EA045998B1 - DRUG DELIVERY DEVICE WITH ELECTRONICS - Google Patents

Description

Cross references to related applications

This application claims benefit from U.S. Provisional Patent Application No. 62/424,306, filed November 18, 2016, the contents of which are incorporated herein by reference in their entirety.

State of the art

Drug delivery devices facilitate the delivery of a drug into the patient's body through various routes of administration. Typical routes of administration include oral, topical, sublingual, injection, and the like. The devices can be used to deliver drugs to treat a variety of diseases, illnesses, and medical conditions. Inhalation devices, for example, can be used to treat asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). While drug delivery devices are intended to deliver the appropriate dose of drug to a patient as part of a therapeutic treatment, the effectiveness of a particular treatment may be influenced by non-physiological factors such as patient compliance and adherence to treatment.

In the context of drug therapy, adherence may refer to the extent to which a patient follows a prescribed dosage regimen. For example, if a patient's prescription requires two doses daily, and the patient takes two doses per day, the patient may be considered 100% compliant. If a patient takes only one dose per day, they may be considered to be only 50% compliant. In the latter case, the patient may not take the treatment prescribed by his doctor, which may negatively affect the effectiveness of the therapeutic treatment.

Medication adherence may relate to a patient's technique when using a particular drug delivery device. If a patient uses a device in a manner recommended by a physician or manufacturer, the device should likely deliver the desired dose of drug and the patient may be considered adherent to treatment. However, if the device is not used correctly during drug administration, the device's ability to deliver the correct dose of drug may be compromised. As such, the patient may be considered non-adherent to treatment. In the case of an inhalation device, for example, the patient may need to perform a minimal respiratory effort to ensure that the full dose of drug is delivered from the device to the patient's lungs. For some patients, such as children and the elderly, meeting the requirements for full adherence to treatment may be difficult due to physical limitations such as limited lung function. Accordingly, similar to adherence, failure to achieve full adherence to treatment may reduce the effectiveness of prescribed treatment.

The patient's ability to achieve full adherence to treatment may be further complicated by certain physical properties of the drug. For example, some respiratory medications may consist of small particles and/or may not have any odor or taste. Thus, a patient using an inhalation device may not be able to correct inappropriate use because he or she may not be able to immediately detect or sense that the drug is being inhaled and/or know whether the amount of drug being inhaled is consistent with the prescription.

Disclosure of the invention

The drug delivery device may be configured to include an electronic module that is configured to detect, monitor, and/or process conditions of use and parameters associated with the device (eg, improve compliance and adherence to medication). The electronic module may be further configured to communicate conditions and parameters to external devices, such as a smartphone, for similar and/or additional processing. Incorporating an electronic module into a drug delivery device opens the door to a variety of digital enhancements and functional features to enhance the use of the device.

The electronic module, in this context, can create a platform to make the most of useful smartphone applications and powerful data analytics. However, introducing electronics into any drug delivery device may introduce some technical challenges such as durability, reliability, electromechanical coupling, power management and drug delivery execution. The present invention provides solutions for incorporating certain electrical components into a drug delivery device such as an inhaler.

Examples of inhalation devices (eg, breath-activated inhalers) are provided herein. The inhalation device may include a main body having a mouthpiece and a mouthpiece cover, a slider at least partially disposed in the body, and an electronic module having a switch and a pressure sensor. The electronic module may be configured to remain in an off state before the user moves the mouthpiece cover to open the mouthpiece for the first time. When moving the mouthpiece cover to open the mouthpiece, the slider may be configured to engage a switch causing the electronic module to switch from an off state to an active state and detect an inhalation from the mouthpiece by a user. The electronic module may be configured not to return to the off state after the mouthpiece cover is moved to open the mouthpiece for the first time by the user (eg, during the life of the inhalation device and/or battery). The electronic module may be configured to start an internal counter upon transition from an off state. The electronic module is configured to time-stamp inhalation events, inhalation indicators, error events, pressure measurements, mouthpiece cover opening events, etc. based on internal counter.

The pressure sensor may be configured to measure a plurality of pressure changes in the inhaler resulting from a user's inhalation through the mouthpiece following movement of the mouthpiece cover from a closed position to an open position. The pressure sensor may be configured to measure for a certain period of time or until a certain event is detected (eg, inhalation, closing of a mouthpiece cover, etc.). The electronic module may also include a processor configured to determine one or more inspiratory parameters based on a plurality of measured pressure changes. Inspiratory parameters may include, but are not limited to, peak flow, time to peak flow, inspiratory volume, and inspiratory duration. The electronic module may also include communication circuitry configured to wirelessly transmit inspiratory parameters to an external device.

When in an active state, the electronic module may be configured to measure one or more pressure changes in the inhaler resulting from a user's inhalation through the mouthpiece, determine inspiratory parameters based on the one or more measured pressure changes, store inspiratory parameters in a local memory, cause an alert to an external device and/or transmitting inhalation parameters to an external device.

The electronic module may be configured to be in a sleep state when not in a powered-off state or an active state. The electronic module may be configured to switch from an active state to a sleep state when the electronic module determines that a pressure measurement received from a pressure sensor does not fall within a certain range for a certain amount of time (e.g., the user does not inhale from the mouthpiece for a certain time interval), with the defined time interval based on an internal counter. The electronic module may be configured to store a timeout event and associated timestamp when the mouthpiece cover is moved to an open position, and the electronic module does not determine that the pressure measurement received from the pressure sensor is within a certain range for a certain time interval (e.g., the user does not inhale from the mouthpiece for a specified period of time), where the time-out event timestamp is based on an internal counter.

Upon determining that the pressure measurement received from the pressure sensor is within a certain range, the electronic module may be configured to generate an inhalation event and an associated time stamp for the inhalation event and store the inhalation event and associated time stamp in a memory of the inhaler, wherein The inspiratory event marker is based on an internal counter. By storing the inhalation event and associated time stamp in memory, the electronic module may be configured to cause the communication circuit to transmit alerts at a first alert rate in an attempt to synchronize with the external device. If the communication circuit is successfully synchronized with the external device, the communication circuit may be configured to transmit the inhalation event and associated time stamp to the external device. If the communication circuitry does not successfully synchronize with the external device after a certain period of time, the communication circuitry may be configured to transmit an alert at a second alert rate that is slower than the first alert rate.

The electronic module may be configured to transition between an active state and a sleep state at a first speed when the mouthpiece cover is in a closed position. The electronic module may be configured to cause the communication circuit to transmit alerts at a first alert rate in an attempt to synchronize with the external device when the mouthpiece cover is in an open position, and to transmit alerts at a second alert rate that is slower than the first alert rate. when the mouthpiece cover is in the closed position.

In an active state, the electronic module may be configured to sample pressure measurements received from the pressure sensor at a certain frequency, and is configured to turn off power to the sensor system between sampling times of pressure measurements received from the pressure sensor. The electronic module may be configured to calculate from pressure measurements received from the pressure sensor between sampling times. The electronic module may be configured to switch from an active state to a sleep state when the mouthpiece cover is returned to a closed position.

The system contains: mobile application; and a breath-activated inhaler to deliver le

- 2 045998 medicinal product to the user, the inhaler contains a mouthpiece, a mouthpiece cover, an electronic module and a reservoir for the medicine, the mouthpiece cover is hinged to the main part, and an electronic module containing a communication circuit, a power source, a sensor system, a battery and a switch; wherein the electronic module is configured to start the internal counter when the mouthpiece cover is first moved from a closed position to an open position by the user; wherein the mobile application is configured to interrogate the breath-activated inhaler to retrieve event data, wherein the event data comprises a mouthpiece cover opening event, a time stamp, and inhalation profile information.

