Medication delivery system and monitor

• US 7,204,823 B2
• Filed: 12/19/2001
• Issued: 04/17/2007
• Est. Priority Date: 12/19/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Talbot, Cary Dean, Estes, Mark C., Bowman, Leif N., Malave, Denetta
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/025,052
• Publication Number:
  US 20030114836A1
• Time in Patent Office: 1,945 Days
• Field of Search: 604/65, 604/66, 604/67, 604 30- 34, 604/218, 604/131, 604/154, 128/DIG.1, 128/DIG.12, 128/DIG.13
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Systems and methods for the delivery and monitoring of a medication, such as insulin, to a recipient are provided. An exemplary feature-rich system comprises an infusion pump with a control system for controlling medication delivery by the infusion pump and a bolus estimator for estimating an appropriate amount of medication for delivery by the control system with the infusion pump. Estimating the appropriate amount of medication for delivery is based upon one or more settings which each vary according to a setting profile. In other embodiments, the control system comprises a suspend function for temporarily suspending medication delivery by the infusion pump, an alarm profile function for programming a variable alarm volume of the alarm and a simplified menu for controlling the dual wave bolus delivery function.

Claims

1. A system for delivering medication, comprising:

an infusion pump coupleable to a medication reservoir; and

a control system having an algorithm for controlling medication delivery by the infusion pump;

wherein the control system includes;

a plurality of medication delivery profiles for delivering a medication from the medication reservoir to a user including a basal profile and a square wave bolus profile or a dual wave bolus profile; and

a plurality of suspend functions capable of separately suspending at least one of the plurality of medication delivery profiles so that a user can suspend a first delivery profile that delivers a medication from the medication reservoir to a user while a second delivery profile continues to deliver the medication from the medication reservoir to the user.

2. The system of claim 1, wherein controlling medication delivery by the pump includes using two or more wave profiles and wherein the control system includes a suspend function for separately suspending each of the two or more wave profiles.

3. The system of claim 2, wherein the control system further includes a resume function for selectively restarting each of the more than one wave profile.

4. The system of claim 2, wherein the control system further includes a compensating function for delivering a compensating bolus to account for any suspended wave profile.

5. The system of claim 2, wherein the suspend function further includes a full suspend function for directly suspending all delivery of medication.

6. The system of claim 2, wherein the more than one wave profiles are selected from the group including a square wave bolus profile, a dual wave bolus profile and a basal profile.

7. The system of claim 1, wherein the suspend function includes a menu system for selecting a period of time for temporarily suspending medication delivery by the infusion pump.

8. The system of claim 7, wherein the menu system includes a plurality of fixed periods from which to select as the period of time for temporarily suspending medication delivery.

9. The system of claim 7, wherein the menu system includes one or more increment periods increment the period of time for temporarily suspending medication delivery.

10. The system of claim 7, wherein the menu system includes a specified time of day to select as an end of the period of time for temporarily suspending medication delivery.

11. The system of claim 7, wherein after the period of time for temporarily suspending medication delivery by the infusion pump has transpired the pump resumes medication delivery.

12. The system of claim 1, wherein the suspend function includes a block function for suspending delivery of medication after a potentially harmful amount of medication requested by a user and a warning to the user of the potentially harmful amount of medication.

13. The system of claim 12, wherein the potentially harmfully amount of medication is bolus.

14. The system of claim 12, wherein the potentially harmfully amount of medication is a bolus requested too soon after a previous bolus is delivered.

15. The system of claim 12, wherein the potentially harmfully amount of medication is too low a total medication dose for the day.

16. The system of claim 12, wherein the block function is triggered after a medication measurement integrated over an integration period exceeds a target value.

17. The system of claim 16, wherein the block function is alternately triggered because a second medication measurement integrated over a simultaneous and overlapping integration period exceeds the target value.

18. The system of claim 16, wherein the integration period is subdivided into a plurality of subperiods and each of the plurality of subperiods is associated with a subtotal representing medication delivered and an oldest subtotal of the subperiods is replaced by a newest subtotal of the subperiods.

