RU2004117068A - Система для извлечения образцов жидкости тела и мониторинга аналита в ней, устройство и способ извлечения внутритканевой жидкости - Google Patents

Система для извлечения образцов жидкости тела и мониторинга аналита в ней, устройство и способ извлечения внутритканевой жидкости Download PDF

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RU2004117068A
RU2004117068A RU2004117068/14A RU2004117068A RU2004117068A RU 2004117068 A RU2004117068 A RU 2004117068A RU 2004117068/14 A RU2004117068/14 A RU 2004117068/14A RU 2004117068 A RU2004117068 A RU 2004117068A RU 2004117068 A RU2004117068 A RU 2004117068A
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vtzh
pressure
user
skin layer
sample
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Джоэл РАККИНИ (US)
Джоэл РАККИНИ
Майкл ХИЛГЕРС (US)
Майкл ХИЛГЕРС
Фил СТАУТ (US)
Фил СТАУТ
Томас РАДЕМАХЕР (US)
Томас РАДЕМАХЕР
Джоэл МЕЧЕЛКЕ (US)
Джоэл МЕЧЕЛКЕ
Кесс А. ХЕНСОН (US)
Кесс А. ХЕНСОН
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Лайфскен, Инк. (Us)
Лайфскен, Инк.
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • 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
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    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
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    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
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    • 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
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    • 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
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
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    • A61B5/1455—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 optical sensors, e.g. spectral photometrical oximeters
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    • 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
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    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
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    • A61B5/6813—Specially adapted to be attached to a specific body part
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Claims (23)

