System and method for neural stimulation

• US 9,002,448 B2
• Filed: 06/03/2013
• Issued: 04/07/2015
• Est. Priority Date: 08/29/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad, Kramer, Andrew P., Caparso, Anthony V., James, Kristofer J., Ruble, Stephen, Zhao, Weiying
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/908,033
• Publication Number:
  US 20130261691A1
• Time in Patent Office: 673 Days
• Field of Search: 607/2
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

Various aspects provide an implantable device. In various embodiments, the device comprises at least one port, where each port is adapted to connect a lead with an electrode to the device. The device further includes a stimulation platform, including a sensing circuit connected to the at least one port to sense an intrinsic cardiac signal and a stimulation circuit connected to the at least one port via a stimulation channel to deliver a stimulation signal through the stimulation channel to the electrode. The stimulation circuit is adapted to deliver stimulation signals through the stimulation channel for both neural stimulation therapy and CRM therapy. The sensing and stimulation circuits are adapted to perform CRM functions. The device further includes a controller connected to the sensing circuit and the stimulation circuit to control the neural stimulation therapy and the CRM therapy. Other aspects and embodiments are provided herein.

Claims

1. A method, comprising:

disposing one or more electrodes at a location for stimulating vagus nerve of a patient;

configuring a stimulation channel of an implantable device to deliver electrical stimulation to the one or more electrodes;

delivering neural stimulation pulses through the stimulation channel, wherein the neural stimulation pulses are delivered as a pulse train having first and second phases of opposite polarities; and

,

while monitoring the patient, adjusting the pulse amplitude and/or pulse width of the first phase to achieve a desired therapeutic benefit and adjusting the pulse amplitude and/or pulse width of the second phase to achieve a desired reduction in side effects.

2. The method of claim 1 wherein the one or more electrodes are disposed at a location for both stimulating the vagus nerve and delivering cardiac pacing pulses and further comprising delivering cardiac pacing pulses through the stimulation channel in accordance with a programmed pacing mode.

3. The method of claim 2 wherein the neural stimulation pulses have a higher frequency and lower amplitude than the cardiac pacing pulses.

4. The method of claim 2 further comprising delivering the neural stimulation pulses and cardiac pacing pulses as a higher frequency neural stimulation signal modulated on a lower frequency cardiac pacing signal.

5. The method of claim 2 further comprising delivering cardiac pacing pulses alternated with neural stimulation pulses.

6. The method of claim 1 further comprising delivering the neural stimulation pulses as a biphasic pulse train with alternating polarities.

7. The method of claim 1 further comprising delivering the neural stimulation pulses a series of monophasic pulse trains where the polarity of each consecutive pulse train alternates.

8. The method of claim 1 wherein the neural stimulation pulses are delivered intermittently with a duty cycle of 10 seconds ON and 50 seconds OFF.

9. The method of claim 1 wherein the neural stimulation pulses are delivered as a biphasic pulse train with alternating first and second phases.

10. The method of claim 1 wherein the neural stimulation pulses are delivered as a series of alternating monophasic pulse trains with opposite polarities.

11. An implantable device, comprising:

stimulation circuitry for delivering electrical stimulation to one or more electrodes adapted for disposition to stimulate the heart and vagus nerve;

a controller connected to the stimulation circuitry for controlling the delivery of electrical stimulation by the stimulation circuitry;

wherein the controller is configured to deliver neural stimulation pulses to the one or more electrodes, wherein the neural stimulation pulses are delivered as a pulse train having first and second phases of opposite polarities; and

,

wherein the pulse amplitude and/or pulse width of the first phase are adjusted to achieve a desired therapeutic benefit and the pulse amplitude and/or pulse width of the second phase are adjusted to achieve a desired reduction in side effects.

12. The device of claim 11 wherein the controller is configured to operate the stimulation circuitry so as to deliver both cardiac pacing pulses and neural stimulation pulses to the one or more electrodes and wherein the neural stimulation pulses have a higher frequency and lower amplitude than the cardiac pacing pulses.

13. The device of claim 12 wherein the controller is configured to deliver the neural stimulation pulses and cardiac pacing pulses as a higher frequency neural stimulation signal modulated on a lower frequency cardiac pacing signal.

14. The device of claim 12 wherein the controller is configured to deliver cardiac pacing pulses alternated with neural stimulation pulses.

15. The device of claim 11 wherein the controller is configured to deliver neural stimulation pulses continuously.

16. The device of claim 11 wherein the controller is configured to deliver neural stimulation pulses intermittently for specified periods of time.

17. The device of claim 11 wherein the controller is configured to deliver neural stimulation pulses intermittently with a duty cycle of 10 seconds ON and 50 seconds OFF.

18. The device of claim 11 wherein the stimulation circuitry further comprises a current source pulse output circuit for outputting neural stimulation pulses at a current amplitude specified by the controller.

19. The device of claim 11 wherein the stimulation circuitry further comprises a capacitive discharge pulse output circuit and a lead impedance measurement circuit for outputting pulses at a current amplitude specified by the controller.

20. The device of claim 11 wherein the controller is configured so that the pulse width, pulse amplitude, duty cycle, and frequency for each of the first and second phases are separately adjustable.