U.S. patent number 3,911,906 [Application Number 05/463,784] was granted by the patent office on 1975-10-14 for dry applied and operably dry electrode device.
This patent grant is currently assigned to Survival Technology, Inc.. Invention is credited to Herbert E. Reinhold, Jr..
United States Patent |
3,911,906 |
Reinhold, Jr. |
October 14, 1975 |
Dry applied and operably dry electrode device
Abstract
An electrode device for establishing an electrical connection
between electromedical apparatus and the skin of the human anatomy
comprising a composite electrode body for self-adhering engagement
with a substantial surface area of the skin to establish the
electrical connection throughout substantially the entire engaged
area of the skin without the use of conductive pastes, gels or
other liquids, such as solvents or the like, the composite
electrode body being porous and hypoallergenic and including a
carrier layer and a thin flexible layer of pressure sensitive
adhesive material having fine electrically conductive particles
dispersed throughout providing a tacky skin-engaging surface the
particles being provided in an amount sufficient to effect the
electrical connection with the engaged area of the skin through the
layer by particle to particle contact while permitting the
skin-engaging surface of the layer to remain tacky prior to skin
engagement. A removable sheet having a release surface engaging the
tacky skin-engaging surface of the layer is operable to be
separated therefrom prior to application without substantially
reducing the tackiness thereof.
Inventors: |
Reinhold, Jr.; Herbert E.
(Rockville, MD) |
Assignee: |
Survival Technology, Inc.
(Bethesda, MD)
|
Family
ID: |
23841360 |
Appl.
No.: |
05/463,784 |
Filed: |
April 24, 1974 |
Current U.S.
Class: |
600/392; 600/394;
600/397 |
Current CPC
Class: |
A61N
1/0492 (20130101); A61B 5/259 (20210101); A61B
5/325 (20210101); A61B 5/411 (20130101); A61N
1/048 (20130101) |
Current International
Class: |
A61B
5/0408 (20060101); A61B 5/0402 (20060101); A61N
1/04 (20060101); A61B 005/04 () |
Field of
Search: |
;128/2.6E,2.1E,404,416,417,418,DIG.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Cushman, Darby & Cushman
Claims
What is claimed is:
1. An electrode device for establishing an electrical connection
between electromedical apparatus and the skin of the human anatomy,
said electrode device comprising composite electrode body means for
self-adhering engagement with a substantial surface area of the
skin to establish the aforesaid electrical connection throughout
substantially the entire engaged area of the skin without the use
of conductive pastes, gels or other liquids, such as solvents or
the like, said composite electrode body means including a tacky
skin-engaging surface formed by a thin flexible layer of pressure
sensitive adhesive material having fine non metallic electrically
conductive particles dispersed throughout including said tacky
skin-engaging surface in an amount sufficient to provide the
aforesaid electrical connection with the engaged area of the skin
through said layer by particle to particle contact while permitting
the skin-engaging surface of said layer to remain tacky prior to
skin engagement, removable sheet means having a release surface
engaging the tacky skin-engaging surface of said layer operable to
be separated therefrom without substantially reducing the tackiness
thereof in response to the removal of said removable sheet means,
said composite electrode body means further including carrier layer
means disposed in substantially coextensive connected relation with
said adhesive layer and presenting a non-tacky exterior surface
generally opposed to said skin-engaging surface and electrical
terminal means carried by said carrier means and forming an
exterior terminal part of the aforesaid electrical connection with
which a detachable electrical connection with the electromedical
apparatus can be effected.
2. An electrode device as defined in claim 1 wherein said composite
body means is porous and hypo-allergenic.
3. An electrode device as defined in claim 1 wherein said fine
conductive particles are carbon particles.
4. An electrode device as defined in claim 1 wherein said terminal
means comprises a male snap fastener element.
5. An electrode device as defined in claim 4 wherein said male snap
fastener element is metal.
6. An electrode device as defined in claim 4 wherein said electrode
body means is circular and said male snap fastener element is
concentrically connected therewith.