The electronic module is configured to start the internal counter after the mouthpiece cover is in the closed position and in the open position after the first time the mouthpiece cover is moved to the open position by the user. The inspiratory profile information comprises one or more of a peak flow rate from the pressure data provided by the sensor system, a volume from the pressure data, a time to peak from the pressure data, or a duration from the pressure data. The event data contains one or more of a status flag indicating whether the inhalation event was a weak inhalation, a good inhalation, no inhalation, or an exhalation. These events contain information related to whether the mouthpiece cover is in the open position or the closed position.

Brief description of drawings

Fig. 1 is a top perspective view of an exemplary inhalation device.

Fig. 2 is a cross-sectional perspective view of the interior of the exemplary inhalation device of FIG. 1.

Fig. 3 is an exploded perspective view of the exemplary inhalation device of FIG. 1 with the top cap removed to reveal the electronics module.

Fig. 4 is an exploded perspective view of the top cap and electronics module of the exemplary inhalation device of FIG. 1.

Fig. 5A is a partial cross-sectional view of the exemplary inhalation device of FIG. 1 with the mouthpiece cover of the inhalation device in the closed position.

Fig. 5B is a partial cross-sectional view of the exemplary inhalation device of FIG. 1 with the mouthpiece cover of the inhalation device in a partially open position.

Fig. 5C is a partial cross-sectional view of the exemplary inhalation device of FIG. 1 with the mouthpiece cover of the inhalation device in a partially open position.

Fig. 5D is a partial cross-sectional view of the exemplary inhalation device of FIG. 1 with the mouthpiece cover of the inhalation device in the fully open position.

Fig. 6A and 6B include a flowchart that illustrates an exemplary process for transitioning between one or more power states and/or operating modes associated with the inhalation device.

Fig. 7 is a graph of approximate air flow rates through the exemplary inhalation device of FIG. 1 based on pressure measurements recorded via an electronic module.

Fig. 8 is a diagram of an exemplary system including an inhalation device.

Description of Embodiments of the Invention

The present invention describes devices, systems and methods for detecting, monitoring and/or processing conditions of use and parameters associated with a drug delivery device. Devices, systems and methods are described in the context of a breath-activated inhalation device for delivering a drug to the lungs of a user. However, the described solutions are equally applicable to other drug delivery devices, such as an injector, metered dose inhaler, nebulizer, transdermal patch or implantable device.

Fig. 1 is a front perspective view of an exemplary inhalation device 100. FIG. 2 is a cross-sectional perspective view of the interior of an exemplary inhalation device 100. FIG. 3 is an exploded perspective view of an exemplary inhalation device 100 with the top cap removed to reveal the electronics module. Fig. 4 is an exploded perspective view of the top cap and electronics module of an exemplary inhalation device 100.

For example, inhalation device 100 may be a breath-activated inhalation device. The inhalation device 100 may include a top cap 102, a main body 104, a mouthpiece 106, a mouthpiece cover 108, an electronics module 120, and a vent 126. The mouthpiece cover 108 may be hinged to the main body 104 so that it can be opened and closed. to open the mouthpiece 106. Although illustrated as a hinge joint, the mouthpiece cover 106 may be attached to the inhalation device 100 through other types of connections. In addition, while the electronic module 120 is illustrated as being located in the top cap 102 on the upper side of the main body 104, the electronic module 120 may be integrated and/or located in the main body 104 of the inhaler

- 3 045998 devices 100.

Within the main body 104, the inhalation device 100 may include a drug reservoir (e.g., container) 110, a bellows 112, a bellows spring 114, a cup 118, a dosing cap 116, a dosing chamber 117, a deagglomerator 121, and a flow channel 119. the drug may contain a drug, such as a drug in the form of a dry powder, for delivery to the user. When the mouthpiece cover 108 is moved to open the mouthpiece 106 (eg, from a closed position to an open position), the bellows 112 can be compressed to deliver a dose of medication from the drug reservoir 110 to the dosing cap 116. Thereafter, the user can inhale through the mouthpiece 106 in an attempt to obtain a dose of the drug. The air flow generated by the user's inhalation may cause the deagglomerator 121 to aerosolize the drug dose by breaking up drug accumulations in the dosing cap 116. The deagglomerator 121 may be configured to aerosolize the drug when air flows through the flow channel 119 meets or exceeds a specific speed, or is within a specific range. When aerosolized, a dose of drug may be transferred from the dosing cap 116 to the dosing chamber 117, through the flow channel 119, and from the mouthpiece 106 to the user. If the air flow through the flow path 119 does not satisfy or exceed a particular speed or is not within a particular range, some or all of the drug may remain in the dispensing cap 116. In the case where the drug in the dispensing cap 116 has not been aerosolized through the deagglomerator 121, another dose of drug may not be delivered from the drug reservoir 110 when the mouthpiece cover 108 is subsequently opened. Thus, a single dose of drug may remain in the dosing cap until the dose is aerosolized by the deagglomerator 121.

When the user inhales through the mouthpiece 106, air may enter the vent 126 to allow air to flow to deliver medication to the user. The flow path 119 may extend from the dispensing chamber 117 to the end of the mouthpiece 106 and include the dispensing chamber 117 and internal portions of the mouthpiece 106. The dispensing cap 116 may be permanently located within or adjacent to the dispensing chamber 117. Additionally, the inhalation device 100 may include a counter. 111 doses, which is configured to initially set the total number of drug doses in the drug reservoir 110 and decrease by one each time the mouthpiece cover 108 is moved from a closed position to an open position.

The top cap 102 may be attached to the main body 104. For example, the top cap 102 may be attached to the main body 104 through the use of one or more fasteners that engage recesses in the main body 104. The top cap 102 may overlap a portion of the main body 104 when attached. , for example, so that substantially a pneumatic seal is present between the top cap 102 and the main body 104. The top surface of the main body 104 may include one or more (e.g., two) passage openings 146. One of the passage openings 146 may be provided with the ability to receive the slider 140. For example, when the top cap 102 is attached to the main body 104, the slider 140 may protrude through the top surface of the main body 104 through one of the passage holes 146.

The slider 140 may define a lever 142, a stopper 144, and a distal base 145. The distal end 145 may be a bottom portion of the slider 140. The distal end 145 of the slider 140 may be configured to abut a cup 118 that is permanently located within the main body 104 (e.g., and mouthpiece cover 108 is in a closed or partially open position). The distal end 145 may be configured to abut the top surface of the cup 118 when the cup 118 is in any radial orientation. For example, the top surface of the cup 118 may include a plurality of holes (not shown), and the distal end 145 of the slider 140 may be configured to abut the top surface of the cup 118, e.g., whether or not one of the holes exists in alignment with the slider 140.

The top cap 102 may include a slider guide 148 that is configured to receive a slider spring 146 and a slider 140. The slider spring 146 may reside within the slider guide 148. The slider spring 146 may engage the interior surface of the top cap 102, and the slider spring 146 may engage (e.g., abut) the upper portion (e.g., the proximal end) of the slider 140. When the slider 140 is installed in the slider guide 148, the slider spring 146 may be partially compressed between the top side of the slider 140 and the inner surface of the top cap 102. For example, the slider spring 146 may be configured such that the distal end 145 of the slider 140 remains in contact with the cup 118 when the mouthpiece cover 108 is closed. The distal end 145 of the slider 145 may also remain in contact with the glass 118 while the mouthpiece cover 108 is opened or closed.

- 4 045998 xia. The stopper 144 of the slider 140 may engage the stopper of the slider guide 148, for example, so that the slider 140 is retained in the slider guide 148 by opening and closing the mouthpiece cover 108, and vice versa. The stopper 144 and the slider guide 148 may be configured to limit the vertical (eg, axial) movement of the slider 14 0. This limitation may be less than the vertical movement of the cup 118. Thus, when the mouthpiece cover 108 is moved to the open position, the cup 118 may continue to move in a vertical direction toward the mouthpiece 106, but the stopper 144 may stop the vertical movement of the slider 140 so that the distal end 145 of the slider 140 may no longer be in contact with the glass 118.

