Monitored medication package

• US 20050241983A1
• Filed: 04/01/2005
• Published: 11/03/2005
• Est. Priority Date: 03/10/2003
• Status: Abandoned Application

• Current Assignee: Healthtrac Systems, Inc.
• Original Assignee: Healthtrac Systems, Inc.
• Inventors: Ancona, Matthew J., Pfeifer, John Edward, Pereira, Fabio Augusto Mendes, Snyder, William B., Flynn, Herbert E.
• Application Number:
  US11/096,994
• Publication Number:
  US 20050241983A1
• Time in Patent Office: Days
• US Class Current: 206/539
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 7/0418 with electronic history memory
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H05K 1/0293 Individual printed conductors which are adapted for modification, e.g. fusable or breakable conductors, printed switches

Abstract

A child resistant medication package and associated system can enable compliance and anti-diversion features. The medication package can include a timing reminder, can detect and record a compliance history of each dose of medication, and can include anti-tamper capabilities to ensure doses are removed in the intended fashion. The medication package can have the capability to exchange data with other devices, including personal computers. The associated system can include a central database that receives data from the medication package, and provides for the transmission of data between various system locations, including not only the individual medication package, but also, for example, drug manufacturers, pharmacies, physician offices, law enforcement agencies, and a database managing agency.

Claims

1. A medication package comprising:

a blister pack defining a plurality of bubble chambers therein, each adapted to receive a dose of medication;

a layer composed of a frangible material covering said plurality of bubble chambers;

a insulating layer of an electrically non-conductive material disposed on said layer of frangible material, said insulating layer defining a plurality of holes therein corresponding to said plurality of bubble chambers; and

a circuit board disposed on said insulating layer opposite said frangible layer, said circuit board defining a plurality of holes therein corresponding to said plurality of holes defined in said insulating layer and said bubble chambers, wherein each of said plurality of holes in said circuit board is surrounded by an electrically conductive trace;

wherein said holes in said insulating layer are slightly larger than said holes in said circuit board, such that said electrically conductive traces surrounding said holes in said circuit board are exposed when said circuit board and said insulating layer are in contact with each other.

2. The medication package of claim 1 wherein said layer of frangible material is electrically conductive and is electrically coupled to said circuit board, said frangible layer and said conductive traces surrounding said plurality of holes on said circuit board forming a plurality of open switches.

3. The medication package of claim 2 wherein removal of a dose of medication from a particular bubble chamber causes the portion of said frangible layer covering said bubble chamber to engage the conductive trace surrounding said corresponding hole in said circuit board, thereby closing said switch.

4. The medication package of claim 3 further comprising:

a logic circuit capable of determining which of said plurality of switches has been closed by a dosage removal event; and

non-volatile memory, for recording said dosage removal event.

5. The medication package of claim 4 wherein said logic circuit includes one or more central processing units and further wherein each of said conductive traces surrounding said holes in said circuit board is directly connected to one of said central processing units.

6. The medication package of claim 4 further comprising:

data transfer circuitry, enabling the transfer of data regarding dosage removal events from said non-volatile memory and the transfer of information into said non-volatile memory regarding the timing of dosage removal events

7. The medication package of claim 6 further wherein said data transfer circuitry includes an infrared LED for transferring data out of said package and an infrared detector for transferring data into said package

8. The medication package of claim 4 further comprising alarm circuitry, for alerting a user of said package to remove one or more of said doses from said package.

9. The medication package of claim 8 wherein said alarm circuitry includes an alarm mechanism selected from a group compromising an LED, a beeper and a vibrator.

10. The medication package of claim 4 further comprising:

a battery, for powering said logic circuit; and

a means for activating said logic circuit.

11. The medication package of claim 4 further comprising:

a sheet of backing material disposed on said circuit board opposite said insulating layer, said backing material having perforated openings defined therein corresponding to said openings defined in said circuit board, said perforated openings tearing open when a dose of medication is forced from a bubble chamber.

