Unit dose compliance monitoring and reporting device and system

• US 6,973,371 B1
• Filed: 10/13/2004
• Issued: 12/06/2005
• Est. Priority Date: 10/13/2004
• Status: Active Grant

• Current Assignee: Nadir Benouali
• Original Assignee: Nadir Benouali
• Inventors: Benouali, Nadir
• Primary Examiner(s): Tran, Khoi H.
• Application Number:
  US10/963,688
• Time in Patent Office: 419 Days
• Field of Search: 700/231, 700/232, 700/236, 700/244, 221/2, 221/8, 221/15, 221/25, 221/26, 368/10, 235/385, 340/3.1, 340/5.92
• US Class Current: 700/244
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/0436 resulting from removing a drug from, or opening, a container
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: G16H 20/13 delivered from dispensers

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.

Claims

1. A unit dose medication 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 retainer sheet configured to be confrontingly affixed to the dispensing face to seal each container opening and to burst proximate to each opening as the unit dose is dispensed through the respective openings of the containers;

a sensor network arranged about the retainer sheet to have a plurality of frangible electrical container integrity signal paths, each path being positioned to substantially extend across a respective opening when the retainer sheet is affixed;

a monitoring and reporting circuit in electrical communication with timer and memory circuits, which are configured to record a time signal at each instance when a one of the frangible signal paths is interrupted as the unit dose is dispensed, the monitoring and reporting circuit being further adapted to compute and record an average time interval signal of the recorded time signals; and

a data display device in electronic communication with the monitoring and reporting circuit and configured to communicate data that includes the average time interval signal of the recorded time signals.

2. The unit dose medication compliance monitoring and reporting device according to claim 1, further comprising:

a user data interface in electronic communication with the monitoring and reporting circuit proximate to the data display and being adapted to selectively adjust the data displayed.

3. The unit dose medication compliance monitoring and reporting device according to claim 1, 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.

4. The unit dose medication compliance monitoring and reporting device according to claim 1, 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 average time interval signal, the doses dispensed signal, and a signal that represents an inbound report code;

and

wherein the signals and the inbound report code are communicated to a clearinghouse for automated validation and compliance reporting and monitoring.

5. The unit dose medication compliance monitoring and reporting device according to claim 1, 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.

6. The unit dose medication compliance monitoring and reporting device according to claim 1, 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 after a first unit dose is dispensed.

7. The unit dose medication compliance monitoring and reporting device according to claim 6, wherein the energy source is a photovoltaic power supply.

8. The unit dose medication compliance monitoring and reporting device according to claim 1, wherein the 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, a metallic layer, and an insulative layer between the metallic and conductor layers.

9. The unit dose medication compliance monitoring and reporting device according to claim 8, 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, the conductor layer also being adapted with grounding bosses in electronic communication with the metallic layer.

10. A unit dose medication 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 configured to be confrontingly affixed to the dispensing face to seal each container opening and to burst proximate to each opening as the unit dose is dispensed through the respective openings of the containers;

a sensor network arranged about the retainer sheet and dispenser shell to have a plurality of frangible electrical container integrity signal paths, each path being positioned to substantially extend across a respective opening when the retainer sheet is affixed;

a monitoring and reporting circuit carried from respective extended edges of the dispenser shell and retainer sheet, and in electrical communication with timer and memory circuits, which monitoring and reporting circuit is configured to record to the memory circuit a time signal of the timer circuit at each instance when a one of the frangible signal paths is broken as the unit dose is dispensed, the monitoring and reporting circuit being further adapted to compute and record an average time interval signal from the recorded time signals; and

a data display device carried from the respective extended edges and in electronic communication with the monitoring and reporting circuit to display data that includes the average time interval signal of the recorded time signals.

11. The unit dose medication compliance monitoring and reporting blister pack according to claim 10, wherein the monitoring and reporting circuit counts and communicates to the data display a signal that represents a number of the unit doses dispensed.

12. The unit dose medication compliance monitoring and reporting blister pack according to claim 11, wherein after the last unit dose is dispensed, the monitoring and reporting circuit stores and communicates to the data display a signal representing the doses dispensed signal, the average time interval signal, and an inbound report code;

and

wherein the signals and the inbound report code are communicated to a clearinghouse for automated validation and compliance reporting and monitoring.

13. The unit dose medication compliance monitoring and reporting blister pack according to claim 10, wherein the monitoring and reporting circuit stores and alternately communicates to the data display a doses remaining quantity signal and a prescription regimen signal.

14. The unit dose medication compliance monitoring and reporting blister pack according to claim 10, further comprising:

an energy source in electrical communication with the monitoring and reporting circuit and the data display, which energizes the circuit and display after a first unit dose is dispensed.

15. The unit dose medication compliance monitoring and reporting blister pack according to claim 14, wherein the energy source is a photovoltaic power supply.

16. The unit dose medication compliance monitoring and reporting blister pack according to claim 10, wherein the retainer sheet incorporates a plurality of sandwiched layers that include a sealing layer that substantially prevents passage of liquids, gases, and solids, a conductor layer that incorporates the sensor network, a metallic layer, and an insulative layer between the metallic and conductor layers.

17. The unit dose medication compliance monitoring and reporting blister pack according to claim 16, wherein the conductor layer includes a patterned conductive substance that forms a part of the sensor network and that includes a sensor network interface, the conductor layer also incorporating grounding bosses in electronic communication with the metallic layer.

18. A unit dose medication 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 configured to be confrontingly affixed to the aperture face to seal each opening and to burst proximate thereto as the unit dose is dispensed;

a dispensement sensing network arranged about the retainer sheet to have a plurality of frangible electrical signal paths that are interrupted upon respective dispensement, each signal path arranged to substantially extend across a respective opening when the retainer sheet is affixed;

a monitoring and reporting circuit with timer and memory circuits, which are configured to record a time signal at each instance when a one of the frangible signal paths of the plurality is interrupted as the unit dose is dispensed, the monitoring and reporting circuit being further adapted to count each unit dose dispensed and to compute and store an average time interval from the recorded time intervals each time a new time signal is recorded; and

a data display device in electronic communication with the monitoring and reporting circuit and configured to display data that includes the average time interval signal of the recorded time signals.

19. The unit dose medication compliance monitoring and reporting apparatus according to claim 18, 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 average time interval signal, the count of doses dispensed, and an inbound report code;

and

wherein the signals and the inbound report code are communicated to a clearinghouse for automated validation and compliance reporting and monitoring.

20. The unit dose medication compliance monitoring and reporting apparatus according to claim 18, wherein the retainer sheet incorporates a plurality of sandwiched layers that include a sealing layer that substantially prevents passage of liquids, gases, and solids, a conductor layer that incorporates the sensor network, a metallic layer, and an insulative layer between the metallic and conductor layers;

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, the conductor layer also incorporating grounding bosses in electronic communication with the metallic layer.