CN116033934A - Method and apparatus for dose detection system module aspects of a drug delivery device - Google Patents

Abstract

Techniques described herein relate to computerized methods and systems for generating at least one of a single light indication pattern for a dose detection system via an LED, eg, based on use case type and battery life state type. A use case type may include pairing, manual sync, and/or dose injection, and a battery life state type may include 1 to 3 different states. Another method and system for reducing battery consumption of a dose detection system by monitoring the continued activation of an energized module and/or alerting a user in a manner that causes the user to take action. At least some of the information obtained from these technologies may be communicated to a paired remote electronic device, such as a user's smartphone.

Description

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

technical field

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

Background technique

Patients suffering from various diseases must frequently inject themselves with drugs. To allow a person to self-administer conveniently and accurately, a variety of devices broadly known as pen injectors or injection pens have been developed. Typically, these pens are equipped with a cartridge that includes a plunger and contains multiple doses of liquid medication. The drive member is movable forwardly to advance a piston in the cartridge to dispense the contained medicament from an outlet at the distal end of the cartridge, usually through a needle. In disposable or prefilled pens, after the pen has been used to deplete the drug supply in the cartridge, the user discards the entire pen and starts using a new replacement pen. In a reusable pen, after the pen has been used to deplete the drug supply within the cartridge, the pen is disassembled to allow the spent cartridge to be replaced with a new one, and then the pen is reassembled for use in its subsequent use.

Many pen injectors and other drug delivery devices utilize mechanical systems in which components rotate and/or translate relative to each other in proportion to the dose the device is operatively delivering. Accordingly, efforts have been made in the art to provide reliable systems that accurately measure the relative movement of the components of a drug delivery device in order to assess the delivered dose. Such a system may include a sensor affixed to a first member of the drug delivery device and detecting relative movement of a sensed component affixed to a second member of the device.

Administering the right amount of drug requires that the drug delivery device deliver an accurate dose. Many pen injectors and other drug delivery devices do not include functionality to automatically detect and record the amount of drug delivered by the device during an injection event. In the absence of an automated system, patients must manually record the amount and timing of each injection. Therefore, there is a need for a device operable to automatically detect a dose delivered by a drug delivery device during an injection event. Furthermore, there is a need for a dose detection device that is detachable and reusable in conjunction with multiple delivery devices. In other embodiments, it is desirable to integrate such a dose detection device with the delivery device.

Contents of the invention

In one embodiment, a system and method configured to generate a light indication pattern for a dose detection system is disclosed. For example, the system may include one or more light emitting diodes (LEDs), one or more batteries, and processing circuitry. The processing circuit may be configured or the method steps may: determine a use case type from a plurality of use case types of the dose detection system; determine a battery life state of one or more batteries from a plurality of battery life states; and provide via one or more LEDs Light indication mode. The light indication mode may include (i) a first light indication portion based on the determined use case type, and (ii) a second light indication based on the determined battery life status after a delay after completion of the first light indication portion part.

In another embodiment, systems and methods configured to reduce battery consumption of a dose detection system are disclosed. For example, the system may include a powered module switchable between an active state and a deactivated state; a battery; processing circuitry. The processing circuitry may be configured or the method steps may be: increasing power drawn by the system from the battery to an increased power state when the energization module switches from a deactivated state to an enabled state; and measuring energized How long the module remains enabled. Decreasing power drawn by the system from the battery to a low power state if the energization module is continuously in the enabled state for a first period of time. subsequently. If the power-on module is continuously enabled for a second period of time in addition to the first period of time, then increases the power drawn by the system from the battery from a low power state to an increased power state and an event is generated and will be indicated The data is stored in the memory of the dose detection system.

Description of drawings

Other embodiments of the invention and its features and advantages will become more apparent by reference to the description herein taken in conjunction with the accompanying drawings. Components in the figures are not necessarily drawn to scale. Furthermore, in the drawings, the same reference numerals designate corresponding parts in different views.

Figure 1A is a schematic diagram of an exemplary system, according to some embodiments.

Figure IB depicts a block diagram of a controller and its components, according to some embodiments.

Figure 1C is a schematic diagram of an exemplary system, according to some embodiments.

2 is a flowchart of an exemplary computerized method for determining a color associated with an object, according to some embodiments.

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

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

5 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present invention is operable.

6 is a cross-sectional perspective view of the exemplary drug delivery device shown in FIG. 5 .

7 is a perspective view of a proximal portion of the exemplary drug delivery device shown in FIG. 5 .

Figure 8 is a partially exploded perspective view of the proximal portion of the exemplary drug delivery device shown in Figure 5, together with the dose detection system of the present invention.

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

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

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

Figure 13 illustrates an exemplary computerized method for determining whether a device is detachably coupled to a medication injection device, according to some embodiments.

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

15 illustrates an exemplary computerized method for generating an indication signal of a single light indication pattern to a system user, according to some embodiments.

Figure 16 illustrates an exemplary computerized method for determining a use case type of a dose delivery detection system from a plurality of use case type configurations, according to some embodiments.

17 illustrates an exemplary computerized method of determining a light indication pattern based on remaining battery state life, according to some embodiments.

18 illustrates an exemplary computerized method of generating an indication to a user if an energized module of a dose detection system has been enabled for a certain period of time, according to some embodiments.

Detailed ways

To promote an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. However, it should be understood that this is not meant to limit the scope of the invention.

Delivering the correct drug is very important. Depending on the situation, patients may need to choose a different drug or choose a different form of a given drug. If a mistake is made as to what drug is in the drug delivery device, the patient will not be dosed correctly and the recording of the administered dose will be inaccurate. The likelihood of this happening is greatly reduced if a dose detection device that automatically confirms the type of drug contained in the drug delivery device is used.

The present invention relates to sensing systems for drug delivery devices. In one aspect, a sensing system is used to generate a single light-indicating pattern for a dose detection system. The inventors have discovered and appreciated that it may be desirable to have a light indication strategy when the dose detection system does not have a display, although the inventors recognize that a light indication strategy may still be advantageous for a dose detection system with a display. However, the inventors have discovered and appreciated that given the various hardware, firmware and/or software it is desirable to include in such a dose sensing system, and the desire to keep the dose sensing system small, user friendly and limited to include only Using components with a low probability of failure, also incorporating additional components (e.g., switches, latches, etc.) to indicate information to the user when the dose sensing system is connected to a remote computing device or whether the injection was successful is challenging . The technique described here provides the use of existing components of the dose sensing device to determine whether the dose sensing device is coupled/coupled to the drug delivery device, whether the sensed element is moving, and how long the energized module is enabled to determine different type of use case. For example, a dose sensing device may comprise a sensor (eg a Hall effect sensor) and associated hardware and/or software to determine the size of a dose delivered by the drug delivery device. The technique may also utilize such hardware and/or software for performing dose detection to determine whether a dose sensing system is coupled to a drug delivery device.

In a second aspect, the sensing system can be used to reduce drain on the sensing system battery. The inventors have discovered and realized that when the energized module is enabled for an extended period of time, the battery is completely depleted much sooner than expected. The inventors have developed techniques for monitoring the continued activation of powered modules to provide techniques for storing events and/or communicating with remote computing systems configured to provide some indication of such events to a user. The term "event" as used herein is defined to include any one or more of the following: (i) a processor interrupt, (ii) the generation of an electrical signal that propagates along a circuit, (iii) the setting or unsetting of one of the registers or multiple bits, (iv) change the value of the programming variable.

For ease of illustration, the drug delivery device is described in the form of a pen injector. However, the drug delivery device may be any device used to set and deliver doses of a drug, such as an infusion pump, bolus injector or auto-injector device. The drug may be of any type that can be delivered by such a drug delivery device.

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. Therefore, the embodiments described here are examples, and not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, nor is it necessarily expected that every embodiment will achieve all of the described advantages.

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

Figure 1A is a schematic diagram of an exemplary system 120, according to some embodiments. System 101 includes sensing system 103 in communication with remote computing device 104 through communication unit 106 (eg, via a wired and/or wireless connection). The communication unit 106 may 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.

As further described herein, sensing system 103 may be configured to determine lighting data indicative of a color of an object. Sensing system 103 includes a processing unit 108 (eg, MCU) in communication with light sensor 110 and control unit 112 . The light sensor 110 is in optical communication with an object 116 (eg, part of a drug delivery device). In some embodiments, light sensor 110 is an ambient light sensor (ALS), eg operating in reflective mode. LED driver 112 is in communication with a set of light emitting diodes (LEDs) 114A, 114B, and 114C (collectively LEDs 114 ), which are in optical communication with object 116 . For example, LEDs 114 may include red LEDs, blue LEDs, and/or green LEDs. Light sensor 110, LED 114, or both light sensor 110 and LED 114 are optionally in optical communication with object 116 through optional light guide 118. The light guide 118 may be a transparent light guide, such as a Makrolon 2458 light guide. In some embodiments, the color sensor is made from individual LEDs, a single packaged RGB LED, or a combination thereof.

FIG. 1B , with additional reference to FIG. 14 , shows a detailed example of the electrical components of a sensing module, labeled 1400 , which may be included in any of the modules described herein. Electronic components include a microcontroller (labeled MCU in FIG. 1B ). The MCU of sensing system 1400 includes a processing unit, which may be or include a processing circuit. "Processing circuitry" may include one or more programmable processors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or combinations thereof. Program the MCU to implement the electronic functions of the module. The MCU includes control logic operable to perform the operations described herein, including detecting connection to a drug delivery device, determining the type of drug delivery device, obtaining data for determining the dose delivered by the drug delivery device, and monitoring Battery life of drug delivery devices. The MCU is operable to obtain data by detecting and/or determining the amount of rotation of a rotary sensor affixed to the flange by detecting the magnetic field of the rotary sensor by a sensing element of a measurement sensor (e.g., a Hall Effect sensor) of the system. Sure.

