Note: Descriptions are shown in the official language in which they were submitted.
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FL~XIBLE AND DISPO~ABLE ELECTRODE BELT DE~ICE
BACgGROUND OF THE IN~ENTION
This invention relates to a device and method for receiving
an~ transmitting electrical signals to and from a patient.
Particularly, this invention relates to a disposable, ~lexible
and layered electrode belt, also referred to as a "belt", for
placement and use on the body of a patient and also ~or use with
medical diagnostic and therapeutic devices.
The belt according to this invention is use~ul in providing
a disposable and ~lexible layered structure which quickly and
easily adheres to the skin of a patient and which is operative on
the patient at predetermined locations. The thin ~lexible belt
provides a patient body contour conforming structure which is in
direct conductive electrical communi¢ation to permit the
transmission of a broad range of electrical signals.
The belt of the invention further permits medical personnel
to inexpensively, e~ficiently, accurately, aseptically and
removably a~fix the belt device to predetermined body locations
of the patient. The device provides means to receive bioeleQtriQ
signals from predetermined anatomical locations ~or subsequent or
simultaneous analysis on diagno~tic equipment, such as cardiac
analyzers, and to transmit an electric current or voltage to
speci~ic anatomical locations ~or therapeutic purposes. The
device is usable on the chest, back, head and limbs of the
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patient and is also usable simultaneously on the patient'q chest
and bac~ areas, for example, for various diagnostic and
therapeutic purposes~
The flexible electrode belt device and method of this
invention provides a means to introduce a plurality of electrode
elements for communication with the body of the patient for
purposes of sensing bioelectric signalst introducing an electric
current or voltage at predetermined locations on the body of the
patient, or for both of these purposes simultaneously. Thus, the
electrode belt is provided to obtain bioelectric data for use in
cardiac or other analyzers or for therapeutic purposes.
The electrode belt of the invention is a ~lexible unitary
composite of layered materials which resists entanglement, is
easy to manipulate and may be quickly and accurately affixed to
the contours of a patient body. The electrode belt of the
invention significantly reduces the number of steps and time
required to per~orm medical diagnostic and therapeutic functions
because the device is provided with conductive adhesive electrode
surface~, with reference means for positioning the device on the
patient and with electrodes that are positioned at predetermined
locations in the device.
The belt device is also adaptable to permit the positioning
of electrodes at locations outside the predetermined positions
on the device. For example, the device may be adjusted to place
electrodes at standard EKG limb electrode locations. The belt
device i~ thin and flexible and it conforms to the contours of an
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individual patient's body for accuracy. The thin configuration
of the device also reduces material usage in manufacture and
proYides an electrode belt that is cost effective.
The invention further provides an electrode belt device that
is disposable, which is an improvement over prior art devices
which typically require much maintenànce and care. Additionally,
its disposabi~lity is particularly beneficial in a medical
setting, wherein the possibility of transfer of communicable
diseases from patient to patient is of great concern. Because
the belt device and its components are designed for individual
patient use, ri~ks that are inherent in multiple patient use
device~s are minimized.
In the past, several types of electrode devices have been
utilized or proposed for use with ele¢tro/medical analyzers, such
as electrodardiograph instruments. These devices have, however,
been limited in signal pickup and placement function and have
generally been designed for use with these specific types of
analyzer instruments. Additionally, various types of layered
devices have been proposed for use in the medical industry which
are designed for use with specific forms or types of insartable
and reusable electrode elements. And, still others have been
provided which do not fit to the human body contours and which
thus limits their effective signal transmissions.
These prior art devices have generally been costly to manu-
facture or have been designed for repeated use and, thus, present
the possibility of transmitting communicable diseases. Still
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~ther devices have proposed electrode placements which make them
unsuitable and cumbersome ~or any other medical analyzirg
purposes.
The flexible and disposable electrode belt of this invention
overcomes the limitations, dif~iculties and shortcomings of these
prior art devices. The device in accordance with the teachings
oP this invention provides a versatile, functional, inexpensive,
aseptic and easy to use disposable and flexible electrode belt
for use by medical personnel in conjunction with medical
diagnostic and therapeutic equipment that utilizes bioeleotric
signal inputs or electric outputs. And, despite the longstanding
need for such a device in the medical diagnostic and therapeutic
area, none in 30 far as is known has been developed.
