Prescription compliance device and method of using device

• US 6,018,289 A
• Filed: 12/15/1997
• Issued: 01/25/2000
• Est. Priority Date: 06/15/1995
• Status: Expired due to Term

• Current Assignee: Bareholdtech LLC (IP Edge LLC)
• Original Assignee: Carol M. Sekura, Ronald D. Sekura
• Inventors: Sekura, Carol M., Sekura, Ronald D.
• Primary Examiner(s): Hofsass, Jeffery A.
• Assistant Examiner(s): TWEEL JR, JOHN ALEXANDER
• Application Number:
  US08/990,811
• Time in Patent Office: 771 Days
• Field of Search: 340/309.4, 340/309.15, 368/2, 368/10, 221/2, 221/3, 221/15, 221/25
• US Class Current: 340/309.4
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0454 for dispensing of multiple drugs
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: G04G 11/00 Producing optical signals at preselected times
• CPC Class Codes: G04G 13/026 acting at a number of different times
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

A prescription compliance device which aids patients in complying with instructions given by a physician for taking prescription medication. The device reminds a patient when the next dose of medication is to he taken and indicates whether a specified dose has been taken. The device includes a microcontroller, a display, a program memory for storing pre-programmed medication-taking regimens for single and multiple medications, a real time clock, a selector for selecting one of the regimens and for programming the device as to the time and day on which a first dose of medication is to be taken, a display which alternately displays the current time and a time at which a next dose of medication is to be taken, and an alarm which alerts the patient at times when a dose of medication is to be taken. The selector includes an event switch which is activated by the patient after taking a dose of medication so as to record the taking of the medication and to cause the microcontroller to effect the display of the next time at which a dose of medication is to be taken. A memory may also be included to record the times at which a patient takes doses of medication. The device is small enough to be attached to medication containers, and includes a remote programming feature via a wireless link.

Claims

1. A prescription compliance device comprising:

microcontroller;

a program memory storing data representing a plurality of pre-programmed commonly prescribed medication-taking regimens;

a selector selecting one of said regimens and programming said device in accordance therewith; and

a display,

said selector including an event switch which is activated in conjunction with a patient taking a dose of a medication corresponding to a respective medication-taking regimen to record the taking of said medication, said event switch causing said microcontroller to effect the display of the time at which a next dose of medication is scheduled to be taken, in accordance with the regimen selected by said selector,

wherein at least one of the plurality of pre-programmed medication-taking regimens causes calculation of acceptable times during which said patient is scheduled to take said medication, and

wherein the calculated times are based on the following factors;

1) a preferred time of day at which the patient is to take a first dose of the medication;

2) a regimen specific predetermined interval of time between doses of the medication; and

3) a regimen specific predetermined time range during which it is medically acceptable for the patient to take the medication.

2. The device according to claim 1, further comprising:

an attaching mechanism for attaching said device to a medication container.

3. The device according to claim 1, further comprising:

a transmitter/receiver; and

an external transmitter/receiver configured to be connected to an input device, said external transmitter/receiver communicating with said transmitter/receiver via a wireless link to select one of said regimens and program said device in accordance therewith from remote locations.

4. The device according to claim 3, wherein said input device is a personal computer.

5. The device according to claim 3, wherein said wireless link is an infrared link.

6. The device according to claim 1, further comprising an alarm circuit alerting said patient at times when said patient is scheduled to take a dose of medication.

7. The device according to claim 1, wherein said event switch is activated to scan through regimen and programming options, and wherein said selector further includes:

a reset button rendering said device on and off; and

a function button selecting an appropriate regimen and programming options.

8. The device according to claim 7, wherein each of said regimens dictates the times at which said medication is to be taken daily or events during which said medication is to be taken, and wherein said programming options include:

a time of day at which the first dose of medication is to be taken or designation of default times in accordance with a selected regimen; and

a day of the week on which said first dose is to be taken.

9. A device according to claim 8, wherein said programming options further include:

said patient'"'"'s specified times for said events; and

a number of doses in a prescription.

