U.S. patent number 3,828,766 [Application Number 05/280,350] was granted by the patent office on 1974-08-13 for disposable medical electrode.
This patent grant is currently assigned to Jet Medical Products Inc.. Invention is credited to David L. Krasnow.
United States Patent |
3,828,766 |
Krasnow |
August 13, 1974 |
DISPOSABLE MEDICAL ELECTRODE
Abstract
A disposable medical electrode comprising a support member made
of a closed cell plastic material having an adhesive surface. A
centrally located contact element is embedded therein so as to
leave an exposed portion thereof at the adhesive side of the
support member. A smaller pad member made up of an open cell
plastic material is adhered to the adhesive surface of the support
member at a position opposite to and in contact with the exposed
portion of the contact element. In use, the pad member has a
conductive gel dispersed throughout so that when the electrode is
placed against the skin of a patient a good conductive path is
present from the skin through the gelled pad to the contact
element.
Inventors: |
Krasnow; David L. (Canton,
MA) |
Assignee: |
Jet Medical Products Inc.
(Braintree, MA)
|
Family
ID: |
23072707 |
Appl.
No.: |
05/280,350 |
Filed: |
August 14, 1972 |
Current U.S.
Class: |
600/391 |
Current CPC
Class: |
A61B
5/25 (20210101) |
Current International
Class: |
A61B
5/0408 (20060101); A61b 005/04 () |
Field of
Search: |
;128/2.6E,2.1E,DIG.4,418,417,416,404,405,410,411 ;204/155B |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Dike, Bronstein, Roberts &
Cushman
Claims
What is claimed is:
1. A monitoring electrode comprising
a substantially flat support member formed of plastic foam material
having a closed cellular configuration throughout, one surface of
which is adhesive;
a contact element embedded in said support member, a first contact
portion thereof being exposed at said one surface and a second
contact portion thereof protruding from the opposite surface of
said support member;
a pad member formed of plastic foam material having an open
cellular configuration adhered to said adhesive surface of said
support member at a position such that the inner surface of said
pad member is in contact with and substantially covers said exposed
portion of said contact element, the outer surface thereof being
capable of contacting a surface to be monitored.
2. A monitoring electrode in accordance with claim 1 and further
including
a conductive gel being dispersed throughout said pad member when
said monitoring electrode is in use to provide a conductive path
from said outer surface of said pad member to said second contact
portion.
3. A monitoring electrode in accordance with claim 2 and further
including
a plastic strip adhered to a portion of said opposite surface of
said support member to impart greater rigidity to said opposite
surface than to said one surface thereof.
4. A monitoring electrode in accordance with claim 2 wherein the
thickness of said support member is in a range from about 1/32 inch
to about 3/16 inches.
5. A monitoring electrode in accordance with claim 4 wherein the
thickness of said support member is about 1/16 inch.
6. A monitoring electrode in accordance with claim 2 wherein the
thickness of said pad member is in a range from about 1/32 inch to
about 3/32 inches.
7. A monitoring electrode in accordance with claim 6 wherein the
thickness of said pad member is about 1/16 inch.
8. A monitoring electrode in accordance with claim 2 wherein
said support member is substantially circular in configuration and
has a diameter in a range from about 1 inch to about 2.25
inches.
9. A monitoring electrode in accordance with claim 8 wherein
said support member is substantially circular in configuration and
has a diameter of about 13/8 inches.
10. A monitoring electrode in accordance with claim 8 wherein
said pad member is substantially circular in configuration and has
a diameter in a range from about 11/16 inches to about 13/16
inches.
11. A monitoring electrode in accordance with claim 10 wherein
said pad member is substantially circular in configuration and has
a diameter of about 3/4 inches.
Description
DISCLOSURE OF THE INVENTION
1. Introduction
This application relates generally to medical electrodes and, more
particularly, to disposable monitoring electrodes utilizing
conductive gels for providing conductive contact between the human
body and a metallic contact element.
