|Publication number||US3590810 A|
|Publication date||Jul 6, 1971|
|Filing date||May 27, 1968|
|Priority date||May 27, 1968|
|Publication number||US 3590810 A, US 3590810A, US-A-3590810, US3590810 A, US3590810A|
|Inventors||Milos T Kopecky|
|Original Assignee||Honeywell Inc|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (10), Referenced by (60), Classifications (15)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent [1 1 3,590,810
[721 inventor Milos T. Kopecky .085.577 4/1963 Berman et al 128/418 LittletomColo. l 1l 619 /1964 Sullivan 128/417  Appl. No. 732.145 '1 187.745 6/1965 Baum et al 128/206  Filed May27 1968 3.253.595 5/1966 Murphy etalr 128/405 Patented July 6, 197] 3,295.515 1/1967 Kahn.....1. l28/2.06  Assignee Honeywell lnc. 3.394.069 7/1968 Solomons. 204/195 Mineapolis, Minn. 1.429 785 2/1969 Ross 204/1 3,464,404 9/1969 Mason .1 l28/2.06
54 BIOMEDlCAL BODY ELECTRODE Primary Examiner-Richard A. Gaudet 8 Chims, 2 Drawing p Assistant Examiner-G. F. Dunne 52 us. Cl 1280.06, A'wmeyhmhur Swanson and l28/4l7,204/l95 1 l hlflcl it a ABSTRACT: A biomedical body electrode is provided having Field 01 Search v .1 128/2. 2.06. a nonconductive housing with an apertured face for applica- 1 1 405.4104! v tion to a body surface. A metallic element is mounted within 1 31 2 6. the housing, the element and the face defining a cavity References Cited therein. An electrolyte fills the cavity and a membrane is secured to the face to cover the apertures, thereby sealing the UNlTED STATES PATENTS electrolyte within the cavity. A lead is connected to the metal- 3,492,216 1/1970 Riseman... 128/201 (X) lic element for connecting the electrode to external instru- 2,782,786 2/1957 Krasno..... 128/417 mentation.
MEMBRANE PATENTED JUL 6197i FIG.
IIIIIIIIIIII 1111111111: 11111111,
MEMBRANE INVENTOR. M l LOS T. KOPECKY ATTORNEY.
BIOMEDICAL BODY ELECTRODE The present invention relates to electrodes, and more particularly to an improved electrode for application to a body surface. Such electrodes, commonly called body electrodes, are used with electromedical diagnostic and therapeutic apparatus, such as electrocardiographs, pacemakers and other devices, as input and output terminals for transferring electrical signals to and from a living body.
One early form of body electrodes comprised a metallic plate secured in direct contact with a patients skin. Such an electrode however, had several distinct drawbacks, a first being that the metal plate-to-skin contact of the electrode generated unwanted contact potentials. A second drawback with this form of electrode was that even the slightest movement between the metal plate of the electrode and the patients skin caused substantial variations in the contact impedance of the electrode, these contact impedance variations being commonly known in the medical profession as motion artifacts.
In order to eliminate contact potentials generated by direct metal-to-skin contact, body electrodes were subsequently developed in which a metallic plate or element was positioned in spaced relation to a patients skin. To establish electrical contact with the patients body, these latter electrodes required the application of a layer oftelectrolyte, in the form of a paste or gel, to that area of the body surface to which the electrode was to be applied. The electrolyte thereby provided the electrical conductive path between the electrodes metallic plate and the patient's body. This type of electrode, however, was very sensitive to mechanical disturbances of the electrolyte material at the metal-electrolyte interface as resulted from motion of the electrode on the patients skin, and motion artifacts were produced as a consequence thereof.
Aside from motion artifacts, use of these latter electrodes had the added disadvantage that skin irritation often resulted therefrom. This skin irritation caused patient discomfort and resulted since patients skins were frequently quite sensitive or allergic to the layer of electrolyte paste or gel which necessarily had to be applied with the use of these electrodes. In order to minimize such patient discomfort, in certain cases it was necessary to periodically relocate the point of electrode at tachment, and in certain other instances it was even necessary to limit the use of therapeutic or diagnostic apparatus requiring the attachment of body electrodes to a patient's body.
In is accordingly, an object of the present invention to provide an improved body electrode which, in situ, does not irritate a patients skin, has a low and stable contact impedance which is substantially unaffected by motion artifacts, and generates contact potentials which are negligible.