Electronic module 120 may include a printed circuit board assembly 122, a switch 130, a power source (eg, battery 126), and/or a battery holder 124. The PCB assembly 122 may include surface-mounted components such as a sensor system 128, a wireless communication circuit 129, a switch 130, and/or one or more indicators (not shown), such as one or more light emitting diodes (LEDs). diode). Electronic module 120 may include a controller (eg, a processor) and/or memory. The controller and/or memory may be physically separate components of the PCB 122. Alternatively, the controller and memory may be part of another chipset installed on the PCB 122. For example, wireless communication circuitry 129 may include a controller and/or memory for electronic module 120. The electronics module 120 controller may comprise a microcontroller, a programmable logic device (PLD), a microprocessor, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or any suitable device. processing or control circuit.

The controller can access information from and store data in memory. The memory may include any type of suitable memory, such as non-removable memory and/or removable memory. Non-removable memory may include random access memory (RAM), read-only memory (ROM), hard disk, or any other type of storage device. The removable memory may include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, and the like. The memory may be internal to the controller. The controller may also access data from, and store data in, memory that is not physically located in electronic module 120, such as on a server or smartphone.

The sensor system 128 may include one or more sensors, including, for example, one or more pressure sensors. The one or more pressure sensors may include a barometric pressure sensor (eg, an atmospheric pressure sensor), a differential pressure sensor, an absolute pressure sensor, and/or the like. The sensors can use the technology of microelectromechanical systems (MEMS microelectromechanical systems) and/or nanoelectromechanical systems (NEMS - nanoelectromechanical systems). The sensor system 128 may be configured to provide instantaneous pressure readings to the controller electronics module 120 and/or cumulative pressure readings over time. As illustrated in FIG. 2 and 3, the sensor system 128 may reside within the inhalation device 100 but remain external to the flow path 119. Accordingly, the sensor system 128 may be configured to measure a plurality of atmospheric pressures within the inhalation device 100.

It will be understood that the atmospheric pressure within the device 100 (eg, inside the top cap 102 or inside the housing 104) may be the same or similar to the atmospheric pressure outside the device 100 when the device 100 is not in use. However, when the user inhales from the mouthpiece 106, the user's inhalation may cause the atmospheric pressure inside the device 100 to decrease. Conversely, exhalation into the mouthpiece 106 may cause the atmospheric pressure inside the device 100 to increase. In both cases, the atmospheric pressure inside the device 100 may be different from the atmospheric pressure outside device 100. Accordingly, certain parameters or indicators associated with inhalation or exhalation can be determined by comparing changes in atmospheric pressure resulting from inhalation or exhalation.

The electronic module controller 120 may receive signals corresponding to pressure measurements from the sensor system 12 8 . The controller may calculate or determine one or more airflow metrics (eg, peak flow rate, time to peak flow rate, inspiratory volume, inspiratory duration, etc.) using signals received from the sensor system 128. The airflow readings may indicate the airflow profile through the flow path 119 of the inhalation device 100. For example, if the sensor system 128 records a change in pressure of 0.3 kilopascals (kPa), the electronics module 120 may determine that the change corresponds to an air flow rate of approximately 45 liters per minute. (l/min) through flow channel 119. FIG. 7 shows an example of air flow rates based on various pressure measurements. It will be understood that the air flow rates and profile shown in FIG. 7 are merely examples and that certain costs may vary depending on

- 5 045998 size, shape and design of the inhalation device 100 and its internal components.

The airflow measures may include one or more of average inspiratory/expiratory flow, peak inspiratory/expiratory flow (eg, maximum inhalation achieved), inspiratory/expiratory volume, time to peak inspiratory/expiratory flow, and/or inspiratory/expiratory duration. The airflow readings may also indicate the direction of flow through the flow path 119. That is, a negative change in pressure may correspond to an inhalation from the mouthpiece 106, while a positive change in pressure may correspond to an exhalation into the mouthpiece 106. When calculating the airflow readings, the electronic module 120 may be configured to eliminate or minimize any distortion caused by environmental conditions. For example, electronics module 120 may be reset to account for changes in barometric pressure before and/or after airflow measurements are calculated. One or more pressure measurements and/or airflow measurements may be time-stamped and stored in the memory of the electronic module 120.

Electronic module controller 120 may compare signals received from sensor system 128 and/or determined airflow metrics to one or more thresholds or ranges, for example, as part of an assessment of how inhalation device 100 is being used and/or whether use is likely to occur. result in delivery of the full dose of drug. For example, when a determined airflow rate corresponds to an inhalation with an air flow rate below a particular threshold value, the electronic module 120 may determine that there was no inhalation, or insufficient inspiration from the mouthpiece 106 of the inhalation device 100. If the determined air flow rate corresponds to an inhalation with an air flow rate above a certain threshold value, the electronics module 120 may determine that there has been an excessive inhalation from the mouthpiece 106. If the determined airflow rate corresponds to an inhalation with an air flow rate in a particular range, the electronics module 120 may determine that the inhalation is good, or is likely to result in that the full dose of drug is delivered. As noted above, electronics module 120 may include indicators such as LEDs. The indicators may be configured to provide feedback to users regarding their use of the inhalation device 100. Thus, in one example, the LED may glow or change color if the airflow readings indicate good inhalation or no inhalation. The air flow indicators can also be calculated and/or evaluated via external devices (for example, partially or completely).

More specifically, wireless communication circuitry 129 in electronics module 120 may include a transmitter and/or receiver (eg, a transceiver), as well as additional circuitry. For example, wireless communication circuitry 129 may include a Bluetooth chipset (e.g., a Bluetooth Low Energy chipset), a ZigBee chipset, a Thread chipset, etc. As such, the electronic module 120 may wirelessly provide data, such as pressure measurements, airflow measurements, and/or other conditions associated with the use of the inhalation device 100, to an external device, including a smartphone. The external device may include software for processing the received information and for providing feedback on medication adherence and compliance to users of the inhalation device 100 through a graphical user interface (GUI).

Battery 126 may provide power to components of the PCB 122. Battery 126 may be any suitable source for powering electronic module 120, such as a coin cell battery, for example. Battery 126 may be rechargeable or non-rechargeable. The battery 12 6 may be located by means of a battery holder 124 . The battery holder 124 may be attached to the PCB 122 such that the battery 126 is in continuous contact with the PCB 122 and/or is in electrical communication with components of the PCB 122. The battery 126 may have a specific battery capacity, which may affect the service life of the battery 126. How will be further discussed below, the distribution of power from the battery 126 to one or more components of the PCB 122 may be controlled to ensure that the battery 126 can supply power to the electronic module 120 for the useful life of the inhalation device 100 and/or the drug contained therein.

Electronic module 120 may have multiple power states, each with corresponding power consumption levels. For example, electronic module 120 may be configured to operate in a system shutdown state, a sleep state, and/or an active state. The system's off state may have very little or no power consumption, while the sleep state may have more power consumption than the off state, and the active state may have more power consumption than the sleep state. While the electronics module 120 is in an active state, the electronics module may operate in one or more modes, such as a measurement mode, a data storage/processing mode, an alert mode, and/or a connection mode. It should be understood that the electronic module 120 may operate

- 6 045998 in multiple modes at the same time (for example, modes may overlap). For example, as described in more detail below, electronic modules 120 may operate in a measurement mode and a data storage/processing mode at separate times or simultaneously. That is, the electronics module 120 may perform all measurements before processing/storing the data, or the electronics module 120 may perform the data processing/storing while also performing additional measurements (e.g., the electronics modules 120 may switch between measurement mode and data saving/data processing mode before either one completes).

When the system is turned off, electronic module 120 may consume the least amount of power compared to other power states (eg, sleep state and active state). Specifically, the electronics module 120 uses a minimal amount of power to monitor some pin(s) on the controller, but other components such as the sensor system 128, wireless communication circuitry 129 (eg, Bluetooth radio), and memory may be turned off. A contact terminal on the controller may be in electrical communication with switch 130 such that activation of switch 130 may result in some reference signal on the contact terminal. The reference signal can initiate a controller transition from the system off state.

