Device and method to monitor, track, map, and analyze usage of metered-dose inhalers in real-time

• US 20090194104A1
• Filed: 01/05/2009
• Published: 08/06/2009
• Est. Priority Date: 02/01/2008
• Status: Active Grant

• Current Assignee: Reciprocal Labs Corporation (ResMed Incorporated)
• Original Assignee: Reciprocal Labs Corporation (ResMed Incorporated)
• Inventors: Van Sickle, John David
• Granted Patent: US 9,550,031 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• 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

Abstract

A system and method for accurately and reliably determining and recording the time, date and location where a medication is used, and a system and method for transmitting, collecting, and using that data to improve clinical care, disease management, and public health surveillance. The device allows information concerning drug usage, including the time, date and location of use, to be transmitted to a remote network computer system so that the data can be evaluated to determine current impairment and future risk, and to identify changes in the frequency, timing, or location of medication usage indicative of change in disease control or management, and to examine spatial, temporal or demographic patterns of medication use or absence of use among individuals and groups. In addition, the device may further be configured to transmit signals indicative of its status, condition or other results to the remote network computer system.

Claims

1. A device for reliably determining and recording and transmitting the time, date, and location where a metered dose inhaler is used comprising:

a medicament dispensing container comprising;

an inhaler housing;

a medication canister within the inhaler housing; and

a medicament device coupled to the medicament dispenser comprising;

a cap or collar,

a communication device;

supporting electronics;

a power supply; and

an actuation switch detector.

2. The device of claim 1 further comprising, a global positioning system receiver.

3. The device of claim 1 wherein, the medicament device is mechanically coupled to the medicament dispenser containing the medication canister by a mechanical mechanism including grip mechanisms, snap-fit mechanisms, one or more straps, one or more clamps, and an adhesive fixing.

4. The device of claim 3 wherein, the medicament device forms a snap-fit module that is received or is receivable by the medicament dispenser'"'"'s housing, or may be mounted on the top of the medication canister by mechanical means.

5. The device of claim 1 wherein,

a cap or collar is mounted to the medicament dispensing container with an integrated miniature magnet, to the top of the medication canister;

a magnetic field sensor is then housed within or on the stationary inhaler body of the medicament device;

when actuated, the inhaler canister is depressed, and the magnet is carried toward the magnetic sensor; and

when the magnet is brought in proximity to the magnetic sensor, the sensor acts as a magnetically actuated switch causing a voltage output change in the sensor, which is recorded.

6. The device of claim 5 further comprising a bounce filter circuit element.

7. The device of claim 3 wherein,

the device is entirely contained in a package mounted on the end of the medication canister;

and

a mechanical switch integrated into the package monitors the dispensing of the medication and is mechanically or electrically actuated when the medication canister is depressed.

8. The device of claim 3 wherein, the switch mechanisms are integrated into a cap mounted onto the medication container and connected by leads to the medicament device, which is attached to the side of the medication housing.

9. The device of claim 3 wherein,

a small tag or label containing a pattern is attached or fixed top the medication canister;

an optical sensor on the medicament device monitors the tag or label on the canister; and

each time the medication canister is depressed, the optical sensor image of the pattern is disrupted, and actuation of the inhalation device is signaled to a controller.

10. The device of claim 3 wherein,

the switch is integrated into the medicament device itself, with a contact lever extending out the back of the device packaging into the area above the top of the inhaler housing;

when the medication canister is depressed, a cap mounted to the top of the medication canister contacts the switch and an actuation is detected.

11. The device of claim 3 wherein, electrical contacts integrated into a cap mounted on the end of the medication canister meet corresponding ones on the device when the canister is depressed, closing a circuit.

12. The device of claim 3 wherein,

a lever or other element extends into the housing, and is positioned for movement each time the medication canister is pushed downwards;

and

movement of the lever actuates a micro-switch on the controller indicating that the inhaler has been actuated.

13. The device of claim 3 wherein,

a mechanical switch is integrated into a cap or collar that is mounted onto the top of the medication canister.

