Implantable, programmable medication infusion system

• US 4,373,527 A
• Filed: 04/27/1979
• Issued: 02/15/1983
• Est. Priority Date: 04/27/1979
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/034,155
• Time in Patent Office: 1,390 Days
• Field of Search: 128/214 E, 128/214 F, 128/260, 128/419 E, 128/419 PG
• US Class Current: 604/891.1
• 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 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 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

An implantable programmable medication infusion system comprises an implantable portion (2) having a medication reservoir (10) at below body pressure and isolated at its input from the body in which it is implanted by an antechamber (8) the pressure integrity of which is checked before filling the medication reservoir (10). Safety features include a leak detector (35), inlet and outlet valves (14 and 212) used with flow impeding filters (12 and 218), and a maximum allowable pressure in a pulsatile bellows pump (202) all of which prevent undesired infusion of medication. Medication flow from the pulsatile bellows pump (202) is in response to programming commands from a drug programming system (1) and processed in an electronics section (30) which uses the commands to program memory units (320 and 322) and to request pulses of medication. Hardwired limit controls (324 and 326) prevent excessive dosage requests from reaching the pulsatile bellows pump (202). For patient convenience and safety, the memory units (320 and 322) are programmed with running integral limits. A record of medication dispensing can be communicated to a physician by means of a telemetry transmitter (336) which sends signals by telemetry to the communications head (300) which information is displayed on the drug programming unit (3).

Claims

1. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusing said selected medication stored in said medication reservoir into said living body, said infusion means having at least one remotely commandable operational characteristic,

command receiver means coupled to said infusion means for receiving command signals, and

means for telemetering operational information pertaining to said infusion apparatus out of said living body;

command source means external to said living body for transmitting said command signals to be received by said command receiver means; and

means for receiving said telemetered operational information external to said living body.

2. A programmable infusion system in accordance with claim 1, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

3. A programmable infusion system in accordance with claim 1, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of said medication dose inputs.

4. A programmable infusion system in accordance with claim 3, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for maintaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication by said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

5. A programmable infusion system in accordance with claim 4, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electronic control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

6. A programmable infusion system in accordance with claim 3, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

7. A programmable infusion system in accordance with claim 1, further comprising means for selectively supplying power to said command receiver means, said supply means being coupled to an external power source, said supply means being external to said living body, said infusion means being powered by an implanted power source.

8. A programmable infusion system, in accordance with claim 7, wherein said supply means provides an alternating field.

9. A programmable infusion system, in accordance with claim 8, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

10. A programmable infusion system in accordance with claim 9, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

11. A programmable infusion system in accordance with claim 10, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

12. A programmable infusion system in accordance with claim 10, wherein said telemetry means is coupled to said rectifier means and is powered by said d.c. power signal.

13. A programmable infusion system in accordance with claim 7, wherein said telemetry means is also supplied power by said supply means.

14. A programmable infusion system in accordance with claim 7, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

15. A programmable infusion system in accordance with claim 1, wherein said infusion means comprises a fluid handling mechanism for delivering said selected medication, said operational information including information about the operation of said fluid handling mechanism.

16. A programmable infusion system in accordance with claim 15, wherein said fluid handling mechanism comprises means for pumping said selected medication.

17. A programmable infusion system in accordance with claim 16, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pump means.

18. A programmable infusion system in accordance with claim 16, wherein said pump means operates in a pulsatile mode.

19. A programmable infusion system in accordance with claim 18, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

20. A programmable infusion system in accordance with claim 16, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

21. A programmable infusion system in accordance with claim 20, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means, and means for moving said at least one flexible wall.

22. A programmable infusion system in accordance with claim 21, further comprising spring means for urging said at least one flexible wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

23. A programmable infusion system in accordance with claim 22, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

24. A programmable infusion system in accordance with claim 23, wherein said plate has a surface in contact with said selected medication when drawn into said variable volume means.

25. A programmable infusion system in accordance with claim 24, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

26. A programmable infusion system in accordance with claim 23, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

27. A programmable infusion system in accordance with claim 26, wherein said plate comprises a permanent magnet.

28. A programmable infusion system in accordance with claim 23, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

29. A programmable infusion system in accordance with claim 20, wherein said infusion means further comprises:

an interface pressure value through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure pulse.

30. A programmable infusion system in accordance with claim 29, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said living body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

31. A programmable infusion system in accordance with claim 19, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

32. A programmable infusion system in accordance with claim 31, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume pulse.

33. A programmable infusion system in accordance with claim 20, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chamber, and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

34. A programmable infusion system in accordance with claim 33, wherein said monitoring means comprises a pressure transducer.

35. A programmable infusion system in accordance with claim 33, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

36. A programmable infusion system in accordance with claim 35, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

37. A programmable infusion system in accordance with claim 16, further comprising means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

38. A programmable infusion system in accordance with claim 37, wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said living body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

39. A programmable infusion system in accordance with claim 38, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

40. A programmable infusion system in accordance with claim 39, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

41. A programmable infusion system in accordance with claim 1, wherein one of said at least one remotely commandable operational characteristic comprises an infusion rate variable on command, said infusion apparatus further comprising means for inhibiting said infusion means from infusing said selected medication if a preselected medication infusion rate is exceeded by a commanded infusion rate, said inhibiting means being operably coupled to said infusion means.

42. A programmable infusion system in accordance with claim 41, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

43. A programmable infusion system in accordance with claim 42, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

44. A programmable infusion system in accordance with claim 41, wherein said preselected medication infusion rate is remotely selectable.

45. A programmable infusion system in accordance with claim 41, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

46. A programmable infusion system in accordance with claim 45, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

47. A programmable infusion system in accordance with claim 46, further comprising command decoder means for coupling each of said at least one programmable rate memory units to said command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage corresponding said at least one programmable rate memory units.

48. A programmable infusion system in accordance with claim 46, wherein each of said at least one limit control units is hardwired.

49. A programmable infusion system in accordance with claim 46, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

50. A programmable infusion system in accordance with claim 46, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

51. A programmable infusion system in accordance with claim 41, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

52. A programmable infusion system in accordance with claim 41, wherein said infusion means includes a pump means which executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

53. A programmable infusion system in accordance with claim 52, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

54. A programmable infusion system in accordance with claim 52, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

55. A programmable infusion system in accordance with claim 54, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

56. A programmable infusion system in accordance with claim 55, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

57. A programmable infusion system in accordance with claim 56, wherein said fixed infusion rate limit is hardwired.

58. A programmable infusion system in accordance with claim 54, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

59. A programmable infusion system in accordance with claim 58, wherein said alarm signal comprises a subcutaneous electrical stimulation.

60. A programmable infusion system in accordance with claim 54, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

61. A programmable infusion system in accordance with claim 41, wherein said inhibiting means is operably coupled to said telemetry means, said inhibiting means providing a signal to said telemetry means for telemetering to said telemetry receiving means operational information pertaining to the functions of said inhibiting means.

62. A programmable infusion system in accordance with claim 41, further comprising means for generating an alarm signal when said inhibiting means inhibits said infusion means.

63. A programmable infusion system in accordance with claim 41, further comprising means for recording when said inhibiting means inhibits said infusion means.

64. A programmable infusion system in accordance with claim 63, wherein said recording means is coupled to said telemetry means, said recording means providing a signal to said telemetry means for telemetering to said telemetry receiving means operational information pertaining to said inhibiting means as recorded by said recording means.

65. A programmable infusion system in accordance with claim 1, said infusion apparatus further comprising means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions.

66. A programmable infusion system in accordance with claim 65, further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

67. A programmable infusion system in accordance with claim 66, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

68. A programmable infusion system in accordance with claim 66, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

69. A programmable infusion system in accordance with claim 66, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled at said alarm generating mean, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

70. A programmable infusion system in accordance with claim 66, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

71. A programmable infusion system in accordance with claim 66, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

72. A programmable infusion system in accordance with claim 66, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

73. A programmable infusion system in accordance with claim 65, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

74. A programmable infusion system in accordance with claim 65, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

75. A programmable infusion system in accordance with claim 65 further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

76. A programmable infusion system in accordance with claim 65, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

77. A programmable infusion system in accordance with claim 65, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises low battery means voltage.

78. A programmable infusion system in accordance with claim 65, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

79. A programmable infusion system in accordance with claim 65, further comprising means for simulating said improper operational conditions for test purposes.

