Prescription compliance device and metod of using device

• US 20050041531A1
• Filed: 06/24/2002
• Published: 02/24/2005
• Est. Priority Date: 06/22/2001
• Status: Active Grant

• Current Assignee: Bareholdtech LLC (IP Edge LLC)
• Original Assignee: Ronald D. Sekura
• Inventors: Sekura, Ronald D.
• Granted Patent: US 7,330,101 B2
• Time in Patent Office: Days
• US Class Current: 368/10
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/04 Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• 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: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

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 be 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 de 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 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 also 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 the microcontroller recalculates the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

2. The device according to claim 1, wherein at least one of the medication-taking regimens includes at least one of an early take window and late take window respectively allowing the patient to take the next dose of medication within medically acceptable times before and after the next dose of medication is to be taken.

3. The device according to claim 1, wherein the microcontroller recalculates the early take window and late take window based on the last time the dose of medication was taken in conjunction with the time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

4. The device according to claim 1, wherein the prescription compliance device is integrated with a cell phone or personal digital assistant (PDA).

5. 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.

6. The device according to claim 5, wherein the time the next dose of medication may be adjusted via the remote location.

7. The device according to claim 5, wherein said input device is a personal computer.

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

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

a trip function configured to indicate how much medication is needed to be taken between a start date and an end date and whether any medications need to be renewed before the end date.

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

a skip function configured to allow the patient to skip taking the next dose of medication.

11. The device according to claim 1, wherein the device is programmed to alert the patient to perform a task different than taking the next dose of medication.

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

a log database configured to record medications taken or skipped and related information input by the patient.

13. The device according to claim 1, 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.

14. The device according to claim 11, further comprising:

a log data base configured to record information entered by the patient corresponding to the additional task performed.

15. 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.

16. 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 selection button selecting an appropriate regimen and programming options.

17. The device according to claim 16, 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.

18. A device according to claim 17, wherein said programming options further include:

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

a number of doses in a prescription.

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

a first display area displaying a name of the medication;

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.

20. The device according to claim 19, wherein said third display area further displays the current time.

21. The device according to claim 20, wherein said third display area further displays the number of doses remaining in a prescription.

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

23. The device according to claim 1, wherein said microcontroller causes said display to display a low battery indication when a measured voltage is below a predetermined low voltage value.

24. The device according to claim 15, wherein said alarm circuit alerts said patient by emitting an audible signal.

25. The device according to claim 15, wherein said alarm circuit alerts said patient by emitting a visible signal.

26. The device according to claim 5, 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.

27. The device according to claim 26, wherein said non-volatile memory comprises an electrically erasable programmable read only memory (EEPROM).

28. The device according to claim 1, wherein a plurality of medications using at least one of the plurality of preprogrammed medication-taking regimens.

29. The device according to claim 28, wherein said event switch is further activated to view prescription information based on said pre-programmed medication-taking regimens.

30. The device according to claim 28, 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.

31. The device according to claim 28, wherein prescription compliance information is generated based on said plurality of pre-programmed medication-taking regimens and said prescription compliance information is recorded.

32. The device according to claim 28, wherein at least one of said plurality of pre-programmed medication-taking regimens calculates times when said patient is scheduled to take at least one of said plurality of medication based on predetermined time intervals and a time a first dose of said medication is to be taken.

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

34. 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.

35. The device according to claim 1, wherein said display comprises:

a first display area which alternately displays alerts, alarms and notifications, menu selections and secondary information;

a second display area which alternately displays the name of the medication, the name of the regimen and secondary information;

a third display area which alternately displays the day of the week and time, and secondary information;

a fourth display area which provides a special alert message and secondary information,

wherein the secondary information includes at least one of the calendar date, the patient name, the patient phone number, an icon indicating the nature of the information currently displayed in the other display areas, AM, PM designations, historical data stored in the memory, codes describing displayed information, and advice on how medication is to be taken.

36. 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 the control means recalculates the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

37. The device according to claim 36, wherein at least one of the medication-taking regimens includes at least one of an early take window and late take window respectively allowing the patient to take the next dose of medication within medically acceptable times before and after the next dose of medication is to be taken.

38. The device according to claim 36, wherein the microcontroller recalculates the early take window and late take window based on the last time the dose of medication was taken in conjunction with the time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

39. The device according to claim 36, wherein the prescription compliance device is integrated with a cell phone or personal digital assistant (PDA).

40. The device according to claim 36, further comprising:

transmitter/receiver means; and

external transmitter/receiver means 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.