12. The medication package of claim 11 wherein said sheet of backing material is composed of stiff paper.

13. A medication package comprising:

a first side comprising;

a blister pack defining a plurality of bubble chambers therein, each adapted to receive a dose of medication; and

a layer of adhesive having a peel-off cover, said adhesive layer being disposed on the surface of said blister pack between said plurality of bubble chambers; and

a second side comprising;

a circuit board, said circuit board defining a plurality of holes therein corresponding to said plurality of bubble chambers defined in said blister pack, wherein each of said plurality of holes in said circuit board is surrounded by an electrically conductive trace;

a insulating layer of an electrically non-conductive material disposed on said circuit board, said insulating layer defining a plurality of holes therein corresponding to said plurality of holes defined in said circuit board, bubble chambers, wherein said holes in said insulating layer are slightly larger than said holes in said circuit board, such that said electrically conductive traces surrounding said holes in said circuit board are exposed when said insulating layer is placed on said circuit board; and

a layer composed of a frangible material disposed on said insulating layer;

wherein said first side and said second side are connected via a hinge mechanism that can be closed to bring said frangible layer into contact with said adhesive layer after said peel-off cover has been removed, thereby sealing said bubble chambers.

14. The medication package of claim 13 wherein said layer of frangible material is electrically conductive and is electrically coupled to said circuit board, said frangible layer and said conductive traces surrounding said plurality of holes on said circuit board forming a plurality of open switches.

15. The medication package of claim 14 wherein removal of a dose of medication from a particular bubble chamber causes the portion of said frangible layer covering said bubble chamber to engage the conductive trace surrounding said hole in said circuit board corresponding to said bubble chamber, thereby closing said switch.

16. The medication package of claim 15 further comprising:

a logic circuit, capable of determining which of said plurality of switches has been closed by a dosage removal event; and

non-volatile memory, for recording said dosage removal event.

17. The medication package of claim 16 wherein said logic circuit includes one or more central processing units and further wherein each of said conductive traces surrounding said holes in said circuit board is directly connected to one of said central processing units.

18. The medication package of claim 16 further comprising:

data transfer circuitry, enabling the transfer of data regarding dosage removal events from said non-volatile memory and the transfer of information into said non-volatile memory regarding the timing of dosage removal events

19. The medication package of claim 18 further wherein said data transfer circuitry includes an infrared LED for transferring data out of said package and an infrared detector for transferring data into said package

20. The medication package of claim 16 further comprising alarm circuitry, for alerting a user of said package to remove one or more of said doses from said package.

21. The medication package of claim 20 wherein said alarm circuitry includes an alarm mechanism selected from a group compromising an LED, a beeper and a vibrator.

22. The medication package of claim 16 further comprising:

a battery, for powering said logic circuitry; and

a means for activating said logic circuitry.

23. The medication package of claim 16 further comprising:

a sheet of backing material disposed on said circuit board opposite said insulating layer, said backing material having perforated openings defined therein corresponding to said openings defined in said circuit board.

24. The medication package of claim 23 wherein said sheet of backing material is coupled to said first side of said package and acts as said hinge between said first and said second sides.

25. The medication package of claim 24 wherein said sheet of backing material is composed of stiff paper.

26. A medication package comprising:

a blister pack defining a plurality of bubble chambers therein, each adapted to receive

a dose of medication;

a layer composed of a frangible material covering said bubble chambers;

a layer of plastic disposed on said frangible layer such that one or more portions of said layer of plastic are obstructing the opening of each of said bubble chambers such that said obstructing portion(s) of said plastic layer are displaced from the plane of the plastic layer when a dose of medication is pushed through said frangible layer;

an electrically conductive layer disposed on said plastic layer opposite said frangible layer;

a insulating layer of an electrically non-conductive material disposed on said electrically conductive layer, said insulating layer defining a plurality of holes therein corresponding to said plurality of bubble chambers; and

a circuit board disposed on said insulating layer opposite said frangible layer, said circuit board defining a plurality of holes therein corresponding to said plurality of holes defined in said insulating layer and said bubble chambers, wherein each of said plurality of holes in said circuit board is surrounded by an electrically conductive trace;

wherein said holes in said insulating layer are slightly larger than said holes in said circuit board, such that said electrically conductive traces surrounding said holes in said circuit board are exposed when said circuit board and said insulating layer are in contact with each other.

