Methods of characterizing ventricular operations and applications thereof

• US 6,438,409 B1
• Filed: 03/24/2000
• Issued: 08/20/2002
• Est. Priority Date: 03/25/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Acar, Burak, Batchvarov, Velislav Nikolaev, Malik, Marek
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/534,454
• Time in Patent Office: 879 Days
• Field of Search: 600/508, 600/509, 600/510, 600/512
• US Class Current: 600/512
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system

Abstract

New methods of characterising ventricular operations by measuring propagation characterisics of the repolarisation wavefront (the T wave) are disclosed, the methods use new descriptions of T wave Morphology Dispersion (TMD), Total Cosin R_ to _T (TCRT) and T wave energy residium to quantify the wavefront characteristics, these descriptors measure the spatial variability of the T wave Morphology, the vector deviations between the depolarisation and repolarisation wavefronts and the energy of the non-dipolar components of the ECG vector respectively. TCRT also provides a responsive descriptor for measuring autonomic tone. As such, has applications for improved pacing and autonomic nervous system monitors.

Claims

1. A method of characterising ventricular operation of a patient'"'"'s heart, comprising sensing a plurality of electrical signals heart from different spatial positions with respect to the heart during depolarisation and repolarisation of the patient'"'"'s heart, the plurality of electrical signals monitoring the propagation of depolarisation and repolarisation waves originating in the patient'"'"'s heart, processing the plurality of electrical signals to yield a vector which describes the propagation direction of one of the depolarisation and repolarisation wavefronts, and a set of a plurality of vectors which describe the propagation direction of the other of the depolarisation and repolarisation wavefronts with respect to time, and determining the vector deviation between the depolarisation and repolarisation wavefronts by measuring the angle between pairs of respective vectors for all combinations of depolarisation vector to repolarisation vector between predetermined time limits, wherein the cosine of the angle between each depolarisation/repolarisation vector pair is calculated.

2. A method as in claim 1, wherein angles are measured between a vector for the repolarisation wave, which corresponds to a direction of maximum energy of the repolarisation wave, and each vector from a set of vectors describing the depolarisation wave at different time instances, the set of vectors corresponding to substantially the whole duration of depolarisation of the patient'"'"'s heart.

3. A method as in claim 1 or 2, wherein the mean cosine of the angle is calculated for all depolarisation/repolarisation vector pairs.

22. A method as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20 or 21, wherein the plurality of electrical signals are measured from electrodes positioned in different spatial positions corresponding to the standard ECG leads of I, II, V1, V2, V3, V4, V5 and V6.

23. A method of detecting whether a patient is healthy or sick, wherein more than one parameter characterising ventricular operation as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22 is calculated.

24. A method of detecting abnormalities of ventricular repolarisation in a patient using a method of characterising ventricular operation as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, wherein preferably said method is a method of detecting the onset of ischemia.

25. A method of determining whether a patient is suffering from heart failure, and preferably a method of determining whether the patient is suffering from one of hypertropic cardiomyopathy, idiopathic dilated cardiomyopathy and acute myocardial infarction, comprising measuring a parameter characterising ventricular operation as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, wherein preferably the method is accomplished by employing an implantable medical device which is capable of sensing depolarisation and repolarisation waves, and processing same.

26. A method of categorising subjects using a method of characterising ventricular operation as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22.

27. A method of monitoring the autonomic system of a subject, wherein a method of characterising ventricular operation as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, is used to measure changes in the autonomic system of the subject, wherein the method is accomplished by employing an implantable medical device which is capable of sensing depolarisation and repolarisation waves and processing same.

28. A method as in claim 27, wherein changes in the autonomic system of the patient are measured to:

f) monitor the progress of a disease in a subject;

g) monitor the influence of drugs on the autonomic system of a subject;

h) control the rate of pacing for a pacemaker;

i) control a drug dispensing pump and/or

j) test the response of the autonomic system of a subject.

29. A method as in claim 28, wherein changes in the autonomic system of the patient are measured while the patient executes a predetermined procedure to effect a change in autonomic system, wherein preferably the autonomic system is measured while Valsalva manoeuvre is performed by the patient and/or while a set of postural changes are executed by the patient.

35. A method as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21 or 33 wherein data from the electrical signals is decomposed into an optimum domain space using singular value decomposition.

