Programmable control means for providing safe and controlled medication infusion

• US 4,731,051 A
• Filed: 02/15/1983
• Issued: 03/15/1988
• Est. Priority Date: 04/27/1979
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University of Baltimore Maryland
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jaworski, F.
• Application Number:
  US06/466,494
• Time in Patent Office: 1,855 Days
• Field of Search: 128/DIG. 12, 128/DIG. 13, 604/891, 604/131, 604/65-66, 604/31, 604/50, 604/67, 604/245
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An implantable programmable infusion pump (IPIP) is disclosed and generally includes: a fluid reservoir filled with selected medication; a pump for causing a precise volumetric dosage of medication to be withdrawn from the reservoir and delivered to the appropriate site within the body; and, a control means for actuating the pump in a safe and programmable manner. The control means includes a microprocessor, a permanent memory containing a series of fixed software instructions, and a memory for storing prescription schedules, dosage limits and other data. The microprocessor actuates the pump in accordance with programmable prescription parameters and dosage limits stored in the memory. A communication link allows the control means to be remotely programmed. The control means incorporates a running integral dosage limit and other safety features which prevent an inadvertent or intentional medication overdose. The control means also monitors the pump and fluid handling system and provides an alert if any improper or potentially unsafe operation is detected.

Claims

1. A medication infusion apparatus having a controller to actuate a pump means, said controller comprising:

a memory means for storing a basal prescription program, said basal prescription program automatically requesting basal delivery of medication to change to preset rates at pre-programmed intervals during a significant periodic physiologic cycle;

a basal delivery means operably coupled to said memory means and said pump means for actuating said pump means in accordance with said basal prescription program, thereby generating a programmed basal dosage profile;

a second memory means for storing supplemental prescription schedules, each of said supplemental prescription schedules comprising a program to sequence pump means actuation over preselected time intervals;

a patient supplemental command means for selecting one of said supplemental prescription schedules from said second memory means, said patient supplemental command means being manually initiated by the patient;

a supplemental delivery means for actuating said pump means in accordance with said selected supplemental prescription schedule, wherein said pump means causes a fixed volumetric dosage of medication to be delivered with each pump means actuation; and

,

a running integral dosage limiting means operably coupled to said basal delivery means and supplemental delivery means for creating and updating a current shifting time window of preselected length, for summing the number of pump means actuation occurring within said current time window of preselected length and for inhibiting pump means actuation while said sum exceeds a running integral dose limit.

2. The apparatus as in claim 1 further comprising a physician command means for programming said running integral dose limiting means with at least one running integral dosage limit, said physician command means being manually.

3. The apparatus of claim 1, wherein said time window of preselected length is a three (3) hour window and wherein runing integral dosage limiting means sums the number of pump means actuations occurring in the most recent 3-hour time period, and inhbiits pump means actuation if said sum exceeds a 3-hour running integral dosage limit.

4. The apparatus of claim 3, wherein said running integral dosage limiting means further comprises a second inhibiting means for summing the number of pump means actuations occurring in the most recent 24-hour time period and inhibiting pump means actuation if said sum exceeds a 24-hour running integral dosage limit.

5. The apparatus of claim 1, wherein each actuation of said pump means delivers a fixed volumetric dosage of medication and wherein said running integral dosage limiting means comprises a means responsive to actual pump means operation for summing the number of actual operations of said pump means within said current time window.

6. The apparatus of claim 1 wherein each actuation of said pump means delivers a fixed volumetric dosage of medication and wherein said basal delivery means and said supplemental prescription delivery means comprises a means for generating an actuation request for each intended pump means actuation, and wherein said running integral dosage limiting means comprises a means for summing the number of actuation requests generated within said current time window.

7. A medication infusion apparatus having a controller to actuate a pump means, said controller comprising:

a memory means for storing a basal prescription program, said basal prescription program automatically requesting basal delivery of medication to change to preset rates at pre-programmed intervals during a significant periodic physiologic cycle;

a basal delivery means operably coupled to said memory means and said pump means for actuating said pump means in accordance with said basal prescription program, thereby generating a programmed basal dosage profile; and

,

a hardwired incremental integrating rate limit means for inhibiting pump means actuation when a certain maximum dosage envelope is exceeded.

