U.S. patent number 3,882,846 [Application Number 05/347,953] was granted by the patent office on 1975-05-13 for insulated electrocardiographic electrodes.
Invention is credited to Robert M. David, James C. Administrator of the National Aeronautics and Space Fletcher, N/A, William M. Portnoy.
United States Patent |
3,882,846 |
Fletcher , et al. |
May 13, 1975 |
Insulated electrocardiographic electrodes
Abstract
Disclosed is an integrated system including an insulated
electrode and an impedance transformer which can be assembled in a
small plastic housing and used for the acquisition of
electrocardiographic data. The electrode may be employed without a
paste electrolyte and may be attached to the body for extended
usage without producing skin reaction. The electrode comprises a
thin layer of a suitable non-toxic dielectric material preferably
deposited by radio frequency sputtering onto a conductive
substrate. The impedance transformer preferably comprises an
operational amplifier having an FET input stage connected in the
unity gain configuration which provides a very low lower cut-off
frequency, a high input impedance with a very small input bias
current, a low output impedance, and a high signal-to-noise ratio.
The electrode may be connected directly into a standard monitoring
system normally employed with conventional paste-type
electrodes.
Inventors: |
Fletcher; James C. Administrator of
the National Aeronautics and Space (N/A), N/A (Austin,
TX), David; Robert M. (Austin, TX), Portnoy; William
M. |
Family
ID: |
23366004 |
Appl.
No.: |
05/347,953 |
Filed: |
April 4, 1973 |
Current U.S.
Class: |
600/395 |
Current CPC
Class: |
A61B
5/302 (20210101); A61B 5/0006 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/0428 (20060101); A61B
5/0402 (20060101); A61b 005/04 () |
Field of
Search: |
;128/2.6E,2.1E,2.6B,DIG.4,418,404,405 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Portnoy et al., "Capacitively Coupled ECG Electrodes," J. Assn. for
Advancement of Med. Instrumentation, Vol. 6, No. 2, March-April,
1972, p. 185. .
Wise et al., "Thin Films of Glass and Their Application to
Biomedical Sensors," Medical & Biological Eng'ng., Vol. 9, pp.
339-349, Pergamon Press, 1971. .
Lagow et al., "Anodic Insulated Tantalum Oxide, ECG Electrodes,"
IEEE Trans. on Bio-Med. Engineering, pp. 162-164, March, 1971.
.
Potter et al., "Capacitive Type of Biomedical Electrode," IEEE
Trans. on Bio-Med. Eng'ng., pp. 350-351. October, 1970..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Cohen; Lee S.
Attorney, Agent or Firm: McClenny; Carl O. Manning; John R.
Matthews; Marvin F.
Government Interests
ORIGIN OF THE INVENTION
The invention described herein was made in the performance of work
under a NASA contract and is subject to the provisions of Section
305 of the National Aeronautics and Space Act of 1958, Public Law
85-568 (72 Stat. 435; 45 U.S.C. 2457).
Claims
We claim:
1. An electrode for detecting bioelectric potentials
comprising:
a. housing means made of substantially non-electrically conductive
material and having a flat outer surface portion;
b. an electrically conductive substrate having a front face and a
back face mounted in a fixed relationship to said outer surface
portion of said housing means such that said substrate and said
outer surface portion of said housing means are essentially
parallel;
c. a substantially non-electrically conductive dielectric material
mechanically bonded to and completely covering said front face of
said substrate by means of radio-frequency sputtering techniques
and wherein said resulting substrate is mounted on said outer
surface portion of said housing means such that said dielectric
material will be in intimate contact with an external body when
said electrode is placed thereon and said back face of said
substrate is exposed to the internal environment of said housing
means;
d. electrically insulative encasing material extending continuously
along and completely covering the edges of said substrate for
preventing electrical current flow between said substrate and the
external body;
e. an impedance transforming means mounted within said housing
means and electrically connected to said back face of said
substrate for providing said electrode with a relatively low output
impedance and a relatively high input impedance whereby the
impedance of said electrode may be matched with and connected
directly to conventional monitoring equipment having a relatively
low input impedance; and,
f. means for connecting said transforming means to the monitoring
equipment.
