Implantable medical device and method using integrated T-wave alternans analyzer

• US 6,823,213 B1
• Filed: 04/28/2000
• Issued: 11/23/2004
• Est. Priority Date: 04/28/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Van Oort, Geeske, Munneke, Dave J., Norris, John F.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/558,871
• Time in Patent Office: 1,670 Days
• Field of Search: 600/508-509, 600/515-518, 607/4-5, 607/9, 607/14, 607/17, 607/25, 607/26
• US Class Current: 607/9
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• 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 5/36 Detecting PQ interval, PR interval or QT interval
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An implantable medical device includes a sensor and a T-wave analyzer. The sensor is implantable within the body of a patient to sense electrical cardiac activity and provide an indication of T-wave alternans within the heart of the patient. The T-wave analyzer is responsive to the sensor, and evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion. The T-wave analyzer may form part of a microprocessor, a digital signal processor, or combination of both. The device may include a pacing generator that applies increased rate pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensor. The device also may incorporate a memory that stores the T-wave alternans indication provided by the sensor, e.g., over a number of heartbeats. In addition, the device may be equipped to provide an alert to the patient or a physician in the event the processor generates the indication of cardiac risk. The results of the T-wave alternans analysis over a period of time can be stored as data in memory for access by a physician, e.g., by telemetry. In response to the alternans data, the physician may prescribe pharmacologic therapy, programmed cardiac electrical stimulation, or modifications to an electrical stimulation program in the existing implanted device. In some cases, the implantable medical device can be programmed to response to the alternans data, e.g., by controlling a pacing generator.

Claims

1. A method for analyzing cardiac electrical activity, the method comprising:

sensing electrical cardiac activity using a sensor that is implanted within the body of a patient to provide an indication of T-wave alternans within the heart of the patient;

evaluating cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion;

sensing a state of increased heart rate by the patient, and

comparing the indication of T-wave alternans to the predetermined criterion in the event the state of increased heart rate is sensed.

2. The method of claim 1, further comprising storing the T-wave alternans indication provided by the sensor in a memory associated with a device implanted within the body of the patient.

3. The device of claim 1, further comprising providing an alert in the event the indication of T-wave alternans satisfies the predetermined criterion.

4. The method of claim 1, further comprising analyzing differences in the QT interval over a series of two or more heartbeats to evaluate the cardiac risk.

5. A method for analyzing cardiac electrical activity, the method comprising:

sensing electrical cardiac activity using a sensor that is implanted within the body of a patient to provide an indication of T-wave alternans within the heart of the patient;

evaluating cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

applying increased rate pacing stimuli to the heart using a pacing generator forming part of a device implanted within the body of the patient to facilitate sensing of the T-wave alternans by the sensor.

6. A method for analyzing cardiac electrical activity, the method comprising:

sensing electrical cardiac activity using a sensor that is implanted within the body of a patient to provide an indication of T-wave alternans within the heart of the patient;

evaluating cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion based on an operation selected from a group consisting of;

(i)

applying a Fourier analysis to at least a portion of the T-wave over a series of two or more heartbeats and providing the indication of T-wave alternans based on differences in the Fourier analysis over the series of two or more heartbeats;

(ii) comparing alternate repolarization signals over a series of two or more heartbeats to evaluate the cardiac risk;

(iii) counting the number of times the T-wave alternans satisfies the criterion, and generating an indication of cardiac risk in the event the number exceeds a predetermined threshold;

(iv) analyzing a relationship between the T-wave alternans and the predetermined criterion over a period of time, and storing results of the analysis in a memory associated with a device implanted within the patient for access by a physician;

(v) analyzing T-wave morphology using a digital signal processor (DSP) associated with a device implanted within the patient as a basis for the indication of the T-wave alternans.

7. The method of claim 6, further comprising applying pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensor, and controlling the pacing stimuli based on the indication of T-wave alternans to reduce cardiac risk for the patient.

8. An implantable medical device system comprising:

a sensor that is implantable within the body of a patent to sense electrical cardiac activity and provide an indication of T-wave alternans within the heart of the patient;

a T-wave analyzer, responsive to the sensor, that evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

a second sensor that senses a state of increased heart rate by the patient, wherein the T-wave analyzer is responsive to the second sensor in the evaluation of cardiac risk.