Sensing module 1400 includes operably coupled to dose sensing elements 1402A-E, memory 1408, identification sensor 1404, counter 1414, light driver 1411 and light indicator 1412, power-on module 1406, communication module 1410, display driver/display 1416, Power supply 1418 and MCU present in one or more of modules 1420 . Sensing module 1400 may include any number of sensing elements, such as five magnetic sensors 1402A-E (shown) or six sensors. The dose sensor can be used to determine the total rotational units of the internal components of the drug delivery device, which can be used to determine the dose administered (e.g., as discussed further herein in connection with FIGS. connection of the device. The MCU may be configured via the presence module 1420, shown as optional in this embodiment by dashed lines, to determine whether this module is coupled/coupled to the device's dosing button via triggering of the presence switch system. The MCU is configured to determine the color of the dosing button by identifying the sensor 1404, and in some examples, with the aid of logic on the onboard sensing module 1400 or logic implemented on an external device (e.g., remote computing device 104) Next, associate the identified color with a specific 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 discussed further herein). of). The MCU is configured to determine activation of the power-on switch (shown at 137, which is activated by button 139, as shown in FIG. 9) to increase power draw from the power supply to the electronic components for use, in FIG. Commonly shown as energization module 1406 . In one example, the total rotation may be communicated to an external device, including a database, lookup table, or other system with a database, lookup table, or other stored in memory, to correlate the total rotation unit with the amount of drug delivered for the identified given drug. Data storage. In another example, the MCU may be configured to determine the amount of drug delivered. The MCU is operable to store the detected dose in local memory 1408 (eg, internal flash memory or on-board EEPROM). The MCU is also operable to wirelessly transmit signals representing device data to a paired remote via Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocol module 1410, such as Near Field Communication (NFC), WiFi, or a cellular network. Electronic devices such as a user's smartphone with device data such as units of rotation, drug identification (e.g. color) data, time stamps, time since last dose, battery charge status, module identification number, time a module was attached or removed , inactivity time, and/or other errors (eg, dose detection and/or delivery errors, drug identification detection and/or delivery errors). Illustratively, the BLE control logic and MCU are integrated on the same circuit. In one example, any of the modules described herein may include a display module 1416 (shown as optional in this embodiment by dashed lines) for indicating information to a user. Such a display, which may be an LED, LCD or other digital or analog display, may be integrated with the proximal portion of the finger pad. The MCU includes a display driver software module and control logic operable to receive and process sensed data and display information on said display, such as dose setting, dose dispensed, injection status, injection complete, date and/or or the time, or the time of the next injection. In another example, the MCU includes an LED driver 1411 coupled to one or more LEDs 1412 (e.g., an amber LED and a green LED) for communicating to the patient whether the data was successfully transmitted, through an on-off and sequence of different colors, Whether the battery level is high or low, or other clinical communication. Counter 1414 is shown as a real time clock (RTC) electrically coupled to the MCU to keep track of time, eg dose time. Counter 1414 may also be a time counter that tracks seconds from zero based on the stimulus. Time or count values can be transmitted to external devices.

With additional reference to FIG. 14 , the remote computing device/smartphone 104 includes a processor 1463 (also referred to herein as processing circuitry), and a memory 1465 (which may be any suitable computer-readable medium accessible to the processor 1463, including easy volatile and non-volatile memory) and a communication device 1467 configured to communicate with the communication protocol module 1410 via wired or wireless signals 1475 and operable to provide user input data to the system And receive and display data, information and prompts generated by the system. Wireless signal 1475 may be configured according to one or more communication protocols previously described with respect to 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, user interface 1461 is a graphical user interface (GUI), including a touch screen display, for displaying data and receiving user input. Touch screen displays allow users to interact with presented information, menus, buttons, and other data to receive information from and provide user input to the system. Alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

In some embodiments, sensing system 103 is configured to connect to a drug delivery device as described in connection with FIGS. 8-12. In some embodiments, the object 116 is a portion of the drug delivery device (eg, a button, label, color of the outer compartment, etc.) that can be used to identify an aspect of the drug delivery device based on the color of the object 116 . For example, the color of object 116 may indicate the drug type of the drug delivery device.

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

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

Referring to FIG. 1A , in some embodiments, sensing system 103 is configured to determine the color of an object (eg, a button of a pen-type drug delivery device). In some embodiments, the sensing system determines the object color by sequentially turning on the LEDs 114 and reading the reflected beam back through the broadband ambient light sensor 110. Sensing system 103 may generate various values, such as three values for each of three LEDs 114 . Sensing system 103 may process the generated values to generate final color values for matching. Sensing system 103 may check the final color value against a predefined set of colors to determine a match.

FIG. 2 is a flowchart of an exemplary computerized method 200 for determining a color associated with an object, according to some embodiments. A processor, such as processing unit 108 of sensing system 103 , may execute computer readable instructions that cause the processor to perform 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 may optionally process the lighting data at steps 204 and/or 206 to generate processed lighting data. At step 204, the sensing system adjusts the lighting data, optionally based on temperature. In step 206, the sensing system optionally normalizes the illumination data. At step 208, the sensing system causes the light sensor to capture illumination data for the object when the object is illuminated by the set of LEDs. At step 208, the sensing system transmits the processed lighting data to a remote device (eg, via a communication module in communication with a processor of the device). In step 210, the remote device determines whether the lighting metric matches a stored set of colors. If the remote device determines a match, then at step 212 the remote device outputs the matched color (eg, to a program, 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 (eg, by returning an error code, mismatch code, etc.).

Referring to step 202, the sensing system may be configured to capture first illumination data when the object is not illuminated by the set of LEDs, capture second illumination data when the object is illuminated by each of the set of LEDs, or capture second illumination data when the object is not illuminated by the set of LEDs. Both first lighting data is captured when the group of LEDs is illuminated and second lighting data is captured when the object is illuminated by each of the group of LEDs. For example, the device may be configured to capture illumination data for an object when the object is only illuminated by ambient light when the LED is not on. In some embodiments, the sensing system may include an exposure time during which dark illumination data is captured.

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

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

rgbTempX＝rgbX*(1-TempCoefficientX*(Temp-CalTemp)) (equation 1)

in:

rgbTempX is the adjusted lighting data value determined for each color, such as red value, green value and blue value, depending on which color Equation 1 was calculated for;

rgbX is each raw lighting data value, such as red value, green value and blue value;

TempCoefficientX is the temperature coefficient of each value, this can allow tracking various temperature measurements with one coefficient (for example, because there may be performance drift in different temperature measurements);

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

• Temp is the measured (eg average) temperature.

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

in:

bNormX is the normalized lighting value, eg red, green or blue normalized value, depending on which color equation 2 is calculated for (multiplied by 100 in percentage);

whiteX represents the illumination values obtained during the calibration phase when using a white target object, such as red, green and blue values (further described in connection with FIG. 3 );

blackX represents the illumination values obtained during the calibration phase when using a black target object, eg red, green and blue values (further described in connection with Figure 3);

calDark is the dark lighting value (LED off) determined during the calibration phase (further described in connection with Figure 3); and

• darkValue is the dark lighting value determined in step 202 .

Referring to step 210, the remote device may be configured to determine a luminance A B(LABc) value. The system can determine the LABc value based on any lighting value, whether raw lighting data or temperature adjusted lighting data and/or normalized lighting data. For illustration purposes, the examples below refer to normalized lighting data for simplicity. The A value can be calculated from the normalized lighting values. For example, depending on whether rgbNormRed is greater than rgbNormGreen determined using Equation 2, then use one of Equations 3 or 4 to determine the A value:

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

The L value can be calculated by Equation 7:

In some embodiments, the remote device may include a meter for determining whether the lighting data conforms to color. The remote device may include a set of colors (eg, gray, blue, dark blue, red, and/or other colors), where each color has an associated set of data. The data associated with each color may include mean data and/or σ (Sigma) variation data determined during calibration and/or design of the system. In some embodiments, each color may include an average of each of the A, B, and L values and a sigma variation value for each of the A, B, and L values. The remote device can determine the lighting data and the σ distance for each color in the stored set of colors. For example, Equation 8 can be used to determine the σ distance for each color in the color set:

in:

SigmaDistanceX is the σ distance of the considered color (X) from the color set;

· For real-time measurement:

o Calculate L using Equation 7;

o Calculate A using equation 3 or 4;

o Calculate B using equation 5 or 6;

· For the considered color (X):

oμLX is the average value of the L value of the color (X);

oσLX is the σ change of the L value of the color (X);

oμAX is the average of the A values of the color (X);

oσAX is the σ change of the A value of the color (X);

o μBX is the average of the B-values of the color (X); and

oσBX is the σ change in the B value of the color (X).

The remote device can use the σ distance to determine whether the lighting data matches a color in the color set. For example, the remote device may select the smallest of the σ distance values (Min1) as the most likely matching color. The second smallest value (Min2) can be used for matching color checking, as discussed further here.

The sensing system and/or remote device may be configured to perform one or more checks on the lighting data. For example, dark-light data can be examined to determine whether subsequent measurements under LED lighting are disturbed by ambient light. As another example, acquired illumination data for LEDs may be checked to ensure that the illumination data is within expected thresholds between the lowest black value and the highest white value. As another example, LABc values can be checked to determine if they are within an acceptable range (eg -100 to 100 for A or B, 0 to 100 for L). As another example, a matching color check can be performed to ensure Minl and/or Min2 are within acceptable values. For example, Min1 can be checked to ensure that Min1 is below the maximum σ distance for an expected color match, and/or the ratio of Min2/Min1 can be compared to the minimum ratio between the two minimum values for an acceptable match.

During calibration, the sensing device can make various measurements that can be used for real-time measurements of the calibration object. Calibration measurements can include temperature and various light measurements, such as those using white targets, black targets, and dim lighting without any LEDs on. FIG. 3 is a flowchart of an exemplary computerized method 300 for generating calibration parameters, according to some embodiments. In step 302, the device measures temperature. At step 304, the device captures lighting data for a white target object (eg, a white object). At step 306, the device captures illumination data for a black target (eg, a black object). At step 308, the device captures lighting data for dim light without the LEDs on. At step 310, the device generates a set of calibration parameters. Calibration parameters may include exposure times (or maximum/minimum exposure times) for dark measurements and/or for each LED (e.g., red, green, and blue LEDs), each in a white and/or black object Counts, temperature, temperature margin, and/or other calibration parameters read during calibration for each LED.

As described herein, a dose sensing system includes a sensing module having various components including a processor/MCU, sensors, LEDs, and other components. In some embodiments, the sensing module may be powered by a power source, such as one or more batteries. Referring to FIG. 1C , for example, sensing system 132 includes a battery 138 that powers the dose sensing system (including the exemplary components shown in FIG. 1C ). The techniques described here can be used to monitor the battery life of dose sensing systems. Battery life can be monitored to provide information to the user, such as a battery status indication that tracks battery life, battery-related alerts (eg, alerting the user of low battery life, when to replace the battery, etc.), and the like. For example, a dose sensing system, whether through a sensing module or a remote computing device, could warn the user when the battery is about to die, thereby giving the user enough time to replace the battery (e.g., a week or two before the end of battery life). week).

The inventors have discovered and realized that since battery behavior may depend on many variables such as temperature, relaxation time between measurements, injection duration of the attached drug delivery device, load variation, battery brand, battery variability and Other parameters, therefore, can be complicated to estimate battery life, for example by using battery voltage measurements. To address these issues, which are often outside the control of the device provider, the inventors have developed techniques based on the device architecture to monitor the battery in a manner that provides sufficient margin in battery life to compensate for potential errors and variability, the inventor It is recognized that these errors and variability would otherwise occur during battery measurements.

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

Referring to step 402, the device (eg, MCU) may 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 (which may be referred to as a sleep state) less electrical power is drawn from the battery than in an increased power state (which may be referred to as an awake state). A lower power state can be achieved by (a) running some or all components in the system at a lower clock speed than they were running in the increased power state, (b) shutting down the increased power state Some or all of the components that operate and consume power, or (c) both. In some embodiments, the device obtains (a) a startup battery voltage when the device is powered on, (b) a high current battery voltage when the processor is running at maximum speed, (c) a low power mode when the processor is running low current battery voltage, or some combination thereof. For example, the start-up battery voltage can be determined by obtaining the high current battery voltage within a certain amount of time from when the sense module is powered on. For example, when the device wakes up (eg, after pressing a button (see reference numeral 139 in FIG. 9 )), the device may increase its draw from the battery of the electronic device to achieve said increased power state. Button 139 is configured more axially relative to dosing body 88 to activate switch 137 when pressed in (shown with a spring biased arm that contacts the sensor pad for activation and the spring Bias arm removed from sensor pad for deactivation). In some embodiments, when awakened, the device may initiate a boot process/boot process/boot process. The start-up process may increase the draw from the battery due to, for example, various self-tests, start-up operations, etc., to place the electronic device in an increased power state. In some embodiments, when awakened, the device may take magnetic measurements (eg, determine the home position of one or more components). Thus, such a starting process and/or magnetic sensing may provide the high current battery voltage for measurement as the starting battery voltage.

