Heart rate variability control of gastric electrical stimulator

• US 20050245986A1
• Filed: 04/30/2004
• Published: 11/03/2005
• Est. Priority Date: 12/03/1999
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Starkebaum, Warren L.
• Application Number:
  US10/836,354
• Publication Number:
  US 20050245986A1
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods and systems for stimulating a gastrointestinal system and for modifying a stimulation signal based on an indicator of autonomic nervous system function are described. One indicator of autonomic nervous system described is cardiac activity, including heart rate variability. Methods for selecting candidate patients for gastrointestinal stimulation therapy based on an indicator of autonomic nervous system function and methods of treating patients at risk of or suffering from gastrointestinal disorders by modifying therapy based on an indicator of autonomic function are also discussed.

Claims

1. A digestive stimulation system, comprising

a lead adapted to apply an electrical stimulation signal to a digestive system or a portion thereof of a patient;

pulse generator operably connected to the lead and capable of generating the stimulation signal;

a sensor for detecting an indicator of autonomic nervous system function, and

a first processor operatively connected to the pulse generator and the sensor, the first processor being capable of modifying a parameter of the stimulation signal based on the sensed indicator.

2. The system of claim 1, wherein the sensor is capable of detecting cardiac activity.

3. The system of claim 2, wherein the processor is capable of detecting an arrhythmia based on the detected cardiac activity.

4. The system of claim 2, wherein the processor is capable of manipulating cardiac activity data to determine heart rate variability.

5. The system of claim 2, further comprising a power spectrum analyzer capable of decomposing the cardiac activity into frequency components.

6. The system of claim 5, wherein the first processor is capable of determining heart rate variability based on the frequency components.

7. The system of claim 5, further comprising a second processor operably coupled to the power spectrum analyzer and the first processor, the second processor being capable of determining heart rate variability based on the frequency components.

8. The system of claim 7, wherein the first processor is implantable and the second processor is adapted to be positioned external to a patient'"'"'s body.

9. The system of claim 5, wherein the power spectrum analyzer is implantable.

10. The system of claim 2, wherein the sensor is implantable.

11. The system of claim 10, wherein the first processor is implantable.

12. The system of claim 11, wherein the pulse generator is implantable.

13. The system of claim 2, wherein the pulse generator is implantable.

14. A method for treating a patient at risk of or suffering from a gastrointestinal disorder, comprising:

placing a lead in a patient in a location adapted to stimulate a patient'"'"'s digestive system or a portion thereof;

applying a stimulation signal to the patient'"'"'s digestive system or a portion thereof via the lead;

detecting an indicator of autonomic nervous system function of the patient; and

modifying a parameter of the stimulation signal based on the detected indicator.

15. The method of claim 14, wherein detecting an indicator of autonomic nervous system function comprises detecting cardiac activity.

16. The method of claim 15, wherein detecting cardiac activity comprises detecting heart rate variability.

17. The method of claim 16, wherein detecting heart rate variability comprises analyzing a power spectrum of cardiac electrical activity.

18. The method of claim 17, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a low frequency range of between about 0.04 Hz to about 0.15 Hz.

19. The method of claim 18, wherein analyzing a power spectrum of cardiac electrical activity further comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

20. The method of claim 19, wherein analyzing a power spectrum of cardiac electrical activity comprises comparing power of the low frequency range to power of the high frequency range.

21. The method of claim 17, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

22. The method of claim 16, wherein detecting heart rate variability comprises determining a standard deviation of mean R-R intervals.

23. A method for identifying a candidate patient for digestive stimulation therapy, comprising:

selecting a patient suffering from or at risk of a gastrointestinal disorder;

detecting an indicator of autonomic nervous system function of the patient; and

determining whether the indicator is indicative of autonomic dysfunction,

wherein the patient is identified as a candidate for digestive stimulation therapy if the indicator is indicative of autonomic dysfunction.

24. The method of claim 23, wherein detecting an indicator of autonomic nervous system function comprises detecting cardiac activity.

25. The method of claim 24, wherein detecting cardiac activity comprises detecting heart rate variability.

26. The method of claim 25, wherein detecting heart rate variability comprises analyzing a power spectrum of cardiac electrical activity.

27. The method of claim 26, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a low frequency range of between about 0.04 Hz to about 0.15 Hz.

28. The method of claim 27, wherein analyzing a power spectrum of cardiac electrical activity further comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

29. The method of claim 28, wherein analyzing a power spectrum of cardiac electrical activity comprises comparing power of the low frequency range to power of the high frequency range.

30. The method of claim 26, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

31. The method of claim 25, wherein detecting heart rate variability comprises determining a standard deviation of mean R-R intervals.

32. A method for modifying a parameter of digestive stimulation therapy, comprising:

detecting an indicator of autonomic nervous system function; and

modifying the parameter of the digestive stimulation therapy based on the detected indicator.

33. The method of claim 32, wherein detecting an indicator of autonomic nervous system function comprises detecting cardiac activity.

34. The method of claim 33, wherein detecting cardiac activity comprises detecting heart rate variability.

35. The method of claim 34 wherein detecting heart rate variability comprises analyzing a power spectrum of cardiac electrical activity.

36. The method of claim 35, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a low frequency range of between about 0.04 Hz to about 0.15 Hz.

37. The method of claim 36, wherein analyzing a power spectrum of cardiac electrical activity further comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

38. The method of claim 37, wherein analyzing a power spectrum of cardiac electrical activity comprises comparing power of the low frequency range to power of the high frequency range.

39. The method of claim 35, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

40. The method of claim 34, wherein detecting heart rate variability comprises determining a standard deviation of mean R-R intervals.

41. A method for modifying a parameter of digestive stimulation therapy, comprising:

detecting an indicator of autonomic nervous system function;

applying a stimulation signal to at least a portion of a digestive system;

redetecting the indicator after applying the stimulation signal;

determining whether the redected indicator is indicative of an improvement in autonomic nervous system function; and

modifying the parameter of the digestive stimulation therapy if no improvement is detected.

42. The method of claim 41, wherein detecting an indicator of autonomic nervous system function comprises detecting cardiac activity.

43. The method of claim 42, wherein detecting cardiac activity comprises detecting heart rate variability.

44. The method of claim 43, wherein detecting heart rate variability comprises analyzing a power spectrum of cardiac electrical activity.

45. The method of claim 44, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a low frequency range of between about 0.04 Hz to about 0.15 Hz.

46. The method of claim 45, wherein analyzing a power spectrum of cardiac electrical activity further comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

47. The method of claim 46, wherein analyzing a power spectrum of cardiac electrical activity comprises comparing power of the low frequency range to power of the high frequency range.

48. The method of claim 44, wherein analyzing a power spectrum of cardiac electrical activity comprises analyzing the spectrum in a high frequency range of between about 0.18 Hz to about 0.4 Hz.

49. The method of claim 43, wherein detecting heart rate variability comprises determining a standard deviation of mean R-R intervals.

50. The method of claim 43, wherein the improvement is an increase in heart rate variability.

51. A computer-readable medium, comprising

program instructions adapted to cause a programmable processor to determine whether an improvement in autonomic function has occurred based on information from a sensor capable of detecting an indicator of autonomic nervous system function.

52. The computer-readable medium of claim 51, further comprising program instructions adapted to cause the programmable processor to instruct a pulse generator to modify a parameter of an electrical stimulation signal based on the determination of whether an improvement has occurred.

53. A pulse generator system comprising the computer-readable medium of claim 51.

54. A pulse generator system comprising the computer-readable medium of claim 52.