drug delivery device. If the scale factor is not between the predetermined thresholds, the detection system can determine that the detection system is likely not attached to the drug delivery device. In some embodiments, the detection system can check the scale factor against a low amplitude margin and a high amplitude margin to determine whether the magnet the module is monitoring is the expected magnet (e.g., approximately + / - 25% of the nominal value is acceptable), thereby ensuring that only required amplitudes are accepted by the module.

[0121] Figure 14 shows a dose delivery detection system 80 including at least some aspects of a system module 1400, which may comprise one or more of the electronics and / or components shown in Figures 1A, 1B, 1C, in any combination. In one embodiment, the system includes detection systems 101, 130, 150, 1400, and one or any combination of the other systems described herein. System 80 is shown in communication via signal 1475 to a remote computing system 104, such as a smartphone.

[0122] The user interface of the system 80 can be further enhanced to provide user information during operation of the system 80 based on its on-board functionality, which may or may not be combined with the off-board functionality of the remote computing system 104. To this end, the system 80 is provided with one or more light indicators for generating light indication patterns. The system 80 may also be provided with a display, an audible unit, or other known indication systems. In one embodiment, the system 80 does not include a display. The light indicator 1412 (which may comprise one or more LEDs, as discussed above) may use various colors and blinking patterns to indicate various use case types. As used herein, a "use case type" is a state or status of the system 80. The system 80 may occupy one of several different use case types. Each use case type may indicate a device status, such as, for example, successful or unsuccessful pairing with a remote computing device, successful or unsuccessful injection, successful or unsuccessful manual synchronization with a remote computing device, and battery status. In some embodiments, the system may be configured to indicate one of the use case types. In other embodiments, the system may be configured to indicate a combination or sequence of two or more use case types. In other embodiments, the system may be configured to indicate a combination of two or more use case types in a single indication, such as with a light indicator 1412, without an on-board display.

[0123] In one embodiment, the detection system may be configured to indicate a combination of battery status and one of the other use case types with a light indication, such as light indicator 1412, without an on-board display. The light indication pattern may be a combination of a first segment of the pattern indicating one of the use case types, a delay segment of the pattern indicating a time delay, and a second segment of the pattern indicating another of the use case types. The color and blinking pattern may be different for each segment. In one embodiment, the detection system may check a scale factor against a low amplitude margin and a high amplitude margin to determine if the magnet the module is monitoring is the expected magnet (e.g., approximately + / - 25% of the nominal value is acceptable), thereby ensuring that only the required amplitude is accepted by the module.

[0124] 15 is a flowchart of an exemplary computerized method 1500 for generating a light indication pattern indication signal to a user of system 80, according to some embodiments. In step 1502, the detection system (via its processor, MCU, etc.) determines a use case type configuration from a plurality of use case type configurations, which may be pre-stored in the processor's memory. In step 1504, the detection system determines a battery life status category from a plurality of battery life statuses, which may be pre-stored in the processor's memory. In step 1506, the detection system provides a light indication pattern comprising a first light indication segment based on the use case type configuration determined from step 1502 and a second light indication segment based on the battery life status determined from step 1504 immediately after a delay period after completion of the first light indication segment.

[0125] FIG. 16 is a flowchart of an exemplary computerized method 1600 for determining a use case type configuration from a plurality of use case type configurations, which can be used in step 1502, according to some embodiments. As can be seen in method 1600, the determined use case type can then be used to determine at least one aspect of the light indication pattern, and in one embodiment, the first segment of the light indication pattern. In step 1602, the detection system (via its processor, MCU, etc.) determines whether and for how long the power-on module has been activated. In optional step 1604, the detection system determines whether a detected element is present. For a fully integrated device, the detected element will always be present, and this step can be omitted. For a dose detection system that removably couples to an injection device, this step can be included in multiple steps. In step 1606, the detection system determines whether the detected element is moving. Steps 1602, 1604, and 1606 can be used individually or in any combination thereof to define a use case type configuration. Although steps 1610, 1612, and 1614 are described including step 1604, steps 1610, 1612, and 1614 can be described without determining "yes" to the presence of a sensing element. It is also contemplated that a use case type may depend on determining one, two, or all of steps 1602, 1604, and 1606.