37. The system of claim 1, wherein the infusion pump includes a reservoir for containing the medication, a drive mechanism to deliver the medication from the reservoir, a processor to control the control system, a memory to store the plurality of medication delivery profiles, an input device to allow a patient to command the infusion pump and a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device, wherein the control system controls medication delivery from the reservoir in accordance with the plurality of medication delivery profiles, such that two or more of the plurality of medication delivery profiles can be used to deliver medication at the same time.

38. The system of claim 37, wherein at least one of the plurality of suspend functions may be used independently of at least one of the other of the plurality of suspend functions, such that medication delivery continues from the reservoir in accordance with at least one of the plurality of medication delivery profiles.

39. The system of claim 1, wherein the infusion pump includes a reservoir for containing the medication, a drive mechanism to deliver the medication from the reservoir, a processor to control the control system, a memory to store the plurality of medication delivery profiles, an input device to allow a patient to command the infusion pump and a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device, wherein the control system controls medication delivery from the reservoir in accordance with the plurality of medication delivery profiles, such that two or more of the plurality of medication delivery profiles can be used to deliver medication at the same time, and wherein at least one of the plurality of suspend functions may be used independently of at least one of the other of the plurality of suspend functions, such that medication delivery continues from the reservoir in accordance with at least one of the plurality of medication delivery profiles.

94. The system of claim 1, wherein the infusion pump is disposed within a housing adapted to he worn on a belt, adapted to be worn under clothing, adapted to be worn against the skin or adapted to fit in a clothing pocket.

19. A method of delivering medication, comprising:

controlling medication delivery by an infusion pump coupled to a medication reservoir, wherein the infusion pump includes a control system comprising an algorithm, and wherein the control system includes a plurality of medication delivery profiles including a basal profile and a square wave bolus profile or a dual wave bolus profile and a plurality of suspend functions capable of separately suspending the plurality of medication delivery profiles so that a user can suspend a first delivery profile that delivers a medication from the medication reservoir to a user while a second delivery profile continues to deliver the medication from the medication reservoir to the user; and

temporarily suspending a medication delivery profile from the infusion pump with a suspend function of the control system.

20. The method of claim 19, wherein the step of controlling medication delivery by the pump includes using two or more wave profiles and wherein the control system includes a suspend function for separately suspending each of the two or more wave profiles.

21. The method of claim 20, further including selectively restarting each of the more than one wave profile with a resume function of the control system.

22. The method of claim 20, further including delivering a compensating bolus to account for any suspended wave profile with a compensating function of the control system.

23. The method of claim 20, wherein the suspend function further includes a full suspend function for directly suspending all medication delivery.

24. The method of claim 20, wherein the more than one wave profiles are selected from the group including a square wave bolus profile, a dual wave bolus profile and a basal profile.

25. The method of claim 19, wherein the suspend function includes a menu system for selecting a period of time for temporarily suspending medication delivery by the infusion pump.

26. The method of claim 25, wherein the menu system includes a plurality of fixed periods from which to select as the period of time for temporarily suspending medication delivery.

27. The method of claim 25, wherein the menu system includes one or more increment periods increment the period of time for temporarily suspending medication delivery.

28. The method of claim 25, wherein the menu system includes a specified time of day to select as an end of the period of time for temporarily suspending medication delivery.

29. The method of claim 25, wherein after the period of time for temporarily suspending medication delivery by the infusion pump has transpired the pump resumes medication delivery.

30. The method of claim 19, wherein the step of temporarily suspending includes suspending delivery of medication with a block function of the control system after a potentially harmful amount of medication is requested by a user and a warning to the user of the potentially harmful amount of medication.

31. The method of claim 30, wherein the potentially harmfully amount of medication is bolus.

32. The method of claim 30, wherein the potentially harmfully amount of medication is a bolus requested too soon after a previous bolus is delivered.

33. The method of claim 30, wherein the potentially harmfully amount of medication is too low a total medication dose for the day.

34. The method of claim 30, wherein the block function is triggered after a medication measurement integrated over an integration period exceeds a target value.

35. The method of claim 34, wherein the block function is alternately triggered because a second medication measurement integrated over a simultaneous and overlapping integration period exceeds the target value.