8. A medication infusion system having a controller to actuate a pump for injection of medication into a selected site in a patient, said controller comprising:

a delivery means for actuating said pump in accordance with a selectable dosage schedule; and

,

a limiting means for monitoring medication delivery and for inhibiting actuation of said pump by said delivery means when said medication delivery exceeds a dosage limit.

9. The apparatus of claim 8, wherein said limiting means comprises:

a running integral dosage limiting means for creating and updating a current shifting time window of preselected length, for determining the amount of medication delivery by said medication infusion system said current time window of preselected length and for inhibiting actuation of said pump while said determined amount exceeds a running integral dosage limit.

10. The apparatus of claim 9, wherein each actuation of said pump delivers a fixed volumetric dosage of medication, and wherein said running integral dosage limiting means comprises a means for summing the number of pump actuations within said current time window to determine the amount of medication delivery in said current time window.

11. The apparatus of claim 9 or 10, wherein said running integral dosage limiting means includes a programmable means for variably adjusting said running integral dosage limit.

12. The apparatus of claim 9 wherein with each actuation of said pump said pump operates to deliver a fixed volumetric dosage of medication and wherein said running integral dosage limiting means comprises a means responsive to pump operation for summing the number of actuations of said pump within said current time window to determine said amount of medication delivery in said current time window.

13. The apparatus of claim 8, wherein said limiting means comprises:

an incremental integrating rate limiting means for inhibiting pump actuation when a certain maximum dosage envelope is exceeded.

14. The apparatus of claim 8, wherein said limiting means further comprises an incremental integrating rate limiting means, said incrmental integrating rate limiting means comprising:

a pump monitor means for providing a pulse each time said pump delivers a fixed volumetric dosage of medication;

a clock capable of delivering N pulses per hour; and

, counter means for storing M counts, operably connected to said clock and said pump monitor means, said counter means initially set at M counts, wherein said counter means includes a means for reducing said counter means by one count for each pulse from said pump monitor means, and a means for increasing said counter means by one count up to the maximum M count for each pulse from said clock, and wherein said counter means further includes a means for inhibiting pump actuation when said count is zero.

15. The apparatus of claim 14, wherein each actuation of said pump delivers a fixed volumetric dosage of medication, and wherein said pump monitor means provides a pulse for each pump actuation attempted by said delivery means.

16. The apparatus of claim 14, wherein said updown counter includes a means for variably adjusting the maximum storage capacity M of said updown counter.

17. The apparatus of claim 14, wherein said clock includes a means for variably adjusting the pulse per hour rate N of said clock.

18. The apparatus of claim 8, wherein said delivery means further comprises:

a memory;

a first control means operably associated with said memory and manually operable for storing a plurality of dosage schedules in said memory;

a second control means operably associated with said memory and said first control means and manually operable for selecting one of said dosage schedules stored in said memory, wherein said delivery means activates said pump in accordance with said selected dosage schedule.

19. The apparatus of claim 8, wherein said delivery means further comprises a means manually operable for selecting a predetermined dosage schedule, said predetermined dosage schedule causing said pump to be actuated in accordance with a certain sequence;

and, a control means manually operably for modifying said sequence of pump actuations within certain predetermined limits.

20. The apparatus of claim 8, wherein each actuation of said pump delivers a fixed volumetric dosage of medication, wherein said delivery means comprises a means for generating an actuation command for each intended pump actuation in accordance with said selectable dosage schedule, and wherein said limiting means comprises a running integral dosage limiting means for creating and updating a current shifting time window of preselected length, for summing the number of actuation commands generated within said current time window to determine said medication delivery and for inhibiting actuation of said pump while said sum exceeds a running integral dosage limit.

21. The apparatus of claim 20, said implanted portion further comprising:

at least one monitor means for detecting an anomaly in the medication infusion system;

an alarm means; and

,

an anomaly alert means for periodically reviewing said at least one monitor and for actuating said alarm means if an anomaly is detected.

22. The apparatus of claim 21, wherein said anomaly monitor means comprises a means for detecting the presence of moisture in a particular portion of said medication infusion system.

23. The apparatus of claim 21, wherein said anomaly monitor means comprises a means for detecting when said reservoir is empty.