[0126] In step 1610, if the detection system determines that the sensed element is not moving and the power-on module is continuously activated for the first time range, the detection system is configured to provide a first pattern for the first light indication segment. Optionally, a determination of whether the sensed element is present may also occur before the detection system's determination that the sensed element is not moving. In such cases, the detection system may also need to determine that the sensed element is present before providing the first pattern. In 1612, if the detection system determines that the sensed element is not moving and the power-on module is continuously activated for a second time range, the detection system is configured to provide a second pattern for the first light indication segment. Optionally, a determination of whether the sensed element is present may also occur before the detection system's determination that the sensed element is moving. In such cases, the detection system may also need to determine that the sensed element is present before providing the second pattern. At 1614, if the detection system determines that the sensed element is moving, the detection system is configured to provide a third light indication pattern for the first light indication segment. Optionally, a determination of whether the sensed element is present may also occur before the detection system's determination that the sensed element is moving. In such a case, the detection system may also need to determine that the sensed element is present before providing the third pattern.

[0127] In one example, if the sensed element is not moving and the power-on module is continuously activated for a first time range, then the sensing system may be configured to implement a use case type configuration for manual data synchronization with a remote computing system, for example, to push data from the sensing system to the remote computing system. This is the use case type configuration corresponding to 1610 in FIG. 16. In one embodiment, when the sensing system implements the manual data synchronization use case type configuration, the sensing system places itself in a low-power state. With further reference to FIG. 9, a user can depress button 139 axially into dose body 88 to activate power-on module 1406 (button 139 and power-on switch 137 collectively constitute power-on module 1406) for a first period of time in the range of 3 to 10 seconds. Note that power-on module 1406 may include a contactable switch. This time range may be modified to be wider, narrower, higher, and / or lower. The detection system can determine whether a magnetic sensed element, such as magnetized ring 902, is rotating by determining that the starting angular position and final angular position, as described above, of a magnetized sensing element having a magnetic sensor, such as magnetic sensor 906 (shown as sensing element 1402), remain unchanged. If there is a change in angular position, the system can determine that there is movement, and if there is no change in angular position, the system can determine that there is no movement. After the user deactivates power-on switch 137 by releasing button 139 and the first time range expires, the detection system can provide a pattern for the first light indication segment, such as flashing the green LED of light indicator 1412 on and off (e.g., 300 ms on / 300 ms off), for multiple cycles, such as three cycles. The color of the LED, the on and off times, and the number of cycles can vary. The detection system can then store data in its memory 1408 indicating the manual synchronization event.

[0128] In one example, a use case type configuration may be for pairing with a remote computing system when the sensed element is not moving and the power-on module is continuously activated for a second time range. This use case type configuration corresponds to 1612 in FIG. 16. In one embodiment, the sensing system is in a low-power state. A user can depress button 139 axially relative to dose body 88 to activate power-on switch 137 for a second period in the range of 10 to 20 seconds. This pairing time range can be modified to be wider, narrower, higher, and / or lower. The second time range for pairing is longer than the first time range. The sensing system can determine whether a magnetic sensed element, such as magnetized ring 902, is rotating by determining that the starting angular position and final angular position, as described above, of a magnetized sensing element having a magnetic sensor, such as magnetic sensor 906 (shown as sensing element 1402), remain unchanged. After the user deactivates the power-on switch by releasing button 139 and the second time range expires, the detection system can provide a different second pattern for the first light indication segment. The different second pattern can be based on whether the pairing is successful or unsuccessful.

[0129] Within the second time range, the detection system may provide a first version of a second pattern for the first light indication segment, such as, for example, flashing the green LED of the light indicator 1412 (e.g., 1000 ms), which may be a single cycle or multiple cycles. This can be used to notify the user that pairing has been successfully initiated and to release the button. The detection system may then store data indicative of the successful pairing initiation event in its memory 1408. After the button is released, the communication unit 1410 of the detection system may initiate a signal advertisement to the remote computing system, and after successful bonding, the communication device 1467 of the remote computing system transmits a signal to the detection system. After successful reception of the remote computing system's transmission by the detection system, the detection system may provide a second version of the second pattern for the first light indication segment that differs from the first version of the second pattern, such as, for example, flashing the green LED of the light indicator 1412 on and off for multiple cycles, such as three cycles (e.g., 300 ms on / 300 ms off). The color of the LED, the length of time it is on and off, and the number of cycles may vary. The detection system may then store data in its memory 1408 indicating the successful pairing event.

[0130] If the pairing is unsuccessful or lost, i.e., if the communication unit 1410 of the detection system initiates a signal advertisement to the remote computing system and does not successfully connect for some reason, the detection system fails to receive a signal about successful bonding from the communication device 1467 of the remote computing system. After unsuccessful pairing, the detection system may provide a third version of the second pattern for the first light indication segment that differs from the first and second of the second pattern, such as, for example, flashing the amber LED of the light indicator 1412 on and off for multiple cycles (e.g., three cycles, etc.) (e.g., 100 ms on / 100 ms off / 100 ms on / 100 ms off / 100 ms on / 400 ms off, etc.). The color of the LED, the on and off durations, and the number of cycles may be different. The detection system may then store data indicative of the successful or unsuccessful pairing event (whatever is determined) in its memory 1408.

