METHOD AND APPARATUS FOR SYNCHRONIZING NEURAL STIMULATION TO CARDIAC CYCLES

• US 20080167693A1
• Filed: 10/05/2007
• Published: 07/10/2008
• Est. Priority Date: 10/04/2004
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Rossing, Martin A., Kieval, Robert S., Irwin, Eric D., Brintnall, John R.
• Application Number:
  US11/868,408
• Publication Number:
  US 20080167693A1
• Time in Patent Office: Days
• US Class Current: 607/18
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

The present invention comprises a neural stimulator having an output to deliver neural stimulation pulses, a sensor to sense a reference signal indicative of cardiac cycles each including a predetermined type timing reference event, the sensor being external to the circulatory system. The neural stimulator further includes detection circuitry coupled to the sensor to detect the predetermined type timing reference event, and a control circuit having an offset interval generator and a pulse delivery controller.

Claims

1. A neural stimulation system coupled to a living subject having a circulatory system, the neural stimulation system comprising:

a stimulation output circuit to deliver neural stimulation pulses;

an implantable reference signal sensor to sense a reference signal indicative of cardiac cycles each including a predetermined type timing reference event, the implantable reference signal sensor configured for placement external to the circulatory system;

a reference event detection circuit coupled to the reference event sensor, the reference event detection circuit adapted to detect the predetermined type timing reference event; and

a stimulation control circuit coupled to the stimulation output circuit and the reference event detection circuit, the stimulation control circuit adapted to control the delivery of the neural stimulation pulses and including a synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type timing reference event.

2. The neural stimulation system of claim 1, further comprising an implantable housing adapted to contain at least the stimulation output circuit, the reference event detection circuit, and the stimulation control circuit.

3. The neural stimulation system of claim 2, wherein the reference signal comprises a subcutaneous electrocardiogram (ECG) signal, and wherein the implantable reference signal sensor comprises one or more subcutaneous electrodes adapted to sense a subcutaneous ECG signal.

4. The neural stimulation system of claim 1, wherein the reference signal comprises an acoustic signal indicative of heart sounds, and wherein the implantable reference signal sensor comprises an acoustic sensor to sense the acoustic signal.

5. The neural stimulation system of claim 1, wherein the reference signal comprises a signal indicative of a hemodynamic signal indicative of hemodynamic performance, and wherein the implantable reference signal sensor comprises a hemodynamic sensor to sense the hemodynamic signal.

6. The neural stimulation system of claim 1, wherein the reference event detection circuit comprises a signal processor adapted to extract the predetermined type timing reference event from the reference signal for each of the cardiac cycles.

7. The neural stimulation system of claim 6, wherein the synchronization module comprises a continuous synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type timing reference event consecutively for each of the cardiac cycles.

8. The neural stimulation system of claim 1, wherein the reference event detection circuit comprises a signal processor adapted to extract the predetermined type timing reference event from a segment of the reference signal associated with a plurality of cardiac cycles.

9. The neural stimulation system of claim 8, wherein the synchronization module comprises a periodic synchronization module adapted to synchronize the delivery of the neural stimulation pulses periodically for a cardiac cycle of a predetermined number of the cardiac cycles.

10. The neural stimulation system of claim 1, wherein stimulation control circuit comprises an offset interval generator to produce an offset interval starting with the predetermined type timing reference event and a pulse delivery controller adapted to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

11. A neural stimulation system, comprising:

a stimulation output circuit to deliver neural stimulation pulses;

one or more implantable electrodes configured to sense a subcutaneous ECG signal;

a cardiac event detection circuit coupled to the one or more implantable electrodes, the cardiac event detection circuit adapted to detect predetermined type cardiac events from the subcutaneous ECG signal; and

a stimulation control circuit coupled to the stimulation output circuit and the cardiac event detection circuit, the stimulation control circuit adapted to control the delivery of the neural stimulation pulses and including a synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type cardiac events.

12. The neural stimulation system of claim 11, wherein the stimulation control circuit comprises an offset interval generator to produce an offset interval starting with one of the detected predetermined type cardiac events and a pulse delivery controller adapted to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

13. The neural stimulation system of claim 11, wherein the cardiac event detection circuit comprises an R-wave detector to detect ventricular depolarizations (R-waves).