24. The apparatus of claim 21, wherein said anomaly monitor means comprises a means for detecting when said reservoir is too full.

25. The apparatus of claim 21, wherein said anomaly monitor means comprises a means for counting the number of actual pump actuations, for counting the number of times the basal and supplemental delivery means request an actuation of said pump means, and for generating an alert signal when there is a discrepancy between said actual pump actuation means count and said basal and supplemental delivery means requested actuation count.

26. The apparatus of claim 21, wherein said anomaly alerting means further comprises a means for checking supplemental prescriptions schedules stored in said memory means, and determining if said supplemental prescription schedules have been altered.

27. The apparatus of claim 21, wherein said anomaly alert means comprises a means for confirming an anomaly by requiring two consecutive anomaly reports from said at least one monitor means before actuating said alarm means.

28. The apparatus of claim 21, wherein said alarm means generates an audio signal.

29. The apparatus of claim 21, wherein said alarm means generates a subcutaneous electrical stimulation.

30. A medication infusion system having a controller to actuate an infusion pump means for infusion of medication into a selected site in a patient, said controller comprising:

a microprocessor;

a pump means operably controlled by said microprocessor for selectively delivering medication to said patient;

a memory means operably associated with said microprocessor for storing prescription parameters; and

wherein said microprocessor comprises;

a control means operably connected to said memory means for selecting at least one of said prescription parameters from said memory means;

a delivery state subroutine means for providing actuation commands to said pump means in accordance with said at least one selected prescription parameter, and;

a limiting means operably coupled to said delivery state subroutine means for inhibiting said pump means actuation commands when medication delivery requested by said delivery state subroutine means exceeds a dosage limit.

31. The apparatus of claim 30 wherein said microprocessor further comprises:

an interrupt subroutine means for storing said prescription parameters into said memory means, said prescription parameters including at least one prescription schedule and a selection code, wherein said selection code causes said interrupt subroutine means to assign a particular one of said at least one prescription schedule to be processed by said delivery state subroutine means.

32. The apparatus of claim 30 or 31, wherein said limiting means comprises:

a means for creating and updating a current shifting time window of preselected length;

a summing means response to said means for creating and updating for counting the number of pump means actuation commands made by said delivery state subroutine means during the most recent shifting time window of preselected length, each actuation of said pump means delivering a fixed volumetric dosage of medication; and

, a means for inhibiting actuation of said pump means by said delivery state subroutine means while said sum exceeds a runnning integral dosage limit.

33. A method of infusing medication into a patient, wherein a controller actuates a pump in accordance with a prescription schedule, said method comprising the steps of:

recording prescription schedules in a memory associated with said controller;

selecting from said memory a particular one of said prescription schedules to be delivered by said controller;

delivering medication in accordance with said selected prescription schedule, wherein said controller applies an actuating voltage to said pump at the appropriate times indicated in said selected prescription schedule, said pump causing a fixed volumetric dosage of medication to be delivered with each actuation of said pump;

creating and updating a shifting time window of preselected length to generate a current time window;

summing the number of times said actuating voltage is applied to said pump by said controller during said current time window; and

,

inhibiting actuation of said pump while said sum exceeds a dosage limit.

34. The method of claim 33, wherein said dosage limit is fixed.

35. The method of claim 33, further comprising the step of setting the value of said dosage limit.

36. The method of claim 33, further comprising the step of programming the value of said dosage limit.

37. The method of claim 33 further comprising the step of:

programming said dosage limit, wherein said programming step is restricted so that only attending medical staff can program said dosage limit.

38. The method of claim 33, wherein said inhibiting step further comprises inhibiting pump actuation when a maximum dosage envelope is exceeded.

39. The method of claim 38, wherein said step of inhibiting pump actuation when a maximum dosage envelope is exceeded, further comprises the steps of:

setting an updown counter with a maximum M count;

subtracting one count from said updown counter each time said pump is operated;

adding one count to said updown counter at a clocking rate of N counts per hour until said updown counter reaches said maximum count of M; and

,

inhibiting pump actuation while said updown counter has a count of zero.

40. The method of claim 39, wherein said maximum count M and said clocking rate of N counts per hour, are set prior to assembly of said medication infusion system.