SUMMARY OF THE INYENTION
The invention provides a flexible and disposable bèlt device
~or the releaseable securement to the body of a patient and ~or
receiving and transmitting electric current and voltage. The
belt has a composite and layered body structure with a ter~inal
end which is connectable for use with a cable set o~ a medical
therapeutic and diagnostic apparatus.
The flexible and layered body structure has a ~lexible non-
conductive base structure layer for supporting and electrically
insulating the remaining elements of the composite and layered
body structure. A conduction network is affixed to the non-
conductive base layer and has a plurality of predetermined
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contact areas ~or receiving and transmit~ing electrical signals
and a sisnal distribution system extending from the contact
areas to the terminal end of the device.
The flexible and disposable belt device is further provided
with an inner non-conductive insulation layer which is affixed
and coextensively disposed to the non-conductive base layer for
insulating thè signal distribution system from the body of a
patient. The inner non-conductive layer has a plurality of
predetermined apertures ~or exposing the conduction network
contact areas, and has a void area at the terminal end for
exposing the signal distribution system.
Conductive adhesive members are affixed and coextensively
disposed at each predetermined aperture of the inner
insulation layer for communicating with the contact areas and
the body of a patient, for transferring electrical signals
therebetween and for holding the device to the patient.
Further provided by the disposable electrode belt device is
at least one conductive shielding layer that iq coextensively
affixed to the non-conductive base layer for reducing
interference with and from the remaining elements of the body
structure, and ~or the electrical grounding of the device. Each
conductive shielding layer is separated by a non-conductive
layer. Each shielding layer is peripherally recessed with
reqpect to each non-conductive layer to minimize the risk of
shorting and patient shock due to device or medical diagnostic
and therapeutic apparatus malfunction.
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Also provided by this invention are belt device body
structures having separable side portions defined by separation
mea~s disposed at predetermined longitudinally extending
locations. The separation means are disposed within and between
the conduction network, and one or more contact areas within the
separable side portions are extendable outwardly from the device
body structure. The body structure is also provided with
anatomical placement reference means to coordinate the contact
areas relative to predetermined body locations of a patient.
Also provided by the invention are device embodiments having
reusable and disposable portions, electrode belt body structures
constructed of particular ~lexible materials and having
predetermined contact areas ~or specific applications.
Finally, provided by this invention are methods for
receiving and transmitting electric current and voltage to a
patient which involve specific steps as well as the use of
particular flexible and disposable electrode belt device
embodiments ~or certain uses.
These and other benefits of this invention will become clear
from the ~ollowing description, by referense to the draNings~
13RIEF DESCRIPTION OF THE DRAWIN&S
FIG. 1 is a frontal view of the flexibIe and disposable
electrode belt of this invention shown in an operative position
on the chest o~ a patient;
~ IG. 2 is a frontal view o~ another embodiment of the
pres;ent invention also shown in an operative position on the
chest of a patient with its extendable side member~ fully
extended and which also shows yet another embodiment of the belt
in an operati~e position on the arm and leg of the patient,
FIG. 3 is a view oP yet another embodiment of the present
inYention where the electrode belt is shown placed both on the
chest and back skin surfaces of a female patienti
FIG. 4 i~ a plan view of the present invention illustrating
its patient contact surface and showing a predetermined electrode
positioning pattern, and further showing two side members
extended from its main body structure;
FIG. 5 is a partial perspective view of the layered
structure of the invention having a corner portion peeled back
for clarity, and being partially in section to show its elements;
FIG. 6 is a cross-sectional view of the present invention
which illustrates its layered body structure;
FIG. 7 is a perspective view of the terminal end of the
pre~ent invention and which is shown enlarged for clarity;
FIG. 8 is a plan view of the patient contact surface of the
present invention showing a predetermined electrode positioning
pattern;
FIG. 9 is a plan view of the patient contact surface of the
present invention showing another predetermined electrode
positioning pattern;
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FIG. 10 is a plan view of the present in~ention showing an
embodiment for u~e on the Qhest of a ~emale patient;
FIG. 1t is a partial perspe¢tive view of another embodiment
o~ the in~ention showing a disposable component for use with a
reusable component; and
FIG. 12 is a partial perspective view of another embodiment
o~ this invention showing a Qeparated structure having reusable
and disposable components~
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Fig. 1 shows the flexible and disposable electrode belt 10
in an operative position on the precordial region of a patient
11. It i3 comprised of a body structure 12 which has a proximal
end 30 and a terminal end 19. A pair of anatomical alignment
means 13 and 14 are located at its proximal end 30. The flexible
and disposable electrode belt 10 is used to receive and transmit
an electric current or voltage from and to the body of a patient.
