System and method for computationally determining migration of neurostimulation leads

• US 9,572,986 B2
• Filed: 12/26/2012
• Issued: 02/21/2017
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A.
• Primary Examiner(s): Kahelin, Michael
• Application Number:
  US13/727,548
• Publication Number:
  US 20130138165A1
• Time in Patent Office: 1,518 Days
• Field of Search: 607/2
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A tissue stimulation system and computer software and method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient (e.g., adjacent the spinal cord) is provided. Neurostimulation lead models are provided, each of which includes estimated electrical parameter data (e.g., electrical field potential data) corresponding to a predetermined position of the neurostimulation lead. Electrical energy is transmitted to or from the electrodes, and electrical parameter data (e.g., electrical field potential data) is measured in response to the transmitted electrical energy. The measured electrical parameter data is compared with the estimated electrical parameter data of each of the neurostimulation lead models, and a position of the neurostimulation lead is determined based on the comparison.

Claims

1. A method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient, the method comprising:

providing a plurality of sets of estimated electrical parameter data, each set corresponding to a predetermined relative position of the neurostimulation lead;

transmitting electrical energy to or from the electrodes;

measuring electrical parameter data in response to the transmitted electrical energy;

comparing the measured electrical parameter data with the estimated electrical parameter data of each of the sets; and

determining a position of the neurostimulation lead based on the comparison.

2. The method of claim 1, wherein the position of the neurostimulation lead is determined relative to another neurostimulation lead implanted within the patient.

3. The method of claim 2, wherein the neurostimulation leads are implanted in a side-by-side arrangement.

4. The method of claim 3, wherein the determined relative position is a stagger between the neurostimulation leads.

5. The method of claim 1, wherein the position of the neurostimulation lead is determined relative to an anatomical feature.

6. The method of claim 1, wherein the neurostimulation lead is implanted adjacent a spinal cord of the patient.

7. The method of claim 1, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

8. The method of claim 1, wherein the determined position is the predetermined position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

9. The method of claim 1, wherein the comparison is performed computationally.

10. The method of claim 9, wherein the comparison is computationally performed using a comparison function selected from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

11. The method of claim 1, further comprising providing a plurality of neurostimulation lead models, the plurality of lead models respectively including the plurality of sets of electrical parameter data, wherein each of the neurostimulation models is selected from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

12. The method of claim 1, further comprising determining whether the neurostimulation lead has migrated based on the determined position.

13. The method of claim 12, further comprising taking corrective action in response to a determination that the neurostimulation lead has migrated.

14. The method of claim 13, wherein the corrective action comprises reprogramming the electrodes.

15. A tissue stimulation system, comprising:

an implantable neurostimulation lead having a plurality of electrodes;

memory;

a plurality of sets of estimated electrical parameter data stored in the memory, each set corresponding to a predetermined position of the neurostimulation lead;

a controller configured for transmitting electrical energy to or from the electrodes and measuring electrical parameter data in response to the transmitted electrical energy; and

a processor configured for comparing the measured electrical parameter data with the estimated electrical parameter data of each of the sets, and determining a position of the neurostimulation lead based on the comparison.

16. The tissue stimulation system of claim 15, further comprising another implantable neurostimulation lead, wherein the position of the neurostimulation lead is determined relative to the other neurostimulation lead.

17. The tissue stimulation system of claim 16, wherein the determined relative position is a stagger between the neurostimulation leads.

18. The tissue stimulation system of claim 17, wherein the position of the neurostimulation lead is determined relative to an anatomical feature.

19. The tissue stimulation system of claim 15, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

20. The tissue stimulation system of claim 15, wherein the determined position is the predetermined position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

21. The tissue stimulation system of claim 15, wherein the comparison is performed computationally.

22. The tissue stimulation system of claim 21, wherein the comparison is computationally performed using a comparison function selected from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

23. The tissue stimulation system of claim 15, further comprising a plurality of neurostimulation lead models stored in the memory, the plurality of lead models respectively including the plurality of sets of electrical parameter data, each of the neurostimulation lead models is selected from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

24. The tissue stimulation system of claim 15, wherein the processor is further configured for determining whether the neurostimulation leads has migrated based on the determined position.

25. The tissue stimulation system of claim 24, wherein the processor is further configured for reprogramming the electrodes in response to a determination that the neurostimulation lead has migrated.