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Last Updated: May 19, 2024

Claims for Patent: 11,351,317


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Summary for Patent: 11,351,317
Title:Drug delivery device with electronics
Abstract: A device for delivering medication to a user may include a main body, an electronics module, and a slider. The main body may include a mouthpiece, a medication reservoir, and a mouthpiece cover, where the mouthpiece cover may be hinged to the main body. The electronics module may include a communication circuit, a pressure sensor, and a switch. The slider may be configured to engage the switch when the mouthpiece cover moves from a closed position to an open position. The switch may be configured to switch the electronics module from an off state or a sleep state to an active state. The electronics module may be configured to never return to the off state after the mouthpiece cover is moved to expose the mouthpiece for the first time by the user.
Inventor(s): Calderon Oliveras; Enrique (Waterford, IE), Lewis; Carl L. (Cambridgeshire, GB), Cotton; Symon D'Oyly (Cambridge, GB), Gardner; Steven D. (Peterborough, GB), Kivlin; Robert O. (Cambridge, GB)
Assignee: Norton (Waterford) Limited (Waterford, IE)
Application Number:16/148,046
Patent Claims: 1. An inhaler for delivering medication to a user, the inhaler comprising: a reservoir for storing the medication; a mouthpiece including a flow pathway through which a dose of the medication can be delivered from the reservoir to the user; a mouthpiece cover configured to release a dose of the medication such that the dose is available to the flow pathway for user inhalation as the mouthpiece cover is moved to expose the mouthpiece; an air vent coupled to the flow pathway, wherein the air vent is configured to provide a flow of air from the exterior of the inhaler to the flow pathway; and an electronics module comprising a controller, a pressure sensor, and a communication circuit; wherein the pressure sensor is configured to measure pressure changes within the inhaler resulting from an inhalation from the mouthpiece; and wherein the controller is configured to generate a mouthpiece cover opening event in response to movement of the mouthpiece cover of the inhaler from a closed position to an open position to make a dose of the medication available to the flow pathway and expose the mouthpiece, receive pressure measurement data from the pressure sensor, generate an inhalation event in response to the pressure measurement data indicating that a flow rate in the flow pathway exceeds a threshold, and cause the communication circuit to transmit the inhalation event and the mouthpiece cover opening event to an external device.

2. The inhaler of claim 1, wherein the controller is configured to generate a no inhalation error event in response to the pressure measurement data indicating that a flow rate in the flow pathway does not exceed the threshold, 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 start a measurement cycle in response to movement of the mouthpiece cover from the closed position to the open position, and generate the no inhalation error event in response to the pressure measurement data indicating that the flow rate in the flow pathway does not exceed the threshold during the measurement cycle, wherein the measurement cycle persists for a predetermined period of time or until the mouthpiece cover is moved from the open position to the closed position, whichever comes first.

4. The inhaler of claim 1, wherein the pressure sensor is further configured to measure the change in pressure within the inhaler resulting from an exhalation into the mouthpiece, and the controller is configured to generate an exhalation event in response to the pressure measure data indicating a positive change in pressure that exceeds an exhalation threshold, and cause the communication circuit to transmit the exhalation event to the external device.

5. The inhaler of claim 1, wherein the mouthpiece cover opening event is indicative of a dose of the medication being delivered from the reservoir.

6. The inhaler of claim 1, further comprising: a dose counter that is configured to decrement based on movement of the mouthpiece cover over the inhaler.

7. The inhaler of claim 1, wherein the controller is configured to determine one or more inhalation parameters based on the pressure measurement data, and cause the communication circuit to wirelessly transmit the inhalation parameters to the external device; wherein the inhalation parameters comprise a peak flow rate, a time to peak flow rate, an inhaled volume, and an inhalation duration.

8. The inhaler of claim 1, further comprising: a dosing chamber coupled to the flow pathway, wherein the dosing chamber is configured to deliver the dose of the medication to the flow pathway during the inhalation from the mouthpiece; and a Quick Response (QR) code that comprises a communication passkey that is unique to the inhaler and enables wireless communication with the electronics module of the inhaler.

9. A method for detecting a usage condition of an inhaler for delivering medication using a device that comprises a mouthpiece, an air vent, a medicament reservoir, a controller, memory, a sensor, and a communication circuit, the method comprising: in response to movement of a mouthpiece cover of the inhaler from a closed position to an open position: generating a mouthpiece cover opening event; releasing a dose of the medication from the medicament reservoir such that the dose is available to a flow pathway of the inhaler as the mouthpiece cover is moved to expose the mouthpiece; and causing the controller to power on the sensor; measuring a change in pressure within the inhaler resulting from an inhalation from the mouthpiece, wherein the inhalation causes a flow of air to travel along the flow pathway of the inhaler between the mouthpiece and the air vent; determining an airflow rate through the flow pathway based on the change of pressure within the inhaler; generating an inhalation event based on the airflow rate exceeding a threshold; and transmitting the mouthpiece cover opening event and the inhalation event to an external device.

