Shock timing technology

• US 8,150,510 B2
• Filed: 05/18/2007
• Issued: 04/03/2012
• Est. Priority Date: 04/15/2002
• Status: Active Grant

• Current Assignee: Imperception, Inc.
• Original Assignee: Imperception, Inc.
• Inventors: Swerdlow, Charles
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US11/804,443
• Publication Number:
  US 20080033494A1
• Time in Patent Office: 1,782 Days
• Field of Search: 607/7, 607/8
• US Class Current: 607/7
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/355 Detecting T-waves
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61N 1/3943 for threshold determination
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A method for accurately determining timing points for T-wave shocks is particularly useful in a system for determining a cardiac shock strength in an implantable cardioverter defibrillator (ICD. The method involves acquiring at least one first signal, acquiring at least a second signal, comparing the signals, and selecting a timing point with the T-wave of the signal. The first and second signals may be two different aspects of a single electrogram, first and second electrograms, or a combination thereof. Comparison preferably involves signal alignment and qualitative analysis.

Claims

1. A method for accurately timing T-wave shocks, comprising the steps of:

(a) deriving a first signal from a cardiac electrical signal from a system for determining implantable cardioverter defibrillator cardiac shock strength, wherein the first derived signal relates to a change with respect to time of the T wave of the cardiac electrical signal (b) deriving at least a second signal from a cardiac electrical signal from the system, wherein the at least second derived signal relates to a change with respect to time of the T wave of its respective cardiac electrical signal, (c) comparing the first derived signal and the at least one second derived signal, and (d) based on the comparison, selecting one or more timing points within the T wave of at least one of the derived signals for delivering shocks.

2. method of claim 1 wherein the comparing step includes quantitative analysis.

3. The method of claim 1 in which a timing point is selected within a T wave of each of the at least two derived signals and further comprising the step of applying an analytical step to determine a final, composite timing point based on the individual timing points selected from the at least two derived signals.

4. The method of claim 1, wherein the first and at least one second derived signals are different changes with respect to time from a single cardiac electrical signal.

5. The method of claim 1, wherein the first and at least one second derived signals are the same change with respect to time of a first cardiac electrical signal and at least one second, different, cardiac electrical signal.

6. The method of claim 1, wherein the first and at least one second derived signals are different changes with respect to time of a first cardiac electrical signal and at least one second, different, cardiac electrical signal.

7. The method of claim 1, wherein comparison includes signal alignment.

8. The method of claim 1 further comprising the step of computing the one or more timing points utilizing one, some, or all points in time in the T wave of the derived signal.

9. The method according to claim 8, wherein the one or more timing points are computed via an arithmetically, geometrically, or harmonically weighted average using parameter values relating to the timing points.

10. The method according to claim 8 wherein the one or more timing points are computed via a weighted ratio or weighted log-ratio using parameter values relating to the timing points.

11. The method of claim 8 in which a single parameter value is selected relating to a set of one or more timing points based on methods to analyze the set of timing points.

12. The method according to claim 11, wherein the single parameter value is selected by sorting the one or more timing point values and then selecting one of the timing points.

13. The method according to claim 12, wherein the single parameter value relates to the minimum, mean, median, mode, or maximum of the values of the timing points.

14. The method of claim 1, wherein at least one timing point is an extreme absolute value of the change with respect to time, selected from the group consisting of a minimum absolute value, a minimum value, and a maximum value.

15. The method of claim 1, further comprising the step of calculating at least one said change with respect to time by a finite difference, an ordinary derivative, a directional derivative, a gradient and a partial derivative, an implicit differential, a variance calculation, a bounded variation calculation, a radial displacement vector, or a tangent vector approximation.

16. The method of claim 14, further comprising the step of calculating the extreme absolute value by a method selected from the group of calculation methods consisting of a finite difference, an ordinary derivative, a directional derivative, a gradient and a partial derivative, an implicit differential, a variance calculation, a bounded variation calculation, a radial displacement vector, and a tangent vector approximation.

17. The method of claim 1, wherein a change with respect to time is the first derivative of T wave amplitude with respect to time.

18. The method of claim 1, wherein a change with respect to time is the second derivative of T wave amplitude with respect to time.

19. The method of claim 1, wherein at least one of the changes with respect to time is the first derivative of T wave amplitude with respect to timeand another of the changes with respect to time is the second derivative of T wave amplitude with respect to time.

20. The method of claim 1 in which said step of selecting T-wave shock times involves selection in relation to the minimum of the absolute value (zero point) of the second derivative of the T wave with respect to time.

21. The method of claim 1, further comprising the step of calculating a level of signal quality for the first derived signal and at least one second derived signal, and the one or more timing points are selected in relation to the calculated values of signal quality.

22. The method of claim 21, in which the level of signal quality is calculated using a pre-determined period of time and using a time-domain-based signal method selected from the group consisting of a minimum, a mean, a median, mode, and a maximum.

