System and method for closed-loop neural stimulation

• US 7,783,349 B2
• Filed: 04/10/2006
• Issued: 08/24/2010
• 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:
  US11/279,188
• Publication Number:
  US 20070239210A1
• Time in Patent Office: 1,597 Days
• Field of Search: 607/62, 607/9, 607/120, 607/2, 607/17, 607/25, 607/45, 607/4, 600/510, 600/509, 600/519
• 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 neural stimulation system to modulate autonomic balance between parasympathetic tone and sympathetic tone in an autonomic nervous system (ANS), the system comprising:

a neural stimulator adapted to generate a stimulation signal adapted to stimulate an autonomic neural target to modulate the autonomic balance in the ANS;

a premature ventricular contraction (PVC) event detector;

a heart rate detector;

an analyzer adapted to, in response to a PVC event signal from the PVC event detector, measure heart rate turbulence (HRT) using pre-PVC heart rate data and post-PVC heart rate data to generate an autonomic balance indicator (ABI); and

a controller adapted to implement a neural stimulation therapy using the neural stimulator and the analyzer to modulate the autonomic balance in the ANS,

wherein the analyzer is configured to generate a plurality of ABIs at discrete times during the neural stimulation therapy,

wherein the controller includes a memory, and

wherein for each discrete time for which the analyzer generates one of the ABIs, the controller is adapted to;

perform the neural stimulation therapy in a closed loop to achieve a desired autonomic balance for the ANS, wherein, in performing the neural stimulation therapy in a closed loop, the controller is configured to;

receive the ABI from the analyzer,

compare the received ABI to a target ABI stored in the memory to determine an error between the received ABI and the target ABI,

use the error to provide stimulation control feedback, and

use the stimulation control feedback to control the neural stimulator to achieve the desired autonomic balance for the ANS,

wherein the target ABI is representative of the desired autonomic balance for the ANS.

2. The system of claim 1, wherein the neural stimulation therapy is a chronic therapy.

3. The system of claim 1, wherein the controller its adapted to make an adjustment to the neural stimulation therapy using at least two of the ABIs.

4. The system of claim 1, wherein the heart rate detector includes an R-R interval detector.

5. The system of claim 1, further comprising a PVC sensor adapted to detect an intrinsic PVC.

6. The system of claim 5, wherein the controller is adapted to:

chronically apply the neural stimulation therapy, and

generate an ABI enable signal at the discrete times during the neural stimulation therapy to enable the heart rate detector to detect the heart rate for use in collecting pre-PVC heart rate data, the PVC sensor being enabled after a predetermined delay after the heart rate detector is enabled.

7. The system of claim 1, further comprising a PVC stimulator.

8. The system of claim 7, wherein the PVC stimulator includes a pulse generator adapted to generate a right ventricle pacing pulse.

9. The system of claim 7, wherein the neural stimulator, the PVC event detector, the heart rate detector, the analyzer, the controller and the PVC stimulator are housed in a single implantable medical device.

10. The system of claim 1, wherein the neural stimulator is adapted to adjust an amplitude of the stimulation signal.

11. The system of claim 1, wherein the neural stimulator is adapted to adjust a frequency of the stimulation signal.

12. The system of claim 1, wherein the neural stimulator is adapted to adjust a burst frequency of the stimulation signal.

13. The system of claim 1, wherein the neural stimulator is adapted to adjust a morphology of the stimulation signal.

14. The system of claim 1, wherein the neural stimulator is adapted to adjust a pulse width of the stimulation signal.

15. The system of claim 1, wherein the neural stimulator, the PVC event detector, the heart rate detector, the analyzer, and the controller are housed in a single implantable medical device.

16. The system of claim 1, 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 event detector and the heart rate detector.

17. The system of claim 16, wherein the CRM device includes a PVC stimulator.

18. The system of claim 1, further comprising a lead with an electrode for use in delivering the stimulating signal to the neural target.

19. The system of claim 1, further comprising a satellite electrode adapted to wirelessly receive the stimulating signal and deliver the stimulating signal to the neural target.

20. The system of claim 1, wherein the controller is adapted to process the ABI as part of a neural stimulation threshold test to verify stimulation of the autonomic neural target and to perform an autocapture routine to automatically adjust stimulation parameters of the stimulation signal to stimulate the autonomic neural target based on results of the neural stimulation capture test.

21. The system of claim 1, wherein the controller is adapted to process the ABI as part of a neural stimulation threshold test to verify stimulation of the autonomic neural target and to automatically change the autonomic neural target to be stimulated based on results of the neural stimulation capture test.

22. The system of claim 1, wherein:

the analyzer is adapted to generate a plurality of ABIs; and

the controller is adapted to average or trend the plurality ABIs, and to control the neural stimulating using the average or trend of the plurality of ABIs to achieve the desired autonomic balance for the ANS.

23. The system of claim 1, 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.

24. The system of claim 1, wherein the neural stimulation therapy is a chronically-delivered intermittent 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.

25. The system of claim 1, wherein the neural stimulation therapy is a chronically-delivered intermittent 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 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.

