Measuring and assessing cardiac electrical stability
First Claim
1. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
- altering a physiologic condition of a patient to stress the heart of the patient without applying pacing stimuli directly to the heart;
receiving a physiologic signal representative of activity of the stressed heart; and
digitally processing the physiologic signal to determine a level of alternans in the signal.
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Accused Products
Abstract
The alternans pattern of cycle-to-cycle variability in physiologic waveforms is assessed by applying transducers to a subject, recording physiologic signals, and analyzing the alternans pattern of variation in waveform morphology. Preferred embodiments include methods and apparatus for measuring and assessing alternans in the presence of physiologic stress, such as exercise, in order to induce or increase the amplitude of the alternans, improvements in signal processing to improve the sensitivity and specificity of the analysis, improvements to provide real-time analysis and feedback to the operator conducting the recording of physiologic signals, reduction in the effect of intercycle interval variability on waveform variability, reduction in the effects of respiration on the alternans measurement, improved means for determining the statistical significance of the alternans measurement, handling of abnormal beats such as atrial and ventricular premature beats, choosing of data epochs over which to perform the alternans measurement, using multiple electrodes to improve the accuracy of the alternans measurement, and combining measurement of alternans with other cardiovascular diagnostic tests to facilitate and improve the combined diagnostic capability.
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Citations
152 Claims
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1. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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altering a physiologic condition of a patient to stress the heart of the patient without applying pacing stimuli directly to the heart; receiving a physiologic signal representative of activity of the stressed heart; and digitally processing the physiologic signal to determine a level of alternans in the signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89)
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90. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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receiving a physiologic signal representative of activity of the heart of the patient; digitally processing the physiologic signal to determine a level of alternans in the physiologic signal; and producing a control signal for controlling a physiologic condition of the patient in a manner such that the effects on the physiologic signal of interfering noise sources is reduced. - View Dependent Claims (91, 92)
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93. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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altering a physiologic condition of the patient to stress the heart of the patient without applying pacing stimuli directly to the heart to achieve a heart rate above a predetermined rate; receiving a physiologic signal representative of activity of the stressed heart of the patient; and digitally processing the physiologic signal to determine a level of alternans in the signal. - View Dependent Claims (94, 95, 96)
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97. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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receiving a physiologic signal representative of activity of the heart of the patient; and digitally processing the physiologic signal to determine a level of alternans in the signal, wherein the processing step comprises processing the signal to reduce the effect of noise signals having a frequency at about half of the patient'"'"'s heart rate and noise signals having a frequency at about a submultiple of half of the patient'"'"'s heart rate. - View Dependent Claims (98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109)
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110. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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receiving a physiologic signal representative of activity of the heart of the patient; digitally processing the physiologic signal to determine a level of alternans in the signal, wherein the processing step comprises characterizing at least one portion of the received signal based on at least one preselected criterion selected from a group consisting of the patient'"'"'s heart rate, the patient'"'"'s respiration rate, or the presence of abnormal beats in the received signal, and using the characterization of the at least one portion of the received signal to determine a level of alternans in the signal. - View Dependent Claims (111, 112, 113, 114, 115, 116, 117, 118, 119, 120)
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121. A real-time method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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receiving a physiologic signal representative of activity of the heart of the patient; digitally processing the physiologic signal to determine a level of alternans in the signal; and concurrently with the processing step, providing an output representative of the level of alternans as the level of alternans is determined. - View Dependent Claims (122, 123, 124)
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125. A method for measuring alternans in at least one physiologic signal representative of activity of the heart of a patient, the physiologic signal including a sequence of substantially repeating physiologic waveforms, the method comprising the steps of:
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receiving a physiologic signal representative of activity of the heart of the patient; digitally processing the received physiologic signal to determine a level of alternans and to determine a level of noise; and using the determined level of noise to determine with a predetermined level of statistical certainty whether the alternans level is above a threshold. - View Dependent Claims (126, 127, 128, 129, 130, 131, 132)
