CA2459398A1 - A system and method for providing closed loop infusion formulation delivery - Google Patents

A system and method for providing closed loop infusion formulation delivery Download PDF

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Publication number
CA2459398A1
CA2459398A1 CA002459398A CA2459398A CA2459398A1 CA 2459398 A1 CA2459398 A1 CA 2459398A1 CA 002459398 A CA002459398 A CA 002459398A CA 2459398 A CA2459398 A CA 2459398A CA 2459398 A1 CA2459398 A1 CA 2459398A1
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CA
Canada
Prior art keywords
method recited
blood glucose
infusion formulation
glucose level
delivery
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Granted
Application number
CA002459398A
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French (fr)
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CA2459398C (en
Inventor
Timothy J. Starkweather
Ronald J. Lebel
Rajiv Shah
Michael E. Miller
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Medtronic Minimed Inc
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Individual
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Priority to CA2764284A priority Critical patent/CA2764284C/en
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders

Abstract

A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time t o compensate for changes in a sensed biological state that may result from dai ly events. Safety limits on the delivery amount may be included in the algorith m. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to th e controller. The controller calculates an infusion formulation delivery amoun t based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Claims (51)

1. A method for calculating a delivery rate of an infusion formulation in response to a sensed biological state, the method comprising:
measuring parameters of a sensed biological state at timed intervals;
processing the measured parameters and times at which the measurements are taken in an algorithm; adjusting control parameters within the algorithm to compensate for changes in the sensed biological state resulting from events affecting the sensed biological state; and calculating an infusion formulation delivery amount after adjusting the control parameters.
2. The method recited in claim 1, wherein the infusion formulation comprises an insulin formulation and wherein the sensed biological state comprises blood glucose levels in a human body.
3. The method recited in claim 2, wherein measuring parameters of the sensed biological state comprises providing a sensing device for measuring a present blood glucose level and a rising or falling rate of change for the blood glucose level.
4. The method recited in claim 3, wherein measuring parameters of the sensed biological state further comprises generating and providing to a computing element a signal representative of the measured parameters.
5. The method recited in claim 4, further comprising providing a low pass filter for reducing noise in the generated signal.
6. The method recited in claim 5, wherein the filter comprises a finite impulse response (FIR) filter.
7. The method recited in claim 6, wherein an order of the filter is programmable.
8. The method recited in claim 7, wherein the filter is programmed to have a higher order when the blood glucose level is falling.
9. The method recited in claim 1, wherein the measured parameters and the times are processed by a controller comprising a computing element for executing a closed-loop algorithm for calculating an insulin formulation delivery amount having proportional, derivative, and basal rate components.
10. The method recited in claim 9, wherein the derivative component is expressed as (G(t) - G(t-x)/x, wherein G(t) denotes a blood glucose level at time t, G(t-x) denotes a blood glucose level at time t - x, and x denotes a numerical value representing an increment of time.
11. The method recited in claim 2, wherein the control parameters comprise at least one of a glucose set point, basal rate, proportional gain, trend term, trend up gain, and trend down gain.
12. The method recited in claim 1, wherein the control parameters are programmable.
13. The method recited in claim 12, wherein the control parameters are programmable in real time.
14. The method recited in claim 11, wherein the trend term is expressed as (G(t) - G(t-x)/x, wherein G(t) denotes a blood glucose level at time t, G(t-x) denotes a blood glucose level at time t - x, and x denotes a numerical value representing an increment of time, and wherein adjusting control parameters comprises adjusting the value of x in the trend term to define a timeframe extending back in time from the time t.
15. The method recited in claim 14, wherein the value of x in the trend term is adjusted only when the blood glucose level is falling.
16. The method recited in claim 11, wherein the trend term is multiplied by one of the trend up gain and the trend down gain and wherein adjusting control parameters comprises adjusting at least one of the trend up gain and the trend down gain.
17. The method recited in claim 16, wherein the trend down gain is greater than the trend up gain.
18. The method recited in claim 16, wherein the trend down gain is adjusted such that the calculation of the trend term results in a negative value high enough to substantially cut off further delivery of insulin formulation.
19. The method recited in claim 11, wherein the trend term is enabled only when the blood glucose level is rising and equal to or greater than a set point value for the blood glucose level.
20. The method recited in claim 11, wherein adjusting control parameters comprises adjusting the basal rate.
21. The method recited in claim 20, wherein adjusting the basal rate comprises disabling the basal rate when the blood glucose level is falling and is below a set point value for the blood glucose level.
22. The method recited in claim 20, wherein adjusting the basal rate comprises including a programmable table of basal rate values and selecting a basal rate value from the table.
23. The method recited in claim 22, wherein the basal rate value is selected from the table at timed intervals.
24. The method recited in claim 23, wherein the timed intervals are programmable.
25. The method recited in claim 23, wherein adjusting the basal rate further comprises selecting a basal rate value from the table at 30 minute intervals.
26. The method recited in claim 23, wherein the basal rate value is selected at timed intervals based on a user's historical physiological data.