80. A programmable infusion system in accordance with claim 1, wherein said infusion means includes means for pumping a preselected amount of medication into said living body, said infusion apparatus further comprising means for recording the rate at which pumping is effected by said pump means.

81. A programmable infusion system in accordance with claim 80, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

82. A programmable infusion system in accordance with claim 81, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

83. A programmable infusion system in accordance with claim 81, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

84. A programmable infusion system in accordance with claim 80, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

85. A programmable infusion system in accordance with claim 84, further comprising means for comparing the rates recorded by both said storing means.

86. A programmable infusion system in accordance with claim 85, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

87. A programmable infusion system in accordance with claim 85, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

88. A programmable infusion system in accordance with claim 84, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

89. A programmable infusion system in accordance with claim 80, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

90. A programmable infusion system in accordance with claim 89, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

91. A programmable infusion system in accordance with claim 90, wherein said alarm signal comprises a subcutaneous electrical stimulation.

92. A programmable infusion system in accordance with claim 90, wherein said counting means comprises a pressure transducer.

93. A programmable infusion system in accordance with claim 89, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

94. A programmable infusion system in accordance with claim 80, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

95. A programmable infusion system in accordance with claim 94, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

96. A programmable infusion system in accordance with claim 95, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

97. A programmable infusion system in accordance with claim 94, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

98. A programmable infusion system in accordance with claim 97, wherein said alarm signal comprises a subcutaneous electrical stimulation.

99. A programmable infusion system in accordance with claim 94, wherein said recording means is coupled to said telemetry means for telemetering information recorded by both said counting means out of said living body.

100. A programmable infusion system in accordance with claim 94, wherein said first recited counting means comprises a pressure transducer.

101. A programmable infusion system in accordance with claim 1, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

102. A programmable infusion system in accordance with claim 101, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

103. A programmable infusion system in accordance with claim 102, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetry receiving means.

104. A programmable infusion system in accordance with claim 103, wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

105. A programmable infusion system in accordance with claim 102, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in said medication chamber by more than a predetermined differential.

106. A programmable infusion system in accordance with claim 105, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

107. A programmable infusion system in accordance with claim 105, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

108. A programmable infusion system in accordance with claim 1, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

109. A programmable infusion system in accordance with claim 1, further comprising means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetering receiver means, and programming means coupled to said telemetry means for indicating when ejection of medication into said medication reservoir is appropriate.

110. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusion said selected medication stored in said medication reservoir into said living body, said infusion means having at least one remotely commandable operational characteristic and being powered by an implanted power source,

command receiver means coupled to said infusion means for receiving command signals, said command receiver means being powered by a power source external to said living body, and

means for telemetering operational information pertaining to said infusion apparatus out of said living body;

command source means external to said living body for transmitting said command signal to be received by said command receiver means;

means for receiving said telemetered operational information external to said living body; and

means for selectively supplying power to said command receiver means, said supply means being coupled to said external power source, said supply means being external to said living body.

111. A programmable infusion system in accordance with claim 110, wherein said supply means provides an alternating field.

112. A programmable infusion system in accordance with claim 111, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

113. A programmable infusion system in accordance with claim 112, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

114. A progammable infusion system in accordance with claim 113, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

115. A programmable infusion system in accordance with claim 113, wherein said telemetry means is coupled to said rectifier means and is powered by said d.c. power signal.

116. A programmable infusion system in accordance with claim 110, wherein said telemetry means is also supplied power by said supply means.

117. A programmable infusion system in accordance with claim 110, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

118. A programmable infusion system in accordance with claim 110, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

119. A programmable infusion system in accordance with claim 110, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of of said medication dose inputs.

120. A programmable infusion system in accordance with claim 119, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for maintaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication of said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

121. A programmable infusion system in accordance with claim 120, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electronic control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

122. A programmable infusion system in accordance with claim 119, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

123. A programmable infusion system in accordance with claim 110, wherein said infusion means comprises a fluid handling mechanism for delivering said selected medication, said operational information including information about the operation of said fluid handling mechanism.

124. A programmable infusion system in accordance with claim 123, wherein said fluid handling mechanism comprises means for pumping said selected medication.

125. A programmable infusion system in accordance with claim 124, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pump means.

126. A programmable infusion system in accordance with claim 124, wherein said pump means operates in a pulsatile mode.

127. A programmable infusion system in accordance with claim 126, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

128. A programmable infusion system in accordance with claim 124 wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

129. A programmable infusion system in accordance with claim 128, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means, and means for moving said at least one flexible wall.

130. A programmable infusion system in accordance with claim 129, further comprising spring means for urging said at least one wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

131. A programmable infusion system in accordance with claim 130, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

132. A programmable infusion system in accordance with claim 137, wherein said plate has a surface in contact with a said selected medication when drawn into said variable volume means.

133. A programmable infusion system in accordance with claim 132, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

134. A programmable infusion system in accordance with claim 131, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pushing of said coil causing said plate to be moved.

135. A programmable infusion system in accordance with claim 134, wherein said plate comprises a permanent magnet.

136. A programmable infusion system in accordance with claim 131, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

137. A programmable infusion system in accordance with claim 128, wherein said infusion means further comprises:

an interface pressure valve through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure plate.

138. A programmable infusion system in accordance with claim 137, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said living body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

139. A programmable infusion system in accordance with claim 127, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

140. A programmable infusion system in accordance with claim 139, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume phase.

141. A programmable infusion system in accordance with claim 124, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chamber, and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

142. A programmable infusion system in accordance with claim 141, wherein said monitoring means comprises a pressure transducer.

143. A programmable infusion system in accordance with claim 141, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

144. A programmable infusion system in accordance with claim 143, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

145. A programmable infusion system in accordance with claim 124, further comprising means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

146. A programmable infusion system in accordance with claim 145, wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said living body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

147. A programmable infusion system in accordance with claim 146, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

148. A programmable infusion system in accordance with claim 147, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

149. A programmable infusion system in accordance with claim 110, wherein one of said at least one remotely commandable operational characteristic comprises an infusion rate variable on command, said infusion apparatus further comprising means for inhibiting said infusion means from infusing said selected medication if a preselected medication infusion rate is exceeded by a commanded infusion rate, said inhibiting means being operably coupled to said infusion means.

150. A programmable infusion system in accordance with claim 149, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

151. A programmable infusion system in accordance with claim 150, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

152. A programmable infusion system in accordance with claim 149, wherein said preselected medication infusion rate is remotely selectable.

153. A programmable infusion system in accordance with claim 149, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

154. A programmable infusion system in accordance with claim 153, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

155. A programmable infusion system in accordance with claim 154, further comprising command decoder means for coupling each of said at least one programmable rate memory units to said command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage in corresponding said at least one programmable rate memory units.

156. A programmable infusion system in accordance with claim 154, wherein each of said at least one limit control units is hardwired.

157. A programmable infusion system in accordance with claim 154, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

158. A programmable infusion system in accordance with claim 157, wherein said alarm signal comprises a subcutaneous electrical stimulation.

159. A programmable infusion system in accordance with claim 154, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

160. A programmable infusion system in accordance with claim 149, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

161. A programmable infusion system in accordance with claim 149, wherein said infusion means includes a pump means which executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

162. A programmable infusion system in accordance with claim 161, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

163. A programmable infusion system in accordance with claim 161, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

164. A programmable infusion system in accordance with claim 163, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

165. A programmable infusion system in accordance with claim 164, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

166. A programmable infusion system in accordance with claim 165, wherein said fixed infusion rate limit is hardwired.

167. A programmable infusion system in accordance with claim 163, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

168. A programmable infusion system in accordance with claim 167, wherein said alarm signal comprises a subcutaneous electrical stimulation.

169. A programmable infusion system in accordance with claim 163, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

170. A programmable infusion system in accordance with claim 149, wherein said inhibiting means is operably coupled to said telemetry means, said inhibiting means providing a signal to said telemetry means for telemetering to said telemetry receiving means operational information pertaining to the functions of said inhibiting means.

171. A programmable infusion system in accordance with claim 149, further comprising means for generating an alarm signal when said inhibiting means inhibits said infusion means.

172. A programmable infusion system in accordance with claim 149, further comprising means for recording when said inhibiting means inhibits said infusion means.

173. A programmable infusion system in accordance with claim 149, wherein said recording means is coupled to said telemetry means, said recording means providing a signal to said telemetry means for telemetering to said telemetry receiving means operationl information pertaining to said inhibiting means as recorded by said recording means.

174. A programmable infusion system in accordance with claim 110, said infusion apparatus further comprising means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions.