1. Система для извлечения образцов жидкости тела и мониторинга аналита в ней, содержащая одноразовый картридж, включающий в себя блок отбора образцов, выполненный с возможностью извлечения образца жидкости тела из тела, и
блок анализа, выполненный с возможностью измерения аналита в образце жидкости тела, и блок локального контроллера, имеющего электронную связь с одноразовым картриджем, причем локальный контроллер выполнен с возможностью приема данных измерения из блока анализа и сохранения данных.
2. Система по п.1, в которой блок отбора образцов выполнен с возможностью извлечения образца внутритканевой жидкости (ВТЖ) и измерения глюкозы в образце ВТЖ.
3. Система по п.2, в которой блок отбора образцов включает в себя проникающий элемент, выполненный с возможностью проникновения в целевую область слоя кожи пользователя и, впоследствии постоянного нахождения в слое кожи пользователя и извлечения образца ВТЖ из нее, и по меньшей мере, одно прижимное кольцо, выполненное с возможностью приложения давления к слою кожи пользователя в непосредственной близости от целевой области, в то время как проникающий элемент находится в слое кожи пользователя, причем блок отбора образцов выполнен таким образом, что прижимное кольцо выполнено с возможностью приложения давления в виде колебаний, посредством чего сглаживается сдвиг глюкозы ВТЖ образца ВТЖ, извлеченного при помощи проникающего элемента.
4. Система по п.1, в которой одноразовый картридж и локальный контроллер выполнены с возможностью ношения на теле.
5. Система по п.1, дополнительно содержащая блок удаленного контроллера, выполненный с возможностью электронной связи с блоком локального контроллера.
6. Система по п.5, в которой блок удаленного контроллера выполнен с возможностью приема тест-полосок глюкозы, измерения концентрации глюкозы образца крови, нанесенного на тест-полоску глюкозы.
7. Система по п.5, в которой блок удаленного контроллера выполнен с возможностью использования алгоритма предсказания для предсказания концентрации глюкозы крови, исходя из концентрации глюкозы ВТЖ, определенной блоком локального контроллера.
8. Система по п.7, в которой блок удаленного контроллера использует алгоритм в следующем виде:
PBGC=f(ISFi k', ratej, manratem p, параметры взаимодействия),
где PBGC является предсказанной концентрацией глюкозы крови;
i является целым, принимающим значение между 0 и 3;
j, n, и m являются целыми, принимающими значения между 1 и 3;
k и р являются целыми со значениями 1 или 2;
ISFi является измеренным значением глюкозы ВТЖ;
ratej является скоростью изменения между смежными значениями
ВТЖ; и
manratem p является скользящим средним скорости между смежными
средними групп значений глюкозы ВТЖ.
9. Система по п.1, в которой блок отбора проб включает в себя проникающий элемент, механизм подачи, и по меньшей мере, одно прижимное кольцо.
10. Система по п.1, в которой блок отбора проб выполнен с возможностью обеспечения непрерывного потока извлекаемого образца жидкости тела в блок анализа.
11. Система по п.1, в которой одноразовый картридж и блок локального контроллера выполнены с возможностью прикрепления к коже пользователя.
12. Устройство для извлечения внутритканевой жидкости (ВТЖ), содержащее проникающий элемент, выполненный с возможностью проникновения в целевую область слоя кожи пользователя и, впоследствии постоянного нахождения в слое кожи пользователя и извлечения образца ВТЖ из нее, и по меньшей мере, одно прижимное кольцо, выполненное с возможностью приложения давления к слою кожи пользователя в непосредственной близости от целевой области, в то время как проникающий элемент находится в слое кожи пользователя, причем устройство для извлечения ВТЖ выполнено таким образом, что прижимное кольцо имеет возможность приложения давления в виде колебаний для сглаживания сдвига глюкозы ВТЖ образца ВТЖ, извлеченного при помощи проникающего элемента.
13. Устройство по п.12, в котором устройство для извлечения ВТЖ выполнено таким образом, что прижимное кольцо имеет возможность приложения давления в виде колебаний, причем давление прикладывается в течение временного периода в пределах от трех секунд до трех часов, давление впоследствии снимается на временной период в пределах от трех секунд до трех часов, и затем давление повторно прикладывается в течение временного периода в пределах от трех секунд до трех часов.
14. Устройство по п.12, дополнительно содержащее по меньшей мере, один первый смещающий элемент, выполненный с возможностью перемещения прижимного кольца между выдвинутым состоянием и втянутым состоянием, и второй смещающий элемент, выполненный с возможностью подачи проникающего элемента.
15. Устройство по п.12, в котором проникающий элемент выполнен с возможностью размещения в слое кожи пользователя в течение периода, по меньшей мере, один час.
16. Устройство по п.12, в котором, по меньшей мере, одно прижимное кольцо представляет собой набор прижимных колец.
17. Устройство по п.16, в котором прижимные кольца размещены концентрически.
18. Устройство по п.12, в котором прижимное кольцо и первый смещающий элемент выполнены с возможностью приложения давления в пределах от 0,1 до 150 фунтов на квадратный дюйм к слою кожи пользователя.
19. Способ извлечения внутритканевой жидкости (ВТЖ), предусматривающий предоставление устройства для извлечения жидкости ВТЖ, которое включает в себя проникающий элемент и, по меньшей мере, одно прижимное кольцо, приведение в контакт прижимного кольца со слоем кожи пользователя, проникновение в слой кожи пользователя проникающего элемента, и извлечение образца ВТЖ из слоя кожи пользователя при помощи проникающего элемента в то время, как к слою кожи пользователя прикладывают давление в виде колебаний, используя прижимное кольцо таким образом, что сглаживают сдвиг глюкозы образца ВТЖ, извлеченного посредством проникающего элемента.
20. Способ по п.19, в котором этап предоставления включает в себя предоставление устройства для извлечения жидкости ВТЖ, которое включает в себя набор прижимных колец.
21. Способ по п.20, в котором этап предоставления включает в себя предоставление устройства для извлечения жидкости ВТЖ с тремя концентрически расположенными прижимными кольцами.
22. Способ по п.19, в котором этап извлечения включает в себя приложение давления в виде колебаний, причем давление прикладывают в течение временного периода в пределах от трех секунд до трех часов, давление впоследствии снимают на временной период в пределах от трех секунд до трех часов, и затем давление повторно прикладывают в течение временного периода в пределах от трех секунд до трех часов.
23. Способ по п.22, в котором этап извлечения включает в себя приложение давления в виде ассиметричных колебаний.
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