Compliance monitoring for inhalers

Abstract

Devices and methods are disclosed for monitoring a patient's compliance with an inhaler treatment regimen. The device may monitor an inhaler's motion to determine whether the motion is characteristic of typical inhaler use. Additionally, the device may monitor a temperature of the inhaler or in proximity to the mouthpiece to determine whether a patient has used the inhaler. The devices and methods may incorporate a smart phone application that provides notifications and alerts to aid in compliance with the medication regimen.

What is claimed is: 
     
         1 . A monitor system for detecting usage of an inhaler, the monitor system comprising:
 a compact housing configured to be removably connectable to an inhaler that is configured to enclose and deliver inhalable medication to a user;   a controller located within the housing;   an inhaler communication interface within the compact housing in electronic communication with the controller and configured to send and receive data;   a memory and a battery in electrical communication with the controller and contained within the housing;   a motion sensor in electrical communication with the controller that outputs data indicative of a motion of the housing, the motion sensor configured to be physically coupled to the inhaler such that it can detect signature motions of the inhaler and the enclosed medication, the signature motions comprising at least two movements of the inhaler occurring within a first time window of one another and indicative of preparation by a user for administration of a dose of the medication;   a temperature sensor in electrical communication with the controller, the temperature sensor configured to detect confirming temperatures on or near the inhaler within a second time window of any signature motions, the temperature sensor configured to be within a given distance of the mouth of the user, the temperatures indicative of a proper dosage breathing pattern, the temperatures indicative that a dose of the medication was administered;   a mobile personal computing device remote from the housing and configured to receive data from the inhaler communication interface, the computing device having a processor configured to:
 process data output from the motion sensor to identify signature motions by comparison to reference data from a database, the reference data indicating sensor results indicative of preparation by a user and proper administration of a dose of the medication; 
 process data output from the temperature sensor to identify confirming temperatures indicative of proper administration of a dose of the medication; and 
 evaluate timing of any signature motions in the first time window and confirming temperatures in the second time window to determine whether a use of the inhaler has occurred; and 
 cause the mobile personal computing device to display information to the user related to compliance with the medication dosage regimen. 
   
     
     
         2 . The monitor of  claim 1  wherein evaluating the timing includes determining whether the temperature data indicative of use occurred later in time than the motion data indicative of use. 
     
     
         3 . The monitor of  claim 1  wherein the confirming temperatures comprise a temperature increase in proximity to a mouthpiece connected to the housing of the inhaler. 
     
     
         4 . The monitor of  claim 1  wherein the confirming temperatures comprise a temperature increase by an amount indicative of a patient's mouth being in proximity to a mouthpiece connected to an inhaler housing. 
     
     
         5 . The monitor of  claim 1  wherein the controller is configured to process data output from the motion sensor to identify signature motions that result from a lever being actuated on a DPI inhaler. 
     
     
         6 . A method of using a disposable sensor package in communication with a mobile personal computing device, the method comprising:
 attaching a disposable package comprising one or more sensors to an inhaler;   using at least one sensor in the disposable package to detect data relating to signature motions that comprise at least two movements of the inhaler and indicative of preparation by a user and administration of a dose of the medication;   using at least one sensor in the disposable package to detect one or more temperatures using a sensor outside and near the mouth of the user within a time window of any signature motions, the temperatures indicative of a dosage breathing pattern for medication dosage;   using an inhaler communication interface within the disposable package to transmit the motion and temperature data to a mobile personal computing device of the user;   using the mobile personal computing device to process the motion data to determine whether it includes one or more signature motions indicative of proper preparation and use of the inhaler;   using the mobile personal computing device to process the temperature data to determine whether it is indicative of proper dosage breathing patterns for effective medication dosage; and   using the mobile personal computing device to evaluate the timing of the signature motion data relative to the temperature data to determine whether the inhaler has been properly used.   
     
     
         7 . The method of  claim 6 , further comprising associating a date, time, and location with a use after the evaluating step has confirmed that a proper use of an inhaler has occurred. 
     
     
         8 . The method of  claim 6 , wherein the disposable package includes a temperature sensor configured to measure the temperature of a medication container and the processing of the temperature data includes determining whether a temperature of the inhaler container has changed. 
     
     
         9 . The method of  claim 6 , wherein using the mobile personal computing device to process the motion data includes determining whether a frequency of the acceleration reaches a threshold magnitude and the duration of acceleration above the threshold. 
     
     
         10 . A universal monitor system for detecting and assessing usage of an inhaler, the monitor system comprising:
 a compact housing configured to be removably connectable to an inhaler;   a controller;   an inhaler communication interface in electronic communication with the controller;   at least two sensors in the compact housing and configured to be physically present during inhaler use, the sensors including at least two of the following:
 a motion sensor; 
 an accelerometer; 
 a temperature sensor; 
 a proximity sensor; 
 an infrared sensor; 
 an audio sensor; and 
 a vibration sensor; 
   a mobile personal computing device remote from the compact housing and configured to receive data from the inhaler communication interface, the computing device having a processor configured to:
 process data output from the at least two sensors to identify at least two relevant sensor readings; 
 process data output from the at least two sensors to assess if the sensor readings are signature readings, indicating proper administration of a dose of the asthma medication; and 
 evaluate timing of any signature readings to determine or confirm whether a proper use of the asthma inhaler has occurred; and 
   a user display configured to receive output from the processor and indicate whether or not proper usage and compliance with the medication dosage regimen has occurred.   
     
     
         11 . The universal monitor system of  claim 10 , wherein:
 the compact housing is configured for connection to at least two of the following inhaler types: metered dose inhaler, dry powder inhaler, disk inhaler, and nebulizer;   the at least two sensors are selected to provide data relevant to assess proper medication dosage from at least the two inhaler types; and   the processor is configured to assess signature readings for the at least two inhaler types so that the universal monitor can be used on either type and is not specific to only one type of inhaler.   
     
     
         12 . The universal monitor of  claim 11  wherein the at least two sensors comprise perpendicular accelerometers. 
     
     
         13 . The accelerometer of  claim 12  wherein the accelerometers monitor motion data for acceleration with respect to at least one reference acceleration in each of two perpendicular dimensions. 
     
     
         14 . The universal monitor of  claim 11  wherein the at least two sensors comprise a gyroscope that monitors orientation. 
     
     
         15 . The universal monitor of  claim 12  wherein the at least two sensors comprise a temperature sensor that monitors changes in temperature in proximity of the inhaler related to medication dispensation or mouth proximity. 
     
     
         16 . The universal monitor of  claim 12  wherein the at least two sensors comprises an infrared proximity sensor that monitors proximity of the inhaler to the user's face. 
     
     
         17 . The universal monitor of  claim 12  wherein the at least two sensors comprise an audio sensor that monitors sounds generated by the user and inhaler during use of the device. 
     
     
         18 . The universal monitor of  claim 12  wherein the at least two sensors comprise a vibration sensor that monitors for a distinct vibration associated with use of the inhaler. 
     
     
         19 . The universal monitor of  claim 11  wherein the at least two sensors comprise multiple temperature sensors, including an ambient temperature sensor that monitors ambient temperature to provide a reference temperature. 
     
     
         20 . The universal monitor of  claim 11  wherein the processor is configured to send a notification to the user that the cartridge is at a certain capacity, to request the user to order a refill cartridge, to receive a command from the user to order the refill cartridges, to connect to a network, or to directly order the refill cartridges.