Method for ischemia detection and apparatus for using same

• US 6,128,526 A
• Filed: 03/29/1999
• Issued: 10/03/2000
• Est. Priority Date: 03/29/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sheldon, Todd J., Stylos, Lee, Stadler, Robert, Nelson, Shannon
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/280,286
• Time in Patent Office: 554 Days
• Field of Search: 600/516, 600/517, 600/518
• US Class Current: 600/517
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/358 Detecting ST segments
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

In determining whether a patient has ischemia or other conditions discernible in the variation occurring in the ST portion of the electrocardiogram signal, we filter out bad ST change parameters that are not changing at a rate representative of human ischemia ST change parameter rates of change. This can be used for driving therapy systems to alleviate cardiac ischemia. This filtering can be enhanced by using multiple cardiac electrical vectors for the electrogram signal vectors, and using a determination of Axis shift to modify filter parameters and the expected ranges of precursors to the ST change parameter (an ST change variable) to eliminate bad cardiac cycles, that is cardiac cycle information that may be misleading.

Claims

1. A method for use in a medical device which reads electrocardiogram signals and finds values associated with changes manifest in an ST segment of said electrocardiogram signal wherein said method filters an ST change parameter found in data extracted from measured samples of said ST segment at each cardiac cycle determined to be valid to determine whether a time course fluctuation of an ST change identified by said ST change parameter is representative of ischemia, said method comprising a repeated cycle comprising the steps:

a) for a given cardiac cycle, collecting a selected set of characteristic portions of the electrocardiogram signal and sampling specific point locations within said portions,

b) parameterizing each said sampled selected portion by calculating a plurality of characteristic parameter values based on measured values of said samples for each said portion collected in step a, wherein a plurality of point values are determined for an ST segment of said selected portion and a point value is determined for an isoelectric point of said selected portion,

c) calculating a current ST change variable value for said given cardiac cycle using said plurality of point values and said isoelectric point value,

d) determining if said current ST change variable value is within a previously determined expected range for said ST change variable wherein said previously determined expected range is based on previously calculated ST change variables and if said current ST change variable is within an expanded expected range beyond the previously determined expected range, said expected range is then updated based on said ST change variable, and said ST change variable is determined fit for use in determining ischemia and added to a series of ST change variables taken over previous cycles to produce an ST change parameter signal,

e) determining whether said ST change parameter is changing in a manner indicative of a physiologic condition by a step of filtering the frequency of said ST change parameter using a bandpass filter and then producing from the output of said bandpas filter a raw physiologic indicator signal and then passing said raw physiologic indicator signal.

2. The method of claim 1 further comprising:

f) repeating said repeating cycle by performing step a for a subsequent given cardiac cycle and further employing said ST change parameter values from a last repetition of said repeating cycle to determine said raw physiologic condition signal, but only if said given cardiac cycle from a previous repeated cycle is determined to be valid in step "d".

3. The method of claim 2 wherein said raw physiologic condition signal is an indication of ischemia.

4. A method as set forth in claim 1 wherein in step `e` said bandpass filtering step comprises using a fast lowpass filter tuned to pass only those frequencies in the ST change parameters that are slow enough to be within the physiologic rate of change of ST change parameters which has been predetermined to occur during a particular physiologic condition in humans and determining whether said change is fast enough to be outside of baseline characteristics by filtering said ST change parameter rate of change through a slow lowpass filter and then, producing from the outputs of both the slow lowpass and fast lowpass filters, a raw physiologic indicator signal, and then passing said raw physiologic indicator signal.

5. The method set forth in claim 4, wherein said fast lowpass filter has an upper cutoff frequency of approximately pi/20 radians per cardiac cycle.

6. The method of claim 4 wherein passing said fast lowpass filter passed ST change parameter through said slow lowpass filter for obtaining the positive or negative deviations from a baseline caused by drift in order to produce a ST baseline signal therefrom, and wherein said raw physiologic indicator signal is produced by combining said ST baseline signal and said fast filter passed ST change parameter.

7. The method set forth in claim 6 wherein step "e" further comprises:

subtracting the ST baseline signal from the fast filtered ST change parameter for each vector, to produce a raw physiologic indicator signal for each vector.

8. The method of claim 7 further comprising a step:

f) determining and producing a normalization factor as a function of either a running mean of an R-wave amplitude or R-wave vector magnitude and applying said normalization factor to said raw physiologic indicator signal to produce a refined physiologic indicator signal.

