Abstract: The invention provides a method of testing an inhaler based on performing an optical analysis of a dry powder medicament plume discharged from the inhaler upon actuation. More particularly, embodiments of the invention comprise illuminating the dry powder plume with a source of electromagnetic radiation and capturing one or more images of a pattern of radiation reflected or diffracted by the illuminated plume. The images are subsequently processed to determine and/or analyse one or more geometric and/or dynamic characteristics of the plume.

Abstract: The invention provides a method of testing an inhaler based on performing an optical analysis of a dry powder medicament plume discharged from the inhaler upon actuation. More particularly, embodiments of the invention comprise illuminating the dry powder plume with a source of electromagnetic radiation and capturing one or more images of a pattern of radiation reflected or diffracted by the illuminated plume. The images are subsequently processed to determine and/or analyse one or more geometric and/or dynamic characteristics of the plume.

Abstract: The introduction of electronics into a drug delivery device may introduce certain technical challenges, such as durability, electro-mechanical integration, and drug delivery performance. The present disclosure provides solutions for inclusion of an electronics module with an inhaler. For example, heat stakes may be used to secure a printed circuit board (PCB) to an electronics module's housing. Also for example, a slider may be used to transfer vertical movement of an inhaler's yoke to an electronics module's switch. Also for example, certain seals may be used when interfacing the electronics module to other portions of the device's housing to achieve a desired performance.

Abstract: A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

Abstract: The introduction of electronics into a drug delivery device may introduce certain technical challenges, such as durability, electro-mechanical integration, and drug delivery performance. The present disclosure provides solutions for inclusion of an electronics module with an inhaler. For example, heat stakes may be used to secure a printed circuit board (PCB) to an electronics module's housing. Also for example, a slider may be used to transfer vertical movement of an inhaler's yoke to an electronics module's switch. Also for example, certain seals may be used when interfacing the electronics module to other portions of the device's housing to achieve a desired performance.

Abstract: A compliance monitoring module for an inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being configured to be pneumatically coupled to a flow channel of said inhaler through which a user can inhale; a processor configured to: receive data from a sensing element of the pressure sensor; receive data from a mode sensor configured to detect when the inhaler changes from an inactive mode to an active mode; and based on said data from said pressure sensor sensing element and said data from said mode sensor, compile a compliance report; and a transmitter configured to issue said compliance report.

Abstract: Provided is a system for determining a probability of a respiratory disease exacerbation in a subject. The system comprises an inhaler arrangement for delivering a medicament to the subject. The medicament may be a rescue medicament and/or a maintenance medicament. The inhaler arrangement has a use-detection system configured to determine an inhalation performed by the subject using the inhaler arrangement. A sensor system is configured to measure a parameter relating to airflow during the inhalation. A user interface enables user-input of an indication of a status of the respiratory disease being experienced by the subject. A processor is configured to determine the probability of the respiratory disease exacerbation based on the recorded inhalation(s) from the use-detection system, the parameter(s) received from the sensor system, and the indication received from the user interface. Further provided is a method for determining the probability of a respiratory disease exacerbation in a subject.

Abstract: A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

Abstract: A compliance monitoring module for an inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being configured to be pneumatically coupled to a flow channel of said inhaler through which a user can inhale; a processor configured to: receive data from a sensing element of the pressure sensor; receive data from a mode sensor configured to detect when the inhaler changes from an inactive mode to an active mode; and based on said data from said pressure sensor sensing element and said data from said mode sensor, compile a compliance report; and a transmitter configured to issue said compliance report.

Abstract: A breath actuated metered dose inhaler may comprise a canister fire system configured to fire a medicament containing canister in response to patient inhalation. The canister fire system may comprise a pneumatic force holding unit and having a rest configuration in which a metering valve of the canister is in a refill configuration; a prepared configuration in which a canister actuation force is retained by the pneumatic force holding unit and the canister fire system is actuatable by patient inhalation induced airflow; and a fire configuration in which the metering valve is in a dose delivery position. When in the prepared configuration, the force retained by the pneumatic force holding unit may be reduced by less than about 6% over a period of 5 minutes, preferably less than about 3% over a period of 5 minutes.

