Method and apparatus for dose detection system module assembly for drug delivery device

Abstract

The technology described herein relates to a computerized method and system for generating at least one of a single light indication pattern for a dose detection system via an LED based, for example, on a use case type and a battery life state type. The case types may include pairing, manual synchronization, and / or dose injection, and the battery life state types may include 1 to 3 different states. Another method and system for reducing battery consumption of a dose detection system by monitoring continuous activation of a power-on module and / or alerting a user in a manner to enable the user to take action. At least a portion of the information obtained from these techniques may be communicated to a paired remote electronic device, such as a user's smartphone.

Description

[0001] This application is a divisional application of the patent application with application number 202180055110.6, filed on July 23, 2021, and titled “Methods and apparatuses for dose detection system module aspects for drug delivery devices”. TECHNICAL FIELD

[0002] The present invention relates to the technology of electronic dose detection systems for drug delivery devices, and in particular to the technology for detecting connection to a drug delivery device, determining the type of drug delivery device, and monitoring battery life. BACKGROUND

[0003] Patients suffering from various ailments must often inject themselves with medication. To allow a person to conveniently and accurately self-administer medication, a variety of devices, broadly referred to as pen injectors or injection pens, have been developed. Typically, these pens are equipped with a cartridge that includes a piston and contains a multi-dose supply of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication, typically through a needle from an outlet at the distal end of the cartridge. In disposable or pre-filled pens, after the pen has been used to deplete 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 deplete the supply of medication in the cartridge, the pen is disassembled to allow a used cartridge to be replaced with a new cartridge, and then the pen is reassembled for its subsequent use.

[0004] 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 that the device operates to deliver. Accordingly, efforts have been made in the art to provide reliable systems that accurately measure the relative motion of the members of a drug delivery device in order to assess the dose delivered. Such systems can include a sensor fixed to a first member of the drug delivery device and detecting the relative motion of a sensed component fixed to a second member of the device.

[0005] The administration of a proper amount of medication requires that the drug delivery device deliver an accurate dose. Many pen injectors and other drug delivery devices do not include a function to automatically detect and record the amount of medication delivered by the device during an injection event. Without an automatic system, the patient must manually record the amount and time of each injection. Accordingly, there is a need for a device that is operable to automatically detect the dose delivered by a drug delivery device during an injection event. Further, there is a need for such a dose detection device that is detachable and reusable in conjunction with multiple delivery devices. In other embodiments, there is a need to integrate such a dose detection device with a delivery device. SUMMARY

[0006] In one embodiment, systems and methods configured to generate a light indication pattern for a dose detection system are disclosed. For example, the system can include one or more light emitting diodes (LEDs), one or more batteries, and processing circuitry. The processing circuitry can be configured or the method steps can: 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 light indication pattern can include (i) a first light indication portion based on the determined use case type, and (ii) a second light indication portion based on the determined battery life status after a delay following completion of the first light indication portion.

[0007] In another embodiment, systems and methods configured to reduce battery consumption of a dose detection system are disclosed. For example, the system can include a power-on module that can be switched between an active state and an inactive state; a battery; processing circuitry. The processing circuitry can be configured or the method steps can: increase power drawn by the system from the battery to an increased power state upon the power-on module being switched from the inactive state to the active state; and measure how long the power-on module remains in the active state. If the power-on module remains in the active state for a first time period, then decrease power drawn by the system from the battery to a low power state. Subsequently, if the power-on module remains in the active state for a second time period in addition to the first time period, then increase power drawn by the system from the battery from the low power state to the increased power state, and generate an event, and store data indicative of the event into a memory of the dose detection system. BRIEF DESCRIPTION OF DRAWINGS

[0008] Other embodiments of the application will become apparent to those skilled in the art from the following description, which is given by way of example only to illustrate the application. Components in the drawings are not necessarily drawn to scale. Furthermore, in the drawings, like reference numerals designate corresponding parts throughout the several views.

[0009] Figure 1A is a schematic diagram of an exemplary system in accordance with some embodiments.

[0010] Figure 1B depicts a block diagram of a controller and components thereof in accordance with some embodiments.

[0011] Figure 1C is a schematic diagram of an exemplary system in accordance with some embodiments.

[0012] Figure 2 is a flowchart of an exemplary computerized method for determining a color associated with an object in accordance with some embodiments.

[0013] Figure 3is a flowchart of an exemplary computerized method for generating calibration parameters, according to some embodiments.

[0014] Figure 4 is a flowchart of an exemplary computerized method for determining a battery indication, according to some embodiments.

[0015] Figure 5 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate.

[0016] Figure 6 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate. Figure 5 is a cross-sectional perspective view of the exemplary drug delivery device shown in

[0017] Figure 7 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate. Figure 5 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate.

[0018] Figure 8 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate. Figure 5 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present application can operate.

[0019] Figure 9 is a side view schematic of a dose detection system module according to another exemplary embodiment, partially in cross-section, attached to a proximal portion of a drug delivery device.

[0020] Figure 10A -B and 11A-B show other exemplary embodiments of dose detection systems utilizing magnetic induction.

[0021] Figure 12 is an axial view of another exemplary embodiment of a dose delivery detection system utilizing magnetic induction.

[0022] Figure 13 An exemplary computerized method for determining whether a device is removably coupled to a drug injection device, according to some embodiments, is shown.

[0023] Figure 14 is a schematic of an exemplary system and remote computing system, according to some embodiments.

[0024] Figure 15 An exemplary computerized method for generating a single light indication pattern indication signal to a system user, according to some embodiments, is shown.

[0025] Figure 16 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, is shown.

[0026] Figure 17 An exemplary computerized method of determining a light indication pattern based on a remaining battery state life is shown in accordance with some embodiments.

[0027] Figure 18 An exemplary computerized method of producing an indication to a user in the event that a power-on module of a dose detection system is continuously enabled for a certain time is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0028] For the purposes of promoting an understanding of the principles of the application, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the application is intended by this specification.

[0029] It is important to deliver the correct medication. Depending on the specific situation, a patient can need to select a different medication or select a different form of a given medication. If the wrong medication is in the medication delivery device, the patient will not be dosed correctly and the record of the dose administered will be inaccurate. If a dose detection device is used that automatically confirms the type of medication contained by the medication delivery device, the likelihood of this occurring is greatly reduced.

[0030] The present application relates to a sensing system for a medication delivery device. In one aspect, the sensing system is used to produce a single light indication pattern for a dose detection system. The inventors have discovered and appreciated that when a dose detection system does not have a display, it can be desirable to have a light indication strategy, although the inventors recognize that a light indication strategy can still have advantages for a dose detection system that has a display. However, the inventors have discovered and appreciated that it is challenging to incorporate additional components (e.g., switches, latches, etc.) to indicate information to a user when the dose detection system is connected to a remote computing device or when an injection was successful, given the various hardware, firmware, and / or software that is desirable to include in such a dose sensing system, as well as the desire to keep the dose sensing system small, user friendly, and limited to only include components that have a low likelihood of failing due to repeated use. The technology described herein provides for utilizing existing components of a dose sensing device to determine whether the dose sensing device is coupled / coupled to a medication delivery device, whether a sensed element is moving, and for how long a power-on module is enabled, to determine different use case types. For example, a dose sensing device can include a sensor (e.g., a Hall effect sensor) and related hardware and / or software to determine the size of a dose that is administered by a medication delivery device. This technology can also utilize such hardware and / or software that is used to perform dose detection to determine whether the dose sensing system is coupled to a medication delivery device.

[0031] In a second aspect, the sensing system can be used to reduce the depletion of the sensing system battery. The inventors have discovered and appreciated that when the energizing module is enabled for a long period of time, the battery can be depleted completely much sooner than expected. The inventors have developed techniques to monitor the continued enablement of the energizing module to provide a storage event and / or to communicate with a remote computing system configured to provide some indication of the event to a user. The term "event" as used herein is defined to include any one or more of: (i) a processor interrupt, (ii) a generation of an electrical signal to propagate along a circuit, (iii) a setting or not setting of one or more bits in a register, (iv) a change in the value of a programmed variable.

[0032] For ease of illustration, the drug delivery device is described in the form of a pen-type injector. However, the drug delivery device can be any device for setting and delivering a dose of a drug, such as an infusion pump, a bolus injector, or an auto-injector device. The drug can be of any type deliverable by such a drug delivery device.

[0033] While various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of the embodiments. Accordingly, the embodiments described herein are meant to be examples and are not intended to be limiting as to the scope of embodiments and implementations. Moreover, the advantages described above are not necessarily the only advantages, and additional advantages can be realized and utilized.

[0034] The devices described herein, such as device 10, can also include a medicament, e.g., within the reservoir or cartridge 20. In another embodiment, the system can include one or more devices, including device 10 and a medicament. The term "medicament" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as insulin degludec or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered by the devices described above. The medicament used in the device can be formulated with one or more excipients. The device is typically operated by the patient, caregiver, or healthcare professional in the manner described above to deliver the medicament to a human.

[0035] Figure 1A is a schematic diagram of an exemplary system 120 according to some embodiments. The system 101 includes a sensing system 103 in communication with a remote computing device 104 through 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 combo chip, or the like.

[0036] As further described herein, the sensing system 103 can be configured to determine illumination data indicative of a color of an object. The sensing 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 an object 116 (e.g., a portion of a medication delivery device). In some embodiments, the light sensor 110 is an ambient light sensor (ALS), for example, operating in a reflective mode. The LED driver 112 is in communication with a set of light emitting diodes (LEDs) 114A, 114B, and 114C (collectively, LEDs 114) that are in optical communication with the object 116. For example, the LEDs 114 can include a red LED, a blue LED, and / or a green LED. The light sensor 110, the LEDs 114, or both the light sensor 110 and the LEDs 114 are optionally in optical communication with the object 116 through an optional light guide 118. The light guide 118 can be a transparent light guide, for example, a Makrolon 2458 light guide. In some embodiments, the color sensor is made from a separate LED, a single packaged RGB LED, or a combination thereof.

[0037] Figure 1B , with additional reference to Figure 14 which shows a detailed example of the electronic components (labeled 1400) of a sensing module, which can be included in any of the modules described herein. The electronic components include a microcontroller (labeled MCU in Figure 1B ). The MCU of the sensing system 1400 includes a processing unit, which can be or include processing circuitry. The “processing circuitry” can include one or more programmable processors, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or a combination thereof. The MCU is programmed to implement the electronic functionality of the module. The MCU includes control logic operable to perform the operations described herein, including detecting connection to a medication delivery device, determining a type of the medication delivery device, obtaining data for determining a dose delivered by the medication delivery device, and monitoring a battery life of the medication delivery device. The MCU is operable to obtain the data by detecting and / or determining an amount of rotation of a rotary sensor secured to a flange, which is determined by detecting a magnetic field of the rotary sensor by a sensing element of a measurement sensor (e.g., a Hall effect sensor) of the system.

