Compliance monitoring module for a breath-actuated inhaler

• US 9,782,550 B2
• Filed: 05/16/2016
• Issued: 10/10/2017
• Est. Priority Date: 08/28/2014
• Status: Active Grant

• Current Assignee: Norton (Waterford) Limited (Teva Pharmaceutical Industries Limited)
• Original Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited), Norton (Waterford) Limited (Teva Pharmaceutical Industries Limited)
• Inventors: Morrison, Mark Steven, Weitzel, Douglas E., Calderon Oliveras, Enrique, Buck, Daniel
• Primary Examiner(s): Ho, Tan-Uyen (Jackie) T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US15/155,400
• Publication Number:
  US 20160339190A1
• Time in Patent Office: 512 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0026 Hinged caps
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0071 having a display or indicator
• CPC Class Codes: A61M 15/0078 on a strip
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3358 : Measuring barometric pressure, e.g. for compensation
• CPC Class Codes: A61M 2205/3372 : Temperature compensation
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/58 : Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/587 : Lighting arrangements
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2205/8212 : with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2206/16 : Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/63 : for local operation

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.

Claims

1. An inhaler comprising:

a hopper comprising medicament;

a dosing chamber;

a mouthpiece;

a cover;

a monitoring module comprising a sensor, a wireless transmitter, and a processor; and

a bellows, wherein the bellows is configured to compress upon movement of the cover to expose the mouthpiece, and wherein the compression of the bellows causes;

a dose of the medicament to be metered from the hopper into the dosing chamber; and

the monitoring module to change from a first power state to a second power state.

2. The inhaler of claim 1, wherein the sensor comprises a pressure sensor.

3. The inhaler of claim 2, wherein the pressure sensor comprises a microelectromechanical system (MEMS) pressure sensor or a nanoelectromechanical system (NEMS) pressure sensor.

4. The inhaler of claim 1, wherein the first power state is associated with a first power consumption and the second power state is associated with a second power consumption;

wherein the first power consumption is different than the second power consumption.

5. The inhaler of claim 1, wherein the first power state is an off state or a sleep state, and the second power state is an on state.

6. The inhaler of claim 1, further comprising a yoke connected to the cover, wherein the yoke is configured to activate the sensor when the cover is moved to expose the mouthpiece, and

wherein the activation of the sensor changes the monitoring module from the first power state to the second power state.

7. The inhaler of claim 1, further comprising a spring, wherein, when the cover is moved to expose the mouthpiece, the bellows and the spring are configured to move in a direction away from the sensor,

wherein movement of the spring and bellows actuates the sensor to change the monitoring module from the first power state to the second power state.

8. The inhaler of claim 1, wherein, when the cover is moved to expose the mouthpiece, the processor is configured to provide an indication to a user that the inhaler is primed.

9. The inhaler of claim 1, wherein the wireless transmitter comprises at least one of a Bluetooth Low Energy (BLE) integrated circuit or a BLE system on chip (SoC).

10. The inhaler of claim 1, further comprising a light emitting diode (LED), wherein the processor is configured to activate the LED upon the monitoring module changing from the first power state to the second power state.

11. The inhaler of claim 1, wherein the sensor is positioned distal to the mouthpiece.

12. The inhaler of claim 1, wherein the sensor is configured to measure a pressure within the monitoring module during an inhalation through a flow channel of the mouthpiece, and

wherein the processor is configured to determine a flow rate associated with the inhalation through the flow channel based on the measured pressure.

13. The inhaler of claim 1, wherein the mouthpiece defines at least a portion of a flow channel.

14. The inhaler of claim 13, wherein movement of the cover further causes the dose of the medicament to be made available to the flow channel.

15. The inhaler of claim 4, wherein the second power consumption is greater than the first power consumption.

16. The inhaler of claim 1, wherein the sensor comprises a switch.

17. The inhaler of claim 1, wherein the sensor is configured to generate a plurality of pressure measurements during an inhalation through a flow channel of the mouthpiece.

18. The inhaler of claim 17, wherein the processor is configured to determine a peak flow rate associated with the inhalation from one or more of the plurality of pressure measurements.

19. The inhaler of claim 17, wherein the processor is configured to determine a duration associated with the inhalation based on the plurality of pressure measurements.

20. The inhaler of claim 17, wherein the processor is configured to determine a volume associated with the inhalation by integrating a plurality of flow rates associated with the plurality of pressure measurements.

21. The inhaler of claim 1, wherein the monitoring module is configured to generate dosing information, the dosing information comprising at least one of:

a time associated with an actuation of the sensor;

a time associated with a successful administering of the dose of the medicament;

a pressure measurement;

an inhalation flow rate;

a peak inhalation flow rate;

an inhalation duration;

or

an inhaled volume.

22. The inhaler of claim 21, wherein the wireless transmitter is configured to transmit the dosing information to a user device, the user device comprising a smartphone, a tablet, a laptop, or a desktop computer.

23. A method of administering a dose of medicament from an inhaler having a bellows, a mouthpiece cover, a hopper, and a monitoring monitor comprising a sensor, a wireless transmitter, and a processor, the method comprising:

compressing the bellows based on a movement of the mouthpiece cover;

changing the monitoring module from a first power state to a second power state based on the compression of the bellows; and

metering the dose of medicament from the hopper based on the compression of the bellows.

24. The method of claim 23, wherein the first power state is an off state or a sleep state, and the second power state is an on state.

25. The method of claim 23, wherein the first power state is associated with a first power consumption and the second power state is associated with a second power consumption that is different than the first power consumption.

26. The method of claim 23, further comprising activating a sensor within the monitoring module during the second power state.

27. The method of claim 23, further comprising moving a yoke connected to the mouthpiece cover to activate a sensor within the monitoring module,

wherein the activation of the sensor causes the monitoring module to change from the first power state to the second power state.

28. The method of claim 23, further comprising sensing a pressure within a housing of the inhaler as the dose of medicament is inhaled from a mouthpiece.

29. The method of claim 23, further comprising generating a plurality of pressure measurements during an inhalation through a flow channel of a mouthpiece of the inhaler.

30. The method of claim 29, further comprising determining a peak flow rate associated with the inhalation from one or more of the plurality of pressure measurements.

31. The method of claim 29, further comprising determining a duration associated with the inhalation based on the plurality of pressure measurements.

32. The method of claim 29, further comprising determining a volume associated with the inhalation by integrating a plurality of flow rates associated with the plurality of pressure measurements.

33. The method of claim 23, further comprising generating dosing information via the monitoring module, the dosing information comprising at least one of:

a time associated with an actuation of the sensor;

a time associated with a successful administering of the dose of medicament;

a pressure measurement;

an inhalation flow rate;

a peak inhalation flow rate;

an inhalation duration;

or

an inhaled volume.

34. The method of claim 33, further comprising transmitting the dosing information to a user device, the user device comprising a smartphone, a tablet, a laptop, or a desktop computer.

35. The method of claim 23, further comprising illuminating an indicator when the mouthpiece cover is moved to expose a mouthpiece of the inhaler.

36. The method of claim 35, wherein the indicator signals that the dose of medicament is available to a flow channel of a mouthpiece.