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

The low current battery voltage can be used to measure the voltage drop at the lowest current load, for example, to simulate an open circuit voltage check of a battery. For example, low power can be determined by having firmware running on the MCU place all loads (e.g., including the MCU) in low power mode for a predetermined period of time (e.g., a rest period specified in ms), and measure the low current battery voltage. 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.

One or more voltage measurements may be used in step 402 as described herein. For example, in some embodiments, may be designed in a manner to obtain voltage readings at high and/or maximum current draw (e.g., point with maximum voltage drop) and representative open circuit voltage measurements at low/minimum current draw to get the voltage. As described herein, voltage can be used to estimate remaining battery energy. In some embodiments, these techniques may use, for example, a single voltage drop, such as a maximum voltage drop, to estimate remaining battery energy (e.g., because the maximum voltage drop may be more dependent on battery state than other voltage drops, which may be more driven by a capacitor). For example, the power-on/start-up voltage drop can simply be compared to the maximum voltage drop. For example, if the voltage drop during power-up is greater than the system's measured maximum voltage drop, the comparison may indicate that there is a risk that the component may reset.

Referring to step 406, the device may store battery indicator tables at different temperatures. For example, the device may store a set of low temperature battery indications comprising a set of battery indications, each battery indication having an associated voltage for low temperature. Table 1 is an example set of low temperature battery indications (for example, at 0°C):

battery indicator Voltage (mV) 100 2460 90 2334 80 2317 70 2310 60 2282 50 2242 40 2214 30 2176 20 2113 10 1998 4 1950

Table 1

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

battery indicator Voltage (mV) 100 2764 90 2710 80 2690 70 2663 60 2626 50 2573 40 2514 30 2454 20 2388 10 2242 4 2050

Table 2

The sensing system may determine a set of temperature adjusted battery indications based on the set of low temperature battery indications, the set of high temperature battery indications, and the temperature measurement obtained at step 402 . In some embodiments, the sensing system (eg, via firmware executing on the MCU) may determine the correction factor based on the temperature measured at step 404 . For example, the sensing system may determine a correction factor based on the measured temperature and one or more correction factors. Logarithmic (as shown below) and/or linear relationships can be established to characterize the correction coefficients. For example, the sensing system can use Equation 9 to determine the correction factor:

corrFactor=A*log ₂ (Temp+LogOffset)+Temp*B+C (equation 9)

in:

CorrFactor is the correction factor;

A, B, and C are coefficients (e.g., determined based on collected data to provide desired degrees of freedom for determining correction coefficients); and

• LogOffset is a coefficient (eg, determined based on collected data to provide the desired degrees of freedom for determining the correction coefficient).

The sensing system may determine a set of corrected battery indications (eg, a corrected battery gauge) based on the temperature correction coefficients. In some embodiments, the sensing system may determine a corrected battery indication based on the low and high temperature battery gauges. For example, the sensing system can use Equation 10 to determine each corrected battery voltage associated with each indication:

CorrBatCurve _x = {(Voltage _TEMPH/x -Voltage _TEMPLOx )/(TEMPHI-TEMPLO)}*(corrFactor-TEMPHI)+Voltage _TEMPHIx (equation 10),

in:

CorrBatCurve _x is the corrected battery curve voltage of row X;

·Voltage _TEMPHIx is the voltage of line X in the high temperature battery meter;

·Voltage _TEMPLOx is the voltage of line X in the low temperature battery meter;

TEMPHI is the temperature used when determining the high temperature battery meter;

TEMPLO is the temperature used when determining the low temperature battery gauge; and

• corrFactor is the correction factor determined using Equation 9.

Referring to step 408, the device may determine a battery indication based on previous battery indications. For example, the device may obtain a previous battery indication for the battery, determine a current battery indication for the battery based on a temperature-adjusted battery indication in a corrected battery gauge and a set of voltage measurements, and based on the previous battery indication and The current battery indication to determine the battery indication.

In some embodiments, the sensing system may determine the current battery indication based on a stored battery gauge and/or a corrected battery gauge. For example, the sensing system may use the high current battery voltage (eg, measured at step 402 in FIG. 4 ) to interpolate points in the corrected battery meter. For example, if the high current battery voltage is equal to the voltage value in the table, the sensing system may 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 may interpolate between the two related battery indications to determine the related battery indication.

In some embodiments, the sensing system may determine a new battery indication based on previous battery indications (eg, which may be stored in the sensing system's memory, such as EEPROM). For example, the sensing system can use Equation 11 to determine a new battery indication:

newBatInd＝(FILTER*batInd+curBatInd)/(FILTER+1) (equation 11)

in:

· newBatInd is the new battery indicator;

batInd is the previous battery indication (e.g. obtained from EEPROM);

· curBatInd is the currently determined battery indication; and

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

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

The apparatus can send the battery indication to a remote device (eg, remote computing device 104). The remote device can handle the new battery indication. For example, the remote device may be configured to determine the battery status based on the battery indication. As an example, Table 3 below shows exemplary battery status and associated battery indications (as a percentage of design capacity to deliver the maximum number of injections):

battery indicator battery status 100 Full 90 Full 80 Full 70 Full 60 medium 50 medium 40 medium 30 medium 20 Low 10 Low 4 Battery replacement - less than 120 injections remaining 3 Battery replacement - less than 90 injections remaining 2 Battery replacement - less than 60 injections remaining 1 Battery replacement - less than 30 injections remaining 0 EOL

table 3

In some embodiments, the sensing device may enter a low battery state once the sensing device first emits a low battery flag (eg, when the device is unlikely to deliver more than a certain number of injections, such as 120 injections). Once in a low battery state, the sensing device may refrain from changing the battery's low battery state (eg, avoid moving back and forth from a low battery state to a non-low battery state). In some embodiments, the sensing device may be configured such that once it is in a low power state, each new operation of the sensing device (eg, a sync, bind, or dosing event) decreases the battery indication by 1. In some embodiments, the sensing device may be configured to decrease the number of remaining injections by 1 for each new operation of the sensing device once it is in a low power state. Once the battery indication is equal to zero, the sensing system may enter an end-of-life state. In some embodiments, the battery can be replaced, and the sensing system can be reset when a new battery is detected. In some embodiments, the sensing system is disposable and can be discarded upon reaching end-of-life.

In some embodiments, the sensing system may perform one or more checks on data obtained and/or measurements made during battery monitoring. For example, the MCU can issue a low-battery warning once the indication of a new battery falls below a predetermined threshold. As another example, the sensing system may check whether a sensed voltage is within a predetermined acceptable range, whether a temperature measurement is within a predetermined acceptable range, and/or the like.

As described herein, the technology can be used with various types of drug delivery devices, including drug delivery devices incorporating aspects described herein, as well as additional components attachable to drug delivery devices. For purposes of illustration, FIGS. 5-12 depict exemplary drug delivery devices and dose sensing systems that may incorporate these technologies. This technique is further discussed in PCT Publication No. WO2019/164955, filed February 20, 2019, which is incorporated herein by reference.

5-6 illustrate an exemplary drug delivery device 10 according to some examples. Drug delivery device 10 is a pen injector configured to inject a drug into a patient through a needle. Pen injector 10 includes a body 11 comprising an elongated pen-shaped housing 12 comprising 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 drug fluid of the drug to be dispensed through its distal outlet port during a dispensing operation. The outlet end of the distal portion 14 is equipped with a removable needle assembly 22 comprising an injection needle 24 closed by a removable cap 25 . Piston 26 is located in reservoir 20 . An injection mechanism located in the proximal portion 16 is operable to advance the piston 26 towards the outlet of the reservoir 20 during a dosing operation to force the contained drug through the needle end. The injection mechanism includes a drive member 28 , shown in the form of a screw, axially movable relative to the housing 12 to advance the piston 26 through the reservoir 20 .

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 helical element operable for helical movement (eg simultaneous axial and rotational movement) relative to the housing 12 during dose setting and dose dispensing. Figures 5 and 6 show the dose setting member 30 fully screwed into the housing 12 in its original or zero dose position. The dose setting member 30 is operatively unscrewed from the housing 12 in the proximal direction until it reaches a fully extended position corresponding to the maximum dose that the device 10 can deliver in a single injection.

Referring to Figures 6-8, the dose setting member 30 comprises a cylindrical dose dial member 32 having a helically threaded outer surface which engages a correspondingly threaded inner surface of the housing 12 to allow the dose setting member 30 moves helically relative to housing 12 . The dose dial member 32 also includes a helically threaded inner surface that engages a threaded outer surface of a sleeve 34 ( FIG. 6 ) of the device 10 . The outer surface of the scale member 32 includes dose indicator markings, such as numbers visible through the dose window 36, to indicate to the user the set dose/dosing amount. The dose setting member 30 also includes a tubular flange 38 coupled in the open proximal end of the dial member 32 and axially and Relatively rotationally locked to the dial member 32 . The dose setting member 30 may also include a collar or skirt 42 positioned around the periphery of the dial member 32 at the proximal end of the dial member 32 . The skirt 42 is axially and relatively 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 skirts.

Thus, the dose setting member 30 may be considered to comprise any or all of the dose dial member 32, flange 38 and skirt 42, since none of them are relatively rotationally and axially fixed together. The dose dial member 32 is directly involved in setting doses and driving drug delivery. A flange 38 is attached to the dose dial member 32 and, as described below, cooperates with a clutch to selectively connect the dial member 32 with the dosing button 56 . The skirt 42 provides a surface on the exterior of the body 11 to enable the user to rotate the dial member 32 to set a dose. For embodiments without a skirt, the dosing button 56 includes a distally extending outer wall to form a surface for rotation by the user.

Skirt 42 illustratively includes a plurality of surface features 48 and an annular ridge 49 formed on an outer surface of skirt 42 . Surface features 48 are illustratively longitudinally extending ribs and grooves that are spaced circumferentially about the outer surface of skirt 42 and facilitate gripping and rotation of the skirt by a user. In an alternative embodiment, the skirt 42 is removed or is 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 the embodiment of FIG. 8, the user can grasp and rotate the radially outer surface of the one-piece dosing button 56, which also includes a plurality of surface features, for dose setting.

The delivery device 10 includes an actuator 50 with a clutch 52 received within the dial member 32 . Clutch 52 includes an axially extending rod 54 at its proximal end. The actuator 50 also includes a dosing button 56 located proximally of the skirt 42 of the dose setting member 30 . The dosing button 56 includes a mounting collar 58 ( FIG. 6 ) centrally located on the distal surface of the dosing button 56 . A collar 58 is attached to the stem 54 of the clutch 52, such as by an interference fit or ultrasonic welding, to secure the dosing button 56 and the clutch 52 together axially and against relative rotation.