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133. An apparatus for measuring an alternans pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating physiologic waveforms in at least one signal measured from a patient, said apparatus comprising:
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one or more transducers for respectively measuring one or more signals from a patient, at least one of said one or more transducers being configured to measure a signal from the heart of the patient; a processor configured to obtain, from said one or more measured signals, a measure of the level of alternans in said signal from the heart of the patient for assessing the condition of the patient'"'"'s heart; and a controller for producing signals to control a stressing device configured to alter a physiologic condition of the patient to stress the heart of the patient and thereby affect the signal from the heart of the patient, the controller producing the signals in response to a signal from the processor. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140)
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141. An apparatus for measuring an alternans pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating physiologic waveforms in at least one signal measured from a patient, said apparatus comprising:
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one or more transducers for respectively measuring one or more signals from a patient, at least one of said one or more transducers being configured to be coupled to the patient to measure a cardiac signal comprising a sequence of substantially repeating waveforms representative of one or more signals from the heart of the patient, said one or more transducers being configured to remain coupled to the patient for a period in excess of about one hour; a recorder coupled to said one or more transducers and configured to store signals, including the cardiac signal, measured by said one or more transducers for a period in excess of one hour, the recorder comprising a portable recorder sized and configured to be carried by the patient as the patient engages in normal activities; and a processor configured to characterize portions of said stored signals corresponding to one or more periods according to one or more preselected criteria, and further configured to obtain from said characterized portions of said stored signals a measure of the level of alternans in the cardiac signal for assessing the condition of the patient'"'"'s heart. - View Dependent Claims (142, 143, 144)
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145. An apparatus for measuring an alternans pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating physiologic waveforms in at least one signal measured from a patient, said apparatus comprising:
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one or more transducers for respectively measuring one or more signals from a patient, at least one of said one or more transducers being configured to be coupled to the patient to measure a cardiac signal comprising a sequence of substantially repeating waveforms representative of one or more signals from the heart of the patient; a heart rate monitor coupled to at least one of said one or more transducers to measure the heart rate of the patient from signals measured by said at least one transducer; and a processor configured to obtain, from said one or more measured signals and from said measured heart rate, a measure of the level of alternans in said cardiac signal for assessing the condition of the patient'"'"'s heart. - View Dependent Claims (146)
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147. A method for measuring a pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating physiologic waveforms in at least one signal measured from a patient, said method comprising the steps of:
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measuring one or more signals from a patient, at least one of said one or more signals comprising a cardiac signal including a sequence of substantially repeating waveforms representative of one or more signals from the heart of the patient; processing said one or more measured signals to obtain a measure of the level of alternans in said one or more measured signals for assessing the condition of a patient'"'"'s heart; and enhancing the measurement of the pattern of cycle-to-cycle morphology variations by reducing the effect of variability in the interval between adjacent waveforms in said cardiac signal. - View Dependent Claims (148)
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149. A method for measuring an alternans pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating waveforms in at least one signal measured from a patient, comprising the steps of:
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measuring one or more signals from a patient, at least one of said one or more signals comprising a sequence of substantially repeating waveforms representative of one or more signals from the heart of the patient; processing the one or more signals to compute a measure of alternans in the repeating waveforms; additionally processing the one or more signals to produce an additional diagnostic from the group consisting of a signal averaged electrocardiogram and an analysis of QRS complex variability. - View Dependent Claims (150)
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151. An apparatus for measuring an alternans pattern of cycle-to-cycle morphology variations in a sequence of substantially repeating waveforms in at least one signal measured from a patient, said apparatus comprising:
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one or more transducers for respectively measuring one or more signals from a patient, at least one of said one or more transducers being coupled to the patient to measure at least one signal comprising a sequence of substantially repeating waveforms representative of one or more signals form the heart of the patient; a processor configured to process the signals to produce a diagnostic corresponding to alternans and an additional diagnostic from the group consisting of a signal averaged electrocardiogram and an analysis of QRS complex variability. - View Dependent Claims (152)
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Specification