The off state of the system may be the initial state of the electronic module 120 after the inhalation device 100 is assembled or manufactured. Thus, the electronic module 120 may be in a system-off state before the device 100 is delivered to the user and/or before the mouthpiece cover 108 is opened for the first time (eg, before the first use of the inhalation device 100 by the user). In addition, after the mouthpiece cover 108 has been opened for the first time, the electronic module 120 may not return to the system off state subsequently. In some examples, the controller may start its internal timer (eg, an internal counter) when the electronics module 120 first exits the off state, and any time stamp data generated by the electronics module 120 may be a relative time based on the controller's internal timer. Accordingly, the internal timer may act as a counter that is started when the electronic module 120 exits the off state. Alternatively or additionally, the controller may include an internal system timer that knows the actual time (e.g., 4:05 p.m. Eastern Standard Time on November 18, 2017), and the timestamp data may include the actual time. In such examples, the controller may use off-state power to run its real-time clock and update its system timer.

As noted above, while the electronics module 120 is in an active state, the electronics module 120 may operate in one or more modes, such as a measurement mode, a data storage/processing mode, an alert mode, and/or a connection mode. In the sleep state, the switch 130 and controller may continue to receive power from battery 126, and the controller may continue to run its clock and periodically update its system timer (e.g., continue to increment the internal counter that was started when electronics module 120 first came out of the off state ). In some examples, the controller may periodically update the system timer every 250 µs.

Additionally, while in the sleep state, the controller may receive power from the battery to operate one or more additional components of the electronic module 120. For example, during an alert mode, the controller may periodically turn on the communication circuit 129 to wirelessly notify an external device that data has been saved. in the inhalation device 100 and are available for wireless downloading. Communication circuitry 129 may transmit alert packets at any interval that is appropriate to control the power consumption of electronic module 120 in a sleep state (eg, compared to the interval at which packets may be sent during an active state). For example, alert packets may be transmitted every 10 seconds when electronics module 120 is operating in a sleep state. It will be understood that electronic module 120 may spend more time in the sleep state than in any of the other power states. Thus, for a given alarm frequency, the electronic module 120 may consume the most power in the sleep state over the life of the inhaler device 100.

In measurement mode, the controller of the electronic module 120 may include a sensor system 128. The controller may instruct the sensor system 128 to receive pressure measurement readings for a specified period of time (eg, up to 60 seconds) and/or until the mouthpiece cover 108 closes or no change in pressure is detected. The controller may turn off one or more components of the electronic module 120 while the sensor system 128 captures pressure measurement readings to further save power. The sensor system 128 may sample pressures at any suitable frequency. For example, sensor system 128 may have a sampling rate of 100 Hz and thus a cycle time of 10 ms.

- 7 045998

The sensor system 128 may generate a measurement completion interrupt after the measurement cycle has completed. The interrupt may wake up the controller or instruct it to turn on one or more components of the electronic module 120. For example, after or while the sensor system 128 samples pressure measurements, the controller may process and/or store the pressure measurements and, if the measurements are complete, turn off system of 128 sensors.

In data storage/processing mode, the controller may include at least a portion of memory in electronics module 120. The controller may process readings from sensor system 128 to determine airflow metrics and store airflow metrics in memory. The controller may also compare the airflow readings and/or readings to one or more thresholds or ranges to evaluate how the inhalation device is being used (eg, whether the pressure readings correspond to no inhalation, good inhalation, exhalation, etc.). Depending on the results of the comparison, the controller may actuate indicators to provide feedback to the user of the inhalation device 100. As noted above, the electronic module 120 may operate in a measurement mode and a data storage/processing mode simultaneously.

In alert mode, the controller may enable communication circuitry 129 (eg, a Bluetooth radio) to notify an external device that data is available from the inhalation device 100 and is ready for wireless download. The alert packets may be transmitted at any interval and for any duration that is suitable for controlling the power consumption of the alert mode electronics module 120. For example, communication circuitry 129 may transmit alert packets every 100 milliseconds (ms) for 3 minutes. Additionally, it should be understood that the alert frequency may vary based on the specific conditions of the electronic module 120. For example, the alert frequency may be low (e.g., packets are transmitted every 10 seconds) when the electronic module 120 transitions from a sleep state and without moving the mouthpiece cover 108 to open position, while the alert rate can be fast (eg packets transmitted every 100 ms) after measurements and data processing/saving have occurred.

In connection mode, the communication circuit and memory may be enabled, and the electronic module 120 may be paired with an external device such as a smartphone. The controller can retrieve data from memory and wirelessly transmit data to an external device. The controller can retrieve and transmit all data currently stored in memory. The controller may also retrieve and transmit a piece of data currently stored in memory. For example, the controller may be configured to determine which fragments have already been transmitted to the external device, and then transmit the fragment(s) that have not previously been transmitted. Alternatively, the external device may request specific data from the controller, such as any data that has been collected by electronic module 120 since a specific time or last transmission to the external device. The controller can retrieve specific data, if any, from memory and transmit specific data to an external device.

The electronic module 120 may switch between power states or operating modes based on certain conditions or events, such as the position of the mouthpiece cover 108 and/or the passage of certain periods of time. For example, the mouthpiece cover 108 may be closed and the electronic module 120 may be in a system off or sleep state. When the mouthpiece cover 108 moves from a closed position to an open position, the switch 130 may be activated. Activation of switch 130 may cause electronic module 120 to switch from one state (eg, a system off state or a sleep state) to another state (eg, an active state). Additionally, activation of the switch 130 may cause the electronic module 120 to begin operating in one or more operating modes, such as a measurement mode and/or a data storage/processing mode. For example, FIG. 6A-B illustrate an exemplary flowchart 200 that illustrates an exemplary process for switching between one or more power states and/or operating modes associated with the inhalation device 100.

Additionally, it should be understood that the electronic module 120 may be in a system off state before the mouthpiece cover 108 is opened by the user for the first time (eg, the initial opening of the mouthpiece cover 108 by the user after removing the inhalation device 100 from its packaging). Subsequently, if the mouthpiece cover 108 returns to the closed state, the electronic module 120 will be in a sleep state (as opposed to an off state). As the user continues to use the inhalation device 100, the electronic module 120 will switch between a sleep state and an active state based, for example, on one or more events (e.g., opening/closing of the mouthpiece cover 108, expiration of a timeout period, detection of pressure measurements that exceed a threshold value (for example, indicate user inhalation), alerts to an external device, etc.).

Fig. 5A-5D describe one example of the internal operation of the inhalation device 100. It should

- 8 045998 understand that other examples of inhalation device 100 may include a subset of the actions described herein. Referring to FIG. 5A, the distal end 145 of the slider 140 may be configured to abut a cup 118 that is permanently located in the main body 104. When the mouthpiece cover 108 is in the closed position, the lever 142 of the slider 140 may not be in contact with the switch 130. Additionally, a spring The slider 144 and bellows spring 114 may be in a compressed state. When the user begins to open the mouthpiece cover 108 to expose the mouthpiece 106, the cup 118 may move upward in the main body 104, for example, due to a mechanical connection between the cup 118 and the mouthpiece cover 108. The upward movement of the cup 118 may cause the slider 140 to move upward in the top cap 102, further compressing the slider spring 144 and the bellows spring 114, for example, as shown in FIG. 5V.

When the mouthpiece cover 108 continues to move toward the fully open state, for example, as shown in FIG. 5C, the mouthpiece cover 108 may cause the cup 118 to descend in the main body 104 (eg, due to a downward force applied to the bellows spring 114). Movement of the cup 118 may cause the slider 140 to lower (eg, due to a downward force applied by the slider spring 144), which may cause the lever 142 of the slider 140 to engage the switch 130 and begin to activate the switch 130. The downward movement of the slider 140 may be limited by the position of the cup 118 because the distal end 145 of the slider 140 may rest on the top side of the cup 118.