[0038] The sensing module 1400 includes an MCU operably coupled to one or more of a dose sensing element 1402A-E, a memory 1408, an identification sensor 1404, a counter 1414, a light driver 1411 and a light indicator 1412, a power-on module 1406, a communication module 1410, a display driver / display 1416, a power source 1418, and a presence module 1420. The sensing module 1400 can include any number of sensing elements, such as five magnetic sensors 1402A-E (shown) or six sensors. The dose sensors can be used to determine total rotational units of internal pieces of the drug delivery device, which can be used to determine an administered dose (e.g., as discussed herein in connection with Figures 5-12 Further discussed), and the dose sensors can also be used to detect connection to the drug delivery device. The MCU can be configured via the presence module 1420, shown by the dashed line in this embodiment as optional, to determine via triggering of the presence switch system whether the module is coupled / coupled to the dosing button of the device. The MCU is configured to determine the color of the dosing button by the identification sensor 1404, and in some examples, using logic on the onboard sensing module 1400 or logic implemented on an external device (e.g., the remote computing device 104) to associate the determined color with a particular drug. In some embodiments, the sensing module 1400 can be configured to provide an external indication to the user indicating the color of the dosing button or the type of drug associated with a particular drug (e.g., using the LED 114, as further discussed herein). The MCU is configured to determine triggering of the power-on switch (shown as reference 137, which is activated by the button 139, as shown) in order to increase power draw from the power source to the electronic components for use, in Figure 9 Figure 14 ​The MCU is also operable to wirelessly transmit signals representing device data, e.g., rotation units, drug identification (e.g., color) data, time stamp, time since last dose, battery charge status, module identification number, module connection or disconnection time, time of inactivity, and / or other errors (e.g., dose detection and / or transmission errors, drug identification detection and / or transmission errors), to a paired remote electronic device, e.g., a user's smartphone, via 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. Illustratively, the BLE control logic and MCU are integrated on the same circuit. In one example, any of the modules described herein can include a display module 1416 (shown by dashed lines in this embodiment as optional) for indicating information to the user. Such a display, which can be an LED, LCD, or other digital or analog display, can be integrated with the proximal portion finger pad. The MCU includes display driver software modules and control logic operable to receive and process sensed data and display information on the display, e.g., dose setting, dispensed dose, injection status, injection complete, date and / or time, or time to next injection. In another example, the MCU includes an LED driver 1411 coupled to one or more LEDs 1412 (e.g., amber and green LEDs) for communicating to the patient whether data was successfully transmitted, battery power is high or low, or other clinical communications via on-off and different color sequences. A counter 1414 is shown as a Real Time Clock (RTC) electrically coupled to the MCU to track time, e.g., dose time. The counter 1414 can also be a time counter based on energization tracking seconds from zero. The time or count value can be transmitted to an external device.

[0039] Further reference is made to Figure 14The remote computing device / smartphone 104 includes a user interface 1461 in communication with a processor 1463 (which can also be referred to herein as processing circuitry), with a memory 1465 (which can be any suitable computer readable medium accessible to the processor 1463, including volatile and non-volatile memory), and a communication device 1467 configured to communicate with the communication protocol module 1410 through wired or wireless signals 1475, and which is operable to provide user input data to the system and to receive and display data, information, and prompts generated by the system. The wireless signals 1475 can be configured according to one or more of the communication protocols previously described with respect to the module 1410. The user interface includes at least one input device for receiving user input and providing user input to the system. In the illustrated embodiment, the user interface 1461 is a graphical user interface (GUI) including a touchscreen display for displaying data and receiving user input. The touchscreen display allows the 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 can be provided.

[0040] In some embodiments, as described 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., a button, a label, a color of an external compartment, etc.) that can be used to identify an aspect of the drug delivery device based on a color of the object 116. For example, the color of the object 116 can indicate a type of drug of the drug delivery device.

[0041] Figure 1C A schematic diagram of an exemplary system 130 according to some embodiments. The system 130 includes aspects of a dose detection system, including a sensing system 132 in communication with a remote computing device 134 through a communication unit 136 (e.g., via a wired and / or wireless connection). As described further herein, the sensing system 132 can be configured to determine a battery indication indicative of a remaining life of a battery 138. The device 132 includes a processing unit 140 in communication with the communication unit 136, the battery 138, and a temperature sensing unit 142.

[0042] The exemplary aspects of the dose detection system described in connection with Figures 1A-1C are for exemplary purposes to highlight various aspects of the dose detection system. Figures 1A-1C The aspects illustrated in Figures 8-12 the dose delivery detection system 80 can be combined into a single device (e.g., in connection with the dose delivery detection system 80 described) and can be implemented using, for example, the various exemplary configurations discussed in connection with those figures. While a battery is described as an exemplary power source, the teachings described herein can be applied to power sources other than batteries.

[0043] Referring to Figure 1A In some embodiments, the sensing system 103 is configured to determine a color of an object (e.g., a button of a pen-style medication delivery device). In some embodiments, the sensing system determines the object color by sequentially turning on the LEDs 114 and reading back the reflected beams by the wide-spectrum ambient light sensor 110. The sensing system 103 can generate various values, such as three values for each of the three LEDs 114. The sensing system 103 can process the generated values to generate a final color value for matching. The sensing system 103 can check the final color value against a predefined set of colors to determine if there is a match.

[0044] Figure 2 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 sensing system 103, can execute computer-readable instructions that cause the processor to perform the method 200. At step 202, the sensing system obtains illumination data of an object illuminated by a set of LEDs (light emitting diodes). The sensing system can optionally process the illumination data at steps 204 and / or 206 to generate processed illumination data. At step 204, the sensing system optionally adjusts the illumination data based on temperature. At step 206, the sensing system optionally normalizes the illumination data. At step 208, the sensing system causes a light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs. At step 208, the sensing system transmits the processed illumination data to a remote device (e.g., via a communication module in communication with the processor of the device). At step 210, the remote device determines whether the illumination metric matches a stored set of colors. If the remote device determines a match, then at step 212, the remote device outputs the matching color (e.g., to a program, a display, etc.). If the remote device does not determine a match, then at step 214, the remote device outputs that no color match was found (e.g., by returning an error code, a no-match code, etc.).

[0045] Referring to step 202, the sensing 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 of the set of LEDs, or both first illumination data when the object is not illuminated by the set of LEDs and second illumination data when the object is illuminated by each of the set of LEDs. For example, the device can be configured to capture illumination data of the object when the object is illuminated only by ambient light when the LEDs are not on. In some embodiments, the sensing system can include an exposure time during which dark illumination data is captured.

[0046] 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 as the object is illuminated by each LED. For example, as shown in FIG. 1, in some embodiments, the device includes a red LED 114A, a blue LED 114B, and a green LED 114C. The device can be configured to coordinate the light sensor 110 and the LED driver 112 to coordinate the lighting of the LEDs 114 and the capture of illumination data such that the light sensor 110 captures illumination data as the object is illuminated by the red LED 114A (and not the other LEDs), as the object is illuminated by the blue LED 114B (and not the other LEDs), and as the object is illuminated by the green LED 114C (and not the other LEDs). In some embodiments, the sensing system can be configured to use an exposure time during which the illumination data is captured, which can be the same for each LED and / or different for one or more LEDs. Figure 1A

[0047] Referring to step 204, the illumination data can be adjusted based on a temperature. In some embodiments, the temperature is taken from the ambient air, the sensing system, and / or the drug delivery device. In some embodiments, the sensing system can capture multiple temperature measurements and average the values to determine an average temperature for adjusting the illumination data. In some embodiments, the sensing system can use Equation 1 to adjust each illumination data value (X):

[0048] rgbTempX = rgbX * (I - TempCoefficientX * (Temp - CalTemp)) (Equation 1)

[0049] where:

[0050] • rgbTempX is the adjusted illumination data value determined for each color, e.g., red, green, and blue values, depending on which color Equation 1 is calculated for;

[0051] • rgbX is each original illumination data value, e.g., red, green, and blue values;

[0052] • TempCoefficientX is a temperature coefficient for each value, which can allow for the use of one coefficient to track various temperature measurements (e.g., because there can be performance drift in different temperature measurements);

[0053] • CalTemp is a temperature measured during calibration of the sensing system, which can be used to account for temperature variations (e.g., for non-calibration measurements); and

[0054] • Temp is the measured (e.g., averaged) temperature. ​

[0055] With reference to step 206, the sensing system can normalize the (temperature adjusted) illumination data based on the dark illumination data captured without LED illumination. In some embodiments, the sensing system can normalize the illumination data based on one or more illumination measurements determined during calibration. For example, Equation 2 can be used to normalize each illumination data value (X):

[0056]

[0057] where:

[0058] • bNormX is the normalized illumination value, e.g., red, green, or blue normalized value, depending on which color Equation 2 is calculated for (in percent multiplied by 100);

[0059] • whiteX represents the illumination values, e.g., red, green, and blue values, obtained during the calibration phase when a white target object is used (in conjunction with Figure 3 further described);

[0060] • blackX represents the illumination values, e.g., red, green, and blue values, obtained during the calibration phase when a black target object is used (in conjunction with Figure 3 further described);

[0061] • calDark is the dark illumination value (LEDs off) determined during the calibration phase (in conjunction with Figure 3 further described); and

[0062] • darkValue is the dark illumination value determined in step 202.

[0063] With reference to step 210, the remote device can be configured to determine a lightness A B (LABc) value. The system can determine the LABc value based on any illumination value, whether raw illumination data or temperature adjusted illumination data and / or normalized illumination data. For purposes of illustration, the following examples refer to normalized illumination data for simplicity. The A value can be calculated from the normalized illumination values. For example, based on whether rgbNormRed determined using Equation 2 is greater than rgbNormGreen, then one of Equations 3 or 4 is used to determine the A value:

[0064]

[0065] The B value can also be calculated based on the normalized lighting values. For example, based on whether rgbNormBlue is greater than rgbNormGreen as determined using Equation 2, then one of Equations 5 or 6 is used to determine the B value. For Equations 3-6, Kn is a coefficient for the RGB to LABc conversion such that the A and B values will be in the range of -100 to 100, and L is in the range of 0 to 100 (e.g., 20, 21.5, 23, etc.).

[0066]

[0067] The L value can be calculated by Equation 7:

[0068]

[0069] In some embodiments, the remote device can include a metric table for determining whether the lighting data is within a color. The remote device can include a set of colors (e.g., gray, blue, dark blue, red, and / or other colors), where each color has an associated set of data. The data associated with each color can include average data and / or sigma (Sigma) variation data determined during calibration and / or design of the system. In some embodiments, each color can include an average value for each of A, B, and L values and a sigma variation value for each of A, B, and L values. The remote device can determine a sigma distance for the lighting data and each color in the set of colors. For example, Equation 8 can be used to determine the sigma distance for each color in the set of colors:

[0070]

[0071] where:

[0072] • SigmaDistanceX is the sigma distance of the color (X) under consideration from the set of colors;

[0073] • For real-time measurements:

[0074] o L is calculated using Equation 7;

[0075] o A is calculated using Equation 3 or 4;

[0076] o B is calculated using Equation 5 or 6;

[0077] • For the color (X) under consideration:

[0078] o μLX is the average value of the L value for the color (X);

[0079] o σLX is the sigma variation of the L value for the color (X);

[0080] o μAX is the average value of the A value for the color (X);

[0081] o σAX is the sigma variation of the A value of color (X);

[0082] o μBX is the mean of the B value of color (X); and

[0083] o σBX is the sigma variation of the B value of color (X).

[0084] The remote device can use the sigma distance to determine whether the lighting data matches a color in the color set. For example, the remote device can select the smallest value (Minl) of the sigma distance values as the most likely matching color. The second smallest value (Min2) can be used for a matching color check, as discussed further herein.

[0085] The sensing system and / or remote device can be configured to perform one or more checks on the lighting data. For example, the dark lighting data can be checked to determine whether subsequent measurements under LED lighting are disturbed by ambient light. As another example, the acquired lighting data for the LEDs can be checked to ensure that the lighting data is within expected thresholds between a minimum black value and a maximum white value. As another example, the LAB c values can be checked to determine whether they are within an acceptable range (e.g., A or B is -100 to 100, L is 0 to 100). As another example, a matching color check can be performed to ensure that Minl and / or Min2 are within acceptable values. For example, Minl can be checked to ensure that Minl is below a maximum sigma distance for an expected color match, and / or a ratio of Min2 / Minl can be compared to a minimum ratio between two minimum values for an acceptable match.

[0086] During calibration, the sensing device can take various measurements that can be used to calibrate real-time measurements of the object. The calibration measurements can include temperature and various light measurements, such as measurements using a white target, a black target, and dark lighting with no LEDs turned on. Figure 3 is a flowchart of an exemplary computerized method 300 for generating calibration parameters, according to some embodiments. At step 302, the device measures temperature. At step 304, the device captures lighting data for a white target object (e.g., a white object). At step 306, the device captures lighting data for a black target (e.g., a black object). At step 308, the device captures lighting data for dark light with no LEDs turned on. At step 310, the device generates a set of calibration parameters. The calibration parameters can include an exposure time (or maximum / minimum exposure time) for dark measurements and / or for each LED (e.g., red, green, and blue LEDs), counts read during calibration for each LED in each of the white and / or black objects, temperature, temperature margin, and / or other calibration parameters.

