WO2000074753A1 - Closed loop system for controlling insulin infusion - Google Patents

Closed loop system for controlling insulin infusion Download PDF

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Publication number
WO2000074753A1
WO2000074753A1 PCT/US2000/015393 US0015393W WO0074753A1 WO 2000074753 A1 WO2000074753 A1 WO 2000074753A1 US 0015393 W US0015393 W US 0015393W WO 0074753 A1 WO0074753 A1 WO 0074753A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
insulin
controller
closed loop
user
Prior art date
Application number
PCT/US2000/015393
Other languages
English (en)
French (fr)
Other versions
WO2000074753A9 (en
Inventor
Garry M. Steil
Kerstin Rebrin
Paul V. Goode, Jr.
John J. Mastrototaro
Richard E. Purvis
William P. Van Antwerp
John J. Shin
Cary D. Talbot
Original Assignee
Minimed Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Minimed Inc. filed Critical Minimed Inc.
Priority to CA002373986A priority Critical patent/CA2373986C/en
Priority to EP00941217A priority patent/EP1185321B1/en
Priority to DE60028569T priority patent/DE60028569T2/de
Priority to AU55956/00A priority patent/AU5595600A/en
Priority to JP2001501285A priority patent/JP3683856B2/ja
Publication of WO2000074753A1 publication Critical patent/WO2000074753A1/en
Publication of WO2000074753A9 publication Critical patent/WO2000074753A9/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7242—Details of waveform analysis using integration
    • 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
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M5/1582—Double lumen needles
    • 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
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • 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
    • A61M2005/1726—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 the body parameters being measured at, or proximate to, the infusion site
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Optics & Photonics (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Artificial Intelligence (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Physiology (AREA)
  • Psychiatry (AREA)
  • Signal Processing (AREA)
  • Primary Health Care (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • External Artificial Organs (AREA)
PCT/US2000/015393 1999-06-03 2000-06-02 Closed loop system for controlling insulin infusion WO2000074753A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA002373986A CA2373986C (en) 1999-06-03 2000-06-02 Closed loop system for controlling insulin infusion
EP00941217A EP1185321B1 (en) 1999-06-03 2000-06-02 Closed loop system for controlling insulin infusion
DE60028569T DE60028569T2 (de) 1999-06-03 2000-06-02 Geschlossener regelkreis für die infusion von insulin
AU55956/00A AU5595600A (en) 1999-06-03 2000-06-02 Closed loop system for controlling insulin infusion
JP2001501285A JP3683856B2 (ja) 1999-06-03 2000-06-02 インシュリン注入を制御するための閉ループシステム

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US13760199P 1999-06-03 1999-06-03
US60/137,601 1999-06-03
US16225599P 1999-10-29 1999-10-29
US60/162,255 1999-10-29
US09/586,175 2000-06-01
US09/586,175 US6558351B1 (en) 1999-06-03 2000-06-01 Closed loop system for controlling insulin infusion

Publications (2)

Publication Number Publication Date
WO2000074753A1 true WO2000074753A1 (en) 2000-12-14
WO2000074753A9 WO2000074753A9 (en) 2001-05-17

Family

ID=27385045

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/015393 WO2000074753A1 (en) 1999-06-03 2000-06-02 Closed loop system for controlling insulin infusion

Country Status (8)

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US (2) US6558351B1 (US06558351-20030506-M00010.png)
EP (1) EP1185321B1 (US06558351-20030506-M00010.png)
JP (1) JP3683856B2 (US06558351-20030506-M00010.png)
AT (1) ATE328623T1 (US06558351-20030506-M00010.png)
AU (1) AU5595600A (US06558351-20030506-M00010.png)
CA (1) CA2373986C (US06558351-20030506-M00010.png)
DE (1) DE60028569T2 (US06558351-20030506-M00010.png)
WO (1) WO2000074753A1 (US06558351-20030506-M00010.png)

Cited By (179)

* Cited by examiner, † Cited by third party
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EP1281351A2 (en) * 2001-07-31 2003-02-05 Roche Diagnostics GmbH Diabetes management system
EP1335199A1 (en) * 2002-02-11 2003-08-13 Bayer Corporation Non-invasive system for the determination of analytes in body fluids
EP1338295A1 (en) * 2002-02-26 2003-08-27 Lifescan, Inc. Systems for remotely controlling medication infusion and analyte monitoring
EP1382363A1 (en) 2002-07-15 2004-01-21 Novo Nordisk A/S Closed loop system for controlling blood glucose levels
EP1436023A2 (en) * 2001-09-07 2004-07-14 Medtronic MiniMed, Inc. Safety limits for closed-loop infusion pump control
WO2004060455A1 (en) * 2002-12-31 2004-07-22 Medtronic Minimed, Inc. Closed loop method for controlling insulin infusion
EP1558121A2 (en) * 2002-10-15 2005-08-03 Medtronic Inc. Signal quality monitoring and control for a medical device system
EP1558128A2 (en) * 2002-10-15 2005-08-03 Medtronic Inc. Signal quality monitoring and control for a medical device system
JP2006510467A (ja) * 2002-10-11 2006-03-30 ベクトン・ディキンソン・アンド・カンパニー 単一針または多針皮内（ｉｄ）送達装置に結合されたフィードバックまたはモデルベースコントローラを使用して患者の体内の物質の濃度の連続長期制御を開始し維持するためのシステムおよび方法
WO2007059061A1 (en) * 2005-11-17 2007-05-24 Medtronic Minimed, Inc. External infusion device with programmable capabilities to time-shift basal insulin and method of using the same
WO2008000634A1 (en) * 2006-06-30 2008-01-03 Novo Nordisk A/S Perfusion device with compensation of medical infusion during wear-time
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EP1921980A1 (en) * 2005-08-31 2008-05-21 University Of Virginia Patent Foundation Improving the accuracy of continuous glucose sensors
WO2008086541A2 (en) * 2006-12-29 2008-07-17 Medtronic Minimed, Inc. Method and system for providing sensor redundancy
US7402153B2 (en) 1997-06-09 2008-07-22 Medtronic Minimed, Inc. Closed-loop method for controlling insulin infusion
EP1945095A2 (en) * 2005-11-04 2008-07-23 Abbott Diabetes Care, Inc. Method and system for providing basal profile modification in analyte monitoring and management systems
EP1949849A1 (en) * 2007-01-29 2008-07-30 Roche Diagnostics GmbH Assessment method to process a glucose concentration signal
WO2008112078A2 (en) * 2007-03-13 2008-09-18 Smiths Medical Md, Inc. Basal rate testing using blood glucose input
JP2008272503A (ja) * 2002-03-29 2008-11-13 Thomas Takemi Aoki インスリンを注入する装置
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US9662056B2 (en) 2008-09-30 2017-05-30 Abbott Diabetes Care Inc. Optimizing analyte sensor calibration
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EP1185321B1 (en) 2006-06-07
CA2373986A1 (en) 2000-12-14
JP3683856B2 (ja) 2005-08-17
DE60028569T2 (de) 2007-05-16
AU5595600A (en) 2000-12-28
WO2000074753A9 (en) 2001-05-17
ATE328623T1 (de) 2006-06-15
US20080188796A1 (en) 2008-08-07
CA2373986C (en) 2005-08-02
JP2003522558A (ja) 2003-07-29
US6558351B1 (en) 2003-05-06
DE60028569D1 (de) 2006-07-20
EP1185321A1 (en) 2002-03-13

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