7. An electrode device as defined in claim 1 wherein said carrier
layer means is formed of a porous nonwoven fabric.
8. An electrode device as defined in claim 7 wherein said adhesive
material is a synthetic acrylic copolymer.
Description
This invention relates to electrodes of the type adapted to
establish an electrical connection between electromedical
apparatus, such as an electrocardiograph or the like, and the skin
of the human anatomy and more particularly to an electrode of this
type which is especially suitable for long term monitoring.
Typical electrodes now available for use in long term monitoring
usually rely upon the utilization of a conductive paste or gel to
establish the actual electrical connection with the patient's skin.
A typical example of an electrode of this type is disclosed in U.S.
Pat. No. 3,713,435. The disclosed arrangement is one in which a
central electrolyte paste receiving structure providing an exterior
terminal, such as a male snap fastener element, is fixedly secured
to a surrounding sheet-like member having a pressure sensitive
adhesive thereon which serves to adhere the central structure to
the skin.
Electrodes of this type have proven quite reliable in effecting the
required electrical connection, however, there are disadvantages
and inconveniences presented. The primary disadvantage resides in
the utilization of the electrolyte gel which requires that such gel
be extraneously supplied during application or that the electrode
be packaged individually with the gel in a liquid tight container.
The necessity to provide extraneous gel during application is an
obvious inconvenience. Where this inconvenience is obviated by
packaging the gel with the electrode structure, overall costs are
increased by the cost of packaging. Moreover, any premature
exposure of the packaged electrode to atmospheric conditions will
result in the drying out of the gel.
In addition to the above application disadvantages, the use of an
electrolyte gel in contact with the skin, especially for long
periods of time, can cause skin irritation and sores to develop.
Another possible source of skin irritation during use is the
adhesive which contacts the larger area of the skin surrounding the
area of electrolyte contact. Thus, with electrodes of this type the
total skin contact area subject to irritation is substantially
greater than the area through which the electrical connection is
made since the area of electrical contact is separate and distinct
from the area of securement. Moreover, because of this separation
the area of electrical contact is capable of surface to surface
shifting which may produce artifact.
Another type of electrode construction is disclosed in U.S. Pat.
No. 3,547,105. The opening paragraphs of the specification of this
patent, by way of background information, refer to NASA Technical
Note D-3414, May 1966 "Dry Electrodes for Physiological
Monitoring", which discusses an electrode which is sprayed on the
skin in the form of a solution of Duco cement made by the DuPont
Company having an acetone solvent and a powdered silver therein.
The electrode of the patent is disclosed as an improvement, set
against this background, in which the Duco cement solution is used
to perform an electrode construction rather than to form the same
on the patient by the spray-on technique. The preformed electrode
consists essentially of two thin disks punched from a thin dried
layer of Duco cement solution which are cemented together with a
terminal lead therebetween. The electrode is referred to as dry but
cannot be applied without utilizing an extraneous supply of acetone
solvent or the like. Thus in applying the electrode, the solvent is
wiped or dabbed on the patient's skin and the electrode is also
wetted with solvent, then immediately pressed upon the wet area and
held for a second or two until the electrode has started to adhere.
The small layer of solvent is then rapidly absorbed into the skin
and dry electrode.
This electrode obviates many of the above-mentioned disadvantages
of the first-mentioned type of electrode. Thus, the electrode is
dry, in the sense of not utilizing an electrolyte paste or gel to
effect the electrical connection during use, and hence the
disadvantages inherent in the use of such electrolytes is obviated.
Moreover, the disadvantages previously discussed in relation to the
provision of separate electrical contact and skin securement areas
are obviated, since skin adherence is obtained coextensively in the
area where electrical contact is made.
