Note: Descriptions are shown in the official language in which they were submitted.
'. 10~
This invention relates to infant or new born
baby care and more particularly to an improved electrode
assembly and method of using the same in the re~piratory
; and/or cardiac monitoring of an infant.
In the care of infants it is frequently neces-
sary to continuously monitor the respiratory and/or heart
.
functions of the infant, usually in conjunction with incu-
bator treatments. The practice heretofore has been to use ~
separate adhesively applied electrodes for purposes of ~ -
respiratory and/ox ECG monitoring. A typical electrode
of the type used in practice is disclosed in U.S. patent
3,713,435. An electrode of ~his type embodies a central
male snap fastener assembly surrounded by a disk of flex-
ible material. The male element of the snap fastener as-
sembly serves as a terminal for connection with the leadof the monitoring equipment. The opposite side of the
male snap fastener assembly serves as a receptacle for a
conductive paste or electrolyte gel. The corresponding
face of the flexible disk is provided with a pressure sen-
sitive adhesive which serves to hold the electrolyte gelinto contact with the skin. In operation, usually three
of these electrodes are applied to the infant's chest area
with the infant being supported in the incubator on his or
her back.
While the use of electrodes of this type produce
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reliable monitoring, this reliability is obtained with
the known inconvenience and aggravation experienced by
- adults when being so monitored. Thus, it is well known
that conductive pastes or electrolyte gels are a source
of skin irritation and maceration. Likewise, the area of
: .
~ the skin contacted by the pressure sensitive adhesive fre-
`~ quently can become irritated and sore. While these ef-
fects can be considered inconveniences and aggravations
by adult patients, they often become severe problems when
applied to new born babies or infants. The severity of
the problem is magnified and multiplied by the frequent
attendant need to X-ray the infant's chest undergoing
treatment. Since the electrodes are adhered to the in-
fant's chest ànd contain metal, each one of the three must
15 be removed each time before the X-ray is taken and then ;
replaced after the X-ray has been completed. This remov-
ing and replacing procedure further increases the chances
of irritation to the infant's tender skin. There exists
a need for a reliable electrode system which will elimin-
ate the prbblems incident to direct skin contact of gels
and adhesives and is either easily and conveniently re-
movable and replaceable for X-ray purposes or permits un-
obstructive X-ray picture taking while attached.
An object of the present invention is the pro-
vision of a reliable electrode system and method of using
,,, ~04~
the same in the respiratory and~or cardiac monitoring of
an infant which will fill the above described need by
eliminating the aforesaid disadvantages of present prac- -
~; tices. In accordance with the principles of the present
invention this objective is obtained by utilizing a plu-
i rality of flexible sheet form electrodes, preferably form- ~ -
- ed of carbon powder loaded polyvinyl chloride, sized and
arranged so as to have a maximum contact area with the in-
fant's skin at a location throughout the back area so that
such contact can be maintained primarily by the weight of
the infant in his or her normally supported position with-
in the incubator. The utilization of flexible sheet form
electrodes enables a reliable electrical connection to be
effected without the use of conductive pastes or electro-
lyte gels since electrical resistance to the connectioncan be minimized by virtue of the greater area of contact
of the connection. Utilizing the infant 1 9 bacX as the
area of contact also secures many advantages. First, it
utilizes a skin area which is normally contacted anyway
by virtue of the infant's normal position in the incubator. - -
Thus, skin areas which do not receive normal intimate con-
tact, such as the chest area, are allowed to remain unen-
- cumbered. Second, the weight of the infant can be utiliz-
ed to facilitate a somewhat pressurized contact. Third,
by utilizing non-metallic electrodes which extend through-
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1~48~11
out the back area, the metal leads of the ECG equipment
can be peripherally attached to the electrodes, thus mak-
ing it possible to maintain the torso area free of ob-
structing metal for X-ray purposes.
