System and method for computationally determining migration of neurostimulation leads

• US 8,019,427 B2
• Filed: 10/06/2010
• Issued: 09/13/2011
• 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): Patel; Niketa I
• Assistant Examiner(s): El-Kaissi; Hiba
• Application Number:
  US12/899,139
• Publication Number:
  US 20110022122A1
• Time in Patent Office: 342 Days
• Field of Search: 607/46, 607/55, 607/57, 607/59, 607/117
• US Class Current: 607/46
• 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. An external control device for use with implantable neurostimulation leads, each having a plurality of electrodes, comprising:

memory;

plurality of neurostimulation lead models stored in the memory, each of the neurostimulation lead models including estimated electrical parameter data corresponding to a predetermined relative position between the neurostimulation leads;

a controller configured for transmitting electrical energy to or from the electrodes of the neurostimulation leads, 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 neurostimulation lead models, and determining a relative position between the neurostimulation leads based on the comparison.

2. The external control device of claim 1, wherein the determined relative position is a stagger between the neurostimulation leads.

3. The external control device of claim 1, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

4. The external control device of claim 1, wherein the relative position is determined to be the predetermined relative position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

5. The external control device of claim 1, wherein the comparison is performed computationally.

6. The external control device of claim 5, 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.

7. The external control device of claim 1, wherein 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.

8. The external control device of claim 1, wherein the estimated electrical parameter data in each of the neurostimulation lead models comprises a two-dimensional array of data.

9. The external control device of claim 1, wherein the processor is further configured for determining whether one of the neurostimulation leads has migrated based on the determined relative position.

10. The external control device of claim 9, wherein the processor is further configured for reprogramming the electrodes in response to a determination that the one neurostimulation lead has migrated.

11. An external control device for use with an implantable neurostimulation lead having a plurality of electrodes, comprising:

memory;

plurality of neurostimulation lead models stored in the memory, each of the neurostimulation lead models including estimated electrical parameter data 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 neurostimulation lead models, and determining a position of the neurostimulation lead based on the comparison.

12. The external control device of claim 11, wherein the external control device is for use with the implantable neurostimulation lead and another implantable neurostimulation lead, wherein each of the neurostimulation lead models includes estimated electrical parameter data corresponding to a predetermined relative position between the neurostimulation lead and the other neurostimulation lead, and wherein the position of the neurostimulation lead is determined relative to the other neurostimulation lead based on the comparison.

13. The external control device of claim 12, wherein the determined relative position is a stagger between the neurostimulation leads.

14. The external control device of claim 11, wherein processor is configured for determining the position of the neurostimulation lead relative to an anatomical feature.

15. The external control device of claim 11, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

16. The external control device of claim 11, wherein the relative position is determined to be the predetermined relative position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

17. The external control device of claim 11, wherein the comparison is performed computationally.

18. The external control device of claim 11, 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.

19. The external control device of claim 11, wherein 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.

20. The external control device of claim 11, wherein the processor is further configured for determining whether the neurostimulation lead has migrated based on the determined position.

21. The external control device of claim 20, wherein the processor is further configured for reprogramming the electrodes in response to a determination that the neurostimulation lead has migrated.