Device For Remote Regulation and Monitoring of Drug Delivery

Abstract

Aspects and embodiments of the present invention generally include a device for patient self-administration of a prescribed medication. The total quantity of doses to be contained in the device, the quantity of prescribed medication comprising each individual dose, and the dosing schedule, collectively referred to as prescription parameters, are determined and controlled solely by a health care provider. In accordance with a prescribed dosing schedule, the device makes available for administration the precise quantity of prescribed medication constituting an individual dose. Patient access to the medication as well as patient control of the device is limited solely to the aspects of the device necessary to administer the available dose. The device also has a monitored subassembly which detects and transmits relevant device information to a remote management system accessible to the HCP, including detected attempts to alter, access, control or otherwise tamper with the device beyond its prescribed use.

What is claimed is: 
     
         1 . A device for use by a patient to self-administer a prescribed medication comprising:
 a delivery interface, responsive to patient control actions, configured to administer a dose of the medication directly into the body of the patient;   a regulated subassembly configured to store a plurality of doses of the medication in at least one patient-inaccessible storage chamber, and for making single dose quantities of the stored medication available to said delivery interface in accordance with a prescribed dose schedule;   a monitored subassembly having at least one sensor connected to said device to detect device parameters including detected attempts to tamper with the device, and to remotely transmit said detected device parameters; and   a command subassembly configured to control said regulated subassembly in response to commands generated by a remote health care provider (HCP) and transmitted to said device.   
     
     
         2 . The device of  claim 1 , wherein said delivery interface comprises a spray nozzle. 
     
     
         3 . The device of  claim 2 , wherein said spray nozzle is configured to be inserted into a nasal passage of the patient. 
     
     
         4 . The device of  claim 1 , wherein said delivery interface comprises an inhaler. 
     
     
         5 . The device of  claim 1 , wherein said delivery interface comprises an aerosolizer. 
     
     
         6 . The device of  claim 1 , wherein said delivery interface comprises an atomizer. 
     
     
         7 . The device of  claim 6 , wherein said atomizer is a nebulizer. 
     
     
         8 . The device of  claim 7 , wherein said nebulizer is configured to deliver the medication to the lungs of the patient. 
     
     
         9 . The device of  claim 1 , wherein said delivery interface comprises a needle. 
     
     
         10 . The device of  claim 9 , wherein said needle is configured to deliver the medication via one of either intramuscular and intravenous injection. 
     
     
         11 . A device for use by a patient to self-administer a prescribed medication in fluid form, the device comprising:
 a delivery interface, responsive to patient control actions, configured to administer a dose of the fluidic medication to the patient;   a regulated subassembly configured to store a plurality of doses of the medication in at least one patient-inaccessible storage chamber, and for making single dose quantities of the stored medication available to said delivery interface in accordance with a prescribed dose schedule;   a monitored subassembly having at least one sensor connected to said device to detect device parameters including detected attempts to tamper with the device, and to remotely transmit said detected device parameters; and   a command subassembly configured to control said regulated subassembly in response to commands generated by a remote health care provider (HCP) and transmitted to said device.   
     
     
         12 . The device of  claim 11 , wherein the fluidic medication is in the form of one of either a liquid and a gas. 
     
     
         13 . The device of  claim 12 , wherein the liquid is in the form of one of either a plurality of droplets and a stream. 
     
     
         14 . The device of  claim 11 , wherein the fluidic medication is in the form of a particle array. 
     
     
         15 . The device of  claim 11 , wherein the fluidic medication is in the form of an aerosol. 
     
     
         16 . The device of  claim 11 , wherein the fluidic medication is in the form of one of either a mist and vapor. 
     
     
         17 . The device of  claim 11 , wherein said delivery interface is configured to dispense the fluidic medication into one of either an external container and an external holding chamber. 
     
     
         18 . A device for use by a patient to self-administer a prescribed medication in fluid form, the device comprising:
 a delivery interface, responsive to patient control actions, configured to administer a dose of the fluidic medication directly into the body of the patient;   a regulated subassembly configured to store a plurality of doses of the medication in at least one patient-inaccessible storage chamber, and for making single dose quantities of the stored medication available to said delivery interface in accordance with a prescribed dose schedule;   a monitored subassembly having at least one sensor connected to said device to detect device parameters including detected attempts to tamper with the device, and to remotely transmit said detected device parameters; and   a command subassembly configured to control said regulated subassembly in response to commands generated by a remote health care provider (HCP) and transmitted to said device.   
     
     
         19 . The device of  claim 18 , wherein said delivery interface is a nasal spray. 
     
     
         20 . The device of  claim 18 , wherein said monitored subassembly comprises a tamper sensor and an administration sensor.