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

• US 7,239,920 B1
• Filed: 02/11/2003
• Issued: 07/03/2007
• Est. Priority Date: 02/12/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Woods, Carla Mann, Thacker, James R
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/364,434
• Time in Patent Office: 1,603 Days
• Field of Search: 607/1, 607/2, 607/43, 607/46, 607/117
• US Class Current: 607/46
• 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 neural stimulation for autocorrection of stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

measuring relative pressure within the epidural space indicative of the coupling efficiency of an electrical stimulus applied to the neural tissue;

correlating a decrease or increase in pressure measurement with an increase or decrease in stimulation energy delivered to the neural tissue; and

automatically adjusting the stimulation energy delivered to the neural tissue through the at least one electrode connected to the lead in order to maintain an optimal level of therapy based on the correlation determination in the previous step.

2. The method of claim 1 wherein measuring the relative pressure comprises:

placing a pressure sensor in the vicinity of an electrode-tissue interface;

monitoring the pressure sensor over time to provide a pressure measurement; and

using changes in the relative pressure measurement as a feedback signal to automatically adjust the magnitude of subsequent stimulation energy.

3. The method of claim 2 wherein the pressure sensor is mounted to the electrode lead.

4. The method of claim 2 wherein the pressure sensor is mounted to a second lead.

5. The method of claim 2 wherein monitoring the pressure sensor comprises sampling the pressure sensor at specified sampling times.

6. The method of claim 2 wherein the step of automatically adjusting the stimulation energy delivered to the neural tissue through the at least one electrode connected to a lead comprises adjusting pulse amplitude, pulsewidth, frequency of pulses, or a combination thereof.

7. The method of claim 1 wherein the optimal level of therapy is a predetermined therapeutic range of stimulation energy actually delivered to the neural tissue that elicits a response that is below that which causes a sensation of pain or discomfort, which is the maximum comfortable threshold.

8. The method of claim 1 wherein correlating a decrease or increase of the pressure measurement with an increase or decrease in the stimulation energy supplied to the neural tissue comprises:

having a patient implanted with the IPG make postural movements to induce changes in measured pressure; and

recording an associated decrease or increase in pressure as well as sensation;

providing a predictive stimulation energy to be applied as a corrective adjustment;

saving the pressure waveform and linked stimulation energy data into an IPG memory for recall and use in the step of automatically adjusting the stimulation energy delivered to the neural tissue.

9. The method of claim 1 wherein the step of automatically adjusting the stimulation energy delivered to the neural tissue through at least one electrode attached to the lead comprises adjusting pulse amplitude, pulsewidth, frequency of pulses or a combination thereof.

10. A neural stimulation system for autocorrection of stimulation, the system comprising:

at least one electrode mounted on a first lead;

an implantable pulse generator connected to the first lead, wherein the pulse generator provides stimulation current pulses to the at least one electrode at a prescribed magnitude;

means for measuring pressure in the vicinity of an electrode-tissue interface within the epidural space;

means for determining a change in measured pressure over time; and

auto correction means for adjusting the stimulation energy as a function of the change detected in pressure measurements over time.

11. The neural stimulation system of claim 10 wherein the means for measuring pressure comprises a pressure transducer mounted on the same first lead having the at least one electrode.

12. The neural stimulation system of claim 10 wherein the means for measuring pressure comprises a pressure transducer that is located on a second lead.

13. The neural stimulation system of claim 10 wherein the means for measuring pressure comprises a strain gage.

14. The neural stimulation system of claim 10 wherein the means for measuring pressure comprises a piezo electric element.

15. An implantable neural stimulator comprising:

an implantable pulse generator (IPG);

a connector for connecting to a lead having at least one electrode;

means for measuring relative pressure within the epidural space indicative of the coupling efficiency of an electrical stimulation current generated by the IPG; and

means for automatically adjusting the stimulation energy of the stimulation delivered through the at least one electrode in order to compensate for variations in the measured coupling efficiency.

16. The implantable neural stimulator of claim 15 further comprising memory that stores data in the IPG, which data correlate changes in pressure measurement with adjustments to the stimulation energy to maintain optimal therapy.

17. The implantable neural stimulator of claim 15 wherein the means for automatically adjusting the stimulation energy delivered through the at least one electrode comprises a magnitude adjust device incorporated in the IPG for adjusting pulse amplitude, pulsewidth, frequency of pulses or a combination thereof.

18. A method of neural stimulation for autocorrection of stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

measuring relative pressure within the epidural space indicative of the coupling efficiency of an electrical stimulation current applied to neural tissue; and

automatically adjusting the magnitude of subsequent stimulation energy delivered to the neural tissue through the at least one electrode connected to the lead in order to maintain an optimal level of therapy,

wherein the adjustment of the stimulation energy is based on the relative measured pressure and its correlation to an increase or decrease in stimulation energy.

19. The method of claim 18 wherein measuring relative pressure comprises:

placing a pressure sensor in the vicinity of an electrode-tissue interface;

monitoring the pressure sensor over time to provide a pressure measurement; and

using changes in relative pressure measurement as a feedback signal to adjust the magnitude of subsequent stimulation energy.

20. The method of claim 19 wherein the pressure sensor is mounted to the electrode lead.

21. The method of claim 18 wherein the pressure sensor is mounted to a second lead.

22. The method of claim 19 wherein monitoring the pressure sensor comprises sampling the pressure sensor at specified sampling times.

23. The method of claim 19 wherein the step of automatically adjusting the magnitude of subsequent stimulation energy delivered to neural tissue through the at least one electrode attached to a lead comprises adjusting pulse amplitude, pulsewidth, frequency of pulses, or a combination thereof.

24. The method of claim 18 wherein the optimal level of therapy is a predetermined therapeutic range of stimulation energy actually delivered to the neural tissue that elicits a response that is below that which causes a sensation of pain or discomfort.

25. The method of claim 18 wherein the step of automatically adjusting the magnitude of subsequent stimulation energy delivered to the neural tissue through the at least one electrode connected to the lead comprises adjusting pulse amplitude, pulsewidth, frequency of pulses or a combination thereof.

26. The method of claim 18 further comprising:

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

storing the linked information between each characteristic morphology to a particular corrective adjustment in the IPG memory; and

recalling the linked information in the step of adjusting the magnitude of subsequent stimulation energy.

27. The method of claim 26, wherein the event is a postural movement;

and wherein the step of linking each characteristic morphology caused by an event to a particular corrective adjustment comprises measuring a pressure waveform for each postural movement while a patient with an IPG implanted makes various postural movements.