System and methods for detecting ischemia with a limited extracardiac lead set

• US 20090048528A1
• Filed: 08/16/2007
• Published: 02/19/2009
• Est. Priority Date: 08/16/2007
• Status: Abandoned Application

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, Tim, John, Michael Sasha, Hopenfeld, Bruce
• Application Number:
  US11/889,752
• Publication Number:
  US 20090048528A1
• Time in Patent Office: Days
• US Class Current: 600/516
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• 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

Abstract

Disclosed is a system for detecting pathophysiological cardiac conditions from a reduced number of extracardiac leads. A right side lead measures the electrical signal between the middle superior chest region over the heart and inferior right torso position. A left side lead measures the electrical signal between the left precordial chest region and an inferior left lateral or posterior torso position. The lead montage is preferably chosen so that, regardless of patient position (e.g. supine, upright), negative ST segments and/or T waves are used to detect right coronary or left circumflex ischemia. Also, in these positions, reduced slope of the final deflection in the QRS can be used to detect these types of ischemia. To detect transmural ischemia, the system examines changes in QRS slopes, ST segment, T wave and the difference between the J point and the PQ potentials. In addition, for transmural ischemia associated with the left anterior descending artery, a proxy for the propagation time across the front of the heart is examined by comparing QRS features of the right side lead with QRS features of the left side lead. Histogram profiles, trends, and statistical summaries, especially running averages, of all of the above mentioned features, corrected for heart rate, are maintained.

Claims

1. A device for assessing the condition of a mammalian heart, comprising:

(a) first and second leads adapted to be disposed outside of the heart;

(b) a processor coupled to the first and second leads, the processor configured to;

(i) obtain first and second signals from the first and second leads, and compute first and second waveforms corresponding to the first and second signals, each of the first and second waveforms being characterized by a QRS complex associated with cardiac activation;

(ii) compare features of the QRS complexes of the first and second waveforms to derive a propagation time estimate that is indicative of the speed of cardiac activation through at least a portion of the heart;

(iii) apply a test to detect a pathological heart condition, wherein the test is based on the propagation time; and

(c) a signaling device in communication with said processor for sending a signal to an indicator device when said pathological heart condition is detected.

2. The device of claim 1 wherein the device is configured to compare features of the QRS complexes of the first and second waveforms by computing first and second fiducial time points corresponding to the QRS complexes of the first and second waveforms respectively, and wherein the propagation time estimate is based on the difference between the first and second fiducial time points.

3. The device of claim 1 wherein the test which is based on the propagation time is also based upon the shape of the QRS complex.

4. The device of claim 2 further comprising a third lead for computing a third waveform having a QRS complex by which a third fiducial timepoint can be calculated in order to define a second propagation time and wherein the test is based on a comparison of the first and second propagation times

5. The device of claim 1 further comprising an implantable metal case, and wherein the processor is disposed within the implantable metal case.

6. The device of claim 1 where the signaling device includes a telemetry mechanism.

7. The devise of claim 6 where the telemetry mechanism includes a wireless transmitter.

8. The device of claim 6 where the telemetry mechanism includes a cell phone.

9. The device of claim 1 where the signaling device includes an alarm mechanism.

10. The device of claim 1 where the signaling device is external to the patient.

11. A device for assessing the condition of a human heart, the human characterized by a torso, the device comprising:

(a) a first lead adapted to be disposed outside of the heart in such a manner as to detect the potential difference between anterior and posterior portions of the torso;

(b) a processor coupled to the first lead, the processor configured to;

(i) obtain a first signal from the first lead, and compute a first waveform corresponding to the first signal, the first waveform being characterized by a QRS complex associated with cardiac activation, the QRS complex characterized by an initial deflection, a primary deflection and a final deflection;

(ii) compute a first value that is indicative of the slope of the final deflection;

(iii) apply a test to detect ischemia in a posterior portion of the heart, wherein the test is based on the first value; and

(c) a signaling device in communication with said processor for sending a signal to an indicator device when said first value is external as predetermined threshold range.

12. The device of claim 11 where the signaling device includes a telemetry mechanism.

13. The device of claim 12 where the telemetry mechanism includes a wireless transmitter.

14. The device of claim 12 where the telemetry mechanism includes a cell phone.

15. The device of claim 11 where the signaling device includes an alarm mechanism.

16. The device of claim 11 where the signaling device is external to the patient.

17. A device that is configured to assess the condition of a human heart, the human characterized by a torso, the device comprising:

(a) a first lead adapted to be disposed to measure the potential difference between a first anterior region on the left precordium of the torso and a first inferior region to the left of the first anterior region;

(b) a second lead adapted to be disposed to measure the potential difference between a second anterior region to the right of the first anterior region and a second inferior region to the right of the second anterior region;

(c) a processor configured to obtain first and second signals from the first and second leads, respectively, and to compute first and second waveforms corresponding to the first and second signals, respectively, and to apply a first plurality of tests and a second plurality of tests to detect ischemia, wherein the first and second pluralities of tests are based on values of features of the first and second waveforms, respectively; and

(d) a signaling device in communication with said processor for sending a signal to an indicator device when said features of said first and second waveforms are external a predetermined threshold range.