[0131] In one example, the use case type configuration may be in a typical injection state of operation when the sensed element is in motion. This is the use case type configuration corresponding to 1614 in FIG. 16 . In one embodiment, the sensing system is in a low-power state. A user can set a dose by turning a system coupled to the dose knob, and the user can press down on the system / dose knob to initiate medication delivery. While the user is pressing down, button 139 can be pressed axially relative to dose body 88 to activate the power-on module. The sensing system can determine whether a magnetic sensed element, such as magnetized ring 902, is rotating by determining that the starting angular position and, as described above, the final angular position of a magnetized sensing element having a magnetic sensor, such as magnetic sensor 906 (shown as sensing element 1402), have changed. After the detection system successfully detects the sensing element rotation, the detection system can provide a third pattern for the first light indication segment, such as, for example, flashing the green LED of light indicator 1412 on and off for multiple cycles, such as three cycles (e.g., 300 ms on / 300 ms off, etc.). The color of the LED, the on and off duration, and the number of cycles can vary. The detection system can then store data indicative of a successful injection event.

[0132] FIG. 17 is a flowchart of an exemplary computerized method 1700 for determining a light indication pattern based on the remaining battery state life, as in step 1504, according to some embodiments. As can be seen in method 1700, the determined remaining battery life state can then be used to determine at least one aspect of the light indication pattern, and in one embodiment, a second segment of the light indication pattern. In step 1702, the detection system (via its processor, MCU, etc.) determines the remaining battery life state. In step 1704, if the remaining battery state is in a first state indicating a relatively high battery charge, the system is configured to determine a first pattern of the second light indication segments. In step 1706, if the remaining battery state is in a second state indicating a relatively low battery charge, the system is configured to determine a second pattern of the second light indication segments. In step 1708, if the remaining battery state is in an intermediate third state (i.e., between the first and second states), the system is configured to determine a third pattern of the second light indication segments.

[0133] For steps 1702, 1704, 1706, and 1708, there may be various ways to determine the remaining battery life status by checking the electrical characteristics of the power source and comparing it to a full charge to determine the percentage of full charge. In one embodiment, FIG. 4 shows a flowchart of an exemplary computerized method for determining a battery indication for the remaining battery status. For example, using Table 3 above, a first state may be when the battery indicator's determination for the remaining battery life status is in a high range, e.g., between 5 and 100 percent of full charge; a second state may be when the battery indicator's determination for the remaining battery life status is in a low range, e.g., between 0 and 1% of full charge; and a third state may be when the battery indicator's determination for the remaining battery life status is in an intermediate range, e.g., between 1 and 4 percent of full charge.

[0134] In one embodiment, if the detection system determines that the remaining battery life status is in the high first state described above, the detection system can provide a first pattern of the second light indication segments in step 1704, such as no blinking. This can indicate to the user that the remaining battery life status is “normal.” In other embodiments, the first pattern of the second light indication segments can include a blinking sequence of LED colors, with the on and off lengths and number of cycles varying. In one embodiment, if the detection system determines that the remaining battery life status is in the low second state described above, the detection system can provide a second pattern of the second light indication segments in step 1706 that differs from the first pattern, such as blinking the green and amber LEDs of light indicator 1412 for one or more cycles. In one example, the on and off can be 100 ms on / 100 ms off / 100 ms on / 100 ms off / 100 ms on / 400 ms off for multiple cycles (e.g., three cycles). This may indicate to a user that the remaining battery life status is "end of life." In some embodiments, the color of the LED, the length of on and off, and the number of cycles may vary. In one embodiment, if the detection system determines that the remaining battery life status is in the above-described intermediate third state, the detection system may provide, in step 1708, a third pattern of the second light indication segment that is different from the first and second patterns, such as the amber LED and / or green LED of light indicator 1412 turning on and off for multiple cycles (e.g., 3 cycles, etc.) (e.g., 150 ms amber on / 150 ms green on, etc.). This may indicate to a user that the remaining battery life status is "low remaining life." The color of the LED, the length of on and off, and the number of cycles may vary.

