Electrocardiogram electrode patch

Details Electrocardiogram electrode patch Electrocardiogram electrode patch

2001-04-13

2002-09-17

Cohen, Lee (Department: 3789)

Surgery

Diagnostic testing

Structure of body-contacting electrode or electrode inserted...

C600S391000, C600S392000, C600S393000

Reexamination Certificate

active

06453186

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to an electrocardiogram (ECG) electrode patch and more particularly to an ECG electrode patch for attachment to a neonatal or infant patient.
ECG devices are medical devices that measure and record electrical potentials generated by a patient's heart. The ECG devices convert the electrical potentials into electrical signals or ECG data. The ECG data is displayed in the form of ECG waveforms on a display monitor or on a continuous stream of paper, called an ECG tracing. Generally, the ECG data is also stored electronically in a hospital storage facility.
For a standard twelve-lead ECG, ten electrodes are attached to the surface of the patient's body, with each electrode corresponding to a particular area of the patient's heart. Six of the ten electrodes (V1, V2, V3, V4, V5, and V6) are positioned on the left side of the patient's chest around the heart in order to detect the electrical activity of the left side of the patient's heart. Four of the ten electrodes are positioned on or near the patient's limbs. Specifically, the four limb electrodes are positioned on the right arm (RA), the left arm (LA), the right leg (RL), and the left leg (LL).
To detect the electrical activity of portions of the patient's heart other than the left side of the patient's heart, additional electrodes may be attached to the patient. Three electrodes (V4R, V5R, and V6R), referred to collectively as the right-sided chest leads, may be positioned on the patient's chest to measure the electrical activity of the right side of the patient's heart. Placement of the V4R, V5R, and V6R electrodes on the right side of the patient's chest mirrors the placement of the V4, V5, and V6 electrodes on the left side of the patient's chest.
The three right-sided chest electrodes are often used for neonatal and infant ECG diagnostic and monitoring procedures. The hearts of neonatal and infant patients are anatomically shifted more to the right of the body than the hearts of adult patients. Due to this difference in the anatomical location of the heart, it is necessary to monitor neonatal and infant patient's hearts with right-sided chest electrodes.
A primary concern when preparing a patient for an ECG procedure is the accurate placement of the electrodes. It is critically important that the electrodes be positioned at the positions associated with a standard twelve-lead ECG to ensure that the acquired signals yield universally acceptable diagnostic data. If the electrodes are not positioned properly or if they do not properly contact the patient's skin, the recorded data may be invalid.
Conventional electrodes are positioned individually on the patient with each electrode being coupled to a separate leadwire. For a standard twelve-lead ECG, ten conventional electrodes and ten leadwires are coupled to the patient. When the three right-sided chest leads are also attached to the patient, thirteen conventional electrodes and thirteen leadwires must be coupled to the patient.
Acquiring a multi-lead ECG for a neonatal or infant patient with conventional electrodes has several limitations. Accurately positioning and attaching as many as thirteen conventional electrodes to a neonatal or infant patient can be difficult and time consuming even for a skilled clinician. Conventional electrodes are physically to large to fit on the chest of neonatal and infant patients and do not adhere well to the skin of neonatal and infant patients. Moreover, clipping on as many as thirteen leadwires to the conventional electrodes is difficult because of the close proximity of each of the electrodes. During the positioning and attachment process, the leadwires also have a tendency to become tangled with one another.
Even if each of the electrodes are accurately attached to the patient initially, leadwires often become tangled and electrodes often detach from the patient's chest when the patient moves. These problems are magnified in the case of neonatal and infant patients whose movements cannot be controlled as easily as the movements of adult patients. Since conventional electrodes do not adhere well to the skin of neonatal and infant patients, the electrodes are even more likely to detach from the patient.
Even if the electrodes remain in place and the leadwires remain untangled while a first set of ECG data is acquired, it is difficult to repeat the exact placement of the electrodes in order to acquire subsequent sets of ECG data from the same patient. Clinicians often acquire subsequent sets of ECG data in order to periodically monitor the patient's recovery progress or to periodically monitor the patient's general cardiac health. The electrode placement for the subsequent sets of ECG data must be the same as the first set of ECG data in order to accurately compare the sets of ECG data.
Due to the difficulties in positioning and attaching conventional electrodes and leadwires to neonatal and infant patients to acquire a multi-lead ECG, multi-lead ECGs are acquired from neonatal and infant patients much less often than multi-lead ECGs are acquired from adult patients.
SUMMARY OF INVENTION
In light of the difficulties and limitations described above, a need exists for the easy, accurate, and consistent attachment of a plurality of electrodes to a neonatal or infant patient in order to acquire a multi-lead ECG.
Accordingly, the invention provides an ECG electrode patch for the easy, accurate, and consistent attachment of a plurality of electrodes to a neonatal or infant patient in order to acquire a multi-lead ECG.
The ECG electrode patch for attachment to a neonatal or infant patient's chest includes a substrate and a plurality of at least three electrodes coupled to the substrate. The plurality of electrodes includes at least one electrode capable of measuring the electrical activity of the right side of the patient's heart. The plurality of electrodes may include up to six left-sided chest electrodes, up to three right-sided chest electrodes, and up to four limb electrodes. A plurality of electrical conductors are coupled to the plurality of electrodes and to the substrate.
The ECG electrode patch may also include a plurality of layers including a flexible backing layer, a skin adhesive layer, a plurality of conductive gel layers, and a releasable liner layer. The ECG electrode patch may be coupled to an ECG machine with a single conductor.
The invention includes a method of acquiring a neonatal or infant patient's ECG including the acts of providing an ECG electrode patch, attaching the electrode patch to the patient's chest, and acquiring ECG data. The ECG electrode patch includes a plurality of electrodes, including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart.
It is an advantage of the invention to reduce the labor and time associated with instrumenting a patient for an ECG procedure.
It is another advantage of the invention to ensure the repeatable and consistent placement of electrodes.
It is still another advantage of the invention to minimize the total material cost of a multi-lead ECG procedure.
It is still another advantage of the invention to eliminate the need for individual leadwires.
It is still another advantage of the invention to provide a low-profile detachable cabling system between the plurality of electrodes and the ECG machine.
It is still another advantage of the invention to improve the reliability and integrity of the acquired ECG data.
It is still another advantage of the invention to improve the procedure for acquiring multi-lead ECGs from neonatal and infant patients.
Various other features and advantages of the invention are set forth in the following drawings, detailed description, and claims.


REFERENCES:
patent: 3409007 (1968-11-01), Fuller
patent: 3534727 (1970-10-01), Roman
patent: 3888240 (1975-06-01), Reinhold et al.
patent: 4353372 (1982-10-01), Ayer
patent: 4391279 (1983-07-01), S

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