Instrumented Metered-Dose Inhaler and Methods for Predicting Disease Exacerbations

Abstract

The present invention is directed to devices, systems, and methods for monitoring inhaled drug usage to predict when an acute attack or exacerbation of a disease, such as a respiratory disease, is imminent. Instrumented inhalers that use modular designs with standard components are disclosed, as are systems for monitoring the instrumented inhalers. Also disclosed are methods for determining whether or not a patient's inhaled drug usage pattern indicates that an acute attack or disease exacerbation is imminent, and notifying appropriate medical personnel of any usage patterns indicative of an attack or disease exacerbation. If such an attack or exacerbation is imminent, additional therapeutic agents may be dispensed to the patient or other interventions made.

What is claimed is: 
     
         1 . A metered dose inhaler, comprising:
 a) an inhaler portion including:
 i) a medication reservoir compartment constructed and adapted to engage a medication canister; 
 ii) a mouthpiece; 
 iii) a flow pathway opening into and connecting the medication reservoir compartment and the mouthpiece so as to deliver a metered dose of a medication from the medication reservoir compartment to the mouthpiece when the inhaler portion is actuated to dispense a metered dose of the medication; 
 iv) a medication canister that fits inside said medication reservoir compartment and acts as a movable part such that when said medication canister is depressed, a dose of drug is delivered into said flow pathway; 
 v) a cap fitted to said medication canister such that when said canister is depressed to dispense a dose, the cap actuates a dose dispensing sensor signaling that a dose has been dispensed; 
   b) a wireless transmitter connected to the dose-dispensing sensor, the wireless transmitter being constructed and arranged to accept a signal from the dose-dispensing sensor and transmit the signal to a remote station thereby indicating that a dose has been dispensed.   
     
     
         2 . The metered dose inhaler of  claim 1 , wherein said dose dispensing sensor is an electrical switch. 
     
     
         3 . The metered dose inhaler of  claim 1 , wherein said dose dispensing sensor is in the form of a depressible button. 
     
     
         4 . The metered dose inhaler of  claim 1 , wherein said canister contains a supply of pressurized medication with a built-in valve. 
     
     
         5 . The metered dose inhaler of  claim 1 , wherein said canister comprises a nozzle that, when said canister is present in said medication reservoir compartment, bears against an opening into said the flow pathway. 
     
     
         6 . The metered dose inhaler of  claim 5 , wherein the wireless transmitter is a cellular network wireless transmitter. 
     
     
         7 . The metered dose inhaler of  claim 1 , further comprising a microprocessor connected between the dose-dispensing sensor and the wireless transmitter. 
     
     
         8 . The metered dose inhaler of  claim 7 , wherein:
 a) the microprocessor controls the wireless transmitter to transmit the signal indicating that the dose has been dispensed at a predetermined interval of time after the dose has been dispensed; and   b) the signal indicating that the dose has been dispensed comprises the amount of the dose or number of times that the inhaler portion was actuated, and the time that the dose was dispensed.   
     
     
         9 . The metered dose inhaler of  claim 1 , wherein said metered dose inhaler communicates via a cellular telephone network and has a telephone number associated with it. 
     
     
         10 . The metered dose inhaler of  claim 1 , further comprising a second, separate medication reservoir compartment. 
     
     
         11 . A metered dose inhaler, comprising:
 a) a medication reservoir compartment constructed and adapted to engage a medication reservoir;   b) a mouthpiece;   c) a flow pathway opening to and connecting the medication reservoir compartment and the mouthpiece so as to deliver a metered dose of a medication from the medication reservoir compartment to the mouthpiece when the inhaler is actuated to dispense a metered dose of the medication;   d) a medication canister that fits inside said medication reservoir compartment and acts as a movable part such that when said medication canister is depressed, a dose of drug is delivered into said flow pathway;   e) a dose-dispensing sensor which is coupled to said medication canister so as to be actuated when said medication canister is depressed and, as a result, signal a wireless transmitter;   f) a wireless transmitter connected to the dose-dispensing sensor, being constructed and arranged to accept a signal from the dose-dispensing sensor and transmit a signal indicating that a dose has been dispensed to a remote station.   
     
     
         12 . The metered dose inhaler of  claim 11 , wherein said dose-dispensing sensor is coupled to said medication canister by a cap that is sized to accommodate the top end of the medication canister. 
     
     
         13 . The metered dose inhaler of  claim 12 , wherein said dose dispensing sensor is an electrical switch. 
     
     
         14 . The metered dose inhaler of  claim 12 , wherein said dose dispensing sensor is in the form of a depressable button. 
     
     
         15 . The metered dose inhaler of  claim 11 , wherein said medication canister comprises a nozzle that, when said medication canister is present in said medication reservoir compartment, bears against an opening into said the flow pathway. 
     
     
         16 . The metered dose inhaler of  claim 15 , wherein the wireless transmitter is a cellular network wireless transmitter. 
     
     
         17 . The metered dose inhaler of  claim 11 , further comprising a microprocessor connected between the dose-dispensing sensor and the wireless transmitter. 
     
     
         18 . The metered dose inhaler of  claim 17 , wherein:
 a) the microprocessor controls the wireless transmitter to transmit the signal indicating that the dose has been dispensed at a predetermined interval of time after the dose has been dispensed; and   b) the signal indicating that the dose has been dispensed comprises the amount of the dose or number of times that the inhaler portion was actuated, and the time that the dose was dispensed.   
     
     
         19 . The metered dose inhaler of  claim 11 , wherein said metered dose inhaler communicates via a cellular telephone network and has a telephone number associated with it. 
     
     
         20 . The metered dose inhaler of  claim 11 , further comprising a second, separate medication reservoir compartment.