It is a further object of the present invention to provide body electrode as set forth, suitable for use in a dynamic environment wherein a patient may perform physical activities characterized by being lightweight, inexpensive to manufacture, and readily attachable to a patient's body for comfortable wear.
In accomplishing these and other objects, there has been provided in accordance with the present invention a body electrode having a nonconductive housing with a metallic element mounted therein. With the electrode in situ on a patients body surface, the housing supports the metallic element in spaced relation to the patients skin. The space within the housing between the metallic element and the patients skin is filled with an electrolyte, and the electrolyte is sealed in the housing by means of a membrane secured across a face of the housing. The face of the housing contacts the patients skin when the electrode is situ and an electrical conductive path is established from the patients skin through the membrane, through the electrolyte, and to the metallic element of the electrode.
A better understanding of the invention may be had from the following detailed description when read in connection with the accompanying drawings in which:
FIG. 1 is a view of the base of an electrode according to the present invention, with the line 2-2 denoting the plane on which FIG. 2 is taken; and
FIG. 2 is an exploded vertical section view of the electrode of FIG. 1.
Referring to the drawings in more detail, there is shown a housing 1 having a base or face 2, apertures 3 in the base 2, and a top surface 4. The top surface 4 has a small opening therein to accommodate the passage of an electrical lead 5. Mounted within the housing 1 in parallel spaced relation to the base 2, and adjacent to the top surface 4 is a metallic element 6. The lead 5 is connected to the upper surface of the metallic element 6, as shown in the FIG. 2. A cavity in the housing 1 is defined, respectively, on its upper and lower boundaries by the metallic element 6 and the base 2, and the cavity is filled with a suitable electrolyte 16. It is here noted that in FIG. 1, the periphery of base 2 is indicated by the dotted circle 11. Further, it is noted that in an electrode constructed in accordance with the present invention, the housing 1 may be made of a nonconductive lightweight material, such as a plastic, and the metallic element 6 may be a silver/ silver chloride tablet of the type described in US. Pat. No. 3, I 37,29] issued to Phipps et al.
A membrane 7 and annulus or attaching means 8 are adhered to the electrode base by a suitable adhesive. The membrane 7 is impermeable to the electrolyte l6 and is so secured to the base 2 to cover the apertures 3, thereby sealing the electrolyte 16 within the housing 1. In FIG. 1, the periphery of the membrane 7 is indicated by the dotted circle 9, and the inner and outer periphery of the annulus 8 are indicated, respectively, by the solid circles 10 and 15, the annulus 8 surrounding the area of the membrane 7 covering the apertures 3. The annulus 8 has an adhesive surface on the side thereof to be applied to a patients body surface or skin 17. Thereby the elec trode when in situ will adhere to the patients body as a result of the action of this adhesive surface of the annulus 8. The electrode may be stored with a protective covering, not shown, placed over the annulus 8 and the membrane 7 in order to protect the membrane 7 and to prevent the adhesive surface of the annulus 8 from drying prior to electrode use. While in the electrode described herein, the annulus 8 was used as attaching means to attach the electrode housing 1 to the patient's body, other attaching means known in the art could easily be substituted therefor, e.g. a suitable belt may be used to strap the electrode to the patients body.
Before application of an electrode constructed in accordance with the present invention to the patient's body surface, the membrane 7 may be wetted with a selected wetting agent which permeates the membrane 7, and which is electrically conductive or will-become conductive upon contact with the patients skin 17. Thereby the conductivity of the membrane 7 is enhanced, and it is insured that a low resistance path will be offered to current flowing between the electrolyte 16, and the patients skin 17. In an exemplary electrode, the membrane 7 was polytetrafluorethylene imbedded with fiber glass and a drop of water was used as the selected wetting agent to wet the membrane 7 to enhance its conductivity. Water, if it is not already conductive due to the presence of impurities, becomes conductive upon contact with the body salts present on the patients skin. After wetting the membrane 7, the base 2 of the electrode may be then applied to the skin 17 with the annulus 8 serving to secure the electrode thereto. The membrane 7 which is flexible, conforms with the patients body surface, thereby making smooth and continuous contact with the skin 17, even in a dynamic environment in which the patient is performing bodily activities. The lead 5 of this electrode may then be connected to diagnositc or therapeutic apparatus, as desired, whereupon electrical signals may be transferred to or from the patients body.