[0087] As described herein, a dose sensing system includes a sensing module comprising various components, including a processor / MCU, a sensor, an LED, and other components. In some embodiments, the sensing module may be powered by a power source, such as one or more batteries. Reference Figure 1C For example, sensing system 132 includes a dose sensing system (including...) Figure 1C The exemplary component shown is powered by a battery 138. The techniques described herein can be used to monitor the battery life of a dose sensing system. Battery life can be monitored to provide information to the user, such as battery status indicators that track battery life, battery-related alarms (e.g., warning the user of low battery life, when to replace the battery, etc.). For example, whether via a sensing module or a remote computing device, the dose sensing system can warn the user when the battery is about to run out, thus giving the user sufficient time to replace the battery (e.g., one or two weeks before the end of battery life).

[0088] The inventors have discovered and recognized that estimating battery life, for example, using battery voltage measurements, can be complex because battery behavior can depend on numerous variables, such as temperature, relaxation time between measurements, injection duration of the attached drug delivery device, load variations, battery brand, battery variability, and other parameters. To address these issues, which are often beyond the control of the device provider, the inventors have developed a technique for monitoring batteries based on device architecture, providing sufficient margin in battery life to compensate for potential errors and variability that would otherwise occur during battery measurements.

[0089] Figure 4 This is a flowchart of an exemplary computerized method 400 for determining a battery indication, according to some embodiments. Such as Figure 1B A processor, such as a processing unit 140 in device 132, is 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-regulated battery indications based on the temperature measurements. In step 408, the device determines a battery indication indicating the remaining battery life based on the temperature-regulated battery indications and the set of voltage measurements.

[0090] 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. In a low-power state (e.g., sleep state), less electrical power is drawn from the battery compared to an increased power state (e.g., awake state). A lower power state can be achieved by (a) operating some or all components of the system at a lower clock speed than they would be operating in an increased power state, (b) shutting down some or all components that are already operating and consuming power in an increased power state, or (c) both. In some embodiments, the device obtains (a) the startup battery voltage when the device is powered on, (b) the high-current battery voltage when the processor is operating at maximum speed, (c) the low-current battery voltage when the processor is operating in a low-power mode, or some combination thereof. For example, the startup battery voltage can be determined by obtaining the high-current battery voltage within a specific amount of time from the start of powering on the sensing module. For example, when the device is woken up (e.g., upon pressing a button (see...)...) Figure 9 (following reference numeral 139 in the accompanying drawings), the device can increase draw from the battery of the electronic device to achieve the increased power state. Button 139 is configured to be more axial relative to the metering body 88 to activate switch 137 (shown as having a spring-biased arm that contacts a sensor pad for activation, and the spring-biased arm is removed from the sensor pad for deactivation) when pressed. In some embodiments, the device can initiate a full power-on process / startup process / boot-up process when woken up. The startup process can increase draw from the battery to place the electronic device in an increased power state due to, for example, various self-tests, startup operations, etc. In some embodiments, the device can perform magnetic measurements (e.g., determining the starting position of one or more components) when woken up. Thus, such a startup process and / or magnetic sensing can provide a high-current battery voltage for measurement as the startup battery voltage.

[0091] A high-current battery voltage can capture high (e.g., maximum) current peaks, which can be used, for example, to measure the voltage drop at that point. For example, a high-current battery voltage can be determined by running the microcontroller at maximum speed and operating all other loads in low-power mode for a predetermined period (e.g., in milliseconds (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 can be calculated at the start and / or end of magnetic sensor activity. For example, the maximum voltage drop of the system can be obtained when the magnetic sensor has completed its measurement.

[0092] Low current battery voltage can be used to measure voltage drop under a minimum current load, e.g., to simulate an open circuit voltage check of the battery. For example, the low current battery voltage can be determined by having firmware running on the MCU put all loads (e.g., including the MCU) into a low power mode for a predetermined time (e.g., a rest period 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 the high current battery voltage measurement is determined.

[0093] As described herein, one or more voltage measurements can be used in step 402. For example, in some embodiments, the voltage can be acquired in a manner designed to obtain a voltage reading at a high and / or maximum current draw (e.g., the point with the maximum voltage drop) as well as a representative open circuit voltage measurement at a low / minimum current draw. As described herein, the voltage can be used to estimate the remaining battery energy. In some embodiments, these techniques can use, for example, a single voltage drop, such as the maximum voltage drop, to estimate the remaining battery energy (e.g., because the maximum voltage drop can be more dependent on the battery state than other voltage drops, which can be more driven by capacitance). For example, the power-on / startup voltage drop can simply be used for comparison to the maximum voltage drop. For example, if the voltage drop during power-on is greater than the measured maximum voltage drop for the system, then this comparison can indicate that there is a risk that components can reset.

[0094] Referring to step 406, the device can store a table of battery indications at different temperatures. For example, the device can store a set of low temperature battery indications, the set of low temperature battery indications including a set of battery indications, each battery indication having an associated voltage for a low temperature. Table 1 is an example of a set of low temperature battery indications (e.g., at 0°C):

[0095]

[0096]

[0097] Table 1

[0098] As another example, the device can store a set of high temperature battery indications, the set of high temperature battery indications including a set of high temperature battery indications, each high temperature battery indication having an associated voltage for a high temperature. Table 2 is an example of a set of high temperature battery indications (e.g., at 22-24°C):

[0099]

[0100] Table 2

[0101] The sensing system can determine a set of temperature-adjusted battery indications from the set of low-temperature battery indications, the set of high-temperature battery indications, and the temperature measurements obtained at step 402. In some embodiments, the sensing system (e.g., via firmware executing on the MCU) can determine a correction factor based on the temperature measured at step 404. For example, the sensing system can determine a correction coefficient based on the measured temperature and one or more correction factors. A logarithmic (as shown below) and / or linear relationship can be established to characterize the correction coefficient. For example, the sensing system can use Equation 9 to determine the correction coefficient:

[0102] corrFactor = A * log2(Temp + LogOffset) + Temp * B + C (Equation 9)

[0103] where:

[0104] • corrFactor is the correction coefficient;

[0105] • A, B, and C are coefficients (e.g., determined based on collected data to provide a desired degree of freedom for determining the correction coefficient); and

[0106] • LogOffset is a coefficient (e.g., determined based on collected data to provide a desired degree of freedom for determining the correction coefficient).

[0107] The sensing system can determine a set of corrected battery indications (e.g., a corrected battery table) from the temperature correction coefficient. In some embodiments, the sensing system can determine the corrected battery indications based on the low-temperature and high-temperature battery tables. For example, the sensing system can use Equation 10 to determine each corrected battery voltage associated with each indication:

[0108] corrBatCurve x = {(Voltage TEMPHIx - Voltage TEMPLOx ) / (TEMPHI - TEMPLO)} * (corrFactor - TEMPLO) + Voltage

[0109] (TEMPHI - TEMPLO)} * (corrFactor - TEMPLO) + Voltage TEMPHIx (Equation 10),

[0110] where:

[0111] • corrBatCurve x is the corrected battery curve voltage for row X;

[0112] • Voltage TEMPHIx is the voltage for row X in the high-temperature battery table;

[0113] • Voltage TEMPLOxV is the voltage of row X in the low temperature battery table;

[0114] TEMPHI is the temperature used to determine the high temperature battery table;

[0115] TEMPLO is the temperature used to determine the low temperature battery table; and

[0116] corrFactor is the correction factor determined using Equation 9.

[0117] With reference to step 408, the device can determine the battery indication based on a previous battery indication. For example, the device can obtain a previous battery indication for the battery, determine a current battery indication for the battery based on the temperature-adjusted battery indication in the corrected battery table and the set of voltage measurements, and determine the battery indication based on the previous battery indication and the current battery indication.

[0118] In some embodiments, the sensing system can determine the current battery indication based on the stored battery table and / or the corrected battery table. For example, the sensing system can interpolate a point in the corrected battery table with the high current battery voltage (e.g., measured at step 402 in FIG. 4). For example, if the high current battery voltage is equal to a voltage value in the table, the sensing system can determine that the battery indication is the relevant indication for that row. As another example, if the high current battery voltage is between two voltage values in the table, the sensing system can interpolate between the two relevant battery indications to determine the relevant battery indication. Figure 4

[0119] In some embodiments, the sensing system can determine the new battery indication based on a previous battery indication (e.g., which can be stored in a memory of the sensing system, such as an EEPROM). For example, the sensing system can determine the new battery indication using Equation 11:

[0120] newBatInd = (FILTER * batInd + curBatInd) / (FILTER + 1) (Equation 11)

[0121] where:

[0122] newBatInd is the new battery indication;

[0123] batInd is the previous battery indication (e.g., obtained from the EEPROM);

[0124] curBatInd is the current determined battery indication; and

[0125] ​• FILTER is a filter value. FILTER can be determined based on an amount of time elapsed since a last operation associated with the sensing system (e.g., a communication sync with a remote computing device such as remote computing device 104, a binding event with a remote computing device, and / or a detection of a dose administered by the associated drug delivery device).

[0126] The sensing system can store the determined new battery indication (e.g., in an EEPROM). In some embodiments, additional data can be stored with the new battery indication, such as a time stamp, a number of remaining injections, etc. For example, the initial number of injections can be configured by the system associated with the new sensing system and / or new battery, and the sensing system can be configured to reduce the number of injections sensed by the drug delivery device per injection.

[0127] The device can transmit the battery indication to a remote device (e.g., remote computing device 104). The remote device can process the new battery indication. For example, the remote device can be configured to determine a battery state based on the battery indication. As an example, Table 3 below shows exemplary battery states and related battery indications (as a percentage of the designed capacity to deliver a maximum number of injections):

[0128]

[0129]

[0130] Table 3

[0131] In some embodiments, once the sensing device first issues a low power flag, the sensing device can enter a low power state (e.g., when the device is unlikely to provide more than a certain number of injections, such as 120 injections). Once in the low battery state, the sensing device can refrain from changing the low battery state of the battery (e.g., refrain from moving back and forth from the low battery state and the non-low battery state). In some embodiments, the sensing device can be configured such that each new operation of the sensing device (e.g., a sync, a bind, or a dose event) decreases the battery indication by 1 once it is in the low power state. In some embodiments, the sensing device can be configured such that each new operation of the sensing device decreases the number of remaining injections by 1 once it is in the low power state. Once the battery indication equals zero, the sensing system can enter an end-of-life state. In some embodiments, the battery can be replaced, and the sensing system can reset upon detection of a new battery. In some embodiments, the sensing system is disposable and can be discarded upon reaching the end-of-life state.

[0132] In some embodiments, the sensing system can perform one or more checks on data obtained and / or measurements made during the battery monitoring process. For example, the MCU can issue a low power warning once a new battery indicates below a predetermined threshold. As another example, the sensing system can check that the sensed voltage is within a predetermined acceptable range, that the temperature measurement is within a predetermined acceptable range, and / or the like.

[0133] As described herein, the technology can be used in various types of drug delivery devices, including drug delivery devices incorporating aspects described herein, as well as additional components that can be attached to drug delivery devices. For illustrative purposes, Figures 5-12 Exemplary drug delivery devices and dose sensing systems that can incorporate these technologies are described. Such technology is discussed further in PCT Publication No. WO 2019 / 164955, filed February 20, 2019, which is incorporated by reference herein.

[0134] Figures 5-6 An exemplary drug delivery device 10 according to some examples is shown. The drug delivery device 10 is a pen injector configured to inject a medicament into a patient through a needle. The pen injector 10 includes a main body 11 including an elongated pen-shaped 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 Figure 6 The distal portion 14 contains a reservoir or cartridge 20 configured to hold a medicament fluid of a medicament to be dispensed through a distal outlet end thereof 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 closed by a removable cap 25. A piston 26 is located in the reservoir 20. An injection mechanism located in the proximal portion 16 is operable to advance the piston 26 toward the outlet of the reservoir 20 during a metered dispensing operation to force the contained medicament through the needle end. The injection mechanism includes a drive member 28, illustrated in the form of a screw rod, axially movable relative to the housing 12 to advance the piston 26 through the reservoir 20.

[0135] A dose setting member 30 is coupled to the housing 12 for setting a dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a screw element operable to screw (e.g., simultaneous axial and rotational movement) relative to the housing 12 during dose setting and dose dispensing. Figure 5 and 6 The dose setting member 30 is shown fully screwed into the housing 12 in its original or zero dose position. The dose setting member 30 is operable to unscrew from the housing 12 in a proximal direction until it reaches a fully extended position corresponding to a maximum dose deliverable by the device 10 in a single injection.

