Stimulation signal generator for an implantable device

• US 20020077670A1
• Filed: 09/11/2001
• Published: 06/20/2002
• Est. Priority Date: 04/05/2000
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Pless, Benjamin D., Archer, Stephen T.
• Granted Patent: US 6,690,974 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36064 Epilepsy

Abstract

An implantable multimodal neurostimulator having improved efficacy in treating epilepsy and other neurological disorders and processes of using that neurostimulator are described herein. The neurostimulator itself generally has two modes of electrical stimulation. The first involves delivering a non-responsive electrical stimulation signal that is applied to the central nervous system to reduce the likelihood of a seizure or other undesirable neurological even from occurring. Various waveform morphologies are described for non-responsive stimulation signals. A second mode involves delivering a responsive electrical stimulation signal when epileptiform waveforms are impending or extant. The responsive electrical stimulation signal is intended to terminate epileptiform activity, e.g., to desynchronize abnormally synchronous brain electrical activity.

Claims

1. A neurostimulation system for treating a disorder in a brain of a patient, comprising:

a stimulation subsystem adapted to apply an electrical stimulation signal to neural tissue of the patient; and

a plurality of electrodes including a first electrode and a second electrode, each in electrical communication with the stimulation subsystem;

wherein the stimulation subsystem includes a stimulation signal generator adapted to deliver a controlled electrical current from a stimulation signal input through a stimulation load between the first electrode and the second electrode; and

wherein the stimulation signal generator includes a programmable current digital-to-analog converter in series with the stimulation load.

2. The neurostimulation system of claim 1, wherein the programmable current digital-to-analog converter comprises a programmable resistor in series with the stimulation load, a reference voltage source providing a reference voltage, and a current controller adapted to match a voltage at an upstream end of the programmable resistor to the reference voltage.

3. The neurostimulation system of claim 2, wherein the current controller comprises a field effect transistor (FET) in series with the stimulation load and the programmable resistor and an operational amplifier (op amp) connected to receive the reference voltage and the voltage at the upstream end of the programmable resistor, wherein conduction of the FET is controlled by the op amp.

4. The neurostimulation system of claim 3, wherein the stimulation signal generator further comprises a tilt detector.

5. The neurostimulation system of claim 4, wherein the tilt detector comprises a tilt detection trigger coupled to the operational amplifier.

6. The neurostimulation system of claim 5, wherein the tilt detection trigger is operative to determine when the op amp is actuated to maximize conduction of the FET.

7. The neurostimulation system of claim 5, wherein the tilt detection trigger comprises a comparator.

8. The neurostimulation system of claim 2, wherein the programmable resistor provides a digitally controlled resistance value.

9. The neurostimulation system of claim 1, wherein the controlled electrical current comprises a stimulation signal.

10. The neurostimulation system of claim 9, wherein the stimulation subsystem includes a charge balancing function adapted to deliver a charge balancing signal equal in amplitude and duration and opposite in polarity to the stimulation signal.

11. The neurostimulation system of claim 9, wherein the neurostimulation system further comprises a central processing unit, and wherein the central processing unit is programmed to cause the stimulation subsystem to deliver a to deliver a charge balancing signal equal in amplitude and duration and opposite in polarity to the stimulation signal.

12. The neurostimulation system of claim 1, wherein the stimulation subsystem is adapted to approximate a substantially continuous waveform through the delivery of a stepwise approximation of the substantially continuous waveform.

13. The neurostimulation system of claim 1, wherein the stimulation signal generator further comprises a leakage detector.

14. The neurostimulation system of claim 13, wherein the leakage detector comprises a leakage prevention component attached to couple a leakage detection electrode to a system ground.

15. The neurostimulation system of claim 14, wherein the leakage prevention component comprises a field effect transistor (FET) having a response threshold, and wherein the FET is substantially conductive at a leakage current below the threshold and comparatively resistive at a leakage current above the threshold.

16. The neurostimulation system of claim 15, further comprising a voltage-dependent leakage trigger coupled to the FET to determine when the leakage current exceeds the threshold.

17. The neurostimulation system of claim 16, wherein the voltage-dependent leakage trigger comprises a digital logic gate.

18. The neurostimulation system of claim 14, further comprising a coupling capacitor in parallel with the leakage prevention component.

19. The neurostimulation system of claim 14, wherein the leakage detection electrode is selected from the plurality of electrodes.

20. The neurostimulation system of claim 1, wherein at least one of the plurality of electrodes has a surface fabricated from a material providing an enhanced surface area.

21. The neurostimulation system of claim 20, wherein the material providing an enhanced surface area is selected from the group consisting of platinum black, titanium nitride, and iridium oxide.

22. The neurostimulation system of claim 20, wherein the stimulation signal generator is programmable to deliver an unbalanced stimulation signal.

23. The neurostimulation system of claim 22, wherein the unbalanced stimulation signal includes a direct current component.

25. The neurostimulation system of claim 24, wherein the H-bridge circuit comprises a switching matrix adapted to select the first electrode and the second electrode from the plurality of electrodes.

26. The neurostimulation system of claim 24, wherein the controlled electrical current comprises a stimulation signal.

27. The neurostimulation system of claim 26, wherein the stimulation subsystem includes a charge balancing function adapted to deliver a charge balancing signal equal in amplitude and duration and opposite in polarity to the stimulation signal.

