System and method for computationally determining migration of neurostimulation leads

• US 10,420,940 B2
• Filed: 02/09/2017
• Issued: 09/24/2019
• 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 W
• Application Number:
  US15/428,414
• Publication Number:
  US 20170151437A1
• Time in Patent Office: 957 Days
• 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 performed using a neurostimulation lead having a plurality of electrodes implanted within a patient, the method comprising:

providing sets of estimated electrical parameter data for estimated lead positions such that each of the estimated lead positions corresponds to a respective one of the sets of estimated electrical parameter data;

transmitting electrical energy using the electrodes;

measuring electrical parameter data that results from the transmitted electrical energy; and

comparing the measured electrical parameter data with the provided sets of estimated electrical parameter data to determine a position of the neurostimulation lead.

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

4. The method of claim 1, wherein the estimated electrical parameter data and the measured electrical parameter data each comprise electrical field potential data.

5. The method of claim 1, wherein the determined position is a position where the estimated electrical parameter data best matches the measured electrical parameter data.

6. The method of claim 1, wherein the comparison is computationally performed using a correlation coefficient function, a least squares based function, or a cross-correlation function.

7. The method of claim 1, further comprising providing a plurality of neurostimulation lead models, the plurality of neurostimulation lead models including the sets of estimated electrical parameter data, wherein each of the plurality of neurostimulation lead models includes at least one of an analytical model, a spatially discretized model, or an empirical data-based model.

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

9. The method of claim 8, further comprising taking corrective action in response to a determination that the neurostimulation lead has migrated.

10. A tissue stimulation system, comprising:

an implantable neurostimulation lead having electrodes;

memory including sets of estimated electrical parameter data stored therein, wherein the sets of estimated electrical parameter data correspond to estimated lead positions such that each of the estimated lead positions corresponds to a respective one of the sets of estimated electrical parameter data;

a controller configured to transmit electrical energy using at least some of the electrodes and measure electrical parameter data that results from the transmitted electrical energy; and

a processor configured to compare the measured electrical parameter data with the estimated electrical parameter data to determine a position of the neurostimulation lead.

11. The tissue stimulation system of claim 10, wherein the estimated electrical parameter data and the measured electrical parameter data each comprise electrical field potential data.

12. The tissue stimulation system of claim 10, wherein the processor is configured to determine the estimated electrical parameter data that best matches the measured electrical parameter data to determine the position of the neurostimulation lead.

13. The tissue stimulation system of claim 10, wherein the processor is configured to perform a comparison function selected from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

14. The tissue stimulation system of claim 10, further comprising neurostimulation lead models stored in the memory, the neurostimulation lead models including the sets of estimated electrical parameter data, the neurostimulation lead models including at least one of an analytical model;

a spatially discretized model, or an empirical data-based model.

15. The tissue stimulation system of claim 10, wherein the processor is further configured to determine whether a neurostimulation lead has migrated based on the determined position.

16. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

provide sets of estimated electrical parameter data for estimated lead positions such that each of the estimated lead positions corresponds to a respective one of the sets of estimated electrical parameter data;

provide instructions transmitting electrical energy using the electrodes;

provide instructions for measuring electrical parameter data that results from the transmitted electrical energy; and

compare the measured electrical parameter data with the provided sets of estimated electrical parameter data to determine a position of the neurostimulation lead.

17. The machine-readable medium of claim 16, wherein the estimated electrical parameter data and the measured electrical parameter data each comprise electrical field potential data.

18. The machine-readable medium of claim 16, wherein the determined position is a position where the estimated electrical parameter data best matches the measured electrical parameter data.

19. The machine-readable medium of claim 16, wherein the instructions include instructions, which when executed by the machine, cause the machine to compare the measured electrical parameter data with the estimated electrical parameter data by performing at least one of a correlation coefficient function, a least squares based function, or a cross-correlation function.

20. The machine-readable medium of claim 16, wherein the instructions include instructions, which when executed by the machine, cause the machine to provide a plurality of neurostimulation lead models, the plurality of neurostimulation lead models respectively, including the sets of estimated electrical parameter data, wherein each of the neurostimulation models includes at least one of an analytical model, a spatially discretized model, or an empirical data-based model.