U.S. patent number 3,923,042 [Application Number 05/510,708] was granted by the patent office on 1975-12-02 for electrical detector/transducer/applicable on the skin surface for biometrical observations.
This patent grant is currently assigned to Medicor Muvek. Invention is credited to Jozsef Balla, Laszlo Hajdu, Gyorgy Hegyessy, Gabor Vitan.
United States Patent |
3,923,042 |
Hajdu , et al. |
December 2, 1975 |
Electrical detector/transducer/applicable on the skin surface for
biometrical observations
Abstract
Electrical detector to be fixed on the skin surface for
biometrical observations, consisting of a silver silverchloride
electrode and outlet placed in a casing, further of a biologically
harmless ion conducting gel placed between the skin surface and the
electrode, the electrode having a porous structure containing
silver grains of less than 800 .mu.m linear size and its density
falling between 2 and 8 g/cm.sup.3, the surfaces of the individual
silver grains being bound by cohesion to the surfaces of the
adjacent silver grains, respectively to the surface of the outlet
shaped from silver and the surfaces of the silver grains not
participating at the cohesive binding being coated by a known
silver-chloride layer.
Inventors: |
Hajdu; Laszlo (Budapest,
HU), Hegyessy; Gyorgy (Budapest, HU),
Balla; Jozsef (Budapest, HU), Vitan; Gabor
(Budapest, HU) |
Assignee: |
Medicor Muvek (Budapest,
HU)
|
Family
ID: |
10999316 |
Appl.
No.: |
05/510,708 |
Filed: |
September 30, 1974 |
Foreign Application Priority Data
|
|
|
|
|
Oct 15, 1973 [HU] |
|
|
ME 1674 |
|
Current U.S.
Class: |
600/392; 600/394;
600/397; 252/514 |
Current CPC
Class: |
A61B
5/25 (20210101); A61B 2562/0215 (20170801) |
Current International
Class: |
A61B
5/0408 (20060101); A61B 005/04 () |
Field of
Search: |
;128/2.6E,2.1E,DIG.4,417,418,404 ;252/514 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Michell; Robert W.
Assistant Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Young & Thompson
Claims
What we claim is:
1. An electrical detector to fix to the skin for biometrical
observations, comprising an electrically conductive housing
defining a cavity having an open side and having a silver inner
surface, a coherent porous body of silver grains compressed in said
housing substantially filling the cavity and having cohesive bonds
between contacting silver surfaces of said grains and between said
grains and said housing surface, and a coating of silver chloride
on the surfaces of substantially all of said grains other than said
contacting surfaces.
2. A detector as claimed in claim 1, said housing comprising a
silver cup that encompasses said grains on three sides.
3. A detector as claimed in claim 2, and an elastic disc of open
cell porous structure soaked with an ion-conducting gel and closing
the open side of said housing and projecting beyond said housing to
contact the surface of the skin.
4. A detector as claimed in claim 2, and a plastic annulus
encircling the cup, and a closed cell foam disc having a surface
secured to and extending beyond said annulus said foam disc
including means for attaching the disc surface to the skin.
5. A detector as claimed in claim 4, and a metallic bell secured to
the external surface of said cup, said form disc being gripped
between the bell and the annulus.
6. A detector as claimed in claim 4, said attaching means including
a protective paper layer covering the surface of the foam disc, and
an adhesive releaseably securing said paper to said foam disc.
7. A detector as claimed in claim 1, said grains being of less than
800 .mu.m linear size and having a density from 2 to 8
g/cm.sup.3.
8. A detector as claimed in claim 1, and a biologically harmless
ion conducting gel being disposed on the open side of the housing
and in contact with the silver grains.
Description
The invention relates to an electrical detector which can be fixed
to the skin surface, to be used for biometrical observations and in
particular for electrocardiographic, e.g. electroencephalographic
examinations.
The electrode incorporated in the detector has the task of picking
up and transferring the potential appearing on the skin surface
without any change in it. Since in the body we can speak of the
second kind-transfer that is of ion transfer, the electrode
transforms substantially the transfer of the second kind to a
transfer of the first kind (to electron transfer). The most
important requirement for the electrodes is the stability over a
period of time of the potential of the electrode, i.e. prevention
of the substantial polarization of the electrode. This can be
achieved, as is known, by means of silver silver-chloride
electrodes in conjunction with an electrolyte containing
Cl.sup.-ions.