14. The neural stimulation system of claim 11, wherein the cardiac event detection circuit comprises a P-wave detector to detect atrial depolarizations (P-waves).

15. The neural stimulation system of claim 14, wherein the P-wave detector comprises a signal averaging circuit to average the subcutaneous ECG signal over a plurality of cardiac cycles.

16. The neural stimulation system of claim 11, further comprising an implantable housing to house the stimulation output circuit, the cardiac event detection circuit, and the stimulation control circuit, and wherein the one or more implantable electrodes are incorporated onto the implantable housing.

17. The neural stimulation system of claim 16, further comprising an arrhythmia detection circuit to detect an arrhythmia from the subcutaneous ECG signal, and wherein the stimulation control circuit is adapted to withhold or adjust the delivery of the neural stimulation pulses when the arrhythmia is detected.

18. The neural stimulation system of claim 16, further comprising a cardiac parameter measurement circuit to measure one or more cardiac parameters from the subcutaneous ECG signal, and wherein the stimulation control circuit is adapted to adjust the delivery of the neural stimulation pulses based on the measured one or more cardiac parameters.

19. A neural stimulation system, comprising:

a stimulation output circuit to deliver neural stimulation pulses;

an acoustic sensor to sense an acoustic signal indicative of heart sounds;

a heart sound detection circuit coupled to the acoustic sensor, the heart sound detection circuit adapted to detect predetermined type heart sounds using the acoustic signal; and

a stimulation control circuit coupled to the stimulation output circuit and the heart sound detection circuit, the stimulation control circuit adapted to control the delivery of the neural stimulation pulses and including a synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type heart sounds.

20. The neural stimulation system of claim 19, wherein the acoustic sensor comprises an implantable accelerometer.

21. The neural stimulation system of claim 20, wherein the stimulation control circuit comprises an offset interval generator to produce an offset interval starting with one of the predetermined type heart sounds and a pulse delivery controller to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

22. The neural stimulation system of claim 21, wherein the heart sound detection circuit comprises one or more of a first heart sound (S1) detector to detect S1, a second heart sound (S2) detector to detect S2, a third heart sound (S3) detector to detect S3, and a fourth heart sound (S4) detector to detect S4.

23. A neural stimulation system, comprising:

a stimulation output circuit to deliver neural stimulation pulses;

a hemodynamic sensor to sense a hemodynamic signal;

a hemodynamic event detection circuit coupled to the hemodynamic sensor, the hemodynamic event detection circuit adapted to detect predetermined type hemodynamic events using the hemodynamic signal; and

a stimulation control circuit coupled to the stimulation output circuit and the reference event detection circuit, the stimulation control circuit adapted to control the delivery of the neural stimulation pulses and including a synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type hemodynamic events.

24. The neural stimulation system of claim 23, further comprising a derivative calculator coupled to the hemodynamic event detection circuit, the derivative calculator adapted to produce a derivative hemodynamic signal by calculating a time derivative of the hemodynamic signal, and wherein the hemodynamic event detection circuit is adapted to detect the predetermined type hemodynamic events from the derivative hemodynamic signal.

25. The neural stimulation system of claim 23, wherein the stimulation control circuit comprises an offset interval generator to produce an offset interval starting with one of the detected predetermined type peaks and a pulse delivery controller to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

26. The neural stimulation system of claim 25, wherein the reference event detection circuit comprises a peak detector to detect predetermined type peaks in the hemodynamic signal.

27. The neural stimulation system of claim 25, wherein the hemodynamic sensor comprises a Doppler echocardiographic sensor to sense a hemodynamic signal indicative of blood flow.

28. The neural stimulation system of claim 25, wherein the hemodynamic sensor comprises a pressure sensor to sense a pressure signal indicative of blood pressure.

29. The neural stimulation system of claim 25, wherein the hemodynamic sensor comprises an impedance sensor to sense an impedance signal indicative of blood flow.

30. A method for operating a neural stimulation system coupled to a living subject having a circulatory system, the method comprising:

sensing a reference signal indicative of cardiac cycles each including a predetermined type timing reference event using an implantable reference signal sensor placed external to the circulatory system;

detecting the predetermined type timing reference event from the reference signal; and

synchronizing a delivery of neural stimulation pulses to the detected predetermined type timing reference event.

31. The method of claim 30, wherein sensing the reference signal comprises sensing a subcutaneous ECG signal using implantable electrodes.