The terminal end 19 o~ the body structure 12 of belt 10 is
connectable to a connector 15 of a cable set 16 of a
complementary diagnosti¢ or therapeutic device 17. Additionally,
as is shown in Fig. 1, the device 17 may be communicatively
linked to a printer 18 to receive hard copy.
Fig. 2 shows other embodiments of the ilexible and
disposable electrode belt 20, 24 and 25. The adjustable belt 20
has extendable side members 22 partially separable from the main
body 21 ~or pla¢ement at locations outside the precordial region
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of a patient 11. Alternate embodiments of the bel~ 24 and 25 may
be placed on the limbs or other par~s of the body o~ a patient
for various therapeutic and diagnostic purposes. Fig. 3 shows
the belts 26 and 27 used simultaneously on the chest 29 and bac~
28 of a patient to receive and transmit electric current or
voltage.
Fig. ~ shows the flexible and disposable electrode belt 20
having a generally reotilinear, layered, composite main body 21
with a proximal end 30 and a terminal end 19. Located at the
proximal end 30 of the belt 20 are a number of electrodes 35.
Anatomical alignment means 13 are disposed on the top lateral
edges of the device 20. The alignment means 13 and 14 are a
notch 13 or aperture 14 through all layers of the device 20 or
printed reference lines or the like. Anatomical reference
aperture 14 is specifically designed for alignment with the
xiphoid process.
Disposed toward the lateral edges of the proximal end 30 of
the main body 21 are adjustable side members 22. The side
members 22 consist of a layered, composite structure of the same
elements o~ which the main body 21 is constructed, af~ixed to the
main body 21 permanently at one end. They may be remo~bly
a~fixed by translayer perforations on at least one lateral edge
or loose as shown, i.e., as having previously been cut during
manufacture. Each side member 22 contains an electrode 33.
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Both the main body and side member eleetrodes 35, 33
transmit and receive electric signals to and from the terminal
end 19 of the belt 20 by way of a current distribution member or
lead strip 34. The lead strips 34 and electrode portions,
discussed below, are o~ a flexible conductive ink compound
having a conductive filler having Silver, Aluminum, or compounds
thereof, or of a 3imilarly suitable material. Preferably, the
ink deposit is of a preselected conductivity to provide a certain
total lead strip resistance so that each strip 34 serves as a
current limiter to protect a patient from shock due to
malfunction of the device 20 or of a complementary medical
device. A conductive filler compo~ition resulting in a lead
strip resistance of approximately 1000 ohms allows for signal
tran~miQQion throughout the lead strip 34 and also providing the
abo~e-mentioned current limlter qualities as is prefered for thi~
invention. The lead strips 34 extend from each electrode 33, 35
to the terminal end 19, where they are aligned generally in a
parallel fashion as shown by leads 49 and are uniformly spaced
apart approx~mately 0.050 inch.