While these disadvantages in the first-mentioned type of electrode
are overcome, the second-mentioned type of electrode presents other
disadvantages which are related to the necessity of utilizing a
solvent to apply the electrode. This necessity essentially raises
the same type of problems which are presented with the use of
electrolyte gels. Thus, application cannot be effectively
accomplished unless a supply of solvent is available. A substantial
inconvenience is presented where the solvent supply is separate
from the electrode supply. The packaging problems presented to
integrate the two are even more formidable than those presented by
electrolyte gels because of the inherent volatile nature of the
solvent. There exists the need for an electrode which will obtain
all of the advantages of both of the above-mentioned types of
electrodes without securing the attendant disadvantages
thereof.
An object of the present invention is to provide an electrode which
will fill such need by securing all of the advantages of the prior
art electrodes without any of the attendant disadvantages. In
accordance with the principles of the present invention this
objective is obtained by providing a composite electrode body
having a tacky skin-engaging surface formed by a thin flexible
layer of pressure sensitive adhesive material having fine
electrically conductive particles dispersed throughout including
the skin-engaging surface in an amount sufficient to provide an
effective electrical connection with the engaged area of the skin
through the layer by particle to particle contact while permitting
the skin-engaging surface of the layer to remain tacky prior to
skin engagement. The tacky surface is protected prior to use by a
removable sheet having a release surface engaging the tacky surface
which, when the sheet is removed, does not substantially reduce the
tackiness of the surface. The composite electrode body also
includes a thin flexible carrier layer or layers coextensively
connected with the tacky surface layer and with an appropriate
terminal structure capable of detachable connection to the
electromedical apparatus. The carrier layer or layers may be either
non-conductive, in which case the terminal structure directly
contacts the conductive particles of the pressure sensitive
adhesive layer, or conductive, in which case the conductive layer
may be interposed in series between the conductive particles of the
pressure sensitive adhesive layer and the terminal structure. An
electrode constructed in accordance with these principles is truly
dry in that no liquid solvent is necessary to effect application
and no electrolyte paste or gel is necessary to effect a reliable
low resistance electrical connection throughout the entire area of
the skin to which the electrode is adhered.
While it can be readily understood that an electrode constructed in
accordance with the principles enunciated above effectively solves
the problems which have been experienced over the years in the long
term monitoring art, such understanding should not imply an
assertion that the present invention resides in the principles
applied. Quite to the contrary, the invention resides in solving
the problems of the long term electrode monitoring art and the
principles, enunciated above, in that solution are derived from a
hind-sight analysis of that solution. These principles derived from
such hind-sight analysis are known per se. See, for example, the
following U.S. Pat. Nos. 2,498,493; 2,670,306; 2,797,370;
2,808,352; 2,822,509; 3,475,213; 3,762,946; and 3,778,306. However,
such knowledge per se does not suggest the solution of the present
invention. Indeed, the separate co-existence of the principles per
se and the problem for an extended period indicates just the
opposite.
Another object of the present invention is the provision of an
electrode of the type described which is simple in construction,
easy and convenient to apply, efficient in operation and economical
to manufacture.
These and other objects of the present invention will become more
apparent during the course of the following detailed description
and appended claims.
The invention may best be understood with reference to the
accompanying drawings, wherein an illustrative embodiment is
shown.
In the drawings:
FIG. 1 is a perspective view of an electrode construction embodying
the principles of the present invention; and
FIG. 2 is an enlarged, sectional view taken along the line 2--2 of
FIG. 1.
Referring now more particularly to the drawings, there is shown
therein an electrode device, generally indicated at 10, for
establishing an electrical connection between electromedical
apparatus, such as an electrocardiograph or the like, and the skin
of the human anatomy. The electrode device consists essentially of
a composite electrode body, generally indicated at 12, for
self-adhering engagement with a substantial surface area of the
skin, to establish the electrical connection therewith throughout
substantially the entire engaged area of the skin without the use
of conductive pastes, gels or other liquids, such as solvents or
the like, and a terminal structure, generally indicated at 14, for
enabling the electrode device to be detachably electrically
connected with the electromedical apparatus.