[0136] With reference to Figures 6-8 , the dose setting member 30 includes a cylindrical dose dial member 32 having a helical threaded outer surface that engages a corresponding threaded inner surface of the housing 12 to allow helical movement of the dose setting member 30 relative to the housing 12. The dose dial member 32 also includes a helical threaded inner surface that engages a threaded outer surface of the sleeve 34 Figure 6 ) of the device 10. The outer surface of the scale component 32 includes dose indication indicia, such as numbers visible through a dose window 36, to indicate to the user the set dose amount / quantity. The dose setting member 30 also includes a tubular flange 38 coupled in an open proximal end of the dial member 32 and axially and non-rotatably locked to the dial member 32 by a pawl 40 received within an opening 41 in the dial member 32. The dose setting member 30 can also include a collar or skirt 42 positioned around the outer periphery of the dial member 32 at the proximal end of the dial member 32. The skirt 42 is axially and non-rotatably locked to the dial member 32 by a protrusion 44 received in a slot 46. Other embodiments described later show examples of devices without a skirt.

[0137] Accordingly, the dose setting member 30 can be considered to include any or all of the dose dial member 32, the flange 38, and the skirt 42, as they are all non-rotatably and axially fixed together. The dose dial member 32 directly participates in setting the dose and driving the drug delivery. The flange 38 is attached to the dose dial member 32 and cooperates with a clutch to selectively connect the dial member 32 with the dosing button 56 as described below. The skirt 42 provides a surface outside of the main body 11 to enable the user to rotate the dial member 32 to set the dose. For embodiments without a skirt, the dosing button 56 includes a distally extending outer wall to form a surface for the user to rotate.

[0138] The skirt 42 illustratively includes a plurality of surface features 48 and an annular ridge 49 formed on the outer surface of the skirt 42. The surface features 48 are illustratively longitudinally extending ribs and grooves that are circumferentially spaced around the outer surface of the skirt 42 and facilitate the user grasping and rotating the skirt. In alternative embodiments, the skirt 42 is removed or integral with the dial member 32 and the user can grasp and rotate the dosing button 56 and / or the dose dial member 32 for dose setting. In Figure 8 embodiments, the user can grasp and rotate a radially outer surface of the single piece dosing button 56, which also includes a plurality of surface features, for dose setting.

[0139] The delivery device 10 includes an actuator 50 with a clutch 52 that is received within the dial member 32. The clutch 52 includes an axially extending stem 54 at its proximal end. The actuator 50 also includes a dosing button 56 that is located proximal of the skirt 42 of the dose setting member 30. The dosing button 56 includes a mounting collar 58 that is centrally located on the distal surface of the dosing button 56. Figure 6 The collar 58 is attached to the stem 54 of the clutch 52, for example, by an interference fit or ultrasonic welding, so as to axially and non-rotatably secure the dosing button 56 and the clutch 52 together.

[0140] The dosing button 56 includes a disc-shaped proximal end surface or face 60 and an annular wall portion 62 that extends distally and is spaced radially inwardly from the outer peripheral edge of the face 60 to form an annular lip 64 therebetween. The proximal end face 60 of the dosing button 56 serves as a push surface upon which a force can be manually applied, i.e., the actuator 50 is directly pushed by the user in the distal direction. The dosing button 56 illustratively includes a recessed portion 66 centrally located on the proximal end face 60, although the proximal end face 60 can alternatively be a flat surface. A biasing member 68, shown as a spring, is disposed between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to urge the actuator 50 and the dose setting member 30 axially away from one another. The user can depress the dosing button 56 to initiate a dose dispensing operation.

[0141] The delivery device 10 is operable in 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 a desired dose to be delivered by the device 10. Dialing in the proximal direction serves to increase the set dose, and dialing in the distal direction serves to decrease the set dose. The dose setting member 30 can be adjusted during the dose setting operation in rotational increments (e.g., clicks) that correspond to minimum increments of increase or minimum increments of decrease of the set dose. For example, one increment or "click" can equal one-half or one unit of medicament. The set dose is visible to the user by the scale indicator markings displayed through the dose window 36. The actuator 50, including the dosing button 56 and the clutch 52, moves axially and rotates with the dose setting member 30 during dialing in the dose setting mode.

[0142] The dose dial member 32, the flange 38, and the skirt 42 are all non-rotatably fixed relative to one another, and the dose dial member 32, the flange 38, and the skirt 42 rotate and extend proximally of the drug delivery device 10 during dose setting due to the threaded connection of the dose dial member 32 with the housing 12. During this dose setting movement, the dosing button 56 is axially and non-rotatably fixed with the clutch 52 by the flange 38. Figure 6) relative to skirt 42, flange 38 and clutch 52 are urged together by biasing member 68. During dose setting, skirt 42 and dosing button 56 are moved in a helical manner from a "start" position to an "end" position relative to housing 12. This rotation relative to the housing is proportional to the dose set by operation of drug delivery device 10.

[0143] After setting the desired dose, device 10 is manipulated so that injection needle 24 properly penetrates, for example, the skin of a user. In response to an axially distally directed force applied to proximal end face 60 of dosing button 56, a dose dispensing mode of operation is initiated. The axial force is applied directly by the user onto dosing button 56. This causes actuator 50 to move axially in a distal direction relative to housing 12.

[0144] The axial movement of actuator 50 compresses biasing member 68 and reduces or closes the gap between dosing button 56 and tubular flange 38. This relative axial movement causes clutch 52 and complementary splines 74 on flange 38 to disengage, thereby releasing actuator 50 (e.g., dosing button 56) from the non-rotatable fixation with dose setting member 30. In particular, dose setting member 30 is rotationally decoupled from actuator 50 to allow dose setting member 30 to be counter-rotated relative to actuator 50 and housing 12. The dose dispensing mode of operation can also be initiated by activating a separate switch or trigger mechanism.

[0145] As actuator 50 continues to be axially inserted without rotation relative to housing 12, dial member 32 is screwed back into housing 12 as it rotates relative to dosing button 56. The dose indicia indicating the amount of injection remaining can be seen through window 36. As dose setting member 30 is screwed distally, drive member 28 advances distally to push piston 26 through reservoir 20 and expel drug through needle 24 Figure 6 ).

[0146] During dose dispensing operation, the amount of drug expelled from the drug delivery device is proportional to the amount of rotational movement of dose setting member 30 relative to actuator 50 as dial member 32 is screwed back into housing 12. When the internal threads of dial member 32 reach the distal end of the corresponding external threads of sleeve 34 Figure 6 ), the injection is complete. As shown in Figs. 3 and 4, device 10 is then again arranged in the ready state or zero dose position. Figure 6 and 7

[0147] ​The initial and final angular positions of the dose dial member 32 and thus the flange 38 and skirt 42 that are not rotationally fixed relative to each other provide an "absolute" change in angular position relative to the start and end angular positions of the dosing button 56 during dose delivery. There are a number of ways to determine if the relative rotation has exceeded 360°. For example, the total rotation can also be determined by considering the incremental motion of the dose setting member 30, which can be measured in a number of ways by the sensing system.

[0148] 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 a sensed element. The sensing element includes the sensing element or "sensor" as well as the associated electrical components that operate the sensing element. The "sensed element" is any component whose position and / or movement relative to the sensing element can be detected by the sensing element. For a dose delivery detection system, the sensed element rotates relative to the sensing element, which can detect the angular position and / or rotational movement of the sensed element. For a dose type detection system, the sensing element detects the relative angular position of the sensed element. The sensing element can include one or more sensing elements, and the sensed element can include one or more sensed elements. The 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.

[0149] The sensor system generally detects a characteristic of a sensed parameter that varies with the position of one or more sensed elements within a sensed region. The sensed element extends into or otherwise affects the sensed region in a manner that directly or indirectly affects the characteristic of the sensed parameter. The relative position of the sensor and the sensed element affects the characteristic of the sensed parameter, allowing the microcontroller unit (MCU) of the sensor system to determine the different rotational positions of the sensed element.

[0150] Suitable sensor systems can include a combination of active and passive components. Since the sensing element operates as an active component, it is not necessary to connect both components to other system elements such as a power source or MCU.

[0151] A variety of sensing technologies can be incorporated, through which the relative position of the two members can be detected. Such technologies can include, for example, technologies based on tactile, optical, inductive, or electrical measurements. Such technologies can include measuring a sensed parameter associated with a field, such as a magnetic field. In one form, a magnetic sensor senses a change in the sensed magnetic field as the magnetic member moves relative to the sensor. In another embodiment, a sensor system can sense a characteristic and / or change in a magnetic field as an object is positioned in and / or moved through the magnetic field. The change in the field changes a characteristic of the sensed parameter related to the position of the sensed element in the sensed region. In such embodiments, the sensed parameter can be capacitance, conductance, resistance, impedance, voltage, inductance, etc. For example, a magneto-resistive type sensor detects distortion of the applied magnetic field that results in a change in the characteristic of the sensor element resistance. As another example, a Hall effect sensor detects a change in voltage resulting from distortion of the applied magnetic field.

[0152] In one aspect, the sensor system detects the relative position or motion of the sensed element, and thereby the relative position or motion of the associated members of the drug delivery device. The sensor system generates an output representative of the position or amount of motion of the sensed element. For example, the sensor system can be operable to generate an output by which the rotation of the dose setting member during dose delivery can be determined. The MCU is operably connected to each sensor to receive the output. In one aspect, the MCU is configured to determine the amount of dosing / dose delivered by the operation of the drug delivery device from the output.

[0153] The dose delivery detection system includes detecting relative rotational motion between the two members. Since the degree of rotation has a known relationship to the amount of dose delivered, the sensor system operates to detect the amount of angular motion from the beginning of dose injection to the end of dose injection. For example, for a pen-type injector, a typical relationship is that an 18° angular displacement of the dose setting member corresponds to one dose unit, although other angular relationships are suitable. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, then 5 dose units have been delivered.

[0154] One method of detecting angular displacement is to count increments of dosing as the injection proceeds. For example, the sensor system can use a repeating pattern of sensed elements, such that each repetition is an indication of a predetermined angular rotation. Conveniently, the pattern can be established such that each repetition corresponds to the smallest dose increment that can be set with the drug delivery device.

[0155] Another approach is to detect the start and stop positions of the relative movement member and determine the delivered dose from the difference between these positions. In this approach, the sensor system detecting the number of complete rotations of the dose setting member can be part of the determination. Various methods for this are well known in the ordinary skill in the art and can include counting the number of increments to assess the number of complete rotations.

[0156] The sensor system components can be permanently or removably attached to the drug delivery device. In illustrative embodiments, at least some of the dose detection system components are provided in the form of a module that is removably attachable to the drug delivery device. This has the advantage that these sensor components can be used with more than one pen injector.

[0157] In some embodiments, the sensed element is mounted on the actuator, the sensed element being attached to the dose setting member. The sensed element can also comprise the dose setting member or any part thereof. The sensor system detects the relative rotation of the sensed element during dose delivery and thus the relative rotation of the dose setting member, thereby determining the dose delivered by the drug delivery device. In one illustrative embodiment, the rotation sensor is attached to and not rotationally fixed relative to the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the sensed element is attached to and not rotationally fixed relative to the dose setting member, which rotates relative to the actuator and the device body during dose delivery. The sensed element can also comprise the dose setting member or any part thereof. In illustrative embodiments, the rotation sensor is not directly attached to the relatively rotating dose setting member during dose delivery.

[0158] Reference is made to Figure 9 A dose delivery detection system 80 is shown in schematic form, including one example of a module 82 that can be used in conjunction with a drug delivery device, such as device 10. The module 82 carries the sensor system, generally shown as a rotation sensor 86 (or more than one rotation sensor) and other related components, such as a processor, memory, battery, etc. The module 82 is configured as a stand-alone component that can be removably attached to the actuator.