2. An electrode as defined in claim 1 wherein said transforming
means includes an operational amplifier having a field effect
transistor input stage connected in a unity gain configuration.
3. An electrode as defined in claim 1 wherein said substrate
material includes silicon and said dielectric is selected from the
group consisting of barium titanate, titanium dioxide, tantalum
pentoxide, and silicon dioxide.
4. An electrode as defined in claim 1 wherein said dielectric
material and said substrate are secured to said outer surface
portion of said housing means by an electrically insulating resin
adhesive.
5. An electrode as defined in claim 1 wherein said outer surface
portion is removably secured to said housing.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to electronic sensors for
monitoring variable parameters. More specifically the present
invention relates to an insulated, capacitively coupled electrode
for sensing bioelectric potentials or signals.
2. Description of the Prior Art
The electrode which has been found most generally satisfactory for
the acquisition of electrocardiographic data is a conducting
silver-silver chloride electrode which makes a low impedance
contact with the skin through a paste electrolyte. However,
conductive electrodes when used for extended periods of time, as
for example by spacecraft personnel and medical patients requiring
intensive care monitoring, exhibit inadequacies which limit their
effectiveness. In such cases, the paste may dry resulting in a
significant increase in skin-to-electrode resistance which may
produce unacceptable biological waveform distortion. Bacterial and
fungal growth can also take place under electrodes worn for
extended periods and skin irritation often occurs when the
electrolyte remains in contact with the skin for long periods of
time. Another disadvantage of the conductive electrode is found in
its electrical behavior in that shifts in D.C. levels at the
electrode-skin interface appear as base line drift in the
monitoring system.
To overcome problems encountered by using the paste-type
electrodes, electrodes have been developed to be used in direct
contact with the skin without the use of a paste electrolyte. Such
sensors use silver electrodes or gold plated electrodes which are
resistively coupled to the amplifier portion of the monitoring
system. These direct contact electrodes have also had various
problems since there is direct contact between the electrode and
the body. Included in these problems are partial rectification or
polarization of the monitored signal, chemical reactions, and
extraneous noise induced by contact movement or contact
pressure.
The prior art has also suggested using an insulated, capacitively
coupled electrode as a sensor. In some of these electrodes,
dielectric films are formed on aluminum bases by anodic oxidation
and by depositing quartz, silicon monoxide, and films of organic
polymers on aluminum. Thermal oxidation of silicon chips has also
been employed in the formation of conventional capacitively coupled
electrodes. Electrodes have also been constructed using Mylar as
the dielectric material. Generally speaking, however, the quartz,
silicon monoxide, and organic films are susceptible to mechanical
damage, and the more mechanically sound anodic aluminum oxide films
exhibit considerable electrical leakage and are difficult to
manufacture.
U.S. Pat. No. 3,568,662 discloses an insulated, capacitively
coupled electrode. The electrode is formed from a conductive
silicon wafer with oxygen diffused into one surface for producing a
silicon dioxide layer which serves as the dielectric of the
capacitor. A doping technique is employed in fabricating the
electrode and formation of the dielectric requires participation of
the substrate material. Because of the nature of capacitive
coupling, an impedance transformer is required as a buffer between
the capacitor and the monitoring device. Therefore, it is not
possible to employ the patented electrode in a conventional
monitoring system designed to use the paste-type electrode. Before
the capacitive type electrode may be thus employed, it is necessary
to modify the internal electronic circuitry of the conventional
monitoring system. Doping techniques are also relatively imprecise
so that production of uniform dielectric films by the method
described in the previously mentioned patent is difficult to
achieve. Moreover, the range of suitable non-toxic dielectric
materials which can be satisfactorily applied by doping techniques
is relatively limited.
Because two or more electrodes may be employed in conjunction with
a differential amplifier, a constant transfer function value is
required for each electrode in the system to prevent relatively
large scale errors in the output. For this reason, any suitable
system of manufacturing electrodes must be capable of reproducing
electrodes exhibiting closely corresponding electrical
characteristics.
