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EP0874585A1 - Methode et electrodes de mesure de la bioimpedance - Google Patents

Methode et electrodes de mesure de la bioimpedance

Info

Publication number
EP0874585A1
EP0874585A1 EP97900003A EP97900003A EP0874585A1 EP 0874585 A1 EP0874585 A1 EP 0874585A1 EP 97900003 A EP97900003 A EP 97900003A EP 97900003 A EP97900003 A EP 97900003A EP 0874585 A1 EP0874585 A1 EP 0874585A1
Authority
EP
European Patent Office
Prior art keywords
electrode
electrodes
bioimpedance
skin
individual
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP97900003A
Other languages
German (de)
English (en)
Inventor
Alexander Tsoglin
Efim Frinerman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
NI Medical Ltd
Original Assignee
NI Medical Ltd
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 NI Medical Ltd filed Critical NI Medical Ltd
Publication of EP0874585A1 publication Critical patent/EP0874585A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531Measuring skin impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0535Impedance plethysmography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes

Definitions

  • U.S. Patent No. 4,117,846 discloses a disposable skin conductive electrode assembly which comprises an electrolyte pad in contact with a metal electrode. The purpose of the electrolyte pad is to improve electrical contact between the electrode and the skin. This electrode is intended for use either as a return electrode during electrosurgery, or as an active electrode in electrotherapy.
  • bioimpedance measurement will be used to denote a measurement in which the relationship between an injected current and a measured voltage of the entire body or part thereof is tested; the term “bipolar bioimpedance measurement” to denote bioimpedance measurement performed by passing current and measuring voltage through the same electrodes.
  • the bioimpedance measurement in accordance with the invention is particularly one aimed at testing the cardiac, vascular and respiratory parameters of a tested individual, e.g. as in the method described in European Patent Application No. 0575984A2 and its corresponding U.S. Patent No. 5,469,859.
  • the present invention provides in accordance with one of its aspects, electrodes for measurement of electrical signals from the human body, injecting electric current to the human body, or both, particularly for bioimpedance measurement, being flexible disposable electrodes with a surface area in the range of about 18-36 cm 2 , preferably in the range of about 19-22 cm 2 .
  • the present invention provides, by another of its aspects, a process for bipolar bioimpedance measurements in an individual comprising attaching two electrodes to the individual's body, the electrodes being flexible, disposable electrodes having a surface area in the range of about 18-36 cm 2 , preferably in the range of about 19-22 cm 2 , injecting an alternating current through said electrodes, measuring current-voltage relationship and processing thereof to obtain bioimpedance parameters.
  • an assembly comprising electrodes for bioimpedance measurements, means for securing the electrodes onto the skin, and means for holding and securing catheter tubes or infusion needles.
  • Electrodes intended for attachment to arms and legs particularly preferred are such having an elongated flat body with broader ends and a narrower middle portion.
  • the electrode is configured and then fixed onto the skin of the arms and legs such that the middle portion of the electrode overlays the area of the arm and leg comprising the veins, and the broader ends are placed over the arteries.
  • the distance between the two main arteries in the wrist area, which are the radial artery and the ulinar artery, is different in each individual; the same applies to the distance between two major groups of arteries in the leg, one group consisting of the anterior and the tibial arteries, and the other group consisting of the posterior and the peroneal arteries.
  • the total length of the electrode for grown up individuals is preferably about 10 cm.
  • Such an electrode is suitable for application on both the wrist and the leg.
  • the electrode may be made of a silver alloy covered with a layer of silver chloride (Ag/AgCl electrode), may be made of gold, aluminum, platinum, etc.
  • the electrode may also be provided with a layer of an electrolytic gel or an electrolytic adhesive or with a pad impregnated with an electrolytic fluid or gel which serves as an interface between the electrode and the skin.
  • the electrode is typically provided with an exposed portion at one of its ends for connecting the electrode to an electrical lead which is in turn connectable to a bioimpedance measurement device.
  • Figs. 7 and 8 show two embodiments of an assembly comprising an electrode and means to hold and secure catheter tubes or infusion needles;
  • Fig. 9 shows the manner of attachment of the assembly of Fig. 7 to an individual's wrist and its use in securing an infusion needle and tube;
  • Fig. 10 shows the resistive and capacitance impedance components as a function of the electrode's area.
  • the device 10 further comprises a cover pad 22, made of an electrically non conducting material (examples of such materials are various plastic materials such as polyethylene, e.g. a polyethylene film), which overlays electrode 12 and which has peripheral portions 23 extending beyond the edges of the electrode.
  • the bottom face 24 of the peripheral portions 23 is adhesive providing_for a firm adherence of the electrode device to the skin.
  • the cross-section in Fig. 2 is schematical and the vertical dimensions are enlarged for ease of description; the thickness of electrode 12 is typically a fraction of a millimeter and thus bottom face 24 of the pad can easily come into tight contact with the skin).
  • the device 10 is secured to the wrist in a manner that the broad portions 16 and 18 of the electrode body overlay portions comprising the radial and the ulinary arteries 34 and 34'.
  • the device in the leg is fixed such that the broad portions 16 and 18 of the electrode overlay the portions comprising the main artery groups 36 and 36'.
  • the middle portion 14 of the electrode overlays an area comprising the veins. This design of the electrode thus permits insertion of catheter tubes, infusion needles, etc. into the veins.
  • FIG. 5 showing an electrode device 42 in accordance with another embodiment of the invention.
  • Fig. 5A shows the device 42 in a storage state, attached to a carrier sheet 43; the device 42 is shown in Fig. 5B removed from the carrier sheet prior to use.
  • the electrode of this embodiment has a general structure similar to that of the electrode device shown in Fig. 1 and is constituted by an elongated flat member comprising wide peripheral portions 45 and 46 and a narrow middle portion 47.
  • FIG. 8 An electrode device 90 in accordance with another embodiment of the invention, which is in fact a modification of the device 60 of Fig. 7 is shown in Fig. 8.
  • member 82 consisting of a loop 84 and a window 86 is arranged to be at the opposite side of the electrode 88 as compared to the arrangement in device 60 of Fig. 7.
  • member 82 has a number of openings 87 at its point of attachment with the major portion 88 of the device, and is detachable by means of a perforated tearline 89.
  • Electrodes having a structure similar to that shown in Fig. 1 were used for bipolar bioimpedance measurement.
  • an electrolytic gel e.g. a gel comprising about 1% or less NaOH, was placed between the electrode and the skin.
  • the bioimpedance was measured using an NICAS 2001 TM apparatus (N.I. Medical, Tel Aviv, Israel) disclosed in European Patent Application No. 0575984A2 (and in the corresponding U.S. Patent 5,469,859), the contents of which is inco ⁇ orated herein by reference.
  • both impedance components were linear when the electrode area was above about 19 cm 2 , but the linearity, particularly of the capacitance component was impaired below the mentioned surface area.
  • Electrodes similar to those tested in Example 1, having a surface area of about 19 cm 2 were used and bioimpedance was measured in a bipolar mode in a similar manner to that described in Example 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Electrodes permettant de réaliser des mesures électriques de courants appliquées à l'organisme ou provenant de celui-ci. Ces électrodes sont des électrodes souples à usage unique dont l'aire se situe dans la plage des 18 à 36 cm2 environ. L'une des utilisations particulières de ces électrodes est la mesure de la bioimpédance, en particulier celle qui s'effectue en utilisant ces électrodes pour le passage d'un courant et la mesure du potentiel. L'invention porte également sur des procédés de mesure de la bioimpédance à l'aide de telles électrodes.
EP97900003A 1996-01-03 1997-01-01 Methode et electrodes de mesure de la bioimpedance Withdrawn EP0874585A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL11666296 1996-01-03
IL11666296A IL116662A0 (en) 1996-01-03 1996-01-03 Disposable electrodes for bioimpedance mesasurements
PCT/IL1997/000001 WO1997024984A1 (fr) 1996-01-03 1997-01-01 Methode et electrodes de mesure de la bioimpedance

