Method and apparatus for controlling autonomic balance using neural stimulation

• US 20060253161A1
• Filed: 05/09/2005
• Published: 11/09/2006
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Kramer, Andrew P., Libbus, Imad
• Granted Patent: US 7,561,923 B2
• Time in Patent Office: Days
• US Class Current: 607/18
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36585 controlled by two or more physical parameters

Abstract

A neural stimulation system senses autonomic activities and applies neural stimulation to sympathetic and parasympathetic nerves to control autonomic balance. The neural stimulation system is capable of delivering neural stimulation pulses for sympathetic excitation, sympathetic inhibition, parasympathetic excitation, and parasympathetic inhibition.

Claims

1. A neural stimulation system, comprising:

a stimulation output circuit adapted to deliver sympathetic stimulation pulses and parasympathetic stimulation pulses;

an autonomic balance monitoring circuit adapted to sense one or more signals indicative of autonomic activities; and

a stimulation control circuit coupled to the stimulation output circuit and the autonomic balance monitoring circuit, the stimulation control circuit including;

a sympathetic stimulation controller adapted to control the delivery of the sympathetic stimulation pulses for sympathetic excitation and sympathetic inhibition; and

a parasympathetic stimulation controller adapted to control the delivery of the parasympathetic stimulation pulses for parasympathetic excitation and parasympathetic inhibition.

2. The system of claim 1, wherein the stimulation control circuit comprises a stimulation parameter adjustment circuit adapted to adjust a plurality of stimulation parameters controlling the delivery of the sympathetic stimulation pulses and parasympathetic stimulation pulses based on the one or more signals indicative of autonomic activities.

3. The system of claim 2, wherein the stimulation parameter adjustment circuit is programmable and is adapted to adjust the plurality of stimulation parameters using programmable parameters mapping the one or more signals indicative of autonomic activities to the stimulation parameters.

4. The system of claim 2, wherein the stimulation parameter adjustment circuit comprises:

a sympathetic stimulation parameter adjustment module adapted to adjust one or more sympathetic stimulation parameters of the plurality of stimulation parameters; and

a parasympathetic stimulation parameter adjustment module adapted to adjust one or more parasympathetic stimulation parameters of the plurality of stimulation parameters,

wherein the sympathetic stimulation controller is adapted to control the delivery of the sympathetic stimulation pulses for the sympathetic excitation and the sympathetic inhibition using the one or more sympathetic stimulation parameters, and the parasympathetic stimulation controller is adapted to control the delivery of the parasympathetic stimulation pulses for the parasympathetic excitation and the parasympathetic inhibition using the one or more parasympathetic stimulation parameters.

5. The system of claim 4, wherein the stimulation parameter adjustment circuit is adapted to adjust the plurality of stimulation parameters dynamically using feedback control with one or more inputs including the one or more signals indicative of autonomic activities.

6. The system of claim 4, wherein the stimulation parameter adjustment circuit is adapted to further adjust the plurality of stimulation parameters based on a predetermined time schedule.

7. The system of claim 4, wherein the autonomic balance monitoring circuit comprises a nerve traffic sensing circuit adapted to sense one or more neural signals indicative of the autonomic activities, and the stimulation parameter adjustment circuit is adapted to adjust the plurality of stimulation parameters based on the one or more neural signals.

8. The system of claim 7, wherein the nerve traffic sensing circuit comprises:

a sympathetic traffic sensing circuit adapted to sense at least one sympathetic neural signal indicative of sympathetic nerve traffic; and

a parasympathetic traffic sensing circuit adapted to sense at least one parasympathetic neural signal indicative of parasympathetic nerve traffic.

9. The system of claim 4, wherein the autonomic balance monitoring circuit comprises a surrogate signal sensing circuit adapted to sense one or more surrogate signals indicative of the autonomic activities, and the stimulation parameter adjustment circuit adapted to adjust the plurality of stimulation parameters based on the one or more surrogate signals.

10. The system of claim 9, wherein the surrogate signal sensing circuit comprises a heart rate variability (HRV) sensing circuit to sense an HRV and produce a surrogate signal of the one or more surrogate signals based on the sensed HRV.

11. The system of claim 4, wherein the autonomic balance monitoring circuit comprises a physiological function sensing circuit to sense one or more physiological function signals each indicative of one of more physiological functions related to the autonomic activities, and the stimulation parameter adjustment circuit is adapted to adjust the plurality of stimulation parameters based on the one or more physiological function signals.

12. The system of claim 11, wherein the physiological function sensing circuit comprises one or more of:

a heart rate sensing circuit to sense a signal indicative of heart rate;

an activity sensing circuit to sense a signal indicative of physical activity level;

a respiration sensing circuit to sense a respiration signal;

an impedance sensing circuit to sense a signal indicative of a transthoracic impedance or cardiac impedance;

a heart sound sensing circuit to sense a signal indicative of heart sounds; and

a pressure sensing circuit to sense a signal indicative of a blood pressure.

13. The system of claim 12, wherein the autonomic balance monitoring circuit comprises a nerve traffic sensing circuit adapted to sense one or more neural signals indicative of the autonomic activities and the physiological function sensing circuit, and the stimulation parameter adjustment circuit is adapted to adjust the plurality of stimulation parameters based on the one or more neural signals and the one or more physiological function signals.

