Methods and apparatus for detecting and/or monitoring heart failure

• US 7,020,521 B1
• Filed: 11/08/2002
• Issued: 03/28/2006
• Est. Priority Date: 11/08/2002
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Kroll, Mark W., Brewer, James E.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/291,267
• Time in Patent Office: 1,236 Days
• Field of Search: 600515-518, 607 9- 14, 607/44
• US Class Current: 607/14
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

Methods and apparatuses are provided for assisting with the diagnosis, monitoring, and/or treatment of patients that are suffering from asymptomatic heart failure or may be susceptible to asymptomatic heart failure. The methods and apparatuses can be implemented with implantable devices. In certain implementations, a method is provided which includes sensing muscle sympathetic nerve activity using at least one nerve sensing electrode that is in electrical contact with a patient'"'"'s efferent muscle-nerve structure, acquiring a muscle sympathetic nerve activity signal from the sensed nerve activity using a nerve activity sensing circuit operatively coupled to the nerve sensing electrode, and analyzing the nerve activity signal for changes in nerve burst activity indicative of the presence and/or severity of asymptomatic heart failure.

Claims

1. A method for use with an implantable device, the method comprising:

extracting muscle sympathetic nerve activity over a period of time from a sensed implantable electrode signal; and

determining a level of heart failure based on the extracted muscle sympathetic nerve activity;

wherein the muscle sympathetic nerve activity is extracted by amplifying the sensed implantable electrode signal in the range between about 10,000 and about 100,000 and bandpass filtering the amplified activity signal on a musde sympathetic nerve activity bandpass range.

2. The method as recited in claim 1, further comprising:

selectively applying cardiac stimulation therapy using at least one implantable cardiac stimulation electrode based at least in part on the determined level of heart failure.

3. The method as recited in claim 1, further comprising:

outputting information to a non-implantable device based on the determined level of heart failure.

4. The method as recited in claim 1, wherein the sensed implantable electrode signal is sensed by at least one implantable electrode operatively configured on a lead.

5. The method as recited in claim 1, wherein the sensed implantable electrode signal is sensed by at least one implantable electrode operatively provided by at least a portion of a body of the implantable device.

6. The method as recited in claim 1, wherein muscle sympathetic nerve activity bandpass range is between about 500 Hz and about 2500 Hz.

7. An implantable device comprising:

a housing;

at least one implantable electrode that is operative to detect nerve activity;

circuitry, at least partially arranged within the housing, and configured to sense nerve activity over a period of time using the at least one implantable electrode and extract muscle sympathetic nerve activity from the nerve activity; and

control circuitry operatively coupled to the circuitry and configured to determine a level of heart failure based on the extracted muscle sympathetic nerve activity;

wherein the circuitry is configured to extract a muscle sympathetic nerve activity signal by amplifying a nerve activity signal in the range between about 10,000 and about 100,000 and bandpass filtering the amplified nerve activity signal on a nerve activity bandpass range.

8. The implantable device as recited in claim 7, further comprising:

therapy applying circuitry, at least partially arranged within the housing and operatively coupled to the control circuitry and configurable to selectively apply shock therapy to a patient'"'"'s heart based at least in part on the determined level of heart failure.

9. The implantable device as recited in claim 7, further comprising:

communication circuitry, at least partially arranged within the housing and operatively coupled to the control circuitry and configurable to output information to a non-implantable device based on the determined level of heart failure.

10. The implantable device as recited in claim 7, wherein the at least one implantable electrode is operatively configured on a lead that extends outwardly from the housing.

11. The implantable device as recited in claim 7, wherein at least a portion of the housing is configurable to act as the at least one implantable electrode.

12. The apparatus as recited in claim 7, wherein the nerve activity bandpass range is between about 500 Hz and about 2500 Hz.