Dosing button 56 includes a disc-shaped proximal surface or end face 60 and an annular wall portion 62 extending distally and spaced radially inwardly from the outer peripheral edge of end face 60 to form an annular lip therebetween. edge64. The proximal end face 60 of the dosing button 56 serves as a push surface on which a force can be applied manually, ie by the user pushing the actuator 50 directly in the distal direction. Dosing button 56 illustratively includes a recessed portion 66 centrally located on proximal end face 60, although proximal end face 60 may alternatively be a flat surface. A biasing member 68 , illustrated as a spring, is disposed between a distal surface 70 of the button 56 and a proximal surface 72 of the tubular flange 38 to urge the actuator 50 and dose setting member 30 axially away from each other. The user may press the dosing button 56 to initiate a dose dispensing operation.

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 the desired dose delivered by the device 10 . The proximal direction dial is used to increase the set dose and the distal direction dial is used to decrease the set dose. The dose setting member 30 is adjustable during a dose setting operation in increments of rotation (eg clicks) corresponding to a minimum incremental increase or minimum incremental decrease of the set dose. For example, one increment or "click" can equal half or one unit of medication. The set dose is visible to the user by the scale indicator marks displayed by the dose window 36 . Actuator 50 comprising dosing button 56 and clutch 52 moves axially and rotates with dose setting member 30 during dialing in the dose setting mode.

The dose dial member 32, the flange 38 and the skirt 42 are fixed against relative rotation, and due to the threaded connection of the dose dial member 32 to the housing 12, the dose dial member 32, the flange 38 and the skirt 42 are fixed in the dose Rotate and extend proximally of the drug delivery device 10 during setting. During this dose setting movement, the dosing button 56 is relatively non-rotatably fixed relative to the skirt 42 by complementary splines 74 of the flange 38 and clutch 52 ( FIG. 6 ), which are biased Members 68 are pushed together. During dose setting, the skirt 42 and dosing button 56 move in a helical fashion relative to the housing 12 from a "start" position to an "end" position. This rotation relative to the housing is proportional to the dose set by operation of the drug delivery device 10 .

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

Axial movement of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dosing button 56 and the tubular flange 38 . This relative axial movement disengages the clutch 52 and the complementary splines 74 on the flange 38 , thereby releasing the actuator 50 (eg, the dosing button 56 ) from relative rotational fixation to the dose setting member 30 . In particular, the dose setting member 30 is rotationally decoupled from the actuator 50 to allow counter-driven rotation of the dose setting member 30 relative to the actuator 50 and housing 12 . The dose-dispensing mode of operation can also be activated by actuating a separate switch or trigger mechanism.

As the actuator 50 continues to be inserted axially without rotation relative to the housing 12 , the dial member 32 is screwed back into the housing 12 as it is rotated relative to the dosing button 56 . Visible through the window 36 are dose markings indicating the amount remaining to be injected. When the dose setting member 30 is tightened distally, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and expel the drug through the needle 24 ( FIG. 6 ).

During a dose dispensing operation, when the dial member 32 is screwed back into the housing 12, the amount of drug expelled from the drug delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50. The injection is complete when the internal threads of the dial member 32 reach the distal end of the corresponding external threads of the sleeve 34 (Fig. 6). As shown in Figures 6 and 7, the device 10 is then again arranged in the ready or zero dose position.

The starting and ending angular positions of the dose dial member 32 and thus the relatively non-rotatably fixed flange 38 and skirt 42 relative to the dosing button 56 provide an "absolute" change in angular position during dose delivery. There are various ways to determine if the relative rotation exceeds 360°. For example, the total rotation may also be determined by taking into account the incremental movement of the dose setting member 30, which may be measured in various ways by the sensing system.

Various sensor systems are envisioned herein. Typically, 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 a sensing element or "sensor", and associated electrical components to operate the sensing element. A "sensed element" is any component of a sensing element capable of detecting the position and/or movement of the sensed element relative to the sensing element. For dose delivery detection systems, the sensed element rotates relative to the sensing element, which enables detection of angular position and/or rotational movement of the sensed element. For dose type detection systems, the sensing elements detect the relative angular position of the sensed elements. The sensing element may include one or more sensing elements, and the sensed element may include one or more sensed elements. A sensor system is capable of detecting the position or motion of a sensed element and providing an output representative of the position or motion of the sensed element.

Sensor systems typically detect a characteristic of a sensed parameter that varies with the position of one or more sensed elements within a sensed area. The sensed element extends into or otherwise affects the sensed region in a manner that directly or indirectly affects a characteristic of the sensed parameter. The relative position of the sensor and sensed element affects the characteristics of the sensed parameter, allowing the sensor system's microcontroller unit (MCU) to determine different rotational positions of the sensed element.

Suitable sensor systems may include a combination of active and passive components. Since the sensing element works as an active part, it is not necessary to interface both parts with other system elements such as power supply or MCU.

Various sensing technologies can be combined by which the relative position of the two components can be detected. Such techniques may include, for example, techniques based on tactile, optical, inductive or electrical measurements. Such techniques may include measuring sensing parameters associated with a field, such as a magnetic field. In one form, the magnetic sensor senses a change in the sensed magnetic field as the magnetic member moves relative to the sensor. In another embodiment, the sensor system may sense characteristics and/or changes in the magnetic field when an object is located in and/or moves through the magnetic field. The change of the field changes the characteristics of the sensing parameter related to the position of the sensed element in the sensed region. In such embodiments, the sensed parameter may be capacitance, conductance, resistance, impedance, voltage, inductance, or the like. For example, magnetoresistive-type sensors detect distortions in an applied magnetic field that cause a characteristic change in the resistance of the sensor element. As another example, a Hall effect sensor detects voltage changes caused by distortion of an applied magnetic field.

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

A dose delivery detection system includes detection of relative rotational movement between 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 start of the dose injection to the end of the dose injection. For example, for pen injectors, a typical relationship is that an angular displacement of the dose setting member of 18° corresponds to one dosage unit, but other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, 5 dosage units have been delivered.

One method of detecting angular displacement is to calculate dosing increments as the injection progresses. For example, the sensor system may use a repeating pattern of the sensed element such that each repetition is indicative of a predetermined angular rotation. Conveniently, the pattern can be set up such that each repetition corresponds to the smallest dose increment that can be set with the drug delivery device.

Another approach is to detect the start and stop positions of the relative moving members and determine the delivered dose based on the difference between these positions. In such an approach, detection by the sensor system of a complete number of revolutions of the dose setting member may be part of the determination. Various methods for this are well known in the art and may include "counting" the number of increments to estimate the number of full revolutions.

Sensor system components may be permanently or detachably attached to the drug delivery device. In an illustrative embodiment, at least some of the dose detection system components are provided in the form of a module that is detachably attachable to the drug delivery device. This has the advantage of making these sensor components available for more than one pen injector.

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

Referring to FIG. 9 , a dose delivery detection system 80 is shown in schematic form, including an example of a module 82 that may be used in conjunction with a drug delivery device such as device 10 . Module 82 carries a sensor system, generally shown as a rotation sensor 86 (or more than one rotation sensor) and other associated components, such as a processor, memory, batteries, and the like. Module 82 is provided as a separate component that can be detachably attached to the actuator.

The dose detection module 82 includes a body 88 attached to the dosing button 56 (shown in phantom). The main body 88 illustratively includes a cylindrical side wall 90 and a top wall 92 that spans and seals the side wall 90 . The dose detection module 82 may alternatively be attached to the dosing button 56 by any suitable fastening means, such as a snap or press fit, threaded interface, etc., as long as in one aspect the module 82 is removable from the first drug delivery device. removed and then attached to a second drug delivery device. The attachment may be anywhere on the dosing button 56 so long as the dosing button 56 is capable of axial movement relative to the dose setting member 30 by any desired amount, as described herein.

During dose delivery, the dose setting member 30 is free to rotate relative to the dosing button 56 and module 82 . In the illustrative embodiment, module 82 is non-rotatably fixed relative to dosing button 56 and does not rotate during dose delivery. This may be provided structurally, for example by protrusions, or by having mutually facing splines or other surface features on the module body 88 and dosing button 56 which 82 engages when moved axially relative to dosing button 56 . In another embodiment, the distal pressing of the module provides sufficient frictional engagement between the module 82 and the dosing button 56 to functionally keep the module 82 and the dosing button 56 held closed during dose delivery. Cannot be fixed together relative to rotation.

Top wall 92 is spaced from face 60 of dosing button 56 to define cavity 96 in which some or all of the rotary sensor and other components may be housed. The cavity 96 may be open at the bottom, or may be closed, for example by a bottom wall 98 . The bottom wall 98 may be positioned directly against the end face of the dosing button 56 . Alternatively, the bottom wall 98 (if present) may be spaced from the dosing button 56 and other contact between the module 82 and the dosing button 56 may be used such that an axial force applied to the module 82 is transmitted to dosing button 56. In another embodiment, the module 82 may be non-rotatably secured to the one-piece dosing button structure.

In an alternative embodiment, the module 82 is instead attached to the dose setting member 30 during dose setting. For example, the side wall 90 may include a lower wall portion 100 having an inward protrusion in the form of a coupling arm 102 that engages the button side wall. In this way, block 82 may operatively engage proximal end face 60 of dosing button 56 and the distal side of annular ridge 49 . In such a configuration, the lower wall portion 100 may be provided with surface features that engage surface features of the dosing button to secure the module 82 against rotation relative to the dosing button. The rotational force applied to the housing 82 during dose setting is thus transmitted to the dosing button through the coupling of the lower wall portion 100 to the side wall of the dosing button. Light guide 118 is shown disposed between LEDs 114A-C and light sensor 110, which together are shown at a single location on the electronics assembly, as well as on the surface of dosing button 56 (when present). The battery 138 is shown disposed above the lighting system 89 and a portion of the electronic assembly.

Exemplary electronic 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 the processor for receiving signals representative of sensed relative rotation from the sensors. The electronic assembly also includes an MCU including at least one processing core and internal memory. An example of a schematic diagram of the electronic assembly is shown in Figure 1B.

Referring to FIGS. 10A , 10B, 11A and 11B, an exemplary 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 sensed element. The magnets described here may 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 may alternatively be attached to the dose dial 32 or other member fixed non-rotatably relative to the dose setting member. Magnets 152 may be constructed from a variety of materials, such as rare earth magnets, such as neodymium and the like.

Sensor system 150 also includes measurement sensor 158 including one or more sensing elements 160 operably connected to sensor electronics (not shown) contained within module 82 . Sensing element 160 of sensor 158 is shown in FIG. 11A as being attached to printed circuit board 162 which in turn is attached to module 82 which is fixed to dosing button 56 non-rotatably relative. Thus, during dose delivery, the magnet 152 rotates relative to the sensing element 160 . Sensing element 160 is operable to detect the relative angular position of magnet 152 . When ring 152 is a metal ring, sensing element 160 may comprise an inductive sensor, a capacitive sensor, or other non-contact sensor. The magnetic sensor system 150 thus operates to detect total rotation of the flange 38 during dose delivery relative to the dosing button 56 and thus relative to the housing 12 . In one example, a magnetic sensor system 150 including a magnet 152 and a sensor 158 with a sensing element 160 may be arranged in a module.

