System for detecting and treating heart instability

• US 10,136,860 B2
• Filed: 06/27/2016
• Issued: 11/27/2018
• Est. Priority Date: 05/13/2008
• Status: Active Grant

• Current Assignee: US Department of Veterans Affairs (Government of the United States of America), Regents of the University of California (University of California)
• Original Assignee: US Department of Veterans Affairs (Government of the United States of America), Regents of the University of California (University of California)
• Inventors: Narayan, Sanjiv
• Primary Examiner(s): Voorhees, Catherine
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US15/193,105
• Publication Number:
  US 20160302734A1
• Time in Patent Office: 883 Days
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system for assessing risk associated with a suspected heart rhythm disorder includes at least one sensor for generating a signal received from a beating human heart over a plurality of time segments, and an analytic engine that receives the signal and calculates a change in the signal among at least a first time segment and a second time segment in response to a change in at least one of rate and regularity induced in the beating human heart. The analytic engine generates a risk score for the heart rhythm disorder based at least in part on the change in the signal. The system may further be configured to control modification of tissue of the beating human heart based on the risk score.

Claims

1. A system for assessing a risk associated with a suspected heart rhythm disorder in a beating human heart, the system comprising:

one or more sensors configured to detect one or more signals from the beating human heart;

a diagnostic unit configured to receive the one or more signals and;

calculate one or more signal changes associated with the one or more signals in response to an induced variation in at least one of rate and regularity in the beating human heart;

determine whether a slope of an action potential duration restitution curve associated with the signal changes indicates the suspected heart rhythm disorder, the action potential duration restitution curve defined by action potential durations corresponding to preceding diastolic intervals associated with the signals;

generate a risk score for the suspected heart rhythm disorder based at least in part on the signal changes and the slope; and

a display device for displaying a clinical representation based at least in part on the risk score for use in assessing the risk associated with the suspected heart rhythm disorder.

2. The system of claim 1, wherein the signals comprise action potentials.

3. The system of claim 1, wherein the slope of the action potential duration restitution curve exceeds a threshold.

4. The system of claim 3, wherein the threshold is a value of one.

5. The system of claim 1, further comprising a detection module to detect conduction slowing.

6. The system of claim 5, wherein the conduction slowing affects at least one of the signal changes calculated in response to the induced variation.

7. The system of claim 1, wherein the one or more signal changes comprise at least one of signal shape, duration of signal components, signal amplitude, duration of signal components, and signal characteristics.

8. The system of claim 1, wherein the one or more signal changes are calculated between alternate beats of the beating human heart.

9. The system of claim 1, further comprising a therapy unit configured to modify at least one of tissue structure and function based at least in part on the signal changes and the slope.

10. The system of claim 9, wherein the therapy unit is further configured to ablate tissue of the heart.

11. A method for assessing a risk associated with a suspected heart rhythm disorder in a beating human heart, the method comprising:

detecting, using one or more sensors, one or more signals from the beating human heart;

calculating, using a diagnostic unit, one or a combination of signal changes associated with the signals in response to an induced variation in at least one of rate and regularity in the beating human heart;

determining, using the diagnostic unit, whether a slope of an action potential duration restitution curve associated with the signal changes indicates the suspected heart rhythm disorder, the action potential duration restitution curve defined by action potential durations corresponding to preceding diastolic intervals associated with the signals;

generating a risk score for the suspected heart rhythm disorder based at least in part on the signal changes and the slope; and

displaying on a display device a clinical representation based at least in part on the risk score for use in assessing the risk associated with the suspected heart rhythm disorder.

12. The method of claim 11, wherein the signals comprise action potentials.

13. The method of claim 11, wherein the slope of the action potential duration restitution curve exceeds a threshold.

14. The method of claim 13, wherein the threshold is a value of one.

15. The method of claim 11, further comprising detecting conduction slowing using a detection module.

16. The method of claim 15, wherein the conduction slowing affects at least one of the signal changes calculated in response to the induced variation.

17. The method of claim 11, wherein the signal changes comprise at least one of signal shape, duration of signal components, signal amplitude, duration of signal components, and signal characteristics.

18. The method of claim 11, further comprising ablating tissue of the heart to modify the at least one of the tissue structure and function.

19. The method of claim 11, wherein the signal changes are calculated between alternate beats of the beating human heart.

20. The method of claim 12, further comprising modifying, using a therapy unit, at least one of tissue structure and function based at least in part on the signal changes calculated and slope determined by the diagnostic unit.