10. A device according to claim 1, wherein said display comprises:

a first display area displaying a number of the regimen selected by said selector;

a second display area displaying a day of the week on which a next dose of said medication is to be taken;

a third display area displaying the time or event during which the next dose of said medication is to be taken;

a fourth display area displaying AM or PM designations for the time at which a next dose of said medication is to be taken; and

a fifth display area displaying an icon indicating the nature of the information currently displayed in said first through fourth display areas.

11. The device according to claim 10, wherein said third display area further displays the current time.

12. The device according to claim 11, wherein said third display area further displays the number of doses remaining in a prescription.

13. The device according to claim 1, wherein said display is a liquid crystal display.

14. The device according to claim 6, wherein said alarm circuit is activated if said patient takes a dose of said medication and presses said event switch more than a predetermined time before or after a time at which a next dose is scheduled to be taken.

15. The device according to claim 1, wherein said microcontroller causes said display to display a low battery indication after a predetermined number of days have elapsed.

16. The device according to claim 6, wherein said alarm circuit alerts said patient by emitting an audible signal.

17. The device according to claim 6, wherein said alarm circuit alerts said patient by emitting a visible signal.

18. The device according to claim 3, further comprising a non-volatile memory recording times at which said patient takes doses of medication when said event switch is activated, contents of said memory being accessible via said wireless link.

19. The device according to claim 18, wherein said non-volatile memory comprises an electrically erasable programmable read only memory (EEPROM).

20. The device according to claim 1, wherein at least one of said plurality of pre-programmed medication-taking regimens corresponds to a plurality of medications.

21. The device according to claim 20, wherein said event switch is further activated to view prescription information based on said pre-programmed medication-taking regimens.

22. The device according to claim 20, further comprising an alarm circuit alerting said patient at times when said patient is scheduled to take at least one of said plurality of medications.

23. The device according to claim 20, wherein prescription compliance information is generated based on said plurality of pre-programmed medication-taking regimens and said prescription compliance information is recorded.

24. The device according to claim 1, further comprising an alarm circuit providing at least one of an audio, voice and vibration indication.

25. The device according to claim 1, further comprising:

a transmitter/receiver; and

an external transmitter/receiver configured to be connected to a secondary device, said transmitter/receiver communication with said external transmitter/receiver via a wireless link to activate said secondary device to perform at least one of generating an alarm, dispensing said medication, and transmitting prescription information based on said pre-programmed medication-taking regimens to at least a third device.

67. The device according to claim 1, wherein said display is configured to identify the medication corresponding to the respective medication-taking regimen.

26. A prescription compliance device comprising:

control means;

program memory means for storing data representing a plurality of pre-programmed commonly prescribed medication-taking regimens;

select means for selecting one of said regimens and programming said device in accordance therewith; and

display means,

said select means including an event switch which is activated in conjunction with a patient taking a dose of a medication corresponding to a respective medication-taking regimen for recording the taking of said medication, said event switch causing said control means to effect the display of the time at which a next dose of medication is scheduled to be taken, in accordance with the regimen selected by said select means,

wherein at least one of the plurality of pre-programmed medication-taking regimens causes calculation of acceptable times during which said patient is scheduled to take said medication, and

wherein the calculated times are based on the following factors;

1) a preferred time of day at which the patient is to take a first dose of the medication;

2) a regimen specific predetermined interval of time between doses of the medication; and

3) a regimen specific predetermined time range during which it is medically acceptable for the patient to take the medication.

27. The device according to claim 26, further comprising:

attach means for attaching said device to a medication container.

28. The device according to claim 26, further comprising:

transmitter/receiver means; and

external transmitter/receiver means configured to be connected to an input device, for communicating with said transmitter/receiver means via a wireless link to select one of said regimens and program said device in accordance therewith from remote locations.

29. The device according to claim 28, wherein said wireless link is an infrared link.

30. The device according to claim 28, wherein said input device is a personal computer.

31. The device according to claim 28, further comprising non-volatile memory means for recording times at which said patient takes doses of said medication when said event switch is activated, contents of said memory means being accessible via said wireless link.

32. The device according to claim 31, wherein said non-volatile memory means comprises an electrically erasable programmable read only memory (EEPROM).