SUMMARY OF THE INVENTION
The present invention provides an insulated, capacitively coupled
electrode which may be employed for detecting biopotential signals
without using conventional paste-type electrolytes. The electrode
of the present invention may be directly connected into the
amplifying and display portions of existing monitoring systems
which are designed to use conventional paste-type electrodes. In a
preferred embodiment, compatability with existing equipment is
provided by a high performance FET operational amplifier connected
in the unity gain configuration to function as an impedance
transformer. By employing an impedance transformer, the high source
impedance of the capacitively coupled electrode is made compatible
with systems designed to be used with paste-type electrodes which
have a relatively low source impedance.
The electrode portion of the present invention is formed by
depositing a thin film dielectric onto a substrate by radio
frequency sputtering which mechanically bonds the dielectric
material to the substrate. The sputtering technique employed
eliminates the requirement for participation of the substrate in
the formation of the dielectric. As a result, a wide selection of
substrate materials is made available, including silicon slices of
the type used as substrates for epitaxial deposition, materials
which can be polished to a very fine finish and a high degree of
flatness before receiving the thin film dielectric layer, and
materials which have sufficient strength so that they can be
handled without damage to the dielectric while simultaneously
providing good electrical conductivity which prevents resistive
losses.
Moreover, because the dielectric thin film is formed on the
substrate by radio frequency sputtering, a wide range of non-toxic
materials may also be employed for the dielectric. The dielectrics
which may be employed are compatible with the skin, are
inexpensive, and may be easily applied uniformly to the
substrate.
The insulated, capacitively coupled electrode of the present
invention is employed on the unprepared skin. In operation, the
skin acts as one plate of a simple capacitor while the substrate
acts as the other. Because of its capacitive action, the electrode
inherently functions to block D.C. drift directly at the
electrode-skin interface.
From the foregoing, it may be appreciated that a primary object of
the present invention is to provide an electrode capable of
monitoring biopotential signals without the use of a paste
electrolyte.
It is also an object of the present invention to provide a
monitoring electrode of the type described which is of small size
and which may be directly employed with existing systems.
A related object of the present invention is to provide a means for
fabricating a monitoring electrode with a wide range of non-toxic
dielectrics where the substrate does not participate in the
dielectric's formation.
One of the important objects of the present invention is to provide
an electrode of the type described which produces clinical quality
records, may be used for extended periods on unprepared skin, and
is immune from noise-producing electrode potentials.
Other features and advantages of the present invention will become
more readily apparent from the following specification, the related
drawings, and the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an enlarged vertical section illustrating details in
construction of the electrode of the present invention;
FIG. 2 is an enlarged front view of the electrode assembly of the
present invention;
FIG. 3 is a view taken along the line 3--3 of FIG. 1;
FIG. 4 is a schematic illustration of the circuit employed with the
electrode of the present invention;
FIG. 5 illustrates the electrode of the present invention applied
to a subject;
FIG. 6 is a block diagram illustrating a typical application of the
present invention; and
FIG. 7 is a vertical cross-sectional view of a work chamber
employed in the r.f. sputtering technique employed in forming the
insulated electrodes of the present invention.
BRIEF DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
With reference to the drawings, the insulated electrocardiogram
electrode of the present invention is indicated generally at 10 in
FIGS. 1, 2, and 3. The electrode 10 comprises a dielectric square
11 having a conductive substrate 11a covered on one surface by a
dielectric thin film material 11b. A grounding resistor 12
illustrated in FIG. 3 and an operational amplifier 13 are
electrically connected to the square 11 and are mounted in a
plastic electrode housing 14. The dielectric square 11 is fastened
to a plastic disc 15 with a suitable insulating resin 16.
Sufficient resin 16 is used not only to assure a secure bond, but
also to cover the edges of the dielectric square 11 to eliminate
any possible contact between the skin and the substrate 11a, thus
avoiding any skin-to-substrate shorts. An opening 17 in the center
of the disc 15 allows an electrical conductor wire 18 to extend
through the disc 15 so that the dielectric square 11 may be
electrically connected to the amplifier 13. The wire 18 is attached
to the substrate 11a by a conductive epoxy 19 which provides
electrical continuity between the dielectric square 11 and the
wire. Electrical connections to the power supplies and monitoring
equipment are provided by six Teflon insulated single strand wires
20 which extend through an opening 21 in the side of the housing
14.
