US5570696A
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US
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Method and apparatus for assessing myocardial electrical stability
Assignee: Spacelabs Healthcare LLC
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Filing: 1994-01-26
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Granted: 1996-11-05
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Expires: 2014-01-26
Abstract
Abstract The temporal pattern of cycle-to-cycle variability in physiologic waveforms, such as alternans, is assessed by applying transducers to a subject, recording physiologic signals, and analyzing the cycle-to-cycle variation in waveform morphology. Preferred embodiments include the application of physiologic stress to the subject in order to adjust heart rate to the desired range, real-time analysis of waveform variability, reduction in the effect of intercycle variability on waveform variability, improved techniques for determining the statistical significance of the amplitude of a temporal pattern of variability, handling of abnormal beats such as atrial and ventricular premature beats, and assessment of the statistical significance of a measured level of a temporal pattern of variability.
Inventors
- 👤 Jeffrey M. Arnold
- 👤 Paul Albrecht
- 👤 Kevin S. Librett
- 👤 Richard J. Cohen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 23:10
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/22; A61B5/221; A61B5/222; A61B5/24; A61B5/25; A61B5/279; A61B5/28
Claims Analysis
Total Claims: 68
Claim 1
Independent Claim
86 words
Method for assessing a temporal pattern of cycle-to-cycle variability in physiologic waveforms of a subject comprising: applying one or more transducers to the subject; recording one or more physiologic signals containing the physiologic waveforms; monitoring the subject's heart rate; applying a physiologic stress to the subject other than pacing the heart via electrodes applied directly to the surface of the heart; adjusting the physiologic stress to achieve a heart rate within a desired range; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms.
Claim 2
Dependent Claim
86 words
Method for assessing a temporal pattern of cycle-to-cycle variability in physiologic waveforms of a subject comprising: applying one or more transducers to the subject; recording one or more physiologic signals containing the physiologic waveforms; monitoring the subject's heart rate; applying a physiologic stress to the subject other than pacing the heart via electrodes applied directly to the surface of the heart; adjusting the physiologic stress to achieve a heart rate within a desired range; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms.
Claim 3
Dependent Claim
36 words
The method of claim 1 wherein the step of applying one or more transducers to a subject comprises applying body surface electrodes to a surface and wherein the step of recording physiologic signals comprises recording electrocardiograms.
Claim 4
Dependent Claim
32 words
The method of claim 2 wherein the step of analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms comprises measuring the alternans pattern of the variation of the physiologic waveforms.
Claim 5
Dependent Claim
31 words
The method of claim 1 wherein the step of analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms comprises measuring the alternans pattern of variation of the physiologic waveforms.
Claim 6
Dependent Claim
21 words
The method of claim 1 wherein the step of applying a physiologic stress to the subject comprises having the subject exercise.
Claim 7
Dependent Claim
22 words
The method of claim 5 wherein the step of applying a physiologic stress to the subject comprises the subject pedalling a bicycle.
Claim 8
Dependent Claim
14 words
The method of claim 5 in which the exercise comprises walking on a treadmill.
Claim 9
Dependent Claim
22 words
The method of claim 1 in which the physiologic stress applied is the administration of a pharmacologic agent that alters heart rate.
Claim 10
Dependent Claim
33 words
The method of claim 1 in which the physiologic stress involves electrically pacing the heart by means of a catheter placed through the nose or mouth into the esophagus and/or into the stomach.
Claim 11
Dependent Claim
19 words
The method of claim 1 in which the physiologic stress applied is the application of lower body negative pressure.
Claim 12
Dependent Claim
29 words
The method of claim 1 wherein the step of analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms is conducted while the physiologic signals are being recorded.
Claim 13
Independent Claim
97 words
A system for assessing a temporal pattern of cycle-to-cycle variability in physiologic waveforms comprising: means for applying one or more transducers to a subject to detect physiologic signals; means for recording said physiologic signals from the subject; means for monitoring the subject's heart rate; means for applying a physiologic stress to the subject other than pacing the heart via electrodes applied directly to the surface of the heart; means for adjusting the physiologic stress to achieve a heart rate within a desired range; and means for analyzing a temporal pattern of cycle-to-cycle variability in the physiologic signals.
Claim 14
Independent Claim
97 words
A system for assessing a temporal pattern of cycle-to-cycle variability in physiologic waveforms comprising: means for applying one or more transducers to a subject to detect physiologic signals; means for recording said physiologic signals from the subject; means for monitoring the subject's heart rate; means for applying a physiologic stress to the subject other than pacing the heart via electrodes applied directly to the surface of the heart; means for adjusting the physiologic stress to achieve a heart rate within a desired range; and means for analyzing a temporal pattern of cycle-to-cycle variability in the physiologic signals.