In accordance with the principles of the present invention it is
essential that the composite body 12 provide a tacky skin-engaging
surface 16 which is formed by a thin flexible layer 18 of
pressure-sensitive adhesive material having fine electrically
conductive particles dispersed throughout, including the tacky
surface 16 in an amount sufficient to provide an electrical
connection from the surface 16 through the layer 18 by particle to
particle contact while permitting the surface 16 to remain tacky
prior to skin engagement. A further critical characteristic of the
composite structure is that the adhesive layer is coextensively
secured with a carrier structure of thin flexible sheet-like form
which in the preferred embodiment shown is a carrier layer 20
laminated to the pressure sensitive adhesive layer 18 by the
adhesive qualities of the latter. The carrier layer 20 provides a
non-tacky exterior surface 22 opposed to the tacky surface 16.
While the preferred embodiment of the composite body is of laminar
construction with a clearly defined interface, it will be
understood that the term composite contemplates constructions other
than the aforesaid clearly defined laminar one and specifically one
in which there are layers of different material characteristics
with merging interfaces which are not well-defined, as
distinguished from interfaces which are sufficiently well-defined
as to be capable of delamination.
Preferably the composite body is thin and flexible to the extent of
readily following the skin movements of the patient to which it is
applied without any portion of the surface 16 losing adherence with
the skin. Moreover, the composite body is preferably hypoallergenic
and porous so as to substantially eliminate any allergic reaction
due to the application of the electrode device to the skin of the
patient and virtually eliminate skin maceration caused by moisture
build-up. These characteristics are greatly preferred where the
electrode device 10 of the present invention is to be used for long
term monitoring. A further highly desirable characteristic is that
the composite body is capable of removal after use without leaving
residue from the layer 18 on the skin.
While the composite body may be formed of any desired materials
capable of providing the above-mentioned essential characteristics,
the preferred construction shown, which admirably meets the
essential characteristics as well as the preferred characteristics
noted above, utilizes the backing layer and pressure sensitive
adhesive material embodied in the surgical tape marketed by 3M
Company under the trademark MICROPORE with fine powder carbon being
utilized as the electrically conductive particles. Thus, the
carrier layer 20 is a thin flexible highly porous non-woven fabric
and the adhesive material is a synthetic acrylic copolymer. A
preferred amount of fine carbon powder to be included in the
adhesive is 25%, although it will be understood that more or less
can be used in accordance with the principles enunciated above. The
composite body is constructed in accordance with known procedures
including specifically those commercially utilized in the formation
of MICROPORE surgical tape with the fine carbon particles in the
above amount being initially mixed uniformly in the syntehtic
acrylic copolymer while in liquid form.
Layer thicknesses are preferably the same as those provided in the
aforesaid MICROPORE tape although either or both may be increased
or decreased if desired. The preferred shape of the composite body
12 is the circular configuration shown in the drawings since the
terminal construction can be centered therein. A preferred diameter
size is 2 inches. However, it will be understood that the composite
body 12 may assume other shapes and sizes. With respect to size,
the contact area provided by the above-preferred diameter dimension
should not be greatly reduced in order to insure a low resistance
connection, while size increase is limited only by practical
considerations. Square and rectangular shape variations are
specifically contemplated as well as elliptical and any others
considered desirable.
As previously stated, it will be understood that the invention is
not limited to the above-preferred specific construction. With
respect to the conductive particle loaded pressure sensitive
adhesive layer 16 per se, any of the known per se constructions in
the aforementioned patents may be utilized and the disclosure of
each is hereby incorporated by reference into the present
specification for that specific purpose per se. Other specific
constructions which clearly meet the essential and preferred
characteristics include a carrier layer and adhesive material such
as embodied in the TRANSPORE and DURAPORE surgical tapes marketed
by 3M Company. Thus, the carrier layer 20 may be a porous
Polyethylene/Ethylene Vinyl Acetate film or a porous woven cloth or
fabric. Also, as previously indicated, porosity in the layer 16 and
20 is not essential where the electrode device is not contemplated
for use in long term monitoring, indeed a carrier layer of thicker
polyethylene may be desirable for short term disposable use since
it is easier to handle. For long term monitoring use, the porous
and hypoallergenic characteristics are practically necessary.
