BACKGROUND

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

In the context of a drug therapy, adherence may refer to the degree to which a patient is following a prescribed dosing regimen. For example, if the patient's prescription calls for two doses each day, and the patient is taking two doses per day, the patient may be considered 100% adherent. If the patient is only taking one dose per day, he or she may be deemed only 50% adherent. In the latter case, the patient may not be receiving the treatment prescribed by his or her doctor, which may negatively affect the efficacy of the therapeutic treatment.

Compliance may refer to a patient's technique when using a particular drug delivery device. If the patient is using the device in a manner that is recommended by a doctor or by a manufacturer, the device is likely to deliver the desired dose of medication and the patient may be deemed compliant. However, if the device is not being used properly during drug administration, the device's ability to deliver a proper dose of medication may be compromised. As such, the patient may be deemed non-compliant. In the case of an inhalation device, for example, the patient may need to achieve a minimum inspiratory effort to ensure a full dose of medication is delivered from the device into the patient's lungs. For some patients, such as children and the elderly, meeting the requirements for full compliance may be difficult due to physical limitations, such as limited lung function. Accordingly, like adherence, failing to achieve full compliance may reduce the effectiveness of a prescribed treatment.

A patient's ability to achieve full compliance may be further complicated by certain physical properties of the medication. For example, some respiratory medications may consist of fine particles and/or may lack any odor or taste. Thus, a patient using an inhalation device may not be able to correct a non-compliant use because he or she may not be able to immediately detect or sense that medication is being inhaled and/or know whether the amount of inhaled medication complies with the prescription.

SUMMARY

A drug delivery device may be adapted to include an electronics module that is configured to sense, track, and/or process usage conditions and parameters associated with the device (e.g., to improve adherence and compliance). The electronics module may be further configured to communicate the conditions and parameters to external devices, such as a smartphone, for similar and/or further processing. The inclusion of an electronics module in a drug delivery device opens the doors to a wealth of digital improvements and features to enhance the use of the device. The electronics module, in this context, may create a platform to leverage helpful smartphone applications and powerful data analytics. However, the introduction of electronics into any drug delivery device may introduce certain technical challenges, such as durability, reliability, electro-mechanical integration, power management, and drug delivery performance. The present disclosure provides solutions for inclusion of certain electrical components with a drug delivery device, such as an inhaler.

Examples of inhalation devices (e.g., breath-actuated inhalers) and system that include inhalation devices are provided herein. A system may include a mobile application residing on an external device and an inhalation device. The inhalation device may include a mouthpiece, a mouthpiece cover, medicament, and an electronics module comprising a processor. The inhalation device may be configured to both prepare a dose of medicament for delivery to a user and cause the processor to transition between power states when the mouthpiece cover is moved from a closed position to an open position to expose the mouthpiece.

The electronics module or the mobile application may be configured to generate usage events based on usage of the inhalation device by the user. For example, the electronics module or the mobile application may be configured to generate a usage event based on movement of the mouthpiece cover from a closed position to an open position. Alternatively or additionally, the electronics module may include a pressure sensor, and the electronics module or the mobile application may be configured to generate a usage event based on feedback from the pressure sensor. The pressure sensor may be configured to measure at least one atmospheric pressure within the inhaler, for example, after the mouthpiece cover is moved from the closed position to the open position.

The electronics module or the mobile application may be configured to determine whether a usage event is a good inhalation event, a fair inhalation event, or a no inhalation event based on feedback from the pressure sensor. The electronics module or the mobile application may be configured to generate a good inhalation event when the feedback from the pressure sensor indicates a pressure measurement of above a specific threshold (e.g., 45 liters per min (L/min)), generate a fair inhalation event when the feedback from the pressure sensor indicates a pressure measurement between two threshold values (e.g., 30 L/min and 45 L/min), and generate a no/low inhalation event when the feedback from the pressure sensor indicates a pressure measurement of less than a threshold value (e.g., 30 L/min).

The electronics module or the mobile application may be configured to determine that a number of good inhalation events over a predetermined period of time is less than a number of predetermined number of good inhalation events, and provide a multiple error event notification to the user. The electronics module or the mobile application may be configured to determine that a number of good inhalation events for a set number of usage events is less than a predetermined amount, and provide a multiple error event notification to the user.

The electronics module or the mobile application may be configured to determine that a number of usage events exceeds a predetermined number of events for a set time period, and provide a notification to the user of an overuse event. The electronics module or the mobile application may be configured to determine that a number of usage events is less than a predetermined number of events for a set time period, and provide a notification to the user of an underuse event.

The electronics module or the mobile application may be configured to determine that feedback from the pressure sensor indicates that there have been multiple inhalation events while the mouthpiece cover is in the open position, and provide a notification to the user that the mouthpiece cover needs to be closed and then re-opened to ensure that a subsequent dose of medication is made available for inhalation. The electronics module or the mobile application may be configured to determine that the mouthpiece cover is in the open position for greater than a predetermine amount of time, and generate a mouthpiece cover event (e.g., and/or provide a notification to the user that the mouthpiece cover should be closed). The notification may, for example, include the illumination of a light emitting diode (LED) of the inhalation device or the mobile application, the generation of an audible output via a speaker of the inhalation device and/or an external device (e.g., a smart home device, a television, a smartphone, etc.), the presentation of a message via the mobile application, or the presentation of an error video or the instructions for use via the mobile application.