[0135] As described herein, the detection system provides a single light indication (LI) having a pattern of a first light indication segment (SI) and a pattern of a second light indication segment (S2) with a delay (D) between the segments (i.e., LI = SI + D + S2). In one embodiment, the maximum total cycle time for a single light indication (LIt) may be 6.4 seconds, with a first segment (SIt) comprising 2.7 seconds, a second segment (S2t) comprising 2.7 seconds, and a delay (Dt) of 1 second delay between (i.e., LIt = SIt + Dt + S2t). In one embodiment, such as for an injection use case for a successful injection and high battery life remaining condition, the total cycle time for a single light indication (LIt) may be 1.8 seconds, with a first segment (SIt) comprising 1.8 seconds, a second segment (S2t) comprising 0 seconds (or no second segment), and a delay (Dt) of 1 second delay between. In one embodiment, for example, for a first pairing use case for successful pairing and a high battery life remaining condition, the total cycle time for a single light indication (L1t) may be 2.0 seconds, with a first segment (S1t) comprising 1.0 seconds, a second segment (S2t) comprising 0 seconds (or no second segment), and a delay (Dt) of 1 second delay in between.

[0136] 18 is a flowchart of an exemplary computerized method 1800 for generating an indication to a user of the dose detection system 80 if the power-on module 1406 of the dose detection system is undesirably activated continuously for a period of time, causing premature depletion of the power source (described below as an exemplary battery), according to some embodiments. For example, a one- or two-year lifespan is reduced to less than one year. Most systems have an internal battery configured to power the system for an extended period of time without recharging. In step 1804, the detection system (via its processor, MCU, etc.) determines whether the power-on module has been activated. Battery depletion can occur with the dose detection system alone, i.e., not coupled to the injection device 10, or while coupled to the device 10.

[0137] In step 1806, the detection system provides an increase in power drawn from the battery to power the detection system electronics in the increased power state. Optionally, in step 1802 (shown in dashed lines), the detection system may determine whether the dose detection system is coupled to the delivery device before step 1804. Determining whether the dose detection system is coupled is described herein. In step 1808, if the detection system determines that the power-on module has been continuously activated for a first period while the system is in the increased power state, it reduces the power drawn from the battery by the detection system electronics to a low power state. In step 1810, if the detection system determines that the power-on module has been continuously activated for a second period in addition to the first period, it increases the power drawn from the battery by the detection system electronics to the increased power state to store data indicative of an event and / or communicate an event signal to a remote computing system. After such event is stored, the system may return to a low power state such that the power drawn from the battery is reduced. Optionally, in step 1812, the remote computing system can provide an indication to the user based on the event signal received from the detection system. This indication can be in the form of sound, light, image, and / or alphanumeric text via the display 1461 of the remote computing system, via a mobile app to the user of system 80. For example, the user can be reminded about the proper handling and care of the dose detection system and / or a warning message, such as, for example, "Remove pressure from button." Types of warnings, in addition to app warnings, can include generating a message for communication via a messaging system on the display of the user's smartphone or another smartphone designated by the user.

[0138] The detection system may continue to monitor the continuous operation of the power-on module for an additional period, a second period (after which the system returns to a low power state), until action is taken by the user to address the problem. For example, if the power-on module is continuously activated for a third period in addition to the first and second periods, the detection system may increase the power drawn from the battery by the system from a low power state to an increased power state and generate another event. The third period may be longer than the first period. In one example, the third period may be the same amount of time as the second period described above. In another example, subsequent periods may be shorter and shorter in the form of escalating subsequent warnings to the user.

[0139] In one embodiment, to determine how long the power-on module has been activated, in step 1807, the system is configured to measure how long the power-on module is continuously maintained in an activated state. If the button 139 is pressed axially into the dose body 88 and the power-on module 1406 is continuously activated for a first period of time, measured by the RTC 1414, for example, in the range of approximately 20 to 60 seconds, in one embodiment, after 60 seconds, the system may consider this an accidental press. This time period may be modified to be shorter or longer than 60 seconds. The initial press of the button 139 will activate the switch 137 to increase the power drawn from the battery by the detection system electronics to an increased power state, as in step 1806. When in the increased power state, the detection system enables powering of a sensing component, such as a Hall Effect sensor, to detect any movement of the sensed element of the injection device. If there is no movement, then the activation may have been accidental. After, for example, 60 seconds of continuous operation, the detection system may reduce the power drawn from the battery by the detection system's electronics to a low power state. The detection system may then store data indicative of an event, such as, for example, "button still pressed," in its memory 1408. In one embodiment, if the power-on module remains continuously activated for a second period of time (after the system returns to the low power state) that is longer than the first period, the system may return to an increased power state. The second period of time may range, for example, from 1 to 9 minutes, and in one embodiment, is 9 minutes as measured by the RTC 1414. The combined total number of minutes of continuous operation is the sum of the first period and the second period, and after the expiration of the second period, the detection system provides an increase in power drawn from the battery by the detection system's electronics from the low power state to the increased power state in order to store data indicative of the event. The stored event may be, for example, "button still pressed" and / or an event signal may be transmitted to the communication device 1467 of the remote computing system 104 via the communication unit 1410 of the dose detection system 80.For example, the combined total time may be 10 minutes of continuous operation (1 minute for the first period and 9 minutes for the second period). For example, the combined total time may be 5 minutes of continuous operation (1 minute for the first period and 4 minutes for the second period). The transmission of the event may occur any time there is storage of the event, or may occur during the next connection to the remote computing system. If the detection system monitors continuous operation of the power-on module beyond the second period, additional events may be triggered and stored. In one embodiment, the system may go through the steps once to transmit only one event signal to the remote computing device.