[0159] The dose detection module 82 includes a body 88 that is attached to the dosing button 56 (shown in dashed line). The body 88 illustratively includes a cylindrical sidewall 90 and a top wall 92 that spans and seals the sidewall 90. The dose detection module 82 can alternatively be attached to the dosing button 56 by any suitable fastening means, such as a snap or press fit, a threaded interface, etc., so long as in one aspect the module 82 can be removed from a first drug delivery device and then attached to a second drug delivery device. The attachment can be at any location on the dosing button 56 so long as the dosing button 56 is able to move axially relative to the dose setting member 30 by any desired amount, as described herein.

[0160] During dose delivery, the dose setting member 30 is free to rotate relative to the dosing button 56 and the module 82. In the illustrative embodiment, the module 82 is not rotationally fixed relative to the dosing button 56 and does not rotate during dose delivery. This can be provided structurally, such as by a protrusion, or by having inter-facing splines or other surface features on the module body 88 and the dosing button 56 that engage as the module 82 is moved axially relative to the dosing button 56. In another embodiment, the distal pressing of the module between the module 82 and the dosing button 56 provides sufficient frictional engagement to functionally cause the module 82 and the dosing button 56 to remain rotationally fixed relative to one another during dose delivery.

[0161] The top wall 92 is spaced from the surface 60 of the dosing button 56, thereby forming a cavity 96 in which some or all of the rotation sensor and other components can be housed. The cavity 96 can be open at the bottom, or can be enclosed, such as by a bottom wall 98. The bottom wall 98 can be positioned to rest directly against the end face of the dosing button 56. Alternatively, the bottom wall 98, if present, can be spaced from the dosing button 56, and other contact between the module 82 and the dosing button 56 can be used so that axial forces applied to the module 82 are transmitted to the dosing button 56. In another embodiment, the module 82 can be rotationally fixed relative to a single-piece dosing button structure.

[0162] In an alternative embodiment, the module 82 is instead attached to the dose setting member 30 during dose setting. For example, the sidewall 90 can include a lower wall portion 100 having inward protrusions in the form of coupling arms 102 that engage the button sidewall. In this approach, the module 82 can effectively engage the proximal end face 60 of the dosing button 56 and the distal side of the annular ridge 49. In this configuration, the lower wall portion 100 can be provided with surface features that engage the surface features of the dosing button to rotationally fix the module 82 with the dosing button. Rotational forces applied to the housing 82 during dose setting are thus transmitted to the dosing button through the coupling of the lower wall portion 100 with the dosing button sidewall. The light guide 118 is shown disposed between the LEDs 114A-C and the light sensor 110, which are collectively shown in a single location of the electronics assembly, as well as the surface of the dosing button 56 (when present). The battery 138 is shown disposed above the illumination system 89 and a portion of the electronics assembly.

[0163] The example electronics assembly 120 includes a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronics assembly includes a sensor system including one or more rotation sensors 86 in operable communication with a processor for receiving signals representative of sensed relative rotation from the sensors. The electronics assembly also includes an MCU including at least one processing core and internal memory. An example of an electronics assembly schematic is shown in Figure 1B

[0164] Referring to Figure 10A , 10B , 11A and 1 IB, an example magnetic sensor system 150 is shown including a ring-shaped bipolar magnet 152 having a north pole 154 and a south pole 156 as the inductive element. The magnets described herein can also be referred to as radially magnetized rings. The magnet 152 is attached to the flange 38 and thus rotates with the flange during dose delivery. The magnet 152 can instead be attached to the dose dial 32 or other member that is not rotationally fixed with the dose setting member. The magnet 152 can be constructed of a variety of materials, such as rare earth magnets, e.g., neodymium, etc.

[0165] The sensor system 150 also includes a measurement sensor 158 including one or more sensing elements 160 in operable connection with sensor electronics (not shown) contained within the module 82. The sensing elements 160 of the sensor 158 are in Figure 11A ​The magnet 152 is shown as a single annular dipole magnet attached to the flange 38. However, alternative configurations and positions of the magnet 152 are contemplated. For example, the magnet can 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 discrete rotational dose setting positions of the flange 38. The magnet 152 can also include multiple independent magnet members. Further, the magnet member can be attached to any portion of a member that is non-rotationally fixed relative to the flange 38 during dose delivery, such as the skirt 42 or the dose dial member 32.

[0166] In one embodiment, the magnetic sensor system 150 includes four sensing elements 160 that are equally spaced radially within the module 82 to define an annular pattern as shown. Alternative numbers and positions of sensing elements can be used. For example, in another embodiment, a single sensing element 160 is used as shown. Figure 11B Further, the sensing elements 160 in the foregoing embodiments are shown as being attached within the module 82. Alternatively, the sensing elements 160 can be attached to any portion of a member that is non-rotationally fixed relative to the flange 38 during dose delivery, such that the member does not rotate relative to the housing 12 during dose delivery. Figure 11B Further, the sensing elements 160 in the foregoing embodiments are shown as being attached within the module 82. Alternatively, the sensing elements 160 can be attached to any portion of a member that is non-rotationally fixed relative to the flange 38 during dose delivery, such that the member does not rotate relative to the housing 12 during dose delivery. Figure 12 Further, the sensing elements 160 in the foregoing embodiments are shown as being attached within the module 82. Alternatively, the sensing elements 160 can be attached to any portion of a member that is non-rotationally fixed relative to the flange 38 during dose delivery, such that the member does not rotate relative to the housing 12 during dose delivery.

[0167] The magnet 152 is shown as a single annular dipole magnet attached to the flange 38. However, alternative configurations and positions of the magnet 152 are contemplated. For example, the magnet can 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 discrete rotational dose setting positions of the flange 38. The magnet 152 can also include multiple independent magnet members. Further, the magnet member can be attached to any portion of a member that is non-rotationally fixed relative to the flange 38 during dose delivery, such as the skirt 42 or the dose dial member 32.

[0168] Alternatively, the sensor system can be an inductive or capacitive sensor system. Such a sensor system utilizes a sensed element that includes a metal band attached to the flange, similar to the attachment of the magnetic ring described herein. The sensor system further includes one or more sensing elements, such as four, five, six, or more independent antennas or armatures that are equally spaced along the distal wall of the module housing or pen housing. These antennas form pairs of antennas that are 180 degrees apart or other angles, and provide a proportional measure of the angular position of the metal ring that is proportional to the dose delivered.

[0169] 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 produces a varying signal as the metal ring rotates relative to the antennas. The antennas are operatively connected with the electronics assembly such that the antennas are used to detect the position of the metal ring relative to the sensor, and thus the metal ring relative to the housing 12 of the pen 10, during dose delivery. The metal band can be a single cylindrical band attached to the outside of the flange. However, alternative configurations and locations of the metal band are contemplated. For example, the metal band can include a plurality of discrete metal elements. In one embodiment, the metal band includes a number of elements equal to the number of discrete rotational dose setting positions of the flange. In an alternative, the metal band can be attached to any portion of a component that is not rotationally fixed relative to the flange 38, such as the dial member 32, during dose delivery. The metal band can include metal elements attached to the rotating member either inside or outside the rotating member, or it can be incorporated into such a member, such as by incorporation of metal particles into the component, or by overmolding the component with a metal band. The MCU is operable to determine the position of the metal ring using the sensor.

[0170] According to standard quadrature differential signal calculations, the MCU can be used to determine the starting position of the magnet 152 by averaging the number of sense elements 160 (e.g., four) at the maximum sampling rate. During the dose delivery mode, the MCU samples at the target frequency to detect the number of revolutions of the magnet 152. At the end of dose delivery, the MCU is operable to determine the final position of the magnet 152 by averaging the number of sense elements 160 (e.g., four) at the maximum sampling rate according to standard quadrature differential signal calculations. The MCU is operable to determine by calculating the total angle of rotation from the determined starting position, the number of revolutions, and the final position. The MCU is operable to determine the number of dose steps or units by dividing the total angle of rotation moved by a predetermined number (e.g., 10, 15, 18, 20, 24) related to the design of the device and the drug.

[0171] Further reference is made to Figure 12 , Figure 12Another example of a magnetic sensor system 900 is shown, including a radially magnetized ring 902 having a north pole 903 and a south pole 905 as the sensed element. As before, the magnetized ring 902 is attached to a dose setting member, such as a flange. Magnetic sensors 906, such as Hall effect sensors, are placed radially relative to the magnetized ring 902 can be equiangular to each other in a ring pattern. In one example, the magnetic sensors 906 are radially disposed in overlapping relation with an outer circumferential edge 902A of the magnetized ring 902, such that a portion of the magnetic sensors 906 are positioned on the magnetized ring 902, while the remaining portion is positioned outside the magnetized ring 902.

[0172] In some embodiments, the sensing system is configured to determine whether the sensing system is coupled / coupled to a drug delivery device. Figure 13 An exemplary computerized method 1300 for determining whether the device is removably coupled / coupled to a drug injection device is shown, in accordance with some embodiments. The sensing system, such as a dose delivery detection system, includes a plurality of sensing elements. For example, the sensing system includes a number of sensing elements, such as four or five sensing elements, that are spaced apart circumferentially equidistantly and radially equidistantly within the device. As described herein, the plurality of sensing elements can include a plurality of Hall effect sensors. In some embodiments, five Hall effect sensors are disposed at 72 degrees equidistantly around a circle having a diameter designed based on the magnetic component of the drug delivery device being sensed. For example, a diameter of about 14 mm can be used, such that the sensors remain on an envelope traced by the maximum of the Z component of the magnetic field when the magnet is rotated about its axis. The sensing system also includes a processor (e.g., MCU) in communication with the set of sensing elements.

[0173] The sensing system (through its processor, MCU, etc.) is configured to execute computer readable instructions that cause the processor to perform the computerized method 1300. At step 1302, the sensing system obtains a set of voltage measurements from each of the plurality of sensing elements. At step 1304, the sensing system determines two-dimensional data representative of a magnetic field of a magnetic component of the drug injection device. At step 1306, the sensing system determines one-dimensional data based on the two-dimensional data. At step 1308, the sensing system determines, based on the one-dimensional data, whether the set of voltage measurements indicates that the device is being coupled to the drug injection device.

[0174] Referring to step 1302, when the user presses the power-on button of the sensing system (see Figure 9When the button 139 and switch 137 are activated (e.g., by a user pressing the button 139 and switch 137), the switch 137 is activated, the sensing system is woken up, and firmware running on the processor turns on the sensing elements (e.g., magnetic sensors) to occupy the starting position of the magnetic components of the drug delivery device (e.g., before any rotation occurs). At this stage, it is important to read the sensor readings immediately after waking up to avoid taking measurements during rotation. In some embodiments, the sensing system can average a certain number of samples for each sensor (e.g., 5, 10, 15, etc. for each sensor), for example, to reduce noise.

[0175] Referring to step 1304, in some embodiments, the sensing system determines a quadrature signal comprising 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, which the sensor values are multiplied by during summation to determine the I value, and a second coefficient for each sensor, which the sensor values are multiplied by during summation to determine the Q value. In some embodiments, the coefficients can be used to combine the results of multiple sensors (e.g., five sensors such as spaced apart at 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 result of the quadrature calculation to have zero error compared to the nominal angle before offset, second harmonic distortion in the measured signal, third harmonic distortion, etc.

[0176] Referring to step 1306, in some embodiments, the sensing system determines a scale factor based on the two-dimensional signal (e.g., the quadrature signal) determined at step 1304. In some embodiments, the sensing system determines the scale factor based on the quadrature signal and one or more of a predetermined offset and a predetermined gain. For example, the processor can determine the scale factor based on the following equation 12:

[0177]

[0178] where:

[0179] • ScaleFactor is the scale factor;

[0180] • I is the in-phase portion of the quadrature signal;

[0181] • Q is the quadrature portion of the quadrature signal;

[0182] • OI is the offset measured on the I signal during calibration;

[0183] • OQ is the offset measured on the Q signal during calibration;

[0184] • G1 is the gain measured on the I signal during calibration; and

[0185] • GQ is the gain measured on the Q signal during calibration.

[0186] Such example I and Q offsets and gains can be used because when I and Q are well balanced, the quadrature works well, for example when the offset is equal to zero and the gain is equal to one. A calibration procedure can be used to determine the offset / gain of the balanced measured I and Q to obtain a sufficient value, to eliminate skew between I and Q, etc. In some embodiments, the sensing system can be configured to normalize the I and Q values and use the I and Q values to determine a normalized angle of the Z component of the magnetic field. After a dose is administered, the sensing system can then monitor the end position of the magnetic component of the drug delivery device to determine the injected dose (e.g., using similar techniques as described herein to monitor the rotation of the magnet and / or determine the end position of the magnet).

