Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
1999-04-21
2001-07-10
Kamm, William E. (Department: 3737)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C128S903000
Reexamination Certificate
active
06259939
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to an electrocardiograph and electrocardiography electrodes holder used to monitor the electrical activity produced by the human heart and, more particularly, to a holder for accepting electrodes useful in electrocardiography (ECG) and for holding at least a portion of a electrocardiograph electronics.
The electrical potential generated by the heart appears throughout the body and on the surface of the body. Such electrical potentials are helpful to physicians in evaluating the heart's condition. Six basic leads, I, II, III, AVR, AVF and AVL, make up the frontal plane ECG. These are derived from the various permutations of pairs of electrodes with one electrode located on the right arm, one located on the left arm, and two located on the legs.
When physicians examine the ECG in the transverse plane, they utilize chest leads. In this procedure, electrodes are placed at various anatomically defined positions on the chest wall, and are connected to a cardiometer (ECG monitor and/or recorder). These leads are known as precordial ECG leads.
The position of these precordial lead electrodes, designated V
1
through V
6
, is as follows: V
1
is located on the fourth intercostal space at the right sternal margin; V
2
is located on the fourth intercostal space at the left sternal margin; V
3
is located midway between electrode V
2
and electrode V
4
; electrode V
4
is located on the fifth intercostal space at the mid-clavicular line; electrode V
5
is located on the same level as electrode V
4
and on an anterior axillary line; and electrode V
6
is located on the same level as electrode V
4
and on a mid-axillary line.
Thus, typically data derived from ten different electrodes serves to derive and analyze electrocardiography data.
Because the surface of the heart is in close proximity to the chest wall, each precordial electrode and its accompanying lead primarily records the electrical activity or potential of the cardiac musculature immediately beneath the electrode's position. Therefore, to achieve proper results, the medical technician, particularly when measuring precordial ECG, must be careful to place each chest electrode at its precise location on the chest.
When using individual electrodes, this procedure can prove to be inconvenient, time consuming and sometimes inaccurate. Furthermore, if for some reason a precordial ECG recording has to be repeated on the same patient, the probability of locating individual electrodes at the same position is slight.
For at risk individuals which preferably periodically conduct self ECG testing at home and/or for individuals under actual pain this task is altogether impossible.
U.S. Pat. Nos. 4,328,814 and 5,341,806 discloses an ECG strip in which individual electrodes are physically connected to one another through bundled conductors terminating in a connector block. Although perhaps more convenient than separate electrodes, this invention also requires a medical technician to individually place each of the electrodes on the body of the patient, thereby consuming valuable time and rendering measurement repeatability subject to inaccuracies because of improper electrodes placement. The bundling of conductors in these invention does not materially improve positioning of the electrodes, as each must be individually placed onto the patient's chest.
U.S. Pat. No. 4,583,549, teaches an ECG electrode pad comprising a flexible non-conductive pad with a plurality of ECG electrodes positioned thereon to correspond with the anatomically correct placement for precordial ECG electrodes to be utilized in electrocardiograph monitoring or recording. Other related art is disclosed in U.S. Pat. Nos. 5,507,290; D0313,652; 5,327,888; 5,042,481; 4,852,572; and 4,763,660. The devices disclosed in these U.S. patents suffer one or more limitations, such as, lack of precise repositioning ability, failure to intimately follow chest curvatures and/or cross talk between ECG leads. These devices are at all not applicable for self ECG testing.
In addition, the prior art fails to teach an electrocardiograph integrated into an electrocardiography electrodes holder, which combination forms an integrated device, diminishing the need for cord connection.
There is thus a widely recognized need for, and it would be highly advantageous to have, an electrocardiography electrodes holder which includes the electrocardiograph electronics and which is devoid of the above limitations.
SUMMARY OF THE INVENTION
According to the present invention there is provided an electrocardiography monitoring system comprising (a) an electrocardiography electrodes holder including (i) a flexible nonconductive flattened article having a fixed precordial configuration, the article featuring a first plane and an opposite second plane, the article serving for holding electrocardiography electrodes; (ii) electrocardiograph electronics attached to the article and in electrical communication with the electrocardiography electrodes; and (iii) a transmitter attached to the article, the transmitter communicating with the electrocardiograph electronics and serving for communicating electrocardiograph signals to a compatible receiver; (b) a receiver compatible for operation with the transmitter; and (c) a computer communicating with the receiver for storing, presenting and/or analyzing the electrocardiograph signals.
According to further features in preferred embodiments of the invention described below, the electrocardiography electrodes holder further includes (iv) six electrocardiography electrode accepting holes formed in the flexible nonconductive flattened article traversing the planes for respectively engaging six electrocardiography electrodes, each of the six electrode accepting holes featuring a conductive inner circumference, the electrode accepting holes being located in a predetermined pattern effective for the precordial electrocardiography recordings; (v) six conductive recording lines electrically communicating with the conductive inner circumference of the six electrode accepting holes, the six conductive lines being on the second plane of the flexible nonconductive flattened article; and (vi) a first set of six conductive grounding lines, each being associated with one of the six conductive recording lines for electrically shielding the six conductive recording lines.
According to still further features in the described preferred embodiments the first set of the six conductive grounding lines are on the second plane of the flexible nonconductive flattened article.
According to still further features in the described preferred embodiments the holder further includes (vii) a second set of six conductive grounding lines being on the first plane of the flexible nonconductive flattened article, each being associated with one of the six conductive recording lines for further electrically shielding the six conductive recording lines.
According to still further features in the described preferred embodiments the second set of six conductive grounding lines are on the second plane of the flexible nonconductive flattened article.
According to still further features in the described preferred embodiments the holder is designed such that when the holder is used for the precordial electrocardiography recordings the first plane faces a chest of a user.
According to still further features in the described preferred embodiments the predetermined pattern effective for the precordial electrocardiography recordings includes two of the electrode accepting holes equidistantly positioned on opposite sides of a user's sternum, whereas the four remaining electrode accepting holes are located at predetermined locations relative to the two electrode accepting holes in an anatomically correct placement for sensing precordial electrocardiography signals from the user's body, at locations corresponding to a first location at a fifth intercostal space along the mid-clavicular line, to a second location about mid-way between th
Friedman Mark M.
Kamm William E.
R. Z. Comparative Diagnostics Ltd.
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