[0140] In addition to, or rather than generating an event signal based on monitoring the amount of time the power-on module is activated, an event signal may be generated in method 1800 by monitoring the number of times the power-on module is activated during or during an injection event in steps 1804 and 1807. For example, the system may generate an event signal when it determines that the number of presses is in a range, such as 10-40 presses / minute, for a total time, such as in a range, such as 1-5 minutes. In one example, the system may generate an event signal when the number of presses is 30 presses / minute for a total time of 2 minutes, or 60 total presses for 2 minutes. Once the number of presses over a selected period of time is reached, the system may increase the power drawn by the system from the battery to an increased power state to store the event and / or communicate the event to a remote computing system configured to generate a warning indication from the device. An exemplary computerized method for generating a sound, light, image, or alphanumeric text indication to a user of the system 80 via a mobile app when the power-on module 1406 of the dose detection system is activated intermittently for a number of times that may lead to premature battery or power source depletion, according to some embodiments.

[0141] The dose detection system has been described using a particular design of a drug delivery device, such as a pen injector, as an example. However, the exemplary dose detection system may also be used with alternative drug delivery devices and with other detection configurations that are operable in the manner described herein. For example, any one or more of the various detection and switching systems may be omitted from the module.

[0142] The various methods or processes outlined herein may be coded as software executable on one or more processors using any one of a variety of operating systems or platforms. In addition, such software may be written using any of a number of suitable programming languages ​​and / or programming or scripting tools, and compiled as executable machine code or intermediate code that runs on a virtual machine or suitable framework.

[0143] In this regard, various inventive concepts may be embodied as at least one non-transitory computer-readable storage medium (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, circuitry 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, perform various embodiments of the present invention. The non-transitory computer-readable medium or media may be portable such that the one or more programs stored thereon can be loaded onto any computer resource to implement various aspects of the present invention as discussed above.

[0144] The terms "program," "software," and / or "application" are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions employed to program a computer or other processor to implement various aspects of the embodiments as discussed above. Additionally, it should be understood that, according to one aspect, one or more computer programs that, when executed, implement the methods of the present invention need not reside on a single computer or processor, but may be distributed in a modular manner among different computers or processors to implement various aspects of the present invention.

[0145] Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of the program modules may be combined or distributed as desired in various embodiments.

[0146] Also, data structures may be stored in any suitable form on a non-transitory computer-readable storage medium. A data structure may include fields that are related by location within the data structure. Such relationships may be achieved by allocating storage to the fields with locations in the non-transitory computer-readable medium that in turn convey the relationship between the fields. However, any suitable mechanism may be used to establish relationships between information in fields of a data structure, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0147] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, while shown as sequential acts in the exemplary embodiments, embodiments may be constructed in which actions are performed in an order different from that illustrated, which may include performing some acts simultaneously.

[0148] As used herein in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one," unless clearly indicated to the contrary. As used herein in the specification and claims, the phrase "at least one," in connection with a list of one or more elements, should be understood to mean at least one element 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 in the list of elements, nor does it exclude any combination of elements in the list of elements. Thus, elements other than those specifically identified in the list of elements to which the phrase "at least one" refers can optionally be present, whether related or unrelated to those elements specifically identified.

[0149] The phrase "and / or," as used herein in the specification and claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so conjoined. Other elements other than the elements specifically identified by the "and / or" clause may optionally be present, whether related to those elements specifically identified or not. Thus, as a non-limiting example, a reference to "A and / or B," when used in combination with open-ended language such as "comprising," may, in one embodiment, be a reference to A only (optionally including elements other than B); in another embodiment, a reference to B only (optionally including elements other than A); in yet another embodiment, a reference to both A and B (optionally including other elements); and so forth.