Besides the primary requirement, that is the stability of potential
the electrode must possess between the electrolyte and the electron
transferring outlet minimum contact resistance, the entire surface
of the electrode must be equipolar. The electrolyte of Cl.sup.-ion
contents placed between the electrode surface and the skin surface
must not irritate the skin surface even during extended use -- e.g.
48 - 72 hours -- and on the other hand it must preserve essentially
its original concentration.
With the development of medical techniques, disposable medical
appliances, including electrical detectors are gaining popularity
at a steadily growing rate, due to their simple manoeuvrability and
quick, hygienic applicability. Disposability sets another
requirement for the electrical detectors. In the interests of quick
and simple manipulation it is desirable that the electrode should
be all ready for use with the electrolyte necessary for its proper
functioning, and with means for ensuring its proper connection to
the skin surface.
In a known type of electrode, the material of the electrode
consists of fine-grained pressed silver silver-chloride mixture to
which an electrical outlet is connected by soldering. The surface
of the electrode formed this way will not be equipotential, since
the individual silver grains are in contact with each other only
through silver-chloride which is a bad electrical conductor. The
currents flowing through the electrode which are of very low value
produce voltage drops at different spots of the electrode surface
which have a disturbing effect on the measurements. Leading out the
current from a soldered joint can be the source additional
problems, since in the presence of the electrolytic substance the
soldering material may cause disturbing potentials, and the
developing corrosion may disadvantageously influence the contact
quality.
In another known construction of the silver silver-chloride
electrode an electrolytic silver-chloride coating is applied on the
surface of a silver plate. The disadvantage of this construction is
that firstly the high specific resistance of the solid
silver-chloride increases the resistance of the electrode, and
secondly the silver-chloride does not adhere well on the surface of
the silver and in aqueous substances, especially during extended
examination periods particles of the silver-chloride may separate,
thus causing fluctuations in the potential. A further disadvantage
of the plainsurface electrode is the fact that in comparison with
electrodes of porous surface it has a surface smaller by several
orders, therefore it is not well suited for examinations over
extended periods, e.g. of 48 - 72 hours. The constantly increasing
popularity of disposable electrical detectors is mainly due to
their simple and quick applicability. The special requirements
necessitated by disposability and in particular the ease of
manufacturing required could not have been met with the known
electrical detectors.
According to the present invention, there is provided an electrical
detector, which can be fixed to the skin for biometrical
observations, consisting of the silver silver-chloride electrode
housed in a casing with an outlet, and a biologically harmless ion
conducting gel arranged between the skin surface and the electrode,
the electrode having a porous structure containing silver grains of
less than 800 .mu.m linear size and with a density falling between
2 and 8 g/cm.sup.3, the surfaces of the individual silver grains
being bound by cohesion to the surface of adjacent silver grains
and/or to the surface of the outlet which is also silver, the free
surfaces of the silver grains being coated by the known
silver-chloride layer.
The silver grains being bonded to each other provide for good
conductivity of the electrode material and by this for the
equipotential character. This formation of the electrode further
maintains the very advantageous large homogenous surface, which
reduces polarisation and ensures the stability of potential. Since
the outlet is also made of silver, and the adjacent silver grains
are bonded to it, a stable and safe electrical contact is obtained
between the material of the electrode and the outlet.
The outlet can also be made of silver wire, which can be placed
between the silver grains of the electrode.
Preferably, the outlet is a silver cup, which surrounds the
electrode on three sides and there exists a cohesive bond between
the inner surface of the cup and the silver grains of the electrode
adjacent to the cup. The outlet can also form the housing of the
electrode at the same time.
The ion transferring gel soaks into the pores of an elastic disc of
porous structure and the disc extends from the electrode so that it
is compressed when the electrode surface and the skin surface are
in contact.
The cup with the electrode placed in it, and the disc soaked by the
ion transferring gel may be surrounded by a disc of closed cell
foam; a plastic annulus can be fastened to between the disc of the
closed cell foam and the exterior of this cup. The surface of the
closed cell foam disc in contact with the skin surface can be
coated by a biologically harmless adhesive layer.
A bell can be fixed to the external surface of the silver cup and
the disc of closed cell foam will be held between the bell and the
plastic annulus.