In use, the electrode 10 is applied to a subject's skin S with
double sided adhesive tape 23 as illustrated in FIG. 5. The
dielectric material 11b is thus held in close contact against the
skin surface to produce the capacitor configuration in which the
skin acts as one plate of the capacitor and the substrate as the
other. The disc 15 is preferably removable so that the dielectric
square 11 may be replaced. The disc 15 can be removably secured to
the housing by double-sided adhesive tape (not illustrated), or
other suitable means.
FIG. 4 schematically illustrates the electrical circuitry employed
in the insulated electrocardiogram electrode 10. The amplifier 13
is a high performance field effect transistor (FET) operational
amplifier employing internal frequency compensation. With this type
amplifier, the need for external compensating networks is
unnecessary which permits the size of the electrode 10 to be
reduced. The operational amplifier 13 used in the illustrated
embodiment of the present invention is a .mu.A740, manufactured by
Fairchild Semiconductors; however, any other suitable amplifier may
be used. As will be noted, the amplifier 13 is connected in the
unity gain configuration with the output at 13a (pin 6) connected
directly to the inverting input at 13b (pin 2). In this
configuration, the amplifier 13 provides a high input impedance and
a low output impedance so that it functions as an impedance
transformer.
Suitable 5K ohm resistors 22a and 22b are connected from 13c (pin
1) and 13d (pin 5) of the amplifier 13 to a positive voltage supply
V+. The remaining amplifier pins are the noninverting input 13e
(pin 3), negative voltage supply 13f (pin 4), positive voltage
supply 13g (pin 7), and ground (pin 8). The output of the electrode
at 13a may be connected to the amplification, recording and display
equipment employed with conventional paste-type electrodes.
In FIG. 6, a conventional configuration for placement of ECG
electrodes 10 to pick-up biopotential signals is represented in a
system designed to transmit signals from a spacecraft to a remote
receiving station. The subject A is equipped with two electrodes
and a common ground connected to the right leg. The output of each
electrode 10 is applied to a differential amplifier 30 by
electrical conductors 31 and 32 and the ground is connected by line
33. The output of the amplifier 30 is provided as an input to a
system 30a which may contain a radio transmitter for transmitting
electrocardiographic data to distant monitoring systems which
include recording and display means 35. It will be appreciated of
course that the output of the system 30a may also be directly
connected to the recording and display instruments 35 which may
include strip chart recorders or oscilloscopes or other
conventional equipment.
FIG. 7 illustrates a work chamber 110 employed for sputtering of
the dielectric material onto a substrate square Q. The basic system
used in applying the dielectric to the square Q was an R. D. Mathis
SP 310A r.f. sputtering module and generator which includes a 1 kW
system having a modified target mount assembly and a glow shorting
skirt to produce uniform thin films. The chamber 110 includes a
target mount assembly 111 formed by a large disc 112 of aluminum
secured by bolts (not illustrated) and conductive epoxy adhesive to
a second smaller disc 113, also of aluminum. The entire target
mount assembly is joined to the dielectric target material 114 with
moldable conductive epoxy adhesive to form one unit which is
screwed into a water cooled, copper cathode 111a. The cathode 111a
is electrically connected through an impedance matching unit 116 to
an r.f. generator 117.
An adjustable height, water cooled copper substrate holder is
indicated at 115. The basic sputtering unit has been modified by
addition of a grounded copper screen skirt 118 mounted around the
periphery of the holder 115 to prevent the glow discharge developed
in the chamber from spreading and leaking through the vacuum system
119. The system 119 provides the necessary evacuation of the
chamber 110 and a source of gas 120 supplies the desired atmosphere
within the chamber required for sputtering. The chamber 110 is
formed by a tubular Pyrex body 121 sealed at its upper and lower
ends.
