Neural stimulation system providing auto adjustment of stimulus output as a function of sensed pressure changes

• US 7,801,621 B1
• Filed: 04/30/2007
• Issued: 09/21/2010
• Est. Priority Date: 02/12/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Woods, Carla Mann, Thacker, James R.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/742,543
• Time in Patent Office: 1,240 Days
• Field of Search: 607/1, 607/2, 607 39- 64
• US Class Current: 607/62
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

A neural stimulation system automatically corrects or adjusts the stimulus magnitude in order to maintain a comfortable and effective stimulation therapy. Auto correction of the stimulus magnitude is linked to the measurement of pressure in the vicinity of the electrode-tissue interface. Because the pressure near the electrode-tissue interface can provide a measure of the electrode contacts'"'"' proximity to the neural tissue, and hence quantity of electrical energy delivered to the neural tissue, a change in the measured pressure or pressure morphology indicates that the stimulation energy may need to be adjusted. Hence, changes in pressure provide a feedback mechanism that permit the system to effectively auto correct the stimulus amplitude in order to maintain a desired therapeutic effect.

Claims

1. A method of stimulating neural tissue using at least one electrode, comprising:

measuring pressure indicative of the electrical coupling efficiency between the at least one electrode and the neural tissue;

delivering stimulation energy through the at least one electrode to the neural tissue; and

automatically adjusting the stimulation energy delivered through the at least one electrode to the neural tissue based on the pressure measurement.

2. The method of claim 1, wherein the pressure is measured in the vicinity of an interface between the at least one electrode and the neural tissue.

3. The method of claim 1, wherein the pressure is measured in an epidural space.

4. The method of claim 1, wherein the pressure is the relative pressure applied between the at least one electrode and the neural tissue.

5. The method of claim 1, wherein the magnitude of the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted based on the pressure measurement.

6. The method of claim 5, wherein the magnitude of the stimulation energy is automatically adjusted from one non-zero level to another different non-zero level.

7. The method of claim 1, wherein one or more of a pulse amplitude, pulse width, and pulse frequency of the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted based on the pressure measurement.

8. The method of claim 1, wherein the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted in order to maintain an optimal level of therapy.

9. The method of claim 8, wherein the optimal level of therapy is a predetermined therapeutic range of stimulation energy that elicits a response between a perception threshold and a discomfort threshold.

10. The method of claim 1, wherein the at least one electrode is mounted to an electrode lead.

11. The method of claim 1, wherein the automatic stimulation energy adjusting is performed in an implantable pulse generator.

12. The method of claim 1, further comprising determining a difference in the measured pressure over time, wherein the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted based on the determined pressure difference.

13. The method of claim 1, further comprising correlating a decrease or increase in the pressure measurement with an increase or decrease in stimulation energy delivered to the neural tissue, wherein the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted based on the correlation.

14. The method of claim 13, wherein the correlation step comprises:

linking each characteristic morphology caused by an event to a particular corrective adjustment for delivering a predetermined stimulation energy to the neural tissue; and

storing the linked information between each characteristic morphology to a particular corrective adjustment;

the method further comprising recalling the linked information, wherein the stimulation energy delivered through the at least one electrode to the neural tissue is automatically adjusted based on the recalled linked information.

15. The method of claim 14, wherein the event is a postural movement, and the linking step comprises measuring a pressure waveform for each postural movement while a patient makes various postural movements.

16. A neural stimulation system, comprising:

at least one electrode;

a pressure transducer configured for detecting pressure indicative of the electrical coupling efficiency between the at least one electrode and neural tissue;

analog circuitry configured for delivering stimulation energy to the at least one electrode in order to stimulate the neural tissue; and

control circuitry configured for automatically adjusting the stimulation energy delivered from the analog circuitry to the at least one electrode based on the detected pressure.

17. The neural stimulation system of claim 16, wherein the pressure transducer is configured for detecting the pressure in the vicinity of an interface between the at least one electrode and the neural tissue.

18. The neural stimulation system of claim 16, wherein the pressure transducer is configured for detecting the pressure in an epidural space.

19. The neural stimulation system of claim 16, wherein the pressure is the relative pressure applied between the at least one electrode and the neural tissue.

20. The neural stimulation system of claim 16, wherein the control circuitry is configured for automatically adjusting the magnitude of the stimulation energy delivered to the at least one electrode based on the pressure detection.

21. The neural stimulation system of claim 20, wherein the control circuitry is configured for automatically adjusting the magnitude of the stimulation energy from one non-zero level to another different non-zero level.

22. The neural stimulation system of claim 16, wherein the control circuitry is configured for automatically adjusting one or more of a pulse amplitude, pulse width, and pulse frequency of the stimulation energy delivered to the at least one electrode based on the pressure detection.

23. The neural stimulation system of claim 16, wherein the control circuitry is configured for automatically adjusting the stimulation energy delivered to the at least one electrode in order to maintain an optimal level of therapy.

24. The neural stimulation system of claim 23, wherein the optimal level of therapy is a predetermined therapeutic range of stimulation energy that elicits a response between a perception threshold and a discomfort threshold.

25. The neural stimulation system of claim 16, further comprises an electrode lead on which the at least one electrode is mounted.

26. The neural stimulation system of claim 16, further comprising an implantable pulse generator in which the analog circuitry and control circuitry are contained.

27. The neural stimulation system of claim 16, wherein the control circuitry is configured for determining a difference in the measured pressure over time, and for automatically adjusting the stimulation energy delivered to the at least one electrode based on the determined pressure difference.

28. The neural stimulation system of claim 16, further comprising memory correlating a decrease or increase in the pressure measurement with an increase or decrease in stimulation energy delivered to the neural tissue, wherein the control circuitry is configured for automatically adjusting the stimulation energy delivered to the at least one electrode based on the correlation.

29. The neural stimulation system of claim 28, wherein the memory correlates by storing information linking each characteristic morphology caused by an event to a particular corrective adjustment for delivering a predetermined stimulation energy to the neural tissue, wherein the control circuitry is configured for recalling the linked information from the memory and automatically adjusting the stimulation energy delivered to the at least one electrode based on the recalled linked information.

30. The neural stimulation system of claim 29, wherein the event is a postural movement, and the linking information comprises a pressure waveform for each of a variety of postural movements.