It is recognized that flexible sheet form elec-
trodes which eliminate the need for conductive paste or
electrolyte gel have long been proposed in the patented
literature as, for example, Ruben Patent 1,973,911 dated
September 18, 1934. The single electrode of the Ruben
patent is provided with a mucilaginous adhesive to effect
securement to the skin, an arrangement which would be un-
suitable for infants and would not fill the need for an
electrode system which maintains reliable contact without
the possibility of skin irritation due to adhesive skin
engagement. The patented literature also contains other
proposals for the use of flexible sheet form electrodes
where skin engagement is maintained by adhesive eliminat-
ing means suitable for specific purposes other than in-
fant monitoring. For example, Browner U.S. patent
3,025,857 dated March 20, 1962, discloses an electrother-
apy device in which a plurality of flexible sheet form
electrodes are affixed to a flexible wall of a treatment
table with certain of the electrodes being carried by
straps affixed to the wall by means of which the patient
is both strapped to the treatment table and contacted with
11~)48~
the electrodes on exposed upwardly facing skin areas.
The Browner arrangement thus provides for the selective
contraction of the strapped patient's muscles by electri-
cal excitement through the various electrodes. Another
5 specialized use is disclosed in Roman U.S. patent
3,534,727 dated October 20, 1970. The purpose of the
Roman arrangement is to enable monitoring to take place
while the patient is physically active. To this end, a
plurality of flexible sheet form electrodes are maintain-
10 ed in skin contact by means of a tightly fitting elasticgarment. Bolduc U.S. patent 3,720,209 dated November 25,
1970, discloses the use of a plurality of flexible sheet
form electrodes mounted on the upper surface of a flat
flexible plate-like base so that an ECG can be taken with
15 t~e patient simply lying on a treatment table with the
base mounted electrodes between the patient and the treat-
ment table.
In filling the aforementioned specific needs in-
cident to infant care, the present invention relies not
20 only upon the use of a plurality of flexible sheet form
electrodes but also upon the combination of such elec
trodes with an effective reliable non-adhesive attaching
structure which fulfills the needs specific to infant
care. The attaching structure of the present invention
25 and its mode of operation differs in principle from the
1~48~
attaching structures of the' prior art discussed above be-
cause it neither utilizes a strapped to the table rela-
tionship, a tight fitting elastic garment relationship
nor a flat plate-like relationship. While these latter
relationships may be desirable or necessary for the par-
ticular application to which they relate, they could not
be satisfactorily applied to infant care. Strapping the
patient down to the treatment table may be regarded as
necessary while giving an adult an electric muscle shock
treatment but would not be desirable for infants. Like-
wise, wearing an elastic garment may be required dress
for astronauts but is hardly suitable for infants. So
also it would be expected that an adult would lie still
on a flat pad long enough for an ECG reading, but such
conduct cannot be expected in the long term monitoring of
. .
an infant.
In accordance with the principles of the pres-
ent invention, an attaching structure is provided which
will maintain a plurality of flexible sheet form electrodes
against the back of an infant in such a way as to maintain
reliable non-adhesive contact over an extended period of
time without strapping the infant to the incu~ator, with-
out requiring the infant to wear tight fitting elastic
garments or to be immobile. The attaching structure em-
bodying these principles includes a pad of soft pliable
104~
material, preferably a very fine open pore foamed poly-
urethane sheet of approximately 1/4" thickness, having a
back engaging area of approximately 4-1/2" by 4-1/2" to
` which the plurality of flexible sheet form electrodes are
attached substantially throughout, the sides of the back
- engaging area having portions which converge outwardly
thereof so as to pass under the infant's armpits and ex-
tend along the lower edge of the infant's rib cage when
held against the sides of the infant's torso. Soft pli-
able quick connect and disconnect strap means, preferably
formed integrally of the pad material, is provided between --
the converging portions to maintain the same against the
sides of the infant's torso which, in turn, maintains the
electrode carrying back engaging area against the infant's
back. The soft pliable strap means extends across the in-
..
fant's chest above the belly area so that attachment is
effected by the application of a soft pliable restraint
which is completely unrestrictive to the breathing move-
ments which occur in the belly area of infants.