41. The method of claim 39, further comprising the step of setting said clocking rate to deliver N counts per hour.

42. The method of claim 41, wherein said maximum count M and said clocking rate of N counts per hour are set by the attending medical staff.

43. The method of claim 39, further comprising the step of programming said maximum count M and said clocking rate of N counts per hour, wherein said step is restricted so that only attending medical staff can program said maximum count M an said clocking rate of N counts per hour.

44. A method for limiting the amount of medication delivered to a patient by a medication infusion system, wherein said medication infusion system comprises a controller to actuate a pump in accordance with parameters, said method comprising the steps of:

creating and updating a shifting time window of preselected length to generate a current time window;

determining the amount of medication delivery by said medication infusion system during said current time window to generate a current dosage sum; and

,

inhibiting actuation of said pump while said sum exceeds a dosage limit.

45. The method of claim 44, wherein each actuation of said pump delivers a fixed volumetric dosage of medication, and said step of determining the amount of medication delivery is enacted by summing the number of pump actuations during said current time window.

46. The method of claim 45, wherein said step of summing pump actuations involves summing the number of times said pump operates.

47. The method of claim 45, wherein said step of summing pump actuations involves summing intended actuations of said pump by said controller.

48. The method of claim 44, wherein said dosage limit is set prior to assembly of said medication infusion system.

49. The method of claim 44, further comprising the step of selecting the value of said dosage limit.

50. The method of claim 44 further comprises the step of programming said dosage limit, wherein said step is restricted so that only attending medical staff can program said dosage limit.

59. The method of claim 44 or 51, wherein said medication infusion system is adaptable to be implanted in said patient.

60. The method of claim 44 or 51, wherein said medication infusion system is adaptable to be located external to said patient.

69. The apparatus of claim 60, wherein said running integral dosage limiting means comprises a means for summing the number of pump means actuations occurring in the most recent 24-hour time period, and for inhibiting pump actuation if said sum exceeds a 24-hour running integral dosage limit.

51. A method for limiting the amount of medication delivered to a patient by a medication infusion system, wherein said medication infusion system comprises a controller to actuate a pump in accordance with prescription parameters, said method comprising the steps of:

setting an updown counter with a maximum M count;

subtracting one count from said updown counter each time said pump causes a fixed volumetric dosage of medication to be delivered;

adding counts to said updown counter at a clocking rate of N counts per hour until said updown counter reaches said maximum count of M; and

,

inhibiting pump actuation while said updown counter has a count of zero.

52. The method of claim 51, wherein each actuation of said pump delivers a fixed volumetric dosage of medication, and wherein said step of subtracting involves subtracting one count from said updown counter for each pump actuation.

53. The method of claim 52, wherein said step of subtracting involves subtracting one count each time said pump operates.

54. The method of claim 52, wherein said step of subtracting involves subtracting one count for each intended actuation of said pump by said controller.

55. The method of claim 51 or 52, wherein said maximum count M and said clocking rate of N counts per hour are set prior to assembly of said medication infusion system.

56. The method of claim 51 or 52, wherein said maximum count M and said clocking rate of N counts per hour are set by attending medical staff.

57. The method of claim 51 or 52, further comprising the step of setting the value of said clocking rate.

58. The method of claim 51, further comprising the step of programming said maximum count M and said clocking rate of N counts per hour, wherein said programming step is restricted so that only attending medical staff can program said maximum count M and said clocking rate of N counts per hour.

61. A medication infusion apparatus having a controller to actuated a pump means, said controller comprising:

a memory means for storing a basal prescription program, said basal prescription program automatically requesting basal delivery of medication to change to preset rates at pre-programmed intervals during a significant periodic physiologic cycle;

a basal delivery means operable coupled to said memory means and said pump means for actuating said pump means in accordance with said basal prescription program, thereby generating a programmed basal dosage profile;

a second memory means for storing supplemental prescription schedules, each of said supplemental prescription schedules comprising a program to sequence pump means actuation over preselected time intervals;

a patient supplemental command means for selecting one of said supplemental prescription schedules from said second memory means, said patient supplemental command means being manually initiated by the patient; and

a supplemental delivery means for actuating said pump means in accordance with said selected supplemental prescription schedule, wherein said pulp means causes a fixed volumetric dosage of medication to be delivered with each pump means actuation.