175. A programmable infusion system in accordance with claim 174, further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

176. A programmable infusion system in accordance with claim 175, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

177. A programmable infusion system in accordance with claim 175, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

178. A programmable infusion system in accordance with claim 175, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

179. A programmable infusion system in accordance with claim 175, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

180. A programmable infusion system in accordance with claim 175, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

181. A programmable infusion system in accordance with claim 175, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

182. A programmable infusion system in accordance with claim 174, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

183. A programmable infusion system in accordance with claim 174, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

184. A programmable infusion system in accordance with claim 174, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

185. A programmable infusion system in accordance with claim 174, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

186. A programmable infusion system in accordance with claim 174, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means wherein one of said improper operational conditions comprises low battery means voltage.

187. A programmable infusion system in accordance with claim 174, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

188. A programmable infusion system in accordance with claim 174, further comprising means for simulating said improper operational conditions for test purposes.

189. A programmable infusion system in accordance with claim 110, wherein said infusion means includes means for pumping a preselected amount of medication into said living body, said infusion apparatus further comprising means for recording the rate at which pumping is effected by said pump means.

190. A programmable infusion system in accordance with claim 189, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

191. A programmable infusion system in accordance with claim 190, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

192. A programmable infusion system in accordance with claim 191, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

193. A programmable infusion system in accordance with claim 189, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

194. A programmable infusion system in accordance with claim 193, further comprising means for comparing the rates recorded by both said storing means.

195. A programmable infusion system in accordance with claim 194, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

196. A programmable infusion system in accordance with claim 194, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

197. A programmable infusion system in accordance with claim 193, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

198. A programmable infusion system in accordance with claim 189, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

199. A programmable infusion system in accordance with claim 198, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

200. A programmable infusion system in accordance with claim 199, wherein said alarm signal comprises a subcutaneous electrical stimulation.

201. A programmable infusion system in accordance with claim 199, wherein said counting means comprises a pressure transducer.

202. A programmable infusion system in accordance with claim 199, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

203. A programmable infusion system in accordance with claim 189, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

204. A programmable infusion system in accordance with claim 203, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

205. A programmable infusion system in accordance with claim 204, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

206. A programmable infusion system in accordance with claim 203, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

207. A programmable infusion system in accordance with claim 206, wherein said alarm signal comprises a subcutaneous electrical stimulation.

208. A programmable infusion system in accordance with claim 203, wherein said recording means is coupled to said telemetry means for telemetering information recorded by both said counting means out of said living body.

209. A programmable infusion system in accordance with claim 203, wherein said first recited counting means comprises a pressure transducer.

210. A programmable infusion system in accordance with claim 189, wherein said recording means is powered by said implanted power source.

211. A programmable infusion system in accordance with claim 110 further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

212. A programmable infusion system in accordance with claim 211, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

213. A programmable infusion system in accordance with claim 212, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetry receiving means.

214. A programmable infusion system in accordance with claim 213, wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

215. A programmable infusion system in accordance with claim 212, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in the said medication chamber by more than a predetermined differential.

216. A programmable infusion system in accordance with claim 215, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

217. A programmable infusion system in accordance with claim 215, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

218. A programmable infusion system in accordance with claim 110, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

219. A programmable infusion system in accordance with claim 110, further comprising means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetering receiver means, and programming means coupled to said telemetry means for indicating when ejection of medication into said medication reservoir is appropriate.

220. A programmable infusion system in accordance with claim 110, wherein said programming means is powered by said supply means.

221. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusing said selected medication stored in said medication reservoir into said living body, said infusion means having a fluid handling mechanism for delivering said selected medication and at least one remotely commandable operational characteristic,

command receiver means coupled to said infusion means for receiving command signals, and

means for telemetering operational information pertaining to said infusion apparatus out of said living body, said operational information including information about the operation of said fluid handling mechanism of said infusion means;

command source means external to said living body for transmitting said command signals to be received by said command receiver means; and

means for receiving said telemetered operational information external to said living body.

222. A programmable infusion system in accordance with claim 221, wherein said fluid handling mechanism comprises means for pumping said selected medication.

223. A programmable infusion system in accordance with claim 222, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pump means.

224. A programmable infusion system in accordance with claim 222, wherein said pump means operates in a pulsatile mode.

225. A programmable infusion system in accordance with claim 224, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

226. A programmable infusion system in accordance with claim 222, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

227. A programmable infusion system in accordance with claim 226, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means, and means for moving said at least one flexible wall.

228. A programmable infusion system in accordance with claim 227, further comprising spring means for urging said at least one flexible wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

229. A programmable infusion system in accordance with claim 228, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

230. A programmable infusion system in accordance with claim 229, wherein said plate has a surface in contact with said selected medication when drawn into said variable volume means.

231. A programmable infusion system in accordance with claim 230, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

232. A programmable infusion system in accordance with claim 229, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

233. A programmable infusion system in accordance with claim 232, wherein said plate comprises a permanent magnet.

234. A programmable infusion system in accordance with claim 229, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

235. A programmable infusion system in accordance with claim 226, wherein said infusion means further comprises:

an interface pressure valve through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure pulse.

236. A programmable infusion system in accordance with claim 235, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said living body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

237. A programmable infusion system in accordance with claim 225, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

238. A programmable infusion system in accordance with claim 237, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume pulse.

239. A programmable infusion system in accordance with claim 226, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chamber, and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

240. A programmable infusion system in accordance with claim 239, wherein said monitoring means comprises a pressure transducer.

241. A programmable infusion system in accordance with claim 239, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

242. A programmable infusion system in accordance with claim 241, further comprising second means for indicating the operation of said pump means wherein a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

243. A programmable infusion system in accordance with claim 222, further comprising means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

244. A programmable infusion system in accordance with claim 243, wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said lining body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

245. A programmable infusion system in accordance with claim 244, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

246. A programmable infusion system in accordance with claim 245, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

247. A programmable infusion system in accordance with claim 221, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

248. A programmable infusion system in accordance with claim 221, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of said medication dose inputs.

249. A programmable infusion system in accordance with claim 248, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for mainitaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication by said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

250. A programmable infusion system in accordance with claim 249, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electronic control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

251. A programmable infusion system in accordance with claim 248, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

252. A programmable infusion system in accordance with claim 221, further comprising means for selectively supplying power to said command receiver means, said supply means being coupled to an external power source, said supply means being external to said living body, said infusion means being powered by an implanted power source.

253. A programmable infusion system, in accordance with claim 252, wherein said supply means provides an alternating field.

254. A programmable infusion system, in accordance with claim 253, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

255. A programmable infusion system in accordance with claim 254, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

256. A programmable infusion system in accordance with claim 255, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

257. A programmable infusion system in accordance with claim 255, wherein said telemetry means is coupled to said rectifier means and is powered by said d.c. power signal.

258. A programmable infusion system in accordance with claim 252, wherein said telemetry means is also supplied power by said supply means.

259. A programmable infusion system in accordance with claim 252, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

260. A programmable infusion system in accordance with claim 221, wherein one of said at least one remotely commandable operational characteristic comprises an infusion rate variable on command, said infusion apparatus further comprising means for inhibiting said infusion apparatus further comprising means for inhibiting said infusion means from infusing said selected medication if a preselected medication infusion rate is exceeded by a commanded infusion rate, said inhibiting means being operably coupled to said infusion means.

261. A programmable infusion system in accordance with claim 260, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

262. A programmable infusion system in accordance with claim 261, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

263. A programmable infusion system in accordance with claim 260, wherein said preselected medication infusion rate is remotely selectable.

264. A programmable infusion system in accordance with claim 260, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

265. A programmable infusion system in accordance with claim 264, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

266. A programmable infusion system in accordance with claim 265, further comprising command decoder means for coupling each of said at least one said programmable rate memory units to command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage in corresponding said at least one programmable rate memory units.

267. A programmable infusion system in accordance with claim 265, wherein each of said at least one limit control units are hardwired.

268. A programmable infusion system in accordance with claim 265, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

269. A programmable infusion system in accordance with claim 265, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

270. A programmable infusion system in accordance with claim 260, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected infusion rate during a fixed window of time which shifts continuously.

