RU2002115721A - Устройства и способы для подкожного отбора проб и измерения компонента биологической жидкости - Google Patents

Устройства и способы для подкожного отбора проб и измерения компонента биологической жидкости Download PDF

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RU2002115721A
RU2002115721A RU2002115721/14A RU2002115721A RU2002115721A RU 2002115721 A RU2002115721 A RU 2002115721A RU 2002115721/14 A RU2002115721/14 A RU 2002115721/14A RU 2002115721 A RU2002115721 A RU 2002115721A RU 2002115721 A RU2002115721 A RU 2002115721A
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biological fluid
galvanic cell
component
electrode
open distal
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RU2002115721/14A
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Борзу СОХРАБ (US)
Борзу СОХРАБ
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Лайфскен, Инк. (Us)
Лайфскен, Инк.
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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
    • A61B5/145—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
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • 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
    • A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—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 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, 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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • 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
    • A61B5/685—Microneedles

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Manufacturing & Machinery (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Urology & Nephrology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Claims (10)

1. Устройство для отбора проб компонента биологической жидкости и измерения концентрации анализируемого вещества, содержащее удлиненный элемент, имеющий открытый дистальный конец, выполненный с возможностью прокола поверхности кожи и обеспечения доступа к биологической жидкости, электроды, концентрично расположенные внутри удлиненного элемента, которые образуют гальванический элемент для измерения концентрации целевого анализируемого вещества в биологической жидкости, среду передачи компонента, содержащую гидрофильный материал, сообщающийся по жидкости с удлиненным элементом и гальваническим элементом, причем среда передачи компонента передает по меньшей мере один компонент биологической жидкости, присутствующий на открытом дистальном конце удлиненного элемента, в гальванический элемент.
2. Устройство по п.1, отличающееся тем, что удлиненный элемент содержит полость, при этом открытый дистальный конец обеспечивает проход в полость.
3. Устройство для отбора проб компонентов биологической жидкости и измерения концентрации по меньшей мере одного целевого компонента в биологической жидкости, содержащее первый электрод, имеющий первую длину, второй электрод, имеющий вторую длину, превосходящую первую длину, и расположенный концентрично и на расстоянии относительно первого электрода, причем второй электрод выполнен с возможностью прокола кожи, и гидрогелевый материал, размещенный в пространстве между первым и вторым электродами.
4. Устройство по п.3, отличающееся тем, что глубина проникновения не превышает глубину дермы.
5. Устройство по п.3, отличающееся тем, что второй электрод имеет открытый дистальный конец и образует в устройстве пространство, по существу заполненное гидрогелевым материалом.
6. Микроигла для отбора проб компонентов биологической жидкости и измерения целевого компонента в биологической жидкости, содержащая сердечник, имеющий длину, первый электрод, соосно сформированный вокруг длины сердечника, второй электрод, соосно пространственно разнесенный с первым электродом и имеющий длину, больше длины сердечника и заканчивающуюся на открытом кончике, гидрогелевый материал, расположенный между первым и вторым электродами, и реагент, содержащийся в микроигле, выбранный в зависимости от целевого компонента.
7. Устройство для отбора проб компонента биологической жидкости и измерения концентрации анализируемого вещества, содержащее удлиненный полый элемент, имеющий открытый дистальный конец, выполненный с возможностью прокола поверхности кожи и обеспечения доступа к биологической жидкости, и проксимальный конец, два электрода расположенных параллельно, на проксимальном конце удлиненного полого средства для отбора проб, которые образуют гальванический элемент для измерения концентрации целевого анализируемого вещества в биологической жидкости, и среду передачи компонента, содержащую водопоглощающий материал, сообщающийся по жидкости с удлиненным полым элементом и гальваническим элементом, причем среда передачи компонента передает биологическую жидкость, присутствующую на открытом дистальном конце по меньшей мере одного прокалывающего элемента, в гальванический элемент.
8. Система для отбора проб компонентов биологической жидкости из кожи пациента и измерения целевого компонента в биологической жидкости, содержащая по меньшей мере одну микроиглу, по меньшей мере часть которой выполнена полой, и имеющую открытый дистальный конец для доступа биологической жидкости, гальванический элемент, связанный с микроиглой и содержащий опорный электрод и рабочий электрод, пространственно разнесенные относительно друг друга, водопоглощающую гелеобразную матрицу, по меньшей мере частично находящуюся в полой части микроиглы и пространстве между электродами, и блок управления, электрически связанный с гальваническим элементом, содержащий средство для подачи электрического опорного сигнала в опорный электрод и приема электрического выходного сигнала из рабочего электрода, программно-реализованный алгоритм, автоматически вычисляющий и определяющий концентрацию целевого компонента в биологической жидкости после приема электрического выходного сигнала.
9. Способ определения концентрации по меньшей мере одного целевого компонента, содержащегося в биологической жидкости, заключающийся в том, что используют по меньшей мере одну микроиглу, содержащую открытый дистальный конец и полость, используют гальванический элемент в полости, содержащий расположенную концентричными слоями систему электродов, вводят открытый дистальный конец микроиглы в кожу на выбранную глубину, передают пробу по меньшей мере одного целевого компонента в биологической жидкости, присутствующей на открытом дистальном конце, через полость в гальванический элемент, подают первый электрический сигнал в гальванический элемент, принимают второй электрический сигнал, выработанный гальваническим элементом, причем второй электрический сигнал представляет концентрацию компонента в биологической жидкости.
10. Способ определения концентрации по меньшей мере одного целевого компонента, содержащегося в биологической жидкости, заключающийся в том, что используют по меньшей мере одну полую микроиглу, содержащую открытый дистальный конец, открытый проксимальный конец и полость между ними, используют гальванический элемент, сообщающийся по жидкости с полой микроиглой и содержащий систему параллельно разнесенных электродов, расположенную на открытом ближнем конце полой микроиглы по существу поперечно микроигле, вводят открытый дистальный конец полой микроиглы в кожу на выбранную глубину, передают пробу по меньшей мере одного целевого компонента биологической жидкости, присутствующей на открытом дистальном конце полой микроиглы, в гальванический элемент, передают первый электрический сигнал в гальванический элемент, принимают второй электрический сигнал, выработанный гальваническим элементом, при этом второй электрический сигнал представляет концентрацию компонента в биологической жидкости.
RU2002115721/14A 2001-06-12 2002-06-11 Устройства и способы для подкожного отбора проб и измерения компонента биологической жидкости RU2002115721A (ru)

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US09/878,742 US6793632B2 (en) 2001-06-12 2001-06-12 Percutaneous biological fluid constituent sampling and measurement devices and methods
US09/878,742 2001-06-12

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US (2) US6793632B2 (ru)
EP (1) EP1266607A3 (ru)
JP (1) JP2003038465A (ru)
KR (1) KR20020094896A (ru)
CN (2) CN1817297A (ru)
AR (1) AR034378A1 (ru)
AU (1) AU784882B2 (ru)
CA (1) CA2390330A1 (ru)
CZ (1) CZ20022023A3 (ru)
HK (1) HK1049595A1 (ru)
IL (2) IL150098A (ru)
MX (1) MXPA02005618A (ru)
PL (1) PL354420A1 (ru)
RU (1) RU2002115721A (ru)
SG (1) SG115479A1 (ru)
TW (1) TWI236364B (ru)

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CN1391102A (zh) 2003-01-15
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US20020188221A1 (en) 2002-12-12
EP1266607A3 (en) 2004-07-21
PL354420A1 (en) 2002-12-16
CZ20022023A3 (cs) 2003-02-12
US20050261606A1 (en) 2005-11-24
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