Systems, devices and methods for assessing inhalation therapy

Patent metadata

Field	Value
Publication number	US-11244748-B2
Application number	US-201716093886-A
Country	US
Kind code	B2
Filing date	Apr 14, 2017
Priority date	Apr 14, 2016
Publication date	Feb 8, 2022
Grant date	Feb 8, 2022

Abstract

Features for assessing patient compliance with therapeutic usage of an inhaler, such as a nebulizer, are disclosed. Nebulizer therapy accessories include mouthpiece, mask and adaptor (i.e. an attachment to a mouthpiece or mask) that may be coupled with the nebulizer. The nebulizer therapy accessory includes at least one sensor that detects a physical parameter generated by a user's body and generates a signal. The signal is used to determine therapy compliance, which may be communicated to the patient and/or the patient's physician.

First claim

The invention claimed is:

1. A method for assisting a user to comply with a nebulizer therapy treatment, the method comprising:
determining, by a nebulizer therapy accessory, a start timestamp indicating a time at which a signal from a sensor configured to indicate a physical parameter generated by a body of the user has reached a threshold value, wherein the nebulizer therapy accessory is at least one of a mouthpiece, an adaptor, or a mask;
recording the start timestamp as a start of a treatment duration;
starting, by the nebulizer therapy accessory, a treatment timer at the start timestamp;
determining a stop timestamp, wherein the determining the stop timestamp comprises:
determining that the signal has not exceeded the threshold value for a first time period;
determining that the first time period exceeded a timeout value; and

recording the stop timestamp as an end of the treatment duration, wherein the stop timestamp indicates a time at which the signal reached the threshold value prior to an end of the first time period;
determining a pause in treatment, wherein the determining the pause in treatment comprises:
determining that a time period between successive threshold crossings of the signal is greater than a pause timeout value and less than the timeout value, wherein the pause timeout value is less than the time out value; and
recording the time period as a pause duration;

calculating an actual treatment duration by subtracting the start timestamp from the stop timestamp to provide the treatment duration and subtracting the pause duration from the treatment duration to provide the actual treatment duration; and
transmitting, by the nebulizer therapy accessory, the actual treatment duration to a relay communication device to determine a compliance score.

2. The method of claim 1 , wherein the timeout value is greater than 1 minute.

3. The method of claim 1 , further comprising:
determining, by the relay communication device communicatively coupled to the nebulizer therapy accessory, the compliance score for the nebulizer therapy treatment, wherein determining the compliance score comprises comparing the actual treatment duration to an expected treatment duration, wherein the expected treatment duration is predetermined based on a treatment characteristic regarding a nebulizer; and
transmitting, by the relay communication device, an alert including the compliance score to a user device via a communication network.

4. The method of claim 1 , wherein the pause timeout value is greater than 15 seconds.

5. The method of claim 1 , wherein the pause timeout value is greater than 30 seconds.

6. The method of claim 1 , wherein the nebulizer therapy accessory is the mouthpiece.

7. The method of claim 1 , wherein the nebulizer therapy accessory is the adaptor.

8. The method of claim 1 , wherein the nebulizer therapy accessory is the mask.

9. The method of claim 1 , wherein the physical parameter is selected from the group consisting of a temperature of a fluid, a humidity of a fluid, a pressure, a volumetric flow rate, a volume of a fluid, a proximity of the user's body to the nebulizer therapy accessory, a carbon dioxide concentration of a fluid, and a pressure of a fluid.

10. The method of claim 1 , wherein the sensor is a temperature sensor, and wherein the physical parameter is a change in temperature of a fluid flowing through the nebulizer therapy accessory.

11. The method of claim 1 , wherein the sensor is a humidity sensor, and wherein the physical parameter is a change in humidity of a fluid flowing through the nebulizer therapy accessory.

12. The method of claim 1 , wherein the sensor is a mass airflow sensor, and wherein the physical parameter is a change in volume of a fluid flowing through the nebulizer therapy accessory.

13. The method of claim 1 , wherein the sensor is a capacitive touch sensor, and wherein the physical parameter is a change in proximity of the user's body to the nebulizer therapy accessory.

14. The method of claim 1 , wherein the sensor is a carbon dioxide sensor, and wherein the physical parameter is a change in carbon dioxide concentration of a fluid flowing through the nebulizer therapy accessory.

15. The method of claim 1 , wherein the sensor is a pressure sensor, and wherein the physical parameter is a change in pressure of a fluid flowing through the nebulizer therapy accessory.

16. The method of claim 1 , wherein the sensor is a first sensor, the physical parameter is a first physical parameter, and the threshold value is a first threshold value, and wherein the start timestamp further indicates a time at which a signal from a second sensor configured to indicate a second physical parameter generated by the user's body has reached a second threshold value.

17. The method of claim 1 , wherein the transmitting, by the nebulizer therapy accessory, the actual treatment duration to the relay communication device to determine the compliance score comprises:
transmitting, by the nebulizer therapy accessory and via a near field communication protocol (NFC), the actual treatment duration to the relay communication device to determine the compliance score.

18. A system for nebulizer therapy treatment, the system comprising:
a sensor configured to detect a physical parameter generated by a user's body and generate a signal indicative of the physical parameter;
a nebulizer therapy accessory comprising at least one of a mouthpiece, an adaptor or a mask, the nebulizer therapy accessory configured to:
determine a start timestamp indicating a time at which the signal from the sensor has reached a threshold value;
record the start timestamp as a start of a treatment duration;
start a treatment timer at the start timestamp:
determine a stop timestamp based on a first time period exceeding a timeout value, over which the signal has not exceeded the threshold value;
record the stop timestamp as an end of the treatment duration;
determine a pause in treatment, wherein when determining the pause in treatment, the nebulizer therapy accessory is configured to:
determine that a time period between successive threshold crossings of the signal is greater than a pause timeout value and less than the timeout value, wherein the pause timeout value is less than the time out value; and
record the time period as a pause duration;

calculate an actual treatment duration by subtracting the start timestamp from the stop timestamp to provide the treatment duration and subtracting the pause duration from the treatment duration to provide the actual treatment duration; and
transmit the actual treatment duration to a relay communication device, based on calculating the treatment duration, to determine a compliance score.

19. The system of claim 18 , wherein the physical parameter is selected from the group consisting of a temperature of a fluid, a humidity of a fluid, a pressure, a volumetric flow rate, a volume of a fluid, a proximity of the user's body to the nebulizer therapy accessory, a carbon dioxide concentration of a fluid, and a pressure of a fluid.

20. A non-transitory computer-readable medium comprising program code, which when executed by a processor of a nebulizer therapy accessory comprising at least one of a mouthpiece, an adaptor or a mask, is configured to cause the processor to:
determine a start timestamp indicating a time at which a signal from a sensor configured to indicate a physical parameter generated by a user's body has reached a threshold value;
record the

Assignees

• Mylan Inc

Inventors

• Starr Eric W
• Knewtson Molly

Classifications

• A61B5/087

  Measuring breath flow · CPC title

• A61M16/0833

  T- or Y-type connectors, e.g. Y-piece · CPC title

• A61M2205/3584

  using modem, internet or Bluetooth® · CPC title

• A61M2205/3592

  using telemetric means, e.g. radio or optical transmission · CPC title

• G16H40/67

  for remote operation · CPC title