[0187] Referring to step 1308, the sensing system can determine whether the one-dimensional data indicates that the sensing system is coupled (or not coupled) to the drug delivery device. The sensing system can use the scaling factor to determine whether the sensing system is mounted or coupled to the drug delivery device. For example, if the scaling factor is between predetermined thresholds, the sensing system can determine that the sensing system is mounted to the drug delivery device. If the scaling factor is not between the predetermined thresholds, the sensing system can determine that the sensing system can not be mounted to the drug delivery device. In some embodiments, the sensing system can check the scaling factor against a low amplitude margin and a high amplitude margin to determine whether the magnet being monitored by the module is the expected magnet (e.g., + / - 25% around the nominal value is acceptable) such that the module will only accept the expected amplitudes.

[0188] Figure 14 A dose delivery detection system 80 is illustrated that includes at least some aspects of a system module 1400, which can include Figure 1A 、 1B one or more electronics and / or components shown in FIG. 1C, and any combination thereof. In one embodiment, the system includes one of the sensing systems 101, 130, 150, 1400, and other systems described herein, or any combination thereof. The system 80 is shown in communication with a remote computing system 104 (e.g., a smartphone) through a signal 1475.

[0189] The user interface of system 80 can be further enhanced to provide user information based on its on-board capabilities during operation of system 80, which can or can not be combined with off-board capabilities of remote computing system 104. To this end, system 80 is provided with one or more light indicators for producing light indication patterns / light indication modes. System 80 can also be provided with display, audible, or other known indication systems. In one embodiment, system 80 does not include a display. Light indicators 1412 (which, as noted above, can include one or more LEDs) can use various colors and flashing patterns to indicate various use case types. As used herein, a “use case type” is a state or condition of system 80. System 80 can occupy one of a plurality of different use case types. Each use case type can indicate a status of the device, such as 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 can be configured to indicate one of the use case types. In other embodiments, the system can be configured to indicate a combination of two or more use case types in sequence. In other embodiments, the system can be configured to indicate a combination of two or more use case types with a single indication notification (such as with light indicators 1412) without the need for an on-board display.

[0190] In one embodiment, the sensing system can be configured to indicate a combination of one of the battery status and other use case types with light indications (such as with light indicators 1412) without the need for an on-board display. The light indication mode can be a combination of a first portion of the mode indicating one of the use case types, a delay portion of the mode indicating a time delay, and a second portion of the mode indicating another use case type. In each portion, the color and flashing pattern can be the same or different. In one embodiment, the sensing system can check the scale factor against a low amplitude margin and a high amplitude margin to determine whether the magnet that the module is monitoring is the expected magnet (e.g., + / - 25% around the nominal value is acceptable) so that the module will only accept the expected amplitude.

[0191] Figure 15A flowchart for an exemplary computerized method 1500 for generating an indication signal for a light indication pattern to a user of a system 80 according to some embodiments. At step 1502, the sensing system (through its processor, MCU, etc.) determines a use case type configuration from a plurality of use case type configurations, which can be pre-stored in the memory of the processor. At step 1504, the sensing system determines a category of battery life status from a plurality of battery life statuses, which can be pre-stored in the memory of the processor. At step 1506, the sensing system provides a light indication pattern comprising a first light indication portion based on the determined use case type configuration from step 1502, and a second light indication portion based on the determined battery life status from step 1504, the second light indication portion being immediately after a time delay following completion of the first light indication portion.

[0192] Figure 16 A flowchart for 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 portion of the light indication pattern. At step 1602, the sensing system (through its processor, MCU, etc.) determines whether the power-on module is enabled and for how long. At optional step 1604, the sensing system determines whether the sensing element is present. For a fully integrated device, the sensing element will always be present, and this step can be removed. For a dose detection system that is removably coupled / coupled to an injection device, this step can be included in the step. At step 1606, the sensing system determines whether the sensed element is moving. Steps 1602, 1604, and 1606 can be used individually or in any combination to define the use case type configuration. Although steps 1610, 1612, and 1614 are described as including step 1604, steps 1610, 1612, and 1614 can be described as not determining the presence of the sensing element as "yes". Furthermore, it is contemplated that the use case type can depend on one, two, or all of the determination steps 1602, 1604, 1606.

[0193] At step 1610, the sensing system is configured to provide a first pattern for the first light indication portion if the sensing system determines that the sensed element is not moving and the energizing module is continuously enabled for a first time range. Optionally, the sensing system can also determine whether the sensed element is present before determining that the sensed element is not moving. In this case, the sensing system can also need to determine that the sensed element is present before providing the first pattern. At 1612, the sensing system is configured to provide a second pattern for the first light indication portion if the sensing system determines that the sensed element is not moving and the energizing module is continuously enabled for a second time range. Optionally, the sensing system can also determine whether the sensed element is present before determining that the sensed element is moving. In this case, the sensing system can also need to determine that the sensed element is present before providing the second pattern. At 1614, the sensing system is configured to provide a third light indication pattern for the first light indication portion if the sensing system determines that the sensed element is moving. Optionally, the sensing system can also determine whether the sensed element is present before determining that the sensed element is moving. In this case, the sensing system can also need to determine that the sensed element is present before providing the third pattern.

[0194] In one example, the sensing system can be configured to implement a use case type configuration for manual data synchronization with the remote computing system to, for example, push data from the sensing system to the remote computing system if there is no movement of the sensed element and the energizing module is continuously enabled for a first time range. This corresponds to the use case type configuration at 1610 in Figure 16 In one embodiment, when the sensing system implements the manual data synchronization use case type configuration, the sensing system puts itself in a low power state. See also Figure 9The user can press the button 139 axially down into the dose body 88 to activate the energizing module 1406 (the button 139 and the energizing switch 137 collectively referred to as the energizing module 1406) for a first time period in the range of 3 to 10 seconds. Note that the energizing module 1406 can include a contactable switch. This time range can be modified to be wider, narrower, higher, and / or lower. The sensing system can determine whether the magnetized sensed element (e.g., the magnetized ring 902) is rotating by determining that the starting angular position and the final angular position of the magnetized sensed element (e.g., as described above) remain unchanged using a magnetic sensor (e.g., the magnetic sensor 906 (shown as the sensing element 1402)). If there is a change in the angular position, the system can determine that there is motion, and if there is no change in the angular position, the system can determine that there is no motion. After the energizing switch 137 is deactivated by the user releasing the button 139 and the first time range expires, the sensing system can provide a pattern / mode for the first light indication portion, for example, flashing the green LED of the light indicator 1412 on and off (e.g., 300 ms on / 300 ms off) for a number of cycles, for example, three cycles. The color of the LED, the on / off times, and the number of cycles can vary. The sensing system can then store data in its memory 1408 indicating a manual synchronization event.

[0195] In one example, if no sensed element movement is detected and the energizing module remains active for a second time range, the use case type configuration can be in an operation to pair with a remote computing system. This is the use case type configuration corresponding to Figure 16 In one example, if no sensed element movement is detected and the energizing module remains active for a second time range, the use case type configuration can be in an operation to pair with a remote computing system. This is the use case type configuration corresponding to

[0196] In the second time range, the sensing system can provide a first version of the second pattern for the first light indication portion, e.g., flashing the green LED of the light indicator 1412 on for one cycle (e.g., 1000 ms on), or can flash for multiple cycles. This can be used to inform the user that the pairing was successfully initiated and to release the button. The sensing system can then store data in its memory 1408 indicating a successful pairing initiation event. After the button is released, the communication unit 1410 of the sensing system can begin sending advertising signals to the remote computing system, and after a successful binding, the communication device 1467 of the remote computing system sends a signal to the sensing system. After the sensing system successfully receives the transmission from the remote computing system, the sensing system can provide a second version of the second pattern that is different from the first version of the second pattern for the first light indication portion, e.g., flashing the green LED of the light indicator 1412 on and off (e.g., 300 ms on / 300 ms off) for multiple cycles, e.g., three cycles. The color of the LED, the length of time on and off, and the number of cycles can vary. The sensing system can then store data in its memory 1408 indicating a successful pairing event.

[0197] If the pairing is not successful or the pairing has been lost, i.e., the communication unit 1410 of the sensing system begins sending signals to the remote computing system and, for whatever reason, is not successfully connected, the sensing system fails to receive a signal from the communication device 1467 of the remote computing system that the binding was successful. After an unsuccessful pairing, the sensing system can provide a third version of the second pattern for the first light indication portion that is different from the first and second versions of the second pattern, e.g., flashing the amber LED of the light indicator 1412 on and off (e.g., 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). The color of the LED, the length of time on and off, and the number of cycles can vary. The sensing system can then store data in its memory 1408 indicating a successful or unsuccessful pairing event (whichever is determined).

[0198] In one example, if the sensed element is moved and present, the use case type configuration can be in operation of a typical injection state. This is corresponding to Figure 16The use case type configuration of 1614. In one embodiment, the sensing system is in a low-power state. The user can set the dose by rotating the system coupled to the dosing button, and the user can press the system / dosing button to start drug delivery. If the user presses button 139, button 139 can be pressed axially relative to the dose body 88 to activate the power-on module. The sensing system can determine whether the magnetically sensed element (e.g., magnetized ring 902) is rotating by using a magnetic sensor (e.g., magnetic sensor 906 (shown as sensing element 1402)) to determine whether the initial angular position and final angular position (e.g., as described above) of the magnetized sensed element has changed. After successfully detecting rotation of the sensed element by the sensing system, the sensing system can provide a third mode for the first light indication portion, for example, causing the green LED of the light indicator 1412 to blink on and off (e.g., 300ms on / 300ms off) for multiple cycles, for example, three cycles. The color of the LED, the length of the on and off time, and the number of cycles may vary. The sensing system can then store data indicating a successful injection event.

[0199] Figure 17 The flowchart illustrates an exemplary computerized method 1700 for determining a light indication mode based on remaining battery life state, according to some embodiments, as shown in step 1504. 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 mode, and in one embodiment, a second portion of the light indication mode. In step 1702, a sensing system (via its processor, MCU, etc.) determines the remaining battery life state. In step 1704, the system is configured to determine a first mode of the second light indication portion if the remaining battery state is in a first state indicating a relatively high battery charge. In step 1706, the system is configured to determine a second mode of the second light indication portion if the remaining battery state is in a second state indicating a relatively low battery charge. In step 1708, the system is configured to determine a third mode of the second light indication portion if the remaining battery state is in a moderate third state (i.e., between the first and second states).

[0200] For steps 1702, 1704, 1706, and 1708, there are multiple methods to determine the remaining battery life state by examining the electrical characteristics of the power supply and comparing them to a full charge to determine a certain percentage of full charge. In one embodiment, Figure 4A flowchart showing an exemplary computerized method for determining a battery indication of a remaining battery status. For example, using Table 3 above, a first status can be when the determination of the battery indication of the remaining battery life status is in a high range, such as in a range of 5 to 100 percent of a full charge, a second status can be when the determination of the battery indication of the remaining battery life status is in a low range, such as 0 and less than 1 percent of a full charge, and a third status can be when the determination of the battery indication of the remaining battery life status is in a medium range, such as in a range of 1 to 4 percent of a full charge.

[0201] In one embodiment, if the sensing system determines that the remaining battery life status is in the above-described high first status, the sensing system can provide a first pattern of the second light indication portion at step 1704, such as no flashing. 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 portion can include a color flashing sequence of the LEDs, through which the length of the on and off and the number of cycles can vary. In one embodiment, if the sensing system determines that the remaining battery life status is in the above-described low second status, the sensing system can provide a second pattern of the second light indication portion different from the first pattern at step 1706, such as causing the green and amber LEDs of the light indicator 1412 to flash on and off for one or more cycles. In one example, for a number of cycles (such as three cycles), the on and off can be 100 ms on / 100 ms off / 100 ms on / 100 ms off / 100 ms on / 400 ms off. This can indicate to the user that the remaining battery life status is “end of life.” In some embodiments, the color of the LEDs, the length of the on and off, and the number of cycles can vary. In one embodiment, if the sensing system determines that the remaining battery life status is in the above-described medium third status, the sensing system can provide a third pattern of the second light indication portion different from the first and second patterns at step 1708, such as a number of cycles (such as three cycles) of the on and off (such as 150 ms amber on / 150 ms green on) of the amber and / or green LEDs of the light indicator 1412. This can indicate to the user that the remaining battery life status is “short remaining life.” The color of the LEDs, the length of the on and off, and the number of cycles can vary.