41. The device according to claim 40, wherein the time the next dose of medication may be adjusted via the remote location.

42. The device according to claim 40, wherein said input device is a personal computer.

43. The device according to claim 40, wherein said wireless link is an infrared link.

44. The device according to claim 36, further comprising:

trip means for indicating how much medication is needed to be taken between a start date and an end date and whether any medications need to be renewed before the end date.

45. The device according to claim 36, further comprising:

skip means for allowing the patient to skip taking the next dose of medication.

46. The device according to claim 36, wherein the device is programmed to instruct the patient to perform a task in addition to taking the next dose of medication.

47. The device according to claim 36, further comprising:

log means for recording medications taken or skipped and related information input by the patient.

48. The device according to claim 36, 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.

49. The device according to claim 46, further comprising:

log means for recording information entered by the patient corresponding to the additional task performed.

50. The device according to claim 40, wherein said wireless link is an infrared link.

51. The device according to claim 40, wherein said input device is a personal computer.

52. The device according to claim 40, 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.

53. The device according to claim 52, wherein said non-volatile memory means comprises an electrically erasable programmable read only memory (EEPROM).

54. The device according to claim 36, 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.

55. The device according to claim 54, 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.

56. A device according to claim 55, wherein said programming options further include:

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

a number of doses in a prescription.

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

a first display area displaying a name of the medication;

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.

58. The device according to claim 57, wherein said third display area further displays the current time.

59. The device according to claim 58, wherein said third display area further displays the number of doses remaining in a prescription.

60. The device according to claim 36, wherein said display means comprises a liquid crystal display.

61. The device according to claim 36, further comprising alarm means for alerting said patient at times when said patient is scheduled to take a dose of said medication.

62. The device according to claim 36, wherein said control means causes said display means to display a low battery indication when a measured voltage is below a predetermined low voltage value.

63. The device according to claim 61, wherein said alarm means alerts said patient by emitting an audible signal.

64. The device according to claim 61, wherein said alarm means alerts said patient by emitting a visible signal.

65. The device according to claim 36, wherein said display means comprises:

a first display area which alternately displays alerts, alarms and notifications, menu selections and secondary information;

a second display area which alternately displays the name of the medication, the name of the regimen and secondary information;

a third display area which alternately displays the day of the week and time, and secondary information;

a fourth display area which provides a special alert message and secondary information,

wherein the secondary information includes at least one of the calendar date, the patient name, the patient phone number, an icon indicating the nature of the information currently displayed in the other display areas, AM, PM designations, historical data stored in the memory, codes describing displayed information, and advice on how medication is to be taken.

66. 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;

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

(g) recalculating the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

67. The method according to claim 66, wherein at least one of the medication-taking regimens includes at least one of an early take window and late take window respectively allowing the patient to take the next dose of medication within medically acceptable times before and after the next dose of medication is to be taken.

68. The method according to claim 66, wherein said step (g) recalculates the early take window and late take window based on the last time the dose of medication was taken in conjunction with the time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

69. The method according to claim 66, wherein the prescription compliance device is integrated with a cell phone or personal digital assistant (PDA).

70. The method according to claim 66, further comprising the step of:

communicating with a transmitter/receiver of the device via a wireless link to select one of said regimens and program said device in accordance therewith from remote locations.

71. The method according to claim 70, wherein the time the next dose of medication may be adjusted via the remote location.

72. The method according to claim 70, wherein said input device is a personal computer.

73. The method according to claim 70, wherein said wireless link is an infrared link.

74. The method according to claim 66, further comprising the step of:

indicating how much medication is needed to be taken between a start date and an end date and whether any medications need to be renewed before the end date.

75. The method according to claim 66, further comprising the step of:

allowing the patient to skip taking the next dose of medication.

76. The method according to claim 66, further comprising the step of:

instructing the patient to perform a task in addition to taking the next dose of medication.

77. The method according to claim 66, further comprising the step of:

recording medications taken or skipped and related information input by the patient.

78. The method according to claim 66, 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.

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

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

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

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

80. The method according to claim 66, wherein said step (b) is executed by activating an event switch to scan through times as displayed on a display, and activating a selection button to select the current time when displayed.

81. The method according to claim 66, 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 selection button to select an appropriate regimen when displayed.

82. The method according to claim 66, 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 selection 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.

83. The method according to claim 79, wherein said step (h) 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.

84. The method according to claim 79, wherein said step (i) is executed by activating an event switch to scan through numbers as displayed on a display, and activating a selection button to select an appropriate number when displayed.