23. The method of claim 21, in which the level of signal quality is calculated using a pre-determined range of frequency and using a frequency-domain-based signal method selected from the group consisting of a minimum, a mean, a median, and a maximum signal value.

24. The method of claim 21, in which the level of signal quality is calculated using a method selected from the group consisting of an average signal difference, a sum of an absolute value of a difference from a signal mean and a power of a signal subtracted from a signal mean, a signal to noise ratio, a coefficient of signal variation, a signal histogram, a signal frequency spectrum, a signal power spectrum, a time-domain convolution technique, and a time-domain correlation technique.

25. The method of claim 21 in which the timing point is selected based on the derived signal with the highest quality.

26. The method of claim 21, in which, if more than one derived signal has sufficient quality, the priority in which such signals are used to select the timing point within the T-wave is specified in advance by predetermined instructions.

27. The method of claim 21, in which, if more than one derived signal has sufficient quality, the timing point for the T-wave shock is selected from a mathematical combination of the intervals from a predetermined base timing point to each of the timing points within the T-wave that can be determined with sufficient quality.

28. The method of claim 27, in which the mathematical combination is selected from the group consisting of an average, a weighted average, a median, and a mode.

29. The method of claim 27, wherein two changes with respect to time of each cardiac electrical signal are derived, the first change with respect to time being the first derivative of one cardiac electrical signal and the second change with respect to time being the second derivative of a different cardiac electrical signal.

30. The method of claim 21, further comprising the step of determining the signal with the highest quality from the set consisting of the base cardiac electrical signal and the one or more signals derived therefrom.

31. The method of claim 1 in which, if an extreme absolute value of the change with respect to time of one cardiac electrical signal occurs at more than one point in time, a timing point selected from one sensed cardiac electrical signal depends on the value of one or more other, different cardiac electrical signals, or of a change with respect to time of one or more other cardiac electrical signals.

32. The method of claim 31, in which a first timing point during the T wave for the test-shock is selected in relation to a maximum of a first derivative of the T wave with respect to time of one cardiac electrical signal and an at least one second timing point during the T wave is selected in relation to a minimum of an absolute value of a second derivative of the T wave with respect to time of the same cardiac electrical signal .

33. The method of claim 32, in which the minimum of the absolute value of the second derivative of the T wave with respect to time is a zero point.

34. The method of claims 33, and in which the zero point of the second derivative of the T wave with respect to time of the second cardiac electrical signal occurs when the first derivative of the same second cardiac electrical signal is not zero.

35. The method according to claim 33 or 34 in which:

(A) the maximum of the first derivative with respect to time of one cardiac electrical signal is used to select the timing point within the T wave only if the second derivative of the same cardiac electrical signal at the same point is a local minimum value, and

(B) otherwise, the minimum absolute value of the second derivative with respect to time of a different cardiac electrical signal is used to select the timing point within the T wave.

36. The method of claim 1, further comprising the step of recording the cardiac electrical signals from a fully implantable device.

37. The method of claims 1 in which the cardiac electrical signals are selected from a subset of cardiac electrical signals which are recorded from permanently implantable and non-implantable electrodes.

38. The method of claim 1 in which the cardiac electrical signals are selected from a subset of non-implantable electrodes and further comprising the step of transmitting the cardiac electrical signals wirelessly to an ICD programmer.

39. The method of claim 1 in which the cardiac electrical signals are selected from a subset of non-implantable electrodes and further comprising the step of transmitting the cardiac signals wirelessly to an ICD generator.

40. The method of claim 1 in which electrodes sense the cardiac electrical signals, the sensed signals being selected from a subset of cardiac electrical signals including but not limited to pacing, sensing, recording, and defibrillation electrodes.

41. The method of claims 1 in which electrodes sense the cardiac electrical signals, the sensed signals being selected from a subset of cardiac electrical signals including but not limited to subcutaneous electrodes, epicardial electrodes, transvenous endocardial electrodes, and transvenous endovascular electrodes.

42. The method of claims 1 in which electrodes sense the cardiac electrical signals, the sensed signals being selected from a subset of cardiac electrical signals including but not limited to a right ventricular pace-sense tip electrode, a right ventricular pace-sense ring electrode, a left ventricular pace-sense tip electrode, a left ventricular pace-sense ring electrode, a left atrial pace-sense tip electrode, a left atrial pace-sense ring electrode, a tip electrode placed in the coronary venous system, a ring electrode placed in the coronary venous system, a defibrillation electrode in the right ventricle, a defibrillation electrode in the left ventricle, a defibrillation electrode in the right atrium, a defibrillation electrode in the left atrium, an epicardial pace-sense electrode, an epicardial defibrillation electrode, a subcutaneous sensing electrode, a subcutaneous defibrillation electrode, a submuscular sensing electrode, a submuscular defibrillation electrode, a localized “

button”

electrode on the housing (“

can”

) of an ICD pulse generator, an electrode consisting of the entire housing (“

can”

) of the ICD pulse generator.

43. The method of claim 1 further comprising the step of determining a predetermined number of T-wave shocks by the quality of the cardiac electrical signal signals.