When the mouthpiece cover 108 continues to open, as shown in FIG. 5D, a lever 142 of the slider 140 may activate a switch 130, which may generate a signal instructing the electronic module 120 to change states, such as from an off or sleep state to an active state. Thus, the controller of the electronic module 120 may wake up and provide power to the sensor system 128 to enable the sensor system 128 to receive pressure measurement readings. In addition, the movement of the cup 118 caused by the opening of the mouthpiece cover 108 may also cause the cup 118 to compress the bellows 112 to cause the delivery of a spherical mass of drug from the drug reservoir 110 to the dispensing cap 116, resulting in the drug becoming accessible to the flow channel 119. The drug may be delivered from the dosing cap 116 through the flow channel and from the mouthpiece 106 when the user inhales from the mouthpiece 106.

Fig. 6A-B illustrate an exemplary procedure 200 for transitioning between one or more power states and/or operating modes associated with inhalation device 100. Although described with reference to inhalation device 100, any inhalation device may perform procedure 200. Electronic module 120 of inhalation device 100 may be in the off state at step 202 when procedure 200 begins. The mouthpiece cover 108 may be in a closed position and the user may not open the mouthpiece cover 108 the first time the electronics module 120 is in the off state at step 202. As mentioned herein, the off state may be characterized by little or no power consumption by the electronics module. 120. At step 204, the electronic module 120 may determine whether the mouthpiece cover 108 has been moved to the open position. If the electronics module 102 determines that the mouthpiece cover 108 has not been moved to the open position, then the electronics module 120 may be permanently turned off at step 202.

If the electronics module 120 determines that the mouthpiece cover 108 has been moved to the open position in step 204, then the electronics module 120 may enter an active system state at step 206. The active state may have greater power consumption compared to the off state (eg, sleep state). When active, the electronic module 120 may operate in one or more modes, such as a measurement mode, a data storage/processing mode, an alert mode, and/or a connection mode. For example, opening the mouthpiece cover 108 may cause activation of the switch 130. Activation of the switch 130 may cause the electronic module 120 to transition from an off state to an on state.

In the active state, and after the mouthpiece cover 108 has been opened, the electronic module 120 may enter a measurement mode at step 208. During the measurement mode, the electronic module 120 may enable the sensor system 128 and may instruct the sensor system 128 to obtain pressure measurement readings within a certain period of time (eg, up to 60 seconds) and/or until the mouthpiece cover 108 closes or changes in pressure are detected.

In some examples, electronics module 120 may remain in measurement mode until the pressure measurement cycle is completed. The pressure measurement cycle may continue for a specified period of time and/or until a specific event is detected. For example, the pressure measurement cycle may continue for up to 60 seconds even if the mouthpiece cover 108 has been closed and the slider 140 has been disengaged from the switch 130. Alternatively, the cycle

- 9 045998 pressure measurements can continue for up to 60 seconds or until the mouthpiece cover 108 is closed, or until no change in pressure is detected for 10 seconds, whichever occurs first. It will be understood that the above conditions are merely examples and that any suitable criteria may be used.

At step 212, electronic module 120 may enter a data processing/data storage mode. During a data processing/data storage mode, the electronics module 120 may power up at least a portion of the memory in the electronics module 120. The electronics module 120 may process readings from the sensor system 128 to determine inspiratory parameters/metrics and store the inspiratory parameters/metrics in memory. Electronic module 120 may also compare readings and/or inspiratory parameters/indicators with one or more thresholds or ranges to evaluate how the inhalation device is being used (e.g., whether pressure readings correspond to no inhalation, good inhalation, exhalation, etc.) . Depending on the results of the comparison, the electronic module 120 may actuate indicators to provide feedback to the user of the inhalation device 100.

Although not illustrated by routine 200, electronic module 120 may operate in a measurement mode and a data storage/processing mode simultaneously. For example, electronics module 120 may switch (eg, periodically switch) between a measurement mode and a data processing/data storage mode. For example, after or while electronics module 120 receives pressure measurements, electronics module 120 may process and/or store pressure measurement data.

Electronic module 120 may remain in data storage/processing mode for a period of time to process and store pressure measurement readings from sensor system 128. For example, electronics module 120 may remain in data storage/processing mode for up to 60 ms. Electronic module 120 may, for example, be used for up to 50 ms to process and calculate airflow readings from pressure measurement readings, and for up to 10 ms to store pressure measurements and/or airflow readings in memory. Alternatively, electronics module 120 may remain in data storage/processing mode for whatever interval it takes the controller to process and store pressure and/or airflow readings.

Electronics module 120 may enter an alert mode at step 216. For example, electronics module 120 may enter an alert mode after a specified period of time for data processing and storage has passed, or after the controller has determined that such processing and storage has completed. . During the alert mode, the electronic module 120 may power up the communication circuit 129 (eg, a Bluetooth radio) to notify an external device that data is available from the inhalation device 100 and is ready for wireless download. The alert packets may be transmitted at any interval and for any duration that is suitable for controlling the power consumption of the alert mode electronics module 120. For example, communication circuit 129 may transmit alert packets every 100 milliseconds (ms) for 3 minutes. Additionally, it should be understood that the alert frequency may vary based on the specific conditions of the electronic module 120. For example, the alert frequency may be slow (eg, packets are transmitted every 10 seconds) when the electronic module 120 is switched from a sleep state and without moving the mouthpiece cover 108 to open position (for example, when moving from step 230 to step 216), while the alert rate can be fast (for example, packets are transmitted every 100 ms) after measurements and data processing/saving have occurred (for example, when moving from step 212 to step 216).

At step 218, electronic module 120 may determine whether the external device is in range. If the external device does not come into a particular range of electronic module 120 during an alert mode, electronic module 120 may determine whether an alert period (e.g., 3 minutes) has passed at step 220. The alert period may be a period of time that electronic module 120 continues to alert. to an external device before changing power states. If the alert period has not passed, then the electronics module 120 may continue to alert the external device at step 216. However, if the alert period has passed, then the electronics module 120 may enter a sleep state at step 222. The sleep state may involve greater power consumption compared to the off state. state, but less power consumption compared to the on state.

The electronic module 120 may remain in a sleep state for a specified period of time or until the electronic module determines that the mouthpiece cover 108 has been moved from a closed position to an open position. For example, electronic module 120 may periodically switch between a sleep state and an alert mode (eg, a slow alert mode) of an active state. For example, at step 224, electronic module 120 may determine whether mouthpiece cover 108 has been moved from a closed to an open position. If the mouthpiece cover 108 has been moved to the open position, then the electronics module 120 may engage

- 10 045998 active state at step 206. For example, opening the mouthpiece cover 108 may cause activation of the switch 130. Activation of the switch 130 may cause the electronic module 120 to transition from a sleep state to an active state.

If the electronic module 120 determines that the mouthpiece cover 108 remains in the closed position, then the electronic module 120 may determine whether a sleep period (e.g., 10 seconds) has passed at step 230. If the sleep period has not passed at step 230, then the electronic module 120 may remain in the sleep state and return to step 222. However, if the sleep period has passed at step 230, then the electronics module 120 may return to the active state alert mode at step 216. When the electronics module 120 moves from step 230 to step 216, the electronics module 120 may transmit alerts at a different, possibly slower rate than when electronics module 120 transitions from step 212 to step 216 (such as once every 10 seconds as opposed to once every 100 ms). As such, electronic module 120 may use less battery power during such alert modes. Additionally, the electronic module 120 may periodically switch between an active state and a sleep state based on the alert period and the sleep period (eg, and while the mouthpiece cover 108 is in the closed position).