Referrlng to Figs. 5 and 6, the belt 10 is illu trated to
have a plurality of electrodes 35. Each electrode 35 has a
conductive grid 56 which is comprised of a matrix- of
approximately 0.050 inch wide lines 42 of conductive ink compound
applied to an insulation and base support layer 44 preferably by
means of a silk screen process. The conductive ink is a silver
compound generally used in the electronics industry. Each matrix
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line is approximately 0.050 inch wide. This width i~ optimal ~or
good conductivity. The conductive ink compound used in the
matriix lines 42 is generally the same as that utilized in the
lead strips 34. Apertures 43 in the conductive ink matrix 42
form the grid configuration. The grid configuration itself is
provided both for proper electrical function as well as to reduce
the amount of ink used while obtaining maximum function. The
in~ulation and base support layer 44 is preferably comprised of
a thin approximately 0.001 inch polyester laminate and serves as
both a base for the silk screened conductive ink used in the
matrix lines 42 and lead strips 34, and as an electrical
insulator.
Another component of the electrode 35 is an aperture 41 in
an inner patient insulation layer 40. The inner patient
insulation layer 40 has a thin non-conducti~e sheet of polyester
coextensive with and bonded to the insulation and base support
layer 44. Bonding may be accomplished by an adhesive or a
lamination process. It serves to insulate the patient's skin ~rom
electric current or voltage in the electrode lead ~trips 34. The
inner patient insulation layer aperture 41 is provided to expose
the conductive grid 56 ~or contact.
As is further shown, conductive gel pads 39 are provided as
conductive interfaces betweèn the conductive grids 56 and a
patient's skin. The gel pads 39 are provided to make contact
with a patient's skin rather than having direct contact with the
conductive ink because the latter provides a less reliable signal
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or input~ Moisture from the skin in direct contact with the
ele~trode may cause changes in conductivity and, therefore, may
lead to erroneous bioelectric data. The gel pad~ 39 maintain
direct electrical contact with the skin, to reduce variations in
conductance, and it permits this contact for long periods of
time. The gel pad 39 is a conductive, gelatinous compound which
also has adhesive properties for contoured adhesion to the body
o~ a patient and the communicating portions of the belt body
structure. Compounds having these characteristics have been
developed by Ninnesota Mining and Nanufacturing, Medtronic Inc.
and Lec Tec (Sync~ra), corporations that are located in
Minnesota, U.S.A. Generally, these compounds are gelatenous,
have adhesive qualities and have low resistivities. Each gel pad
39 is pLaced in such a position so as to cover and fill into the
entire inner patient insulation layer aperture 41. For example,
gel pad 39 generally fills the apertures 43 in the grid electrode
con~iguration 42, shown in Fig. 6. Alternatively, a layer of the
conductive, adhesive gel, generally coextensive with the proximal
end 30 o~ the body 12 o~ the device 10 may be used, ~or example,
gel layer 53 in Figs. 11 and 12. The gel pad 39 has a pressure-
sensitive, moisture resistant adhesive property which causes the
entire belt 10 to adhere to a patient's skin, thus obviatin~ the
need for cumbersome straps or other retainers.
The elements of the belt 10 described heretofore are
shielded ~rom outqide electrical interference by a shielding
layer 46. The shielding layer 46 also prevents interference
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fro~l th~ de~ice 10 with other medical diagnostic and therapeutic
de~ices. T~e shielding layer 46, in addition to being a general
qtat.ic shield, al~o ~erves to ground the belt tO. It i3
comprised of a conductive substance such as a ~ilver or aluminum
composition, for example. In the present invention, the
shielding layer 46 is preferably thin and is generally
coextensive with and bonded to the insulation and base support
layer 44. Bonding may be accompli~hed by a non-conductive
adhesive layer 45 o~ a standard acrylic adhesi~e composition, for
example, permanently applied to the outer side of the insulation
and base support layer 44, or by a lamination process.
The composite layers of the device tO e~fectively form a
capacitor comprising a first plate, a second plate and a
dielectric. The first plate is the conductive grid 56. The
shielding layer 46 acts as the second plate while the insulation
and base support layer 44 acts as the dielectric between the two
plates. These three elements of the device 10 in conjunction
with the gel pad 39 resistance and a patient's skin resistance
provide a low pass filter which shunts high frequency
interference to ground. The e~ectiveness o~ this con~iguration
is dependent upon grid 56 dimensions which have optimally been
found to be about 1 inch square in conjunction with an
approximately 1 mil. thick insulation layer.