In one embodiment, magnetic sensor system 150 includes four sensing elements 160 equally spaced radially within module 82 to define a circular pattern as shown. Alternative numbers and locations of sensing elements can be used. For example, in another embodiment, as shown in FIG. 11B , a single sensing element 160 is used. Additionally, sensing element 160 in FIG. 11B is shown as being centered within module 82, although other locations may be used. In another embodiment, as shown in FIG. 12, for example, five sensing elements 906 are equally spaced circumferentially and radially within the module. In the foregoing embodiments, sensing element 160 was shown attached within module 82 . Alternatively, the sensing element 160 may be attached to any part of a component that is relatively non-rotatably fixed to the dosing button 56 so that the component does not rotate relative to the housing 12 during dose delivery.

For ease of illustration, magnet 152 is shown as a single annular dipole magnet attached to flange 38 . However, alternative configurations and locations of magnets 152 are contemplated. For example, a magnet may include multiple poles, such as alternating north and south poles. In one embodiment, the magnet comprises a number of pole pairs equal to the number of discrete rotational dose setting positions of the flange 38 . Magnet 152 may also include multiple individual magnet components. Furthermore, the magnet component may be attached to any part of a member that is relatively non-rotatably fixed to the flange 38 during dose delivery, such as the skirt 42 or the dose dial member 32 .

Alternatively, the sensor system may be an inductive or capacitive sensor system. This sensor system utilizes a sensed element comprising a metal strip attached to a flange, similar to the attachment of the magnetic ring described here. The sensor system also includes one or more sensing elements, such as four, five, six or more individual antennas or armatures, equiangularly spaced along the distal wall of the module housing or pen housing open. These antennae form pairs of antennae separated by 180 degrees or other angles and provide a proportional metric measurement of the angular position of the metal ring which is proportional to the dose delivered.

The metal band loop is shaped to detect one or more different rotational positions of the metal loop relative to the module. The metal strip has a shape that produces a changing signal when the metal ring is rotated relative to the antenna. The antenna is operatively connected to the electronics assembly such that the antenna is used to detect the position of the metal ring relative to the sensor, and thus relative to the housing 12 of the pen 10, during dose delivery. The metal band may be a single cylindrical band attached to the outside of the flange. However, alternative configurations and locations of the metal straps are contemplated. For example, a metal strip may comprise a plurality of discrete metal elements. In one embodiment, the metal band comprises a plurality of elements equal to the number of discrete rotational dose setting positions of the flange. In the alternative, the metal band may be attached to any part of a component that is relatively non-rotatably fixed to the flange 38 during dose delivery, such as the dial member 32 . The metal strip may comprise a metal element attached to the rotating component inside or outside the rotating component, or it may be incorporated into such a component, for example by metal particles incorporated into the component, or by overmolding with the metal strip Parts combined. The MCU is operable to determine the position of the metal ring using the sensor.

The MCU can be used to determine the home position of the magnet 152 by averaging the number (eg, four) of the inductive elements 160 at the maximum sampling rate, based on a standard quadrature differential signal calculation. 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 (eg, four) of sensing elements 160 at a maximum sampling rate from standard quadrature differential signal calculations. The MCU is operable to determine by calculating the total rotation angle from the determined starting position, the number of revolutions and the final position. The MCU is operable to determine the number of dosage steps or units by dividing the total rotational angle of movement by a predetermined number (eg 10, 15, 18, 20, 24) related to the design of the device and drug.

Further reference is made to FIG. 12 , which shows another example of a magnetic sensor system 900 comprising 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, eg a flange. The radial placement of the magnetic sensors 906 (eg, Hall Effect sensors) relative to the magnetized ring 902 may be equiangular to each other in the annular pattern. In one example, magnetic sensor 906 is disposed radially in overlapping relationship with outer circumferential edge 902A of magnetized ring 902 such that a portion of magnetic sensor 906 is located on magnetized ring 902 and a remaining portion is located outside magnetized ring 902 .

In some embodiments, the sensing system is configured to determine whether the sensing system is coupled/coupled to the drug delivery device. Figure 13 illustrates an exemplary computerized method 1300 for determining whether the device is removably coupled/coupled to a medication injection device, according to some embodiments. Sensing systems such as dose delivery detection systems comprise a plurality of sensing elements. For example, the sensing system comprises a number of sensing elements, eg four or five sensing elements, equally spaced circumferentially and radially within the device. As described herein, the plurality of sensing elements may include a plurality of Hall effect sensors. In some embodiments, five Hall effect sensors are spaced at 72 degrees equidistant around a circle whose diameter is designed based on the magnetic component of the drug delivery device being sensed. For example, a diameter of about 14mm may be used so that when the magnet is rotated about its axis, the sensor remains on the envelope described by the maximum value of the Z component of the magnetic field. The sensing system also includes a processor (eg, MCU) in communication with the set of sensing elements.

The sensing system (via 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 the magnetic field of the 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 whether the set of voltage measurements indicates that the device is being coupled to a medication injection device based on the one-dimensional data.

Referring to step 1302, when the user presses the power on button of the sensing system (see button 139 and switch 137 in FIG. 9), the switch 137 is activated, the sensing system is woken up, and the firmware running on the processor turns on the sensing element (eg, a magnetic sensor) to occupy the initial position of the magnetic component of the drug delivery device (eg, before any rotation occurs). At this stage, it is important to take sensor readings immediately after waking up to avoid taking measurements during rotation. In some embodiments, the sensing system may average a certain number of samples per sensor (eg, 5, 10, 15, etc. per sensor), eg, to reduce noise.

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 I and Q values based on the sum of each sensor value. In some embodiments, the sensing system uses coefficients when summing sensor values. For example, the system may store one or more coefficients for each sensor. In some embodiments, the sensing system stores one coefficient for each sensor by which the sensor values are multiplied during the summation to determine the I value, and stores a second coefficient for each sensor by which the sensor values are multiplied during the summation Use this factor to determine the value. In some embodiments, the coefficients may be used to combine the results of multiple sensors (eg, such as five sensors equally spaced at 72 degrees from each other) for I and Q calculations. In some embodiments, the coefficients can be obtained by solving a system of equations that forces the results of quadrature calculations prior to offset, second harmonic distortion in the measurement signal, third harmonic distortion, etc. to be compared to the nominal angle with zero error.

Referring to step 1306 , in some embodiments, the sensing system determines a scaling factor based on the two-dimensional signal (eg, quadrature signal) determined at step 1304 . In some embodiments, the sensing system determines the scaling factor based on the quadrature signal and one or more of a predetermined offset and a predetermined gain. For example, the processor may determine the scale factor based on Equation 12 below:

in:

· ScaleFactor is the scaling factor;

I is the in-phase part of the quadrature signal;

Q is the quadrature part of the quadrature signal;

OI is the offset measured on the I signal during calibration;

OQ is the offset measured on the Q signal during calibration;

GI is the gain measured on the I signal during calibration; and

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

Such exemplary I and Q offsets and gains can be used because quadrature works well when I and Q are well balanced, eg, when offset equals zero and gain equals one. The calibration process can be used to determine the offset/gain of I and Q for balanced measurements to obtain sufficient values, to remove skew between I and Q, and so on. In some embodiments, the sensing system may be configured to normalize the I and Q values and use the I and Q values to determine the normalized angle of the Z component of the magnetic field. After a dose is administered, the sensing system may 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) .

Referring to step 1308, the sensing system may determine whether the one-dimensional data indicates that the sensing system is coupled (or not) to the drug delivery device. The sensing system may use a scaling factor to determine whether the sensing system is installed or coupled to the drug delivery device. For example, the sensing system may determine that the sensing system is fitted to the drug delivery device if the scaling factor is between predetermined thresholds. If the scaling factor is not between predetermined thresholds, the sensing system may determine that the sensing system may not be mounted to the drug delivery device. In some embodiments, the sensing system can check the scaling factor against the low and high amplitude margins to determine if the magnet the module is monitoring is the expected magnet (e.g., +/- 25% around nominal is Acceptable) so that the module will only accept the desired amplitude.

Figure 14 illustrates a dose delivery detection system 80 that includes at least some aspects of a system module 1400, which may include one or more of the electronics and/or components shown in Figures 1A, 1B, 1C, and any combination thereof. In one embodiment, the system includes one of sensing systems 101, 130, 150, 1400 and other systems described herein, or any combination thereof. System 80 is shown communicating with remote computing system 104 (eg, a smartphone) via signal 1475 .

The user interface of system 80 may be further enhanced to provide user information during system 80 operation based on its on-board capabilities, which may or may not be combined with remote computing system 104 off-board capabilities. To this end, the system 80 is provided with one or more light indicators for generating light indicating patterns/patterns. System 80 may also be provided with display, audio or other known indication systems. In one embodiment, system 80 does not include a display. Light indicator 1412 (which, as described above, may include one or more LEDs) may use various colors and blink 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 number of different use case types. Each use case type may indicate the status of the device, eg, successful or unsuccessful pairing with the remote computing device, successful or unsuccessful injection, successful or unsuccessful manual synchronization with the 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 may be configured to indicate combinations of two or more use case types in sequence. In other embodiments, the system may be configured to indicate combinations of two or more use case types with a single indication notification (eg, with light indicator 1412 ), without requiring an onboard display.

In one embodiment, the sensing system may be configured to indicate a combination of battery status and one of the other use case types via a light indication, such as light indicator 1412, without requiring an on-board display. The light indication pattern may be a combination of a first part of the pattern indicating one of the use case types, a delayed part of the pattern indicating a time delay, and a second part of the pattern indicating the other use case type. Within each section, the colors and patterns of flashing can be the same or different. In one embodiment, the sensing system can check the scaling factor against the low and high amplitude margins to determine if the magnet the module is monitoring is the expected magnet (e.g. +/- 25% around nominal is acceptable). Accepted) so that the module will only accept the desired amplitude.

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

16 is a flowchart of an exemplary computerized method 1600 for determining a use case type configuration from a plurality of use case type configurations that may be used in step 1502, according to some embodiments. As can be seen in method 1600, the determined use case type may then be used to determine at least one aspect of the light indication pattern, and in one embodiment, a first portion of the light indication pattern. At step 1602, the sensing system (via its processor, MCU, etc.) determines whether and for how long the power module is enabled. At optional step 1604, the sensing system determines whether a sensing element is present. For a fully integrated device, the sensing element will always be present and this step can be eliminated. For dose detection systems that are detachably coupled/coupled to an injection device, this step may be included in the steps. At step 1606, the sensing system determines whether the sensed element is moving. Steps 1602, 1604 and 1606 may be used individually or in any combination to define a use case type configuration. Although steps 1610, 1612, and 1614 are described as including step 1604, steps 1610, 1612, and 1614 may be described as determining the presence of the sensing element as "yes." Furthermore, it is contemplated that the use case type may depend on one, two or all of the determining steps 1602 , 1604 , 1606 .

