Unit dose compliance monitoring & reporting device & system

Abstract

A unit dose medication compliance monitoring and reporting apparatus and system that includes a dispenser shell formed with dose compartments. A retainer sheet affixed to the shell seals each compartment and partially bursts upon dispensing. A sensor network and monitoring and reporting circuitry records dispensing times and determines an average time interval, which can be reported with other data on an integral data display. The system can thereby monitor and report patient compliance with prescription regimens. Additional data can be recorded and displayed for augmented patient compliance assistance and analysis, which data can include customized informational messages, telephone and other patient support contact information, unit doses dispensed and remaining, reminder alarms, identification data, prescription regimens, among other data. In myriad variations and alternative preferred configurations, the devices and systems have demonstrated efficacy in minimalist to complex monitoring and reporting applications ranging from routine prescription monitoring to detailed clinical trial assessments.

1 - 20 . (canceled)  
   
   
       21 . A unit dose medication dispensing and compliance monitoring and reporting device, comprising: 
 a dispenser shell with a dispensing face and defining a plurality of unit dose containers, each container defining an opening through the dispensing face;    a layered retainer sheet configured to be confrontingly affixed to the dispensing face to seal each container opening;    a sensor network arranged about a layer of the retainer sheet and having electrical container integrity signal paths;    a monitoring and reporting circuit in electrical communication with timer and memory circuits, which are configured to detect a time interval when a one of the signal paths is interrupted; and    a data display device in electronic communication with the monitoring and reporting circuit and configured to communicate data that includes a time signal representing the detected time intervals.    
   
   
       22 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , further comprising: 
 a user data interface in electronic communication with the monitoring and reporting circuit proximate to the data display and being adapted to select data to be displayed.    
   
   
       23 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , wherein the monitoring and reporting circuit is further adapted to count and to communicate to the data display a number signal representing the unit doses dispensed.  
   
   
       24 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , wherein the monitoring and reporting circuit is further adapted to, after the last unit dose is dispensed, store and to communicate to the data display a signal that embodies the time intervals, the doses dispensed signal, and a signal that represents a report code.  
   
   
       25 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , wherein the monitoring and reporting circuit is further adapted to store and to alternately communicate to the data display a doses remaining quantity signal and a prescription regimen signal.  
   
   
       26 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , further comprising: 
 an energy source in electrical communication with the monitoring and reporting circuit and the data display, the energy source adapted to energize the monitoring and reporting circuit and data display.    
   
   
       27 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 26 , wherein the energy source is a photovoltaic power supply.  
   
   
       28 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 21 , wherein the layered retainer sheet incorporates a plurality of sandwiched layers that include a sealing layer adapted to substantially prevent passage of liquids, gases, and solids, a conductor layer configured to receive the sensor network, and an insulative layer between the sealing and conductor layers.  
   
   
       29 . The unit dose medication dispensing and compliance monitoring and reporting device according to  claim 28 , wherein the conductor layer is treated with a conductive substance in a circuit pattern that establishes the sensor network, and that includes a sensor network interface.  
   
   
       30 . A unit dose medication dispensing and compliance monitoring and reporting blister pack, comprising: 
 a dispenser shell with a dispensing face and defining a plurality of unit dose containers, each container defining an opening through the dispensing face;    a retainer sheet integrally formed of a plurality of layers and configured to be confrontingly affixed to the dispensing face to seal each container opening;    a sensor network arranged about at least one layer of the retainer sheet to have a plurality of electrical signal paths, each path being positioned to substantially extend about a respective container opening;    a monitoring and reporting circuit carried from an extended edge of the unit dose device, and configured to detect signal path interruptions and to generate a time signal, the monitoring and reporting circuit being further adapted to compute and record a compliance time interval signal from the time signals; and    a data display device carried from the extended edge and in electronic communication with the monitoring and reporting circuit to display data that includes the time interval signal of the generated time signals.    
   
   
       31 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 30 , wherein the monitoring and reporting circuit counts and communicates to the data display a signal that represents a number of the unit doses dispensed.  
   
   
       32 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 31 , wherein after the last unit dose is dispensed, the monitoring and reporting circuit stores and communicates to the data display a compliance reporting signal representing the doses dispensed signal, the compliance time interval signal, and a report code.  
   
   
       33 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 30 , wherein the monitoring and reporting circuit stores and alternately communicates to the data display a doses remaining quantity signal and a prescription regimen signal.  
   
   
       34 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 30 , further comprising: 
 an energy source in electrical communication with the monitoring and reporting circuit and the data display, which energizes the circuit and display.    
   
   
       35 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 34 , wherein the energy source is a photovoltaic power supply.  
   
   
       36 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 30 , wherein the retainer sheet incorporates at least 2 sandwiched layers that include a sealing layer that substantially prevents passage of liquids, gases, and solids, a conductor layer that incorporates the sensor network, and an insulative layer between the sealing and conductor layers.  
   
   
       37 . The unit dose medication dispensing and compliance monitoring and reporting blister pack according to  claim 36 , wherein the conductor layer includes a patterned conductive substance that forms a part of the sensor network and that includes a sensor network interface.  
   
   
       38 . A unit dose medication dispensing and compliance monitoring and reporting apparatus, comprising: 
 a dispenser pack with an aperture face and defining a plurality of blister compartments sized to contain respective unit doses, each blister compartment defining a recess with an opening in the aperture face;    a retainer sheet formed of at least 2 layers and configured to be confrontingly affixed to the aperture face to seal each opening;    a dispensement sensing network arranged about at least one of the at least 2 layers of the retainer sheet to have a plurality of signal paths that are interrupted upon dispensement of the unit dose, each signal path arranged to substantially extend proximate to a respective opening;    a monitoring and reporting circuit with timer and memory circuits, which are configured to generate a time signal at each instance when a one of the signal paths of the plurality is interrupted, the monitoring and reporting circuit being further adapted to compute and store the time signals; and    a data display device in electronic communication with the monitoring and reporting circuit and configured to display data that includes a representation of the time signals.    
   
   
       39 . The unit dose medication dispensing and compliance monitoring and reporting apparatus according to  claim 38 , wherein the monitoring and reporting circuit is further configured to, after the last unit dose is dispensed, store and to communicate to the data display a signal that embodies the time signals and a report code.  
   
   
       40 . The unit dose medication dispensing and compliance monitoring and reporting apparatus according to  claim 38 , wherein the at least two layers of the retainer sheet include an insulative sealing layer that substantially prevents passage of liquids, gases, and solids, and a conductor layer that incorporates the sensor network; and 
 wherein the conductor layer includes a patterned conductive substance that forms a part of the sensor network and that includes a sensor network interface.