36. The method of claim 34, wherein the integration period is subdivided into a plurality of subperiods and each of the plurality of subperiods is associated with a subtotal representing medication delivered and an oldest subtotal of the subperiods is replaced by a newest subtotal of the subperiods.

40. The method of claim 19, wherein the infusion pump includes a reservoir for containing the medication, a drive mechanism to deliver the medication from the reservoir, a processor to control the control system, a memory to store the plurality of medication delivery profiles, an input device to allow a patient to command the infusion pump and a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device, wherein the control system controls medication delivery from the reservoir in accordance with the plurality of medication delivery profiles, such that two or more of the plurality of medication delivery profiles can be used to deliver medication at the same time.

41. The method of claim 40, wherein at least one of the plurality of suspend functions may be used independently of at least one of the other of the plurality of suspend functions, such that medication delivery continues from the reservoir in accordance with at least one of the plurality of medication delivery profiles.

42. The method of claim 19, wherein the infusion pump includes a reservoir for containing the medication, a drive mechanism to deliver the medication from the reservoir, a processor to control the control system, a memory to store the plurality of medication delivery profiles, an input device to allow a patient to command the infusion pump and a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device, wherein the control system controls medication delivery from the reservoir in accordance with the plurality of medication delivery profiles, such that two or more of the plurality of medication delivery profiles can be used to deliver medication at the same time, and wherein at least one of the plurality of suspend functions may be used independently of at least one of the other of the plurality of suspend functions, such that medication delivery continues from the reservoir in accordance with at least one of the plurality of medication delivery profiles.

95. The method of claim 19, wherein the infusion pump is disposed within a housing adapted to be worn on a belt, adapted to be worn under clothing, adapted to be worn against the skin or adapted to fit in a clothing pocket.

43. An infusion device for delivering a fluid from a reservoir to the body of a patient, the infusion device comprising:

a drive mechanism to deliver the fluid from the reservoir to the body of the patient;

a processor including a control system for controlling delivery of the fluid;

a memory to store two or more medication delivery profiles associated with the reservoir;

an input device to allow the patient to command the processor; and

a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device;

wherein the control system controls fluid delivery from the reservoir in accordance with the two or more medication delivery profiles, such that the two or more medication delivery profiles can be used to deliver fluid at the same time,

wherein the control system includes at least two suspend functions capable of separately suspending at least one of the two or more medication delivery profiles, such that fluid delivery continues in accordance with at least one of the two or more medication delivery profiles, wherein each of the at least two suspend functions may be used independently of the other of the at least two suspend functions so that a user can suspend a first delivery profile that delivers a fluid from the reservoir to a user while a second delivery profile continues to deliver the fluid from the reservoir to the user.

44. The infusion device of claim 43, wherein the control system further includes a resume function for selectively restarting each of the two or more medication delivery profiles.

45. The infusion device of claim 43, wherein the control system further includes a compensating function for delivering a compensating bolus to account for any suspended medication delivery profile.

46. The infusion device of claim 43, wherein the at least two suspend functions further include a full suspend function for directly suspending all fluid delivery.

47. The infusion device of claim 43, wherein the two or more medication delivery profiles are selected from the group including a square wave bolus profile, a dual wave bolus profile and a basal profile.

48. The infusion device of claim 43, wherein the at least two suspend functions include a menu system for selecting a period of time for temporarily suspending fluid delivery by the infusion device.

49. The infusion device of claim 48, wherein the menu system includes a plurality of fixed periods from which to select as the period of time for temporarily suspending fluid delivery.

50. The infusion device of claim 48, wherein the menu system includes one or more increment periods to increment the period of time for temporarily suspending fluid delivery.

51. The infusion device of claim 48, wherein the menu system includes a specified time of day to select as an end of the period of time for temporarily suspending fluid delivery.

52. The infusion device of claim 48, wherein after the period of time for temporarily suspending fluid delivery by the infusion device has transpired the infusion device resumes fluid delivery.

53. The infusion device of claim 43, wherein the at least two suspend functions include a block function for suspending delivery of the fluid after a potentially harmful amount of fluid is requested by a user and a warning to the user of the potentially harmful amount of fluid.