18. The device of claim 17 where the signaling device includes a telemetry mechanism.

19. The device of claim 18 where the telemetry mechanism includes a wireless transmitter.

20. The device of claim 18 where the telemetry mechanism includes a cell phone.

21. The device of claim 17 where the signaling device includes an alarm mechanism.

22. The device of claim 17 where the signaling device is external to the patient.

23. The device of claim 17 wherein first and second tests that are part of the first plurality of tests involve the application of weights to waveform feature values.

24. The device of claim 23 wherein the first and second tests apply different weights to the same waveform feature value.

25. The device of claim 24 wherein the first test involves a single waveform feature value and the second test involves more than one waveform feature value.

26. The device of claim 25 wherein the first test involves an ST segment related waveform feature value, and the second test involves the ST segmented related waveform feature value and a QRS related waveform feature value.

27. The device of claim 17 wherein first and second tests that are part of the first plurality of tests involve the application of test parameter values to waveform feature values.

28. The device of claim 27 wherein each of at least two of the test parameter values is a threshold value associated with a corresponding waveform feature value.

29. The device of claim 28 wherein first and second tests that are part of the first plurality of tests involve the application of different threshold values to the same waveform feature value.

30. The device of claim 29 wherein the waveform feature value is related to the ST segment, and wherein the different threshold values correspond to opposite polarities of the same waveform feature value.

31. A device for assessing the condition of a human heart, the human characterized by a torso, the device comprising:

(a) a first lead adapted to be disposed outside of the heart in such a manner as to detect the potential difference between a superior anterior portion of the torso and an inferior portion of the torso to the right of the superior anterior portion;

(b) a processor coupled to the first lead, the processor configured to;

(i) obtain a first signal from the first lead, and compute a first waveform corresponding to the first signal, the first waveform being characterized by a QRS complex associated with cardiac activation, the QRS complex characterized by an initial deflection, a primary deflection and a final deflection;

(ii) compute a first value that is indicative of a feature of the initial deflection;

(iii) apply a test to detect ischemia in the right ventricle, wherein the test is based at least in part on the first value; and

(c) a signaling device in communication with said processor for receiving said first value and sending a signal to an indicator device when said first value is external a predetermined threshold range.

32. The device of claim 31 where the signaling device includes a telemetry mechanism.

33. The device of claim 32 where the telemetry mechanism includes a wireless transmitter.

34. The device of claim 32 where the telemetry mechanism includes a cell phone.

35. The device of claim 31 where the signaling device includes an alarm mechanism.

36. The device of claim 31 where the signaling device is external to the patient.

37. The device of claim 31 wherein the feature of the initial deflection is a measure of slope.

38. A device for assessing the condition of a human heart, the human characterized by a torso, the device comprising:

(a) a first lead adapted to be disposed outside of the heart;

(b) a processor coupled to the first lead, the processor configured to;

(i) obtain a first signal from the first lead, and compute a first waveform corresponding to the first signal, the first waveform being characterized by a QRS complex associated with cardiac activation and an ST segment, the QRS complex characterized by an initial deflection, a primary deflection and a final deflection;

(ii) compute a first value that is indicative of the amplitude of the final deflection;

(iii) compute a second value that is indicative of the magnitude and polarity of at least a portion of the ST segment;

(iii) apply a test to detect ischemia, wherein the test associates a greater likelihood of ischemia with changes in both the first value and the second value; and

(c) a signaling device in communication with said processor for receiving said first and second values and sending a signal to an indicator device when said first or second value is external a predetermined threshold range.

39. The device of claim 38 where the signaling device includes a telemetry mechanism.

40. The design of claim 39 where the telemetry mechanism includes a wireless transmitter.

41. The device of claim 39 where the telemetry mechanism includes a cell phone.

42. The device of claim 38 where the signaling device includes an alarm mechanism.

43. The device of claim 38 where the signaling device is external to the patient.

44. The device of claim 38 wherein the changes in both the first value and the second value are in relation to a self norm.

45. The device of claim 38 wherein the changes in both the first value and the second value are in relation to a self norm from within the prior 2 hour period.

46. The device of claim 38 wherein the changes in both the first value and the second value occur approximately concurrently.

47. The device of claim 38 wherein the changes in both the first value and the second value occur for a specified number of beats.

48. The device of claim 38 wherein the test detects ischemia based upon both the amount of the changes in both the first value and the second value and the duration of such changes, such that increases in the amount of changes will result in a positive detection of ischemia over a decreased duration.

49. The device of claim 48 wherein duration is defined by a specified number of beats.

50. The device of claim 48 wherein the test is based on moving averages of the first and second values.

51. The device of claim 50 wherein the moving averages are exponential moving averages.