32. The method of claim 31, wherein detecting the predetermined type timing reference event from the reference signal comprises detecting an atrial depolarization (P-wave) from the subcutaneous ECG signal.

33. The method of claim 30, wherein sensing the reference signal comprises sensing an acoustic signal indicative of heart sounds, and detecting the predetermined type timing reference event from the reference signal comprises detecting predetermined type heart sounds from the acoustic signal.

34. The method of claim 30, wherein sensing the reference signal comprises sensing a hemodynamic signal indicative of blood flow or pressure.

35. The method of claim 34, wherein detecting the predetermined type timing reference event from the reference signal comprises detecting predetermined type peaks from the hemodynamic signal.

36. The method of claim 30, further comprising staring an offset interval with the detected timing reference event, and wherein synchronizing the delivery of neural stimulation pulses to the detected timing reference event comprises starting a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

37. The method of claim 36, wherein synchronizing the delivery of neural stimulation pulses comprises synchronizing the delivery of the neural stimulation pulses to the timing reference event of consecutive heart beats on a continuous basis.

38. The method of claim 36, wherein synchronizing the delivery of neural stimulation pulses comprises synchronizing the delivery of the neural stimulation pulses to the timing reference event of selected heart beats on a periodic basis.

39. The method of claim 36, wherein detecting the timing reference event from the reference signal comprises extracting the timing reference event from a segment of the reference signal recorded during a plurality of cardiac cycles.

40. A neural stimulation system coupled to a living subject having a circulatory system, the neural stimulation system comprising:

a stimulation output circuit to deliver neural stimulation pulses;

an implantable reference signal sensor to sense a reference signal indicative of cardiac cycles each including a predetermined type timing reference event, the implantable reference signal sensor configured for placement external to the circulatory system;

a reference event detection circuit coupled to the implantable reference signal sensor, the reference event detection circuit adapted to detect the predetermined type timing reference event; and

a stimulation control circuit coupled to the stimulation output circuit and the reference event detection circuit, the stimulation control circuit including;

an offset interval generator adapted to produce an offset interval starting with the predetermined type timing reference event; and

a pulse delivery controller adapted to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

41. The neural stimulation system of claim 40, further comprising an implantable housing adapted to contain at least the stimulation output circuit, the reference event detection circuit, and the stimulation control circuit.

42. The neural stimulation system of claim 41, wherein the reference signal comprises a subcutaneous electrocardiogram (ECG) signal, and wherein the implantable reference signal sensor comprises one or more subcutaneous electrodes adapted to sense a subcutaneous ECG signal.

43. The neural stimulation system of claim 40, wherein the reference event detection circuit comprises a signal processor adapted to extract the predetermined type timing reference event from the reference signal for each of the cardiac cycles.

44. The neural stimulation system of claim 43, wherein the synchronization module comprises a continuous synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type timing reference event consecutively for each of the cardiac cycles.

45. A neural stimulation system, comprising:

a stimulation output circuit to deliver neural stimulation pulses;

implantable electrodes configured to sense a subcutaneous ECG signal;

a cardiac event detection circuit coupled to the one or more implantable electrodes, the cardiac event detection circuit adapted to detect predetermined type cardiac events from the subcutaneous ECG signal;

a stimulation control circuit coupled to the stimulation output circuit and the cardiac event detection circuit, the stimulation control circuit adapted to control the delivery of the neural stimulation pulses and including a synchronization module adapted to synchronize the delivery of the neural stimulation pulses to the predetermined type cardiac events; and

an implantable housing adapted to house the stimulation output circuit, the cardiac event detection circuit, and the stimulation control circuit, wherein the implantable electrodes are incorporated onto the implantable housing.

46. The neural stimulation system of claim 45, wherein the stimulation control circuit comprises an offset interval generator to produce an offset interval starting with one of the detected predetermined type cardiac events and a pulse delivery controller adapted to start a delivery of a burst of a plurality of neural stimulation pulses when the offset interval expires.

47. The neural stimulation system of claim 45, wherein the cardiac event detection circuit comprises a P-wave detector to detect atrial depolarizations (P-waves).

48. The neural stimulation system of claim 47, wherein the P-wave detector comprises a signal averaging circuit to average the subcutaneous ECG signal over a plurality of cardiac cycles.