54. The infusion device of claim 53, wherein the potentially harmful amount of fluid is a bolus.

55. The infusion device of claim 53, wherein the potentially harmful amount of fluid is a bolus requested too soon after a previous bolus is delivered.

56. The infusion device of claim 53, wherein the potentially harmful amount of fluid is too low a total fluid dose for the day.

57. The infusion device of claim 53, wherein the block function is triggered after a fluid measurement integrated over an integration period exceeds a target value.

58. The infusion device of claim 57 wherein the block function is alternately triggered because a second fluid measurement integrated over a simultaneous and overlapping integration period exceeds the target value.

59. The infusion device of claim 57, wherein the integration period is subdivided into a plurality of subperiods and each of the plurality of subperiods is associated with a subtotal representing the fluid delivered and an oldest subtotal of the subperiods is replaced by a newest subtotal of the subperiods.

96. The device of claim 43, wherein the infusion pump is disposed within a housing adapted to be worn on a belt, adapted to be worn under clothing, adapted to be worn against the skin or adapted to fit in a clothing pocket.

60. An infusion device for delivering a fluid from a reservoir to the body of a patient, the infusion device comprising:

a drive mechanism to deliver the fluid from the reservoir to the body of the patient;

a processor including a control system for controlling delivery of the fluid;

a memory to store at least one basal rate profile and at least one bolus profile associated with the reservoir;

an input device to allow the patient to command the processor; and

a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device;

wherein the control system controls fluid delivery from the reservoir in accordance with the at least one basal rate profile and the at least one bolus profile, such that the at least one basal rate profile and the at least one bolus profile can be used to deliver fluid at the same time,

wherein the control system includes at least two suspend functions capable of separately suspending at least one of the at least one basal rate profile and the at least one bolus profile, wherein each of the at least two suspend functions may be used independently of the other of the at least two suspend functions so that a user can suspend a first delivery profile that delivers a fluid from the reservoir to a user while a second delivery profile continues to deliver the fluid from the reservoir to the user.

61. The infusion device of claim 60, wherein the control system further includes a resume function for selectively restarting each of the at least one basal rate profile and the at least one bolus profile.

62. The infusion device of claim 60, wherein the control system further includes a compensating function for delivering a compensating bolus to account for any suspended at least one basal rate profile and at least one bolus profile.

63. The infusion device of claim 60, wherein the at least two suspend functions further include a full suspend function for directly suspending all fluid delivery.

64. The infusion device of claim 60, wherein the at least one basal rate profile and the at least one bolus profile are selected from the group including a square wave bolus profile, a dual wave bolus profile and a basal profile.

65. The infusion device of claim 60, wherein the at least two suspend functions include a menu system for selecting a period of time for temporarily suspending fluid delivery by the infusion device.

66. The infusion device of claim 65 wherein the menu system includes a plurality of fixed periods from which to select as the period of time for temporarily suspending fluid delivery.

67. The infusion device of claim 65, wherein the menu system includes one or more increment periods to increment the period of time for temporarily suspending fluid delivery.

68. The infusion device of claim 65, wherein the menu system includes a specified time of day to select as an end of the period of time for temporarily suspending fluid delivery.

69. The infusion device of claim 65, wherein after the period of time for temporarily suspending fluid delivery by the infusion device has transpired the infusion device resumes fluid delivery.

70. The infusion device of claim 60, wherein the at least two suspend functions include a block function for suspending delivery of the fluid after a potentially harmful amount of fluid is requested by a user and a warning to the user of the potentially harmful amount of fluid.

71. The infusion device of claim 70, wherein the potentially harmful amount of fluid is a bolus.

72. The infusion device of claim 70, wherein the potentially harmful amount of fluid is a bolus requested too soon after a previous bolus is delivered.

73. The infusion device of claim 70, wherein the potentially harmful amount of fluid is too low a total fluid dose for the day.

74. The infusion device of claim 70, wherein the block function is triggered after a fluid measurement integrated over an integration period exceeds a target value.

75. The infusion device of claim 74, wherein the block function is alternately triggered because a second fluid measurement integrated over a simultaneous and overlapping integration period exceeds the target value.