At step 1610, the sensing system is configured to provide a first pattern for a first light indicating portion if the sensing system determines that the sensing element is not moving and the energization module is continuously enabled for a first time frame. Alternatively, the presence of the sensed element may also be determined before the sensing system determines that the sensed element is not moving. In this case, the sensing system may also need to determine the presence of the sensed element before providing the first pattern. At 1612, the sensing system is configured to provide a second pattern for the first light indicating portion if the sensing system determines that the sensed element is not moving and the energization module is enabled for a second time frame. Alternatively, the presence of the sensed element may also be determined before the sensing system determines that the sensed element is moving. In this case, the sensing system may also need to determine the presence of the sensed element before providing the second pattern. At 1614, the sensing system is configured to provide a third light indicating pattern for the first light indicating portion if the sensing system determines that the sensed element is moving. Alternatively, the presence of the sensed element may also be determined before the sensing system determines that the sensed element is moving. In this case, the sensing system may also need to determine the presence of the sensed element before providing the third pattern.

In one example, the sensing system may be configured to implement manual data synchronization with a remote computing system to, for example, push data from the sensing system to the Use-case type configuration for remote computing systems. This is the use case type configuration corresponding to 1610 in FIG. 16 . In one embodiment, when the sensing system implements a manual data synchronization use case type configuration, the sensing system places itself in a low power state. 9, the user may press button 139 axially downward into dose body 88 to activate energization module 1406 (button 139 and energization switch 137 are collectively referred to as energization module 1406) for a first time in the range of 3 to 10 seconds. period. Note that the energization module 1406 may include a contactable switch. The time frame can be modified to be wider, narrower, higher and/or lower. The sensing system can be determined by utilizing a magnetic sensor (e.g., magnetic sensor 906 (shown as sensing element 1402)) to determine that the starting and final angular positions (e.g., as described above) of a magnetized sensed element remain unchanged. It is determined whether the magnetic sensed element (eg, magnetizing ring 902 ) is rotating. If there is a change in angular position, the system can determine that there is motion, and if there is no change in angular position, the system can determine that there is no motion. After the power switch 137 is deactivated by the user release button 139 and the first time frame expires, the sensing system may provide a mode/pattern for the first light indicating portion, for example, blinking the green LED of the light indicator 1412 on and on. Off (eg, 300ms on/300ms off) for a number of cycles, eg, three cycles. LED colors, on and off times and number of cycles may vary. The sensing system may then store in its memory 1408 data indicative of the manual synchronization event.

In one example, the use case type configuration may be in operation paired with a remote computing system if no sensed element movement is detected and the energization module is continuously enabled for a second time frame. This is the use case type configuration corresponding to 1612 in FIG. 16 . In one embodiment, the sensing system is in a low power state. The user may press the button 139 axially downward relative to the dose body 88 to activate the energize switch 137 for a second period of time in the range of 10 to 20 seconds. The pairing time range can be modified to be wider, narrower, higher and/or lower. The second time range for pairing is greater than the first time range. The sensing system may remain unchanged by utilizing a magnetic sensor (eg, magnetic sensor 906 (shown as sensing element 1402 )) to determine that the starting and final angular positions (eg, as described above) of a magnetized sensed element remain unchanged. to determine whether the magnetic sensed element (eg, magnetized ring 902) is rotating. After the power switch is deactivated by the user releasing the button 139 and the second time frame expires, the sensing system may provide the first light indicating portion with a different second pattern/mode. The different second mode may be based on whether the pairing was successful or unsuccessful.

During the second time frame, the sensing system may provide the first version of the second mode for the first light indicating portion, e.g., blinking the green LED of light indicator 1412 for a period (e.g., 1000 milliseconds on), or Can blink for multiple cycles. This can be used to notify the user that pairing was successfully initiated and release the button. The sensing system may then store in its memory 1408 data indicative of a successful pairing initiation event. After the button is released, the sensing system's communication unit 1410 may begin sending advertising signals to the remote computing system, and upon successful binding, the remote computing system's communication device 1467 sends a signal to the sensing system. After the sensing system successfully receives the transmission from the remote computing system, the sensing system may provide the first light indicating portion with a second version of the second mode that is different from the first version of the second mode, e.g., causing the light indicator 1412 The green LED blinks on and off (eg, 300ms on/300ms off) for multiple cycles, eg, three cycles. LED color, length of time it turns on and off, and number of cycles may vary. The sensing system may then store in its memory 1408 data indicative of a successful pairing event.

If the pairing is unsuccessful or the pairing has been lost, i.e. the sensing system's communication unit 1410 begins sending a signal to the remote computing system, and the connection is unsuccessful for whatever reason, the sensing system fails to receive a success from the remote computing system's communication device 1467 Binding signal. After an unsuccessful pairing, the sensing system may provide a third version of the second mode for the first light indicating portion that is different from the first and second versions of the second mode, for example, making the light indicator 1412 The amber LED blinks on and off (eg, 100ms on/100ms off/100ms on/100ms off/100ms on/400ms off) for multiple cycles (eg, three cycles). LED color, length of time it turns on and off, and number of cycles may vary. The sensing system may then store in its memory 1408 data indicative of a successful or unsuccessful pairing event (whatever was determined).

In one example, a use case type configuration may be in operation for a typical injection state if the sensed element is moved and present. This is the use case type configuration corresponding to 1614 in FIG. 16 . In one embodiment, the sensing system is in a low power state. The user can set the dose by turning the system coupled to the dosing button, and the user can depress the system/dosing button to initiate drug delivery. If the user is in the process of depressing the button 139, the button 139 can be pressed axially relative to the dose body 88 to activate the energization module. The sensing system may determine by utilizing a magnetic sensor (e.g., magnetic sensor 906 (shown as sensing element 1402 )) to determine that the starting and final angular positions (e.g., as described above) of a magnetized sensed element have changed. Whether the magnetic sensed element (eg, magnetized ring 902 ) is rotating. After the sensed element rotation is successfully detected by the sensing system, the sensing system may provide a third mode for the first light indicating portion, for example, blinking the green LED of the light indicator 1412 on and off (e.g., 300 ms on/off 300ms off) multiple cycles, for example, three cycles. LED color, length of time it turns on and off, and number of cycles may vary. The sensing system can then store data indicative of a successful injection event.

17 is a flowchart of an exemplary computerized method 1700 of determining a light indication mode based on a remaining battery life state, as in step 1504, according to some embodiments. As can be seen in method 1700, the determined remaining battery life state may then be used to determine at least one aspect of the light indication pattern, and in one embodiment, a second portion of the light indication pattern. At step 1702, the sensing system (via its processor, MCU, etc.) determines the remaining battery life status. At step 1704, the system is configured to determine a first mode of the second light indicating portion if the remaining battery state is in the first state indicating a relatively high battery charge. At step 1706, the system is configured to determine a second mode of the second light indicating portion if the remaining battery state is in a second state indicative of a relatively low battery charge. At step 1708, the system is configured to determine a third mode of the second light indicating portion if the remaining battery state is an intermediate third state (ie, between the first and second states).

For steps 1702, 1704, 1706, 1708, there may be various ways to determine the remaining battery life status by examining the electrical characteristics of the power supply and comparing it to a full charge to determine a certain percentage of full charge. In one embodiment, FIG. 4 shows a flowchart of an exemplary computerized method for determining a battery indication of remaining battery status. For example, using Table 3 above, the first state may be when the determination of the battery indication of the remaining battery life state is in the high range, such as in the range of 5 to 100 percent of full charge, and the second state may be when the remaining when the determination of the battery indication of the battery life state is in the low range, such as 0 percent of full charge and less than one percent, and the third state may be when the determination of the battery indication of the remaining battery life state is in the medium range, For example when in the range of 1% to 4% of full charge.

In one embodiment, if the sensing system determines that the remaining battery life state is in the above-mentioned high first state, the sensing system may provide the first mode of the second light indicating part at step 1704, such as not blinking. This may indicate to the user that the remaining battery life status is "normal". In other embodiments, the first pattern of the second light indicating portion may comprise a sequence of color flashes of the LEDs through which the length and number of periods of on and off may vary. In one embodiment, if the sensing system determines that the remaining battery life state is in the aforementioned low second state, then at step 1706, the sensing system may provide a second mode of the second light indicating portion different from the first mode, for example, The green and amber LEDs of light indicator 1412 are blinked on and off for one or more cycles. In one example, the on and off may be 100ms on/100ms off/100ms on/100ms off/100ms on/400ms off for multiple cycles (eg, three cycles). This may 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 on and off, and the number of cycles can vary. In one embodiment, if the sensing system determines that the remaining battery life state is in the intermediate third state described above, the sensing system may provide a third mode of the second light indicating portion different from the first and second modes at step 1708, For example, multiple cycles (eg, three cycles) of on and off (eg, 150 ms amber on/150 ms green on) of the amber LED and/or green LED of light indicator 1412 . This may indicate to the user that the remaining battery life status is "short life remaining". LED color, length of time it turns on and off, and number of cycles may vary.

As described herein, the sensing system provides a single light indicator (LI) having a pattern of a first light indicating portion (S1) and a pattern of a second light indicating portion (S2) with a delay (D) between the portions (or LI=S1+D+S2). In one embodiment, the maximum total cycle time for a single light indication (LIt) may be 6.4 seconds, with a first portion (S1t) comprising 2.7 seconds, a second portion (S2t) comprising 2.7 seconds, and a delay of one second in between The delay (Dt) (or LIt=S1t+Dt+S2t). In one embodiment, for example, for an injection use case of a successful injection and a high battery life remaining state, the total cycle time for a single light indication (LIt) may be 1.8 seconds, with a first portion (S1t) comprising 1.8 seconds, comprising 0 Second part of a second (S2t) (or no second part) with a delay (Dt) of one second delay in between. In one embodiment, for example, for a successful pairing and a first pairing use case of a high battery life remaining state, the total cycle time of a single light indication (LIt) may be 2.0 seconds, with a first portion (S1t) consisting of 1.0 seconds, A second part (S2t) consisting of 0 seconds (or no second part) with a delay (Dt) of one second delay in between.

18 is a flow diagram of an exemplary computerized method 1800 for undesirably premature depletion of a power source (described below as an exemplary battery) when the power-on module 1406 of the dose detection system is continuously enabled for a period of time in accordance with some embodiments. An indication is given to the user of the system 80 when the time is up. For example, a lifespan of one or two years is shortened to less than a year. Most systems have an enclosed battery configured to power the system for an extended period of time without recharging. At step 1804, the sensing system determines (via its processor, MCU, etc.) whether the power module is enabled. Battery draining occurs as far as possible only in the case of the dose detection system, that is to say not coupled to the injection device 10 , or when coupled to the device 10 .

At step 1806, the sensing system increases the power drawn from the battery to power the sensing system's electronics in the increased power state. Optionally, at step 1802 (shown in dashed lines), the sensing system may determine, prior to step 1804, whether a dose detection system is coupled to the delivery device. This article describes determining whether a dose detection system is coupled. At step 1808, if the sensing system determines that the energized module is enabled for the first period of time while the system is in an increased power state, the power drawn by the sensing system's electronics from the battery is reduced to place it in a low power state. At step 1810, if the sensing system determines that the energized module is continuously enabled for a second time period in addition to the first time period, the power drawn by the electronics of the sensing system from the battery is increased to an increased power state to store Data indicating the event and/or communicating the event signal to a remote computing system. After such an event is stored, the system can return to a low power state so that less power is drawn from the battery. Optionally, at step 1812, the remote computing system may provide an indication to the user based on the event signal received from the sensing system. The indication may be in the form of sound, light, image and/or alphanumeric text communicated to the user of the system 80 via the mobile application via the remote computing system's display 1461 . For example, the user may be reminded about the correct operation of the dose detection system with caution and/or warning messages such as "Remove pressure from button". In addition to applying alerts, such alerts may include generating a message for communication via a messaging system on the user's smartphone display or another smartphone designated by the user.