9. The system of claim 8, further comprising a pacing generator that applies increased rate pacing stimuli to the heart to facillitate sensing of the T-wave alternans by the sensor.

10. The system of claim 8, further comprising a memory that stores the T-wave alternans indication provided by the sensor.

11. The system of claim 8, further comprising a device that provides an alert in the event the indication of T-wave alternans satisfies the predetermined criterion.

12. The system of claim 8, wherein the T-wave analyzer analyzes differences in the QT interval over a series of two or more heartbeats to evaluate the cardiac risk.

13. An implantable medical device system comprising:

a sensor that is implantable within the body of a patient to sense electrical cardiac activity and provide an indication of T-wave alternans within the heart of the patient;

a T-wave analyzer, responsive to the sensor, that evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

wherein the T-wave analyzer analyzes differences in the amplitude of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

14. An implantable medical device system comprising:

a sensor that is implantable within the body of a patient to sense electrical cardiac activity and provide an indication of T-wave alternans within the heart of the patient;

a T-wave analyzer, responsive to the sensor, that evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

wherein the T-wave analyzer analyzes differences in the slope of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

15. An implantable medical device system comprising:

a sensor that is implantable within the body of a patient to sense electrical cardiac activity and provide an indication of T-wave alternans within the heart of the patient;

a T-wave analyzer, responsive to the sensor, that evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

wherein the T-wave analyzer operates to perform an operation selected from a group consisting of;

(i) applying a Fourier analysis to at least a portion of the T-wave over a series of two or more heartbeats and assessing cardiac risk based on differences in the Fourier analysis over the series of two or more heartbeats;

(ii) comparing alternate repolarization signals over a series of two or more heartbeats to evaluate the cardiac risk; and

(iii) counting the number of times the T-wave alternans satisfies the criterion and indicating cardiac risk in the event the number exceeds a predetermined threshold.

16. The system of claim 15, further comprising a memory, wherein the T-wave analyzer analyzes a relationship between the T-wave alternans and the predetermined criterion over a period of time;

and stores results of the analysis in the memory for access by a physician.

17. The system of claim 15, wherein the T-wave analyzer includes a digital signal processor (DSP) that analyzes T-wave morphology as a basis for the evaluation of cardiac risk.

18. The system of claim 15, further comprising a pacing generator applies pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensor, the system further comprising a processor that controls the pacing generator based on the indication of T-wave alternans to reduce cardiac risk for the patient.

19. An implantable cardiac pacemaker device comprising:

a pacing generator that generates electrical pacing stimuli;

one or more leads, coupled to the pacing generator, that apply the electrical pacing stimuli to the heart of a patient;

a sensor that senses electrical cardiac activity and provides an indication of T-wave alternans within the heart of the patient; and

a T-wave analyzer, responsive to the sensor, that controls the pacing generator to generate increased rate electrical pacing stimuli, whereby the desired physiological conditions for T-wave alternans analysis can be invoked to facilitate the sensing of the electrical cardiac activity by the sensor, and evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion, wherein the T-wave analyzer analyzes differences in the amplitude of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

20. The device of claim 19, further comprising a memory that stores the T-wave alternans indication provided by the sensor.

21. The device of claim 19, further comprising a device that provides an alert in the event the indication of T-wave alternans satisfies the predetermined criterion.

22. The device of claim 19, wherein the T-wave analyzer analyzes differences in the QT interval over a series of two or more heartbeats to evaluate the cardiac risk.

23. The device of claim 19, further comprising a pacing generator that applies pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensor, and a controller that controls the pacing generator based on the indication of cardiac risk to reduce cardiac risk for the patient.