While with the exemplary electrode the membrane therein was dampened with a drop of water in order to enhance its conductivity, this procedure may not be necessary in all situations. For example with a body surface already wet, such as from a patients perspiration it may then be unnecessary to further dampen the membrance.
Thus, there has been provided an improved body electrode which makes electrical contact with a patients body surface by means of a flexible membrane which conforms to the body surface. The improved body electrode provides an electrical contact with the patients skin characterized by a low and stable contact impedance which is substantially unaffected by motion artifacts, the generation of minimal contact potentials, and its nonirritating effect on the patient's skin. Further, the improved electrode is lightweight, inexpensive to manufacture due to its simplicity, and readily attachable to a patients body for comfortable wear. The ease of attachment and lightweightedness of this electrode, coupled with its low and stable contact impedance substantially unaffected by motion artifacts, makes this electrode suitable for use in dynamic environments wherein a patient is performing physical activities.
The embodiments of the invention in which I claim an exclusive property or privilege are defined as follows:
1. An electrode for establishing electrical contact with a body surface of a living organism, said electrode comprising:
a nonconductive housing having a face at one end for contacting said body surface, said face having an aperture therein;
a metallic element mounted at the other end within said housing in spaced parallel relation to said face whereby said metallic element and said face define a cavity within said housing;
an electrolyte filling said cavity; a membrane secured to said face to cover said aperture, said membrane being impermeable to said electrolyte thereby to seal said electrolyte within said housing, said membrance being permeable to at least one selected wetting agent, for dampening said membrane whereby to enhance the electrical conductivity thereof; and
an electrical lead connected to said metallic element for connecting said electrode to external instrumentation.
2. The electrode as recited in claim 1 wherein said face has a plurality of apertures therein, and said membrance is secured to said face to cover all of said several apertures.
3. The electrode as recited in claim 1 including means for attaching said electrode to said body surface.
4. The electrode as recited in claim 3 wherein said attaching means comprises an annulus, said annulus being secured to said face surrounding the area of said membrance covering said aperture whereby to expose said membrane area to said body surface, said annulus having an adhesive surface on the side thereof to be applied to said body surface.
5. The electrode as recited in claim 1 wherein said membrane is polytetrafluorethylene embedded with fiber glass.
6. The electrode as recited in claim 5 wherein said housing in nonconductive plastic and said metallic element is a silver silver chloride tablet.
7. The electrode as recited in claim 6 wherein said face has a plurality of apertures therein and said membrance is secured to said face to cover all of said several apertures.
8. The electrode as recited in claim 7 including means for attaching said electrode to said body surface, said attaching means comprising an annulus, said annulus being secured to said face surrounding the area of said membrance covering said apertures whereby to expose said membrane area to said body surface, said annulus having an adhesive surface on the side thereof to be applied to said body surface.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2782786 *||Oct 10, 1955||Feb 26, 1957||Krasno Louis R||Electrocardiograph electrode with absorbent contact surface|
|US3085577 *||Jun 12, 1961||Apr 16, 1963||Vector Mfg Company Inc||Body electrode|
|US3151619 *||Jul 17, 1961||Oct 6, 1964||Spacelab Inc||Electrode for electromedical equipment|
