ES2544874T3 - Dispositivo de administración de insulina - Google Patents

Dispositivo de administración de insulina Download PDF

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Publication number
ES2544874T3
ES2544874T3 ES11833366.5T ES11833366T ES2544874T3 ES 2544874 T3 ES2544874 T3 ES 2544874T3 ES 11833366 T ES11833366 T ES 11833366T ES 2544874 T3 ES2544874 T3 ES 2544874T3
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controller
zone
blood glucose
insulin delivery
glucose
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Francis J. Doyle, Iii
Benyamin Grosman
Eyal Dassau
Lois Jovanovic
Howard Zisser
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SANSUM DIABETES RESEARCH INSTITUTE
University of California
SANSUM DIABETES RES INST
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SANSUM DIABETES RESEARCH INSTITUTE
University of California
SANSUM DIABETES RES INST
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    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/62—Insulins

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Diabetes (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Databases & Information Systems (AREA)
  • Data Mining & Analysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)

Abstract

Un dispositivo de administración de insulina que comprende un sistema de sensor para la medición de la glucosa, un controlador y un sistema de administración de insulina, en que el sistema de sensor de glucosa genera una señal de sensor representativa de los niveles de glucosa en sangre y proporciona las señales del sensor al controlador, en que el controlador recibe la señal del sensor y genera comandos que se comunican al sistema de administración de insulina, en que el sistema de administración de insulina recibe los comandos e infunde la insulina en el cuerpo en respuesta a los comandos, caracterizado porque el controlador comprende un algoritmo de control predictivo de modelo multi-zona (MPC) basado en cuatro distribuciones regionales de glucemia, que comprende zonas de hipoglucemia, normoglucemia, glucemia elevada e hiperglucemia, en que en la zona de hiperglucemia, es decir, una concentración de glucosa en sangre de G > 180 mg / dL, las acciones de control se limitan a evitar la sobredosis, en que en la zona de glucemia elevada, es decir 140 < G < 180 mg / dL se implementan la mayor parte de las acciones de control, en que en la zona de normoglucemia, es decir 80 < G < 140 mg / dL, el controlador es quiescente a la desviación en las mediciones de glucosa, y en que en la zona de hipoglucemia, es decir G < 80 mg / dL, al controlador se le permite una respuesta rápida a una hipoglucemia potencial.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
E11833366
07-08-2015
donde PH es el horizonte de predicción de ocho horas y veinte minutos. La optimización se lleva a cabo bajo las siguientes limitaciones:
1.
Para la estabilidad y el anti-aliasing, las raíces del polinomio característico,
se encuentran todas dentro del lado derecho (RHS) de la unidad de círculo, donde de insulina y de glucosa tal como se describe en (1).
2. Requisito de ganancia negativa de insulina, imagen8, dónde imagen9son los regresores de glucosa e insulina, respectivamente, tal como se describe en (1).
3.
Requisito de ganancia positiva de comida,
imagen10
imagen11
dónde imagen12son los regresores de glucosa y de la comida, respectivamente, tal como se describe en (1).
4. Ninguna respuesta inversa en la insulina y la comida. Esto se consigue limitando todos los βi ≥ 0 y 15 todos los χi ≤0.
El resultado de la optimización se representa en la Fig. 1 (b) y describe un modelo que capta el comportamiento general de la población de 10 sujetos.
20 El MPC optimiza cada muestra de control con una función de coste que incluye P instantes de proceso futuro, conocida como horizonte de predicción, y CM futuro de M, el horizonte de control. En cada muestra, la optimización se repite utilizando los datos de proceso actualizados. Sin embargo, sólo el primer CM de cada secuencia optimizada se implementa en el proceso. Las limitaciones del proceso de entrada se incluyen para que la solución óptima impida la futura violación de la limitación.
25 Guiada por la práctica médica, la concentración de glucosa en sangre se puede dividir en cuatro zonas: Zona 1, hiperglucemia, BG> 180 mg / dL; zona 2, glucemia cerca de la normalidad, 140 <BG <180 mg / dl; zona 3, normoglucemia, 80 <BG <140 mg / dL, y zona 4, peligro inminente de hipoglucemia, BG <80 mg / dL. Estas zonas se incluyen en la función de costes utilizada en el MPC Multi-Zona que se describe
30 mediante la siguiente ecuación:
imagen13
donde Ḡ’k es una función binaria que produce los valores del límite superior de la zona de la normoglucemia (140 mg / dL) cuando Ḡ’k > 140 mg / dL, y proporciona de los valores del límite inferior de
35 la zona de normoglucemia (80 mg / dL) cuando Ḡ’k <80 mg / dL. Qk y Rk son pesos de optimización dependientes de la concentración de glucosa en sangre predichos, tal como se enumeran en la Tabla 1. P y M son el horizonte de predicción y el horizonte de control de salida, respectivamente.
El MPC Multi-Zona predice P fases en cada muestra de control. Qk y Rk cambian los valores según las
40 predicciones. Si 80 ≤ Ḡ’k <140, entonces Qk se pone a cero. Si Ḡ’k > 180 mg / dL durante al menos una sola predicción, entonces Qk y Rk se cambian a Qk = 1 y Rk =5000. De lo contrario, Rk = 0.5 para todas las predicciones y Qk cambia de acuerdo con cada valor de Ḡ’k.
Tabla 1. Pesos de MPC Multi-Zona como función de la concentración de glucosa en sangre
45
9
imagen14
imagen15

Claims (1)

  1. imagen1
ES11833366.5T 2010-10-12 2011-10-12 Dispositivo de administración de insulina Active ES2544874T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US392399P 2002-06-28
US39239910P 2010-10-12 2010-10-12
PCT/US2011/056022 WO2012051344A2 (en) 2010-10-12 2011-10-12 Maintaining multiple defined physiological zones using model predictive control

Publications (1)

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ES2544874T3 true ES2544874T3 (es) 2015-09-04

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US (1) US9700708B2 (es)
EP (1) EP2628115B1 (es)
JP (1) JP6062859B2 (es)
CA (1) CA2816388C (es)
DK (1) DK2628115T3 (es)
ES (1) ES2544874T3 (es)
HK (1) HK1182496A1 (es)
WO (1) WO2012051344A2 (es)

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US9700708B2 (en) 2017-07-11
WO2012051344A3 (en) 2012-07-19
CA2816388C (en) 2016-12-06
WO2012051344A2 (en) 2012-04-19
US20130231642A1 (en) 2013-09-05
JP2013542011A (ja) 2013-11-21
CA2816388A1 (en) 2012-04-19
DK2628115T3 (en) 2015-08-24
JP6062859B2 (ja) 2017-01-18
EP2628115B1 (en) 2015-06-03
EP2628115A2 (en) 2013-08-21
HK1182496A1 (en) 2013-11-29
EP2628115A4 (en) 2014-04-23

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