2. Background of the Invention
Disposable electrodes have found widespread use in the medical
field where it is desired to make electrical contact at some point
on a patient's body so that electrical signals therefrom can be
applied to appropriate monitoring equipment. The primary
characteristic of such electrodes is to obtain as good a contact as
possible between the skin area which is being monitored and the
metallic contact element of the electrode so that a maximum
electrical signal can be obtained for use in the monitoring
equipment. An improtant further characteristic of such electrodes
is that they be so designed as to minimize the discomfort which a
patient will suffer, especially when such electrode may be required
to be used over a prolonged period of time, sometimes for several
days.
It is particularly desirable that such electrodes provide maximum
signal strength with minimal discomfort for more sensitive
patients, such as adults with sensitive skin and children or
infants whose skin is apt to be more tender than that of adults.
The comfort factor may be particularly important when used with
extremely small infants, less than 30 days old, in the growing
field of neo-natalogy.
DESCRIPTION OF THE PRIOR ART
A conventionally structured electrode presently available for use
in the medical field is a type which utilizes a conductive gel
between the skin area which is being contacted and the metallic
contact element of the electrode to which the monitoring circuit is
connected. In such presently used electrodes the metal contact
element is normally affixed to a rigid plastic base member of the
electrode, the contact element being in the form of a snap fastener
assembly having a first side to which a monitoring circuit is snap
connected and a second oppositely disposed side which is in contact
with a pad member made of an open cell plastic material permeated
with a conductive gel. The pad is in turn in pressure contact with
the skin, the conductive gel thereby assuring that a good
conductive path is present from the skin to the metal contact
element for the signal which is being monitored.
In such prior art electrodes the gel pad is freely nested in a
recessed region of the electrode which is formed by a solid ridged
portion of the rigid plastic body member, the outer surface of the
ridge coming into pressure contact with the skin adjacent the outer
perimeter of the gel pad when the electrode is in use. The ridged
body member containing the snap fastener contact element is
attached to a circularly shaped open cell plastic foam material one
side of which has an adhesive thereon so that the electrode can
adhere to the skin. The protruding ridge is thereby between the
open cell adhesive foam material and the open cell gel pad foam
material to form a barrier therebetween so as to prevent the
conductive gel in the gel pad from being absorbed by and dispersed
throughout the open cell adhesive foam portion of the overall
electrode. Unfortunately, however, the presence of the ridge tends
to cause excessive discomfort to the patient on whom the electrode
is being used since the ridge which digs into the skin of the
patient can become extremely irritating.
Moreover, since the gel pad itself is held within the recessed
portion of the electrode only by means of the surface tension
created between the gel material and the surface of the solid
ridged member of the electrode, the gel pad can often fall out of
its recessed nest during handling and must be replaced by hand or
other means, all of which tends to cause the gel pad to become less
sanitary in use than is desired.
SUMMARY OF THE INVENTION
In the monitoring electrode of the invention the need for a ridged
barrier between a conductor gel pad and an adhesive portion of the
electrode is eliminated so that a relatively smooth surface is
presented to the skin of the patient and any irritation and
discomfort caused by the presence of a ridge is completely avoided.
In the structure of the invention, the adhesive base member of the
electrode to which a snap fastener contact element is attached is
made of a plastic foam material having a closed cell configuration.
A gel pad made of a plastic foam material having an open cell
configuration is then adhered to the underside of the closed cell
foam material opposite the underside of the snap fastener contact
element.
In one preferred embodiment of the invention a thin vinyl plastic
strip is adhered to the upper side of the closed cell body member
to provide some rigidity thereto. Because of the closed cell nature
of the adhesive base member of the electrode, substantially none of
the conductive gel which is dispersed throughout the open cell gel
pad can be absorbed by or dispersed within the closed cell material
and the gel is adequately retained within the open cell gel pad
during manufacture, shipment and use. Moreover, because no solid
plastic ridged member is used, the surface of the electrode which
comes into contact with the skin of the patient is essentially soft
and relatively smooth with no protruding ridges so that it can be
readily placed on the patient's skin for good adherence without
discomfort even with prolonged use.
