Method and apparatus for discrimination of monomorphic and polymorphic arrhythmias and for treatment thereof

• US 5,447,519 A
• Filed: 03/19/1994
• Issued: 09/05/1995
• Est. Priority Date: 03/19/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Peterson, David K.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/206,486
• Time in Patent Office: 535 Days
• Field of Search: 607/4, 607/5, 607/14, 128/702, 128/705, 128/696, 364/413.06
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable cardioverter/defibrillator system provided with method and apparatus for discrimination between monomorphic arrhythmias, e.g. ventricular tachycardia from polymorphic arrhythmias, e.g. ventricular fibrillation. A fiducial point of each successive QRS complex is detected prompting the storage of sampled and digitized waveform data within a timing window bridging the point in time of fiducial point detection. Stored sets of such sampled wave shape data are compared data point to data point resulting in a sampled morphology index value for each compared set. The magnitude of the sampled morphology index value or a series such index values are analyzed to determine the presence of a single or a progression of beat-to-beat waveform changes indicative of a polymorphic single transition or progression of QRS complexes from monomorphic to polymorphic waveforms indicative of an arrhythmia that should be treated with aggressive cardioversion/defibrillation therapies. The system is preferably provided with a closely spaced and widely spaced pairs of electrodes for sensing each QRS complex of the patient'"'"'s electrocardiogram. The closely spaced electrode pair is coupled to sense detect circuitry for identifying a predetermined fiducial point in the electrical signal associated with a ventricular depolarization and to counting and comparison circuitry for developing rate and onset data. The widely spaced pair of electrodes is coupled to sense and digitizing circuitry for developing the sampled waveform amplitude data from which the morphology index values are derived.

Claims

1. In a cardioverter/defibrillator of the type comprising treatment means for delivering a first therapy to a patient'"'"'s heart to treat tachycardia and a second therapy to said patient'"'"'s heart to treat fibrillation in response to criteria for discriminating tachycardia from fibrillation, a method of assisting the discrimination between tachycardia and fibrillation through a comparison of the degree of morphology of a series of cardiac electrical signals associated with cardiac depolarizations comprising the steps of:

sensing electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear;

successively sampling, processing and temporarily storing the sensed electrical signals as sets of wave shape amplitude data values of the sensed electrical signals;

successively determining the sampled point at which the sensed electrical signal meets predetermined sense detect criteria and for issuing a fiducial point signal indicative thereof;

successively selecting sub-sets of the sets of the processed and stored wave shape data referenced to the fiducial point signal, the sub-sets of wave shape data of a series of data sets being consistently selected with respect to the fiducial point signal so the selected sub-sets of data are consistent in number and sample point position with respect to each fiducial point signal;

successively positionally aligning the fiducial point signals of a series of subsets of wave shape data to positionally align the series of wave shape sub-set data;

first, comparing the values of the aligned data of at least two successive selected sub-sets of the processed and stored wave shape data to derive a like numbered sub-set of morphology difference data;

summing the sub-set of morphology difference data to provide a sampled morphology index value;

providing a threshold morphology index value which, if exceeded is indicative of the onset of polymorphic cardiac rhythm indicative of fibrillation; and

second, comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation discrimination signal for use in confirming tachycardia or fibrillation and for selecting the appropriate therapy.

2. The method of claim 1 wherein:

the step of sensing electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear further comprises;

providing a pair of widely spaced sense electrodes in relation to the heart and a first sense amplifier coupled to the widely spaced sense electrodes to detect the far field electrical signals accompanying depolarization of the heart; and

the steps of successively determining the sample point at which the sensed electrical signal meets predetermined sense detect criteria and for issuing a fiducial point signal indicative thereof further comprises;

providing a pair of closely spaced sense electrodes in relation to the heart and a second sense amplifier coupled to the closely spaced sense electrodes to detect the near field electrical signals accompanying depolarization of the heart; and

sampling the value of the near field electrical signals and issuing the fiducial point signal when a sampled value meets the predetermined sense detect criteria.