Abstract: A system may limit the number of times an inhalation device transmits inhalation data to a single time to reduce the battery usage of the inhalation device. The system may include an inhalation device that has medicament and an electronics module. The system may limit the number of times the inhalation device transmits new inhalation data to any mobile device to a single time by causing the server to receive the new inhalation data from one of the mobile devices and causing the server to transmit the new inhalation data to other of the mobile devices prior to the other mobile devices transmitting a request for the new inhalation data to the inhalation device. The inhalation device may include a Quick Response (QR) code, and a mobile application may determine at least one of a medication type or a number of doses of the inhalation device from the QR code.

Abstract: A system may include an external device and an inhaler. The external device may include a processor, a communication circuit, and memory. The inhaler may include a mouthpiece, medicament, a mechanical dose counter, and an electronics module comprising a processor and a communication circuit. The electronics module may record a dosing event when the inhaler is actuated, such as when the mouthpiece cover is opened, and send a signal indicating the dosing event to the external device. The external device may receive a mechanical dose reading of the mechanical dose counter, determine an electronic dose reading based on the signal indicating the dosing event, determine that a discrepancy between the mechanical dose reading and the electronic dose reading exceeds a threshold, and notify the user of the discrepancy, for example, by providing a notification to the user by way of a mobile application residing on the external device.

Abstract: Provided is a system (10) for determining a probability of an asthma exacerbation in a subject. The system comprises an inhaler (100) for delivering a rescue medicament to the subject. The inhaler has a use-detection system (12B) configured to determine a rescue inhalation performed by the subject using the first inhaler. A sensor system (12A) is configured to measure a parameter relating to airflow during the rescue inhalation. The system further comprises a processor (14) configured to determine a number of the rescue inhalations during a first time period, and receive the parameter measured for at least some of the rescue inhalations. The processor determines, using a weighted model, the probability of the asthma exacerbation based on the number of rescue inhalations and the parameters. The model is weighted such that the number of rescue inhalations is more significant in the probability determination than the parameters.

Abstract: A breath actuated metered dose inhaler may include a canister fire system configured to fire a medicament containing canister in response to patient inhalation. The canister fire system may include a pneumatic force holding unit and having a rest configuration in which a metering valve of the canister is in a refill configuration; a prepared configuration in which a canister actuation force is retained by the pneumatic force holding unit and the canister fire system is actuatable by patient inhalation induced airflow; and a fire configuration in which the metering valve is in a dose delivery position. When in the prepared configuration, the force retained by the so pneumatic force holding unit may be reduced by less than about 6% over a period of 5 minutes, preferably less than about 3% over a period of 5 minutes.

Abstract: An inhaler includes a main body having a canister housing, a medicament canister retained in a central outlet port of the canister housing, and a dose counter having an actuation member for operation by movement of the medicament canister. The canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall. The canister housing has a longitudinal axis X which passes through the center of the central outlet port. The first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

Abstract: The invention provides a method of testing an inhaler based on performing an optical analysis of a dry powder medicament plume discharged from the inhaler upon actuation. More particularly, embodiments of the invention comprise illuminating the dry powder plume with a source of electromagnetic radiation and capturing one or more images of a pattern of radiation reflected or diffracted by the illuminated plume. The images are subsequently processed to determine and/or analyse one or more geometric and/or dynamic characteristics of the plume.

Abstract: The present disclosure describes an inhaler for the inhalation of powder medication. The inhaler has a body and at least one reservoir containing powder medication, the body having an air inlet and an outlet for the transmission to a patient of air entering the body through the air inlet and powder medication. The outlet has a total cross-sectional area for flow which is more than 80% of the total cross-sectional area of the air inlet.

Abstract: A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

Abstract: A dose counter for an inhaler includes a counter display arranged to indicate dosage information, and a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input. A regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

Abstract: An inhaler includes a mouthpiece cover, a pressure sensor, a first indicator and a second indicator. The first indicator may be configured to indicate based on a state of the cover, and the second indicator may be configured to indicate based on an output of the pressure sensor. For example, when the mouthpiece cover opens, the first indicator may illuminate and a dose of medication may be transferred from a reservoir to a dosing cup. The second indicator may illuminate if an amount of inhaled medication reaches a predetermined threshold for successful inhalation.