36. A system for measuring characteristics of ventricular operation of patient'"'"'s heart in accordance with any of the methods of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, comprising a plurality of electrodes for sensing a plurality of electrical signals in different spatial positions in, on or near to a patient'"'"'s heart to monitor the propagation of depolarisation and repolarisation waves originating in the patient'"'"'s heart, a microprocessor for processing the plurality of electrical signals to determine a characteristic of ventricular operation, and an indicator to convey the value of the measured characteristic, or condition of the patient'"'"'s autonomic system, to an observer, wherein preferably the indicator is a visual display and/or an audible alarm.

37. A system as in claim 36, wherein the system senses the plurality of electrical signals via:

e) at least one electrode attached to a medical electrical lead of an implantable medical device selected from the group of pacemaker, cardioverter, defibrillator, pacemaker-cardioverter-defibrillator and heart monitor which is implanted within the subject'"'"'s body;

f) at least one electrode provided on a housing of an implantable medical device;

g) at least one subcutaneous electrode; and

/or

h) at least one external electrode applied to the patient'"'"'s body.

38. A system as in any of claim 36 or 37, wherein the system has eight electrodes which correspond to the standard electrode positions of I, II, V1, V2, V3, V4, V5 and V6.

39. An implantable medical device which measures characteristics of ventricular operation of a patient'"'"'s heart in accordance with any of the methods of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, comprising a plurality of electrodes for sensing a plurality of electrical signals in different spatial positions in, on or near to a patient'"'"'s heart to monitor the propagation of depolarisation and repolarisation waves originating in the patients heart, and a microprocessor for processing the plurality of electrical signals to measure a characteristic of ventricular operation, and to generate an output signal corresponding to said measured characteristic.

40. An apparatus as in claim 39, wherein the apparatus is at least one of:

f) a pacemaker or pacemaker-cardioverter-defibrillator having a pacing rate which is controlled in response to the calculated characteristic of ventricular operation;

g) a cardioverter or a defibrillator, the operation of which is controlled in response to the calculated characteristic of ventricular operation;

h) a monitor for detecting abnormalities in ventricular repolarisation, the device preferably being able to trigger a warning signal when the calculated characteristic of ventricular operation is within certain limits;

i) a monitor for measuring changes in the autonomic system of a subject, the device preferably being able to trigger a warning signal when the calculated characteristic of ventricular operation is within certain limits; and

/or

j) a device for controlling a drug dispensing pump.

41. A computer program, comprising software code portions for performing the method as claimed in any of claim 1, 3, 4, 5, 6, 14, 15, 16, 17, 19, 20, 21, 33 or 22, a computer program product which is directly loadable into the internal memory of a digital computer, comprising software code portions for performing said method, a microprocessor which is programmed with software code portions for performing said method, or a digital computer which is programmed with software code portions for performing said method.

4. A method of characterising ventricular operation of a patient'"'"'s heart, comprising sensing the propagation of depolarisation and repolarisation waves originating in the heart, determining vectors which are representative of the direction of the wavefronts of the depolarisation and repolarisation waves, and determining the vector deviation between the depolarisation and repolarisation vectors by determining the cosine of the angle between the vectors describing the depolarisation and repolarisation wavefronts, wherein the vector deviation is a function of:

a) the cosine of the angle between two vectors, each vector describing one of the depolarisation and repolarisation wavefronts;

d) the cosines of the angles between a vector describing either the depolarisation or repolarisation wavefront and a set of vectors describing the other of the depolarisation or repolarisation wavefront for a plurality of time instances;

or

e) the cosines of the angles between a set of vectors describing the depolarisation wavefront for a plurality of lime instances and a set of vectors describing the repolarisation wavefront for a plurality of time instances.

5. A method as in claim 4, wherein data is produced for the propagation of the depolarisation and repolarisation wave with respect to a first set of axes, the data is transformed to a new set of axes defining an optimised orthogonal domain having a first axis aligned with a direction of maximum energy for depolarisation or repolarisation and wherein the vector deviation is measured in the optimised orthogonal domain.