3. The method of claim 2 wherein the second comparing step further comprises:

measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and for providing a further tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

4. The method of claim 3 wherein the second comparing step further comprises:

comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation count signal for a series of sampled morphology index values;

counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

5. The method of claim 4 wherein the first comparing step further comprises:

periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference subset to derive the like numbered sub-set of morphology difference data in each case; and

after the series of comparing steps, selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

6. The method of claim 5 wherein the first comparing step further comprises:

adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

7. The method of claim 1 wherein the second comparing step further comprises:

measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and for providing a further tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

8. The method of claim 7 wherein the second comparing step further comprises:

comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation count signal for a series of sampled morphology index values;

counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

9. The method of claim 8 wherein the first comparing step further comprises:

periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

after the series of comparing steps, selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

10. The method of claim 9 wherein the first comparing step further comprises:

adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

11. The method of claim 1 wherein the second comparing step further comprises:

comparing the sampled morphology index value to the threshold morphology index value and generating a

tachycardia or a fibrillation count signal for a series of sampled morphology index values;

counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

12. The method of claim 11 wherein the first comparing step further comprises:

periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub- set to derive the like numbered sub-set of morphology difference data in each case; and

after the series of comparing steps, selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

13. The method of claim 12 wherein the first comparing step further comprises:

adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

14. The method of claim 1 wherein the first comparing step further comprises:

periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference subset to derive the like numbered sub-set of morphology difference data in each case; and

after the series of comparing steps, selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

15. The method of claim 14 wherein the first comparing step further comprises:

adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

16. In a cardioverter/defibrillator of the type comprising treatment means for delivering a first therapy to a patient'"'"'s heart to treat tachycardia and a second therapy to said patient'"'"'s heart to treat fibrillation in response to criteria for discriminating tachycardia from fibrillation, a apparatus for assisting the discrimination between tachycardia and fibrillation through a comparison of the degree of morphology of a series of cardiac electrical signals associated with cardiac depolarizations comprising:

means for sensing electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear;

means for successively sampling, processing and temporarily storing the sensed electrical signals as sets of wave shape data representative of a like numbered set of wave shape amplitude values of the sensed electrical signals;

means for successively determining the sample point at which the sensed electrical signal meets predetermined sense detect criteria and for issuing a fiducial point signal indicative thereof;

means for successively selecting sub-sets of the sets of the processed and stored wave shape data referenced to the fiducial point signal, the sub-sets of wave shape data of a series of data sets being consistently selected with respect to the fiducial point signal so the selected sub-sets of data are consistent in number and sample point position with respect to each fiducial point signal;

means for successively positionally aligning the fiducial point signals of a series of sub-sets of wave shape data to positionally align the series of wave shape sub-set data;

first means for comparing the values of the aligned data of at least two successive selected sub-sets of the processed and stored wave shape data to derive a like numbered sub-set of morphology difference data;

means for summing the sub-set of morphology difference data to provide a sampled morphology index value;

means for providing a threshold morphology index value which, if exceeded is indicative of the onset of polymorphic cardiac rhythm indicative of fibrillation; and

second means for comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation discrimination signal for use in confirming tachycardia or fibrillation and for selecting the appropriate therapy.

17. The apparatus of claim 16 wherein:

said means for sensing electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear further comprises;

a pair of widely spaced sense electrodes adapted to be positioned in relation to the heart; and

a first sense amplifier coupled to the widely spaced sense electrodes to detect the far field electrical signals accompanying depolarization of the heart; and

said means for successively determining the sample point at which the sensed electrical signal meets predetermined sense detect criteria and for issuing a fiducial point signal indicative thereof further comprises;

a pair of closely spaced sense electrodes adapted to be positioned in relation to the heart; and

a second sense amplifier coupled to the closely spaced sense electrodes to detect the near field electrical signals accompanying depolarization of the heart; and

means for issuing the fiducial point signal when a value of the near field electrical signal meets the predetermined sense detect criteria.