Another object of the present invention is the
provision of a reliable infant long term monitoring elec-
trode assembly of the type described which is sufficiently
simple and economical in construction as to be made ster-
ile and disposable after one use.
; 25 These and other objects of the present invention
will become more apparent during the course of the follow- ;
ing detailed description and appended claims.
. The invention may best be understood with ref-
erence to the accompanying drawings wherein illustrative
embodiments are shown.
: In the drawings:
Figure 1 is a perspective view illustrating the
manner in which a preferred electrode assembly embodying
the principles of the present invention is disposed in
attached relation with an infant;
~ Figure 2 is a perspective view showing the elec-
- trode assembly in attached relation with an infant;
Figure 3 is a top plan view of the electrode as-
sembly disposed in a flat condition prior to attachment
to the infant;
Figure 4 is an enlarged, fragmentary sectional
view taken along the line 4-4 of Figure 3 illustrating an
electrode assembly of modified form embodying the prin-
ciples of the present invention;
Figure 5 is a view similar to Figure 3 illus-
trating an electrode assembly of modified form embodying
the principles of the present invention; and
Figure 6 is an enlarged fragmentary sectional
view taken along the line 6-6 of Figure 5.
Referring now more particularly to the drawings,
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~148f~11
there is shown in Figures 1-4 thereof a disposable elec-
trode assembly, generally indicated at 10, which, in ac-
- cordance with the principles of the present invention, is
particularly suitf~d for the respiratory and/or cardiac
5 monitoring of infants or new born babies. As best shown
in Figure 3, the electrode assembly comprises a sheet-like
pad 12 of soft pliable non-conductive material having an
infant back receiving area 14 of approximately 4-1/2" by
4-1/2". A plurality of separate flexible sheet form elec-
10 trodes 16, 18, 20 and 22 of conductive particle impregnat-
ed plastic material are affixed in surface-to-surface en-
gagement with the pad 12 so as to extend ~ubstantially
throughout the back receiving area thereof.
The pad 12 also includes integral portions 24
15 which converge outwardly from opposite sides of the back
receiving area 14 thereof for extending generally beneath
the armpits and along the lower edge of the rib cage of
an infant when the converging side portions are held to
the sides of the infant's torso. The converging side por-
20 tions 24 are arranged to be held to the sides of the in-
fant by appropriate ~oft pliable strap means which in the
preferred embodiment are in the form of a pair of integral
strap portions 26. Mounted ori the strap portions 26 are
cooperating Velcro fastener strips 28 and 30 which serve
25 to releasably adjustably secure the strap portions 26 in
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a position extending across the chest cage of the infant.
In the embodiment shown in Figures 1-4, the pad
12 also includes an infant head receiving and terminal
carrying portion 32 extending outwardly from the area 14
^~5 in the direction of and beyond an infant's head whose back
is received on the back receiving area 14. The electrode
assembly 10 also includes terminal means for effecting a
detachable electrical connection of each electrode 16, 18,
'~20 and 22 with a lead of a monitoring machine. In the em-
bodiment shown in Figures 1-4, the terminal means includes
strips 34, 36, 38 and 40 which are integral with and ex-
tend from the peripherie.s of the electrodes 16, 18, 20
and 22, respectively. The strips extend through openings
~42, 44, 46 and 48, respectively, in the pad 12 and are
;15 affixed in surface-to-surface engagement with the exteri-
;or of the pad in an outwardly extending parallel relation
in the direction of the portion 32. The terminal means
also includes male ~nap fastener elements 50, 52, 54, and
56 which are fixedly secured to the free ends of the
strips 34, 36, 38 and 40, respectively, and the associated
pad portion 32.