|US3187745 *||Aug 1, 1961||Jun 8, 1965||Melpar Inc||Electrodes|
|US3253595 *||Aug 7, 1963||May 31, 1966||Cordis Corp||Cardiac pacer electrode system|
|US3295515 *||Nov 5, 1963||Jan 3, 1967||Beckman Instruments Inc||Electrode assembly|
|US3394069 *||Apr 17, 1964||Jul 23, 1968||Honeywell Inc||Electrochemical gas sensor|
|US3429785 *||Aug 17, 1964||Feb 25, 1969||Corning Glass Works||Organic liquid ion-exchanger electrode and method of using same|
|US3464404 *||Jun 17, 1966||Sep 2, 1969||Univ Johns Hopkins||Bio-medical instrumentation electrode|
|US3492216 *||Mar 9, 1967||Jan 27, 1970||Orion Research||Electrochemical device|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3725237 *||Oct 26, 1970||Apr 3, 1973||Beckman Instruments Inc||Apparatus for measuring ion activity of solutions|
|US3823706 *||Aug 10, 1972||Jul 16, 1974||Davis M||Blood flow diagnostic method|
|US3862633 *||May 6, 1974||Jan 28, 1975||Allison Kenneth C||Electrode|
|US3972329 *||Nov 25, 1974||Aug 3, 1976||Kaufman John George||Body electrode for electro-medical use|
|US4002547 *||Jul 22, 1974||Jan 11, 1977||Beckman Instruments, Inc.||Electrochemical reference electrode|
|US4052285 *||Mar 20, 1975||Oct 4, 1977||National Research Development Corporation||Ion selective electrodes|
|US4220159 *||Apr 23, 1976||Sep 2, 1980||Biomedical International Company||Electrode|
|US4250878 *||Nov 22, 1978||Feb 17, 1981||Motion Control, Inc.||Non-invasive chemical species delivery apparatus and method|
|US4617935 *||Mar 12, 1985||Oct 21, 1986||Ndm Corporation||Medical electrode|
|US4647363 *||Sep 3, 1985||Mar 3, 1987||Dragerwerk Aktiengesellschaft||Electrochemical measuring cell|
|US4682602 *||Jun 24, 1985||Jul 28, 1987||Ottosensor Corporation||Probe for medical application|
|US5148806 *||Dec 22, 1989||Sep 22, 1992||Yasuhiro Fukui||Electrode for use with a living body|
|US5152882 *||Sep 28, 1990||Oct 6, 1992||Rosemount Inc.||Integral hydrolysis layer junction|
|US5458630 *||Apr 12, 1994||Oct 17, 1995||Pacesetter Ab||Medical electrode device having a non-gaseous fluid conductor|
|US5833622 *||Oct 31, 1996||Nov 10, 1998||Graphic Controls Corporation||Non-invasive fetal probe having improved mechanical and electrical properties|
|US5848966 *||Mar 4, 1997||Dec 15, 1998||Graphic Controls Corporation||Medical device easily removed from skin and a method of removal therefrom|
|US5961484 *||Jan 23, 1998||Oct 5, 1999||Graphic Controls Corporation||Method for removal of medical device, especially a transducer patch|
|US7532921 *||Aug 20, 2003||May 12, 2009||Ruediger Eichler||Measuring electrode system|
|US8506502||Sep 14, 2007||Aug 13, 2013||Terence Gilhuly||Sensors and sensing for monitoring neuromuscular blockade|
|US8676330||May 17, 2011||Mar 18, 2014||ElectroCore, LLC||Electrical and magnetic stimulators used to treat migraine/sinus headache and comorbid disorders|
|US8798710 *||Oct 19, 2012||Aug 5, 2014||Cognionics, Inc.||Apparatuses, systems and methods for biopotential sensing with dry electrodes|
|US8874205||Mar 30, 2011||Oct 28, 2014||ElectroCore, LLC||Device and methods for non-invasive electrical stimulation and their use for vagal nerve stimulation|
|US8948873||Dec 17, 2013||Feb 3, 2015||ElectroCore, LLC||Electrical stimulation treatment of hypotension|
|US8972004||Jul 10, 2013||Mar 3, 2015||ElectroCore, LLC||Magnetic stimulation devices and methods of therapy|
|US8983628||Sep 5, 2012||Mar 17, 2015||ElectroCore, LLC||Non-invasive vagal nerve stimulation to treat disorders|
|US8983629||Sep 5, 2012||Mar 17, 2015||ElectroCore, LLC||Non-invasive vagal nerve stimulation to treat disorders|
|US9014823||Sep 16, 2013||Apr 21, 2015||ElectroCore, LLC||Methods and devices for treating primary headache|
|US9020598||Sep 16, 2013||Apr 28, 2015||ElectroCore, LLC||Methods and devices for treating primary headache|
|US9043001||Sep 16, 2013||May 26, 2015||ElectroCore, LLC||Methods and devices for treating primary headache|
|US9067054||Feb 24, 2014||Jun 30, 2015||ElectroCore, LLC||Devices and methods for non-invasive capacitive electrical stimulation and their use for vagus nerve stimulation on the neck of a patient|