[0150] As used in this specification and the claims, "or" should 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" should be interpreted as inclusive, i.e., to include at least one, but not more, of a plurality of elements or a list of elements, and, optionally, to include additional, unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," refer to the inclusion of exactly one element of a plurality of elements or a list of elements. Generally, as used herein, the term "or" when followed by exclusive terms such as "either," "one of," "only one of," or "exactly one of," should be interpreted to indicate exclusive selection (i.e., "one or the other but not both"). "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0151] In the claims, the use of ordinal terms such as "first," "second," "third," etc. to modify claim elements does not, by itself, imply any priority, precedence, or ordering of one claim element relative to another claim element, or the temporal order in which the actions of a method are performed. Such terms are used solely as labels to distinguish one claim element having a particular name from another element having the same name (but by virtue of the use of ordinal terms).

[0152] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof, is meant to encompass the items listed thereafter and additional items.

[0153] While several 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 by way of example only and is not intended to be limiting.

[0154] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0155] 1. A system configured to generate a light indication pattern for a dose detection system, the system comprising one or more light emitting diodes (LEDs), one or more batteries, and a processing circuit, the processing circuit configured to determine a use case type from a plurality of use case types for the dose detection system, determine a battery life status of the one or more batteries from a plurality of battery life statuses, and provide a light indication pattern via the one or more LEDs, the one or more LEDs comprising: (i) a first light indication segment based on the determined use case type; and (ii) a second light indication segment based on the determined battery life status after a delay period after completion of the first light indication segment.

[0156] 2. The system of aspect 1, further comprising a power-on module switchable between an active state and an inactive state, wherein the processing circuit determines whether the power-on module is in an active state continuously for a period of time, and the use case type is determined based at least in part on the determined period of continuous operation of the power-on module.

[0157] 3. The system of aspect 1 or 2, further comprising a sensing element configured to sense movement of a sensed element used during dose injection, wherein the processing circuit determines whether the sensed element is present via the sensing element, and determines a use case type based on the determined presence of the sensing element.

[0158] 4. The system of aspect 4, wherein the processing circuit determines whether the sensed element is moving via the sensing element, and determines the use case type based on the determined movement of the sensing element.

[0159] 5. The system of aspect 1, further comprising a power-on module switchable between an activated state and an inactivated state, and a sensing element configured to sense movement of a sensed element used during dose injection, wherein the processing circuitry (a) determines whether the power-on module is continuously activated for a period of time, and (b) determines whether the sensed element is moving via the sensing element, and the use case type is determined based on the determined period of continuous activation of the power-on module and the determined movement of the sensing element.

[0160] 6. The system of aspect 5, wherein when the continuous operating period of the power-on module is within a first time range and when the processing circuit determines that the sensed element is not moving, the processing circuit provides a first pattern of a first light indication segment of a single light indication pattern via the set of LEDs.

[0161] 7. The system of aspect 5 or 6, wherein when the continuous operating period of the power-on module is within a second time range and the processing circuit determines that the sensed element is not moving, the processing circuit provides a second pattern of the first light indication segments of the single light indication pattern via the set of LEDs.

[0162] 8. The system of any one of aspects 5-7, wherein when the sensed element is determined to be moving, the processing circuit provides a third pattern of the first light indication segments of the single light indication pattern via the set of LEDs.

[0163] 9. The system of any one of aspects 5-8, wherein the determined battery life state comprises a first state, a second state, a third state, or any combination thereof.

[0164] 10. The processing circuitry A system as described in aspect 9, wherein in response to determining that the battery life state is a first state, a first pattern of second light indication segments is provided, in response to determining that the battery life state is a second state, a second pattern of second light indication segments is provided, and in response to determining that the battery life state is a third state, a third pattern of second light indication segments is provided.

[0165] 11. The system of aspect 1, further comprising: a power-on module switchable between an activated state and an inactivated state; and a sensing element configured to sense movement of a sensed element used during dose injection; wherein the processing circuitry (a) determines whether the power-on module is continuously activated for a period of time; (b) determines via the sensing element whether the sensed element is present; and (c) determines via the sensing element whether the sensed element is rotating; and the use case type is determined based on the determined presence of the sensing element during the determined period of continuous activation of the power-on module and the determined rotational movement of the sensing element; and wherein the dose detection system is removably attached to the pen injection device, the dose detection system including the sensing element, the power-on module, and an LED, and the pen injection device includes the sensed element.

[0166] 12. The system of aspect 11, wherein the sensing element comprises a plurality of magnetic sensors and the sensed element comprises a rotatable magnetic ring.