76. The infusion device of claim 74, wherein the integration period is subdivided into a plurality of subperiods and each of the plurality of subperiods is associated with a subtotal representing the fluid delivered and an oldest subtotal of the subperiods is replaced by a newest subtotal of the subperiods.

97. The device of claim 60, wherein the infusion pump is disposed within a housing adapted to be worn on a belt, adapted to be worn under clothing, adapted to be worn against the skin or adapted to fit in a clothing pocket.

77. An infusion device for delivering a fluid from a reservoir to the body of a patient, the infusion device comprising:

a drive mechanism to deliver the fluid from the reservoir to the body of the patient;

a processor including a control system for controlling delivery of the fluid;

a memory to store two or more medication delivery profiles;

an input device to allow the patient to command the processor; and

a housing that houses at least a portion of the reservoir, at least a portion of the drive mechanism, the processor, the memory and at least a portion of the input device;

wherein the two or more medication delivery profiles include at least one basal rate profile and at least one bolus profile,

wherein the control system controls fluid delivery from the reservoir in accordance with the at least one basal rate profile and the at least one bolus profile, such that the at least one basal rate profile and the at least one bolus profile can be used to deliver fluid at the same time,

wherein the control system includes at least two suspend functions capable of separately suspending at least one of the two or more medication delivery profiles, such that fluid delivery continues in accordance with at least one of the two or more medication delivery profiles, wherein each of the a least two suspend functions may be used independently of the other of the at least two suspend functions so that a user can suspend a first delivery profile that delivers a fluid from the reservoir to a user while a second delivery profile continues to deliver the fluid from the reservoir to the user.

78. The infusion device of claim 77, wherein the control system further includes a resume function for selectively restarting each of the two or more medication delivery profiles.

79. The infusion device of claim 77, wherein the control system further includes a compensating function for delivering a compensating bolus to account for any suspended medication delivery profiles.

80. The infusion device of claim 77, wherein the at least two suspend functions include a full suspend function for directly suspending all fluid delivery.

81. The infusion device of claim 77, wherein the two or more medication delivery profiles are selected from the group including a square wave bolus profile, a dual wave bolus profile and a basal profile.

82. The infusion device of claim 77, wherein the at least two suspend functions include a menu system for selecting a period of time for temporarily suspending fluid delivery by the infusion device.

83. The infusion device of claim 77, wherein the menu system includes a plurality of fixed periods from which to select as the period of time for temporarily suspending fluid delivery.

84. The infusion device of claim 82, wherein the menu system includes one or more increment periods to increment the period of time for temporarily suspending fluid delivery.

85. The infusion device of claim 82, wherein the menu system includes a specified time of day to select as an end of the period of time for temporarily suspending fluid delivery.

86. The infusion device of claim 82, wherein after the period of time for temporarily suspending fluid delivery by the infusion device has transpired the infusion device resumes fluid delivery.

87. The infusion device of claim 77, wherein the at least two suspend functions include a block function for suspending delivery of the fluid after a potentially harmful amount of fluid is requested by a user and a warning to the user of the potentially harmful amount of fluid.

88. The infusion device of claim 87, wherein the potentially harmful amount of fluid is a bolus.

89. The infusion device of claim 87, wherein the potentially harmful amount of fluid is a bolus requested too soon after a previous bolus is delivered.

90. The infusion device of claim 87, wherein the potentially harmful amount of fluid is too low a total fluid dose for the day.

91. The infusion device of claim 87, wherein the block function is triggered after a fluid measurement integrated over an integration period exceeds a target value.

92. The infusion device of claim 91, wherein the block function is alternately triggered because a second fluid measurement integrated over a simultaneous and overlapping integration period exceeds the target value.

93. The infusion device of claim 91, wherein the integration period is subdivided into a plurality of subperiods and each of the plurality of subperiods is associated with a subtotal representing the fluid delivered and an oldest subtotal of the subperiods is replaced by a newest subtotal of the subperiods.

98. The device of claim 77, wherein the infusion pump is disposed within a housing adapted to be worn on a belt, adapted to be worn under clothing, adapted to be worn against the skin or adapted to fit in a clothing pocket.