In the preferred embodiment of the invention the lower surface of
the contact element which is in contact with the gel pad may be
coated with silver so that, in reacting with the gel substance a
silver/silver chloride conductive coating is formed which enhances
the signal carrying properties of the electrode.
The elimination of the need for a ridged barrier also permits the
formation of a relatively smaller electrode than that of presently
available electrodes and permits their use with regions of the body
where the larger electrodes have not been readily useable. A
smaller size also makes the electrode more convenient for use with
child and infant patients.
The invention is described in more detail with reference to the
attached drawings wherein
FIG. 1 shows a view in cross-section of a monitoring electrode of
the prior art;
FIG. 1A shows a plan view of the electrode of FIG. 1;
FIG. 2 shows a view in cross-section of a preferred embodiment of
the electrode in accordance with the invention;
FIG. 2A shows a plan view of the electrode of FIG. 2;
FIG. 3 shows a view in cross-section of a portion of the electrode
of FIG. 2; and
FIG. 4 shows a view in cross-section of a preferred embodiment for
packaging one or more of the electrodes of FIG. 2.
FIG. 1 depicts a conventional monitoring electrode of the prior art
which has found relatively widespread use in the medical field at
the present time. As can be seen therein the electrode 10 comprises
a solid plastic ridged body member having an upper portion 11A and
a lower portion 11B, each of a circular configuration, which
portions each include flat body portions 12A and 12B respectively,
and ridged portions 13A and 13B, respectively, forming the outer
peripheries thereof. A contact element 14 is positioned within
apertures at the centers of solid portions 11A and 11B, the contact
element being in the form of a conventional male snap fastener
having a first upper portion 14A with a protruding snap at the
center thereof and a lower portion 14B which nests within the upper
portion so that the overall element can be attached to and retained
in the solid ridged member. The snap fastener 14 provides a snap
contact to a corresponding female snap fastener (not shown) which
is in turn connected to an appropriate lead for connection to
suitable monitoring equipment (also not shown). The upper and lower
solid portions 11A and 11B may be made of any appropriately chosen
plastic material and are arranged to enclose an adhesive pad member
16 also of substantially circular configuration, as shown. One side
of foam pad 16 has a layer 17 of double faced adhesive material
placed thereon and extending from ridge 13B to the periphery
thereof so as to provide an adhesion surface which permits the
electrode to be placed in an adhering manner on the skin of a
patient. A circular pad 19 of foam plastic material is nested
within the recess 18 formed by ridge 13B, pad 19 being
substantially permeated with a conductive gel substance forming a
gel pad for providing a good conductive path from the skin which
contacts the outer exposed surface thereof and the lower portion
14B of contact element 14, which is in contact with the inner
surface of gel pad 19. Gel pad 19 is retained within the recess 18
by the surface tension action of the gel on the underside of solid
plastic portion 12B.
In the prior art structure shown both of the plastic pad materials
forming the adhesive pad 16 and the gel pad 19 are made of an open
cellular plastic foam material which is readily absorbent to
liquids and gels which can thereby penetrate into and become
dispersed throughout such materials. In order to permit dispersion
of conductive gel throughout gel pad 19 without permitting a
similar dispersion in the adhesive pad 16, the ridge 13B and body
portion 12B form a barrier so that none of the gel in gel pad 19
comes into contact with the adhesive pad 16. Were the conductive
gel to become dispersed throughout adhesive pad 16 as well as gel
pad 19, the conductivity of the path through pad 19 would be
greatly reduced and the effectiveness of the electrode would become
diminished. Further, when the prior art electrode 10 is placed on
the skin of a patient for any prolonged period of time, ridge 13B
tends to dig into the skin and become so irritating that a high
degree of discomfort may result, particularly with patients having
relatively tender skin.
Moreover, when the electrode has been placed on the skin the
presence of ridge 13B tends to cause the adhesive surfaces in the
regions adjacent the ridges to be raised out of contact with the
skin so that the area of adhesive contact with the skin is reduced.
