Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1999-09-24
2002-04-09
Sykes, Angela D. (Department: 3737)
Surgery
Diagnostic testing
Cardiovascular
C600S509000, C600S515000, C600S516000, C600S517000, C600S518000, C600S519000, C600S521000, C600S523000, C600S524000, C600S544000, C600S546000
Reexamination Certificate
active
06370423
ABSTRACT:
FIELD OF THE INVENTION
The instant invention relates to improved methods and systems for analysis of dynamic electrocardiograms and other similar waves of biological origin with the purpose of facilitating improved diagnosis of pathological states in human and veterinary medicine. More particularly, the instant invention advantageously uses advances in sound wave technology to improve the recovery, preservation, enhancement and cost effective analysis of biological signals to aid research as well as medical and veterinary diagnosis.
BACKGROUND OF THE INVENTION
Coronary heart disease is the main cause of death in many countries. About 50% of those affected do not reach the hospital due to poor recognition of the disease before a cataclysmic, often terminal event has occurred. The present invention facilitates improved recognition of myocardial ischemia in and out of the hospital by lay people with minimum training. Once the nature of the event is recognized, prompt treatment can then be obtained with a net effect in the decrease of morbidity and mortality and thereby providing substantial gains in life span and in quality of life.
Heretofore, visual analysis of the ambulatory electrocardiogram, in its original analog format, has been and remains unsurpassed and it is superior to any and all current computerized forms of analysis. Visual analysis is a very time consuming (hence costly) process, which required an operator with intimate knowledge of electrocardiography and cardiology. For this reason the use of visual analysis has been limited to academic research and it has not been possible to extend its benefit to patient care in the community. The instant invention overcomes this problem and enables identification of the abnormal patterns by any person with normal intelligence with a minimum (few hours) amount of training in the recognition of the discrete visual patterns which are repetitive between and within patients.
The instant invention, referred to herein as the Computerized Visual Analysis Technique or “CVAT”, generally relates to the use of state-of-the-art electronics, computer hardware and software and forward looking signal analysis principles of technology for the evaluation of biological signals obtained from isolated cells, tissues, human and animal species to aid research and diagnosis of medical and veterinary disease states. CVAT can be used to process biologic signals such as, but not limited to: 1) the electrocardiogram in all it's forms, and in particular, the continuous electrocardiographic signal such as that obtained with the Holter technique or during on-line, real time monitoring of a patient; 2) the electroencephalogram; 3) the myogram; 4) the phonocardiogram; and 5) Respiratory sound waves including their correlation with the electrocardiogram and encephalogram to diagnose sleep disorders in the hospital and in out of hospital settings.
CVAT remedies major limitations of the current Holter analysis paradigm which is useful only to detect gross arrhythmia on the 24-hr electrocardiogram (ECG). Current computerized analysis of the ambulatory ECG is done without due regards for protection of the integrity, fidelity, resolution or dynamic range of the analog signal recorded. The current methods are unable to reliably detect ambulatory ischemia or risk for potentially lethal arrhythmia. Such risks are not detectable in a cost-effective manner with prior art techniques. These shortcomings of the prior art have a significant impact on cardiovascular morbidity and mortality. CVAT remedies the failure of the current methodology by making full use of the valuable information encoded in the ambulatory electrocardiogram. By failing to disclose evidence of risks for catastrophic events, current Holter analysis lulls clinicians into the falsehood of absence of evidence misrepresented as evidence of absence of potentially lethal risks. Consecutive obsolete methodologic steps in current Holter analysis severely diminish the quantity and degrade the quality of the signal encoded in original Holter recording media.
Mass screening for patients silently at risk for potentially lethal cardiovascular events could save hundreds of thousands lives in the United States alone. Well done ambulatory ECG monitoring is the only method able to detect transient myocardial ischemia and spontaneously occurring electrical alternans. More than half of the myocardial infarcts and sudden cardiac deaths happen without any prior history of cardiac disease. The instant inventor has determined that these occult and lethal risks can be detected and lives saved if Holter analysis is done with all the resources made available by the fast advances constantly made in signal analysis and computer technology.
As many as 80 to 100% of the myocardial ischemic episodes in a patient can be asymptomatic or have uncharacteristic manifestations known as “anginal equivalents” by cardiologists but frequently undetected by non-cardiologists. Silent and or uncharacteristic ischemic events are common especially in females, diabetics, hypertensives, smokers, hypercholesterolemics, etc. Endothelial cell dysfunction and occult coronary heart disease are frequently hidden pathophysiologic causes of catastrophic or lethal cardiac events.
Silent ischemia, especially that which is not induced by physical stress, can be detected only by ambulatory ECG. However, today, the only reliable form of Holter analysis is visual scanning of the magnetic tape itself, not the “over reading” of the expunged and distorted digital file which misrepresents the original signal. Visual analysis by an expert electrocardiographer is a very time consuming method used only by highly motivated experts in research programs. Due to time and cost involved, visual analysis of the analog signal cannot be applied to clinical practice or mass screening of at risk population with known methods. To detect ischemia, special attention must be paid to microvolt range changes in the ECG, which are not preserved or duly analyzed by current Holter algorithms. There is a need in the art to develop an improved method of Holter analysis that can be made cost effective by not requiring highly sophisticated operator skills. In accordance with the invention, preservation of the signal integrity, dynamic range, fidelity and resolution in the time and voltage domains are of paramount importance for accurate diagnosis of electrocardiographic abnormalities. These considerations are literally of vital importance especially regarding the microvolt region of the ECG where the ventricular repolarization is encoded.
The current computerized methods of Holter analysis use communications engineering techniques and thoroughly obsolete computer hardware and software. Communications engineering paradigms and techniques are best limited to the evaluation of non-biological signals where reproducibility and repetition of waves and other phenomena are the norm. Biologic signals, such as the electrocardiogram, arise from complex biological entities where individuality, constant variation and irreproducibility are expected. A major drawback of engineering autocorrelation is that it is sensitive to waveform changes in the time domain (X-axes) and poorly sensitive to changes in the voltage domain (Y-axes). In current Holter analysis, autocorrelation is wrongly applied to a small sample of degraded biological signal with poor dynamic gain which magnifies the limitations of autocorrelation to recognize voltage changes. Non-biological techniques used to analyze biological data yield, at best, mediocre results, which become poor when analysis is done using a distorted, minuscule fraction of the original signal recorded.
The present invention remedies the deficiency of the current art by completely turning away from over reliance in engineering paradigms not applicable to biology and technology and methodology which has long become obsolete. Rather than using autocorrelational techniques, CVAT analyzes morphology, Avisual patterns and internal harmony in the time intervals. Since i
Guerrero Juan C.
Guerrero Juan R.
Nixon & Vanderhye P.C.
Oropeza Frances P.
Sykes Angela D.
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