U.S. patent number 3,817,252 [Application Number 05/251,179] was granted by the patent office on 1974-06-18 for electrode for transcutaneous stimulation.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Donald D. Maurer.
United States Patent |
3,817,252 |
Maurer |
June 18, 1974 |
ELECTRODE FOR TRANSCUTANEOUS STIMULATION
Abstract
An electrode for transcutaneous stimulation capable of operating
within an optimum power density range. The electrode is provided
with a current diffusing screen which maintains a physiologically
acceptable power density by increasing the effective stimulation
surface area. In addition, a second screen is employed to increase
the surface area of the input electrical connection to inhibit
electrolysis as well as to lower the overall electrode impedance.
The entire electrode structure is flexible so that it is easily
conformable to any surface of the body.
Inventors: |
Maurer; Donald D. (Anoka,
MN) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
22950822 |
Appl.
No.: |
05/251,179 |
Filed: |
May 8, 1972 |
Current U.S.
Class: |
607/152;
607/153 |
Current CPC
Class: |
A61N
1/0492 (20130101); A61N 1/048 (20130101); A61N
1/0456 (20130101); A61N 1/0452 (20130101) |
Current International
Class: |
A61N
1/04 (20060101); A61n 001/18 () |
Field of
Search: |
;128/416,417,418,419,404,405,410,411,DIG.4,2.6E,2.1E |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Schwartz; Lew Sivertson; Wayne
A.
Claims
What is claimed is:
1. A body conformable electrode which comprises:
electrical connection means including
means for increasing the electrical contact area of said electrical
connection means comprising a substantially flat electrical
conductor of a size greater than said electrical connection
means;
skin interface means; and
electrically conductive flexible means positioned between said
electrical connection means and said contact area increasing means
for diffusing current flow from said electrical connection means
with substantial uniformity across substantially the entire surface
of said skin interface means.
2. The electrode of claim 1 wherein said flexible means has an
interrupted surface.
3. The electrode of claim 1 wherein said flexible means comprises a
conductive screen.
4. The electrode of claim 1 wherein said flexible means comprises a
metal screen.
5. The electrode of claim 1 wherein said skin interface means has
an effective skin contact surface area of at least 3.5 cm.sup.2 but
no greater than 50 cm.sup.2.
6. The electrode of claim 5 wherein said skin interface means has
an effective skin contact surface area of approximately 12
cm.sup.2.
7. The electrode of claim 1 wherein said contact area increasing
means is metal and has a surface area sufficient to inhibit
electrolysis and polarization.
8. The electrode of claim 7 wherein said contact area increasing
means comprises a metal screen.
9. The electrode of claim 8 wherein said flexible means has an
interrupted surface.
10. The electrode of claim 8 wherein said flexible means comprises
a conductive screen.
11. The electrode of claim 8 wherein said flexible means comprises
a metal screen.
12. The electrode of claim 8 wherein said skin interface means has
an effective skin contact surface area of at least 3.5 cm.sup.2 but
no greater than 50 cm.sup.2.
13. The electrode of claim 12 wherein said skin interface means has
an effective skin contact surface area of approximately 12
cm.sup.2.
Description
BACKGROUND OF THE INVENTION
Man has long transmitted electrical signals to and from the body by
way of electrical contact with the skin. Early examples of a device
which was applied to the skin to accomplish an electrical
"treatment" are found in the U.S. Pat. Nos. 1,059,090 and
1,305,725. The electrodes used with these devices have been found
to be poor for chronic stimulation (24 to 48 hours continuous
stimulation) because of their rigidity and inability to be readily
conformed to many parts of the body. These electrodes are extremely
bulky because of the very thick sponge which they use to avoid "hot
spots". In addition, these electrodes use a rigid metal plate which
prevents adequate current diffusion across the surface of the
sponge because the plate does not allow the surface of the sponge
to readily conform to the body. Later developments are typified by
the electrodes used in conjunction with the well-known
electrocardiograph (EKG).
A typical EKG electrode generally consists of a rigid or semi-rigid
metal plate covered by a sponge-like material. A conductive paste
permeates the sponge to limit motion artifacts so as to provide an
ionic conductive path which avoids high concentration gradients of
metallic ions between the plate and skin. The function of such an
electrode is merely to make an electrical contact with the skin for
monitoring purposes only. EKG electrodes are generally not
appropriate for stimulation purposes because they are so thick that
they do not readily conform to all parts of the body and create hot
spots due to high power density because of their relatively small
surface area.
When I first explored the viability of specific transcutaneous
nerve stimulation, an electrode similar to the EKG electrode and
having an increased surface area was employed. I found that this
electrode had hot spots due to its rigidity and lack of current
diffusion and operated with excessive power densities due to high
interface impedance. As indicated in The Skin Senses, edited by
Donald R. Kenshalo, published by Charles C. Thomas Company (1968),
a power density of 250 millicalories/cm.sup.2 will result in skin
tissue damage when the current exceeds 100 milliamps and the duty
cycle (ratio of on time to off time) exceeds 20 percent. That
current level and duty cycle are generally considered as maximums
for skin stimulation because above those values excessive muscle
stimulation may take place. In addition, it has been determined
that human tissue resistance decreases with an increase in current.
The practical consequence of this is that transcutaneous
stimulation should be accomplished with constant current
stimulators. Also, constant current stimulation has a long term
continuous effect which is not present with constant voltage
stimulation and, constant current stimulation is independent of
tissue and electrode impedance variations from one patent to
another. With the constant current restraint, it was discovered
that electrode power densities can best be optimized by operating
upon the electrode impedance and the effective stimulation surface
area.