It will be understood that the pad 12 may be
constructed of any soft pliable non-conductive material
or composite construction, however, a preferred material
.
is a very fine open pore polyurethane of approximately
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1/4" thickness. A pore size of 100 PPI is preferred. As
to the size of the back engaging area 14, it will be un-
derstood that a measure of variation from the exact 4-1/2
x 4-1/2 dimension previously stated is clearly within the
purview of the present invention. Basically, it is de-
sirable to make the area be as large as possible to in-
crease the electrical contact area and hence minimize the
resistance of the connector. On the other hand, it is
desirable to make the area as small as possible to accom-
modate the smallest size in~ant encountered.
Commensurate with this view, a 4" by 3" dimen-
sion of the area is desirable and, of course, the term
"approximately" contemplates a slightly lower dimension
as well as dimensions above the exact 4-1/2 x 4-1/2 di- ~ -
mension specified. Moreover, it will be appreciated that
a variation in the dimension across the back is more re-
stricted than the dimension normal thereto in order to
achieve the proper functioning of the converging portions
24.
The electrodes can be of any desired electri-
cally conductive flexible material, the preferred material
shown being carbon powder impregnated polyvinyl chloride.
While cooperating Velcro fastener elements 28 and 30 are
pre~erred, other fastening elements or assemblies may be
utilized. Likewise, while male snap fastener elements
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made of metal are preferred as a terminal construction,
other types of terminals may be utilized, including simple
wires.
The electrodes are preferably relatively thin,
the preferred thickness shown being 0.030 inches. The
shape of the electrodes and the number of electrodes pro-
vided can be varied. It is preferred that they be of gen-
erally equal size extending over as much of the back re-
ceiving area 14 as possible but at least 5~% of the area.
In the preferred embodiment shown, there are four elec-
trodes of generally equal square configuration (approxi-
mately 2" by 1-15/16" for the 4-1/2" x 4-1/2" size and
1-1/2" by 1-1/2" for the 4" x 3-1/2" size) extending over
; approximately 80% of the back receiving area 14.
With the above in mind, it will be understood
that the terms "pad of soft pliable material" and "flex-
ible sheet form electrodes" are not limited to the pre-
fer:red embodiments specifically described above but com-
prehend other types of constructions. For example, the
pad and electrodes could be formed of woven or knitted
material with the electrodes being provided by electrical-
ly conductive yarns (e.g. carbon powder loaded resin or
metallic coated thread) positioned in the fabric to en-
gage the infant's back by the weaving or knitting opera-
tion. Other arrangements will readily occur to those
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skilled in the art.
In practicing the present method, the electrode
assembly 10 is first placed in a generally flat condition,
as shown in Figure 1, on the upper surface of the incuba-
tor with the exterior surface of the pad 12 engaging theupper surface of the incubator and the exposed surfaces
of the electrodes 16, 18, 20 and 22 facing upwardly.
Next, the leads of the monitoring instrument are detach-
ably connected with the snap fastener terminal elements
50, 52, 54 and 56. ~ext, the infant is placed in the in-
cubator in a position such that his or her back rests upon
the electrodes 16, 18, 20 and 22 and the infant's head
rests upon the pad portion 32, as is shown in Figure 1.
Next, the strap portions 26 are brought up around the in-
; 15 fant's chest and the cooperating Velcro fastening elements
28 and 30 are brought into engagement. Figure 2 illus-
trates the operative position of the assembly 10 when ap
plied to the infant.
In summary, the method of the present invention
involves the steps of positioning the infant's back into
skin engagement with a plurality of generally coplanar
flexible sheet form electrodes substantially throughout
the back area of the infant while flexibly retaining the
electrodes in a generally fixed relation with respect to
one another within said generally coplanar relationship,
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1~4~611
applying a slight flexible retaining pressure along the
infant's sides generally between the lower edge portion
of the rib cage and the armpits and across the infant's
chest above the belly area to the aforesaid flexlble re-
tention of the electrodes to maintain the aforesaid skinengagement between the infant's back and the electrodes,
and utilizing the skin engagement of the electrodes with
the infant's back to establish a circuit for the electri-
cal signals thus captured to a monitoring device. The
monitoring device may be of any well-known construction
capable of providing an indication of the infant's respir-
ation and/or ECG based upon the electrical signals convey-
ed thereto through the established circuit.