|US9126050 *||Jan 8, 2013||Sep 8, 2015||ElectroCore, LLC||Non-invasive vagus nerve stimulation devices and methods to treat or avert atrial fibrillation|
|US9174049||Jan 27, 2014||Nov 3, 2015||ElectroCore, LLC||Systems and methods for electrical stimulation of sphenopalatine ganglion and other branches of cranial nerves|
|US9205258||Nov 4, 2013||Dec 8, 2015||ElectroCore, LLC||Nerve stimulator system|
|US9233242 *||Dec 30, 2012||Jan 12, 2016||ElectroCore, LLC||Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders|
|US9233246||Mar 29, 2014||Jan 12, 2016||ElectroCore, LLC||Methods and devices for treating primary headache|
|US9233258||Mar 3, 2015||Jan 12, 2016||ElectroCore, LLC||Magnetic stimulation devices and methods of therapy|
|US9248286||Apr 8, 2013||Feb 2, 2016||ElectroCore, LLC||Medical self-treatment using non-invasive vagus nerve stimulation|
|US9254383||Apr 28, 2013||Feb 9, 2016||ElectroCore, LLC||Devices and methods for monitoring non-invasive vagus nerve stimulation|
|US9283390||Jan 13, 2015||Mar 15, 2016||ElectroCore, LLC||Methods and apparatus for treating anaphylaxis using electrical modulation|
|US9327118||Jul 22, 2014||May 3, 2016||ElectroCore, LLC||Non-invasive treatment of bronchial constriction|
|US9333347||Jul 22, 2014||May 10, 2016||ElectroCore, LLC||Devices and methods for non-invasive electrical stimulation and their use for vagal nerve stimulation on the neck of a patient|
|US9339653||Feb 2, 2015||May 17, 2016||ElectroCore, LLC||Electrical stimulation treatment of hypotension|
|US9375571||May 30, 2014||Jun 28, 2016||ElectroCore, LLC||Mobile phone using non-invasive nerve stimulation|
|US9399134||Sep 23, 2014||Jul 26, 2016||ElectroCore, LLC||Non-invasive vagal nerve stimulation to treat disorders|
|US9403001 *||Dec 30, 2012||Aug 2, 2016||ElectroCore, LLC||Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders|
|US9415219||Mar 17, 2015||Aug 16, 2016||ElectroCore, LLC||Non-invasive vagal nerve stimulation to treat disorders|
|US20060155181 *||Aug 20, 2003||Jul 13, 2006||Ruediger Eichler||Measuring electrode system|
|US20100081963 *||Sep 14, 2007||Apr 1, 2010||Terence Gilhuly||Improved sensors and sensing for monitoring neuromuscular blockade|
|US20110230701 *||Sep 22, 2011||ElectroCore, LLC.||Electrical and magnetic stimulators used to treat migraine/sinus headache and comorbid disorders|
|US20110230938 *||Sep 22, 2011||ElectroCore, LLC.||Device and methods for non-invasive electrical stimulation and their use for vagal nerve stimulation|
|US20130085366 *||Apr 4, 2013||Sony Corporation||Biological signal detection electrode and biological signal detection apparatus|
|US20130102874 *||Apr 25, 2013||Cognionics, Inc.||Apparatuses, systems and methods for biopotential sensing with dry electrodes|
|US20130131746 *||Jan 8, 2013||May 23, 2013||ElectroCore, LLC.||Non-invasive vagus nerve stimulation devices and methods to treat or avert atrial fibrillation|
|US20130131753 *||May 23, 2013||ElectroCore, LLC.||Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders|
|US20130184792 *||Mar 3, 2013||Jul 18, 2013||ElectroCore, LLC.||Non-invasive magnetic or electrical nerve stimulation to treat or prevent autism spectrum disorders and other disorders of psychological development|
|US20140257438 *||May 23, 2014||Sep 11, 2014||ElectroCore, LLC||Systems and methods for vagal nerve stimulation|
|US20150190637 *||Mar 17, 2015||Jul 9, 2015||ElectroCore, LLC||Non-invasive vagal nerve stimulation to treat disorders|
|EP2768383A4 *||Oct 19, 2012||May 4, 2016||Cognionics Inc||Apparatuses, systems and methods for biopotential sensing with dry electrodes|
|EP2962724A1||Aug 31, 2011||Jan 6, 2016||Electrocore LLC||Device with enclosure for nerve modulation|
|EP2962725A1||Aug 31, 2011||Jan 6, 2016||Electrocore LLC||Apparatus for nerve modulation|
|U.S. Classification||600/396, 607/129, 204/403.6, 600/397, 204/415|
|International Classification||A61N1/04, A61B5/0408|
|Cooperative Classification||A61B5/0408, A61N1/0492, A61B5/411, A61N1/0408|
|European Classification||A61B5/41B, A61N1/04E2P, A61N1/04E1, A61B5/0408|