24. An implantable cardiac pacemaker device comprising:

a pacing generator that generates electrical pacing stimuli;

one or more leads, coupled to the pacing generator, that apply the electrical pacing stimuli to the heart of a patient;

a sensor that senses electrical cardiac activity and provides an indication of T-wave alternans within the heart of the patient; and

a T-wave analyzer, responsive to the sensor, that controls the pacing generator to generate increased rate electrical pacing stimuli, whereby the desired physiological conditions for T-wave alternans analysis can be invoked to facilitate the sensing of the electrical cardiac activity by the sensor, and evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion, wherein the T-wave analyzer analyzes differences in the slope of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

25. An implantable cardiac pacemaker device comprising:

a pacing generator that generates electrical pacing stimuli;

one or more leads, coupled to the pacing generator, that apply the electrical pacing stimuli to the heart of a patient;

a sensor that senses electrical cardiac activity and provides an indication of T-wave alternans within the heart of the patient; and

a T-wave analyzer, responsive to the sensor, that controls the pacing generator to generate increased rate electrical pacing stimuli, whereby the desired physiological conditions for T-wave alternans analysis can be invoked to facilitate the sensing of the electrical cardiac activity by the sensor, and evaluates cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion, wherein the T-wave analyzer applies a Fourier analysis to at least a portion of the T-wave over a series of two or more heartbeats and evaluates cardiac risk based on differences in the Fourier analysis over the series of two or more heartbeats.

26. The device of claim 25, wherein the T-wave analyzer compares alternate repolarization signals over a series of two or more heartbeats to evaluate the cardiac risk.

27. The device of claim 25, wherein the T-wave analyzer counts the number of times the T-wave alternans satisfies the criterion, and generates an indication of cardiac risk in the event the number exceeds a predetermined threshold.

28. The device of claim 25, further comprising a memory, wherein the T-wave analyzer analyzes a relationship between the T-wave alternans and the predetermined criterion over a period of time, and stores results of the analysis in the memory for access by a physician.

29. The device of claim 25, wherein the T-wave analyzer includes a digital signal processor (DSP) that analyzes T-wave morphology as a basis for the evaluation of cardiac risk.

30. An implantable medical device system comprising:

means, implantable within the body of a patient, for sensing electrical cardiac activity and providing an indication of T-wave alternans within the heart of the patient;

means, responsive to the sensing means, for evaluating cardiac risk based on comparison of the indication of T-wave alternans to a predetermined criterion; and

means for applying increased rate pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensing means.

31. The system of claim 30, further comprising means for sensing a state of increased heart rate by the patient, wherein the evaluating means is responsive to the state sensing means in evaluating cardiac risk.

32. The system of claim 30, further comprising means for storing the T-wave alternans indication provided by the sensing means.

33. The system of claim 30, further comprising means for providing an alert in the event the indication of T-wave alternans satisfies the predetermined criterion.

34. The system of claim 30, wherein the evaluating means analyzes differences in the QT interval over a series of two or more heartbeats to evaluate the cardiac risk.

35. The system of claim 30, wherein the evaluating means analyzes differences in the amplitude of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

36. The system of claim 30, wherein the evaluating means analyzes differences in the slope of the T-wave over a series of two or more heartbeats to evaluate the cardiac risk.

37. The system of claim 30, wherein the evaluating means analyzes differences in T-wave characteristics over a series of two or more heartbeats to evaluate the cardiac risk.

38. The system of claim 37, wherein the evaluating means applies a Fourier analysis to at least a portion of the T-wave over a series of two or more heartbeats and provides the evaluation of cardiac risk based on differences in the Fourier analysis over the series of two or more heartbeats.

39. The system of claim 37, wherein the evaluating means compares alternate repolarization signals over a series of two or more heartbeats to evaluate the cardiac risk.

40. The system of claim 37, wherein the evaluating means counts the number of times the T-wave alternans satisfies the criterion, and generates an indication of cardiac risk in the event the number exceeds a predetermined threshold.

41. The system of claim 30, further comprising a memory, wherein the evaluating means analyzes a relationship between the T-wave alternans and the predetermined criterion over a period of time, and stores results of the analysis in the memory for access by a physician.

42. The system of claim 30, wherein the evaluating means includes a digital signal processor (DSP) that analyzes T-wave morphology as a basis for the evaluation of cardiac risk.

43. The system of claim 30, further comprising means for applying pacing stimuli to the heart to facilitate sensing of the T-wave alternans by the sensing means, the system further comprising a means for controlling the pacing generator based on the indication of T-wave alternans to reduce cardiac risk for the patient.