In order to assure that the surface area of adhesive contact is
sufficient, the diameter of the overall electrode must be made
relatively large and the electrode becomes less useful for some
applications.
A preferred embodiment of the monitoring electrode of the invention
is depicted in FIGS. 2 and 2A and shows the contrast between the
structure thereof and that of the prior art electrode shown in
FIGS. 1 and 1A.
As can be seen in FIGS. 2 and 2A, the electrode 20 of the invention
comprises an adhesive foam pad portion 21 which forms the main body
of the electrode and has on one surface thereof a layer 22 of
double-faced adhesive which effectively covers the entire surface.
In a preferred embodiment adhesive foam pad 21 has a substantially
circular configuration and at the central region of the surface 24
opposite to the adhesive surface thereof a paper thin circular
piece 23 of vinyl plastic material is positioned. Vinyl piece 23
imparts a slightly greater degree of rigidity for the surface 24 of
the electrode than to the adhesive surface thereof and, further,
can be used as an appropriate label for identifying the electrode
and the manufacturer thereof.
A snap fastener contact element 25 is machine fastened at the
center of adhesive foam pad 21 as shown. After the fastening
process the presence of fastener 25 forms slight depressions at
both the upper and the lower surfaces of foam pad 21, as shown. The
peripheral region of a gel pad 26 is caused to adhere to the
adhesive surface of pad 21 so that the pad 26 is placed at a
position opposite the lower contact surface 25A of contact element
25 as shown in enlarged detail in FIG. 3.
Adhesive foam pad 21 is made of a closed cell plastic material,
such as a closed cell polyethylene or polyurethane plastic
material, while gel pad 26 is made of an open cell material, such
as polyurethane foam material. The use of a closed cell material
for pad 21 effectively prevents any penetration through the pad 21
of any conductive gel which is present in gel pad 26 within which
it is in contact. One such closed cell plastic successfully used in
the electrode of the invention is a polyethylene plastic sold under
the name "Volara" by the Voltech Company of Lawrence,
Massachusetts. One such open cell gel pad material which has been
successfully used to provide the necessary gel dispersion action is
a polyurethane foam material sold by Rogers Foam Company,
Somerville, Massachusetts.
Further, the double sided adhesive layer 22 is selected so as to
avoid causing any irritation to the skin, to which it adheres. One
such adhesive which has been successfully used and which has been
approved for such use by the Federal Drug Administration of the
United States Government is identified as Adhesive No. 1524, made
by 3M Company, Minneapolis, Minnesota.
The cellular density of open cell material 26 is such as to be
sufficiently dense to hold a conductive gel within the material and
at the same time sufficiently porous to allow the gel to penetrate
throughout the material so that a good electrical contact is made
between the skin of the patient and the lower surface 25A of
contact element 25. Conductive gels for this purpose are readily
available to those in the art and any convenient gel such as that
identified as Spectra 360 as sold by Parker Laboratories,
Irvington, New Jersey, may be used in the electrode of the
invention.
In order to enhance the conductive path from the skin to the
contact element 25, the bottom surface 25A thereof is coated with
silver. When the conductive gel comes into contact with the silver
coated surface thereof it forms a combination silver/silver
chloride coating which enhances the conductive properties
therebetween. In using conventional snap fasteners which have
chrome plated surfaces, for example, contact with electrode
conductive gels often causes the formation of an acid coating which
may be injurious to the skin against which the electrode is
pressed. The silver/silver chloride coating not only has been found
to increase the conductivity of the overall electrode, it has also
been found to be essentially harmless to the skin of the patient.
It can also be seen that when the electrode is applied to the skin
of a patient, gel pad 26 is effectively compressed and the lower
surface of the electrode forms an effectively soft and smooth
contact with the skin over its entire area and little or no
discomfort is felt by the patient.