~ormally, the skin engagement is effected with
the electrodes in a dry condition, however, it is within
the contemplation of the present invention to place a
small quantity of water te.g. a~drop or a few drops) upon
the skin engaging surface of the electrodes before posi-
tioning the infant's back into skin engagement therewith.
The water is preferably sterilized water to eliminate any
possibility of irritation.
With the four electrode assembly shown, it will
be understood that one of the electrodes, such as the
electrode 22, constitutes the ground electrode. Normally,
only two of the other three electrodes, in addition to the
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1~48611
ground electrode, would be operable at any one time. The
provision of the four electrodes enables the operator to
achieve a conventional Lead I reading, as by utilizing
electrodes 16 and 18 along with the ground electrode 22;
a conventional Lead II reading, as by utilizing electrode
18 and electrode 20 along with the ground electrode 22;
or conventional Lead III reading, as by utilizing elec- ;
trodes 16 and 20 along with the ground 22.
It will be understood that the electrical sig-
nals which are thus captured by the use of the present
electrode assembly 10 are suitable for either respiratory
; monitoring or cardiac monitoring or both. In accordance
with known practices, the signals captured which are suit-
able for respiratory monitoring are the variations in the
electrical resistance of the infant's thorax due to breath-
ing, while the signals captured which are suitable for
ECG monitoring are the electrical signals which trigger
the heart beat. Circuitry suitable to provide appropriate ~ -
output monitoring signals corresponding to each type of
, 20 captured signal is alYo well-known.
`` The provision of the head receiving and terminal
carrying pad portion 32 is preferred since it serves to
; present the terminals which are connected with the leads
of the monitoring instrument in a controlled manner which
is spaced from the infant. With this arrangement, ~-rays
" -16-
1~)4~li11
can be taken with the assembly 10 attached to the infant
since the electrical wires of the leads of the instrument
are maintained out of contact with the infant and there
are no metallic materials embodied in the assembly 10
which would obstruct an X-ray picture when taken with the
device applied to the infant.
It will be understood that while the provision
of the pad portion 32 is preferred, it is within the con-
templation of the present invention to eliminate the por-
tion 32 from the pad. A modification of this type is il-
lustrated in Figures 5 and 6. Since the embodiment of
Figures 5 and 6 varies from that of the preferred embodi-
ment of Figures 1-4 solely in the elimination of the pad
portion 32 and the specific configuration of the terminal
means, corresponding elements of the assembly illustrated
in Figures 5 and 6 are designated by corresponding prime
numerals which do not require further detailed description.
Suffice it to say that the electrode assembly 10' includes
terminal means in which the electrodes 16', 18', 20' and
22' are provided with integral triangular portions or
strips 58, 60, 62 and 64 which extend in affixed surface- ~`
to-surface engagement with the associated converging side ~;
pad portions 24. These terminal electrode portions have
small snap fastener elements 66, 68, 70 and 72, respec-
tively, fixed thereto. As best shown in Figure 6, the pad
~L~486~1
adjacent each snap fastener element is preferably aper-
tured, as indicated at 74, to receive the lead connection
therein. In this embodiment the exterior surface portion
of each snap fastener element on the electrode side of
the pad is provided with electrical insulation in order
to prevent metal-to-infant skin contact. Such insulation
can be provided in any suitable manner, such as making the
snap fastener portions of a non-metallic material, by ap-
plying insulating tape thereto, or by plastic coating the
snap fastener portions, as indicated in Figure 6.
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 embodiments have been shown and described for the
purpose of illustrating the functional and structural prin-
ciples of this invention and are subject to change without
departure from such principles. Therefore, this invention
includes all modifications encompassed within the spirit
and scope of the following claims.
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