The inhalation device may include a medication reservoir comprising the medicament. The electronics module or the mobile application may be configured to estimate the number of doses that remain in the medication reservoir, and provide a refill notification to the user. For example, the electronics module may include a switch that is configured to power the processor of the electronics module and is configured to activated when the mouthpiece cover is moved from the closed position to the open position. In such instances, the electronics module or the mobile application may be configured to estimate the number of doses that remain in the medication reservoir based on the number of actuations of the switch. Alternatively or additionally, the electronics module or the mobile application may be configured to estimate the number of doses that remain in the medication reservoir based on feedback from the pressure sensor. In some examples, the electronics module or the mobile application may be configured to send a notification to a pharmacy based on the refill notification.

The mobile application may be configured to determine multiple error events of a same error type, and present an instructional video to the user that is specific to the error type. The error type may be, for example, one or more of a no inhalation event, a fair inhalation event, an excessive inhalation event, an exhalation event, an air vent obstruction event, an overuse event, an underuse event, or mouthpiece cover closure event. Further, the mobile application may be configured to provide one or more of a daily report that explains the usage events for a day, a weekly report that explains the usage events for a week, or a monthly report that explains the usage events for a month.

The inhalation device may include a main body having a mouthpiece and a mouthpiece cover, a slider at least partially disposed within the main body, and an electronics module having a switch and a pressure sensor. The electronics module may be configured to be in an off state prior to a user moving the mouthpiece cover to expose the mouthpiece for the first time. When the mouthpiece cover is moved to expose the mouthpiece, the slider may be configured to engage the switch, which may cause the electronics module to transition from the off state to an active state and to sense inhalation by the user through the mouthpiece. The electronics module may be configured to not return to the off state after the mouthpiece cover is moved to expose the mouthpiece for the first time by the user (e.g., throughout the life of the inhalation device and/or battery). The electronics module may be configured to start an internal counter when transitioning from the off state. The electronics module is configured to timestamp inhalation events, inhalation metrics, error events, pressure measurements, mouthpiece cover opening events, etc. based on the internal counter.

The pressure sensor may be configured to measure a plurality of pressure changes within the inhaler resulting from the user's inhalation through the mouthpiece after the mouthpiece cover is moved from the closed position to the open position. The pressure sensor may be configured to take measurements for a predetermined period of time or until a predetermined event is detected (e.g., an inhalation, a closing of the mouthpiece cover, etc.). The electronics module may also include a processor configured to determine one or more inhalation parameters based on the plurality of measured pressure changes. The inhalation parameters may include, but are not limited to, a peak flow rate, a time to peak flow rate, an inhaled volume, and an inhalation duration. The electronics module may also include a communications circuit configured to wirelessly transmit the inhalation parameters to an external device.

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

The electronics module may be configured to be in a sleep state when not in the off state or the active state. The electronics module may be configured to change from the active state to the sleep state upon the electronics module determining that the pressure measurement received from a pressure sensor does not fall within the predetermined range for a predetermined amount of time (e.g., a user not inhaling from the mouthpiece for the predetermined amount of time), where the predetermined amount of time is based on the internal counter. The electronics module may be configured to store a timeout event and associated timestamp when the mouthpiece cover is moved to the open position and the electronics module does not determine that a pressure measurement received from the pressure sensor is within the predetermined range within the predetermined amount of time (e.g., a user not inhaling from the mouthpiece for the predetermined amount of time), where the timestamp of the timeout event is based on the internal counter.

Upon determining that the pressure measurement received from a pressure sensor is within the predetermined range, the electronics module may be configured to generate an inhalation event and associated timestamp for the inhalation event, and store the inhalation event and associated timestamp in memory of the inhaler, where the timestamp of the inhalation event based on the internal counter. Upon storing the inhalation event and associated timestamp in memory, the electronics module may be configured to cause the communication circuit to transmit advertisements at a first advertising rate in an attempt to sync up with an external device. If the communication circuit successfully syncs with the external device, the communication circuit may be configured to transmit the inhalation event and associated timestamp to the external device. If the communication circuit does not successfully sync with the external device after a predetermined amount of time, the communication circuit may be configured to transmit the advertisements at a second advertising rate that is slower than the first advertising rate.

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

When in the active state, the electronics module may be configured to sample pressure measurements received from a pressure sensor at a predetermined rate, and configured to power off the sensor system between the sampling times of the pressure measurements received from the pressure sensor. The electronics module may be configured to perform calculations on the pressure measurements received from the pressure sensor between the sampling times. The electronics module may be is configured to change from the active state to a sleep state upon the mouthpiece cover returning to the closed position.

A system comprising: a mobile application; and a breath-actuated inhaler for delivering medication to a user, the inhaler comprising a mouthpiece, a mouthpiece cover, an electronics module, and a medication reservoir, the mouthpiece cover hinged to the main body, and the electronics module comprising a communication circuit, a power supply, a sensor system, a battery, and a switch; wherein the electronics module is configured to start an internal counter when the mouthpiece cover is first moved from a closed position to an open position by a user; wherein the mobile application is configured to query the breath-actuated inhaler to retrieve event data, the event data comprising a mouthpiece cover opening event, a timestamp, and inhalation profile information.

The electronics module is configured to run the internal counter upon when 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 inhalation profile information comprises one or more of peak flow of pressure data provided by the sensor system, volume of the pressure data, time-to-peak of the pressure data, or duration of the pressure data. The event data comprises one or more of a status flag indicating whether an inhalation event was fair inhalation, good inhalation, no inhalation, or an exhalation. The event data comprises information relating to whether the mouthpiece cover is in the open position or the closed position.