With reference to the dimensions of the various elements of the
electrode of the invention, it has been found that the thickness of
the adhesive foam pad 21 preferably lies within a range of from
1/32nd of an inch to about 3/16ths of an inch, with a thickness of
about 1/16th of an inch being successfully used in a preferred
embodiment of the electrode. The thickness is primarily selected so
as to retain sufficient flexibility for the overall electrode to
permit it to be used in various skin areas, even those having a
relatively deep curvature. Moreover, it has been found that if the
adhesive foam pad portion is at least 1/32nd of an inch thick, it
becomes much easier to remove the electrode both from the card on
which it is shipped, as described below, and from the skin after
use.
The vinyl label 23 has been found preferably to have a diameter
lying 0etween about 0.75 inches to up to the diameter of the foam
pad 16. The latter preferably has a diameter of from about 1 inch
to 21/4 inches and in a preferred embodiment a diameter of 13/8
inches has been found to be satisfactory for use not only on adult
patients but also on child and infant patients.
The diameter of gel pad 26 is preferably between about 11/16 inch
and 13/16 inch with a diameter of about 3/4 inch being successfully
used in a preferred embodiment. Thus, the gel pad must be
sufficiently large to cover the bottom contact element surface and
yet have enough surface area in contact with the adhesive layer 22
to permit the gel pad to be adequately attached to the foam pad 21
about its entire periphery. Since the gel pad 26 is retained on
foam pad 21 by the adhesive layer 22 it does not depend for its
retention upon the surface tension of the gel itself. Accordingly,
in shipping the overall electrode the electrode can be shipped
either in a "dry" form, that is, a form wherein the gel is not
applied to the open cell pad 26 until just prior to use, or in a
"wet" form, that is, where the gel is applied when the electrode is
packaged so that it arrives for use in a "pre-gelled" state. Such a
construction is in contrast with that of the prior art where the
gel must be shipped in a "wet" state so as to be retained within
the recess 18 of electrode 10, for example.
The electrode may be shipped by affixing one or more of said
electrodes to an appropriate card having one or more circular
apertures each with a diameter substantially equal to the diameter
of the gel pad 26. As can be seen in FIG. 4 the electrodes are
adhered to the upper surface of a card 31 by means of adhesive
layer 22 with the gel pads 26 extending through apertures 30
thereof below the bottom surface of the card 31. The gel pads are
further protected by applying a clear plastic cover member 32
having relatively rigid raised portions 33 positioned above each
gel pad 26, as shown. Cover member 32 may be appropriately fastened
with adhesive material, such as a suitable glue, at appropriate
points on the lower surface of the card.
Each card may be inserted into an hermetically sealed bag 35 which
also has a light opaque inner surface. If the electrode is of a
pre-gelled form, the hermetically sealed bag prevents the escape of
any moisture from the gel and keeps the gel pad 26 in an
appropriately "wet" conductive state. The use of a light opaque bag
prevents the penetration into the interior of the bag of
ultraviolet rays which may cause a deterioration of the adhesive
layer 22. Accordingly, when the electrode is ready for use it will
adhere firmly to the skin without any problems. The semi-rigid
cover 32 prevents the gel pad from being inadvertently squeezed
during shipment which action would cause an irretrievable loss of
the gel material.
In manufacturing the electrodes of the invention, a sheet of closed
cell plastic foam material is covered on one surface thereof with a
double sided layer of adhesive material. A plurality of vinyl
labels are then adhered at various regions to the opposite side
thereof and the snap fasteners 25 are machine installed at the
center of each vinyl label. A plurality of open cell foam plastic
pads are then adhered to the adhesive layer of the closed cell
material at positions opposite each snap fastener. The open cell
pads can be so applied in a "dry" state and the electrodes then
appropriately punched out from the closed cell plastic sheet. If it
is desired to ship the electrodes in a wet state, a conductive gel
is applied to each of the gel pads before packaging.
Whether in a wet or in a dry state, one or more of the punched
electrodes are mounted on a card having one or more circular
apertures each having a diameter the same as that of the open cell
gel pads and the relatively rigid plastic cover is then glued to
thsurface of the card through which the open cell gel pad
protrudes. The cards are then placed into hermetically sealable and
light opaque bags and appropriately sealed for storage and/or
shipment.
* * * * *