27. The method recited in claim 1, wherein the sensed biological state comprises one of a sensed blood oxygen level, a temperature, and motion.
28. The method recited in claim 27, wherein the infusion formulation comprises an insulin formulation.
29. The method recited in claim 1, wherein calculating an infusion formulation delivery amount further comprises storing the calculated infusion formulation delivery amount in an accumulator while a volume of infusion formulation in the accumulator is less than a predefined volume.
30. The method recited in claim 29, wherein the volume of infusion formulation stored in the accumulator is delivered to an infusion site when it is substantially equal to the predefined volume.
31. The method recited in claim 29, further comprising purging the volume of infusion formulation stored in the accumulator when the stored volume is less than the predefined volume and a purge command is generated.
32. The method recited in claim 29, further comprising limiting to a predefined amount the amount of infusion formulation that may be stored in the accumulator at any one timed interval.
33. The method recited in claim 30, wherein the predefined volume is a pump stroke volume.
34. The method recited in claim 30, further comprising limiting the volume of infusion formulation that may be delivered to the infusion site during a predefined interval.
35. The method recited in claim 34, wherein the predefined interval is an hour.
36. A method for delivering a bolus of insulin formulation, the method comprising: sampling a blood glucose level at predefined timed intervals; comparing the sampled blood glucose level to a predefined blood glucose level threshold; and disabling a bolus delivery if the sampled blood glucose level is less than the predefined blood glucose level threshold.
37. The method recited in claim 36, further comprising: determining if a predefined time interval has been exceeded since a previous bolus delivery; and disabling the bolus delivery if the predefined time interval has not been exceeded.
38. The method recited in claim 36, further comprising: determining if the sampled blood glucose level is rising at a predefined rate; and disabling the bolus delivery if the sampled blood glucose level is rising at a rate less than the predefined rate.
39. A closed loop infusion formulation delivery system for controlling a biological state in the body of a user, comprising a sensor for measuring parameters of a sensed biological state at timed intervals and generating a signal representative of the measured parameters and times at which the measurements are taken; a computing element for receiving and processing the generated signal, wherein the computing element adjusts control parameters within the algorithm to compensate for changes in the sensed biological state resulting from events affecting the sensed biological state; calculates a delivery rate of an infusion formulation after adjusting the control parameters; and generates commands based on the calculated delivery rate; and a delivery device for receiving the generated commands and delivering the infusion formulation based on the generated commands.
40. The closed loop infusion formulation delivery system recited in claim 39, wherein the infusion formulation comprises an insulin formulation and wherein the sensed biological state comprises blood glucose levels in a human body.
41. The closed loop infusion formulation delivery system recited in claim 39, wherein the measured parameters of the sensed biological state comprise a present blood glucose level and a rising or falling rate of change for the blood glucose level.
42 42. The method recited in claim 40, wherein the control parameters comprise at least one of a glucose set point, basal rate, proportional gain, trend term, trend up gain, and trend down gain.
43. The closed loop infusion formulation delivery system recited in claim 40, wherein the control parameters are programmable.
44. The closed loop infusion formulation delivery system recited in claim 43, wherein the control parameters are programmable in real time.
45. The closed loop infusion formulation delivery system recited in claim 39, wherein the sensed biological state comprises one of a sensed blood oxygen level, a temperature, and motion.
46. The closed loop infusion formulation delivery system recited in claim 45, wherein the infusion formulation comprises an insulin formulation.
47. The closed loop infusion formulation delivery system recited in claim 39, wherein the sensor comprises a sensor for measuring at least one of a blood glucose level, a blood oxygen level, a temperature, and motion.
48. The closed loop infusion formulation delivery system recited in claim 39, wherein the sensor comprises a two or more sensors, each of the two or more sensors measuring at least one of a blood glucose level, a blood oxygen level, a temperature, and motion.
49. A method for disabling a calculation of a delivery rate of an infusion formulation by a computing element in response to a sensed biological state, the method comprising: determining a time window for disabling a calculation of a delivery rate of an infusion formulation;
sampling a current time; determining if the current time is within the time window;

and disabling the calculation of the delivery rate of the infusion formulation if the current time is within the time window.
50. The method recited in claim 49, wherein determining a time window further comprises providing programmable start and stop times for the time window.
51. The method recited in claim 50, wherein the programmable start and stop times for the time window are determined from historical physiological data.
CA2459398A 2001-09-07 2002-09-04 A system and method for providing closed loop infusion formulation delivery Expired - Lifetime CA2459398C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2764284A CA2764284C (en) 2001-09-07 2002-09-04 A system and method for providing closed loop infusion formulation delivery

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US31806201P 2001-09-07 2001-09-07
US60/318,062 2001-09-07
US33566401P 2001-10-23 2001-10-23
US60/335,664 2001-10-23
US10/033,173 2001-12-26
US10/033,173 US6740072B2 (en) 2001-09-07 2001-12-26 System and method for providing closed loop infusion formulation delivery
PCT/US2002/028015 WO2003023708A2 (en) 2001-09-07 2002-09-04 A system and method for providing closed loop infusion formulation delivery

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CA2459398C CA2459398C (en) 2012-04-03

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AU (1) AU2002323575A1 (en)
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