System and method for testing neural stimulation threshold

• US 8,175,701 B2
• Filed: 10/14/2011
• Issued: 05/08/2012
• Est. Priority Date: 04/10/2006
• 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.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): WIELAND, ROBERT N
• Application Number:
  US13/273,436
• Publication Number:
  US 20120035682A1
• Time in Patent Office: 207 Days
• Field of Search: 600/509, 600/510, 607/2, 607/4, 607/25, 607/45
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

Various system embodiments comprise a neural stimulator, a premature ventricular contraction (PVC) event detector, a heart rate detector, an analyzer, and a controller. The neural stimulator is adapted to generate a stimulation signal adapted to stimulate an autonomic neural target. The analyzer is adapted to, in response to a PVC event signal from the PVC event detector, generate an autonomic balance indicator (ABI) as a function of pre-PVC heart rate data and post-PVC heart rate data. Other aspects and embodiments are provided herein.

Claims

1. A method for implanting a neural stimulator, comprising:

implanting a neural stimulation lead;

delivering neural stimulation through the neural stimulation lead to an autonomic neural target; and

verifying neural stimulation capture of the autonomic neural target, wherein verifying capture includes measuring heart rate turbulence (HRT) and using the measured HRT to determine if the neural stimulation is capturing the autonomic neural target.

2. The method of claim 1, wherein measuring HRT includes detecting heart rate data before a premature ventricular contraction (PVC) event and heart rate data after the PVC event, and using the heart rate data before the PVC event and the heart rate data after the PVC event to measure HRT.

3. The method of claim 2, further comprising inducing the PVC event.

4. The method of claim 3, wherein inducing the PVC event includes delivering a myocardial pace to induce the PVC event.

5. The method of claim 4, further comprising implanting a temporary pacing catheter, and using the temporary pacing catheter to deliver the myocardial pace to induce the PVC event.

6. The method of claim 5, further comprising using the temporary pacing catheter to detect heart rate data before the PVC event and heart rate data after the PVC event.

7. The method of claim 4, further comprising communicating between an external programmer and an implanted cardiac rhythm management (CRM) device, wherein delivering the myocardial pace to induce the premature ventricular contraction includes delivering the myocardial pace using the implanted CRM device.

8. The method of claim 7, further comprising using the implanted CRM device to detect heart rate data before the PVC event and heart rate data after the PVC event.

9. The method of claim 1, further comprising adjusting a position of the neural stimulation lead if it is determined, using the measured HRT, that the delivered neural stimulation through the neural stimulation lead does not provide threshold stimulation.

10. The method of claim 1, further comprising changing electrical stimulation vectors if it is determined, using the measured HRT, that the delivered neural stimulation through the neural stimulation lead does not provide threshold stimulation.

11. A neural stimulation system for setting a stimulation level for stimulating an autonomic nervous system (ANS), the system comprising:

a neural stimulator configured to stimulate an autonomic neural target in the ANS;

a heart rate detector configured to detect heart rate;

an analyzer connected to the heart rate detector and configured to measure heart rate turbulence (HRT) using detected heart rate before a premature ventricular contraction (PVC) and detected heart rate after the PVC; and

a controller configured to receive HRT measurements from the analyzer and provide an indication whether a stimulation level provides threshold stimulation.

12. The system of claim 11, further comprising a PVC stimulator configured to deliver a pacing pulse to induce the PVC, and the controller is configured to control the PVC stimulator to induce the PVC.

13. The system of claim 12, wherein the controller is configured to:

control the neural stimulator to generate a neural stimulation signal to stimulate the autonomic neural target and step through a plurality of stimulation levels for stimulating the autonomic neural target; and

for each of the stimulation levels, control the PVC stimulator to induce the PVC and receive HRT measurements from the analyzer, and provide the indication whether the stimulation level provides threshold stimulation.

14. The system of claim 12, wherein the neural stimulator, the PVC stimulator, the heart rate detector, the analyzer, and the controller are housed in a single implantable medical device.

15. The system of claim 12, further comprising an implantable neural stimulator device and an implantable cardiac rhythm management (CRM) device configured to communicate with each other, the implantable neural stimulator device including at least the neural stimulator and the controller, the implantable CRM device including at least the PVC stimulator.

16. The system of claim 12, further comprising an implantable neural stimulator device, an implantable cardiac rhythm management (CRM) device, and a programmer configured to communicate with the implantable neural stimulator device and the implantable CRM device, the implantable neural stimulator device including at least the neural stimulator, the implantable CRM device including at least the PVC stimulator, and the programmer including the analyzer and the controller configured to automatically perform an auto-threshold test.

17. The system of claim 11, further comprising communication circuitry configured to communicate with a programmer configured for use by a clinician to program the neural stimulator, wherein the controller and the communication circuitry are configured to cooperate to communicate the HRT measurements to the programmer.

18. The system of claim 11, wherein the analyzer is configured to validate PVCs and R-R intervals used to measure HRT.

19. The system of claim 11, wherein the controller and the neural stimulator are configured to deliver an intermittent neural stimulation therapy with stimulation bursts, and wherein the system is configured to measure HRT for a time between successive stimulation bursts when the stimulation signal is not generated.

20. The system of claim 11, wherein the controller and the neural stimulator are configured to deliver an intermittent neural stimulation therapy with stimulation bursts, and wherein the system is configured to measure HRT for a time that includes a beginning of one of the stimulation bursts to reflect heart rate from a time without neural stimulation to a time with neural stimulation, or to measure HRT for a time that includes an end of one of the stimulation bursts to reflect heart rate from a time with neural stimulation to a time without neural stimulation.

21. The system of claim 11, further comprising communication circuitry configured to communicate with a programmer configured for use by a clinician to program the neural stimulator, wherein the controller and the communication circuitry are configured to cooperate to communicate the HRT measurements to the programmer.

22. A neural stimulation system to modulate autonomic balance in an autonomic nervous system (ANS), the system comprising:

a neural stimulator configured to stimulate an autonomic neural target to modulate the autonomic balance in the ANS;

a premature ventricular contraction (PVC) stimulator configured to induce a PVC using a myocardial pacing pulse;

a heart rate detector configured to detect heart rate;

an analyzer connected to the heart rate detector and configured to measure heart rate turbulence (HRT) for the induced PVC using the detected heart rate; and

a controller configured to;

control the neural stimulator to generate a neural stimulation signal to stimulate the autonomic neural target;

control the PVC stimulator to induce the PVC; and

use the measured HRT to determine whether the neural stimulation signal evokes a response above a threshold.

23. A method for modulating autonomic balance in an autonomic nervous system (ANS), the method comprising:

stimulating an autonomic neural target to modulate the autonomic balance in the ANS; and

performing a neural stimulation threshold test, wherein performing the neural stimulation threshold test includes;

inducing a premature ventricular contraction (PVC) event or detecting an intrinsic PVC event;

detecting heart rate;

measuring heart rate turbulence (HRT) in response to the PVC event using the detected heart rate; and

determining whether the neural stimulation signal evokes a threshold response based on the measured HRT.