[0202] As described herein, the sensing system provides a single light indication (LI) having a pattern of a first light indication portion (SI) and a pattern of a second light indication portion (S2) with a delay (D) between the portions (or LI = SI + D + S2). In one embodiment, the maximum total cycle time of the single light indication (LIt) can be 6.4 seconds with a first portion (SI t) comprising 2.7 seconds, a second portion (S2t) comprising 2.7 seconds, and a delay (Dt) of one second therebetween (or LIt = SI t + Dt + S2t). In one embodiment, for example, for a successful injection and high battery life remaining status injection use case, the total cycle time of the single light indication (LIt) can be 1.8 seconds with a first portion (SI t) comprising 1.8 seconds, a second portion (S2t) comprising 0 seconds (or no second portion), and a delay (Dt) of one second therebetween. In one embodiment, for example, for a first pairing use case of a successful pairing and high battery life remaining status, the total cycle time of the single light indication (LIt) can be 2.0 seconds with a first portion (SI t) comprising 1.0 seconds, a second portion (S2t) comprising 0 seconds (or no second portion), and a delay (Dt) of one second therebetween.

[0203] Figure 18 A flowchart for an exemplary computerized method 1800 for indicating to a user of a dose detection system 80 when the continuous activation of the power-on module 1406 for a certain time causes the power source (described below as an exemplary battery) to be undesirably prematurely depleted, in accordance with some embodiments. For example, a life of a year or two is reduced to less than a year. Most systems have a sealed battery that is configured to power the system for an extended period of time without charging. At step 1804, the sensing system (through its processor, MCU, etc.) determines whether the power-on module is activated. The battery depletion can occur only in the case of the dose detection system, that is, not coupled to an injection device 10, or when coupled to the device 10.

[0204] At step 1806, the sensing system increases the power drawn from the battery to power the electronics of the sensing system in an increased power state. Optionally, at step 1802 (shown in dashed lines), the sensing system can determine whether the dose detection system is coupled to the delivery device prior to step 1804. Determining whether the dose detection system is coupled is described herein. At step 1808, if the sensing system determines that the power-on module is continuously enabled for a first period of time while the system is in the increased power state, the power drawn from the battery to power the electronics of the sensing system is decreased to place it in a low power state. At step 1810, if the sensing system determines that the power-on module is continuously enabled for a second period of time other than the first period of time, the power drawn from the battery to power the electronics of the sensing system is increased to the increased power state to store data indicative of the event and / or transmit an event signal to the remote computing system. After such an event is stored, the system can return to the low power state such that the power drawn from the battery is decreased. Optionally, at step 1812, the remote computing system can provide an indication to the user based on the event signal received from the sensing system. The indication can be in the form of a sound, light, image, and / or alphanumeric text that is communicated to the user of the system 80 via the display 1461 of the remote computing system via the mobile application. For example, a reminder message about the proper operation and attention of the dose detection system and / or a warning message such as "remove pressure from the button" can be provided to the user. In addition to applying the warning, such a warning can include generating a message for communication via a message system on the user's smartphone display or another smartphone designated by the user.

[0205] The sensing system can continue to monitor the continuous enablement of the power-on module for an additional period of time after the second period of time (after which the system returns to the low power state) until the user takes action to resolve the issue. For example, if the power-on module is continuously in the enabled state for a third period of time in addition to the first and second periods of time, the sensing system can increase the power drawn from the battery to power the system from the low power state to the increased power state and generate another event. The third period of time can be greater than the first period of time. In one example, the third period of time can be the same amount of time as the second period of time described above. In other examples, the period of time after the second period of time can gradually decrease in the form of escalating subsequent warnings to the user.

[0206] In one embodiment, to determine how long the power-on module is enabled, in step 1807, the system is configured to measure how long the power-on module remains enabled. If the button 139 is pressed axially down into the dose body 88 and the power-on module 1406 is continuously enabled for a first period of time (which is measured by the RTC 1414, in a range of, for example, about 20 seconds to 60 seconds, and in one embodiment, 60 seconds), then the system can consider this to be an accidental press. This time can be modified to be less than or greater than 60 seconds. As in step 1806, the initial press of the button 139 will activate the switch 137 to increase the power drawn by the electronics of the sensing system from the battery to an increased power state. While in the increased power state, the sensing system allows power to be supplied to the sensing components (e.g., Hall effect sensors) to sense any movement of the sensed elements of the injection device. If there is no movement, then the activation can be accidental. After a continuous enablement of, for example, 60 seconds, the sensing system can decrease the power drawn by the electronics of the sensing system from the battery to a low power state. The sensing system can then store data in its memory 1408 indicating the event, for example, “button still pressed.” In one embodiment, if the power-on module remains continuously enabled for a second period of time that is greater than the first period of time (after the system has returned to the low power state), then the system can return to the increased power state. The second period of time can be in a range of, for example, 1 minute to 9 minutes, and in one embodiment, 9 minutes, as measured by the RTC 1414. The total combined minutes of continuous enablement will be the sum of the first period of time and the second period of time, after the expiration of the second period of time, the sensing system provides an increase in the power drawn by the electronics of the sensing system from the battery from the low power state to the increased power state to store data indicating the event. The stored event can be, for example, “button still pressed” and / or the communication of the event signal to the communication device 1467 of the remote computing system 104 by the communication unit 1410 of the dose detection system 80. For example, the total combined time can be 10 minutes of continuous enablement (1 minute first period of time, 9 minutes second period of time). For example, the total combined time can be 5 minutes of continuous enablement (1 minute first period of time, 4 minutes second period of time). The transmission of the event can occur at any time the event is stored, or can occur during the next connection to the remote computing system. If the sensing system monitors the continuous enablement of the power-on module for more than the second period of time, an additional event can be triggered and stored. In one embodiment, the system can go through these steps once to send only one event signal to the remote computing device.

[0207] In addition to or in lieu of generating an event signal based on the amount of time the power-on module is enabled, an event signal can be generated in method 1800 by monitoring the number of times the power-on module is enabled over a period of time or between injection events in steps 1804 and 1807. For example, the system can generate an event signal when the number of presses is determined to be in a range of, for example, 10-40 presses per minute, and the total time is in a range of, for example, 1 minute to 5 minutes. In one example, the system can generate an event signal when the number of presses is 30 presses per minute and the total presses are for 2 minutes, or 60 presses in 2 minutes. When the number of presses is reached within the selected time period, the system can increase the power drawn from the battery by the system to an increased power state to store the event and / or transmit the event from the device to a remote computing system configured to generate a warning indication. According to some embodiments, if the power-on module 1406 of the dose detection system is enabled intermittently multiple times, which can result in premature depletion of the battery or power source, the example computerized method generates an indication of sound, light, image, or alphanumeric text to the user of the system 80 through a mobile application.

[0208] The dose detection system is described in the context of a particular design of a drug delivery device, such as a pen injector. However, the example dose detection system can also be used with alternative drug delivery devices, as well as with other sensing configurations that operate in the manner described herein. For example, any one or more of the various sensing and switch systems can be removed from the module.

[0209] The various methods or processes outlined herein can be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software can be written using any of a number of suitable programming languages and / or programming or scripting tools, and also can be compiled as executable machine language code or intermediate code that is executed on a virtual machine or a suitable framework. In this respect, various inventive concepts can be embodied as one or more non-transitory computer-readable storage media (e.g., computer memory, one or more soft discs, optical discs, tape, flash memory, field programmable gate arrays, or other semiconductor devices, etc.) encoded with one or more programs that, when executed on one or more computers or other processors, implement the various embodiments of the present invention. The one or more non-transitory computer-readable media or storage media can be transportable, such that the one or more programs stored thereon can be loaded into the transitory computer memory of any computer resource to implement various aspects of the present invention as described above.

[0210] In this respect, various inventive concepts can be embodied as one or more non-transitory computer-readable storage media (e.g., computer memory, one or more soft discs, optical discs, tape, flash memory, field programmable gate arrays, or other semiconductor devices, etc.) encoded with one or more programs that, when executed on one or more computers or other processors, implement the various embodiments of the present invention. The one or more non-transitory computer-readable media or storage media can be transportable, such that the one or more programs stored thereon can be loaded into the transitory computer memory of any computer resource to implement various aspects of the present invention as described above.

[0211] 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 that can be employed to program a computer or other processor to implement various aspects of embodiments as described above. Additionally, it should be appreciated that according to one aspect, one or more computer programs that when executed perform some or all of the methods of the present application need not reside on a single computer or processor, but can be distributed in a modular fashion amongst different computers or processors to implement various aspects of the present application.

[0212] Computer-executable instructions can be in many forms, such as program modules, executed by one or more computers or other machines. 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 can be combined or distributed as desired in various embodiments.

[0213] Also, data structures can be stored in non-transitory computer-readable media in any suitable form. A data structure can have fields that are related to one another through the data structure's placement in the non-transitory computer-readable media. Such relationships can also be achieved by storing the data structure as a linked list or as a linked list of linked lists in the non-transitory computer-readable media. However, any suitable mechanism can be used to establish a relationship between information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish a relation between data elements.

[0214] Various inventive concepts can be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method can be ordered in any suitable way. Accordingly, embodiments can be constructed in which acts are performed in an order different than illustrated, which can include performing some acts simultaneously, even though shown as serial act in illustrative embodiments.

[0215] The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean at least one. As used herein in the specification and claims, the phrase "at least one," with respect to a list of one or more elements / elements, should be understood to mean at least one of each listed element / element, but not necessarily including at least one of every element / specie in the list. It is further recognized that the term "comprising" as used herein is specifically intended to encompass the presence of stated elements / elements (e.g., steps), but does not exclude the presence of additional unstated elements / elements (e.g., steps). Further, it should be understood that any of the embodiments of the present application can include one, some or all of the features discussed herein.

[0216] The phrase “and / or,” as used herein in the specification and in 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 construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements can optionally be present other than the elements specifically named with “and / or.” A “and / or” clause does not by itself require that a limitation be present three times in a claim; rather, such a clause shall be construed in the manner most compatible with the draftsperson’s chosen predicate structure.

[0217] “Or” as used in the specification and in claims herein, 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” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly

[0218] The use of the terms “first,” “second,” “third,” and the like in the claims is merely used to identify features being described and does not imply any priority, order or sequence in the performance of the functions of the elements identified with such terms. The terms “first,” “second,” “third,” and the like are not used to designate a priority, order or sequence in the performance of the functions of the elements identified with such terms.

[0219] The phrase “consisting essentially of” or “consisting of’ shall have the same meaning as the term “comprising” as defined above.

[0220] Having described several embodiments of the application, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to fall within the spirit and scope of the application. Accordingly, the foregoing description is by way of example only, and is not intended to be limiting.

[0221] Aspects of the present application are described herein, including the following aspects, but not limited to:

[0222] 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 processing circuitry 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 light indication pattern comprising: (i) a first light indication portion based on the determined use case type, and (ii) a second light indication portion based on the determined battery life status after a delay following completion of the first light indication portion.

[0223] 2. The system of aspect 1, further comprising a power-up module switchable between an enabled state and a disabled state, wherein the processing circuitry is caused to determine whether the power-up module is continuously in the enabled state for a period of time, wherein the use case type is determined based at least in part on the determined period of time for which the power-up module is continuously enabled.

[0224] 3. The system of any of aspects 1-2, further comprising a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuitry is caused to determine whether the sensed element is present via the sensing element, and determine the use case type based on the determined presence of the sensing element.

[0225] 4. The system of aspect 4, wherein the processing circuitry is caused to determine whether the sensed element is moving via the sensing element, and determine the use case type based on the determined movement of the sensing element.

