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RU2003105304A - Системы и способы для дистанционного управления вливанием лекарственных средств и мониторинга анализируемых соединений - Google Patents

Системы и способы для дистанционного управления вливанием лекарственных средств и мониторинга анализируемых соединений Download PDF

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Publication number
RU2003105304A
RU2003105304A RU2003105304/14A RU2003105304A RU2003105304A RU 2003105304 A RU2003105304 A RU 2003105304A RU 2003105304/14 A RU2003105304/14 A RU 2003105304/14A RU 2003105304 A RU2003105304 A RU 2003105304A RU 2003105304 A RU2003105304 A RU 2003105304A
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patient
physiological fluid
drug
infusion
remote control
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RU2003105304/14A
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Адам Дэвид БАЙЛУНД (US)
Адам Дэвид БАЙЛУНД
Уилль м Джеффри ДЕРБАН (US)
Уилльям Джеффри ДЕРБАН
Майкл Д. УОРДЛ (US)
Майкл Д. УОРДЛ
Кэрен М. ЛОНГ (US)
Кэрен М. ЛОНГ
Джо МАККЛАСКИ (US)
Джо МАККЛАСКИ
Ульрих КРАФТ (DE)
Ульрих КРАФТ
Манфред ЭБНЕР (DE)
Манфред ЭБНЕР
Маттиас ШТАЙНЕ (GB)
Маттиас ШТАЙНЕ
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Лайфскен, Инк. (Us)
Лайфскен, Инк.
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Publication of RU2003105304A publication Critical patent/RU2003105304A/ru

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    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
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    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or 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
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
    • 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
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A—HUMAN NECESSITIES
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    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Optics & Photonics (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Diabetes (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Emergency Medicine (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • External Artificial Organs (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Claims (11)

1. Система, содержащая насос для вливания лекарственных средств, конфигурированный для ношения на теле пациента, устройство для мониторинга физиологических жидкостей, конфигурированное для ношения на теле пациента, для непрерывного, по существу, мониторинга, по меньшей мере, одной характеристики физиологической жидкости, и устройство для дистанционного управления, предназначенное для дистанционного управления насосом для вливания лекарственных средств и устройством для мониторинга физиологической жидкости, при этом устройство для дистанционного управления содержит устройство для мониторинга физиологической жидкости, предназначенное для эпизодического мониторинга, по меньшей мере, одной характеристики физиологической жидкости.
2. Система по п.1, дополнительно содержащая устройство для обмена информацией между устройством для дистанционного управления, насосом для вливания лекарственных средств и устройством для мониторинга физиологической жидкости.
3. Система по п.1, где указанное устройство для дистанционного управления содержит модуль обмена информацией, предназначенный для обмена информацией с насосом для вливания лекарственных средств и с устройством для мониторинга физиологической жидкости, одну или несколько кнопок управления для взаимодействия пользователя с устройством для дистанционного управления, и контроллер для управления передачей и приемом данных к модулю обмена информацией и от него, и для обработки данных, получаемых от пользователя.
4. Система по п.1, где указанное устройство для дистанционного управления дополнительно содержит приемный узел для оперативного приема тест-полоски с физиологической жидкостью.
5. Система по п.1, где указанный насос для вливания лекарственных средств дополнительно содержит модуль для передачи информации, предназначенный для обмена информацией с устройством для дистанционного управления, одну или несколько кнопок управления для взаимодействия пользователя с насосом для вливания лекарственных средств, и контроллер для управления передачей и приемом данных к устройству для дистанционного управления и от него, и для обработки данных, получаемых от пользователя.
6. Система по п.1, где указанное устройство для мониторинга физиологической жидкости содержит устройство для отбора образцов физиологической жидкости, и сенсор для измерения концентрации одного или нескольких анализируемых соединений в физиологической жидкости, где указанный сенсор соединен в рабочем состоянии и делает возможным сообщение жидкости с указанным устройством, для отбора образцов физиологической жидкости.
7. Система по п.6, где указанное устройство для мониторинга физиологической жидкости дополнительно содержит модуль для передачи информации, предназначенный для обмена информацией с устройством для дистанционного управления, одну или несколько кнопок управления для взаимодействия пользователя с насосом для вливания лекарственных средств, и контроллер для управления передачей и приемом данных к устройству для дистанционного управления и от него, и для обработки данных, получаемых от пользователя.
8. Система для введения лекарственного средства, содержащая насос для вливания лекарственных средств, конфигурированный для ношения на теле пациента, устройство для дистанционного управления, предназначенное для дистанционного управления насосом для вливания лекарственных средств, и процессор, связанный с указанным устройством для дистанционного управления, и программное обеспечение для использования вместе с указанным процессором, предназначенное для осуществления протоколов доставки лекарственных средств с помощью указанного насоса для вливания лекарственных средств, указанные протоколы доставки лекарственных средств содержат первый протокол доставки лекарственного средства для немедленного вливания выбранной дозы лекарственного средства, второй протокол доставки лекарственного средства для вливания выбранной дозы лекарственного средства в течение заданного периода времени и третий протокол доставки лекарственного средства для немедленного вливания первой выбранной дозы лекарственного средства с последующим вливанием второй выбранной дозы лекарственного средства в течение выбранного периода времени.
9. Система по п.8, где указанное программное обеспечение содержит алгоритмы для вычисления текущего или по существу текущего уровня глюкозы в крови пациента, или ожидаемого или реального потребления углеводов пациентом, и для модификации указанных протоколов доставки лекарственных средств в соответствии с указанным уровнем глюкозы в крови или указанным потреблением углеводов.
10. Способ мониторинга и управления концентрацией анализируемого соединения в физиологической жидкости пациента, включающий в себя эпизодическое измерение концентрации анализируемого соединения из образца физиологической жидкости, взятой у пациента, где эпизодическое измерение осуществляется с использованием дистанционного устройства, по существу непрерывный отбор образцов физиологической жидкости у пациента с использованием чрескожных устройств, по существу непрерывное измерение концентрации анализируемого соединения в отобранных образцах физиологической жидкости, передачу данных, представляющих концентрацию анализируемого соединения, дистанционному устройству, определение того, попадает ли концентрация анализируемого соединения за пределы предварительно заданного приемлемого диапазона, и подстройку протокола доставки лекарственного средства, при определении того, что концентрация анализируемого соединения попадает за пределы заданного приемлемого диапазона.
11. Способ мониторинга и управления уровнем глюкозы у пациента, включающий в себя эпизодическое измерение концентрации глюкозы из образца физиологической жидкости, взятой у пациента, получение значения, представляющего потребление углеводов пациентом, вычисление дозы инсулина, которая должна вводиться пациенту, на основе указанной концентрации глюкозы и на основе указанного значения потребления углеводов, передачу радиочастотного сигнала, представляющего указанную дозировку, насосу для вливания инсулина, носимому пациентом, указанный насос для вливаний содержит приемник радиочастот для приема указанного радиочастотного сигнала, и введение указанной дозы инсулина пациенту посредством указанного насоса для вливаний.
RU2003105304/14A 2002-02-26 2003-02-25 Системы и способы для дистанционного управления вливанием лекарственных средств и мониторинга анализируемых соединений RU2003105304A (ru)

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US60/360,401 2002-02-26

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