27. The medication package of claim 26 wherein said electrically conductive layer is electrically coupled to said circuit board, said electrically conductive layer and said conductive traces surrounding said plurality of holes on said circuit board forming a plurality of open switches.

28. The medication package of claim 27 wherein said electrically conductive layer is composed of aluminum foil.

29. The medication package of claim 27 wherein removal of a dose of medication from a particular bubble chamber causes said portion(s) of said plastic layer obstructing the opening of said bubble chamber to be displaced toward said circuit board.

30. The medication package of claim 29 wherein the displacement of said portion(s) of said plastic layer obstructing the opening of said bubble chamber causes said electrically conductive layer to engage said conductive trace surrounding said hole in said circuit board corresponding to said bubble chamber, thereby closing said switch.

31. The medication package of claim 30 wherein said portion(s) of said plastic layer obstructing the opening of said bubble chamber are resilient and further wherein said portion(s) of said plastic layer obstructing the opening of said bubble chamber cause said electrically conductive layer to disengage from said conductive trace surrounding said hole in said circuit board corresponding to said bubble chamber when said dose of medication has been completely removed from said medication package, thereby opening said switch.

32. The medication package of claim 31 further comprising:

a logic circuit capable of determining which of said plurality of switches has been closed by a dosage removal event; and

non-volatile memory, for recording said dosage removal event.

33. The medication package of claim 32 wherein said logic circuit includes one or more central processing units and further wherein each of said conductive traces surrounding said holes in said circuit board is directly connected to one of said central processing units.

34. The medication package of claim 32 further comprising:

data transfer circuitry, enabling the transfer of data regarding dosage removal events from said non-volatile memory and the transfer of information into said non-volatile memory regarding the timing of dosage removal events

35. The medication package of claim 34 further wherein said data transfer circuitry includes an infrared LED for transferring data out of said package and an infrared detector for transferring data into said package

36. The medication package of claim 32 further comprising alarm circuitry, for alerting a user of said package to remove one or more of said doses from said package.

37. The medication package of claim 36 wherein said alarm circuitry includes an alarm mechanism selected from a group compromising an LED, a beeper and a vibrator.

38. The medication package of claim 32 further comprising:

a battery, for powering said logic circuitry; and

a means for activating said logic circuitry.

39. The medication package of claim 32 further comprising:

a sheet of backing material disposed on said circuit board opposite said insulating layer, said backing material having perforated openings defined therein corresponding to said openings defined in said circuit board, said perforated openings tearing open when a dose of medication is forced from a bubble chamber.

40. The medication package of claim 39 wherein said sheet of backing material is composed of stiff paper.

41. A medication package comprising:

a first side comprising;

a blister pack defining a plurality of bubble chambers therein, each adapted to receive a dose of medication; and

a layer of adhesive having a peel-off cover, said adhesive disposed on the surface of said blister pack between said plurality of bubble chambers; and

a second side comprising;

a circuit board, said circuit board defining a plurality of holes therein corresponding to said plurality of bubble chambers defined in said blister pack, wherein each of said plurality of holes in said circuit board is surrounded by an electrically conductive trace;

an insulating layer of an electrically non-conductive material disposed on said circuit board, said insulating layer defining a plurality of holes therein corresponding to said plurality of holes defined in said circuit board, wherein said holes in said insulating layer are slightly larger than said holes in said circuit board, such that said electrically conductive traces surrounding said holes in said circuit board are exposed when said insulating layer is placed on said circuit board;