271. A programmable infusion system in accordance with claim 260, wherein said fluid handling mechanism of said infusion means includes a pump means which executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

272. A programmable infusion system in accordance with claim 271, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said fluid handling mechanism to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

273. A programmable infusion system in accordance with claim 271, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

274. A programmable infusion system in accordance with claim 273, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said fluid handling mechanism to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

275. A programmable infusion system in accordance with claim 274, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

276. A programmable infusion system in accordance with claim 275, wherein said fixed infusion rate limit is hardwired.

277. A programmable infusion system in accordance with claim 273, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

278. A programmable infusion system in accordance with claim 277, wherein said alarm signal comprises a subcutaneous electrical stimulation.

279. A programmable infusion system in accordance with claim 273, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

280. A programmable infusion system in accordance with claim 260, wherein said inhibiting means is operably coupled to said telemetry means, said inhibiting means providing a signal to said telemetry means for telemetering to said telemetry receiving means operational information pertaining to the functions of said inhibiting means.

281. A programmable infusion system in accordance with claim 260, further comprising means for generating an alarm signal when said inhibiting means inhibits said infusion means.

282. A programmable infusion system in accordance with claim 260, further comprising means for recording when said inhibiting means inhibits said infusion means.

283. A programmable infusion system in accordance with claim 282, wherein said recording means is coupled to said telemetry means, said recording means providing a signal to said telemetry means for telemetering to said telemetry receiving means operational information pertaining to said inhibiting means as recorded by said recording means.

284. A programmable infusion system in accordance with claim 221, said infusion apparatus further comprising means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions.

285. A programmable infusion system in accordance with claim 284, further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

286. A programmable infusion system in accordance with claim 285, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

287. A programmable infusion system in accordance with claim 285, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

288. A programmable infusion system in accordance with claim 285, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

289. A programmable infusion system in accordance with claim 285, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

290. A programmable infusion system in accordance with claim 285, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

291. A programmable infusion system in accordance with claim 285, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

292. A programmable infusion system in accordance with claim 284, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

293. A programmable infusion system in accordance with claim 284, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

294. A programmable infusion system in accordance with claim 284, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

295. A programmable infusion system in accordance with claim 284, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

296. A programmable infusion system in accordance with claim 284, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means wherein one of said improper operational conditions comprises low battery means voltage.

297. A programmable infusion system in accordance with claim 284, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

298. A programmable infusion system in accordance with claim 284, further comprising means for simulating said improper operational conditions for test purposes.

299. A programmable infusion system in accordance with claim 221, wherein said fluid handling mechanism includes means for pumping a preselected amount of medication into said living body, said infusion apparatus further comprising means for recording the rate at which pumping is effected by said pump means.

300. A programmable infusion system in accordance with claim 299, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

301. A programmable infusion system in accordance with claim 300, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

302. A programmable infusion system in accordance with claim 300, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

303. A programmable infusion system in accordance with claim 299, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

304. A programmable infusion system in accordance with claim 303, further comprising means for comparing the rates recorded by both said storing means.

305. A programmable infusion system in accordance with claim 304, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

306. A programmable infusion system in accordance with claim 304, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

307. A programmable infusion system in accordance with claim 303, wherein said recording means is coupled to said telemetry means for telemetering information recorded by said recording means out of said living body.

308. A programmable infusion system in accordance with claim 299, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

309. A programmable infusion system in accordance with claim 308, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

310. A programmable infusion system in accordance with claim 309, wherein said alarm signal comprises a subcutaneous electrical stimulation.

311. A programmable infusion system in accordance with claim 309, wherein said counting means comprises a pressure transducer.

312. A programmable infusion system in accordance with claim 308, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

313. A programmable infusion system in accordance with claim 309, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

314. A programmable infusion system in accordance with claim 313, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

315. A programmable infusion system in accordance with claim 314, wherein said comparing means is coupled to said telemetry means for telemetering information outputted by said comparing means out of said living body.

316. A programmable infusion system in accordance with claim 315, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

317. A programmable infusion system in accordance with claim 316, wherein said alarm signal comprises a subcutaneous electrical stimulation.

318. A programmable infusion system in accordance with claim 315, wherein said recording means is coupled to said telemetry means for telemetering information recorded by both said counting means out of said living body.

319. A programmable infusion system in accordance with claim 315, wherein said first recited counting means comprises a pressure transducer.

320. A programmable infusion system in accordance with claim 221, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

321. A programmable infusion system in accordance with claim 320, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

322. A programmable infusion system in accrodance with claim 321, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetry receiving means.

323. A programmable infusion system in accordance with claim 322, wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

324. A programmable infusion system in accordance with claim 321, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in said medication chamber by more than a predetermined differential.

325. A programmable infusion system in accordance with claim 324, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

326. A programmable infusion system in accordance with claim 324, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

327. A programmable infusion system in accordance with claim 221, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

642. A programmable infusion system in accordance with claim 221, further comprising means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetering receiver means, and programming means coupled to said telemetering means for indicating when ejection of medication into said medication reservoir is appropriate.

328. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusing said selected medication stored in said medication reservoir into said living body, said infusion means having an infusion rate variable upon command,

command receiver means coupled to said infusion means for receiving command signals, and

means for inhibiting said infusion means for infusing said selected medication if a preselected medication infusion rate is exceeded, said inhibiting means being operably coupled to said infusion means; and

command source means external to said living body for transmitting said command signals to be received by said command receiver means.

329. A programmable infusion system in accordance with claim 328, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

330. A programmable infusion system in accordance with claim 329, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

331. A programmable infusion system in accordance with claim 328, wherein said preselected medication infusion rate is remotely selectable.

332. A programmable infusion system in accordance with claim 328, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

333. A programmable infusion system in accordance with claim 332, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

334. A programmable infusion system in accordance with claim 333, further comprising command decoder means for coupling each of said at least one programmable rate memory units to said command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage in corresponding said at least one programmable rate memory units.

335. A programmable infusion system in accordance with claim 333, wherein each of said at least one limit control units is hardwired.

336. A programmable infusion system in accordance with claim 333, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

337. A programmable infusion system in accordance with claim 333, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

338. A programmable infusion system in accordance with claim 328, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

339. A programmable infusion system in accordance with claim 328, wherein said infusion means includes a pump means which executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

340. A programmable infusion system in accordance with claim 339, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

341. A programmable infusion system in accordance with claim 339, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

342. A programmable infusion system in accordance with claim 341, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

343. A programmable infusion system in accordance with claim 342, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

344. A programmable infusion system in accordance with claim 343, wherein said fixed infusion rate limit is hardwired.

345. A programmable infusion system in accordance with claim 341, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

346. A programmable infusion system in accordance with claim 345, wherein said alarm signal comprises a subcutaneous electrical stimulation.

347. A programmable infusion system in accordance with claim 341, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

348. A programmable infusion system in accordance with claim 328, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, said operational information including information pertaining to the functions of said inhibiting means, and means for receiving said telemetered operational information external to said living body.

349. A programmable infusion system in accordance with claim 328, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

350. A programmable infusion system in accordance with claim 328, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of said medication dose inputs.

351. A programmable infusion system in accordance with claim 350, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for maintaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication by said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

352. A programmable infusion system in accordance with claim 351, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electronic control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

353. A programmable infusion system in accordance with claim 331, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

354. A programmable infusion system in accordance with claim 328, further comprising means for selectively supplying power to said command receiver means, said supply means being coupled to an external power source, said supply means being external to said living body, said infusion means being powered by an implanted power source.

355. A programmable infusion system, in accordance with claim 344, wherein said supply means provides an alternating field.

356. A programmable infusion system, in accordance with claim 355, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

357. A programmable infusion system in accordance with claim 356, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

358. A programmable infusion system in accordance with claim 357, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

359. A programmable infusion system in accordance with claim 357, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means being coupled to said rectifier means and being powered by said d.c. power signal.

360. A programmable infusion system in accordance with claim 354, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means also being supplied power by said supply means.

361. A programmable infusion system in accordance with claim 354, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

362. A programmable infusion system in accordance with claim 328, wherein said infusion means comprises a fluid handling mechanism for delivering said selected medication, said operational information including information about the operation of said fluid handling mechanism.

363. A programmable infusion system in accordance with claim 362, wherein said fluid handling mechanism comprises means for pumping said selected medication.

364. A programmable infusion system in accordance with claim 363, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pump means.

365. A programmable infusion system in accordance with claim 364, wherein said pump means operates in a pulsatile mode.

366. A programmable infusion system in accordance with claim 365, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

367. A programmable infusion system in accordance with claim 364, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

368. A programmable infusion system in accordance with claim 367, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means, and means for moving said at least one flexible wall.