Returning to FIG. 218, if an external device (such as a smartphone or tablet) comes into specific range of electronic device 120 during an alert mode, electronic module 120 may pair with the external device and enter pairing mode at step 226. In pairing mode, electronic module 120 may turn on power. communication and memory circuits. Electronic module 120 may retrieve data from memory and wirelessly transmit data to an external device. At step 228, the electronic module 120 may determine whether the transmission is complete or the external device is out of communication range. If the transfer is not completed and the external device is in communication range, then the electronics module 120 will remain in connection mode. However, if the transfer is complete, or if the external device is out of communication range, then the electronic module 120 will enter a sleep state at step 222.

During the connection mode, the electronic module 120 may retrieve and transmit all of the data currently stored in the memory, or the controller may retrieve and transmit a portion of the data currently stored in the memory. For example, the controller may be configured to determine which fragments have already been transmitted to an external device, and then transmit the fragment(s) that were not previously transmitted (eg, based on an internal counter). Alternatively or additionally, the external device may request specific data from the electronic module 120, such as any data that has been collected by the electronic module 120 since a specific time or since the last transmission to the external device. Electronic module 120 may retrieve specific data, if any, from memory and transmit specific data to an external device.

Additionally, when connected to an external device, the electronic module 120 may be configured to transmit special interest group (SIG) characteristics over Bluetooth to control access to records stored in the module 120. The Bluetooth SIG characteristics may include one or more more of the manufacturer's name of the inhalation device 100, the serial number of the inhalation device 100, the hardware version number of the inhalation device 100, and/or the software version number of the inhalation device 100. When connected to an external device, the electronic module 120 can retrieve data from memory and transmit data to an external device. device.

The inhalation device 100 may transmit an inhalation event, an inhalation parameter, a pressure measurement, a mouthpiece cover 108 event, an error event, an inhalation device performance characteristic (e.g., remaining battery life), and/or associated timestamps (e.g., based on an internal counter) to an external device. when in connection mode. For example, signals generated by switch 130, pressure measurement readings obtained by sensor system 128, and/or airflow readings calculated by electronics module controller 120 may be time stamped and stored in memory. The above data may indicate various usage parameters associated with the inhalation device 100. For example, since movement of the slider 140 causes the switch 130 to switch between an on and off state, the controller of the electronic module 120 may use signals from the switch 130 to record and time each switch. Additionally, since the switch 130's switching between an on and off state may correlate with the position of the mouthpiece cover 108 (eg, open or closed), the electronic module 120 may be configured to detect and monitor the position of the mouthpiece cover 108 over time. It will be understood that the electronic module 120 may be configured to detect and monitor the condition of the mouthpiece cover 108 without interfering with drug delivery through the flow path 119 of the inhalation device 100.

Pressure measurement readings and/or calculated airflow readings may indicate

- 11 045998 to determine the quality or strength of the inhalation from the inhalation device 100. For example, compared to a particular threshold value or range of values, the readings and/or indicators can be used to determine the category of an inhalation as some type of event, such as a good inhalation event, an event weak inspiration, no inspiration event, or over inspiration event.

A no-inspiration event may be associated with pressure readings and/or airflow readings below a specific threshold, such as air flow less than 30 L/min. A no-inhalation event may occur when the user does not inhale from the mouthpiece 106 after opening the mouthpiece cover 108 and during the measurement cycle. A no-inhalation event may also occur when the user's respiratory effort is insufficient to ensure proper delivery of drug through the flow channel 119, such as when the respiratory effort generates insufficient airflow to activate the deagglomerator 121 and thus aerosolize. medicine in dosing cap 116.

A weak inhalation event may be associated with pressure readings and/or airflow readings in a specific range, such as air flow between 30 L/min and 45 L/min. A weak inhalation event may occur when the user inhales from the mouthpiece 106 after opening the mouthpiece cover 108, and the inhalation effort of the user causes at least a partial dose of medication to be delivered through the flow channel 119. That is, the inhalation may be sufficient to activate deagglomerator 121 such that at least a portion of the drug is aerosolized from the dispensing cap 116.

A good inspiration event may be associated with pressure readings and/or airflow readings above a weak inspiration event, such as air flow between 45 L/min and 200 L/min. A good inhalation event may occur when the user inhales from the mouthpiece 106 after opening the mouthpiece cover 108 and the user's inhalation effort is sufficient to ensure proper delivery of medication through the flow path 119, such as when the inhalation effort generates sufficient airflow to activate the deagglomerator 121 and transfer the full dose of the drug in the dosing cap 116 into an aerosol state.

An over-inhalation event may be associated with pressure readings and/or airflow readings above a good inhalation event, such as air flow above 200 L/min. An over-inhalation event may occur when the user's inspiratory effort exceeds the normal operating parameters of the inhalation device 100. An over-inhalation event can also occur if the device 100 is not correctly positioned or held during use, even if the user's inhalation effort is within the normal range. For example, the calculated air flow may exceed 200 L/min if the vent 126 is blocked or obstructed (e.g., by a finger or thumb) while the user inhales from the mouthpiece 106.

It will be appreciated that any suitable thresholds or ranges may be used to categorize a particular event. It will be further understood that some or all of the events may be used. For example, a no-inspiration event may be associated with an air flow rate below 45 L/min, and a good inspiration event may be associated with an air flow rate between 45 L/min and 200 L/min. As such, the weak inhalation event may not be used at all in some cases.

The pressure measurement readings and/or calculated airflow readings may also indicate the direction of flow through the flow path 119 of the inhalation device 100. For example, if the pressure measurement readings reflect a negative measurement in pressure, the readings may indicate the flow of air from the mouthpiece 106 through the flow path 119. If the readings are pressure measurements reflect a positive change in pressure, the readings may indicate air flowing into the mouthpiece 106 through the flow path 119. Accordingly, the pressure measurement readings and/or air flow readings may be used to determine whether a user is exhaling into the mouthpiece 106, which may indicate that the user is not using the device 100 correctly.

By time stamping and storing signals generated by switch 130, reading pressure measurements obtained by sensor system 128, and/or airflow measurements calculated by electronics module 120 controller, data collected and stored by electronics module 120 can be used to determining whether usage parameters are appropriate or appropriate for a given period of time. As such, the data may indicate other events, such as an abuse event, an underutilization event, or an optimal utilization event.

For example, a user of inhalation device 100 may be directed by his or her physician to take two doses of medication through inhalation device 100 each day. In addition, the drug contained in the inhalation device 100 may also be suitable

- 12 045998 reno (for safety and regulatory purposes) to be taken no more than eight times a day. An abuse event may occur if the electronic module 120 registers more than two good breaths in a twenty-four hour period (i.e., the actual dosage exceeds the prescribed number of doses), and/or if the electronic module 120 registers more than eight good breaths in a twenty-four hour period (i.e. ., the actual dosage exceeds the regulatory approved number of doses). An underutilization event may occur if the electronic module 120 registers less than two good breaths in a twenty-four hour period (ie, the actual dosage is below the prescribed number of doses). An optimal use event may occur if the electronic module 120 detects two good breaths in a twenty-four hour period (ie, the actual dosage is below the prescribed number of doses). It will be understood that optimal use events may indicate a user who is adherent to treatment. It will be further understood that the prescribed dosage schedule and/or the maximum approved dosage schedule may depend on the type of drug contained in the inhalation device 100. In addition, events may be defined using any suitable number of doses over any suitable period of time, e.g. two doses per day, fourteen doses per week, 60 doses per month, etc.

Data collected and stored by the electronic module 120 may also be used to estimate the number of doses that have been delivered from the inhalation device 100 and/or estimate the number of doses that remain in the medication reservoir 110. For example, each time the switch 130 is activated by opening the mouthpiece cover 108, the signal generated by the switch 130 may be counted as a dose delivery event. Thus, the inhalation device 100 can be considered to have delivered 60 doses when the mouthpiece cover 108 has been opened 60 times. The inhalation device 100 may be configured to store enough drug in the drug reservoir 110 to deliver a certain total number of doses, for example, a total of 200 doses. As such, the inhalation device 100 may also be considered to have 140 doses remaining after the mouthpiece cover 108 has been opened 60 times.