The shielding layer 46 is bonded to an outer insulation
layer 47 that is generally coextensive therewith. The outer
insulation layer 4~ is comprisèd of a non-conductive polyester
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laminate, for example. The outer insulation layer 47 serves,
general}y, to protect the integrity of the other elements of the
belt 10. In the preferred embodiment, the shielding layer 46 is
metalized to the outer insulation layer 47, but bonding may be
made by an adhesive or by a lamination proce~s. Alternatively,
it is within the purview of this invention to have the shielding
layer 46 dire~tly deposited onto the base support layer 44, a
process known in the art~
The shielding layer 46 is preferably recessed inwardly at
its outer boundaries to minimize the risk of electrical shorting
and patient shock in the event of device 10 failure. In this
configuration, insulation and base support layer 44 and outer
insulation layer 47, instead of being coextensive with the
shielding layer 46, overlap the shielding layer 46 slightly,
approximately 0.1 inch for example, as shown by "X" in Figs. 5
and 6, ~nd thus permits the bonding of base support layer 44 to
outer insulation layer 47 to further insulate the belt 10.
A sanitary release liner 38 is provided to protect the belt
10, particularly the patient contact surface of the gel pads 39,
while in storage and during handling. It is generally coextensive
with the shielding layer 46~ The sanitary release liner 38 is
comprised o~ a paper base which is preferably coated with
silicone, or other similarly ef~ective release agent, on one side
for contact with the gel pads 39. The adhesivity of the gel pad
39 acting in concert with the coating allows the sanitary release
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liner 38 to adhere and re-adhere, subsequent to removal, to the
bod~ structure of belt 10.
Fig. 7 shows the terminal end 19 of the belt 10 in an
expanded or exploded view. The terminal end 19 includes a
rectilinear extention of the proximal end 30 of the main body 12
smaller in width than said proximal end 30 that is a composite of
the various layers ~hich comprise the main body 12 o~ the belt
10, an inner patient insulation layer terminal aperture 48, a
passive polarization means 36, a ground contact 37, an active
polarization means 57 and a plurality of exposed lead strips 49.
These various elements cooperate generally to provide a terminal
end 19 for hook up and communication with complementary medical
devices.
The ground contact portion 37 is comprised of an exposed
area, as shown in Fig. 7, of shielding layer 46 to expose the
insulation and base support layer 44 and the adhesive layer 45.
Thus, the exposed area 37 of the shielding layer 46 directly
contacts a complementary ground connection of a medical device.
The inner patient insulation layer terminal void 48 is a
terminal line of demarcation in the inner patient insulation
layer 40 located approximately at the mid-point or intermediate
in the length of the terminal end 19 itself such that the ground
contact area 37, active polarization means 57 and the electrode
lead strips 49 are exposed for contact with complementary
elements of medical devices used in conjuntion therewith.
~ he passi~e and active polarization means 36 and 57 are
provided to in~ure that the terminal end 19 is properly mated to
its complementary medical device. In the preferred embodiment,
the pas~i~e polarization means 36 is a channel in the inner
patient insulation layer terminal 48 disp~osed toward one lateral
edge of the terminal end 19 and extending into the inner patient
insulation layer 40 exposing the insulation and base support
layer 44 Por visual inspection. It is provided to allow operator
identiPication oP the electrode lead strip 4g pattern Por mating
with complementary elements of medical devices used in
conjunction with the device 10. The active polarization means 57
is pro~ided to insure correct alignment of the exposed lead
strips 49 with the above-mentioned complementary elements. It is
prePerrably a notch in the terminal end 19 such that mating is
impossible if the belt-to-connector orientation is reversed.
Figs. 8 and 9 ~how predetermined electrode 35 locations on
the ~lexible and disposable electrode belts 10 and 26 which are
respectively designed for use on the precordial (Fig. 8) and back
body (Fig. 9) portions of a patient. For example, the body
structure of belt 10 i5 approximately 6 1/2 x 15 inches in size
excluding its terminal end t9.