6. A method of characterising ventricular operation of a patient'"'"'s heart, comprising sensing a plurality of electrical signals from different spatial positions with respect to the heart during depolarisation and repolarisation of the heart, the plurality of electrical signals being sensed by an implantable medical device and being associated with the propagation of depolarisation and repolarisation waves originating from a patient'"'"'s heart, processing the electrical signals to yield a plurality of vectors which describe the propagation direction of a wavefront for a depolarisation wave and a plurality of vectors which describe the propagation direction of a wavefront for a repolarisation wave, wherein ventricular operation is characterised in terms of the cosine of the angle between the plurality of vectors for the depolarisation and repolarisation waves, wherein at least one of the plurality of vectors describes the propagation of the wavefront as a function of time and the mean of the cosine of the angle between pairs of vectors is determined.

7. An implantable medical device comprising a plurality of medical electrical leads, the leads having electrodes for sensing electrical signals from different spatial positions in, on or near a patient'"'"'s heart, wherein the device processes the electrical signals to yield directions of propagation for depolarisation and repolarisation waves of a patients heart, calculates the angle of deviation between the depolarisation and repolarisation waves, and generates an output signal corresponding to the angle of deviation, wherein the output signal varies in accordance with the cosine of the angle of deviation.

8. A device as in claim 7, wherein the angle of deviation between the depolarisation and repolarisation waves is calculated with respect to time and the output signal varies in accordance with the mean of the cosine of the angle of deviation for a plurality of time instances.

9. A device as in claim 8, wherein the output signal varies in accordance with the mean of a set of cosine values for the angle of deviation between the direction of the repolarisation wavefront for a maximum energy value and the direction of the depolarisation wavefront as a function of time for all time instances between start and finish points of depolarisation.

10. A device as in any of claim 7, 8, or 9, wherein the output signal is used for at least one of:

g) control pacing of the patient'"'"'s heart;

h) monitor the condition of the patient'"'"'s heart;

i) monitor the progression of disease in the patient'"'"'s heart;

j) raise an alarm when the angle is outside predetermined limits;

k) control a drug dispensing pump; and

/or

l) monitor the response of the patient'"'"'s autonomic system.

11. A device as in any of claims 7 through 10, wherein the device is selected from the group of pacemaker, cardioverter, defibrillator, pacemaker-cardioverter-defibrillator, heart monitor and drug dispensing pump.

12. A device as in any of claims 7 through 11, wherein additional electrical signals are sensed by:

d) at least one electrode provided on a housing of the device;

e) at least one subcutaneous electrode; and

/or

f) at least one external electrode that is applied to a patient'"'"'s body.

13. A device as in claim 12, wherein the at least one electrode is coupled to the device by a medical electrical lead, by an electrical connection or by a radio frequency transmitter.

14. A method of characterising ventricular operation, comprising sensing a plurality of electrical signals associated with the propagation of a repolarisation wave originating in the patient'"'"'s heart, the plurality of electrical signals being sensed from different spatial positions on, in or near the patient'"'"'s heart, processing the plurality of electrical signals to yield a plurality of vectors that are representative of the wavefront of the repolarisation wave, and determining a measure of the spatial variation of the repolarisation wavefront, wherein the spatial variation is calculated by determining vector contributions for the repolarisation wavefront in each of a set of predetermined directions and measuring the angle between pairs of vector contributions.

15. A method as in claim 14, wherein the pre-determined directions correspond with at least three of the standard ECG channels of I, II, V1, V2, V3, V4, V5 and V6, and preferably the vector contribution for the ECG channel of V1 is ignored in the calculation.

16. A method of characterising ventricular operation of a patient'"'"'s heart, comprising sensing a plurality of electrical signals to monitor repolarisation of the heart from different spatial positions with respect to the patients heart, processing the plurality of signals to yield a vector describing the propagation of a repolarisation wave through the heart, projecting the vector onto a set of axes to determine vector contributions of the signal vector in the directions of the axes, and measuring the angle between pairs of vector contributions, wherein the vector corresponds to a direction of maximum energy of the repolarisation wave.

17. A method of characterising ventricular operation of a patient'"'"'s heart comprising sensing a plurality of electrical signals to monitor propagation of repolarisation through the heart from different spatial positions with respect to the patient'"'"'s heart, processing the plurality of electrical signals to yield a vector describing the propagation of a repolarisation wave with respect to time and with respect to a first set of axes defining an optimum domain space, mapping the path of a tip of the vector in the optimum domain space to generate a T-wave loop and calculating a parameter describing the morphology variation of that loop, wherein the parameter is determined by projecting the T-wave loop on to reconstruction vectors corresponding to electrode positions to generate vector contributions in those electrode directions, and determining the angle between all pairs of vector contributions.

