Interactive respiratory device usage tracking system

• US 10,019,555 B2
• Filed: 10/20/2014
• Issued: 07/10/2018
• Est. Priority Date: 10/19/2013
• Status: Active Grant

• Current Assignee: AptarGroup Incorporated
• Original Assignee: Cohero Health, Inc. (AptarGroup Incorporated)
• Inventors: Manice, Melissa P., Manice, Charles D., Weinstein, Daniel W.
• Primary Examiner(s): Paulson, Sheetal R
• Application Number:
  US14/518,529
• Publication Number:
  US 20150112707A1
• Time in Patent Office: 1,359 Days
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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 2205/3569 sublocal, e.g. between console and disposable
• 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 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: G06Q 10/087 : Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G09B 19/00 : Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A monitoring system for inhalers includes a tracker module configured to be secured to a variety of inhalers, including both controller and rescue inhalers. The tracker module has a flexible shell that fastens around an inhaler and an activation sensor for sensing use of the inhaler, an internal memory for storing inhaler use data, and a communication component for forwarding the stored usage data to a processor for analyzing the data. The activation sensor is flexibly connected to the flexible shell with a flexible cable and is placed over the end of the inhaler canister. The processor is located in a local station separate from the tracker module but wirelessly synchronized therewith. In one embodiment, the system also collects lung function data, e.g., from a spirometer, and then processes all of the controller inhaler data, the rescue inhaler data, and the lung function data, to generate alerts and other messages.

Claims

1. A system for monitoring and facilitating use of a respiratory device by a patient, wherein the respiratory device comprises an inhaler having a body with an opening at the top into which is positioned a canister of respiratory medication, and a mouthpiece, the body and canister having complementary interactive configurations such that depressing the canister into the body causes the canister to deliver a treatment dose of the respiratory medication through the mouthpiece to be administered to the patient, the patient having a usage plan of the inhaler, the system comprising:

a tracking module comprising a flexible shell configured to be mounted around and in contact with the body of the inhaler, the flexible shell having embedded therein a tracking module memory, a tracking module battery, and a tracking module communication component, the flexible shell also comprising an inhaler activation sensor connected with the shell memory, the activation sensor comprising a pressure-activated switch located in a cap outside the shell connected to the shell with a flexible cable, the cap being located in contact with the canister at the top of the inhaler body such that a user must press the pressure-activated switch when depressing the inhaler canister for activation of the inhaler thereby causing the pressure-activated switch to provide an inhaler activation signal, and to store an inhaler activation signal in the tracking module memory each time the inhaler is activated in this way, the tracking module memory storing inhaler activation data relating to each detected activation of the inhaler as inhaler data, the communication component configured to wirelessly transmit the stored inhaler data; and

a processor located at a local station removed from the inhaler and tracking module mounted thereto, the processor storing the patient'"'"'s inhaler usage plan and configured to communicate with the communication component of the tracking module, receive the stored inhaler data from the tracking module memory, compare it to the inhaler usage plan, and interact with the patient by providing a statement of compliance of the patient with the usage plan.

2. The system according to claim 1, wherein the local station further comprises a display connected with the processor, wherein the processor determines from the stored inhaler data received from the tracking module memory the number of doses remaining in the canister of the inhaler and controls the display to visually display an indication of the number of doses remaining in the inhaler.

3. The system according to claim 2, wherein the processor is configured to determine from the received stored inhaler data from the tracking module memory the number of doses remaining in the canister of the inhaler, and is further configured to respond to that information to send a prescription refill request to a medication supplier.

4. A system in which the same patient is using a second respiratory device comprising a spirometer, the spirometer providing lung function data of the patient, the system according to claim 1, wherein the processor also receives the lung function data from the spirometer and correlates the lung function data with the inhaler data.

5. The system according to claim 4, wherein the processor is also configured to control the display to visually display lung function over time.

6. A system in which the same patient is also using a second respiratory device comprising a rescue inhaler, the rescue inhaler also having a body with an opening at the top into which is positioned a canister of rescue respiratory medication, and a mouthpiece, the body and canister having complementary interactive configurations such that depressing the canister into the body causes the canister to deliver a treatment dose of the rescue respiratory medication through the mouthpiece to be administered to the patient, the system according to claim 4, wherein one respiratory device is a controller medication inhaler and a second respiratory device is a rescue medication inhaler, and a third device is the spirometer;

the rescue inhaler providing a rescue inhaler activation signal each time the rescue inhaler is activated and wirelessly communicating each rescue inhaler activation signal;

wherein the processor is further configured to communicate with the spirometer, the controller inhaler, and the rescue inhaler to receive the lung function data, the rescue inhaler activation data, and the controller inhaler data, to correlate all data and to perform predictive analytics on lung function data, controller medication inhaler data, and rescue inhaler medication data, to predict potential future events and issues and transmit messages relevant to the predictions.

7. The system according to claim 6, wherein the predictions relate to at least one of potential exacerbation, potential complication, potential acute event, effectiveness of current usage plan, and potential change to said usage plan.