Fig. 10 shows an embodiment of the Plexible and disposable
electrode belt 27 for use on the chest of a female patient. It
has breast apertures 51 and 52 in its main body 50 as well as
predetermined electrode 35 positions.
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A replacement pa~ient inter~ace structure 54 is shown in
Fig. 11 and which is useable to produce a partly disposable
~tructure 60 a~ shown in Fig. t2. The disposable structure 54
has release liners 55 and 58 attached to its opposing body
3ides to ~aintain asepsis and to protect it during storage. To
attach the replacement patient interface structure 54 to a
reusable portioh 61 as shown in Fi~. 12, liner 58 is removed.
The exposed side o~ the patient interface structure 54 i~ then
attached to the main structure 61 by aligning and placing the
replacement patient interface structure 54 on the inner patient
insulation layer 40 of the main structure 61. A slight pre~sure
is then applied to either sur~ace which will cause proper
adhesion. The remaining sanitary release liner 55 is then
removed to expose the conductive gel layer 53 and the device 60
is ready for another use.
Fig. 12 illustrates the flexible and disposable elec~rode
belt 60 having a reusable portion 61 and the disposable portion
62 adhesively secured thereto. The reusable main structure 61 is
compriqed generally of the same elements a3 belt 10 shown in
Figs. 5 and 6 except ~or the conductive gel pads 39 and the
release liner 38. The disposable structure 62 tPatient interface
structure 54 of Fig. 11 with liners 55 and 58 removed) is
generally coextensive with the proximal end 30 of the belt 60 and
i~ comprised o~ a main structure release layer 63 and a
coextensive conductive adhesive gel layer 53. In use, the
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disposable pa~ient inter~ace structure 62 is placed 90 that its
nonconductive main structure release layer 63 i~ in contact with
the inner patient insulation layer 40 o~ the main structure 61.
The patient inter~ace structure 62 has apertures 64 at
predetermined locations corresponding with the conductive ink
grids 56 to expose the gel layer 5~. The adhesive contact
between the gèl layer 53 and the conductive ink grids 56,
therefore, serves to hold the main structure 61 and the patient
inter~ace structure 62 together during use.
The device 60 is used in generally the same way as the other
embodiments previously discussed. It is placed on the body of a
patient and attached to a therapeutic or diagnostic medical
apparatus by removing the sanitary release liner 55 from the gel
layer 53 of the patient inter~ace structure 62.
Since adhesive contact is limited to certain specific
locations, the two structures are easily separated subsequent to
use on the body of a patient by lifting tab 65 o~ the patient
interface structure 62. The patient interface structure 62 may
then be disposed of. Thus, embodiment 60 allows for multiple
uses o~ its main structure 61.
A method o~ receiving and transmitting electric current or
voltage from and to a patient is also provided by this invention.
Initially a set of patient body locations are selected for
testing or treating purposes. A belt device 10 is provided
having a body structure with electrode contact areas located
therein to correspond with the Qet of predetermined patient body
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locations. After the sanitary release liner 38 i~ removed the
belt structure is placed using its anatomical alignment means 13
and t~ to the patient's body.
The terminal end 19 of the belt 10 body structure 12 is
matingly connected to connector 15 o~ cable set 16 of a
diagnostic or therapeutic device 17. After the diagnostic or
therapeutic procedure is performed, the belt device body is
removed from the patient and discarded.
Although the electrode belts o~ this invention are
disposable, it i9 within the purview of the invention to provide
belt structures that have disposable portions which cooperate
with reusable portion.
As shown by the belt embodiments of Figures 4, 8, 9 and 10,
the belt of this inyention, utilizing the flexible layered body
structure and having the printed conduction network therein,
permits a broad range of electrode 35 and electrode 33 placements
so that a belt device can be easily manufactured to correspond
with any predetermined patient body locations.
As many changes are possible to the embodiments of this
invention utilizing the teachings thereof, the descriptions
aboYe, and the accompanying drawings should be interpreted in the
illustrati~e and not in the limited sense.
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