369. A programmable infusion system in accordance with claim 368, further comprising spring means for urging said at least one flexible wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

370. A programmable infusion system in accordance with claim 369, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

371. A programmable infusion system in accordance with claim 370, wherein said plate has a surface in contact with said selected medication when drawn into said variable volume means.

372. A programmable infusion system in accordance with claim 371, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

373. A programmable infusion system in accordance with claim 370, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

374. A programmable infusion system in accordance with claim 373, wherein said plate comprises a permanent magnet.

375. A programmable infusion system in accordance with claim 370, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

376. A programmable infusion system in accordance with claim 367, wherein said infusion means further comprises:

an interface pressure valve through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure pulse.

377. A programmable infusion system in accordance with claim 376, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said living body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

378. A programmable infusion system in accordance with claim 366, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

379. A programmable infusion system in accordance with claim 378, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume pulse.

380. A programmable infusion system in accordance with claim 367, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chamber;

and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

381. A programmable infusion system in accordance with claim 380, wherein said monitoring means comprises a pressure transducer.

382. A programmable infusion system in accordance with claim 380, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

383. A programmable infusion system in accordance with claim 382 further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

384. A programmable infusion system in accordance with claim 363, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, means for receiving said telemetered operational information external to said living body, and means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

385. A programmable infusion system in accordance with claim 384 wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said living body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

386. A programmable infusion system in accordance with claim 385, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

387. A programmable infusion system in accordance with claim 386, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

388. A programmable infusion system in accordance with claim 328, said infusion apparatus further comprising means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions.

389. A programmable infusion system in accordance with claim 388, further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

390. A programmable infusion system in accordance with claim 389, further comprising means for detecting a medication leak, said medication detection means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

391. A programmable infusion system in accordance with claim 389, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm means wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

392. A programmable infusion system in accordance with claim 389, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

393. A programmable infusion system in accordance with claim 389, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

394. A programmable infusion system in accordance with claim 389, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

395. A programmable infusion system in accordance with claim 389, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

396. A programmable infusion system in accordance with claim 388, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

397. A programmable infusion system in accordance with claim 388, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

398. A programmable infusion system in accordance with claim 388, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

399. A programmable infusion system in accordance with claim 389, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

400. A programmable infusion system in accordance with claim 388, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means wherein one of said improper operational conditions comprises low battery means voltage.

401. A programmable infusion system in accordance with claim 388, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting, means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

402. A programmable infusion system in accordance with claim 388, further comprising means for simulating said improper operational conditions for test purposes.

403. A programmable infusion system in accordance with claim 328, wherein said infusion means includes means for pumping a preselected amount of medication into said living body, said infusion apparatus further comprising means for recording the rate at which pumping is effected by said pump means.

404. A programmable infusion system in accordance with claim 403, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

405. A programmable infusion system in accordance with claim 404, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

406. A programmable infusion system in accordance with claim 404, further comprising means for telemetering information recorded by said recording means out of said living body, said telemetry means being coupled to said recording means, and means for receiving said telemetered information external to said living body.

407. A programmable infusion system in accordance with claim 403, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

408. A programmable infusion system in accordance with claim 407, further comprising means for comparing the rates recorded by both said storing means.

409. A programmable infusion system in accordance with claim 408, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

410. A programmable infusion system in accordance with claim 408, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

411. A programmable infusion system in accordance with claim 407, further comprising means for telemetering information recorded by said recording means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

412. A programmable infusion system in accordance with claim 403, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

413. A programmable infusion system in accordance with claim 412, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

414. A programmable infusion system in accordance with claim 413, wherein said alarm signal comprises a subcutaneous electrical stimulation.

415. A programmable infusion system in accordance with claim 413, wherein said counting means comprises a pressure transducer.

416. A programmable infusion system in accordance with claim 413, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered operational information external to said living body.

417. A programmable infusion system in accordance with claim 403, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

418. A programmable infusion system in accordance with claim 417, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

419. A programmable infusion system in accordance with claim 418, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

420. A programmable infusion system in accordance with claim 417, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

421. A programmable infusion system in accordance with claim 420, wherein said alarm signal comprises a subcutaneous electrical stimulation.

422. A programmable infusion system in accordance with claim 417, further comprising means for telemetering information recorded by both said counting means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

423. A programmable infusion system in accordance with claim 417, wherein said first recited counting means comprises a pressure transducer.

424. A programmable infusion system in accordance with claim 328, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

425. A programmable infusion system in accordance with claim 424, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

426. A programmable infusion system in accordance with claim 425, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetry receiving means.

427. A programmable infusion system in accordance with claim 426 wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

428. A programmable infusion system in accordance with claim 425, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in said medication chamber by more than a predetermined differential.

429. A programmable infusion system in accordance with claim 428, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

430. A programmable infusion system in accordance with claim 428, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

431. A programmable infusion system in accordance with claim 430, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

432. A programmable infusion system in accordance with claim 430, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, means for receiving said telemetered operational information external to said living body, and means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetry receiver means, and programming means coupled to said telemetry means for indicating when injection of medication into said medication reservoir is appropriate.

433. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusing said selected medication stored in said medication reservoir into said living body, said infusion means having at least one remotely commandable operational characteristic,

command receiver means coupled to said infusion means for receiving command signals, and

means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions in said system; and

command source means external to said living body for transmitting said command signals to be received by said command receiver means.

434. A programmable infusion system in accordance with claim 433, further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

435. A programmable infusion system in accordance with claim 433, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

436. A programmable infusion system in accordance with claim 433, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

437. A programmable infusion system in accordance with claim 433, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

438. A programmable infusion system in accordance with claim 433, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

439. A programmable infusion system in accordance with claim 433, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

440. A programmable infusion system in accordance with claim 433, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

441. A programmable infusion system in accordance with claim 433, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

442. A programmable infusion system in accordance with claim 433, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

443. A programmable infusion system in accordance with claim 433, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

444. A programmable infusion system in accordance with claim 433, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

445. A programmable infusion system in accordance with claim 433, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

446. A programmable infusion system in accordance with claim 433, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

447. A programmable infusion system in accordance with claim 433, further comprising means for simulating said improper operational conditions for test purposes.

448. A programmable infusion system in accordance with claim 433, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

449. A programmable infusion system in accordance with claim 433, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of said medication dose inputs.

450. A programmable infusion system in accordance with claim 449, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for maintaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication by said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

451. A programmable infusion system in accordance with claim 450, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electronic control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

452. A programmable infusion system in accordance with claim 450, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

453. A programmable infusion system in accordance with claim 434, further comprising means for selectively supplying power to said command receiver means, said supply means being coupled to an external power source, said supply means being external to said living body, said infusion means being powered by an implanted power source.

454. A programmable infusion system, in accordance with claim 453, wherein said supply means provides an alternating field.

455. A programmable infusion system, in accordance with claim 454, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

456. A programmable infusion system in accordance with claim 455, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

457. A programmable infusion system in accordance with claim 456, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

458. A programmable infusion system in accordance with claim 456, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means being coupled to said rectifier means and being powered by said d.c. power signal.

459. A programmable infusion system in accordance with claim 453, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means also being supplied power by said supply means.

460. A programmable infusion system in accordance with claim 453, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

461. A programmable infusion system in accordance with claim 433, wherein said infusion means comprises a fluid handling mechanism for delivering said selected medication, said operational information including information about the operation of said fluid handling mechanism.

462. A programmable infusion system in accordance with claim 461, wherein said fluid handling mechanism comprises means for pumping said selected medication.

463. A programmable infusion system in accordance with claim 462, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pumping means.

464. A programmable infusion system in accordance with claim 463, wherein said pump means operates in a pulsatile mode.

465. A programmable infusion system in accordance with claim 464, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

466. A programmable infusion system in accordance with claim 463, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

467. A programmable infusion system in accordance with claim 466, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means, and means for moving said at least one flexible wall.

468. A programmable infusion system in accordance with claim 467, further comprising spring means for urging said at least one flexible wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

469. A programmable infusion system in accordance with claim 468, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

470. A programmable infusion system in accordance with claim 469, wherein said plate has a surface in contact with said selected medication when drawn into said variable volume means.

471. A programmable infusion system in accordance with claim 470, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

472. A programmable infusion system in accordance with claim 469, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

473. A programmable infusion system in accordance with claim 472, wherein said plate comprises a permanent magnet.

474. A programmable infusion system in accordance with claim 473, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

475. A programmable infusion system in accordance with claim 466, wherein said infusion means further comprises:

an interface pressure valve through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure pulse.