As noted above, the drug will not be delivered from the drug reservoir 110 when the user opens the mouthpiece cap 108 unless the previous dose of drug has been correctly aerosolized by the deagglomerator 121 and/or transferred from the dosing cap 116. Thus, there will be It will be understood that counting the number of doses based on the opening of the mouthpiece cover 108 may not accurately reflect the actual number of doses delivered through the device 100 if, for example, the user opens and closes the mouthpiece cover 108 without inhaling from the mouthpiece 106. Accordingly, other data in the electronics module 120 may be used and/or combined with signals from switch 130 to determine the number of doses delivered and/or remaining in device 100. For example, a dose may be counted as delivered each time the calculated airflow rate is above a threshold or within a particular range, for example, when a good inspiration event was recorded. By calculating and tracking the number of doses delivered and/or remaining, the electronic module 120 may be configured to identify a refill event, which may indicate a time when the user should expect to receive a new inhalation device 100.

Data collected and stored by electronics module 120 may also be used to determine various error conditions associated with the operation of module 120. For example, when processing data, electronics module 120 may generate a bad data flag, a data corruption flag, a timestamp error flag, and/or or the like The electronics module 120 may generate a bad data flag when the controller of the electronics module 120 determines that one or more signals received from the sensor system 128 are outside a certain range, which may indicate a malfunction in the sensor system 128. Electronic module 120 may generate a data corruption flag when the controller's cyclic redundancy check (CRC) for data does not match what is stored in memory, which may indicate a memory failure and/or that the data in memory has been corrupted. Electronic module 120 may generate a timestamp error flag when the controller loses its electrical connection to battery 126, causing the controller's system timer to be reset. If the controller's system timer is reset, the controller can restart its timer from the last saved counter value.

Electronic module 120 (e.g., and/or a mobile application residing on an external device) may also analyze logged events over a period of time to identify multiple error events, which may include a usage pattern indicating a user who is not familiar with the correct operation of the inhalation device 100, and thus the user, who may require additional training. For example, the electronic module 120 may check the number of good inhalation events during a certain period of time and/or during a certain number of openings of the mouthpiece cover 108. A multiple error event can occur when the user has only had two good events

- 13,045,998 breaths during the past week, or had six or fewer good breaths during the last twelve openings of the mouthpiece cover 108. It will be understood that the above conditions are merely exemplary, and that any suitable usage pattern may be used to define a multiple error event.

Data collected and stored by electronic module 120 may also be used to estimate the amount of power remaining in battery 126. For example, the controller may determine whether a low battery event or condition exists, such as whether the battery has less than a certain amount of charge remaining ( for example, below 10%).

It will be appreciated that electronic module 120 may process and analyze data stored in memory (e.g., signals generated by switch 130, pressure measurement readings obtained by sensor system 128, and/or airflow readings calculated by PCB controller 122), to determine usage parameters associated with inhalation device 100. For example, electronic module 120 may process data to identify non-inhalation events, weak inhalation events, good inhalation events, over-inhalation events, and/or exhalation events. Electronic module 120 may also process data to identify underutilization events, overuse events, and optimal utilization events. Electronic module 120 may further process the data to estimate the number of doses delivered and/or remaining and identify error conditions, such as conditions associated with a timestamp error flag. The electronic module 120 may inform the user of some or all of the above parameters for use of the inhalation device 100 through indicators such as one or more LEDs. As an example, the electronic module 120 may illuminate the LED to indicate a good inspiration event, or change the color of the LED to indicate a weak inspiration event or a no inspiration event. Usage parameters may be indicated to the user through any combination of light sequences and/or lighting color schemes.

It will be further understood that data stored in the memory of the electronics module 120 (e.g., signals generated by the switch 130, pressure measurement readings obtained by the sensor system 128, and/or airflow metrics calculated by the controller of the electronics module 120) may also be transmitted to an external device that can process and analyze the data to determine usage parameters associated with the inhalation device 100. Additionally, a mobile application residing on the mobile device can generate feedback to the user based on data received from the electronic module 120. For example, , the mobile application may generate a daily, weekly, or monthly report, provide confirmation of error events or notifications, provide instructional feedback to the user, and/or the like.

Fig. 8 is a diagram of an exemplary system 300 including an inhalation device 302, an external device (eg, mobile device 304), a public and/or private network 306 (eg, Internet, cloud network), a healthcare provider 308, and a third party 310 (eg friends, family, pharmaceutical manufacturer, etc.). Mobile device 304 may include a smartphone (e.g., an iPhone® smartphone, an Android® smartphone, or a Blackberry® smartphone), a personal computer, a laptop computer, a wireless media device (e.g., an MP3 player, a gaming device, a television, media streaming devices ( e.g. Amazon Fire TV, Nexus Player, etc.), etc.), tablet device (e.g. iPad® handheld computing device), Wi-Fi or wireless TV, or any other suitable device with enabled Internet Protocol. For example, mobile device 304 may be configured to transmit and/or receive RF signals via a Wi-Fi link, Wi-MAX link, Bluetooth® or Bluetooth Smart link, Near Field Communication (NFC) near field communication), cellular communication line, television white space communication line (TVWS - television white space) or any combination thereof. Mobile device 304 may transmit data via public and/or private network 306 to healthcare provider 308 and/or one or more third parties 310 (eg, friends, family, pharmaceutical company, etc.).

Inhalation device 302 may be an example of inhalation device 100. Inhalation device 302 may include communication circuitry, such as a Bluetooth radio, for transmitting data to mobile device 304. Data may include signals generated by switch 130, reading pressure measurements obtained through a sensor system, and/or air flow indicators calculated through an electronic module controller. The inhalation device 302 may receive data from the mobile device 304, such as, for example, software instructions, operating system changes, dosage information, alerts or notifications, confirmations, etc.

Mobile device 304 may process and analyze data to determine pair

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Claims (20)