62. The apparatus of claim 61, wherein each of said supplemental subscription schedules includes a pre-programmed time delay between selection of the particular supplemental subscription schedule and initiation of actual medication delivery.

63. The apparatus sof claim 61 further comprising:

a running integral dosage limiting means for creating and updating a current time window of preselected length, for determining the amount of medication delivery by said medication infusion apparatus within said current time window of preselected length and for inhibiting actuation of said pump means while said determined amount exceeds a running integral dosage limit.

64. A medication infusion apparatus having a controller to actuate a pump means, said controller comprising:

a memory means for storing a basal prescription program, said basal prescription program automatically requesting basal delivery of medication to change to preset rates at pre-programmed intervals during a significant periodic physiologic cycle;

a basal delivery means operably coupled to said memory means and said pump means for actuating said pump means in accordance with said basal prescription program, thereby generating a programmed basal dosage profile; and

,

a running integral dosage limiting means for creating and updating a current time window of preselected length, for determining the amount of medication delivery sequenced by said basal delivery means within said current time window of preselected length, and for inhibiting pump means actuation while said determined amount exceeds a running integral dose limit.

65. A programmable medication infusion apparatus for providing medication to the living body of a patient, comprising:

an assembly for implantation within a living body, said assembly including;

a medication reservoir for storing selected medication,

a pump means for infusing said selected medication stored in said medication reservoir into said living body,

a memory means for storing supplemental prescription schedules and at least one basal prescription schedule, each of said supplemental prescription schedules comprising a program to sequence pump actuation over preselected time intervals, and said at least one basal prescription schedule comprising a program to sequence pump means actuation at a basal delivery rate;

a basal delivery means for actuating said pump in accordance with said at least one basal prescription, schedule;

a communication means for receiving a signal carrying programming information;

a supplemental command means responsive to said programming information received by said communication means for selecting a particular supplemental prescription schedule from said memory means; and

a supplemental delivery means responsive to said supplemental command means for actuating said pump means in accordance with said selected supplemental prescription schedule, wherein said pump means causes a fixed volumetric dosage of medication to be delivered with each pump actuation; and

,

an external patient programming means, external to said body for transmitting a signal carrying said programming information to said communication means, said programming information including a selection code requesting said supplemental command means to selectively assign a supplemental prescription schedule to said supplemental delivery means.

66. The apparatus of claim 65, further comprising:

a running integral dosasge limiting means for creating and updating a current, shifting time window of preselected length, for determining the amount of medication delivery by said medication infusion system within said current time window of preselected length and for inhibiting actuation of said pump means while said determined amount exceeds a running integral dosage limit.

67. The apparatus of claim 66, wherein each actuation of said pump means delivers a fixed volumetric dosage of medication, and wherein said running integral dosage limiting means includes a means for summing the number of pump means actuations in said current time window, thereby determining the amount of medication delivery in said current time window.

68. The apparatus of claim 66, wherein said running integral dosage limiting means comprises a means for summing the number of pump means actuations occurring in the most recent three-hour time period, and for inhibiting pump actuation if said sum exceeds a three-hour running integral dose limit.

70. The apparatus of claim 65, further comprising an external physician programming means, external to said body for transmitting a signal carrying a supplemental prescription schedule to said communication means and wherein said communication means further includes a means for storing said received supplemental prescription schedule in said memory means wherein programming information transmitted by said external programming means and received via said communication means includes said at least one prescription schedule and causes said command means to store said at least one prescription schedule in memory.

71. The apparatus of claim 70, wherein said external physician programming means comprises a means for transmitting a signal carrying a running integral dosage limit to said communication means and wherein said communication means comprises a means for programming said running integral dosage limiting means with said running integral dosage limit.

72. The apparatus of claim 70, wherein said external physician programming means comprises a means for transmitting a signal carrying a basal program to said communication means and wherein said communication means comprises a means for programming said basal prescription programming means with said received basal program.

73. The apparatus of claim 70 wherein said external physician programming means comprises a means for transmitting a signal carrying a programming code to said communication means, and wherein said communication means comprises a means for ignoring selected programming information transmitted by said external patient programming means in response to said received programming code.