476. A programmable infusion system in accordance with claim 475, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said living body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

477. A programmable infusion system in accordance with claim 464, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

478. A programmable infusion system in accordance with claim 477, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume pulse.

479. A programmable infusion system in accordance with claim 466, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chamber, and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

480. A programmable infusion system in accordance with claim 479, wherein said monitoring means comprises a pressure transducer.

481. A programmable infusion system in accordance with claim 479, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

482. A programmable infusion system in accordance with claim 481, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

483. A programmable infusion system in accordance with claim 482, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, means for receiving said telemetered operational information external to said living body, and means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

484. A programmable infusion system in accordance with claim 483, wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said living body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

485. A programmable infusion system in accordance with claim 484, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease of volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

486. A programmable infusion system in accordance with claim 485, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

487. A programmable infusion system in accordance with claim 433, wherein one of said at least one remotely commandable operational characteristic comprises an infusion rate variable on command, said infusion apparatus further comprising means for inhibiting said infusion means from infusing said selected medication if a preselected medication infusion rate is exceeded by a commanded infusion rate, said inhibiting means being operably coupled to said infusion means.

488. A programmable infusion system in accordance with claim 487, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

489. A programmable infusion system in accordance with claim 488, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

490. A programmable infusion system in accordance with claim 487, wherein said preselected medication infusion rate is remotely selectable.

491. A programmable infusion system in accordance with claim 487, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

492. A programmable infusion system in accordance with claim 491, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

493. A programmable infusion system in accordance with claim 492, further comprising command decoder means for coupling each of said at least one programmable rate memory units to said command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage in corresponding said at least one programmable rate memory units.

494. A programmable infusion system in accordance with claim 492, wherein each of said at least one limit control units is hardwired.

495. A programmable infusion system in accordance with claim 492, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

496. A programmable infusion system in accordance with claim 492, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

497. A programmable infusion system in accordance with claim 487, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

498. A programmable infusion system in accordance with claim 487, wherein said infusion means includes a pump means which executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

499. A programmable infusion system in accordance with claim 498, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

500. A programmable infusion system in accordance with claim 498, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

501. A programmable infusion system in accordance with claim 500, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

502. A programmable infusion system in accordance with claim 501, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

503. A programmable infusion system in accordance with claim 502, wherein said fixed infusion rate limit is hardwired.

504. A programmable infusion system in accordance with claim 500, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

505. A programmable infusion system in accordance with claim 504, wherein said alarm signal comprises a subcutaneous electrical stimulation.

506. A programmable infusion system in accordance with claim 500, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

507. A programmable infusion system in accordance with claim 487, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, said operational information including information pertaining to the functions of said inhibiting means, and means for receiving said telemetered operational information external to said living body.

508. A programmable infusion system in accordance with claim 433, wherein said infusion means includes means for pumping a preselected amount of medication into said living body, said infusion apparatus further comprising means for recording the rate at which pumping is effected by said pump means.

509. A programmable infusion system in accordance with claim 508, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

510. A programmable infusion system in accordance with claim 509, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

511. A programmable infusion system in accordance with claim 509, further comprising means for telemetering information recorded by said recording means out of said living body, said telemetry means being coupled to said recording means and means for receiving said telemetered information external to said living body.

512. A programmable infusion system in accordance with claim 508, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

513. A programmable infusion system in accordance with claim 512, further comprising means for comparing the rates recorded by both said storing means.

514. A programmable infusion system in accordance with claim 513, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemeterd information external to said living body.

515. A programmable infusion system in accordance with claim 513, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

516. A programmable infusion system in accordance with claim 512, further comprising means for telemetering information recorded by said recording means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemeterd information external to said living body.

517. A programmable infusion system in accordance with claim 508, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

518. A programmable infusion system in accordance with claim 517, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

519. A programmable infusion system in accordance with claim 518, wherein said alarm signal comprises a subcutaneous electrical stimulation.

520. A programmable infusion system in accordance with claim 518, wherein said counting means comprises a pressure transducer.

521. A programmable infusion system in accordance with claim 518, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered operational information external to said living body.

522. A programmable infusion system in accordance with claim 508, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

523. A programmable infusion system in accordance with claim 522, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

524. A programmable infusion system in accordance with claim 523, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

525. A programmable infusion system in accordance with claim 522, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

526. A programmable infusion system in accordance with claim 525, wherein said alarm signal comprises a subcutaneous electrical stimulation.

527. A programmable infusion system in accordance with claim 522, further comprising means for telemetering information recorded by both said counting means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

528. A programmable infusion system in accordance with claim 522, wherein said first recited counting means comprises a pressure transducer.

529. A programmable infusion system in accordance with claim 433, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

530. A programmable infusion system in accordance with claim 529, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

531. A programmable infusion system in accordance with claim 530, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetering receiving means.

532. A programmable infusion system in accordance with claim 531, wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

533. A programmable infusion system in accordance with claim 530, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in said medication chamber by more than a predetermined differential.

534. A programmable infusion system in accordance with claim 533, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

535. A programmable infusion system in accordance with claim 534, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

536. A programmable infusion system in accordance with claim 534, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

537. A programmable infusion system in accordance with claim 534, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, means for receiving said telemetered operational information external to said living body, and means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetry receiver means, and programming means coupled to said telemetry means for indicating when injection of medication into said medication reservoir is appropriate.

538. A programmable infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, said apparatus including

a medication reservoir for storing selected medication,

means for infusing said selected medication stored in said medication reservoir into said living body, said infusion means having at least one remotely commandable operational characteristic and including means for pumping a preselected amount of medication into said living body,

means for recording the rate at which pumping is effected by said pump means, and

command receiver means coupled to said infusion means for receiving command signals; and

command source means external to said living body for transmitting said command signals to be received by said command receiver means.

539. A programmable infusion system in accordance with claim 538, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period;

means for storing a programmable input corresponding to a minimum medication infusion rate; and

means for comparing the rate recorded by said first recited storing means to the rate stored in said second recited storing means.

540. A programmable infusion system in accordance with claim 539, further comprising means for providing an alarm signal when said rate recorded by said first recited storing means is less than said programmable input corresponding to said minimum medication infusion rate recorded by said second recited storing means.

541. A programmable infusion system in accordance with claim 539, further comprising means for telemetering information recorded by said recording means out of said living body, said telemetry means being coupled to said recording means, and means for receiving said telemetered information external to said living body.

542. A programmable infusion system in accordance with claim 538, wherein said recording means comprises:

means for storing the rate at which said pump means pumps over a preselected time period; and

means for storing the rate at which said pump means is signalled to pump over said preselected time period.

543. A programmable infusion system in accordance with claim 542, further comprising means for comparing the rates recorded by both said storing means.

544. A programmable infusion system in accordance with claim 543, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

545. A programmable infusion system in accordance with claim 543, further comprising means for providing an alarm signal when the rate at which said pump means pumps is different than the rate at which said pump means is signalled to pump.

546. A programmable infusion system in accordance with claim 542, further comprising means for telemetering information recorded by said recording means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

547. A programmable infusion system in accordance with claim 538, wherein said pump means executes in pulses, said recording means comprising a pulse rate detector comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count;

minimum rate memory means for storing a programmable number input corresponding to a minimum medication infusion rate; and

means for comparing the number counted by said counting means with said programmable number input stored in said minimum rate memory means.

548. A programmable infusion system in accordance with claim 547, further comprising means for providing an alarm signal when said count is less than said programmable number input stored in said minimum rate memory means.

549. A programmable infusion system in accordance with claim 548, wherein said alarm signal comprises a subcutaneous electrical stimulation.

550. A programmable infusion system in accordance with claim 548, wherein said counting means comprises a pressure transducer.

551. A programmable infusion system in accordance with claim 548, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered operational information external to said living body.

552. A programmable infusion system in accordance with claim 538, wherein said pump means executes in pulses, said recording means comprising a pulse recorder comprising:

means for counting the number of times said pump means pumps over a preselected time period, said counting means storing the count; and

means for counting the number of times said pump means is commanded to pump over said preselected time period.

553. A programmable infusion system in accordance with claim 552, wherein said pulse recorder further comprises means for comparing the numbers recorded by both said counting means.

554. A programmable infusion system in accordance with claim 553, further comprising means for telemetering information outputted by said comparing means out of said living body, said comparing means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

555. A programmable infusion system in accordance with claim 554, further comprising means for providing an alarm signal when said numbers recorded by both said counting means are different.