18. A method as in claim 17, wherein the reconstruction vectors correspond to the position of at least three of the standard ECG leads of I, II, V1, V2, V3, V4, V5 and V6, and preferably the vector contribution from the standard ECG lead of V1 is ignored in the calculation.

19. A method as in any of claim 17 or 18, wherein the T-wave loop is mapped in two orthogonal dimensions and the energy of the T-wave loop in the two orthogonal dimensions is equalised prior to calculating said parameter.

20. A method of characterising ventricular operation of a patient'"'"'s heart comprising sensing a plurality of electrical signals associated with the propagation of a repolarisation wave originating in the patient'"'"'s heart from different spatial positions with respect to the patient'"'"'s heart, processing the plurality of electrical signals to yield a vector which is representative of the wavefront of the repolarisation wave with respect to a first set of axes, transforming the vector to a second set of axes defining an optimised orthogonal domain having a first axis aligned with a direction of maximum energy, the domain comprising three dimensions representing the dipolar components of the repolarisation wavefront vector and at least one further dimension representing the non-dipolar components of the repolarisation wavefront vector and determining the energy of the non-dipolar components, wherein said optimised orthogonal domain has eight dimensions and the transformed repolarisation wavefront vector S has eight components s₁ to s₈ corresponding one to each dimension, wherein the vector components are ranked in order of most significance with respect to energy and the non-dipolar components are represented by the fourth to eighth components s₄ to s₈.

21. A method as in claim 20, wherein the energy of the non-dipolar components is determined for a portion of the repolarisation wave corresponding to a particular region of the heart muscle.

30. A method of determining depolarisation start and end points for measuring characteristics of a signals representing changes in energy during depolarisation of a patient'"'"'s heart, comprising finding a first peak in the energy of the signal corresponding to depolarisation of the patient'"'"'s heart, determining a point in time, t_RP, corresponding to the peak energy and determining the maximum energy E_Rmax of the signal at that point, determining a point in time t′

_RS before t_RP and a point in time t′

_RE after t_RP where the energy of the signal drops to a predetermined percentage of the maximum energy, determining the depolarisation start point by subtracting a first predetermined time interval from time t′

_RS and determining the depolarisation end point by adding a second predetermined time interval to time t′

_RE.

31. A method as claimed in claim 30, wherein said predetermined percentage of the maximum energy E_Rmax is in range of 50 to 90% of E_Rmax, preferably in the range of 60 to 80% of E_Rmax, and most preferably 70% of E_Rmax.

32. A method as claimed in claim 31, wherein said first and second predetermined time intervals are in the range of 38 to 58 msec, preferably in the range of 43 to 53 msec, and most preferably 48 msec.

33. A method of determining repolarisation start and end points for a signal representing changes in energy during depolarisation and repolarisation of a patient'"'"'s heart, comprising:

finding a first peak in the energy of the signal corresponding to depolarisation of the patient'"'"'s heart, determining the maximum energy E_Rmax of the signal at the peak and determining a point in time t′

_RE where the energy of signal has dropped to a predetermined percentage of E_Rmax, finding the next peak in the signal energy corresponding to repolarisation and determining the point in time t_TP where that peak occurs, determining the repolarisation start point as a predetermined fraction of the time interval between t′

_RE and t_TP;

determining the repolarisation end point by determining a vector s_2D(t_i) which describes the repolarisation wavefront as projected on to a plane spanned by two orthogonal vectors u₁ and u₂ which represent the maximum energy and next most energy of the repolarisation wave in two orthogonal directions for t_i≧

t_TS, the vector having a tip which defines a path on said plane, dividing the area defined by the path of the tip of S_2D(t_i) in the plane of u₁ and u₂ into a plurality of equal rectangular cells, assigning a measure D_i to each cell dependent on the time spent by the tip of s_2D(t_i) in the i^th cell, discarding cells having the measures D_i=0 and ordering all other cells in respect of D_i, determining a threshold value D_th of D_i which is greater than the mean value of D_i, and determining the end point of repolarisation t_TE as a point at which D_i ≧

D_th.

34. A method as claimed in claim 33, wherein said predetermined fraction of the time interval between t′

_RE and t_TP is in the range ¼

to ½

preferably said predetermined fraction of the time interval between t′

_RE and t_TP is □

.