26. A neural stimulation system to modulate autonomic balance between parasympathetic tone and sympathetic tone in an autonomic nervous system (ANS), the system comprising:

neural stimulation means for stimulating an autonomic neural target to modulate the autonomic balance in the ANS;

means for identifying a premature ventricular contraction (PVC) event;

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

means for 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 to generate an autonomic balance indicator (ABI);

the system further comprising means for controlling the neural stimulation means using the ABI to titrate the stimulation of the autonomic neural target to achieve a desired autonomic balance for the ANS,

wherein the means for controlling the neural stimulation means includes means for receiving the ABI, comparing the received ABI to a target ABI stored in the memory to determine an error between the received ABI and the target ABI, using the error to provide stimulation control feedback, and using the stimulation control feedback to control the neural stimulator to achieve the desired autonomic balance for the ANS, wherein the target ABI is representative of the desired autonomic balance for the ANS.

27. The system of claim 26, wherein the means for identifying a PVC event includes means for performing a process to detect an intrinsic PVC.

28. The system of claim 26, wherein the means for identifying a PVC event includes means for inducing the PVC event.

29. The system of claim 26, wherein the means for identifying a PVC event includes means for performing a process to detect an intrinsic PVC, and means for inducing the PVC event if the intrinsic PVC is not detected within a predetermined time.

30. The system of claim 26, wherein the ABI includes a turbulence onset (TO) value, a turbulence slope (TS) value, or both a TO value and a TS value.

31. The system of claim 26, wherein the means for detecting pre-PVC heart rate data and post-PVC heart rate data includes means for detecting a predetermined number of R-R intervals immediately before the PVC event and a predetermined number of R-R intervals immediately after the PVC event.

32. A method for modulating autonomic balance between parasympathetic tone and sympathetic tone in an autonomic nervous system (ANS), the method comprising:

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

identifying a premature ventricular contraction (PVC) event;

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

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 to generate an autonomic balance indicator (ABI);

the method further comprising titrating the stimulation of the autonomic neural target using the ABI to achieve a desired autonomic balance for the ANS,

wherein titrating the stimulation includes;

receiving the ABI;

comparing the received ABI to a target ABI to determine an error between the received ABI and the target ABI;

using the error to provide stimulation control feedback; and

using the stimulation control feedback to control the neural stimulator to achieve the desired autonomic balance for the ANS,

wherein the target ABI is representative of the desired autonomic balance for the ANS.

33. The method of claim 32, wherein the method includes titrating the stimulation of the autonomic neural target using the ABI to achieve the desired autonomic balance for the ANS.

34. The method of claim 33, further comprising measuring HRT to generate a plurality of ABIs, and averaging or trending the plurality of ABIs, wherein titrating the stimulation of the autonomic neural target includes titrating the stimulation of the autonomic neural target using the average or the trend of ABIs to achieve the desired autonomic balance for the ANS.

35. The method of claim 32, wherein the method includes testing capture of the stimulation of the autonomic neural target using the ABI, and further includes performing an autocapture routine to automatically adjust stimulation parameters of the stimulation signal to stimulate the autonomic neural target based on results of the neural stimulation capture test.

36. The method of claim 32, wherein the method includes testing capture of the stimulation of the autonomic neural target using the ABI, and further includes automatically changing the autonomic neural target to be stimulated based on results of the neural stimulation capture test.

37. The method of claim 32, wherein:

identifying the PVC event includes applying rules or criteria to select valid PVCs; and

detecting pre-PVC heart rate data and post-PVC heart rate data includes 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.

38. The method of claim 32, 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.

39. The method of claim 32, 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 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.

40. The method of claim 32, wherein identifying a PVC event includes performing a process to detect an intrinsic PVC.

41. The method of claim 32, wherein identifying a PVC event includes inducing the PVC event.

42. The method of claim 41, wherein inducing the PVC event includes pacing a right ventricle.

43. The method of claim 42, wherein identifying a PVC event includes performing a process to detect an intrinsic PVC, and inducing the PVC event if the intrinsic PVC is not detected within a predetermined time.

44. The method of claim 32, wherein the ABI includes a heart rate turbulence (HRT) value, and the HRT value includes turbulence onset.

45. The method of claim 32, wherein the ABI includes a heart rate turbulence (HRT) value, and the HRT value includes turbulence slope.

46. The method of claim 32, wherein detecting pre-PVC heart rate data and post-PVC heart rate data includes detecting a predetermined number of R-R intervals immediately before the PVC event and a predetermined number of R-R intervals immediately after the PVC event.

47. The method of claim 32, wherein identifying a premature ventricular contraction (PVC) event includes intermittently identifying the PVC event.

48. The method of claim 32, wherein identifying a premature ventricular contraction (PVC) event includes periodically identifying the PVC event.

49. The method of claim 32, wherein titrating the stimulation of the autonomic neural target using the ABI includes:

storing a plurality of ABIs, each of the ABIs being generated at a discrete time over a predetermined time period; and

using the plurality of ABIs to perform an adjustment of the stimulation of the autonomic neural target.

50. The method of claim 32, wherein the neural target includes a vagus nerve.

51. The method of claim 50, wherein the neural target includes a cardiac branch of the vagus nerve.

52. The method of claim 32, wherein the neural target includes a cardiac fat pad.