14. The device of claim 13 wherein, the switch consists of a spring-loaded lever that is mechanically depressed by the body of the medicament device, the inhaler housing, or a collar around the housing by the downward movement of the canister when it is actuated.

15. The device of claim 13 wherein, the switch consists of a momentary push button switch surrounded by a spring and discs which actuates when the cap and canister are depressed, compressing the discs and spring and closing the switch circuit signaling actuation of the inhaler;

and

the tension of the spring is set to preclude accidental actuation of the switch circuit, when no actuation of the inhaler occurs or is intended.

16. The device of claim 3 wherein,

a thermistor is used to measure the change in the temperature of the pressurized medication canister resulting from the expulsion of medication and propellant,

and detection of any change in the temperature of the medication canister signifying actuation of the inhaler is signaled to the controller.

17. The device of claim 1 wherein, the support electronics arranged on the medicament device comprises:

a microprocessor and memory for storage of information related to the medication events;

the memory comprises a non-volatile memory chip that is capable of storing the information; and

light elements consisting of one or more diodes; and

speakers.

18. The device of claim 1 further comprising:

a communication device for wireless communication with a terminal device, wireless communication network, or a remote network computer system to enable transfer of data to and from the medicament device to a remote network computer system, is arranged in the medicament device; and

the terminal device, wireless communication network, and the remote network computer system can, in addition to receiving information from the communication device, transfer information to the communication device.

19. A method for reliably determining and recording and transmitting the time, date, and location where a metered dose inhaler is used comprising the steps of:

a. observing a medication event by a medicament device through means for obtaining information related to the medication;

b. monitoring the dispensing of medication in order to register events, or the absence of events, related to the dispensing of the medication;

c. determining the geographic location where the medication was used;

d. storing information related to a medication event or events in a memory of the medicament device;

e. transferring information related to a medication event or events to a network computer system either directly or via a wireless communication network, or a terminal device; and

f. confirming receipt of information by the terminal device, wireless communication network or remote network computer system, and sending a receipt notification to the medicament device.

20. The method of claim 19 further comprising the steps of:

g. monitoring a communication port on a terminal device to determine when a message was received from the communication device in the medicament;

h. generating, upon receiving a message on the terminal device, a time stamp, and process the information by the processing means of the terminal device;

i. the processing means of the terminal device determines the location of the terminal device at the time of receipt of medication event information using the available means;

j. formatting the time and location information into a message and preparing it for transmission;

k. connecting the terminal device to a network computer system via a wireless communication system for two-way transfer of data between the terminal device and a network computer system;

l. determining the optimum means for transmitting information to the network computer system and establishing any and all necessary connections;

m. creating a connection between the terminal device and the network computer system; and

n. transmitting information about the medication event from the terminal device to the network computer system.

21. The method of claim 19 wherein,

the terminal device is a cellular phone or other mobile electronic device;

and

the terminal device contains a global positioning system (GPS) receiver and processor, which relies on the use of multiple communications signals and a triangulation algorithm.

22. The method of claim 19 or 20 further comprising the steps of:

o. receiving the medication event information by a network computer server;

p. triggering a variety of applications on a remote computer system or server;

q. performing an initial set of application functions including checking the validity of the incoming data, passing the verified data to the relevant database(s), and confirming that the database(s) have been updated;

r. automatically executing programs to prepare, read, analyze, and display accumulated data on medication events;

s. providing a control application to execute an input formatting application as necessary, which reads relevant data from the accumulated database and outputs files necessary for subsequent statistical analyses;

t. executing a statistical analysis by the control program application as necessary, which reads the relevant files and performs statistical analysis in accordance with user established parameters, and outputs or writes the results into one or more separate files;

u. executing an output formatting application by the control program to reformat the statistical results output files into new files to be read by applications that display the accumulated information and otherwise make the data available to authorized users; and

v. selecting the appropriate test statistics or analytical methods and process the incoming and accumulated data to identify events of interest.