usage meters associated with inhalation device 302. For example, mobile device 304 may process data to identify no-inhalation events, weak inhalation events, good inhalation events, over-inhalation events, and/or exhalation events. Mobile device 304 may also process data to identify underutilization events, overuse events, and optimal usage events. Mobile device 304 may further process the data to estimate the number of doses delivered and/or remaining and identify error conditions, such as conditions associated with a timestamp error flag. Mobile device 304 may include a display and software for visually presenting usage parameters via a GUI on the display. Additionally, in some examples, inhalation device 300 may include an actuator to initiate the pairing process with mobile device 304. However, inhalation device 300 may include other means for facilitating the pairing process. For example, the top cap of the inhalation device 300 may include a quick response (QR) code. Mobile device 304 may include a camera and a software system application for accessing the camera and reading a QR code. The QR code may include a BLE passkey that is unique to the inhalation device 300. When the QR code is read or scanned using a camera, the software system application may receive the BLE passkey associated with the device 300 and complete the process authentication, thereby allowing it to communicate with the electronic module using a BLE access key. If the communication session is subsequently lost due to, for example, the inhalation device 300 going out of range, the mobile device 304 may be configured to use a BLE passkey to automatically pair with the electronic module without using a QR code when the inhalation device 300 returns into the range. CLAIM 1. An inhaler for delivering a medicinal product to a user, containing: a mouthpiece including a flow channel configured to deliver a dose of a medicinal product to a user; a mouthpiece cover configured to prepare a dose of medicament such that the dose is available in the inhalation flow path of the user when the mouthpiece cover is moved to open the mouthpiece; a vent hole connected to the flow path, wherein the vent hole is configured to allow air to flow from outside the inhaler into the flow path; and an electronic module containing a controller, a sensor and a communication circuit; wherein the sensor is configured to generate a signal in response to inhalation through the mouthpiece; and wherein the controller is configured to generate a mouthpiece cover opening event in response to movement of the inhaler mouthpiece cover from a closed position to an open position to allow access of a dose of medicinal product to the flow channel and opening of the mouthpiece, receiving a signal from the sensor, generating an inhalation event in response to the signal, indicating that the flow path flow rate exceeds a threshold value, and causing the communication circuit to transmit the inhalation event and the mouthpiece cover opening event to the external device. 2. The inhaler of claim 1, wherein the controller is further configured to generate a no-inhalation error event in response to a signal indicating that the flow path flow rate does not exceed a threshold value, and cause the communication circuit to transmit the no-inhalation error event to the external device. 3. The inhaler of claim 2, wherein the controller is configured to initiate a measurement cycle in response to movement of the mouthpiece cover from a closed position to an open position, and generate a no-inhalation error event in response to a signal indicating that the flow channel flow rate does not exceed a threshold value during a measurement cycle, with the measurement cycle continuing for a specified period of time or until the mouthpiece cap moves from the open position to the closed position, whichever occurs first. 4. The inhaler of claim 1, wherein the sensor is a pressure sensor, wherein the pressure sensor is further configured to measure pressure changes in the inhaler resulting from exhalation through the mouthpiece, and the controller is configured to generate an exhalation event in response to the measurement data pressures indicating a positive change in pressure that exceeds an exhalation threshold, and causing the communication circuit to transmit the exhalation event to an external device. 5. The inhaler of claim 1, wherein the opening event of the mouthpiece cover is indicative of delivery of a dose of drug from the inhaler reservoir. 6. Inhaler according to claim 1, additionally containing: dose counter configured to decrease based on movement of the lid - 15 045998 inhaler mouthpiece. 7. The inhaler of claim 1, wherein the controller is configured to determine one or more inhalation parameters based on the signal, and cause the communication circuit to wirelessly transmit the inhalation parameters to the external device; in this case, the inspiratory parameters contain peak flow, time to peak flow, inhaled volume and inspiratory duration. 8. An inhaler according to claim 1, additionally containing: a dosing chamber connected to the flow channel, wherein the dosing chamber is configured to deliver a dose of the medicinal product into the flow channel during inhalation through the mouthpiece; and a Quick Response (QR) code, which contains a communication passkey that is unique to the inhaler and enables wireless communication with the inhaler electronics module. 9. A method for detecting a condition of use of a drug delivery inhaler using a device comprising a mouthpiece, a vent, a controller, a memory, a sensor and a communication circuit, the method comprising: in response to moving the inhaler mouthpiece cover from the closed position to the open position: generating the event of opening the mouthpiece cover; preparing a dose of the drug such that the dose is available in the flow channel of the inhaler when the mouthpiece cover is moved to open the mouthpiece; and causing the controller to turn on the sensor; generating a signal in response to inhalation through the mouthpiece, wherein the inhalation causes air flow to move along the flow channel of the inhaler between the mouthpiece and the vent; determining the air flow rate through the flow channel based on the signal; generating an inhalation event based on an air flow rate exceeding a threshold value, and transmitting the mouthpiece cover opening event and the inhalation event to an external device. 10. The method according to claim 9, additionally containing: determining that the air flow rate exceeds a certain threshold value; generating an over-inhalation event in response to an air flow rate exceeding a threshold value; and displaying an over-inhalation event notification. 11. The method of claim 10, wherein the over-inhalation event notification indicates that the inhaler vent is blocked or obstructed. 12. The method of claim 9, wherein the sensor comprises a pressure sensor, and wherein the method further comprises measuring a positive change in inhaler pressure resulting from exhalation through the mouthpiece, generating an exhalation event based on the positive change in pressure exceeding an exhalation threshold, and transmitting the inhalation exhalation event to the external device. 13. The method according to claim 9, additionally containing: starting a measurement cycle in response to movement of the mouthpiece cover from a closed position to an open position; generating a no-inspiratory event based on airflow not exceeding a threshold during a measurement cycle, with the measurement cycle continuing for a specified period of time or until the mouthpiece cover moves from the open position to the closed position, whichever occurs first; and transmitting the no-inhalation event to the external device. 14. A system for detecting conditions for using an inhaler for drug delivery, comprising: an inhaler containing: a mouthpiece including a flow channel configured to deliver a dose of a medicinal product to a user; a mouthpiece cover configured to prepare a dose of medicament such that the dose is available in the inhalation flow path of the user when the mouthpiece cover is moved to open the mouthpiece; a vent hole connected to the flow path, wherein the vent hole is configured to allow air to flow from outside the inhaler into the flow path; and an electronic module containing a controller, a sensor and a communication circuit; wherein the sensor is configured to generate a signal in response to inhalation through the mouthpiece; and the controller is configured to: receiving a signal from the sensor; - 16 045998 determining the air flow rate through the flow channel based on the signal; generating an inhalation event based on an air flow rate exceeding a threshold value; and generating a no-inhalation error event based on an air flow rate not exceeding a threshold value for a certain period of time after the inhaler mouthpiece cover is moved to the open position, or based on an air flow rate not exceeding a threshold value until the mouthpiece cover is moved from open position to closed position; and wherein the communication circuit is configured to transmit an inhalation event or a non-inhalation event and an inspiratory air flow rate to an external device, and a computer readable storage medium residing on the external device, wherein the computer readable storage media contains machine-executable instructions such that when executed by the processor external device cause the processor of the external device to: receiving an inhalation event wirelessly via an external device interface, generating a good inhalation event when the airflow rate is between a lower and an upper threshold value, and generating an overinspiration event when the airflow rate is above an upper threshold value, wherein the overinspiration event is indicative of obstruction of the inhaler vent. 15. The system of claim 14, wherein the sensor comprises a pressure sensor, and wherein the pressure sensor is further configured to measure changes in pressure in the inhaler resulting from exhalation through the mouthpiece, and the controller is configured to generate an exhalation event based on the pressure measurement data indicating a positive change in pressure, wherein the communication circuit is configured to transmit the exhalation event to an external device; wherein the application of the software system is further configured to receive an exhalation event and display a notification of the exhalation event via a display device of the external device. 16. The system of claim 14, wherein the inhaler includes a quick response (QR) code that contains a communication access key that is unique to the inhaler; wherein the application of the software system is additionally configured to receive a communication access key via a QR code to provide wireless communication between the inhaler and an external device. 17. The system of claim 14, wherein the controller is further configured to initiate a measurement cycle in response to movement of the inhaler mouthpiece cover from a closed position to an open position, and generate a no-inhalation error event when the air flow rate does not exceed a lower threshold value during a measurement cycle, wherein the measurement cycle continues for a specified period of time or until the mouthpiece cover moves from the open position to the closed position, whichever occurs first; wherein the communication circuit is configured to send a no-inhalation event to an external device; and when executed by the processor of the external device, the computer-readable storage medium is configured to cause the processor of the external device to receive no-inhalation events and display an indication of the no-inhalation event via a display device of the external device. 18. The system of claim 14, wherein the controller is configured to generate a mouthpiece cover opening event in response to movement of the inhaler mouthpiece cover from a closed position to an open position to provide access of a dose of medicinal product to the flow channel and open the mouthpiece; and when executed by the external device processor, the computer readable storage medium is configured to cause the external device processor to determine the number of drug doses remaining in the inhaler reservoir based on the number of mouthpiece cover opening events received from the inhaler controller. 19. The system of claim 18, wherein when executed by the external device processor, the computer readable storage medium is configured to cause the external device processor to determine the number of doses of drug remaining in the reservoir based on the subsequent number of inhalation events received from the inhaler controller. 20. The system of claim 18, wherein when executed by the external device processor, the computer readable storage medium is configured to cause the external device processor to generate a refill notification based on the number of mouthpiece cover opening events received from the inhaler controller. -