33. The device according to claim 26, wherein said event switch is activated to scan through regimen and programming options, and wherein said select means further includes:

a reset button for rendering said device on and off; and

a function button for selecting an appropriate regimen and programming options.

34. The device according to claim 27, wherein each of said regimens dictates the times at which said medication is to be taken daily or events during which said medication is to be taken, and wherein said programming options include:

a time of day at which the first dose of medication is to be taken or designation of default times in accordance with a selected regimen; and

a day of the week on which said first dose is to be taken.

35. A device according to claim 34, wherein said programming options further include:

said patient'"'"'s specified times for said events; and

a number of doses in a prescription.

36. A device according to claim 26, wherein said display means comprises:

a first display area displaying a number of the regimen selected by said selector;

a second display area displaying a day of the week on which a next dose of said medication is to be taken;

a third display area displaying the time or event during which the next dose of said medication is to be taken;

a fourth display area displaying the time at which a next dose of said medication is to be taken; and

a fifth display area displaying an icon indicating the nature of the information currently displayed in said first through fourth display areas.

37. The device according to claim 36, wherein said third display area further displays the current time.

38. The device according to claim 37, wherein said third display area further displays the number of doses remaining in a prescription.

39. The device according to claim 26, wherein said display means comprises a liquid crystal display.

40. The device according to claim 26, further comprising alarm means for alerting said patient at times when said patient is scheduled to take a dose of said medication.

41. The device according to claim 40, wherein said alarm means is activated if said patient takes a dose of said medication and presses said event switch more than a predetermined time before or after a time at which a next dose is scheduled to be taken.

42. The device according to claim 26, wherein said control means causes said display means to display a low battery indication after a predetermined number of days have elapsed.

43. The device according to claim 40, wherein said alarm means alerts said patient by emitting an audible signal.

44. The device according to claim 40, wherein said alarm means alerts said patient by emitting a visible signal.

68. The device according to claim 26, wherein said display means identifies the medication corresponding to the respective medication-taking regimen.

45. A method of operating a prescription compliance device, comprising the steps of:

(a) switching said device to a setup state;

(b) programming the current time into said device;

(c) selecting one of a plurality of pre-programmed commonly prescribed medication-taking regimens;

(d) programming a time of day a first dose of medication is to be taken in accordance with the selected regimen;

(e) switching said device from a setup state to an operation state; and

(f) indicating to said device that a dose of medication has been taken,

wherein at least one of the plurality of pre-programmed medication-taking regimens causes calculation of acceptable times during which said patient is scheduled to take said medication, and

wherein the calculated times are based on the following factors;

1) a preferred time of day at which the patient is to take a first dose of the medication;

2) a regimen specific predetermined interval of time between doses of the medication; and

3) a regimen specific predetermined time range during which it is medically acceptable for the patient to take the medication.

46. The method according to claim 45, further comprising the steps of:

(g) programming a day of the week on which said first dose of medication is to be taken;

(h) programming a number of doses in a prescription; and

(i) switching said device from an operation state to an off state after said prescription has been nearly exhausted.

47. The method according to claim 45, wherein said step (b) is executed by activating an event switch to scan through times as displayed on a display, and activating a function button to select the current time when displayed.

48. The method according to claim 45, wherein said step (c) is executed by activating an event switch to scan through said pre-programmed regimens as displayed on a display, and activating a function button to select an appropriate regimen when displayed.

49. The method according to claim 45, wherein said step (d) is executed by activating an event switch to scan through times or events as displayed on a display, and activating a function button to select an appropriate time or event when displayed, or activating an event switch to designate pre-programmed default times in accordance with a selected regimen.

50. The method according to claim 46, wherein said step (g) is executed by activating an event switch to scan through days of the week as displayed on a display, and activating a function button to select an appropriate day when displayed.

51. The method according to claim 46, wherein said step (h) is executed by activating an event switch to scan through numbers as displayed on a display, and activating a function button to select an appropriate number when displayed.

52. The method according to claim 45, wherein said step (e) is executed by activating an event switch after one of said regimens has been selected and said device has been programmed.