Publications (1)

Publication Number Publication Date
EP0874585A1 true EP0874585A1 (fr) 1998-11-04

Family

ID=11068396

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97900003A Withdrawn EP0874585A1 (fr) 1996-01-03 1997-01-01 Methode et electrodes de mesure de la bioimpedance

Country Status (7)

Country Link
EP (1) EP0874585A1 (fr)
JP (1) JP2000502930A (fr)
CN (1) CN1210455A (fr)
AU (1) AU1108197A (fr)
CA (1) CA2242052A1 (fr)
IL (1) IL116662A0 (fr)
WO (1) WO1997024984A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030055357A1 (en) * 2001-09-20 2003-03-20 Razvan Rentea Method and apparatus for determining electrical parameters of a body
JP2003111749A (ja) * 2001-10-09 2003-04-15 Bmf:Kk ヒューマン判定装置
JP5449647B2 (ja) * 2003-08-20 2014-03-19 フィロメトロン,インコーポレイティド ハイドレーションモニタリング
CN1299641C (zh) * 2004-12-16 2007-02-14 浙江大学 并行接口生物阻抗采集器
WO2009101626A2 (fr) 2008-02-14 2009-08-20 N.I. Medical Ltd. Procédé et système de surveillance de la dysfonction ventriculaire gauche
KR101736978B1 (ko) * 2010-06-10 2017-05-17 삼성전자주식회사 생체 신호를 측정하는 장치 및 방법
GB2634343A (en) * 2024-01-10 2025-04-09 B Secur Ltd Health monitor device, system and method

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4539996A (en) * 1980-01-23 1985-09-10 Minnesota Mining And Manufacturing Company Conductive adhesive and biomedical electrode
US4331153A (en) * 1980-11-13 1982-05-25 Healy James W Disposable EKG electrode
SE455043B (sv) * 1982-04-22 1988-06-20 Karolinska Inst Anordning for overvakning av menniskokroppens vetskebalans genom metning av kroppens impedans

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9724984A1 *

Also Published As

Publication number Publication date
WO1997024984A1 (fr) 1997-07-17
IL116662A0 (en) 1996-05-14
JP2000502930A (ja) 2000-03-14
CA2242052A1 (fr) 1997-07-17
AU1108197A (en) 1997-08-01
CN1210455A (zh) 1999-03-10

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