Claim 15
Dependent Claim
21 words
The system of claim 12 where said one or more transducers are body surface electrodes and the recorded signals are electrocardiograms.
Claim 16
Dependent Claim
30 words
The system of claim 13 wherein the means for analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform comprises means for detecting an alternans pattern of waveform variation.
Claim 17
Dependent Claim
30 words
The system of claim 12 wherein the means for analyzing the temporal pattern of cycle-to-cycle variability in the physiologic signals comprises means for detecting an alternans pattern of waveform variation.
Claim 18
Dependent Claim
24 words
The system of claim 12 wherein the means for applying a physiologic stress to the subject comprises means for enabling the subject to exercise.
Claim 19
Dependent Claim
17 words
The system of claim 16 wherein the means for allowing the subject to exercise comprises a bicycle.
Claim 20
Dependent Claim
14 words
The system of claim 16 in which the exercise comprises walking on a treadmill.
Claim 21
Dependent Claim
22 words
The apparatus of claim 12 in which the physiologic stress applied is the administration of a pharmacologic agent that alters heart rate.
Claim 22
Dependent Claim
33 words
The apparatus of claim 12 in which the physiologic stress involves electrically pacing the heart by means of a catheter placed through the nose or mouth into the esophagus and/or into the stomach.
Claim 23
Dependent Claim
19 words
The system of claim 12 in which the physiologic stress applied is the application of lower body negative pressure.
Claim 24
Dependent Claim
33 words
The system of claim 12 wherein the means for analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveforms comprises means for conducting the analysis while the physiologic signals are being recorded.
Claim 25
Dependent Claim
63 words
Method for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: physiologically stressing a subject to achieve a heart rate within a desired range other than by pacing the heart via electrodes applied directly to the surface of the heart; detecting physiologic waveform signals from the subject; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals.
Claim 26
Dependent Claim
63 words
Method for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: physiologically stressing a subject to achieve a heart rate within a desired range other than by pacing the heart via electrodes applied directly to the surface of the heart; detecting physiologic waveform signals from the subject; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals.
Claim 27
Dependent Claim
12 words
The method of claim 23 wherein the analyzing step comprises detecting alternans.
Claim 28
Independent Claim
20 words
The method of claims 23 or 24 wherein the analyzing step comprises performing quantitative analysis of the physiologic waveform signals.
Claim 29
Dependent Claim
11 words
The method of claim 25 wherein the physiologic stress is exercise.
Claim 30
Independent Claim
13 words
The method of claims 23 or 24 wherein the physiologic stress is exercise.
Claim 31
Dependent Claim
12 words
The method of claim 27 wherein the exercise includes a rhythmic component.
Claim 32
Dependent Claim
20 words
The method of claim 28 wherein the rhythmic component is selected to minimize the interference with the physiologic waveform signals.
Claim 33
Dependent Claim
19 words
The method of claim 29 wherein the rhythmic component frequency is selected to avoid interference with the alternans frequency.
Claim 34
Independent Claim
14 words
The method of claims 29 or 30 wherein the exercise is turning a crank.
Claim 35
Dependent Claim
22 words
The method of claim 31 further including adjusting resistance to turning the crank to achieve the heart rate within the desired range.
Claim 36
Dependent Claim
14 words
The method of claim 31 wherein the turning rate is approximately one-third heart rate.
Claim 37
Dependent Claim
14 words
The method of claim 31 wherein the turning rate is approximately two-thirds heart rate.
Claim 38
Dependent Claim
12 words
The method of claim 31 wherein the crank is a bicycle pedal.
Claim 39
Dependent Claim
13 words
The method of claim 28 wherein the exercise is walking on a treadmill.
Claim 40
Dependent Claim
21 words
The method of claim 36 wherein incline of the treadmill is selected to achieve a heart rate within the desired range.
Claim 41
Dependent Claim
20 words
The method of claim 36 wherein step rate of the walking is between 0.285 and 0.43 of the heart rate.
Claim 42
Dependent Claim
69 words
Method for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform in a subject comprising: detecting physiologic waveform signals from the subject during a period of physiologic stress other than pacing the heart via electrodes applied directly to the surface of the heart; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals when heart rate of the subject is in a desired range.
Claim 43
Dependent Claim
69 words
Method for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform in a subject comprising: detecting physiologic waveform signals from the subject during a period of physiologic stress other than pacing the heart via electrodes applied directly to the surface of the heart; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals when heart rate of the subject is in a desired range.