74. The apparatus of claim 70 wherein said external a physician programming means comprises a means for transmitting a signal carrying a selection code to said communication means, and wherein said supplemental command means selects a particular supplemental prescription schedule from said memory for delivery by said supplemental delivery means in response to said received selection code from said physician programming means.

75. The apparatus as in claim 65, wherein each of said supplemental prescription schedule schedules is a sequence of integers with each integer corresponding to the lapse time since that particular supplemental prescription schedule was assigned to said supplemental delivery means, said supplemental delivery means comprises a means for evaluating each integer in sequence and actuating said pump when means actual lapse time equals the lapse time corresponding to that integer presently under evaluation.

76. The apparatus of claim 75, wherein the value of each of said integers corresponds to the number of minutes of lapse time since the particular supplemental prescription schedule was assigned to said supplemental delivery means.

77. The apparatus of claim 65, wherein said at least one basal prescription schedule a sequence of binary bits, each bit corresponding to a fixed time interval, and wherein said basal delivery means comprises a means for evaluating each bit in sequence moving from the present bit to the next bit each fied time interval, and for actuating sai pump if the current bit is active.

78. The apparatus of claim 77, wherein said basal program is a sequence of binary bits, each bit representing a quarter-hour lapse time, wherein said delivery means will actuate the pump means during a particular quarter-hour, if the sequence bit corresponding to that particular quarter-hour lapse time is active.

79. The apparatus of claim 65, wherein said communication means further comprises a handshaking means for verifiying programming information transmitted by said patient programming means, wherein said handshaking means comprises a means for transmitting to said external programming means the received programming information, said external programming means comprising a means for receiving and verifying said received programming information and for transmitting an execution code, said handshaking means further comprising a means for evaluating a selection code received by said communication means to determine if a valid execution code was received in a timely fashion said handshaking means comprises a means for instructing said supplemental command means to perform the requested selection code.

80. The apparatus of claim 65, wherein said external patient programming means comprises a means for transmitting programming information containing a basal adjustment code to said communication means, said basal adjustment code requesting adjustment of the amplitude of said variable basal delivery profile, and wherein said basal delivery means further comprises a means operably coupled to said communication means for adjusting the amplitude of said variable basal delivery profile for a certain time period in accordance with said received basal adjustment code.

81. The apparatus of claim 80, wherein said basal adjustment code requests half or full delivery of said basal delivery profile.

82. The apparatus of claim 81, further comprising a data recording means for recording the number of times said communication means receives said basal adjustment code requesting half or full basal delivery.

83. The apparatus of claim 80, wherein said external patient programming means includes a means for transmitting an inhibit command for inhibiting pump means actuation for a certain set period of time and wherein said basal delivery means further comprises a means operably coupled to said communication means for inhibiting pump means actuation for said set period of time in response to said inhibit command.

84. The apparatus of claim 83, further comprising a data recording means for recording the number of times said communication means receives said inhibit command.

85. The apparatus of claim 65, wherein said external patient programming means comprises a means for transmitting programming information containing a countermand code to said communication means, wherein said command means further comprises a means associated with said basal delivery means and said supplemented delivery means for countermanding the most recent programming information entry in response to said received countermand code.

86. The apparatus of claim 85, further comprising a data recording means for recording the number of times said communication means receives said countermand code.

87. The apparatus of claim 65, wherein said supplemental command means further comprises a means for checking an assigned supplemental prescription schedule for errors and for alerting said patient to such errors.

88. The apparatus of claim 65 comprising an incremental integrating rate limiting means for inhibiting pump means actuation when a certain maximum dosage envelope is exceeded.

89. The apparatus of claim 65 further comprising an incremental integrating rate limiting means, said incremental integrating rate limiting means comprising:

a pump means monitoring means for providing a pulse each time said pump means delivers a certain volumetric dosage of medication,

a clock capable of delivering N pulses per hour; and

,

an updown counter capable of storing M counts, operably connected to said clock and said pump means monitoring means, said updown counter initially set at M counts, each pulse from said pump means monitoring means reducing said updown counter by one count, each pulse from said clock increasing said updown counter by one count up to the maximum M counts, and wherein said updown counter includes a means for inhibiting pump means actuation when the count in said updown counter is zero.

90. The appapatus of claim 89, wherein said pump means monitoring means provides a pulse each time said pump means is activated.