10. The method of claim 9, further comprising: determining that the airflow rate exceeds the threshold; generating an excessive inhalation event in response to the airflow rate exceeding the threshold; and displaying a notification of the excessive inhalation event.

11. The method of claim 10, wherein the notification of the excessive inhalation event indicates that the air vent of the inhaler has been blocked or obstructed.

12. The method of claim 9, further comprising measuring a positive change in pressure within the inhaler resulting from an exhalation into the mouthpiece, generating an exhalation event based on the positive change in pressure exceeding an exhalation threshold, and transmitting the exhalation inhalation event to the external device.

13. The method of claim 9, further comprising: starting a measurement cycle in response to movement of the mouthpiece cover from the closed position to the open position; generating a no inhalation event based on the airflow rate not exceeding the threshold during the measurement cycle, wherein the measurement cycle persists for a predetermined period of time or until the mouthpiece cover is moved from the open position to the closed position, whichever comes first; and transmitting the no inhalation event to the external device.

14. A system for detecting a usage condition of an inhaler for delivering medication, the system comprising: an inhaler comprising: a reservoir for storing the medication; a mouthpiece including a flow pathway through which a dose of the medication is configured to be delivered from the reservoir to a user; a mouthpiece cover configured to release a dose of the medication such that the dose is available to the flow pathway for user inhalation as the mouthpiece cover is moved to expose the mouthpiece; an air vent coupled to the flow pathway, wherein the air vent is configured to facilitate a flow of air from the exterior of the inhaler to the flow pathway; and an electronics module comprising a controller, a pressure sensor, and a communication circuit; wherein the pressure sensor is configured to measure a change in pressure within the inhaler resulting from an inhalation from the mouthpiece; and wherein the controller is configured to: receive pressure measurement data from the pressure sensor, determining an airflow rate through the flow pathway based on the pressure measurement data; generate an inhalation event based on the airflow rate exceeding a threshold; and generate a no inhalation error based on the airflow rate not exceeding the threshold for a predetermined period of time after the mouthpiece cover of the inhaler is moved to an open position or based on the airflow rate not exceeding the threshold until the mouthpiece cover is moved from the open position to a closed position; wherein the communication circuit is configured to transmit the inhalation event or the no inhalation event, and an airflow rate of the inhalation to an external device; and a software application residing on the external device, wherein the software application is configured to receive the inhalation event and the airflow rate data via a wireless interface of the external device, generate a good inhalation event when the airflow rate is between a lower and upper threshold, and generate an excessive inhalation event when the airflow rate is above the upper threshold, wherein the excessive inhalation event is indicative of the obstruction of the air vent of the inhaler.

15. The system of claim 14, wherein the pressure sensor is further configured to measure a change in pressure within the inhaler resulting from an exhalation into the mouthpiece, and the controller is configured to generate an exhalation event based the pressure measurement data indicating a positive change in pressure, and wherein the communication circuit is configured to transmit the exhalation event to the external device; wherein the software application is further configured to receive the 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 comprises a Quick Response (QR) code that comprises a communication passkey that is unique to the inhaler; wherein the software application is further configured to receive the communication passkey via the QR code to enable wireless communication between the inhaler and the external device.

17. The system of claim 14, wherein the controller is further configured to start a measurement cycle in response to movement of the mouthpiece cover of the inhaler from the closed position to the open position, and generate the no inhalation error event when the airflow rate does not exceed the lower threshold during the measurement cycle, wherein the measurement cycle persists for the predetermined period of time or until the mouthpiece cover is moved from the open position to the closed position, whichever comes first; wherein the communication circuit is configured to send the no inhalation event to the external device; and wherein the software application is configured to receive the no inhalation event 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 mouthpiece cover of the inhaler from the closed position to the open position to make a dose of the medication available to the flow pathway and expose the mouthpiece; and wherein the software application is further configured to determine a number of doses of the medication remaining in the reservoir based on a number of mouthpiece cover opening events received from the controller of the inhaler.

19. The system of claim 18, wherein the software application is further configured to determine the number of doses of the medication remaining in the reservoir based further on a number of inhalation events received from the controller of the inhaler.

20. The system of claim 18, wherein the software application is further configured to identify a refill event based on the number of mouthpiece cover opening events received from the controller of the inhaler.

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