SUMMARY OF THE INVENTION
The present invention provides a disposable electrode which is
especially adapted for chronic transcutaneous stimulation. It is
designed such that its impedance lies within an optimum range and
incorporates a conductive member with substantially uniformly
diffuses the current over a contact area greater than that in the
prior art devices thus avoiding excessive power densities. Through
these features, the power density of the electrode of the present
invention is maintained within an optimum range which is below the
damaging value stated above. In addition, the entire electrode
structure may be made flexible so that it will conform to any
surface of the body.
The present invention provides a body conformable electrode which
comprises an electrical connection means, a skin interface means,
and a flexible means for diffusing current flow from said
electrical connection means with substantial uniformity across
substantially the entire surface area of said skin interface
means.
BRIEF DESCRIPTION OF THE DRAWINGS
The FIG. 1 is an exploded view of a preferred embodiment of the
present invention.
FIG. 2 is a cross-section of the embodiment of FIG. 1 is an
assembled state .
DETAILED DESCRIPTION OF THE DRAWINGS
FIG. 1 shows in exploded form a chronic disposable transcutaneous
stimulator electrode in a preferred embodiment. Specifically there
is shown an adhesive member 10 having a single adhesive surface 11.
On the adhesive surface 11 of the member 10, there is positioned a
snap button mount 12, having a head 13 which passes through a hole
18 in the member 10. Snap button 12 provides a means for
electrically attaching the electrode via a lead to a stimulator
(not shown). The snap button 12 may be of a type commonly employed
on EKG electrodes, it being understood that the particular
attachment may take various forms such as, for example, a screw-on
type of attachment. Positioned on the adhesive side 11 of the
member 10 and in contact with the button 12, is a low impedance
screen 14. A snap ring 15 provides an electrical connection for the
electrode by being inserted through the screen 14 and into
electrical contact and mechanical locking engagement with snap
button 12. Snap ring 15 also serves to hold screen 14 in intimate
electrical contact with the snap button 12. Alternatively, the snap
ring 15 could be eliminated and snap button 13 could be spot welded
in position on the screen 14. Although shown as a screen, the
element 14 may, within the restriction that it be flexible, be a
solid metal foil, or a conductive plastic or rubber.
On top of, and in electrical contact with the screen 14 and snap
ring 15 is a diffuser screen 16. The diffuser screen 16 is a highly
flexible screen which acts as a low impedance current diffuser.
Above the diffuser screen 16 is a skin interface pad 17 whose
function is to prevent direct contact between the skin and the
diffuser screen 16.
The electrode shown in FIG. 2 is assembled by placing the various
elements into contact with each other and the adhesive surface 11.
First, the head 13 of snap button 12 is forced through the hole 18
of the member 10. The low impedance screen 14 is then adhered to
the surface 11 and the snap ring 15 is placed through it and into
electrical contact and mechanical locking engagement with the snap
button 12. The diffuser screen 16, which is larger than the low
impedance screen 14, is then placed over the screen 14. Because of
the size difference, the outer border of the diffuser screen 16
will be in direct contact with the adhesive surface 11. The
interface pad 17, which is larger than the diffuser screen 16, is
placed over the diffuser screen 16 into border contact with the
adhesive surface 11. The interface pad 17 may be a foam material as
commonly applied to EKG electrodes or, in the alternative, may be a
cloth material. Because of the use of the thin flexible screens 14
and 16, the interface pad 17 may be much thinner than the sponge
material used with the devices of U.S. Pat. Nos. 1,095,090 and
1,305,725. Both the low impedance screen 14 and the current
diffuser screen 16 may be made of 316 stainless steel. All of the
elements of the electrode with the possible exclusion of the snap
ring 15 and snap button 12, are highly flexible which makes it
possible to conform the electrode to any surface of the body.
In use, an electrically conductive paste, Saline or any other
suitable substance is applied to the assembled electrode which is
then adhered to the body by the remaining adhesive surface 11. The
diffuser screen 16 allows the paste to permeate through to the low
impedance screen 14. The diffuser screen 16 may alternatively be a
flexible solid member having an interrupted surface to allow the
suitable substance to flow through to the low impedance screen 14.
In those instances where the low impedance screen 14 is a metallic
substance, its surface area is sufficient to inhibit excessive
polarization and electrolysis which might otherwise develop at both
the snap button and snap ring due to excessive current densities.
In any event, the surface area of the low impedance screen 14 when
added to the surface area of the snap ring 15, is an aid to
lowering the overall impedance of the electrode, without regard to
the material used. Since the characteristics of the human
skin-stimulator interface dictate a constant current stimulator,
power density control can best be achieved by controlling the
effective electrode contact area and electrode impedance. To
eliminate hot spots, it is imperative that the current be diffused
in a substantially uniform manner over the entire electrode contact
area.
All of the above objects are accomplished in the electrode of the
present invention. The impedance is held at a minimum through the
combined effects of the low impedance screen 14 and current
diffuser 16. In addition the current diffuser 16 provides a low
impedance conformal contact to the skin interface pad 17 which
increases the possible effective electrode contact area while
eliminating hot spots. That is, the current is diffused in a
substantially uniform manner over substantially the entire
electrode contact area.
It has been determined that the optimum average power density range
is 7.14 microwatts/cm.sup.2 /second to 357 microwatts/cm.sup.2
/second. The power density is within these limits when the
effective electrode surface area is within the range of 3.5
cm.sup.2 to 50 cm.sup.2, and when the stimulator parameters of
current and duty cycle are within the limits stated above. The most
effective electrode surface area has been found to be approximately
12 cm.sup.2.
Obviously, many modifications and variations of the present
invention are possible in view of the above teachings. One example
of such a modification is the combination of the low impedance
screen and diffuser screen into a single screen folded over on
itself. Therefore, it is to be understood, that within the scope of
the appended claims, the invention may be practiced otherwise than
as specifically described.
* * * * *