53. The method according to claim 45, wherein said step (f) is executed by activating an event switch after a dose of medication has been taken so as to cause said device to display a time at which a next dose of said medication is to be taken.

54. The method according to claim 46, wherein said steps (a)-(i) are executed by activating an input device which communicates with said prescription compliance device.

55. The method according to claim 54, wherein said input device communicates with said prescription compliance device via a wireless link.

56. The method according to claim 55, wherein said wireless link is an infrared link.

57. The method according to claim 55, further comprising the step of recording times at which doses of medication are taken when said event switch is activated.

58. The method according to claim 56, further comprising the step of accessing the recorded times via said wireless link.

69. The method according to claim 45, wherein the prescription compliance device includes a display configured to identify the medication.

70. The method according to claim 46, wherein said steps (a) and (i) are executed by activating a reset button.

59. A prescription compliance device comprising:

microcontroller;

a program memory storing data representing a plurality of pre-programmed medication-taking regimens;

a selector selecting one of said regimens and programming said device in accordance therewith;

a display;

an alarm circuit alerting a patient at times when said patient is scheduled to take a dose of medication,

wherein said selector includes an event switch which is activated by said patient after taking a dose of said medication to record the taking of said medication, said event switch causing said microcontroller to effect the display of the time at which a next dose of said medication is scheduled to be taken, in accordance with the regimen selected by said selector, and

wherein said alarm circuit is activated if said patient takes a dose of said medication and presses said event switch more than a predetermined time before or after a time at which a next dose is scheduled to be taken.

60. A prescription compliance device comprising:

control means;

program memory means for storing data representing a plurality of pre-programmed medication-taking regimens;

select means for selecting one of said regimens and programming said device in accordance therewith;

display means;

alarm means for alerting a patient at times when said patient is scheduled to take a dose of said medication,

wherein said select means includes an event switch which is activated by said patient after taking a dose of said medication for recording the taking of said medication, said event switch causing said control means to effect the display of the time at which a next dose of said medication is scheduled to be taken, in accordance with the regimen selected by said select means, and

wherein said alarm means is activated if said patient takes a dose of said medication and presses said event switch more than a predetermined time before or after a time at which a next dose is scheduled to be taken.

61. A prescription compliance system, comprising:

a prescription compliance device configured to indicate when a prescription is to be administered;

a patient identifying device configured to identify a patient taking the prescription; and

a recorder configured to record received signals from the prescription compliance device and the patient identifying device,

wherein the prescription compliance device transmits a signal directly or indirectly to the patient identifying device and the recorder when the prescription is to be taken or has been taken,

the patient identifying device transmits a patient identification signal to the recorder when the patient has taken the prescription, and

the recorder records the signals transmitted by the prescription compliance device and the patient identifying device so as to confirm that the prescription was taken by the identified patient.

62. The system according to claim 61, wherein a location of the recorder is identified allowing correlation of the prescription-taking event with the patient and the location.

63. A prescription compliance system, comprising:

prescription compliance means for indicating when a prescription is to be administered;

patient identifying means for identifying a patient taking the prescription; and

recorder means for recording received signals from the prescription compliance means and the patient identifying means,

wherein the prescription compliance means transmits a signal directly or indirectly to the patient identifying means and the recorder means when the prescription is to be taken or has been taken,

the patient identifying means transmits a patient identification signal to the recorder means when the patient has taken the prescription, and

the recorder means records the signals transmitted by the prescription compliance means and the patient identifying means so as to confirm that the prescription was taken by the identified patient.

64. The system according to claim 63, wherein a location of the recorder is identified allowing correlation of the prescription-taking event with the patient and the location.

65. A prescription compliance method, comprising the steps of:

transmitting, by a prescription compliance device, a signal directly or indirectly to a patient identifying device and a recorder when a prescription is to be administered or has been administered;

transmitting a patient identification signal to the recorder when the patient has taken the prescription;

recording the signals transmitted by the prescription compliance device and the patient identifying device; and

confirming that the prescription was taken by the identified patient by correlating the recorded signals.

66. The method according to claim 65, further comprising the steps of:

identifying a location of the recorder; and

correlating the prescription-taking event with the patient and the location.