The terminal structure 14 may assume a variety of forms including
the simple wire construction of the aforesaid U.S. Pat. No.
3,547,105. A male snap fastener construction such as that shown in
the aforesaid U.S. Pat. No. 3,713,435 is preferred. The male snap
fastener terminal structure 14 shown in the drawings consists
essentially of two similarly shaped metallic elements 24 and 26
crimped together. Each element includes a generally flange-shaped
mounting portion and a projecting generally knob-shaped terminal
portion. As shown, the terminal structure is fixedly connected to
the carrier layer 20 prior to lamination with the layer 16, the
connection being effected by suitably perforating the layer,
extending the knob portion of the smaller element upwardly through
the perforation while the larger element is held thereover and
effecting the crimping action. The mounting flange portions of the
two elements thus grip the marginal portions of the layer 20
defining the perforation. By effecting securement of the terminal
with the layer 20 prior to the lamination with the layer 16,
electrical connection between the conductive particles of the layer
16 and mounting portion of the terminal is simply effected in a
manner which effectively prevents direct contact of the metal of
the terminal with the skin during use. Avoidance of metal-to-skin
contact is desirable because of the battery effect, as is well
known. This effect may be likewise avoided by constructing the
terminal of carbon loaded plastic in which case the terminal may
extend through the skin engaging surface 18, if desired.
The above construction of the terminal also suggests the
utilization of carbon loaded plastic as the carrier layer in which
case a single unitary terminal could be secured to the exterior
surface of the carrier layer or even made integral therewith. Thus,
it will be apparent that while the preferred embodiments of the
carrier layer 20 are constructed of nonconductive material, it is
within the contemplation of the present invention to form the
carrier layer of conductive material such as carbon loaded plastic,
metallic foil, etc.
In accordance with the principles of the present invention, the
tacky surface 18 of the carbon loaded pressure sensitive adhesive
layer 20 is protected prior to the application of the electrode
device 10 with removable sheet means, a preferred form of which is
shown in the drawings as a paper sheet 28 having a release surface
30 of silicone or other well-known release material disposed in
coextensive engagement with the tacky surface 18. The exterior
surface of the paper sheet 28 is preferably provided with abrasive
granules 32 or similar substances which will perform the usual
known function of such granules. The removable sheet 28 is formed
essentially of very fine sand paper with the non-abrasive surface
thereof coated with silicone.
Since the construction is dry and application can be effected dry,
elaborate packaging is not required. Application is readily
effected by first rubbing the area of the skin to which the
electrode device is to be applied with the abrasive surface 32 in
the usual manner in which sand paper or the like is normally used.
As would be expected, this operation has the effect of removing a
layer of dead cells from the skin area. This removal enhances the
electrical connection to be effected and is preferable as a dry
pretreatment which is consistent with the dry construction and
operation of the electrode itself. Abrasive pretreatment is often
performed together with sterilization of the skin area b y swabs
containing alcohol and pumice. It will be understood that abrasive
pretreatment of the skin, whether wet or dry, is not at all
essential to the pretreatment. Next, the removable sheet 28 is
separated and then the composite body 12 is simply pressed onto the
abraded skin area so that the tacky surface 18 is firmly adhered
thereto. Connection with the electromedical apparatus is effected
simply by detachably connecting the lead thereof to the terminal
structure 14 in conventional fashion. While the application has
been described above in a sequence in which the rubbing of the skin
with the abrasive surface 32 is performed prior to the removal of
the sheet, the sequence of these procedures may be reversed.
Moreover, the removable sheet means may be formed of two sheets,
rather than one as shown, with each sheet having removal tabs, as
is well known.
It thus will be seen that the objects of this invention have been
fully and effectively accomplished. It will be realized, however,
that the foregoing preferred specific embodiment has been shown and
described for the purpose of illustrating the functional and
structural principles of this invention and is subject to change
without departure from such principles. Therefore, this invention
includes all modifications encompassed within the spirit and scope
of the following claims.
* * * * *