9. The method of any of claims 4-8 wherein said slow filter operation is adapted to respond to axis shifts by the step of checking to see if an axis shift has occurred and if so, deciding whether to temporarily accelerate the response rate of the slow lowpass filter.

10. The method of any of claims 4-8 wherein said slow filter is adapted to respond to ischemia by temporarily decreasing the response rate of the slow lowpass filter if an ischemia flag is set.

11. The method of claim 1 wherein in step "a," a plurality of sets of characteristic portions is collected, and wherein in step "b," said plurality is parameterized and wherein each of said plurality is used to produce its own set of parameters which for each set may be called its vector, and wherein step "c" and "d" are performed for each vector.

12. The method of claim 11 wherein and an additional sub step is performed in step "d" wherein if any vector is determined to be invalid the plurality of sets of vectors is declared invalid.

13. The method of claim 1 wherein in step "a," a plurality of sets of characteristic portions is collected, and wherein in step "b", said plurality is parameterized and wherein each of said plurality is used to produce its own set of parameters which for each set may be called its vector, and wherein step "c" and "d" are performed for each vector and an additional sub step is performed in step "d" wherein a vector space of allowed ranges is determined and the validity of the plurality of vectors is determined to be invalid based on whether a combination of the vectors is found to be within said allowed vector space.

14. The method of claim 1 wherein in step "a," a plurality of sets of characteristic portions is collected, and wherein in step "b," said plurality is parameterized and wherein each of said plurality is used to produce its own set of corresponding parameters which for each set may be called its vector, and wherein step "c" and "d" are performed for at least one said corresponding parameter from each vector and an additional sub step is performed in step "d" wherein an allowed space of range is determined for said at least one corresponding parameter for all the vectors and the validity of the plurality of vectors is determined to be invalid based on whether a combination of said at least one corresponding parameter values is found to be within said allowed space range.

15. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, wherein a further step of removing from consideration any cardiac cycles that occur during a time that pacing is performed.

16. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, wherein a further step of removing from consideration any cardiac cycles that occur during pacing is performed and further including the step of disabling pacing from being performed for short pluralities of cardiac cycles during which said method of determining ST change parameters is conducted.

17. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, wherein ST change parameter determination only occurs during times when a pacing rate is held constant.

18. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, wherein temporal location of sampling is modified by reference to a current heart rate.

19. The method of any of claims 1-8 or 11-14, but excluding the multiply dependent claims, wherein an additional step is performed comprising determining if said ST change parameter has undergone an axis shift.

20. The method of any of claims 1-7 or 11-14 wherein an additional step is performed comprising/determining if said ST change parameter has undergone an axis shift and a further additional step employs said Axis shift information to modify the recalculations of the expected space for said ST parameter or to eliminate use of ST parameter values during particular cardiac cycles depending on the nature of the axis shift information.

21. The method as set forth in any of claims 1-8 or 11-14 but excluding the multiply dependent claims, further comprising the steps;

providing said filtered ST change parameter values to a physiologic signal interpreter, deciding on a value of a physiologic parameter based on said ST change parameter values received by said interpreter and providing a therapy value to a therapy controller, and delivering a therapy to a body based on said therapy value.

22. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, further comprising the steps;

providing said physiologic condition indicator signal to a physiologic signal interpreter, deciding on a value of said physiologic indicator signal, and providing a therapy signal value to a therapy controller, and delivering a therapy to a body based on said therapy value, and additionally comprising the steps of evaluating in said therapy controller an additional physiologic parameter based on signals from a physiologic sensor value sensing acceleration in the heart of a patient, before deciding on said therapy signal.

23. The method as set forth in any of claims 1-8 or 11-14, but excluding the multiply dependent claims, further comprising the steps;

providing said physiologic condition indicator signal to a physiologic signal interpreter, deciding on a value of said physiologic indicator signal, and providing a therapy signal value to a therapy controller, and delivering a therapy to a body based on said therapy value, and additionally comprising the steps of evaluating in said therapy controller an additional physiologic parameter based on signals from a physiologic sensor value sensing pressure in the heart of a patient, before deciding on said therapy signal.

