Drug delivery management system

• US 6,574,166 B2
• Filed: 07/09/2001
• Issued: 06/03/2003
• Est. Priority Date: 07/07/2000
• Status: Expired due to Term

• Current Assignee: DDMS Holdings, LLC (Stanley Black & Decker, Inc.)
• Original Assignee: DDMS Holdings, LLC (Stanley Black & Decker, Inc.)
• Inventors: Niemiec, Mark A.
• Primary Examiner(s): MISKA, VIT W
• Application Number:
  US09/901,475
• Publication Number:
  US 20020017996A1
• Time in Patent Office: 694 Days
• Field of Search: 368/10, 368/11, 368/204, 368/205, 340/568.1, 206/531-534, 221/2, 221/3, 221/15
• US Class Current: 368/10
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 2200/72 for temperature
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: H05K 1/0293 Individual printed conductors which are adapted for modification, e.g. fusable or breakable conductors, printed switches

Abstract

A system for managing delivery of medication is formed of a blister package that includes a plurality of cells wherein each cell is sealed by a breakable wall and holds a unit-dose of medication. A user gains access to the medication by puncturing the breakable wall. A severable conductor is positioned proximate to each breakable wall and ruptures upon puncturing. A monitoring circuit senses the puncturing of each of the severable conductors. An RF transmitter sends information corresponding to usage of each medication stored in the blister package to a remote information transceiver. The package may also be provided with environmental monitoring sensors to allow analytical determinations of medication expiration. The package may furthermore be provided with a power supply which conforms to the back side of the package and an antenna formed by a printing a conductive element on the back side of the package.

Claims

1. A package for medication, the package comprising:

(a) a medication container containing a plurality of storage cells;

(b) an electronic monitoring circuit affixed to said medication container;

(c) at least one breakable closure associated with a storage cell, said at least one breakable closure further comprising a severable conductor proximate to said storage cell, said at least one breakable closure securing a unit dose of medication, said severable conductor being communicably connected to said electronic monitoring circuit;

(d) at least one environment sensor affixed to said medication container, said at least one environment sensor being communicably connected to said electronic monitoring circuit;

(e) an RF transceiver affixed to said medication container, said RF transceiver being communicably connected to said at least one monitoring circuit;

(f) an RF antenna affixed to said medication container, said RF sensor being communicably connected to said RF transceiver; and

(g) a power supply;

wherein least one severable conductor is severed upon breaking of the breakable closure, said severance being detected by said monitoring circuit, wherein data associated with said at least one environment sensor is acquired by said electronic monitoring circuit, wherein said RF transceiver transmits said data associated with said severance and said data associated with said at least one environment sensor, and wherein said data is radiated from said RF antenna.

2. A package for medication according to claim 1 wherein said at least one environment sensor comprises a temperature sensor.

3. A package for medication according to claim 2, wherein said temperature sensor is a thermistor.

4. A package for medication according to claim 2, wherein said temperature sensor is a thermocouple.

5. A package for medication according to claim 1, wherein said at least one environment sensor comprises a humidity sensor.

6. A package for medication according to claim 1, wherein said at least one environment sensor comprises a light sensor.

7. The package for medication according to claim 1 wherein said RF transceiver is integrated with said electronic monitoring circuit.

8. A package for medication according to claim 1 wherein said RF transceiver comprises at least one radio frequency identification device.

9. A package for medication according to claim 8, wherein said RF transceiver transmits in response to an RF signal received by said RF transceiver.

10. A package for medication according to claim 1, wherein the data transmitted by said transceiver comprises a medication package identifier, a status of said severable conductors, and data associated with said at least one environmental sensor.

11. The package for medication according to claim 1 wherein said RF antenna comprises a printed circuit trace.

12. A package for medication, the package comprising:

(a) a medication container containing a plurality of storage cells;

(b) at least one monitoring circuit affixed to said medication container;

(c) at least one breakable closure associated with a storage cell, said breakable closure further comprising a severable conductor proximate to said storage cell, said at least one breakable closure securing a unit dose of medication, said severable conductor being communicably connected to said electronic monitoring circuit;

(d) a conformal power supply, said conformal power supply comprising a plurality of layers printed on the medication package, said plurality of layers comprising at least one anode, at least one cathode, and at least one electrolytic layer interposed between said at least one anode and said at least one cathode;

(e) an RF transceiver affixed to said medication container, said RF transceiver being communicably connected to said at least one monitoring circuit; and

(f) an RF antenna affixed to said medication container, said RF antenna being communicably connected to said RF transceiver;

wherein at least one severable conductor is severed upon breaking of the breakable closure, said severance being detected by said at least one monitoring circuit, wherein said RF transceiver transmits said detection associated with said severance, and wherein said detection is radiated from said RF antenna.

13. A package for medication according to claim 12, wherein said medication package has an open cell side and a closed cell side, said cells protruding from said closed cell side, and where said conformal power supply is printed on said closed cell side.

14. A package for medication according to claim 12, further comprising at least one environmental sensor, said at least one environment sensor affixed to said medication container, said at least one environment sensor being communicably connected to said electronic monitoring circuit, wherein data associated with said at least one environment sensor is acquired by said electronic monitoring circuit, wherein said RF transceiver further transmits said data associated with said at least one environment sensor, and wherein said data associated with said at least one environment sensor is radiated from said RF antenna.

15. A package for medication according to claim 14 wherein said at least one environment sensor comprises a temperature sensor.