[0226] 5. The system of aspect 1, further comprising a power-up module switchable between an enabled state and a disabled state, and a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuitry is caused to: (a) determine whether the power-up module is continuously in the enabled state for a period of time; and (b) determine whether the sensed element is moving via the sensing element; wherein the use case type is determined based on the determined period of time for which the power-up module is continuously enabled and the determined movement of the sensing element.

[0227] 6. The system of aspect 5, wherein the processing circuit is caused to provide, via the LED set, a first pattern of a first light indication portion of a single light indication pattern when the energization module is continuously enabled for a time period that is within a first time range and when the processing circuit determines that the sensed element is not moving.

[0228] 7. The system of any of aspects 5-6, wherein the processing circuit is caused to provide, via the LED set, a second pattern of the first light indication portion of the single light indication pattern when the energization module is continuously enabled for a time period that is within a second time range and when the processing circuit determines that the sensed element is not moving.

[0229] 8. The system of any of aspects 5-7, wherein the processing circuit is caused to provide, via the LED set, a third pattern of the first light indication portion of the single light indication pattern when the sensed element is determined to be moving.

[0230] 9. The system of any of aspects 5-8, wherein the determined battery life state comprises a first state, a second state, a third state, or any combination thereof.

[0231] 10. The system of aspect 9, wherein the processing circuit is caused to:

[0232] provide a first pattern of a second light indication portion in response to determining that the battery life state is the first state, provide a second pattern of the second light indication portion in response to determining that the battery life state is the second state, and provide a third pattern of the second light indication portion in response to determining that the battery life state is the third state.

[0233] 11. The system of aspect 1, further comprising an energization module that is switchable between an enabled state and a disabled state, a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuit is caused to: (a) determine whether the energization module is continuously in the enabled state for a time period; (b) determine, by the sensing element, whether the sensed element is present; and (c) determine, by the sensing element, whether the sensed element is rotating, wherein a use case type is determined based on the determined time period for which the energization module is continuously enabled, the presence determined by the sensing element, and the rotational movement determined by the sensing element, wherein the dose detection system is removably attached to a pen injection device, wherein the dose detection system comprises the sensing element, the energization module, and the LEDs, and the pen injection device comprises the sensed element.

[0234] 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.

[0235] 13. A method for generating a single light indication pattern for a dose detection system, the dose detection system comprising 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 for the one or more batteries from a plurality of battery life statuses; and providing a light indication pattern via the one or more LEDs, the light indication pattern comprising a first light indication portion based on the determined use case type, and a second light indication portion based on the determined battery life status after a delay from completion of the first light indication portion.

[0236] 14. The method of aspect 13, wherein the step of determining the use case type comprises at least one of: determining a time period for which a power-on module is continuously enabled; determining, by a sensed element, whether the sensed element is present; and determining, by the sensed element, whether the sensed element is moving.

[0237] 15. The method of aspect 14, wherein when the time period for which the power-on module is continuously enabled is within a first time range, and when the sensed element is determined to be not moving, the step of providing the light indication pattern comprises providing a first pattern of the first light indication portion via the one or more LEDs; wherein when the time period for which the power-on module is continuously enabled is within a second time range, and when the sensed element is determined to be not moving, the step of providing the light indication pattern comprises providing a second pattern of the first light indication portion via the one or more LEDs; or wherein when the sensed element is determined to be moving, the processing circuit is caused to provide a third pattern of the first light indication portion via the one or more LEDs.

[0238] 16. The method of aspect 15, wherein the step of determining the battery life status comprises distinguishing / differentiating the battery life status between a first status, a second status, a third status, wherein the step of providing the single light indication pattern comprises: providing a first pattern of the second light indication portion when the battery life status is in the first status; providing a second pattern of the second light indication portion when the battery life status is in the second status; or providing a third pattern of the second light indication portion when the battery life status is in the third status.

[0239] 17. A system configured to reduce battery consumption of a dose detection system, the system comprising: a power-on module switchable between an active state and an inactive state; a battery; 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 switches from the inactive state to the active state; measure how long the power-on module remains in the active state; decrease power drawn from the battery by the system to a low power state if the power-on module remains in the active state for a first period of time; subsequently, if the power-on module remains in the active state for a second period of time other than the first period of time, increase power drawn from the battery by the system from the low power state to the increased power state and generate an event; and store data indicative of the event into a memory of the dose detection system.

[0240] 18. The system of aspect 17, wherein the processing circuit is further caused to: transmit the data indicative of the event to a remote computing system configured to generate a notification to a user of the remote computing system indicative of the event.

[0241] 19. The system of any of aspects 17-18, wherein the processing circuit is further caused to: decrease power drawn from the battery to the low power state after the data indicative of the event is stored; subsequently, if the power-on module remains in the active state for a third period of time other than the first and second periods of time, increase power drawn from the battery from the low power state to the increased power state and generate a second event; and store data indicative of the second event into the memory.

[0242] 20. The system of aspect 19, wherein the processing circuit is further caused to: transmit the data indicative of the second event to a remote computing system configured to generate a second notification to a user of the remote computing system indicative of the second event.

[0243] 21. The system of any of aspects 19-20, wherein the first period of time is in a range of 20 seconds to 1 minute, and each of the second and third periods of time is greater in time than the first period of time.

[0244] 22. The system of any of aspects 17-18, wherein the first period of time is in a range of 20 seconds to 1 minute, and the second period of time is greater in time than the first period of time.

[0245] 23. A method for reducing battery consumption of a dose detection system, the system comprising an energization module and a battery, the method comprising: increasing power drawn by the system from the battery to an increased power state when the energization module is switched to an active state; measuring how long the energization module remains in the active state; decreasing power drawn by the system from the battery from the increased power state to a low power state if the energization module remains in the active state for a time period comprising a first time period; subsequently, increasing power drawn by the system from the battery from the low power state to the increased power state and generating an event if the energization module remains in the active state for a time period comprising a second time period other than the first time period; and

[0246] storing data indicative of the event into a memory of the dose detection system.

[0247] 24. The method of aspect 23, further comprising: transmitting data indicative of the event to a remote computing system configured to generate a notification to a user of the remote computing system indicative of the event.

[0248] 25. The method of aspect 24, further comprising: decreasing power drawn by the system from the battery to the low power state after data indicative of the event is stored; subsequently, increasing power drawn by the system from the battery from the low power state to the increased power state and generating a second event if the energization module remains in the active state for a third time period other than the first and second time periods; and storing data indicative of the second event into the memory.

[0249] 26. The method of aspect 25, further comprising: transmitting data indicative of the second event to a remote computing system configured to generate a second notification to a user of the remote computing system indicative of the second event.

[0250] 27. The method of any of aspects 25-26, wherein the first time period is in a range of 20 seconds to 1 minute, and each of the second and third time periods is greater than the first time period.

[0251] 28. The method of aspect 23, wherein the first time period is in a range of 20 seconds to 1 minute, and the second time period is greater than the first time period.

[0252] 29. The system of aspect 1 or aspect 17, further comprising a drug delivery device to which the dose detection system is coupled, wherein the drug delivery device comprises a drug.

[0253] 30. A system configured to reduce battery consumption of a dose detection system, the system comprising: a power-on module switchable between an active state and an inactive state; a battery; 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 a number of times the power-on module is in the active state for a time period; increase power drawn from the battery by the system from the low power state to the increased power state and generate an event if the number of times the power-on module is in the active state for the first time period reaches a first number; and store data indicative of the event into a memory of the dose detection system.

[0254] 31. A method for reducing battery consumption of a dose detection system, the system comprising a power-on module and a battery, the method comprising: increasing power drawn from the battery by the system to an increased power state when the power-on module is switched to an active state; measuring a number of times the power-on module is in the active state for a time period; decreasing power drawn from the battery by the system from the increased power state to a low power state if the power-on module is continuously in the active state for a time period comprising the first time period; increasing power drawn from the battery by the system from the low power state to the increased power state and generating an event if the number of times the power-on module is in the active state for the first time period reaches a first number; and storing data indicative of the event into a memory of the dose detection system.

Claims

1. A system configured to reduce battery consumption of a dose detection system, the system comprising: a power-on module switchable between an enabled state and a disabled state; a battery; processing circuitry configured to execute computer-readable instructions that cause the processing circuitry to: increase power drawn from the battery by the system to an increased power state when the power-on module is switched from the disabled state to the enabled state; measure how long the power-on module remains in the enabled state; decrease power drawn from the battery by the system to a low power state if the power-on module remains in the enabled state for a first time period; subsequently, if the power-on module remains in the enabled state for a second time period other than the first time period, increase power drawn from the battery by the system from the low power state to the increased power state and generate an event; and store data indicative of the event into a memory of the dose detection system. the processing circuitry is further caused to:

2. The system of claim 1, wherein, communicate the data indicative of the event to a remote computing system configured to generate a notification to a user of the remote computing system indicative of the event. the processing circuitry is further caused to:

3. The system of claim 1 or 2, wherein, decrease power drawn from the battery to the low power state after the data indicative of the event is stored; subsequently, if the power-on module remains in the enabled state for a third time period other than the first and second time periods, increase power drawn from the battery from the low power state to the increased power state and generate a second event; and store data indicative of the second event into the memory. the processing circuitry is further caused to: communicate the data indicative of the second event to the remote computing system configured to generate a second notification to a user of the remote computing system indicative of the second event.

4. The system of claim 3, wherein, the first time period is in a range of 20 seconds to 1 minute, and each of the second and third time periods is greater in time than the first time period. the first time period is in a range of 20 seconds to 1 minute, and the second time period is greater in time than the first time period.

5. The system of claim 3 or 4, wherein, 7. A method for reducing battery consumption of a dose detection system, the system comprising a power-on module and a battery, the method comprising:

6. The system of claim 1 or 2, wherein, increasing power drawn from the battery by the system to an increased power state when the power-on module is switched to an enabled state; measuring how long the power-on module remains in the enabled state; decreasing power drawn from the battery by the system from the increased power state to a low power state if the power-on module remains in the enabled state for a time period comprising a first time period; subsequently, increasing power drawn from the battery from the low power state to the increased power state and generating an event if the power-on module remains in the enabled state for a time period comprising a second time period other than the first time period; storing data indicative of the event into a memory of the dose detection system.

8. The method of claim 7, further comprising: ​ ​ ​ transmitting data indicative of the event to a remote computing system configured to generate a notification to a user of the remote computing system indicative of the event.

9. The method of claim 8, further comprising: reducing power drawn by the system from the battery to a low power state after data indicative of the event is stored; subsequently, if the power-on module remains in the enabled state for a third time period other than the first time period and the second time period, increasing power drawn by the system from the battery from the low power state to an increased power state and generating a second event; and storing data indicative of the second event into the memory.

10. The method of claim 9, further comprising: transmitting data indicative of the second event to the remote computing system configured to generate a second notification to a user of the remote computing system indicative of the second event.

11. The method of claim 9 or 10, wherein, the first time period is in a range of 20 seconds to 1 minute, and each of the second time period and the third time period is greater than the first time period.

12. The method of claim 7, wherein, the first time period is in a range of 20 seconds to 1 minute, and the second time period is greater than the first time period.

13. The system of claim 1, further comprising a drug delivery device to which the dose detection system is coupled, wherein the drug delivery device comprises a drug.

14. A system configured to reduce battery consumption of a dose detection system, the system comprising: a power-on module switchable between an enabled state and a disabled state; a battery; processing circuitry configured to execute computer-readable instructions that cause the processing circuitry to: increase power drawn by the system from the battery to an increased power state when the power-on module switches from the disabled state to the enabled state; measure a number of times the power-on module is in the enabled state for a time period; if the number of times the power-on module is in the enabled state for a first time period reaches a first number, increase power drawn by the system from the battery from the low power state to the increased power state and generate an event; and store data indicative of the event into a memory of the dose detection system.

15. A method for reducing battery consumption of a dose detection system, the system comprising a power-on module and a battery, the method comprising: increasing power drawn by the system from the battery to an increased power state when the power-on module is switched to an enabled state; measuring a number of times the power-on module is in the enabled state for a time period; reducing power drawn by the system from the battery to a low power state if the power-on module remains in the enabled state for a time period comprising a first time period; if the number of times the power-on module is in the enabled state for a first time period reaches a first number, increasing power drawn by the system from the battery from the low power state to the increased power state and generating an event; and storing data indicative of the event into a memory of the dose detection system. ​ ​

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