The sensing system may continue to monitor the continued activation of the powered 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 problem. For example, if the energization module is continuously enabled for a third time period in addition to the first and second time periods, the sensing system may increase the power drawn by the system from the battery from a low power state to an increased power state, and Generate another event. The third time period may be greater than the first time period. In one example, the third period of time may be the same amount of time as the second period of time described above. In other examples, the time period after the second time period may be gradually shortened in the form of escalating subsequent warnings to the user.

In one embodiment, to determine how long the powered module has been enabled, in step 1807, the system is configured to measure how long the powered module remains enabled. If the button 139 is pressed axially downward into the dose body 88, and the energization module 1406 is continuously enabled for a first period of time (the first period of time is measured by the RTC 1414, for example in the range of about 20 seconds to 60 seconds, and 60 seconds in one embodiment), 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, an initial press of button 139 will activate switch 137 to increase the power drawn by the electronics of the sensing system from the battery to an increased power state. When in the increased power state, the sensing system allows power to the sensing component (eg, Hall effect sensor) to sense any movement of the sensed element of the injection device. If there is no movement, then the activation may be unexpected. After continuous activation, for example 60 seconds, the sensing system may reduce the power drawn from the battery by the sensing system's electronics to a low power state. The sensing system may then store in its memory 1408 data indicative of an event such as "button still pressed". In one embodiment, the system may return to the increased power state if the powered module remains continuously enabled for a second period of time greater than the first period of time (after the system has returned to the low power state). The second period of time may range, for example, from 1 minute to 9 minutes, and in one embodiment, is 9 minutes as measured by the RTC 1414 . The total combined minutes of continuous activation will be the sum of the first time period and the second time period, after the second time period expires, the sensing system provides power drawn from the battery by the sensing system electronics from a low power state An increase to an increased power state to store data indicative of the event. The stored event may be, for example, "button still pressed" and/or signal the event to the communication device 1467 of the remote computing system 104 via the communication unit 1410 of the dose detection system 80 . For example, the total combined time may be 10 minutes of continuous activation (first time period of 1 minute and second time period of 9 minutes). For example, the total combined time may be 5 minutes of continuous activation (1 minute for the first time period and 4 minutes for the second time period). The transmission of the event may occur at any time the event is stored, or may occur during the next connection to the remote computing system. An additional event may be triggered and stored if the sensing system monitors continued activation of the energized module for more than a second time period. In one embodiment, the system may go through these steps once to send only one event signal to the remote computing device.

In addition to or instead of generating an event signal based on monitoring the amount of time the energized module is activated, an event may be generated in method 1800 by monitoring the number of times the energized module is activated over a period of time or between injection events in steps 1804 and 1807 Signal. For example, the system may generate an event signal when the system determines that the number of compressions is in the range of, for example, 10-40 per minute, and the total time is in the range of, for example, 1 minute to 5 minutes. In one example, the system may generate an event signal when the number of compressions is 30 per minute and a total of 2 minutes have passed, or a total of 60 compressions have occurred within 2 minutes. When the number of presses is reached within a selected period of time, the system may increase the power the system draws from the battery to an increased power state, to store the event and/or communicate the event from the device to a remote computing device configured to generate a warning indication system. According to some embodiments, if the dose detection system's power-on module 1406 is activated multiple times intermittently (which could lead to premature battery or power drain), an exemplary computerized method generates sound, light , an image, or an indication of alphanumeric text.

Dose detection systems are illustrated with specific designs for drug delivery devices such as pen injectors. However, the exemplary dose detection system may 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 switching systems can be eliminated from the module.

The various methods or processes outlined herein can be encoded as software executable on one or more processors employing any of a variety of operating systems or platforms. Furthermore, such software can be written using any of a number of suitable programming languages and/or programming or scripting tools, and can also be compiled into executable machine language code or intermediate code.

In this regard, various inventive concepts can be embodied in at least one non-transitory computer-readable storage medium (e.g., computer memory, one or more floppy diskettes, CD-ROM drives, optical disks, magnetic tape, flash memory, field programmable gate array or circuit configurations in other semiconductor devices, etc.), encoded with one or more programs that, when executed on one or more computers or other processors, implement various embodiments of the present invention. The one or more non-transitory computer-readable media or media may be transportable such that the one or more programs stored thereon can be loaded onto any computer resource to implement the various aspects of the present invention as described above .

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 used to program a computer or other processor to implement Various aspects of the above-described embodiments. Furthermore, it should be understood that, according to one aspect, the one or more computer programs that, when executed, perform the methods of the present invention need not reside on a single computer or processor, but can be distributed across different computers in a modular fashion or in a processor to implement various aspects of the present invention.

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

Also, data structures may be stored in any suitable form in non-transitory computer-readable storage media. Data structures may have fields that are related by position within the data structure. This relationship can also be implemented by allocating storage locations for the fields in the non-transitory computer readable medium that convey the relationship between the fields. However, any suitable mechanism may be used to establish relationships between information in fields of data structures, including through the use of pointers, tags, or other mechanisms for establishing relationships between data elements.

Various inventive concepts can be embodied in one or more methods, examples of which are provided. Acts performed as part of a method may be ordered in any suitable manner. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts concurrently, even though shown as sequential acts in illustrative embodiments.

As used in the specification and claims, the indefinite articles "a" and "an" are to be read as "at least one" unless expressly indicated to the contrary. As used in the specification and claims, with reference to a list of one or more elements/elements, the phrase "at least one" should be understood to mean at least one selected from any one or more elements/elements in the list of elements/elements An element/element, but not necessarily including at least one of each and every element/element specifically listed in the list of elements/elements, and does not exclude any combination of elements/elements in the list of elements/elements. This allows for elements/elements to optionally be present other than those specifically identified in the list of elements/elements to which the phrase "at least one" refers, whether related or not to those elements/elements specifically identified.

The phrase "and/or" as used in the specification and claims should be understood to mean "either or both" of the elements so conjoined, i.e., elements that, in some cases, exist in conjunction, and Elements that otherwise exist separately. Multiple elements listed with "and/or" should be construed in the same fashion, ie, "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, in one embodiment, a reference to "A and/or B" may refer to only A (optionally including other than B) when used in conjunction with open-ended language such as "comprising". elements other than A); in another embodiment, only B (optionally including elements other than A); in yet another embodiment, both A and B (optionally including other elements); etc.

"or" used in the specification and claims should be understood as having the same meaning as "and/or" defined above. For example, "or" or "and/or" when separating items in a list should be construed as inclusive, i.e. including at least one of a number or series of elements, but also more than one , and optionally, additional unlisted items. Only terms expressly stated to the contrary, such as "only one" or "exactly one", or "consisting of" when used in a claim will mean including exactly one of the number or series of elements. In general, when preceded by an exclusive term such as "either of the two", "one of them", "only one of them" or "exactly one of them", the term "or" as used herein shall only is construed to mean exclusive alternatives (i.e. "one or the other, but not both"). When used in the claims, "consisting/consisting essentially of" shall have its ordinary meaning as used in the field of patent law.

The use of ordinal terms such as "first", "second", "third", etc. in a claim to modify a claim element does not in itself imply any priority, order of priority, of one claim element over another or sequence, or does not imply the chronological order in which the method's actions are performed. These terms are used only as labels to distinguish one claim element with a certain name from another element with the same name (however ordinal terms are used).

The phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "comprising", "having", "containing", "involving" and variations thereof means that the items listed thereafter and additional items are included.

Having described several embodiments of the present invention in detail, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description is exemplary only, and not restrictive.

The disclosure describes various aspects, including but not limited to the following:

1. A system configured to generate a light indicating 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 the use case type from a plurality of use case types for the dose detection system; determine the battery life state of the one or more batteries from a plurality of battery life states; and provide a light indication mode via one or more LEDs, the light indication Modes 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 after completion of the first light indication portion .

2. The system of aspect 1, further comprising an energization module switchable between an enabled state and a deactivated state, wherein the processing circuit is caused to determine whether the energization module has been continuously in the enabled state for a period of time, wherein A use case type is determined based at least in part on the determined period of time that the powered module has been enabled.

3. A system according to any one of aspects 1-2, further comprising a sensing element configured to sense movement of a sensed element used during dose injection, wherein the processing circuit is passed through the sensing element. The element determines whether the sensed element is present, and determines a use case type based on the determined presence of the sensed element.

4. The system of clause 4, wherein the processing circuit is caused to determine, via the sensing element, whether the sensed element is moving, and the use case type is determined based on the determined movement of the sensing element.

5. The system of aspect 1, further comprising an energization module switchable between an active state and a deactivated state, a sensing element configured to sense movement of the sensed element used during dose injection, wherein causing the processing circuit to: (a) determine whether the energized module has been continuously enabled for a period of time; and (b) determine, via the sensing element, whether the sensed element is moving; wherein based on the determined period of time the energized module has been continuously enabled and the movement determined by the sensing element to determine the use case type.

6. The system of aspect 5, wherein the processing circuit is caused to provide a single light indication via the set of LEDs when the energized module is continuously enabled for a period of time within the first time frame and when the processing circuit determines that the sensed element is not moving A first light of the pattern indicates a first pattern of the portion.

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

8. The system of any one of clauses 5-7, wherein when the sensed element is determined to be moving, the processing circuit is caused to provide a third of the first light-indicating portion of the single light-indicating pattern via the set of LEDs. model.

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

10. The system of clause 9, wherein the processing circuit is caused to:

Providing a first mode of the second light indicating portion in response to determining the battery life state as the first state; providing a second mode of the second light indicating portion in response to determining the battery life state as the second state; and providing a second mode of the second light indicating portion in response to determining the battery life state The state is a third state providing a third mode of the second light indicating portion.

11. The system of aspect 1, further comprising an energization module switchable between an active state and a deactivated state, a sensing element configured to sense movement of the sensed element used during dose injection, wherein causing the processing circuit to: (a) determine whether the energized module is continuously enabled for a period of time; (b) determine, via the sensing element, whether a sensed element is present; and (c) determine, via the sensing element, whether the sensed element is Rotating, wherein the use case type is determined based on the determined period of time the energized module has been 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 the pen An injection device, wherein the dose detection system includes a sensing element, an energization module and an LED, and the pen injection device includes a sensed element.

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.

13. A method for generating a single light indicating pattern for a dose detection system comprising one or more light emitting diodes (LEDs) and one or more batteries, the method comprising: Determining a use case type in the use case type; determining a battery life state of the one or more batteries from a plurality of battery life states; and providing a light indication pattern via one or more LEDs, the light indication pattern comprising and a second light indicating portion based on the determined battery life state after a delay after completion of the first light indicating portion.

14. The method according to aspect 13, wherein the step of determining the use case type comprises at least one of: determining a time period during which the powered module is continuously enabled; determining by the sensing element whether a sensed element is present; and determining by the sensing element Whether the sensed element is moving.

