EP0874585A1 - Methode et electrodes de mesure de la bioimpedance - Google Patents
Methode et electrodes de mesure de la bioimpedanceInfo
- 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- Withdrawn
Links
- 238000005259 measurement Methods 0.000 title claims abstract description 46
- 238000000034 method Methods 0.000 title claims abstract description 11
- 230000008569 process Effects 0.000 claims abstract description 7
- 239000000853 adhesive Substances 0.000 claims description 17
- 230000001070 adhesive effect Effects 0.000 claims description 17
- 230000002093 peripheral effect Effects 0.000 claims description 10
- 238000001802 infusion Methods 0.000 claims description 8
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 6
- 229910052782 aluminium Inorganic materials 0.000 claims description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 4
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims description 3
- 229910021607 Silver chloride Inorganic materials 0.000 claims description 3
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 3
- 229910052737 gold Inorganic materials 0.000 claims description 3
- 239000010931 gold Substances 0.000 claims description 3
- 229910052697 platinum Inorganic materials 0.000 claims description 3
- 229910052709 silver Inorganic materials 0.000 claims description 3
- 239000004332 silver Substances 0.000 claims description 3
- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 claims description 3
- 239000004020 conductor Substances 0.000 claims description 2
- 238000012545 processing Methods 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 210000000707 wrist Anatomy 0.000 description 10
- 239000000499 gel Substances 0.000 description 9
- 210000001367 artery Anatomy 0.000 description 8
- 239000010410 layer Substances 0.000 description 7
- 210000003462 vein Anatomy 0.000 description 5
- 239000004698 Polyethylene Substances 0.000 description 4
- 239000003792 electrolyte Substances 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 239000011888 foil Substances 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- -1 polyethylene Polymers 0.000 description 3
- 229920000573 polyethylene Polymers 0.000 description 3
- 238000011871 bio-impedance analysis Methods 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 239000000017 hydrogel Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229910001316 Ag alloy Inorganic materials 0.000 description 1
- 239000003522 acrylic cement Substances 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- GTKRFUAGOKINCA-UHFFFAOYSA-M chlorosilver;silver Chemical compound [Ag].[Ag]Cl GTKRFUAGOKINCA-UHFFFAOYSA-M 0.000 description 1
- 238000002790 cross-validation Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000001827 electrotherapy Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000013861 fat-free Nutrition 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000012811 non-conductive material Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 210000002321 radial artery Anatomy 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 210000002465 tibial artery Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0531—Measuring skin impedance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0535—Impedance plethysmography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
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.
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)
| 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)
| 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 |
-
1996
- 1996-01-03 IL IL11666296A patent/IL116662A0/xx unknown
-
1997
- 1997-01-01 AU AU11081/97A patent/AU1108197A/en not_active Abandoned
- 1997-01-01 EP EP97900003A patent/EP0874585A1/fr not_active Withdrawn
- 1997-01-01 CA CA002242052A patent/CA2242052A1/fr not_active Abandoned
- 1997-01-01 JP JP9525047A patent/JP2000502930A/ja not_active Ceased
- 1997-01-01 WO PCT/IL1997/000001 patent/WO1997024984A1/fr not_active Ceased
- 1997-01-01 CN CN97192013.3A patent/CN1210455A/zh active Pending
Non-Patent Citations (1)
| 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
| 17P | Request for examination filed |
Effective date: 19980728 |
|
| AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE |
|
| 17Q | First examination report despatched |
Effective date: 19981123 |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
|
| 18D | Application deemed to be withdrawn |
Effective date: 19990407 |