14. The system of claim 12, wherein the autonomic balance monitoring circuit comprises a surrogate signal sensing circuit adapted to sense one or more surrogate signals indicative of the autonomic activities and the physiological function sensing circuit, and the stimulation parameter adjustment circuit is adapted to adjust the plurality of stimulation parameters based on the one or more surrogate signals and the one or more physiological function signals.

15. The system of claim 1, further comprising an implantable housing to house the stimulation output circuit, the autonomic balance monitoring circuit, and the stimulation control circuit.

16. The system of claim 15, further comprising one or more implantable neural leads coupled to the stimulation output circuit, the one or more neural leads configured for delivering the sympathetic stimulation pulses and parasympathetic stimulation pulses.

17. The system of claim 15, further comprising a cardiac stimulation circuit coupled to the stimulation control circuit and housed within the implantable housing, the cardiac stimulation circuit adapted to deliver cardiac stimulation pulses.

18. The system of claim 15, further comprising an external system including:

an external device communicatively coupled to the stimulation control circuit via telemetry;

a remote device; and

a telecommunication network coupled between the external device and the remote device.

19. A method for neural stimulation, comprising:

sensing one or more signals indicative of autonomic activities; and

controlling a delivery of sympathetic and parasympathetic stimulation pulses using feedback control with one or more inputs including the one or more signals indicative of autonomic activities,

wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses includes;

controlling the delivery of the sympathetic stimulation pulses for sympathetic excitation and sympathetic inhibition; and

controlling the delivery of the parasympathetic stimulation pulses for parasympathetic excitation and parasympathetic inhibition.

20. The method of claim 19, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises controlling the delivery of sympathetic and parasympathetic stimulation pulses to achieve a selected autonomic balance.

21. The method of claim 19, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises controlling the delivery of sympathetic and parasympathetic stimulation pulses to shift automatic balance for a predetermined period of time.

22. The method of claim 21, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises controlling the delivery of sympathetic and parasympathetic stimulation pulses to control autonomic balance according to a predetermined time schedule.

23. The method of claim 19, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises controlling the delivery of sympathetic and parasympathetic stimulation pulses to increase sympathetic tone and decrease parasympathetic tone.

24. The method of claim 19, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises controlling the delivery of sympathetic and parasympathetic stimulation pulses to decrease sympathetic tone and increase parasympathetic tone.

25. The method of claim 19, wherein controlling the delivery of sympathetic and parasympathetic stimulation pulses comprises adjusting a plurality of stimulation parameters controlling the delivery of sympathetic and parasympathetic stimulation pulses based on the one or more signals indicative of autonomic activities.

26. The method of claim 25, further comprising programming parameters mapping the one or more signals indicative of autonomic activities to the stimulation parameters.

27. The method of claim 25, wherein adjusting the plurality of stimulation parameters comprises adjusting one or more sympathetic stimulation parameters controlling the sympathetic excitation and the sympathetic inhibition and adjusting one or more parasympathetic stimulation parameters controlling the parasympathetic excitation and the parasympathetic inhibition.

28. The method of claim 25, wherein sensing the one or more signals indicative of autonomic activities comprises sensing one or more neural signals indicative of the autonomic activities, and adjusting the plurality of stimulation parameters comprises adjusting the plurality of stimulation parameters based on the one or more neural signals.

29. The method of claim 28, wherein sensing the one or more neural signals comprises sensing at least one sympathetic neural signal indicative of sympathetic nerve traffic and at least one parasympathetic neural signal indicative of parasympathetic nerve traffic.

30. The method of claim 28, wherein sensing the one or more signals indicative of autonomic activities comprises sensing one or more surrogate signals indicative of the autonomic activities, and adjusting the plurality of stimulation parameters comprises adjusting the plurality of stimulation parameters based on the one or more surrogate signals.

31. The method of claim 30, wherein sensing the one or more surrogate signals comprises sensing an signal indicative of a heart rate variability (HRV).

32. The method of claim 25, wherein sensing the one or more signals indicative of autonomic activities comprises sensing one or more physiological function signals each indicative of one of more physiological functions related to the autonomic activities, and adjusting the plurality of stimulation parameters comprises adjusting the plurality of stimulation parameters based on the one or more physiological function signals.

33. The method of claim 32, wherein sensing the one or more physiological function signals comprises sensing one or more of a signal indicative of heart rate, a signal indicative of an activity level, a signal indicative of respiratory activities, a signal indicative of transthoracic impedance or cardiac impedance, a signal indicative of heart sounds, and a signal indicative of a blood pressure.

34. The method of claim 32, wherein sensing the one or more signals indicative of autonomic activities comprises sensing one or more neural signals indicative of the autonomic activities and the one or more physiological function signals, and adjusting the plurality of stimulation parameters comprises adjusting the plurality of stimulation parameters based on the one or more neural signals and the one or more physiological function signals.

35. The method of claim 32, wherein sensing the one or more signals indicative of autonomic activities comprises sensing one or more surrogate signals indicative of the autonomic activities and the one or more physiological function signals, and adjusting the plurality of stimulation parameters comprises adjusting the plurality of stimulation parameters based on the one or more surrogate signals and the one or more physiological function signals.