556. A programmable infusion system in accordance with claim 555, wherein said alarm signal comprises a subcutaneous electrical stimulation.

557. A programmable infusion system in accordance with claim 554, further comprising means for telemetering information recorded by both said counting means out of said living body, said recording means being coupled to said telemetry means, and means for receiving said telemetered information external to said living body.

558. A programmable infusion system in accordance with claim 554, wherein said first recited counting means comprises a pressure transducer.

559. A programmable infusion system in accordance with claim 538, wherein one of said command signals transmitted by said command source means comprises a signal which corresponds to a selected operational rate at which said infusion means will infuse said selected medication into said living body.

560. A programmable infusion system in accordance with claim 538, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said command source and said telemetry receiving means are embodied in a patient programming unit external to said living body, said patient programming unit having a plurality of operational medication dose inputs each corresponding to a medication infusion rate selectable and requestable by the patient, said patient programming unit for selectively transmitting a command signal corresponding to a selected one of said medication dose inputs.

561. A programmable infusion system in accordance with claim 560, wherein said infusion apparatus further comprises electronic control means coupled to said infusion means and said command receiver means, said electronic control means including means for maintaining a history of the infusion rate at which said infusion means has operated, said electronic control means including means for precluding the infusion of said selected medication by said infusion means if said rate requested by said patient programming unit exceeds a predetermined safe medication infusion rate based on said maintained history.

562. A programmable infusion system in accordance with claim 561, wherein said electronic control means is coupled to said telemetry means, said patient programming unit including means for indicating to said patient if said selected infusion rate exceeds said predetermined safe medication infusion rate, said electric control means selectively sending a signal to said indicating means via said telemetry means and said telemetry receiving means, said telemetry receiving means being coupled to said indicating means.

563. A programmable infusion system in accordance with claim 561, wherein said patient programming unit further comprises annunciator means and visual display means for providing information regarding previously selected medication infusion rates, for indicating whether a proper programming of a presently requested infusion rate has been communicated to said command receiver, and for selectively providing information as to the time and rate of previously selected medication infusion.

564. A programmable infusion system in accordance with claim 538, further comprising means for selectively supplying power to said command receiver means, said supply means being coupled to an external power source, said supply means being external to said living body, said infusion means being powered by an implanted power source.

565. A programmable infusion system, in accordance with claim 564, wherein said supply means provides an alternating field.

566. A programmable infusion system, in accordance with claim 565, wherein said infusion apparatus further comprises detector means for detecting said alternating field and for converting the same into electrical energy, said detecting means being coupled to said command receiver.

567. A programmable infusion system in accordance with claim 566, wherein said infusion apparatus further comprises means for rectifying said electrical energy into a d.c. power signal.

568. A programmable infusion system in accordance with claim 567, wherein said d.c. power signal is coupled to said implanted power source to effect the charging thereof.

569. A programmable infusion system in accordance with claim 567, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means being coupled to said rectifier means and being powered by said d.c. power signal.

570. A programmable infusion system in accordance with claim 564, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said telemetry means also being supplied power by said supply means.

571. A programmable infusion system in accordance with claim 564, further comprising means for selectively recharging said implanted power source, said recharging means being powered by said supply means.

572. A programmable infusion system in accordance with claim 538, wherein said infusion means comprises a fluid handling mechanism, said fluid handling mechanism including said pump means, said operational information including information about the operation of said fluid handling mechanism.

573. A programmable infusion system in accordance with claim 572, wherein said pump means further comprises pressure limiting means for controlling the amount of medication pumped by said pump means.

574. A programmable infusion system in accordance with claim 573, wherein said pump means operates in a pulsatile mode.

575. A programmable infusion system in accordance with claim 574, wherein said pump means pumps a fixed volume of said selected medication each time said pump means is pulsed.

576. A programmable infusion system in accordance with claim 575, wherein said pump means comprises variable volume means for storing said selected medication within said at least one, pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means.

577. A programmable infusion system in accordance with claim 576, wherein said variable volume means comprises at least one flexible wall, movement of said at least one flexible wall varying the volume of said variable volume means and means for moving said at least one flexible wall.

578. A programmable infusion system in accordance with claim 577, further comprising spring means for urging said at least one flexible wall in a manner which decreases the volume of said variable volume means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said variable volume means increases due to the displacement of said at least one flexible wall thereof by said moving means.

579. A programmable infusion system in accordance with claim 578, wherein said at least one flexible wall comprises a bellows assembly having mounted on one end thereof a plate, the other end of said bellows assembly being in communication with said selected medication, the walls of said bellows assembly serving as said spring means.

580. A programmable infusion system in accordance with claim 579, wherein said plate has a surface in contact with said selected medication when drawn into said variable volume means.

581. A programmable infusion system in accordance with claim 580, wherein said bellows assembly is inhibited from moving said plate when the pressure (p) in said variable volume means exceeds the spring force (F) of said bellows assembly divided by the wetted area (A) of said surface of said plate in contact with said selected medication, that is when p>

F/A.

582. A programmable infusion system in accordance with claim 579, wherein said plate is magnetizable, said moving means comprising a coil disposed proximate to said plate, said coil selectively radiating a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

583. A programmable infusion system in accordance with claim 582, wherein said plate comprises a permanent magnet.

584. A programmable infusion system in accordance with claim 583, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

585. A programmable infusion system in accordance with claim 576, wherein said infusion means further comprises:

an interface pressure value through which said selected medication enters said variable volume means from said medication reservoir, said interface pressure valve being normally closed;

an outlet chamber which is in communication with said living body; and

an outlet pressure valve located between said variable volume means and said outlet chamber, said outlet pressure valve being normally closed, an increase in volume of said variable volume means causing said interface pressure valve to open and medication to enter said variable volume means, a decrease in volume of said variable volume means causing said outlet pressure valve to open and said interface pressure valve to close, so as to permit medication to enter said outlet chamber as a pressure pulse.

586. A programmable infusion system in accordance with claim 585, wherein said outlet chamber comprises an elastic wall having a fluidic capacitive effect on the flow of said selected medication and a filter element through which liquid flow to the said lining body is resisted, said elastic wall and said filter comprising a fluid resistance-capacitance arrangement with respect to said flow of said selected medication from said outlet chamber into said living body.

587. A programmable infusion system in accordance with claim 575, further comprising means for feeding said selected medication into said living body from said pump means in a flow which decays exponentially over time.

588. A programmable infusion system in accordance with claim 586, wherein said feeding means comprises a mechanical resistance (R) and a mechanical capacitance (C) circuit resulting in an exponentially decaying outflow of medication for each said fixed volume pulse.

589. A programmable infusion system in accordance with claim 576, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, wherein said infusion means further comprises an outlet chamber which is in communication with said living body, said pump means expelling said selected medication into said outlet chambers, and means for monitoring the operation of said pump means, said monitoring means being disposed in said outlet chamber and providing a signal in response to a pressure pulse in said outlet chamber caused by said pump means, said monitoring means being operably coupled to said telemetry means.

590. A programmable infusion system in accordance with claim 589, wherein said monitoring means comprises a pressure transducer.

591. A programmable infusion system in accordance with claim 589, further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

592. A programmable infusion system in accordance with claim 591, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

593. A programmable infusion system in accordance with claim 582, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, means for receiving said telemetered operational information external to said living body, and means for monitoring the operation of said pump means, said monitoring means being operably coupled to said telemetry means.

594. A programmable infusion system in accordance with claim 593, wherein said monitoring means comprises pressure sensing means disposed in the path of flow of said selected medication into said living body, said pressure sensing means providing a signal in response to a pressure pulse in said path of flow.

595. A programmable infusion system in accordance with claim 594, wherein said pump means comprises variable volume means for storing said selected medication within said pump means, an increase in volume of said variable volume means permitting drawing of said selected medication into said pump means, a decrease in volume of said variable volume means permitting expulsion of said selected medication from said pump means, said system further comprising first means for indicating the operation of said pump means when a decrease in volume of said variable volume means is not followed by a signal from said monitoring means corresponding to a pressure pulse of said selected medication expelled into said outlet chamber, said first indicating means being operably coupled to said telemetry means.

596. A programmable infusion system in accordance with claim 595, further comprising second means for indicating the operation of said pump means when a signal is provided by said monitoring means absent a decrease in volume of said variable volume means, said second indicating means being operably coupled to said telemetry means.