When the detector is adapted to be used once only, the adhesive
coated surface of the disc of closed cell foam is made suitably of
polyethylene and covered by a protective paper of silicon lining.
The protective paper hermetically seals the disc soaked by the
conductive gel, thus protecting it from drying. Before use the
paper cover must be removed from the surface of the disc.
The electrical detector may be placed in a hermetically sealed
container containing saturated water vapour.
The invention will now be described in more detail, by way of
example, with reference to the accompanying drawing, in which:
FIG. 1 represents the scheme of the electrode structure connected
to the outlet,
FIG. 2 is a simplified sectional drawing of a disposable
electrode.
In FIG. 1, the grain structure of the electrical detector
(transducer) according to the invention is shown. Electrode 4 is
formed by silver grains 1 connected to each other and silver grains
13 connected also to the outlet. Owing to the porous structure of
the electrode, only specific parts of the surfaces of the silver
grains 1, 13 are connected to each other. The silver grains 1 have
edge portions 2 along which the silver grains are connected to each
other by cohesive bonding. Silver grains 13 adjacent to the outlet
are connected along edge portions 14, also by cohesive bonding, to
the outlet made of silver. The size of silver grains 1, 13 is less
than 800 .mu.m and the density of the material of the electrode in
this embodiment was 3.5 g/cm.sup.3. The free surfaces of silver
grains 1, 13 are coated by a silver-chloride layer.
In FIG. 2, an embodiment of the electrical detector according to
the invention is shown, which has been designed to be used once and
then discarded.
In this case the outlet of the electrode 4 is a cup 6 made of
silver, which surrounds the electrode 4 on three sides. The
external flange of cup 6 joins to the inner surface of a plastic
annulus 7 and this annulus 7 also forms the seat for a disc 5 made
of porous plastic foam. A metallic bell 12 is attached by solid
binding to the outside of cup 6. In the space between bell 12 and
annulus 7 a plastic foam disc 8 of closed cell structure is
situated. On the surface of plastic foam disc 8 which will be in
contact with the skin, a known adhesive coat 9, which will not
dissolve in water, is put on so that the electrode can be attached
to the skin. In this embodiment plastic foam disc 8 of closed cell
structure has been made of polyurethane with a diameter of 50 mm
and a thickness of 3 mm. The adhesive coating 9 applied to the disc
can be any glue not harmful to the human organism and non-soluble
in water, for instance glue of poly-isobutylene base.
A plastic foam disc 5 is placed in the interior of annulus 7 and
its thickness exceeds the depth of the recess in annulus 7 and
consequently the external surface of disc 5 protrudes beyond the
external flange of annulus 7. Disc 5 is soaked in a gel containing
Cl.sup.-ions and is harmless to the human organism. The gel
utilized can contain, for example, 1% of Cl.sup.-, 6% of glycerine,
and 1% of carboxy-methyl-cellulose. The other components of the gel
can be various perfume substances, e.g. lemon oil, further
distilled water.
Before use, the surface coated by layer 9 of disc 8 is protected by
a multi-layer protective paper 10, the surface of the paper in
contact with the layer 9 being for instance a silicone lining,
which will not adhere to the glue.
The electrode is placed in a hermetically sealed multilayer bag
containing saturated water vapour and this bag has at least one
polythene layer and one aluminum foil layer. The ion conducting gel
contained in disc 5 and stored in the bag containing saturated
water vapour does not dry out for a long time.
When the electrode is to be used, the bag is opened and protective
paper 10 is removed from plastic foam disc 8, thereafter the
electrical detector is placed on the skin surface to be examined,
and is held there by the adhesive layer 9. When placed on the skin,
plastic foam disc 5 is compressed and the ion conducting gel stored
in it establishes a safe electrical contact between the skin
surface and the electrode 4. Since the ion conducting gel is
encircled by a hermetically sealed surface it cannot evaporate and,
once in place, the electrode provides for an excellent connection
for several days.
Electrical connection between the detector according to the
invention and the examining device can be established by a
contactor of suitable design attached to the external surface of
bell 12, for instance by the connector as detailed in our Hungarian
Patent Application with base no. ME-1673. Due to its advantageous
properties the electrode according to the invention is outstanding
among the detectors of known designs: its stability of potential,
contact resistance, stability in time is remarkably better than
those of the electrodes known up to now. From the simple design it
is also evident, that the production costs of the detector are
moderate too.
* * * * *