85. The method according to claim 66, 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.

86. The method according to claim 66, 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.

87. The method according to claim 79, wherein said steps (a)-(j) are executed by activating an input device which communicates with said prescription compliance device.

88. The method according to claim 87, wherein said input device communicates with said prescription compliance device via a wireless link.

89. The method according to claim 88, wherein said wireless link is an infrared link.

90. The method according to claim 88, further comprising the step of recording times at which doses of medication are taken when said event switch is activated.

91. The method according to claim 90, further comprising the step of accessing the recorded times via said wireless link.

92. A computer program product for operating a prescription compliance device, comprising the steps of:

(a) a first computer code configured to switch said device to a setup state;

(b) a second computer code configured to program the current time into said device;

(c) a third computer code configured to select one of a plurality of pre-programmed commonly prescribed medication-taking regimens;

(d) a fourth computer code configured to program a time of day a first dose of medication is to be taken in accordance with the selected regimen;

(e) a fifth computer code configured to switch said device from a setup state to an operation state;

(f) a sixth computer code configured to indicate to said device that a dose of medication has been taken; and

(g) a seventh computer code configured to recalculate the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

93. The computer program product according to claim 92, wherein at least one of the medication-taking regimens includes at least one of an early take window and late take window respectively allowing the patient to take the next dose of medication within medically acceptable times before and after the next dose of medication is to be taken.

94. The computer program product according to claim 92, wherein said seventh computer code recalculates the early take window and late take window based on the last time the dose of medication was taken in conjunction with the time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

95. The computer program product according to claim 92, wherein the prescription compliance device is integrated with a cell phone or personal digital assistant (PDA).

96. The computer program product according to claim 92, further comprising:

an eighth computer code configured to communicate with a transmitter/receiver of the device via a wireless link to select one of said regimens and program said device in accordance therewith from remote locations.

97. The computer program product according to claim 96, wherein the time the next dose of medication may be adjusted via the remote location.

98. The computer program product according to claim 96, wherein said input device is a personal computer.

99. The computer program product according to claim 96, wherein said wireless link is an infrared link.

100. The computer program product according to claim 92, further comprising:

an eighth computer code configured to indicate how much medication is needed to be taken between a start date and an end date and whether any medications need to be renewed before the end date.

101. The computer program product according to claim 92, further comprising:

an eighth computer code configured to allow the patient to skip taking the next dose of medication.

102. The computer program product according to claim 92, further comprising:

an eighth computer code configured to indicate the patient to perform a task in addition to taking the next dose of medication.

103. The computer program product according to claim 92, further comprising:

an eighth computer code configured to record medications taken or skipped and related information input by the patient.

104. The computer program product according to claim 92, 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.

105. The computer program product according to claim 92, further comprising:

(h) an eighth computer code configured to program a day of the week on which said first dose of medication is to be taken;

(i) a ninth computer code configured to program a number of doses in a prescription; and

(j) a tenth computer code configured to switch said device from an operation state to an off state after said prescription has been nearly exhausted.

106. The computer program product according to claim 92, wherein said second computer code is executed by activating an event switch to scan through times as displayed on a display, and activating a selection button to select the current time when displayed.

107. The computer program product according to claim 92, wherein said third computer code is executed by activating an event switch to scan through said pre-programmed regimens as displayed on a display, and activating a selection button to select an appropriate regimen when displayed.

108. The computer program product according to claim 92, wherein said fourth computer code is executed by activating an event switch to scan through times or events as displayed on a display, and activating a selection 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.

109. The computer program product according to claim 105, wherein said eighth computer code 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.

110. The computer program product according to claim 105, wherein said ninth computer code is executed by activating an event switch to scan through numbers as displayed on a display, and activating a selection button to select an appropriate number when displayed.

111. The computer program product according to claim 92, wherein said fifth computer code is executed by activating an event switch after one of said regimens has been selected and said device has been programmed.

112. The computer program product according to claim 92, wherein said sixth computer code 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.

113. The computer program product according to claim 105, wherein said first to tenth computer codes are executed by activating an input device which communicates with said prescription compliance device.

114. The computer program product according to claim 113, wherein said input device communicates with said prescription compliance device via a wireless link.

115. The method according to claim 114, wherein said wireless link is an infrared link.

116. The method according to claim 114, further comprising the step of recording times at which doses of medication are taken when said event switch is activated.

117. The method according to claim 116, further comprising an eleventh computer code configured to access the recorded times via said wireless link.