597. A programmable infusion system in accordance with claim 538, wherein one of said at least one remotely commandable operational characteristic comprises an infusion rate variable on command, said infusion apparatus further comprising means for inhibiting said infusion means from infusing said selected medication if a preselected medication infusion rate is exceeded, said inhibiting means being operably coupled to said infusion means.

598. A programmable infusion system in accordance with claim 597, wherein said inhibiting means comprises at least one means for defining a fixed infusion rate limit.

599. A programmable infusion system in accordance with claim 598, wherein said at least one means for defining a fixed infusion rate limit is hardwired.

600. A programmable infusion system in accordance with claim 597, wherein said preselected medication infusion rate is remotely selectable.

601. A programmable infusion system in accordance with claim 597, wherein said preselected medication infusion rate comprises a remotely selectable rate and a fixed rate, said remotely selectable rate being limited by said fixed rate.

602. A programmable infusion system in accordance with claim 601, wherein said inhibiting means comprises:

at least one programmable rate memory unit coupled to said command receiver means, each of said at least one programmable rate memory units for receiving and storing an infusion rate input command corresponding to said remotely selectable rate;

at least one limit control unit, each of said at least one limit control units providing a fixed rate limit; and

means for comparing each of said infusion rate input commands to a corresponding said fixed rate limit, infusion of said medication at a rate exceeding said fixed rate limit being inhibited.

603. A programmable infusion system in accordance with claim 602, further comprising command decoder means for coupling each of said at least one programmable rate memory units to said command receiver means, said command decoder means for decoding said command signals received by said command receiver means into said infusion rate inputs for receipt by and storage in corresponding said at least one programmable rate memory unit.

604. A programmable infusion system in accordance with claim 602, wherein each of said at least on limit control units is hardwired.

605. A programmable infusion system in accordance with claim 602, further comprising means for generating an alarm signal when any infusion rate input command exceeds a corresponding fixed rate limit.

606. A programmable infusion system in accordance with claim 605, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined which shifts continuously.

607. A programmable infusion system in accordance with claim 597, wherein said inhibiting means precludes infusion of said medication by said infusion means when the selected said commandable infusion rate exceeds said preselected medication infusion rate during a window of time of a predetermined length which shifts continuously.

608. A programmable infusion system in accordance with claim 597, wherein said pump means executes in pulses, said inhibiting means comprising a programmable memory rate unit coupled to said command receiver for storing initially a dose limit number corresponding to a first maximum number of infusion pulses preselected as allowable during a first shifting time window of a predetermined length, pulse quantities being subtracted from said number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said stored number as time elapses such that said number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said dose limit number stored in said programmable memory rate unit.

609. A programmable infusion system in accordance with claim 608, wherein said memory rate unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted as a result of the elapse of time from said dose limit number stored in said programmable memory rate unit.

610. A programmable infusion system in accordance with claim 608, wherein said programmable memory rate unit also stores initially another dose limit number corresponding to a second maximum number of infusion pulses preselected as allowable during a second shifting time window of a predetermined length, said second shifting time window being longer in length than said first shifting time window, pulse quantities being subtracted from said another dose limit number stored in said programmable memory rate unit as infusion pulses are executed by said infusion means, pulse quantities being added to said another dose limit number as time elapses such that said another dose limit number does not exceed said first maximum number, said subtraction and addition being accomplished in running integral fashion, said inhibiting means not permitting pulsing of said pump means at a rate in excess of the rate represented by said another dose limit number stored in said programmable memory rate unit.

611. A programmable infusion system in accordance with claim 610, wherein said rate memory unit also records the number of pulses which have been inhibited and causes said pump means of said infusion means to execute said pulses when said pulses can be subtracted from both said dose limit numbers stored in said programmable memory rate unit.

612. A programmable infusion system in accordance with claim 611, wherein said inhibiting means further comprises at least one fixed infusion rate limit which limits the total maximum infusion rate of said infusion means.

613. A programmable infusion system in accordance with claim 612, wherein said fixed infusion rate limit is hardwired.

614. A programmable infusion system in accordance with claim 613, further comprising means for generating an alarm signal when any commanded infusion rate results in the inhibiting of pulsing of said pump means by said inhibiting means.

615. A programmable infusion system in accordance with claim 614, wherein said alarm signal comprises a subcutaneous electrical stimulation.

616. A programmable infusion system in accordance with claim 610, further comprising command decoder means for coupling said command receiver means to said programmable memory rate unit, said command decoder means for decoding said command signals received by said command receiver means into said first and second maximum numbers of infusion pulses.

617. A programmable infusion system in accordance with claim 538, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, said operational information including information pertaining to the functions of said inhibiting means, and means for receiving said telemetered operational information external to said living body.

618. A programmable infusion system in accordance with claim 538, said infusion apparatus further comprising means for generating a distinctive alarm signal pattern for each of a plurality of improper operational conditions.

619. A programmable infusion system in accordance with claim 618 further comprising means for delivering said alarm signal pattern to said living body subcutaneously.

620. A programmable infusion system in accordance with claim 619, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

621. A programmable infusion system in accordance with claim 619, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

622. A programmable infusion system in accordance with claim 619, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

623. A programmable infusion system in accordance with claim 619, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

624. A programmable infusion system in accordance with claim 619, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises low battery means voltage.

625. A programmable infusion system in accordance with claim 619, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

626. A programmable infusion system in accordance with claim 618, further comprising means for detecting a medication leak, said medication detecting means being coupled to said alarm means, wherein one of said improper operational conditions comprises a medication leak out of said medication reservoir.

627. A programmable infusion system in accordance with claim 618, further comprising means for detecting a body fluid leak, said body fluid detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises a leak of body fluids into said infusion apparatus.

628. A programmable infusion system in accordance with claim 618, further comprising means for detecting the rate at which said infusion means is operating, said rate detecting means being coupled to said alarm generating means, wherein one of said improper operational conditions comprises operation of said infusion means at an improper rate.

629. A programmable infusion system in accordance with claim 618, wherein one of said improper operational conditions comprises receiving of a command by said command receiver means which cannot be executed.

630. A programmable infusion system in accordance with claim 618, further comprising battery means for powering said infusion means and means for determining the voltage of said battery means, said voltage determining means being coupled to said alarm generating means wherein one of said improper operational conditions comprises low battery means voltage.

631. A programmable infusion system in accordance with claim 618, further comprising means for detecting the amount of medication disposed in said reservoir, said medication amount detecting means being coupled to said alarm generating means wherein one of said improper operational conditions comprises a preselected amount of medication remaining in said medication reservoir.

632. A programmable infusion system in accordance with claim 618, further comprising means for simulating said improper operational conditions for test purposes.

633. A programmable infusion system in accordance with claim 538, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

634. A programmable infusion sytem in accordance with claim 633, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

635. A programmable infusion system in accordance with claim 634, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, said infusion apparatus further comprising switch means disposed within said medication reservoir, said switch means being coupled to said telemetry means and being activated when said flexible diaphragm is disposed in a preselected relationship relative to said switch means, said telemetry means telemetering a signal indicative of such an operational condition to said telemetry receiving means.

636. A programmable infusion system in accordance with claim 635 wherein said switch means is activated by pressure exerted thereon by said flexible diaphragm, said pressure being less than the ambient pressure of said body.

637. A programmable infusion system in accordance with claim 634, said infusion apparatus further comprising an antechamber through which access is gained to said medication reservoir, and a reservoir inlet valve located between said antechamber and said medication chamber, said reservoir inlet valve being operable when the pressure in said antechamber exceeds the pressure in said medication chamber by more than a predetermined differential.

638. A programmable infusion system in accordance with claim 637, wherein the volume of said antechamber is less than 10% the volume of said medication chamber.

639. A programmable infusion system in accordance with claim 637, further comprising an inlet filter means operably disposed between said antechamber and said medication chamber for preventing impurities in said selected medication in said antechamber from passing into said medication chamber when said reservoir inlet valve is opened, said filter means also preventing said selected medication in said medication chamber from rapidly entering said living body in the event of a leak in said inlet valve.

640. A programmable infusion system in accordance with claim 538, further comprising means for programmed pumping of fixed-volume pulses of medication into said living body.

641. A programmable infusion system in accordance with claim 538, further comprising means for telemetering operational information pertaining to said infusion apparatus out of said living body, and means for receiving said telemetered operational information external to said living body, and means for injecting medication into said medication reservoir, said injecting means being coupled to said telemetry receiver means, and programming means coupled to said telemetry means for indicating when injection of medication into said medication reservoir is appropriate.