IP Library › Granted Patent US 9,782,551
Granted Patent B2
US 9,782,551 · App. 15/155,808 · Granted Oct 10, 2017

Compliance monitoring module for a breath-actuated inhaler

Inventors: Mark Steven Morrison (Basking Ridge, NJ); Douglas E. Weitzel (Hamilton, NJ); Enrique Calderon Oliveras (Waterford, IE); Daniel Buck (Waterford, IE)
Assignees: MicroDose Therapeutx, Inc.; Norton (Waterford) Limited
A61M15/0065A61M15/008A61M15/009A61M15/0026A61M15/0091A61M15/00A61M2205/3331A61M2205/3576A61M2205/3584A61M2205/50A61M2205/58A61M2205/583A61M2205/584A61M2205/587A61M2209/088
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Quick Facts
Patent No.
US 9,782,551
App. No.
15/155,808
Granted
Oct 10, 2017
Kind
B2
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 (57)

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.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2018
From: MICRODOSE THERAPEUTX, INC.
To: NORTON (WATERFORD) LIMITED
Reel/Frame 044665/0902 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2017
From: MORRISON, MARK STEVEN; WEITZEL, DOUGLAS E.
To: MICRODOSE THERAPEUTX, INC.
Reel/Frame 043335/0863 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2017
From: CALDERON OLIVERAS, ENRIQUE; BUCK, DANIEL
To: NORTON (WATERFORD) LIMITED
Reel/Frame 043335/0982 →
Continuity (4)
Continuation 15155400 · May 16, 2016
Continuation PCTUS2015047366 · Aug 28, 2015
Provisional Application 62043120 · Aug 28, 2014
Related Publication 20160325057A1 · Nov 10, 2016