8. A system in which the same patient is using a second respiratory device comprising a rescue inhaler, the rescue inhaler also having a body with an opening at the top into which is positioned a canister of rescue respiratory medication, and a mouthpiece, the body and canister having complementary interactive configurations such that depressing the canister into the body causes the canister to deliver a treatment dose of the rescue respiratory medication through the mouthpiece to be administered to the patient, the system according to claim 1, wherein one respiratory device is a controller medication inhaler and a second respiratory device is a rescue medication inhaler;

the rescue inhaler providing a rescue inhaler activation signal each time the rescue inhaler is activated and wirelessly communicating each rescue inhaler activation signal;

wherein the processor is further configured to communicate with the rescue inhaler to receive the rescue inhaler activation signals and to correlate the rescue inhaler signals with the controller medication inhaler activation signals.

9. The system according to claim 1, wherein the local station further comprises a display connected with the processor, wherein the processor is configured to visually provide the statement of compliance with the usage plan on the display.

10. The system according to claim 9, wherein the processor is also configured to determine from the stored usage plan the next scheduled use of the inhaler and control the display to visually display the next scheduled use.

11. The system according to claim 9, wherein the processor of the local station is also configured to display a link for initiating an emergency communication.

12. The system according to claim 9, wherein the processor of the local station is also configured to display a link for a prescription refill, and is further configured to generate an e-prescription directly to a pharmacy.

13. The system according to claim 1, wherein the flexible shell is formed of a stretchable material whereby when it is secured to the outside of an inhaler, the flexible shell stretches to conform to a shape of the inhaler and its tendency to contract secures it to the inhaler, and its stretchable material permits it to be secured to inhalers of different sizes.

14. The system according to claim 1, further comprising a remote server in communication with the local station, wherein the remote server is configured to store a patient'"'"'s inhaler usage plan, receive the inhaler data from the processor of the local station, determine the patient'"'"'s compliance with the usage plan, and make the determination available to those having authorization to access the server.

15. The system according to claim 14, wherein the remote server is also configured to generate communications, including alerts, regarding the patient'"'"'s compliance with the usage plan to a third party selected from the group comprising a healthcare professional, a family member, an insurance carrier, and a caregiver.

16. The system according to claim 14, wherein the remote server is also configured to generate communications that include lung function data and medication usage plan compliance data to send to an Electronic Medical Records system of a physician.

17. The system according to claim 1, wherein said local station comprises a smartphone.

18. The system according to claim 1, wherein at least one of the tracking module and the local station is configured to issue an alert to the patient if the respiratory device is not used according to the usage plan.

19. The system according to claim 1, wherein said tracking module is configured to respond to detected pressure on the pressure-activated switch of the flexible shell during depressing of said canister by:

awakening from a standby mode;

storing inhaler activation signals in the tracking module memory;

searching for proximity to the local station, and transmitting stored inhaler activation data to the local station when the local station is found; and

returning to standby mode after transmission of the stored inhaler activation data to the local station.

20. The system according to claim 1 wherein the processor of the local station is further configured to provide reminders to the patient according to the usage plan, the frequency of the reminders being dependent on at least one of patient behavior and patient preference.

21. The system according to claim 20 wherein the processor is further configured to decrease the frequency of the reminders in response to increased patient compliance with the usage plan.

22. The system according to claim 1, wherein the tracking module is configured to:

operate in an off/standby mode to conserve life of the battery;

automatically awaken to store a date/time stamp when the pressure-activated switch detects pressure on the canister when depressing the canister;

thereafter attempt to connect with the local station processor to transfer the date/time stamp data;

but

if unsuccessful in connecting with the processor, will continue trying at intervals to connect with the processor until successful;

whereby the local station processor need not be in proximity when an inhaler dose is taken.

23. A system for monitoring and facilitating use of a respiratory device by a patient, wherein the respiratory device comprises an inhaler having a body with an opening at the top into which is positioned a canister of respiratory medication, and a mouthpiece, the body and canister having complementary interactive configurations such that depressing the canister into the body causes the canister to deliver a treatment dose of the respiratory medication through the mouthpiece to be administered to the patient, the patient having a usage plan of the inhaler, the system comprising:

a tracking module comprising a flexible shell configured to be mounted around and in contact with the body of the inhaler, the flexible shell having embedded therein a tracking module memory, a tracking module battery, and a tracking module communication component, the flexible shell also comprising an inhaler activation sensor connected with the shell memory, the activation sensor comprising a pressure-activated switch located in a cap outside the shell connected with the shell, the cap being located in contact with the canister at the top of the inhaler body such that a user must press the pressure-activated switch when depressing the canister for activation of the inhaler thereby causing the pressure-activated switch to provide an inhaler activation signal, and to store the inhaler activation signal in the tracking module memory each time the inhaler is activated in this way, the tracking module memory storing activation data relating to each detected activation of the inhaler as inhaler data, the communication component configured to wirelessly transmit the stored inhaler data;