Claim 44
Dependent Claim
87 words
Method for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform in a subject comprising: detecting physiologic waveform signals from the subject during a period of physiologic stress other than pacing the heart via electrodes applied directly to the surface of the heart having a rhythmic component; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals when the heart rate of the subject is in a desired range and the rhythmic component does not substantially interfere with the physiologic waveform signals.
Claim 45
Dependent Claim
87 words
Method for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform in a subject comprising: detecting physiologic waveform signals from the subject during a period of physiologic stress other than pacing the heart via electrodes applied directly to the surface of the heart having a rhythmic component; and analyzing the temporal pattern of cycle-to-cycle variability in the physiologic waveform signals when the heart rate of the subject is in a desired range and the rhythmic component does not substantially interfere with the physiologic waveform signals.
Claim 46
Independent Claim
13 words
The method of claims 39 or 40 wherein the temporal pattern is alternans.
Claim 47
Dependent Claim
11 words
The method of claim 41 wherein the physiologic stress is exercise.
Claim 48
Independent Claim
14 words
The method of claims 39 or 40 wherein the physiologic stress is ordinary activity.
Claim 49
Independent Claim
13 words
The method of claims 39 or 40 wherein the physiologic stress is exercise.
Claim 50
Dependent Claim
12 words
The method of claim 44 wherein the exercise is turning a crank.
Claim 51
Dependent Claim
13 words
The method of claim 45 wherein the turning rate is one-third heart rate.
Claim 52
Dependent Claim
13 words
The method of claim 45 wherein the turning rate is two-third heart rate.
Claim 53
Dependent Claim
12 words
The method of claim 45 wherein the crank is a bicycle pedal.
Claim 54
Dependent Claim
29 words
The method of claim 48 wherein the bicycle exercise is conducted according to a protocol designed for the detection of the presence of coronary artery disease and data segments.
Claim 55
Dependent Claim
13 words
The method of claim 44 wherein the exercise is walking on a treadmill.
Claim 56
Dependent Claim
22 words
The method of claim 50 in which treadmill exercise is conducted according to a protocol designed for detection of coronary artery disease.
Claim 57
Independent Claim
72 words
A system for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to achieve a heart rate in a desired range; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals to determine the temporal pattern of cycle-to-cycle variability in the physiologic waveform.
Claim 58
Independent Claim
72 words
A system for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to achieve a heart rate in a desired range; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals to determine the temporal pattern of cycle-to-cycle variability in the physiologic waveform.
Claim 59
Dependent Claim
11 words
The system of claim 52 wherein the temporal pattern is alternans.
Claim 60
Independent Claim
14 words
The system of claims 52 or 53 wherein the exercise apparatus is a bicycle.
Claim 61
Independent Claim
14 words
The system of claims 52 or 53 wherein the exercise apparatus is a treadmill.
Claim 62
Independent Claim
78 words
A system for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to alter heart rate; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals when heart rate of the subject is in a desired range to determine the temporal pattern of cycle-to-cycle variability in the physiologic waveform.
Claim 63
Independent Claim
78 words
A system for assessing the temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to alter heart rate; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals when heart rate of the subject is in a desired range to determine the temporal pattern of cycle-to-cycle variability in the physiologic waveform.
Claim 64
Independent Claim
89 words
A system for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to alter heart rate; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals when heart rate of the subject is in a desired range and use of the exercise apparatus does not substantially interfere with the physiologic waveform signals to determine the temporal pattern of cycle-to-cycle variability.
Claim 65
Independent Claim
89 words
A system for assessing a temporal pattern of cycle-to-cycle variability in a physiologic waveform comprising: exercise apparatus for use by a subject to alter heart rate; transducer apparatus responsive to physiologic waveform signals in the subject during the use of the exercise apparatus to generate electrical signals; and computing apparatus for analyzing the electrical signals when heart rate of the subject is in a desired range and use of the exercise apparatus does not substantially interfere with the physiologic waveform signals to determine the temporal pattern of cycle-to-cycle variability.
Claim 66
Independent Claim
13 words
The system of claims 56 or 57 wherein the temporal pattern is alternans.
Claim 67
Independent Claim
14 words
The system of claims 56 or 57 wherein the exercise apparatus is a bicycle.
Claim 68
Independent Claim
14 words
The system of claims 56 or 57 wherein the exercise apparatus is a treadmill.
References Cited (Backward Citations)
US4802491A
Cited
US4732157A
Cited
US5234404A
Cited
US5010888A
Cited
US5148812A
Cited
US5265617A
Cited
US5323783A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-11-05 | 2000-05-06 | 2000-11-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-11-05 | 2004-05-06 | 2004-11-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-11-05 | 2008-05-06 | 2008-11-05 | $7700.00 | Window Closed / Lapsed |