28. The neurostimulation system of claim 27, wherein the charge balancing function is operative to deliver the charge balancing signal by reversing a polarity of the H-bridge circuit.

29. The neurostimulation system of claim 26, wherein the neurostimulation system further comprises a central processing unit, and wherein the central processing unit is programmed to cause the stimulation subsystem to deliver a to deliver a charge balancing signal equal in amplitude and duration and opposite in polarity to the stimulation signal.

30. The neurostimulation system of claim 29, wherein the central processing unit commands the stimulation subsystem to reverse a polarity of the H-bridge circuit when delivering the charge balancing signal.

31. The neurostimulation system of claim 24, wherein the stimulation subsystem is adapted to approximate a substantially continuous waveform through the delivery of a stepwise approximation of the substantially continuous waveform.

32. The neurostimulation system of claim 31, wherein the stepwise approximation has a positive portion and a negative portion, and wherein the stimulation subsystem is operative to deliver the positive portion with the H-bridge circuit configured to pass current in a first direction and the negative portion with the H-bridge circuit configured to pass current in a second direction opposite to the first direction.

33. The neurostimulation system of claim 24, wherein the stimulation signal generator further comprises a leakage detector.

34. The neurostimulation system of claim 33, wherein the leakage detector comprises a leakage prevention component attached to couple a leakage detection electrode to a system ground.

35. The neurostimulation system of claim 34, wherein the leakage prevention component comprises a field effect transistor (FET) having a response threshold, and wherein the FET is substantially conductive at a leakage current below the threshold and comparatively resistive at a leakage current above the threshold.

36. The neurostimulation system of claim 35, further comprising a voltage-dependent leakage trigger coupled to the FET to determine when the leakage current exceeds the threshold.

37. The neurostimulation system of claim 36, wherein the voltage-dependent leakage trigger comprises a digital logic gate.

38. The neurostimulation system of claim 34, further comprising a coupling capacitor in parallel with the leakage prevention component.

39. The neurostimulation system of claim 34, wherein the leakage detection electrode is selected from the plurality of electrodes.

24. A neurostimulation system for treating a disorder in a brain of a patient, comprising:

a stimulation subsystem adapted to apply a therapeutic electrical stimulation signal to the brain of the patient; and

a plurality of electrodes including a first electrode and a second electrode, each in electrical communication with the stimulation subsystem;

wherein the stimulation subsystem includes a stimulation signal generator adapted to deliver a controlled electrical current through a stimulation load between the first electrode and the second electrode; and

wherein the stimulation signal generator includes a programmable H-bridge circuit adapted to control the direction of current flow between the first electrode and the second electrode.

40. A method for treating a disorder in a brain of a patient, the method comprising the steps of:

generating a stimulation voltage;

configuring a switching matrix to select a first electrode and a second electrode from a plurality of electrodes;

connecting the stimulation voltage source to the first electrode and a programmable digital-to-analog current sink to the second electrode, thereby delivering a stimulation signal to the brain of the patient; and

controlling the programmable digital-to-analog current sink with a stimulation waveform to regulate an electrical current present in the stimulation signal.

41. The method for treating a disorder of claim 40, wherein the stimulation signal comprises a non-pulsatile waveform.

42. The method for treating a disorder of claim 40, wherein the stimulation signal comprises a substantially continuous waveform.

43. The method for treating a disorder of claim 40, wherein the stimulation signal comprises at least one pulse.

44. The method for treating a disorder of claim 40, wherein the stimulation signal is unbalanced.

45. The method for treating a disorder of claim 44, wherein the unbalanced stimulation signal includes a direct current component.

46. The method for treating a disorder of claim 40, further comprising the step of charge balancing the stimulation signal.

47. The method for treating a disorder of claim 46, wherein the charge balancing step comprises the steps of:

connecting the stimulation voltage source to the second electrode and the programmable digital-to-analog current sink to the first electrode, thereby delivering a charge balancing signal to the brain of the patient; and

controlling the programmable digital-to-analog current sink with a charge balancing waveform to regulate the electrical current present in the charge balancing signal.

48. The method for treating a disorder of claim 47, wherein the stimulation waveform is substantially identical to the charge balancing waveform.

49. The method for treating a disorder of claim 46, wherein the charge balancing step comprises the steps of:

calculating an accumulated charge in the stimulation waveform; and

controlling the programmable digital-to-analog current sink to achieve an accumulated charge near zero.

50. The method for treating a disorder of claim 49, wherein the charge balancing step further comprises the step of controlling the programmable digital-to-analog current sink to ensure the accumulated charge does not exceed a threshold.

51. The method for treating a disorder of claim 40, further comprising the step of determining whether the stimulation voltage is sufficient to enable delivery of a desired electrical current through a load defined by the brain of the patient between the first electrode and the second electrode.

52. The method for treating a disorder of claim 51, further comprising the step of generating a current tilt signal if the stimulation voltage is insufficient.

53. The method for treating a disorder of claim 52, further comprising the step of performing an action in response to the current tilt signal.

54. The method for treating a disorder of claim 40, firther comprising the step of determining whether a leakage current from a leakage electrode in the brain of the patient exceeds a threshold.

55. The method for treating a disorder of claim 54, further comprising the step of generating a leakage current signal if the leakage current exceeds the threshold.

56. The method for treating a disorder of claim 55, further comprising the step of performing an action in response to the leakage current signal.