a processor located at a handheld local station removed from the inhaler and tracking module mounted thereto, the processor storing the patient'"'"'s inhaler usage plan and configured to communicate with the communication component of the tracking module, receive the stored inhaler data from the tracking module memory, compare it to the inhaler usage plan, and interact with the patient by providing a statement of compliance of the patient with the usage plan;

a display connected with the processor, wherein the processor determines from the stored inhaler data received from the tracking module memory the number of doses remaining in the canister of the inhaler and controls the display to visually display an indication of the number of doses remaining in the inhaler, the processor also being configured to control the display to display the statement of compliance with the usage plan on the display; and

a remote server in communication with the local station, wherein the remote server is configured to store a patient'"'"'s inhaler usage plan, receive the inhaler data from the processor of the local station, determine the patient'"'"'s compliance with the usage plan, and make the compliance determination available to those having authorization to access the server;

wherein at least one of the tracking module, the local station, and the remote server is configured to issue an alert to the patient if the inhaler is not used according to the usage plan.

24. The system for monitoring and facilitating use of a respiratory device by a patient in which the same patient is using a second respiratory device comprising a spirometer, the spirometer providing lung function data of the patient, the system, according to claim 23, wherein the processor also receives the lung function data from the spirometer and correlates the lung function data with the inhaler data.

25. The system for monitoring and facilitating use of a respiratory device by a patient according to claim 23, wherein the processor is also configured to control the display to visually display lung function over time.

26. A system in which the same patient is using a second respiratory device comprising a rescue inhaler, the rescue inhaler also having a body with an opening at the top into which is positioned a canister of rescue respiratory medication, and a mouthpiece, the body and canister having complementary interactive designs such that depressing the canister into the body causes the canister to provide a treatment dose of the rescue respiratory medication through the mouthpiece to be administered to the patient, the system according to claim 25, wherein one respiratory device is a controller medication inhaler and a second respiratory device is a rescue medication inhaler, the rescue inhaler providing a rescue inhaler activation signal each time the rescue inhaler is activated and wirelessly communicating each rescue inhaler activation signal, wherein the processor is further configured to communicate with the rescue inhaler to receive the rescue inhaler activation signals and to correlate the rescue inhaler signals with the controller medication inhaler activation signals.

27. A system for monitoring and facilitating use of respiratory devices by a patient, wherein the respiratory devices comprise a controller inhaler and a rescue inhaler, each of which has a body with an opening at the top into which is positioned a canister of respiratory medication, and a mouthpiece, the body and canister having a complementary interactive configuration such that depressing the canister into the body causes the canister to provide a treatment dose of the respiratory medication through the mouthpiece to be administered to the patient, the patient having a usage plan for the controller inhaler, the system comprising:

a separate tracking module attached to each of the controller and rescue inhalers, each tracking module comprising a flexible shell configured to be secured around and in contact with the body of the inhaler, the flexible shell having embedded therein a tracking module memory, a tracking module battery, and a tracking module communication component, the flexible shell also comprising an inhaler activation sensor connected with the shell memory, the activation sensor comprising a pressure-activated switch located in a cap outside the shell connected to the shell with a flexible cable, the cap being located in contact with the canister at the top of the inhaler body such that a user must press the pressure-activated switch when depressing the inhaler canister for activation of the inhaler thereby causing the pressure-activated switch to provide an inhaler activation signal, and to store an inhaler activation signal in the tracking module memory each time the inhaler is activated in this way, the tracking module memory storing inhaler activation data relating to each detected activation of the inhaler as inhaler data, the communication component configured to wirelessly transmit the stored inhaler data;

wherein each of the tracking modules attached to the controller and the rescue inhaler is configured to;

operate in an off/standby mode to conserve life of the battery;

automatically awaken to store a date/time stamp when inhaler is used;

thereafter attempt to connect with the local station processor to transfer the date/time stamp data;

but

if unsuccessful in connecting with the processor, will continue trying at intervals to connect with the processor until successful;

whereby the local station processor need not be in proximity when an inhaler dose is taken;

a spirometer configured to sense the lung function of a patient and provide lung function data representative thereof;

a processor located at a handheld local station removed from the inhalers and tracking modules mounted thereto, the processor storing the patient'"'"'s controller inhaler usage plan and configured to communicate with the communication component of each of the tracking modules, receive the stored inhaler data from each tracking module memory, compare it to the usage plan, and interact with the patient by providing a statement of compliance of the patient with the inhaler usage plan, the processor also configured to receive the lung function data from the spirometer and correlate the lung function data with the inhaler data;

a display connected with the processor, wherein the processor determines from the stored data of the inhalers received from the tracking modules'"'"' memories the number of doses remaining in the canister of each of the inhalers and controls the display to visually display an indication of the number of doses remaining in the inhalers, the processor also configured to control the display to visually display lung function over time; and

a remote server connected with the local station, wherein the remote server is configured to receive a patient'"'"'s inhaler usage plan, receive the inhaler data from the processor of the local station, determine the patient'"'"'s compliance with the usage plan, and make the determination available to those having authorization to access the server;

wherein at least one of the tracking modules, the local station, and the server is configured to issue an alert to the patient if the controller respiratory device is not used according to the usage plan.