Compliance monitoring module for a breath-actuated inhaler

• US 9,782,551 B2
• Filed: 05/16/2016
• Issued: 10/10/2017
• Est. Priority Date: 08/28/2014
• Status: Active Grant

• Current Assignee: Norton Healthcare Incorporated
• Original Assignee: Norton Healthcare Incorporated, MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Morrison, Mark Steven, Weitzel, Douglas E., Calderon Oliveras, Enrique, Buck, Daniel
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US15/155,808
• Publication Number:
  US 20160325057A1
• 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 mouthpiece comprising a flow channel through which a user can inhale a dose of medicament;

a monitoring module comprising a processor, a pressure sensor, and a wireless transmitter, wherein the pressure sensor is pneumatically coupled to the flow channel;

a reservoir for storing the dose of medicament, wherein the reservoir is linearly arranged between at least a portion of the mouthpiece and the pressure sensor; and

a mouthpiece cover, wherein the monitoring module is configured to change from a first state associated with a first power consumption to a second state associated with a second power consumption when the mouthpiece cover is moved to expose the mouthpiece, and

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

2. The inhaler of claim 1, wherein the monitoring module is adapted to measure a pressure within the inhaler during an inhalation through the flow channel and to determine a flow rate associated with the inhalation based on the measured pressure.

3. The inhaler of claim 1, 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 state is an off state or a sleep state, and the second state is an on state.

5. The inhaler of claim 1, wherein the dose of medicament is made available to the flow channel when the mouthpiece cover is moved to expose the mouthpiece.

6. The inhaler of claim 1, wherein the monitoring module further comprises a light emitting diode (LED), and

wherein the processor is configured to activate the LED upon the monitoring module changing from the first state to the second state.

7. The inhaler of claim 1, wherein the processor is configured to generate a time stamp when the mouthpiece cover is moved to expose the mouthpiece.

8. The inhaler of claim 7, wherein the wireless transmitter is configured to transmit the time stamp to a user device, the user device comprising at least one of a smartphone, a tablet, a laptop, or a desktop computer.

9. The inhaler of claim 1, further comprising:

a switch; and

a yoke connected to the mouthpiece cover, wherein the yoke is configured to actuate the switch when the mouthpiece cover is moved to expose the mouthpiece, and the actuation of the switch changes the monitoring module from the first state to the second state.

10. The inhaler of claim 1, further comprising:

a bellows;

a spring; and

a switch, wherein, when the mouthpiece cover is moved to expose the mouthpiece, the bellows and the spring are configured to move in a direction away from the switch, and

wherein the actuation of the switch causes the monitoring module to change from the first state to the second state.

11. 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).

12. The inhaler of claim 1, wherein the pressure sensor is disposed at a top portion of the inhaler and the mouthpiece is disposed at a bottom portion of the inhaler.

13. The inhaler of claim 1, wherein the pressure sensor is positioned external to the flow channel, and the pressure sensor is pneumatically coupled to the flow channel via an opening in a wall of the flow channel.

14. The inhaler of claim 1, wherein the second power consumption is greater than the first power consumption.

15. The inhaler of claim 1, wherein the reservoir is arranged entirely between the mouthpiece and the pressure sensor.

16. The inhaler of claim 1, wherein the monitoring module is configured to determine a plurality of pressure measurements associated with an inhalation through the flow channel of the mouthpiece.

17. The inhaler of claim 16, wherein the monitoring module is configured to determine a peak flow rate from the plurality of pressure measurements.

18. The inhaler of claim 16, wherein the monitoring module is configured to determine an inhalation duration based on the plurality of pressure measurements.

19. The inhaler of claim 16, wherein the monitoring module is configured to determine an inhalation volume by integrating a plurality of flow rates associated with the plurality of pressure measurements.

20. 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 the monitoring module changing from the first state to the second state;

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.

21. The inhaler of claim 20, wherein the wireless transmitter is configured to transmit the dosing information to a user device, the user device comprising at least one of a smartphone, a tablet, a laptop, or a desktop computer.

22. The inhaler of claim 6, wherein the processor is configured to change a color of the LED or flash the LED.

23. An inhaler comprising:

a switch;

a mouthpiece cover;

a mouthpiece comprising a flow channel through which a user can inhale a dose of medicament;

a monitoring module comprising a processor, a pressure sensor, and a wireless transmitter, wherein the pressure sensor is pneumatically coupled to the flow channel;

a reservoir for storing the dose of medicament, wherein the reservoir is linearly arranged between at least a portion of the mouthpiece and the pressure sensor; and

a yoke connected to the mouthpiece cover, wherein the yoke is configured to actuate the switch when the mouthpiece cover is moved to expose the mouthpiece, and the actuation of the switch changes the monitoring module from a first state to a second state.

24. An inhaler comprising:

a mouthpiece comprising a flow channel through which a user can inhale a dose of medicament;

a mouthpiece cover;

a bellows;

a spring;

a monitoring module comprising a processor, a pressure sensor, and a wireless transmitter, wherein the pressure sensor is pneumatically coupled to the flow channel;

a reservoir for storing the dose of medicament, wherein the reservoir is linearly arranged between at least a portion of the mouthpiece and the pressure sensor; and

a switch, wherein, when the mouthpiece cover is moved to expose the mouthpiece, the bellows and the spring are configured to move in a direction away from the switch; and

wherein the actuation of the switch causes the monitoring module to change from a first state to a second state.