18. The apparatus of claim 17 wherein said second comparing means further comprises:

means for measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and for providing a further tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

19. The apparatus of claim 18 wherein said second comparing means further comprises:

means for comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation count signal for a series of sampled morphology index values;

means for counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

means for providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

20. The apparatus of claim 19 wherein said first comparing means further comprises:

means for periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

means for comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

means for selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

21. The apparatus of claim 20 wherein said first comparing means further comprises:

means for adjusting the number of the series of comparisons between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

22. The apparatus of claim 16 wherein said second comparing means further comprises:

means for measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and for providing a further tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

23. The apparatus of claim 22 wherein said second comparing means further comprises:

means for comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation count signal for a series of sampled morphology index values;

means for counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

means for providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

24. The apparatus of claim 23 wherein said first comparing means further comprises:

means for periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

means for comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

means for selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

25. The apparatus of claim 24 wherein said first comparing means further comprises:

means for adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

26. The apparatus of claim 16 wherein said second comparing means further comprises:

means for comparing the sampled morphology index value to the threshold morphology index value and generating a tachycardia or a fibrillation count signal for a series of sampled morphology index values;

means for counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

means for providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

27. The apparatus of claim 26 wherein said first comparing means further comprises:

means for periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

means for comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

means for selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

28. The apparatus of claim 27 wherein said first comparing means further comprises:

means for adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

29. The apparatus of claim 16 wherein said first comparing means further comprises:

means for periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

means for comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

means for selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

30. The apparatus of claim 29 wherein said first comparing means further comprises:

means for adjusting the number of the series of comparing steps between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.

31. In a cardioverter/defibrillator of the type comprising treatment means for delivering a first therapy to a patient'"'"'s heart to treat a monomorphic arrhythmia and a second therapy to said patient'"'"'s heart to treat a polymorphic arrhythmia in response to criteria for discriminating therebetween, a method of assisting the discrimination through a comparison of the degree of morphology of the far field electrogram associated with cardiac depolarizations recurring at a tachycardia rate comprising the steps of:

providing a first pair of closely spaced electrodes in or adjacent to a chamber of a heart from which a near field electrogram may be detected;

providing a second pair of widely spaced electrodes in or adjacent to a chamber of a heart from which a far field electrogram may be detected;

sensing the near field waveform of the electrogram successively appearing across the first pair of electrodes and successively determining a fiducial point at which the sensed waveform amplitude value meets predetermined sense detect criteria and issuing a fiducial point signal indicative thereof;

sensing the far field waveform of the electrogram successively appearing across the second pair of electrodes and providing a set of far field sampled amplitude data;

aligning successive sets of far field sampled amplitude data positionally aligned to the near field fiducial point of each such data set;

processing the values of the aligned successive sets of data to provide a sampled morphology index value; and

generating a tachycardia or a fibrillation discrimination signal as a function of the sampled morphology index value for use in confirming monomorphic tachycardia or polymorphic tachycardia or fibrillation and for selecting the appropriate therapy.

32. The method of claim 31 wherein the generating step further comprises:

providing a threshold morphology index value which, if exceeded is indicative of the onset of polymorphic cardiac rhythm; and

comparing the sampled morphology index value to the threshold morphology index value and generating a polymorphic or a monomorphic discrimination signal for use in confirming the nature of the arrhythmia and for selecting the appropriate therapy.

33. The method of claim 32 wherein the processing step further comprises:

establishing event data windows in alignment with and extending for predetermined time windows with respect to each detected fiducial point;

comparing sub-sets of the far field sampled amplitude data values of the aligned successive sets of data falling within the event data windows to develop a subset of sampled amplitude difference data values; and

summing the sampled amplitude difference data values to derive the sampled morphology index value.

34. The method of claim 31 wherein the processing step further comprises:

establishing event data windows in alignment with and extending for predetermined time windows with respect to each detected fiducial point;

comparing sub-sets of the far field sampled amplitude data values of the aligned successive sets of data falling within the event data windows to develop a subset of sampled amplitude difference data values; and

summing the sampled amplitude difference data values to derive the sampled morphology index value.

