Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2000-12-29
2003-10-21
Wolfe, Willis R. (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
C600S382000, C600S515000
Reexamination Certificate
active
06636761
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a method and apparatus for generating a twelve-lead electrocardiogram (ECG) from a plurality of fewer than ten electrodes for attachment to a patient in the standard ten-electrode, twelve-lead ECG positions.
A standard, resting ECG is acquired with ten electrodes. Four of the ten electrodes are placed on the patient's limbs. Six of the ten electrodes are attached to the patient's chest over the heart. The signals acquired by the ten electrodes are amplified and processed to generate twelve channels of ECG data. The twelve channels or leads are generally split into two groups—the frontal plane leads (I, II, III, aVR, aVL, aVF) and the horizontal plane leads (V
1
, V
2
, V
3
, V
4
, V
5
, V
6
).
A standard, resting ECG has several limitations. First, the six electrodes attached to the patient's chest inhibit the clinicians access to the patient's chest. Second, clinicians may not be able to attach all six chest electrodes due to wounds or bandages on the patient's chest. The electrodes, leadwires, and amplifiers necessary to acquire twelve channels of ECG data increase the cost of the ECG machine. Fourth, the amount of data representing twelve channels of ECG generally exceeds the maximum amount or bandwidth that typical telemetry units are able to transmit.
U.S. Pat. No. 4,850,370 provides a solution to some of the above-described limitations. The '370 Patent discloses a method of sensing and analyzing the electrical activity of the human heart by sensing the voltage signals generated by the heart between four electrodes located at key positions on the surface of the subject's body. A signal processing means produces electrocardiographic signals corresponding to the lead signals of a twelve-lead electrocardiogram.
FIG. 3
illustrates the electrode placement for the method of generating a twelve-lead ECG from four electrodes as disclosed in the '370 Patent. The four electrodes are designated as E, A, S, and I (hereinafter referred to collectively as the “EASI electrodes”). The E electrode is located at the front midline over the lower end of the sternum. The A electrode is located at the left mid-axillary line. The S electrode is located at the front midline over the upper end of the sternum. The I electrode is located at the right mid-axillary line.
The EASI electrodes are coupled to a signal processor (not shown) having a first stage and a second stage. The first stage of the signal processor does not generate the twelve-lead ECG, but rather generates xyz vectorcardiographic signals. The twelve-lead ECG is then derived from the xyz vectorcardiographic signals in the second stage of the signal processor. As a result of the two stage signal processing, each of the twelve leads generated from the EASI electrodes are mathematically generated. In other words, none of the leads are the same as the leads that would be generated from the electrical signals of a standard ten-electrode, twelve-lead ECG.
The method of the '370 Patent has several limitations. First, the four electrodes are placed in non-standard positions, i.e. positions different from the electrode positions for a standard ten-electrode, twelve-lead ECG. This requires clinicians to be trained specifically for the method of the '370 Patent. Second, twelve leads of ECG data are generated, but all twelve leads are generated mathematically. None of the twelve leads in the method of the '370 Patent are the same as the leads that would be generated from a standard ten-electrode, twelve-lead ECG. Rather, all twelve leads are mere approximations of the leads of a standard ten-electrode, twelve-lead ECG. Third, two of the four electrodes are placed directly over the sternum. The sternum is cracked for all open chest surgeries in a procedure called sternotomy. Thus, the clinician may not be able to attach the two electrodes directly over the sternum due to sternotomy wounds and bandages.
SUMMARY OF THE INVENTION
In light of the limitations described above, a need exists for a method and apparatus for generating a twelve-lead ECG from less than ten electrodes for attachment to a patient in the standard ten-electrode, twelve-lead ECG positions.
Accordingly, the invention provides a method and apparatus for generating a twelve-lead ECG from fewer than ten electrodes for attachment to a patient in at least some of the standard ten-electrode, twelve-lead ECG positions.
The apparatus is a device for acquiring and processing electrical signals produced by a patient's heart. The device includes fewer than ten electrodes for attachment to the patient. Each electrode is attached in a respective one of the standard ten-electrode, twelve-lead ECG positions. The device includes a signal processor connected to the electrodes. The signal processor acquires electrical signals from the electrodes and generates a twelve-lead ECG from the electrical signals. The signal processor generates less than twelve of the leads mathematically.
For the method of the invention, a plurality of less than ten electrodes are attached to the patient. Each electrode is attached in a respective one of the standard ten-electrode, twelve-lead ECG positions. Electrical signals are acquired from the electrodes and a twelve-lead ECG is generated from the acquired electrical signals. But not all twelve leads are generated mathematically.
The device employs multiple-linear regression using expansion-coefficient equations to mathematically generate fewer than twelve of the leads. The expansion-coefficient equations are determined either from ECGs from a hospital's general population, from a sub-population of the hospital's general population, or from ECGs previously acquired from the patient. The invention employs multiple-linear regression to generate the leads that are missing due to the use of fewer than ten electrodes. Stated differently, some of the leads (for the twelve lead ECG) are generated from a standard electrical manipulation of the signals acquired from the electrodes, while the remaining leads are generated mathematically by a signal processor.
The invention further includes a telemetry unit to acquire electrical signals from the plurality of less than ten electrodes and to transmit the electrical signals to the signal processor to generate a twelve-lead ECG.
It is an advantage of the invention to reduce the number of electrodes, leadwires, and amplifiers necessary to acquire a twelve-lead ECG while still employing some of the standard electrode positions commonly known to clinicians.
It is another advantage of the invention to provide a method of generating a twelve-lead ECG without generating all twelve leads mathematically.
It is still another advantage of the invention to provide a method of electrode placement that allows for better access by clinicians to the patient's chest.
It is still another advantage of the invention to provide a method of electrode attachment that avoids electrode placement over the sternum in order to avoid sternotomy wounds and bandages.
It is still another advantage of the invention to reduce the bandwidth required to transmit the acquired electrical signals representing the patient's ECG from a telemetry unit to a signal processor.
It is still another advantage of the invention to provide a telemetry system capable of monitoring the ECG of more than one patient.
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patent: 4850370 (1989-07-01), Dower
patent: 5058598 (1991-10-01), Nicklas et al.
patent: 5711304 (1998-01-01), Dower
patent: 5794624 (1998-08-01), Kwong
patent: 5913828 (1999-06-01), Russell
patent: 6006125 (1999-12-01), Kelly et al.
patent: 6167258 (2000-12-01), Schmidt et al.
patent: 6505067 (2003-01-01), Lee et al.
patent: 2002/0035334 (2002-03-01), Meij et al.
patent: 2002/0045837 (2002-04-01), Wei et al.
patent: 2002-34943 (2002-04-01), None
GE Medical Systems Information Technologies Inc.
Michael & Best & Friedrich LLP
Wolfe Willis R.
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