[0167] 13. A method for generating a single light indication pattern for a dose detection system, the dose detection system including one or more light emitting diodes (LEDs) and one or more batteries, the method comprising: determining a use case type from a plurality of use case types for the dose detection system; determining a battery life status of the one or more batteries from a plurality of battery life statuses; and providing a light indication pattern via the one or more LEDs comprising: a first light indication segment based on the determined use case type; and a second light indication segment based on the determined battery life status after a delay period after completion of the first light indication segment.

[0168] 14. The method of aspect 13, wherein the step of determining the use case type includes at least one of determining a continuous operation period of the power-on module, determining whether a sensed element is present via the sensing element, and determining whether the sensed element is moving via the sensing element.

[0169] 15. The method of aspect 14, wherein when the continuous operation period of the power-on module is within a first time range and it is determined that the sensed element is not moving, the step of providing the light indication pattern includes providing a first pattern of first light indication segments of the light indication pattern via one or more LEDs; when the continuous operation period of the power-on module is within a second time range and it is determined that the sensed element is not moving, the step of providing the light indication pattern includes providing a second pattern of the first light indication segments via one or more LEDs; or when it is determined that the sensed element is moving, the processing circuit provides a third pattern of the first light indication segments via one or more LEDs.

[0170] 16. The method of aspect 15, wherein the step of determining one battery life state includes distinguishing the battery life state among a first state, a second state, and a third state, and the step of providing a single light indication pattern includes providing a first pattern of second light indication segments when the battery life state is in the first state, providing a second pattern of second light indication segments when the battery life state is in the second state, or providing a third pattern of second light indication segments when the battery life state is in the third state.

[0171] 17. A system configured to reduce battery drain for a dose detection system, the system comprising: a power-on module switchable between an active state and an inactive state; a battery; and a processing circuit configured to execute computer-readable instructions that cause the processing circuit to increase the power drawn from the battery by the system to an increased power state when the power-on module is switched from the inactive state to the active state; measure how long the power-on module is continuously maintained in the active state; if the power-on module is continuously in the active state for a first period of time, reduce the power drawn from the battery by the system to a low power state; thereafter, if the power-on module is continuously in the active state for a second period of time in addition to the first period of time, increase the power drawn from the battery by the system from the low power state to an increased power state; generate an event; and store data indicative of the event in a memory of the dose detection system.

[0172] 18. The system of aspect 17, wherein the processing circuitry is further configured to communicate the data indicative of the event to a remote computing system, and the remote computing system is configured to generate a notification indicative of the event to a user of the remote computing system.

[0173] 19. The system of aspect 17 or 18, wherein the processing circuit further reduces the power drawn from the battery to a low power state after the data indicative of the event is stored, and then, if the power-on module is continuously in an operational state for a third period in addition to the first and second periods, increases the power drawn from the battery from the low power state to an increased power state, generates a second event, and stores data indicative of the second event in the memory.

[0174] 20. The system of aspect 19, wherein the processing circuit is further configured to communicate the data indicative of the second event to a remote computing system, and the remote computing system is configured to generate a second notification indicative of the second event to a user of the remote computing system.

[0175] 21. The system of aspect 19 or 20, wherein the first period of time is in the range of 20 seconds to 1 minute, and the second period of time and the third period of time are each longer than the first period of time.

[0176] 22. The system of aspect 17 or 18, wherein the first period of time is in the range of 20 seconds to 1 minute, and the second period of time is longer than the duration of the first period of time.

[0177] 23. A method for reducing battery drain for a dose detection system, the system including a power-on module and a battery, the method comprising: when the power-on module is switched to an active state, increasing power drawn from the battery by the system to an increased power state; measuring how long the power-on module is continuously maintained in the active state; when a period of time includes a first period, if the power-on module is in the active state continuously during the period, reducing power drawn from the battery by the system from the increased power state to a low power state; thereafter, when the period of time includes a second period in addition to the first period, if the power-on module is in the active state continuously, increasing power drawn from the battery by the system from the low power state to an increased power state; generating an event; and storing data indicative of the event in a memory of the dose detection system.

[0178] 24. The method of aspect 23, further comprising communicating data indicative of the event to a remote computing system, the remote computing system configured to generate a notification indicative of the event to a user of the remote computing system.

[0179] 25. The method of aspect 24, further comprising: after data indicative of the event is stored, reducing the power drawn from the battery by the system to a low power state; and thereafter, if the power-on module is continuously in an operational state for a third period in addition to the first and second periods, increasing the power drawn from the battery by the system from the low power state to an increased power state to generate a second event; and storing data indicative of the second event in the memory.

[0180] 26. The method of aspect 25, further comprising communicating data indicative of the second event to a remote computing system, the remote computing system configured to generate a second notification indicative of the second event to a user of the remote computing system.