24. Apparatus for filtering ST change parameter information signals present in a cardiac electrogram signal to eliminate consideration of out of range ST parameter values in using said ST change parameter signals for evaluating a physiologic condition and producing a physiologic condition indicator signal, said cardiac electrogram signal being received by said apparatus through a plurality of electrical leads connected to receive said cardiac electrogram signal in a plurality of electrical vectors, said apparatus comprising:

an electrogram reading device connected to said plurality of electrodes for sensing the amplitude variation in the electrical signal of a heart,

a sampling and digitizing circuit for digitizing samples of said cardiac electrical amplitude signal and to provide an output stream of digitized sample point values representative of said samples,

a V-event detection circuit for generating a V-event signal at its output indicating that a ventricular event has occurred,

a buffer circuit for holding a set of point values that are temporally related to a time in a cardiac cycle when said V-event signal is output from said V-event detection circuit,

a fiducial point determining circuit means for reading the set of point values from said buffer circuit for determining which of said point values is a fiducial point related to said V-event signal,

a subset determining and selecting circuit for determining based at least in part on a temporal relative location of said determined fiducial point to said set of point values which subset of said set of point values to select and selecting them,

a parameterizing processor circuit for producing a set of parameter values related to said set of point values selected and determined by said subset determining circuit wherein at least some of the parameters produced are evaluatable by an ST change parameter processor circuit,

an ST calculating circuit means for calculating a current ST change variable value,

an expected range value recalculating circuit for employing said set of parameter values and said pre-calculated expected ranges to produce new pre-calculated expected ranges and values for a next set of parameter values to be compared with a comparison circuit for comparing said pre-calculated expected ranges with each parameter value from said set of parameter values to determine if it is within its expected range and producing a validity value as an output,

a cardiac cycle validity determining circuit for determining if said validity value is sufficient to employ said set of parameter values for determining a physiologic condition and for recalculating said set of expected ranges by said recalculating circuit and for providing a flag value signal representing whether the determination of cycle validity for a cardiac cycle is sufficient,

an evaluation circuit for evaluating said physiologic condition based on running changes in said current ST Change variable value from those cycles determined to be sufficiently valid,

a filter circuit means for filtering said ST Change variable values so as to produce a physiologic indicator signal.

25. Apparatus as set forth in claim 24 further comprising means for locating an isoelectric level and wherein said physiologic indicator signal represents a level of ischemia and one of said parameter values is ST segment change and wherein said parameterizing processor determines ST segment change value based upon point values within said set of point values located temporally after said fiducial point and at said isoelectric level.

26. Apparatus as set forth in either of claims 24 or 25 wherein said fiducial point is at a peak of an R-wave temporally associated with said V event, called R-peak.

27. The apparatus of claim 24 further comprising therapy delivery means for delivering a therapy to a body from which said electrocardiogram signal is received, having a therapy control means responsive to changes in said physiological signal for directing and adapting said therapy delivery means to provide said therapy responsive to said physiological signal.

28. The apparatus of claim 24 wherein said therapy delivery means comprises stimulation circuit means for delivering timed electrical pulses to specific sites in said body via electrodes connecting said therapy delivery means to said body.

29. The apparatus of claim 24 wherein said therapy delivery means comprises drug delivery means for delivering physiologically active substances to said body in a time and dosage regulated manner.

30. The apparatus of claim 24 wherein said apparatus is a hermetically sealed chronically implantable medical device.

31. The apparatus of claim 24 wherein said sampling and digitizing circuit operates to produce digitized samples of said electrical cardiac signal for multiple electrode vectors simultaneously.

32. The apparatus of claim 31 wherein said expected range recalculating circuit recalculates expected ranges for each of said electrode vectors.

33. The apparatus of claim 32 further comprising expected space calculating and comparison circuit for calculating the expected space for a multidimensional parameter based on a combination of the expected ranges for each of said vectors.

34. The apparatus of claim 31 further comprising an axis shift determining circuit for determining whether a parameter value from a cardiac cycle for a plurality of vectors from said a cardiac cycle indicate an axis shift, and if so for producing an axis shift signal indicative of the axis shift.

35. The apparatus of claim 34 wherein said evaluation circuit for evaluating said physiologic condition further comprises a circuit for calculating the absolute value of the difference between the output from said fast filter circuit means and the output from said slow filter means and dividing it by a normalization factor.

36. The apparatus of claim 35 wherein said normalization factor calculator circuit further comprises an axis shift signal checking means and alternative normalization factor calculation means for computing said normalization factor based on the value of an axis shift signal factor if the axis shift signal is a predetermined level.

37. The apparatus of claim 24 wherein said filter circuit means for filtering said ST Change variable values further comprises a slow lowpass and a fast lowpass filter circuit for filtering said ST change variable values and wherein an output from said fast filter provides an input to both said slow lowpass filter and to said evaluation circuit for evaluating said physiologic condition.

38. The apparatus of claim 35 further comprising a normalization factor calculator circuit employing a value representative of either R-wave amplitude values or R-wave vector magnitude values and a previous normalization factor to compute said normalization factor.