91. The apparatus of claim 89, further comprising an external physician programming means, external to said body for transmitting a code to said communication means setting the storage capacity (M) of said updown counter to a value and wherein said communication means further includes a means operably coupled to said incremental integrating rate limiting means for programming the storage capacity (M) of said updown counter in accordance with said received code.

92. The apparatus of claim 89, further comprising an external physician programming means, external to said body for transmitting a code to said communication means setting the pulse per hour rate (N) of said clock to a value and wherein said communicaton means further includes a means operably coupled to said incremental integrating rate limiting means for programming the pulse per hour (N) rate of said clock in accordance with said received code.

93. The apparatus of claim 65 further comprising a data recording means included within said assembly adapted for implantation and operably connected to said supplemental command means, said basal prescription programming means and said communication means for recording utilization data nad monitoring and recording performance of said medication infusion system.

94. The apparatus of claim 93, further comprising an external physician programming means, external to said body for transmitting a code from said external programming means to said communication means requesting a dump of recorded data, and wherein said communication menas further includes a means operably coupled to said data recording means for transmitting data recorded by said data recording means in response to said received code.

95. The apparatus of claim 93, wherein said data recording means comprises a means for recording the number times said basal delivery means and said supplemental delivery means request an actuation of said pump means.

96. The apparatus of claim 93, wherein said data recording means comprises a means for recording the number of times programming information specifies a particular selection code.

97. The apparatus of claim 93, wherein said data recording means comprises a verification means for comparing a received selection code with all possible allowed selection codes and further comprises a means for recording the number of unverifiable selection codes, received by said communication means.

98. The apparatus of claim 93, wherein said data recording menas further comprises a means for monitoring and recording the extent of reservoir fill.

99. The apparatus of claim 93, wherein said data recording means further comprises a means for monitoring and recording actual pump means operation.

100. The apparatus of claim 93, wherein said data recording means further comprises a means for monitoring medication infusion outflow.

101. The apparatus of claim 93, wherein said data recording means further comprises a means for monitoring and recording moisture in various parts of said medication infusion system.

102. The apparatus of claim 65, wherein said communication means further comprises an operator error determining means for actuating an alarm means when an incorrect selection code is received.

103. The apparatus of claim 102, wherein said alarm means is included in said assembly adapted to be implanted and generates a subcutaneous electrical stimulation.

104. The apparatus of claim 102, wherein said alarm means generates an audio alarm.

105. The apparatus of claim 102, wherein said operator error determining means comprises a means for actuating said alarm means when said supplemental command means attempts to assign a supplemental prescription schedule having a format error.

106. The apparatus of claim 102, wherein said operator error determining means comprises a means for actuating said alarm means when programming information transmitted by said external patient programming means contains codes requesting particular operations.

107. The apparatus of claim 106 further comprising an operator error determining means for actuating said alarm means when said communication means receives said basal adjustment code requesting half basal rate.

108. The apparatus of claim 107, wherein said operator error determining means comprises a means for actuating said alarm means when said communication means receives said basal adjusting code requesting a return to a full basal rate delivery.

109. The apparatus of claim 106, further comprising an operator error determining means for actuating said alarm means when said communication means receives said inhibit command.

110. The apparatus of claim 106, further comprising an operator error determining means for actuating said alarm means when said communication means receives said countermand code.

111. The apparatus of claim 102, further comprising an external physician programming means, external to said body, for transmitting a code to said communication means requesting that said operator error determining means disregards certain types of anomalies, and wherein said communication means comprises a means operably coupled to said operator error determining means for causing said operator error determining means to disregard certain types of an anomalies in response to said received code.

112. A medication infusion apparatus having a controller to actuate a pump means, said controller comprising:

a memory means for storing a basal prescription program, said basal prescription program automatically requesting basal delivery of medication to change to preset rates at pre-programmed intervals during a significant periodic physiological cycle;

a basal delivery means operably coupled to said memory means in accordance with said basal prescription program, thereby generating a programmed basal dosage profile; and

,

a running integral dosage limiting menas for creating and updating a current time window of preselected length, for determining the amount of medication delivery by said medication infusion apparatus within said current time window of preselected length and for inhibiting actuation of said pump means while said determined amount exceeds a running integral dosage limit.