35. The method of claim 31 wherein the comparing step further comprises:

measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and providing a further morphology discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

36. The method of claim 31 wherein the comparing step further comprises:

comparing the sampled morphology index value to the threshold morphology index value and generating a monomorphic or polymorphic count signal for a series of sampled morphology index values;

counting the relative numbers of fibrillation and tachycardia count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic fibrillation may be confirmed; and

providing the tachycardia or fibrillation discrimination signal for selecting between the appropriate therapies as a function of the count.

37. The method of claim 31 wherein the processing step further comprises:

periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating mono-morphology;

comparing the values of the aligned data of a succeeding series of selected subsets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

after the series of comparing steps, selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating mono-morphology, if any.

38. In a cardioverter/defibrillator of the type comprising treatment means for delivering a first therapy to a patient'"'"'s heart to treat a monomorphic arrhythmia and a second therapy to said patient'"'"'s heart to treat polymorphic arrhythmia in response to criteria for discriminating therebetween, apparatus for assisting the discrimination through a comparison of the degree of morphology of a series of cardiac electrical signals associated with cardiac depolarizations recurring at a tachycardia rate comprising:

means for sensing near field and far field electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear;

means for sampling the far field electrical signals and for providing sets of waveform data representative of a like numbered set of wave shape amplitude values of the sensed far field electrical signals;

means for successively determining a fiducial point at which the sensed near field electrical signal amplitude values meets predetermined sense detect criteria and for issuing a fiducial point signal indicative thereof;

means for aligning successive sets of far field wave shape data positionally aligned with the fiducial point of each corresponding near field electrical signal;

means for processing the values of the aligned data of at least two selected sub-sets of the stored far field wave shape data to provide a sampled morphology index value;

means for providing a threshold morphology index value which, if exceeded is indicative of the onset of polymorphic cardiac rhythm indicative of fibrillation; and

means for comparing the sampled morphology index value to the threshold morphology index value and generating a morphology discrimination signal for use in confirming monomorphic tachycardia or polymorphic tachycardia or fibrillation and for selecting the appropriate therapy.

39. The apparatus of claim 38 wherein:

said sensing means for sensing electrical signals from said patient'"'"'s heart accompanying the depolarization of a chamber or chambers of said patient'"'"'s heart as the electrical signals successively appear further comprises;

a pair of widely spaced sense electrodes adapted to be positioned in relation to the heart; and

a first sense amplifier coupled to the widely spaced sense electrodes to detect the far field electrical signals accompanying depolarization of the heart; and

said means for successively determining the fiducial point further comprises;

a pair of closely spaced sense electrodes adapted to be positioned in relation to the heart; and

a second sense amplifier coupled to the closely spaced sense electrodes to detect the near field electrical signals accompanying depolarization of the heart; and

means for issuing the fiducial point signal when a value of the near field electrical signal meets the predetermined sense detect criteria.

40. The apparatus of claim 38 wherein said comparing means further comprises:

means for measuring the cumulative variability of a series of sampled morphology index values of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart and for providing a further morphology discrimination signal for selecting between the appropriate therapies as a function of said measured variability.

41. The apparatus of claim 38 wherein said comparing means further comprises:

means for comparing the sampled morphology index value to the threshold morphology index value and generating a monomorphic or a polymorphic count signal for a series of sampled morphology index values;

means for counting the relative numbers of monomorphic and polymorphic count signals in the series, whereby a progression from a monomorphic tachycardia to a polymorphic tachycardia or fibrillation may be confirmed; and

means responsive to the counted number for selecting between the appropriate therapies as a function of the count.

42. The apparatus of claim 38 wherein said processing means further comprises:

means for periodically selecting and storing a reference sub-set of processed and stored wave shape data having a sampled morphology index value confirmed as indicating tachycardia;

means for comparing the values of the aligned data of a succeeding series of selected sub-sets of the processed and stored wave shape data to the reference sub-set to derive the like numbered sub-set of morphology difference data in each case; and

means for selecting and storing an updated reference sub-set of processed and stored data having a sampled morphology index value confirmed as indicating tachycardia, if any.

43. The apparatus of claim 42 wherein said comparing means further comprises:

means for adjusting the number of the series of comparisons between the selection and storage of the updated reference sub-set as a function of rate or stability of a series of depolarizations of said chamber or chambers of said patient'"'"'s heart.