an electrically conductive layer disposed on said insulating layer;

a layer of resilient plastic disposed on said electrically conductive layer such that one or more portions of said layer of plastic are obstructing the holes defined in said insulating layer and said circuit board, such that said obstructing portion(s) of said plastic layer can be displaced from the plane of the plastic layer toward said circuit board; and

a layer composed of a frangible material disposed on said plastic layer opposite said electrically conductive layer;

wherein said first side and said second side are connected via a hinge mechanism that can be closed to bring said frangible layer into contact with said adhesive layer after said peel-off cover has been removed, thereby sealing said bubble chambers.

42. The medication package of claim 41 wherein said electrically conductive layer is electrically coupled to said circuit board, said electrically conductive layer and said conductive traces surrounding said plurality of holes on said circuit board forming a plurality of open switches.

43. The medication package of claim 41 wherein said electrically conductive layer is composed of aluminum foil.

44. The medication package of claim 41 wherein removal of a dose of medication from a particular bubble chamber causes said portion(s) of said plastic layer obstructing the hole defined in said insulating layer and a said circuit board to be displaced toward said circuit board.

45. The medication package of claim 44 wherein the displacement of said portion(s) of said plastic layer obstructing the opening of said bubble chamber causes said electrically conductive layer to engage the conductive trace surrounding said hole in said circuit board corresponding to said bubble chamber, thereby closing said switch.

46. The medication package of claim 45 wherein said portion(s) of said plastic layer obstructing the opening of said bubble chamber are resilient and further wherein said portion(s) of said plastic layer obstructing the opening of said bubble chamber causes said electrically conductive layer to disengage from said conductive trace surrounding said hole in said circuit board corresponding to said bubble chamber when said dose of medication has been completely removed from said medication package, thereby opening said switch.

47. The medication package of claim 46 further comprising:

a logic circuit capable of determining which of said plurality of switches has been closed by a dosage removal event; and

non-volatile memory, for recording said dosage removal event.

48. The medication package of claim 47 wherein said logic circuit includes one or more central processing units and further wherein each of said conductive traces surrounding said holes in said circuit board is directly connected to one of said central processing units.

49. The medication package of claim 47 further comprising:

data transfer circuitry, enabling the transfer of data regarding dosage removal events from said non-volatile memory and the transfer of information into said non-volatile memory regarding the timing of dosage removal events

50. The medication package of claim 49 further wherein said data transfer circuitry includes an infrared LED for transferring data out of said package and an infrared detector for transferring data into said package

51. The medication package of claim 47 further comprising alarm circuitry, for alerting a user of said package to remove one or more of said doses from said package.

52. The medication package of claim 51 wherein said alarm circuitry includes an alarm mechanism selected from a group compromising an LED, a beeper and a vibrator.

53. The medication package of claim 47 further comprising:

a battery, for powering said logic circuit; and

a means for activating said logic circuit.

54. The medication package of claim 47 further comprising:

a sheet of backing material disposed on said circuit board opposite said insulating layer, said backing material having perforated openings defined therein corresponding to said openings defined in said circuit board, said perforated openings tearing open when a dose of medication is forced from a bubble chamber.

55. The medication package of claim 54 wherein said sheet of backing material is coupled to said first side of said package and acts as said hinge between said first and said second sides.

56. The medication package of claim 55 wherein said sheet of backing material is composed of stiff paper.

58. The medication package of claim 53 wherein said plurality of switches are of the momentary contact type.

59. The medication package of claim 58 further comprising:

a logic circuit capable of determining which of said plurality of switches has been closed by a dosage removal event; and

non-volatile memory, for recording said dosage removal event.

57. A medication package comprising:

a plurality of bubble chambers defined in a blister pack; and

a plurality of switches corresponding to each of said bubble chambers;

wherein a unique one of said plurality of switches is closed when a dose of medication is removed from a bubble chamber.