16. A package for medication according to claim 15, wherein said temperature sensor is a thermistor.

17. A package for medication according to claim 15, wherein said temperature sensor is a thermocouple.

18. A package for medication according to claim 14, wherein said at least one environment sensor comprises a humidity sensor.

19. A package for medication according to claim 14, wherein said at least one environment sensor comprises a light sensor.

20. The package for medication according to claim 14, wherein said RF transceiver is integrated with said electronic monitoring circuit.

21. A package for medication according to claim 14 wherein said RF transceiver comprises at least one radio frequency identification device.

22. A package for medication according to claim 21, wherein said RF transceiver transmits in response to an RF signal received by said RF receiver.

23. A package for medication according to claim 14, wherein the data transmitted by said transceiver comprises a medication package identifier, a status of said severable conductors, and data associated with said at least one environmental sensor.

24. The package for medication according to claim 14, wherein said RF antenna comprises a printed circuit trace.

25. A package for medication, the package comprising:

(a) a medication container, the medication container having a plurality of storage cells, at least one storage cell being sealed by an associated breakable closure and holding a unit dose of a medication, said medication container comprising a first means for sensing temperature exposure;

(b) a severable conductor proximate to the breakable closure associated with said at least one storage cell sealed by a breakable closure, wherein said severable conductor is severed upon breaking of the associated breakable closure;

(c) an electronic monitoring circuit comprising means for monitoring

(i) a first status indicating a severed condition of the associated breakable closure,

(ii) a second status indicating temperature exposure of said medication container,

(d) a means for transmitting said first status and said second status to a remote monitor.

26. A package for medication according to claim 25, wherein said medication container further comprises a light sensor, and wherein said electronic monitoring circuit further comprises means for monitoring a third status indicating light exposure of said medication container, and wherein said means for transmitting said first status and said second status to a remote monitor is further for transmitting said third status to a remote monitor.

27. The package for medication according to claim 26 wherein said means for monitoring a third status indicating light exposure of said medication container comprises a light detector, a threshold detector for comparison with light limits, and an elapsed time indicator whereby time duration of light exposure is monitored.

28. A package for medication according to claim 25, wherein said medication container further comprises a means for sensing humidity exposure, and wherein said electronic monitoring circuit further comprises means for monitoring a fourth status indicating humidity exposure of said medication container, and wherein said means for transmitting said first status and said second status to a remote monitor is further for transmitting said fourth status to a remote monitor.

29. The package for medication according to claim 28 wherein said means for monitoring a fourth status indicating humidity exposure of said medication container comprises a humidity sensor, a threshold detector for comparison with humidity limits, and an elapsed time indicator whereby time duration of humidity exposure is monitored.

30. The package for medication according to claim 25 wherein said electronic monitoring circuit further comprises one or more of a group consisting of a digital ASIC, an analog ASIC, a mixed mode ASIC, an FPGA, an LSI integrated circuit, and a VLSI integrated circuit.

31. The package for medication according to claim 25 wherein said means for monitoring a first status of the associated breakable closure comprises a digital multiplexer.

32. The package for medication according to claim 25 wherein said means for monitoring a second status indicating temperature exposure of said medication container comprises a threshold detector for comparison with temperature limits, and an elapsed time indicator whereby time duration of temperature exposure is monitored.

33. The package for medication according to claim 25 wherein said means for transmission of said first status and said second status comprises an RF transceiver and an RF antenna.

34. The package for medication according to claim 33, wherein said RF transceiver comprises one or more of the group consisting of an RFID, a digital ASIC, an analog ASIC, a mixed mode ASIC, an FPGA, a LSI integrated circuit, and a VLSI integrated circuit.

35. The package for medication according to claim 34 wherein said RF antenna comprises a printed circuit conductor trace.

36. The package for medication according to claim 25 wherein said electronic monitoring circuit, said severable conductors, and said means for transmission are mounted entirely on a single side of the package for medication.

37. The package for medication according to claim 25 wherein said electronic monitoring circuit, said severable conductors, and said means for transmission are mounted utilizing surface area of both sides of the package for medication wherein open cell side to closed cell side electrical connections are implemented as either plated-through holes or edge connections.

38. The method of monitoring the environment of a package for medication comprising the steps of:

providing a network of monitoring stations;

providing managed medication packaging for at least one medication, wherein the managed medication packaging includes severable conductors associated with individual medication cells, at least one environmental sensor, an RF transceiver, and monitoring circuitry for monitoring the severable conductors and the at least one environmental sensor;

providing said managed medication packaging for at least one medication with threshold information;

dispensing said managed medication packaging for at least one medication to a patient;

monitoring environmental exposures through the monitoring circuitry associated with the medication package;

monitoring through the monitoring circuit associated with the medication package the condition of severable conductors associated with the package;

transmitting from the medication package to a monitoring station data associated with the condition of the severable conductors and the environmental sensor.

39. The method of claim 38, further comprising the step of analyzing the data associated with the at least one environmental sensor to estimate the degradation of the efficacy of the at least one medication contained in the medication package, and determining based on the analysis whether the at least one medication has degraded to a point where the medication is unsuitable for use.

40. The method of claim 39, further comprising the step of informing a patient to whom the at least one medication has been prescribed that the at least one medication has expired when analysis of the data associated with the at least one environmental sensor yields a determination that the at least one medication has degraded to a point where the at least one medication is unsuitable for use.

41. The method of claim 39, further comprising the step of informing a physician responsible for the patient to whom the at least one medication package has been dispensed that the at least one medication has expired when analysis of the data associated with the at least one environmental sensor yields a determination that the at least one medication has degraded to a point where the at least one medication is unsuitable for use.