System and method for testing neural stimulation threshold

• US 8,041,423 B2
• Filed: 02/09/2011
• Issued: 10/18/2011
• Est. Priority Date: 04/10/2006
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kramer, Andrew P., Libbus, Imad
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US13/024,120
• Publication Number:
  US 20110130802A1
• Time in Patent Office: 251 Days
• Field of Search: 607/4, 607/2, 607/17, 607/45, 600/509
• 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 setting a stimulation level for stimulating an autonomic nervous system (ANS), the method comprising:

automatically performing an auto-threshold test, including

stimulating an autonomic neural target in the ANS, wherein stimulating the autonomic neural target includes stepping through a plurality of stimulation levels;

performing a threshold test for each of the stimulation levels, wherein performing the threshold test includes;

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

detecting pre-PVC heart rate data and post-PVC heart rate data;

measuring heart rate turbulence (HRT) in response to the PVC event using the pre-PVC heart rate data and the post-PVC heart rate data; and

determining, using the measured HRT, whether the stimulation level provides threshold stimulation; and

setting the stimulation level for stimulating the ANS based on the threshold test for each of the stimulation levels.

2. The method of claim 1, further comprising storing the measured HRT values generated during the auto-threshold test in memory.

3. The method of claim 1, wherein setting the stimulation level for stimulating the ANS includes automatically setting the stimulation level for stimulating the ANS based on the threshold test for each of the stimulation levels.

4. The method of claim 1, further comprising reporting the measured HRT values to a clinician to inform the clinician if the stimulation level provides the threshold stimulation.

5. The method of claim 4, wherein reporting the measured HRT values to a clinician includes reporting the measured HRT values to a programmer.

6. The method of claim 1, wherein inducing the PVC event includes pacing a ventricle.

7. The method of claim 1, performing the threshold test includes performing a process to detect the intrinsic PVC, and inducing the PVC event if the intrinsic PVC is not detected within a predetermined time.

8. The method of claim 1, further comprising changing the autonomic neural target to be stimulated based on results of the auto-threshold test.

9. The method of claim 1, further comprising changing a stimulation vector based on results of the auto-threshold test.

10. The method of claim 1, further comprising changing an intensity of the stimulation based on results of the auto-threshold test.

11. The method of claim 1, further comprising applying rules or criteria to select valid PVCs, and applying rules or criteria to select valid R-R intervals used to detect the pre-PVC heart rate data and the post-PVC heart rate data.

12. The method of claim 1, wherein stimulating the autonomic neural target includes generating stimulation bursts, and wherein measuring HRT includes measuring HRT during a time between successive stimulation bursts when the stimulation signal is not generated.

13. The method of claim 1, wherein stimulating the autonomic neural target includes generating stimulation bursts, and wherein measuring HRT includes:

measuring 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 measuring HRT includes measuring 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.

14. A neural stimulation system for setting 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 premature ventricular contraction (PVC) stimulator configured to induce a PVC using a ventricular pacing pulse;

a heart rate detector configured to detect heart rate both before and after the induced PVC;

an analyzer connected to the heart rate detector and configured to measure heart rate turbulence (HRT) using pre-PVC heart rate data and post-PVC heart rate data; and

a controller configured to automatically perform an auto-threshold test, wherein in performing the auto-threshold test the controller is configured to;

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

perform a threshold test for each of the stimulation levels;

control the PVC stimulator to induce the PVC; and

receive measured HRT values from the analyzer for the induced PVC, wherein the measured HRT values indicate whether the stimulation level provides threshold stimulation.

15. The system of claim 14, 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 measured HRT values to the programmer.

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

17. The system of claim 14, further comprising an implantable neural stimulator device and an implantable cardiac rhythm management (CRM) device adapted 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.

18. The system of claim 14, 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.

19. The system of claim 14, wherein the PVC event detector is adapted to apply rules or criteria to select valid PVCs and to select valid R-R intervals used to determine pre-PVC and post-PVC heart rate data.

20. The system of claim 14, 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.

21. The system of claim 14, 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.

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

implanting a neural stimulation lead;

delivering neural stimulation through the neural stimulation lead;

inducing a premature ventricular contraction (PVC) event, wherein inducing the PVC event includes delivering a myocardial pace to induce the premature ventricular contraction;

detecting pre-PVC heart rate data and post-PVC heart rate data;

measuring heart rate turbulence (HRT) in response to the PVC event using the pre-PVC heart rate data and the post-PVC heart rate data; and

determining, using the measured HRT, whether the delivered neural stimulation through the neural stimulation lead provides threshold stimulation.

23. The method of claim 22, 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.

24. The method of claim 22, 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.

25. The method of claim 22, further comprising implanting a temporary pacing catheter, wherein delivering the myocardial pace to induce the premature ventricular contraction includes delivering the myocardial pace through the temporary pacing catheter.

26. The method of claim 25, wherein detecting pre-PVC heart rate data and post-PVC heart rate data includes using the temporary pacing catheter to detect pre-PVC heart rate data and post-PVC heart rate data.

27. The method of claim 22, 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.

28. The method of claim 27, wherein detecting pre-PVC heart rate data and post-PVC heart rate data includes using the implanted CRM device to detect pre-PVC heart rate data and post-PVC heart rate data.

29. The method of claim 22, further comprising communicating between an external programmer and an implanted neural stimulator, wherein delivering neural stimulation through the neural stimulation lead includes using the implanted neural stimulator to deliver the neural stimulation.