Metered-Dose Inhaler Security System

Abstract

Security features for an electronic metered-dose smart inhaler, mobile app, and cloud-based software system for use with medical prescriptions and clinical trial regimens. The smart inhaler requires several types of user validation and feedback, and enters a locked-out state when required user feedback is not received or when received user feedback raises a suspicion of fraudulent or improper use. While the smart inhaler system is well suited for aerosol medical marijuana products, it may be used to deliver and conduct clinical trials on any type of product suitable for aerosol administration including other types of medication and non-medical products, such as nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, etc. The security features are not limited to aerosol inhalers, and may be applied more widely to other types of in-home, patient-administered products.

The invention claimed is: 
     
         1 . An electronic metered-dose inhaler system including security features comprising a cartridge, a pump unit, and a mobile app, wherein:
 the cartridge comprises:
 a canister containing pressurized contents for aerosol dispensing without burning or vaporizing the contents of the canister, 
 a mouthpiece unit holding the canister against a spring biasing the canister in a retraction direction allowing the canister to be reciprocated between the retraction direction and an opposing insertion direction to dispense a portion of the contents of the canister through the mouthpiece unit each time the canister is reciprocated, 
   the pump unit comprises:
 a pump actuator positioned to reciprocate the canister to dispense the contents of the canister through the mouthpiece unit when the cartridge is attached to the pump unit in the operational configuration; 
 a battery powering a microprocessor, a memory, and a wireless radio; 
 wherein the memory is operative for storing the security information and associated security procedures; 
 wherein the microprocessor is operative for unlocking the pump actuator to allow operation of the pump actuator in accordance with the security procedures and security information, and for locking the pump actuator to prevent operation of the pump actuator that is not in accordance with the security procedures and security information; 
   wherein the mobile app is configured to run on a mobile device associated with a user configured to pair and communicate with the microprocessor of the pump unit, and   wherein the mobile app is configured to communicate with other systems over a network and execute computer instructions comprising:
 receiving pre-dose authorization information from the pump unit, 
 validate pre-dose authorization, 
 unlocking inhaler for an a dose, 
 entering the inhaler into a locked-out state in response to determining that required post-dose feedback was not received or that received post-dose feedback raises a suspicion of fraudulent or improper use. 
   
     
     
         3 . The electronic metered-dose inhaler system of  claim 1 , further comprising activating an alarm displayed or played by the mobile device in association with entering the inhaler into the locked-out state. 
     
     
         4 . The electronic metered-dose inhaler system of  claim 1 , further comprising activating an alarm displayed or played by the pump unit in association with entering the inhaler into the locked-out state. 
     
     
         5 . The electronic metered-dose inhaler system of  claim 1 , further comprising transmitting a notification from the mobile device to an cooperating system over the network in association with entering the inhaler into the locked-out state. 
     
     
         6 . The electronic metered-dose inhaler system of  claim 5 , wherein the cooperating system is associated with a prescriber of a medication in the canister. 
     
     
         7 . The electronic metered-dose inhaler system of  claim 5 , wherein the cooperating system is associated with a clinical trial administrator associated with a substance in the canister. 
     
     
         8 . The electronic metered-dose inhaler system of  claim 5 , wherein the cooperating system is associated with a law enforcement agency. 
     
     
         9 . The electronic metered-dose inhaler system of  claim 5 , wherein the cooperating system is associated with a parent, guardian or care taker of an authorized used of a substance in the canister. 
     
     
         10 . The electronic metered-dose inhaler system of  claim 1 , wherein the step of entering the inhaler into a locked-out state comprises determining that required post-dose feedback was not received. 
     
     
         11 . The electronic metered-dose inhaler system of  claim 1 , wherein the step of entering the inhaler into a locked-out state comprises:
 analyzing received post-dose feedback; and   determining that the post-dose feedback raises a suspicion of fraudulent or improper use of the inhaler.   
     
     
         12 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises feedback required during a predefined time interval. 
     
     
         13 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises feedback required during a plurality of predefined time intervals. 
     
     
         14 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a bio-identifier entered into the mobile device. 
     
     
         15 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a password entered into the mobile device. 
     
     
         16 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a registration number entered into the mobile device. 
     
     
         17 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises interactive feedback conducted with a cooperating system over the network. 
     
     
         18 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a photograph taken with the mobile device. 
     
     
         19 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a user's assessment of efficacy of a substance in the canister. 
     
     
         20 . The electronic metered-dose inhaler system of  claim 1 , wherein the required post-dose feedback comprises a user's assessment of side effects caused by a substance in the canister.