[0181] 27. The method of aspect 25 or 26, wherein the first period of time is in the range of 20 seconds to 1 minute, and the second period of time and the third period of time are each longer than the first period of time.

[0182] 28. The method of embodiment 23, wherein the first period of time is in the range of 20 seconds to 1 minute, and the second period of time is longer than the duration of the first period of time.

[0183] 29. The system of aspect 1 or aspect 17, further comprising a drug delivery device to which the dose detection system is coupled, the drug delivery device containing a drug.

[0184] 30. A system configured to reduce battery drain for a dose detection system, the system comprising: a power-on module switchable between an active state and an inactive state; a battery; and a processing circuit configured to execute computer-readable instructions that cause the processing circuit to increase power drawn from the battery by the system to an increased power state when the power-on module is switched from the inactive state to the active state; measure how many times the power-on module is in the active state in a period of time; and if the power-on module is in the active state a first number of times in a first period of time, increase power drawn from the battery by the system from a low power state to an increased power state; generate an event; and store data indicative of the event in a memory of the dose detection system.

[0185] 31. A method for reducing battery drain for a dose detection system, the system including a power-on module and a battery, the method including: when the power-on module is switched to an active state, increasing power drawn from the battery by the system to an increased power state; measuring how many times the power-on module is in the active state during a period of time; when the period includes a first period of time, if the power-on module is in the active state continuously during the period, reducing power drawn from the battery by the system from the increased power state to a low power state; when the power-on module is in the active state a first number of times during the first period of time, increasing power drawn from the battery by the system from the low power state to an increased power state and generating an event; and storing data indicative of the event in a memory of the dose detection system.

Claims

1. 1. A system configured to generate a light indication pattern for a dose detection system, the system comprising: a sensing element configured to sense movement of a sensed element used during dose injection; one or more light emitting diodes (LEDs); one or more batteries; a processing circuit, the processing circuit comprising: determining whether the sensed element is moving via the sensing element; determining a use case type from a plurality of use case types indicative of a system state for the dose detection system based on the determined movement of the sensed element; determining a battery life status of the one or more batteries from a plurality of battery life statuses; and configured to provide a single light indication pattern via the one or more LEDs, the one or more LEDs comprising: (i) a first light indication segment based on the determined use case type; and (ii) a second light indication segment based on the determined battery life status after a delay period after completion of the first light indication segment.

2. 2. The system of claim 1, further comprising a power-on module switchable between an active state and an inactive state, wherein the processing circuitry determines whether the power-on module is in the active state continuously for a period of time, and wherein the use case type is determined based at least in part on the determined period of continuous operation of the power-on module.

3. A system as described in claim 1 or 2, wherein the processing circuit determines whether the detected element is present via the detection element, and determines the use case type based on the determined presence of the detected element.

4. 3. The system of claim 2, wherein the processing circuit provides a first pattern of the first light indication segments of the single light indication pattern via the set of LEDs when the continuous activation period of the power-on module is within a first time range and when the processing circuit determines that the sensed element is not moving.

5. 5. The system of claim 4, wherein when the continuous activation period of the power-on module is within a second time range and when the processing circuit determines that the sensed element is not moving, the processing circuit provides a second pattern of the first light indication segments of the single light indication pattern via the set of LEDs.

6. 6. The system of claim 4 or 5, wherein when the sensed element is determined to be moving, the processing circuitry provides a third pattern of the first light indication segments of the single light indication pattern via the set of LEDs.

7. The system of any one of claims 4 to 6, wherein the determined battery life state comprises a first state, a second state, a third state, or any combination thereof.

8. The processing circuitry providing a first pattern of the second light indication segments in response to determining the battery life status to be the first state; providing a second pattern of the second light indication segments in response to determining the battery life status to be the second state; 8. The system of claim 7, providing a third pattern of the second light indication segments in response to determining the battery life condition to be the third state.

9. a power-on module switchable between an active state and an inactive state, (a) determining whether the power-on module is continuously in the operational state for a period of time; (b) determining whether the sensed element is present via the sensing element; and (c) determining whether the detected element is rotating via the detecting element; the use case type is determined based on the determined continuous operation period of the power-on module, the determined presence of the sensed element, and the determined rotational movement of the sensed element; 2. The system of claim 1, wherein the dose detection system is removably attached to a pen injection device, the dose detection system including the sensing element, the power-on module, and the LED, and the pen injection device includes the sensed element.

10. The system of claim 9 , wherein the sensing element comprises a plurality of magnetic sensors and the sensed element comprises a rotatable magnetic ring.

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