While a variety of substrate materials Q may be employed, it has
been determined that highly polished pieces of silicon are
particularly suitable. In one form of the electrode, the substrates
employed were slices of n-type silicon, Blanchard ground to a very
high polish and degree of flatness. The slices were about
1.OMEGA./cm in resistivity and about 0.25 mm thick. To prepare the
silicon substrate for sputtering, the slices were degreased for 15
minutes in a boiling methanol-xylene (1:1) solution. The slices
were then rinsed with deionized water and immersed in hot sulphuric
acid for 15 minutes, rinsed again in deionized water and immersed
in hot nitric acid for 15 minutes; they were then rinsed clean in
deionized water. A final rinse was made in trichloroethylene after
which the slices were dried in air and then placed in the
sputtering chamber.
The sputtering was performed in an argon-oxygen mixture at a
pressure of about 25 .mu.mHg (except for the silicon dioxide
deposition, which was performed in argon) to prevent reduction of
the oxides to their metals.
The dielectric targets 114 used in fabricating one group of
electrodes had 43/4 inch diameters and were 1/4 inch thick. The
discs 112 had diameters of 43/8 inches and were 1/8 inch thick. The
discs 113 had diameters of 3 inches and were 1/4 inch thick.
Eccobond 59C, a moldable conductive epoxy adhesive, was employed to
bond the discs 112 and 114 to each other and a similar adhesive,
Eccobond 56C, was employed to secure the disc 113 to the disc
112.
Four different dielectrics were examined during the development of
the electrode, barium titanate, titanium dioxide, tantalum
pentoxide, and silicon dioxide. Each dielectric was deposited onto
the substrate with varying film thicknesses using a sputtering
system having the specifications previously set forth. The
capacitance was then measured and compared with the calculated
capacitance. The results of this test are listed below in Table
I.
TABLE I
__________________________________________________________________________
Lower Capacitance per Material Nominal relative Film Electrode
Cut-Off unit area bulk permittivity Thickness Area Frequency
Measured Calculated
__________________________________________________________________________
A cm.sup.2 Hz .mu.F/cm.sup.2 .mu.F/cm.sup.2 BaTiO.sub.3 1500 47000
0.81 0.032 0.044 0.29 47000 0.80 0.021 0.064 0.29 24000 0.81 0.024
0.058 0.57 24000 0.76 0.032 0.047 0.57 17000 0.72 0.016 0.097 0.75
17000 0.76 0.014 0.11 0.75 TiO2 100 14500 0.80 0.016 0.086 0.060
14500 0.81 0.018 0.079 0.060 8800 0.80 0.012 0.17 0.10 8800 0.79
0.013 0.11 0.10 5900 0.72 0.010 0.16 0.15 5900 0.63 0.013 0.14 0.15
Ta.sub.2 O.sub.5 25 47000 0.80 0.11 0.013 0.0048 47000 0.80 0.14
0.0099 0.0048 32000 0.85 0.11 0.013 0.0068 32000 0.85 0.080 0.017
0.0068 17000 0.80 0.057 0.025 0.012 17000 0.80 0.072 0.020 0.012
SiO.sub.2 4 32000 0.85 1.0 0.0013 0.0011 32000 0.70 1.1 0.0014
0.0011 20000 1.0 0.64 0.0018 0.0018 20000 0.80 0.76 0.0019 0.0018
4000 0.75 0.17 0.0088 0.0088 4000 0.75 0.14 0.10 0.0088
__________________________________________________________________________
While the preferred form of the invention has been disclosed as
employing a radio frequency sputtering technique in the fabrication
of the electrode, it will be appreciated that other methods and
apparatus capable of providing a uniform thin film of a desired
dielectric material bonded mechanically to a desired substrate
material may also be employed. Similarly, dielectric materials such
as silicon carbide and silicon nitride as well as others may be
employed in the electrode of the present invention. It will also be
appreciated that substrate materials other than those specifically
described herein may be satisfactorily employed in the present
invention.
The foregoing disclosure and description of the invention is
illustrative and explanatory thereof, and various changes in the
size, shape, and materials as well as in the details of the
illustrated construction may be made within the scope of the
appended claims without departing from the spirit of the
invention.
* * * * *