13. A method for detecting heart failure, the method comprising:

sensing nerve activity using at least one nerve sensing electrode that is in electrical contact with a patient'"'"'s efferent muscle-nerve structure, and extracting a corresponding muscle sympathetic nerve activity signal;

analyzing the muscle sympathetic nerve activity signal for changes in nerve burst activity over time; and

determining a degree of heart failure based on the changes in nerve burst activity over time;

wherein the muscle sympathetic nerve activity signal is extracted by receiving a nerve activity signal from the at least one nerve sensing electrode, amplifying the nerve activity signal in the range between about 10,000 and about 100,000, and bandpass filtering the amplified nerve activity signal on a nerve activity bandpass range.

14. The method as recited in claim 13, wherein analyzing the nerve activity signal for changes in nerve burst activity further comprises:

producing a nerve burst count based on a number of applicable bursts in the nerve activity signal;

constructing histogram information based on the nerve burst count; and

determining a degree of heart failure severity based on the histogram information.

15. The method as recited in claim 14, wherein determining the degree of heart failure further comprises using neural network logic to determine the degree of heart failure severity.

16. The method as recited in claim 14, wherein determining the degree of heart failure severity further comprises using at least one statistically derived histogram characteristic to determine the degree of heart failure severity.

17. The method as recited in claim 14, wherein the degree of heart failure severity is between 0 and 1.

18. The method as recited in claim 13, further comprising monitoring the degree of heart failure severity over an extended period of time to possibly detect long-term changes thereto.

19. The method as recited in claim 18, wherein monitoring the degree of heart failure severity over an extended period of time further comprises using linear regression analysis to detect the long-term changes.

20. The method as recited in claim 18, further comprising reporting the detected long-term changes.

21. The method as recited in claim 13, further comprising reporting information associated with the nerve burst activity and indicative of heart failure.

22. The method as recited in claim 21, wherein the information comprises degree of heart failure severity information.

23. The method as recited in claim 13, wherein sensing nerve activity is performed substantially continuously.

24. The method as recited in claim 13, wherein sensing nerve activity is performed periodically.

25. The method as recited in claim 13, wherein the efferent muscle-nerve structure comprises a pectoral structure.

26. The method as recited in claim 13, further comprising selectively applying shock therapy to the patients heart based on the nerve burst activity.

27. The method as recited in claim 13, wherein nerve activity bandpass range is between about 500 Hz and about 2500 Hz.

28. An apparatus for detecting heart failure in a patient, the apparatus comprising:

a nerve activity sensor operatively configurable to sense nerve activity within a patient and output a corresponding nerve activity signal; and

control circuitry operatively coupled to the nerve activity sensor and configured to extract a muscle sympathetic nerve activity signal from the nerve activity signal and analyze the muscle sympathetic nerve activity signal for changes in nerve burst activity that is indicative of heart failure;

wherein the control circuitry is configured to extract the muscle sympathetic nerve activity signal by amplifying the nerve activity signal in the range between about 10,000 and about 100,000 and bandpass filtering the amplified nerve activity signal on a nerve activity bandpass range.

29. The apparatus as recited in claim 28, wherein the nerve activity sensor comprises at least one nerve sensing electrode configurable to be placed in electrical contact with a selected nerve fiber bundle within the patient.

30. The apparatus as recited in claim 29, wherein the selected nerve fiber bundle is within an efferent muscle-nerve structure that comprises a pectoral structure.

31. The apparatus as recited in claim 28, wherein the control circuitry is configured to analyze the muscle sympathetic nerve activity signal for changes in nerve burst activity by producing a nerve burst count based on a number of applicable bursts in the muscle sympathetic nerve activity signal, generating histogram information based on the nerve burst count, and determining a degree of heart failure severity based on the histogram information.

32. The apparatus as recited in claim 31, wherein the control circuitry further comprises neural network circuitry configured to determine the degree of heart failure severity.

33. The apparatus as recited in claim 31, wherein the control circuitry determines the degree of heart failure severity based on at least one statistically derived histogram characteristic.

34. The apparatus as recited in claim 28, further comprising:

treatment circuitry operatively coupled to the control circuitry and configured to selectively cause shock therapy to be applied to the patient'"'"'s heart based on the nerve burst activity.

35. The apparatus as recited in claim 28, wherein the nerve activity bandpass range is between about 500 Hz and about 2500 Hz.