15. The method of clause 14, wherein when the energized module is continuously enabled for a period of time within a first time frame, and when the sensed element is determined to be non-moving, the step of providing the light indication mode comprises via the The one or more LEDs provide a first mode of a first light indicating portion of the light indicating mode; wherein when the energized module is continuously enabled for a period of time within a second time range, and when the sensed element is determined to be absent When moving, said step of providing a light indicating mode comprises providing a second mode of said first light indicating portion via said one or more LEDs; or wherein, when the sensed element is determined to be moving, causing the processing A circuit provides a third mode of the first light indicating portion via the one or more LEDs.

16. The method of clause 15, wherein the step of determining a battery life state comprises differentiating/distinguishing the battery life state between a first state, a second state, a third state, wherein the step of providing a single light indicating pattern comprises : when the battery life state is in the first state, provide the first mode of the second light indicating part; when the battery life state is in the second state, provide the second mode of the second light indicating part; or when the battery life state is in the second state In three states, a third mode of the second light indicating portion is provided.

17. A system configured to reduce battery consumption of a dose detection system, the system comprising: an energization module switchable between an enabled state and a deactivated state; a battery; a processing circuit configured to execute computer readable instructions , the computer readable instructions cause the processing circuit to: increase power drawn by the system from the battery to an increased power state when the energization module switches from the deactivated state to the enabled state; measuring how long the powered module remains enabled; if the powered module remains enabled for a first period of time, reducing the power drawn by the system from the battery to a low power state; subsequently, if the powered module Continued in the enabled state for a second period of time other than the first period of time, increasing power drawn by the system from the battery from a low power state to an increased power state and generating an event; and data indicative of the event stored in the memory of the dose detection system.

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 message indicative of the event to a user of the remote computing system notify.

19. The system of any one of clauses 17-18, wherein the processing circuit is further caused to: after the data indicative of the event is stored, reduce the power drawn from the battery to a low power state; subsequently, increasing the power drawn from the battery from the low power state to the increased power state and generating a second event if the powered module is continuously in the enabled state for a third time period other than the first time period and the second time period ; and storing data indicative of said second event into said memory.

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 user of the remote computing system indicative of the The second notification for the second event.

21. The system of any one of clauses 19-20, wherein the first time period is in the range of 20 seconds to 1 minute, and each of the second and third time periods is greater than the first time period A period of time.

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

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 the power drawn by the system from the battery when the energization module is switched to an enabled state to an increased power state; measuring how long the energization module remains in the enabled state; and switching the system from the battery to the the power drawn is decreased from said increased power state to a low power state; then, where said energization module is continuously in an enabled state for a time period comprising a second time period in addition to said first time period, increasing power drawn by the system from the battery from a low power state to an increased power state, and generating an event; and

Data indicative of the event is stored in a memory of the dose detection system.

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

25. The method of clause 24, further comprising: after the data indicative of the event is stored, reducing power drawn by the system from the battery to a low power state; increasing the power drawn by the system from the battery from a low power state to an increased power state and generating a second event for the duration of the enabled state for a third time period other than the second time period; and indicating the second event data stored in the memory.

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 event indicative of the second event to a user of the remote computing system. notify.

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

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

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.

30. A system configured to reduce battery consumption of a dose detection system, the system comprising: an energization module switchable between an enabled state and a deactivated state; a battery; a processing circuit configured to execute a computer readable instructions that cause the processing circuit to: increase power drawn by the system from the battery to an increased power state when the energization module switches from the deactivated state to the enabled state ; measuring the number of times the powered module is enabled during a period of time; if the powered module is enabled a first number of times during a first period of time, reducing the power drawn by the system from the battery to The low power state is increased to the increased power state, and an event is generated; and data indicative of the event is stored in a memory of a dose detection system.

31. A method for reducing battery consumption of a dose detection system, the system comprising an energization module and a battery, the method comprising: increasing the power drawn by the system from the battery when the energization module is switched to an enabled state to an increased power state; measuring the number of times the energization module is in the active state during a period of time; and switching the system from the Decrease the power drawn by the battery from the increased power state to the low power state; if the power module is in the enabled state a first number of times within a first time period, then reduce the power drawn by the system from the battery increasing 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.

Claims (31)

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:

determining a use case type from a plurality of use case types for the dose detection system;

determining a battery state of life of the one or more batteries from a plurality of battery states of life; and

providing a light indication pattern via the one or more light emitting diodes, the light indication pattern comprising:

(i) A first light indication portion based on the determined use case type, and

(ii) A second light indicating portion based on the determined battery life state after a delay after completion of the first light indicating portion.

2. The system of claim 1, further comprising a power-on module switchable between an enabled state and a disabled state, wherein the processing circuit is caused to determine whether the power-on module is continuously in an 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 that the power-on module is continuously enabled.

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

4. A system according to claim 3, wherein the processing circuitry is caused to determine, by the sensing element, whether the sensed element is moving, and to determine the use case type based on the movement determined by the sensing element.

5. The system of claim 1, further comprising a power-on module 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) Determining whether the power-on module is continuously in an enabled state for a period of time; and

(b) Determining by the sensing element whether the sensed element is moving,

wherein the use case type is determined based on the determined period of time that the power-on module is continuously enabled and the determined movement of the sensing element.

6. The system of claim 5, wherein the processing circuit is caused to provide a first pattern of a first light indication portion of a single light indication pattern via the set of light emitting diodes when the power-on module is continuously enabled for a period of time within a first time range and when the processing circuit determines that the sensed element is not moving.

7. The system of any of claims 5-6, wherein when the power-on module is continuously enabled for a period of time within a second time range and when the processing circuit determines that the sensed element is not moving, the processing circuit is caused to provide a second mode of a first light indication portion of a single light indication mode via a set of light emitting diodes.

8. The system of any of claims 5-7, wherein when the sensed element is determined to be moving, causing the processing circuitry to provide a third pattern of the first light indication portion of the single light indication pattern via the set of light emitting diodes.

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

10. The system of claim 9, wherein the processing circuitry is caused to:

providing a first mode of the second light indicating portion in response to determining that the battery state of life is the first state;

providing a second mode of the second light indicating portion in response to determining that the battery state of life is a second state; and

in response to determining that the battery state of life is a third state, a third mode of the second light indicating portion is provided.

11. The system of claim 1, further comprising a power-on module 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) Determining whether the power-on module is continuously in an enabled state for a period of time;

(b) Determining, by the sensing element, whether a sensed element is present; and

(c) Determining by the sensing element whether the sensed element is rotating,

wherein the use case type is determined based on the determined period of time that the power-on module is continuously enabled, the determined presence of the sensing element, and the determined rotational movement of 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 energizing module and the light emitting diode, and the pen injection device comprises the sensed element.

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

13. A method for generating a single light indication pattern for a 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 of the dose detection system;

determining a battery state of life of the one or more batteries from a plurality of battery states of life; and

a light indication pattern is provided via one or more light emitting diodes, 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 state after a delay after completion of the first light indication portion.

14. The method of claim 13, wherein determining a use case type comprises at least one of:

determining a time period for which the power-on module is continuously enabled;

determining, by the sensing element, whether the sensed element is present; and

determining, by the sensing element, whether the sensed element is moving.

15. The method of claim 14, wherein when the power-on module is continuously enabled for a period of time within a first time range and when the sensed element is determined to be not moving, providing a light indication pattern comprises providing a first pattern of a first light indication portion of the light indication pattern via the one or more light emitting diodes;

Wherein when the period of time that 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 a light indication pattern comprises providing a second pattern of the first light indication portion via the one or more light emitting diodes; or alternatively

Wherein when the sensed element is determined to be moving, causing the processing circuitry to provide a third mode of the first light indicating portion via the one or more light emitting diodes.

16. The method of claim 15, wherein determining a battery state of life comprises distinguishing between a first state, a second state, and a third state,

wherein the step of providing a single light indication pattern comprises:

providing a first mode of the second light indicating portion when the battery life state is in the first state;

providing a second mode of the second light indicating portion when the battery state of life is in the second state; or alternatively

When the battery life state is in the third state, a third mode of the second light indicating portion is provided.

17. 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:

increasing power drawn by the system from the battery to an increased power state when the power-on module switches from the deactivated state to the activated state;

measuring how long the power-on module remains in the enabled state;

reducing power drawn by the system from the battery to a low power state if the power-on module is continuously in an enabled state for a first period of time;

subsequently, if the power-on module is in an enabled state for a second period of time other than the first period of time, increasing power drawn by the system from the battery from a low power state to an increased power state and generating an event; and

data indicative of the event is stored in a memory of the dose detection system.

18. The system of claim 17, wherein the processing circuitry is further caused to:

the data indicative of the event is transmitted to a remote computing system configured to generate a notification indicative of the event to a user of the remote computing system.

19. The system of any of claims 17-18, wherein the processing circuitry is further caused to:

reducing power drawn from the battery to a low power state after the data indicative of the event is stored;

subsequently, if the power-on module is continuously in the enabled state for a third period of time other than the first period of time and the second period of time, increasing power drawn from the battery from a low power state to an increased power state and generating a second event; and

data indicative of the second event is stored in the memory.

20. The system of claim 19, wherein the processing circuitry is further caused to:

transmitting the data indicative of the second event to the remote computing system, the remote computing system configured to generate a second notification indicative of the second event to a user of the remote computing system.

21. The system of any of claims 19-20, 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 a time of the first time period.

22. The system of any of claims 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 than a time of the first period of time.

23. A method for reducing battery consumption of a dose detection system, the system including 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 how long the power-on module remains in an enabled state;

reducing power drawn by the system from the battery from the increased power state to a low power state with the power-on module in an enabled state for a period of time including a first period of time;

subsequently, increasing power drawn by the system from the battery to an increased power state and generating an event if the power-on module is in an enabled state for a period of time including a second period of time other than the first period of time; and

data indicative of the event is stored in a memory of the dose detection system.

24. The method of claim 23, further comprising:

data indicative of the event is transmitted to a remote computing system configured to generate a notification indicative of the event to a user of the remote computing system.

25. The method of claim 24, further comprising:

reducing power drawn by the system from the battery to a low power state after the data indicative of the event is stored;

subsequently, if the power-on module is continuously in an enabled state for a third period of time other than the first period of time and the second period of time, increasing power drawn by the system from the battery from a low power state to an increased power state and generating a second event; and

data indicative of the second event is stored in the memory.

26. The method of claim 25, further comprising:

transmitting data indicative of the second event to the remote computing system, the remote computing system configured to generate a second notification indicative of the second event to a user of the remote computing system.

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

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

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

30. 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:

increasing power drawn by the system from the battery to an increased power state when the power-on module switches from the deactivated state to the activated state;

measuring the number of times the power-on module is in an enabled state within a period of time;

if the number of times the power-on module is in the enabled state for a first period of time 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

data indicative of the event is stored in a memory of the dose detection system.

31. A method for reducing battery consumption of a dose detection system, the system including 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 the number of times the power-on module is in an enabled state within a period of time;

reducing power drawn by the system from the battery from the increased power state to a low power state with the power-on module in an enabled state for a period of time including a first period of time;

if the number of times the power-on module is in the enabled state for a first period of time 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

data indicative of the event is stored in a memory of the dose detection system.

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