Management of stimulation safety limits in a neurostimulation system

• US 10,258,799 B2
• Filed: 04/17/2018
• Issued: 04/16/2019
• Est. Priority Date: 04/04/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Steinke, Gustav Karl, Moffitt, Michael A.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/955,453
• Publication Number:
  US 20180236239A1
• Time in Patent Office: 364 Days
• Field of Search: 607 59
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An electrical stimulation system for use with a plurality of electrodes implanted within a tissue region comprises a neurostimulator configured for delivering electrical stimulation energy to the plurality of electrodes in accordance with a set of stimulation parameters, thereby injecting a charge into the tissue region, a control device configured for receiving user input to modify the set of stimulation parameters, and controller/processor circuitry configured for, in response to the user input computing a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of the electrodes, wherein the electrode set comprises at least two electrodes, comparing the computed charge injection metric value to a safety threshold value, and performing a corrective action based on the comparison.

Claims

1. A neurostimulation system, comprising:

a memory having a safety threshold value stored in the memory; and

a processor coupled to the memory and configured for computing, for a set of stimulation parameters, a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of at least two electrodes;

comparing the computed charge injection metric value to the safety threshold value; and

performing a corrective action based on the comparison.

2. The neurostimulation system of claim 1, wherein the function comprises independent contributions of the physical electrode parameter and the electrical source parameter for each of the electrodes in the first set.

3. The neurostimulation system of claim 1, wherein performing the corrective action comprises conveying a warning signal to a user.

4. The neurostimulation system of claim 1, further comprising a plurality of electrodes.

5. The neurostimulation system of claim 4, wherein performing the corrective action comprises preventing delivery of electrical stimulation energy to the at least two electrodes using the set of stimulation parameters.

6. The neurostimulation system of claim 4, wherein performing the corrective action comprises delivering electrical stimulation energy to the at least two electrodes in accordance with a different set of stimulation parameters.

7. The neurostimulation system of claim 1, wherein the physical electrode parameter is at least one of an electrode surface area, an electrode surface shape, and an electrode material.

8. The neurostimulation system of claim 1, wherein the electrical source parameter is at least one of a current, a voltage, a charge, charge density, and an impedance.

9. The neurostimulation system of claim 1, further comprising an implantable pulse generator comprising the processor.

10. The neurostimulation system of claim 1, further comprising a programmer comprising the processor.

11. A method of operating a neurostimulation system, the method comprising:

computing, for a set of stimulation parameters, a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of at least two electrodes;

comparing the computed charge injection metric value to a safety threshold value; and

performing a corrective action based on the comparison.

12. The method of claim 11, wherein the function comprises independent contributions of the physical electrode parameter and the electrode source parameter for each of the electrodes in the first set.

13. The method of claim 11, wherein performing the corrective action comprises conveying a warning signal to a user.

14. The method of claim 11, wherein performing the corrective action comprises preventing delivery of electrical stimulation energy to the at least two electrodes using the set of stimulation parameters.

15. The method of claim 11, wherein performing the corrective action comprises delivering electrical stimulation energy to the at least two electrodes in accordance with a different set of stimulation parameters.

16. The method of claim 11, wherein the physical electrode parameter is at least one of an electrode surface area, an electrode surface shape, and an electrode material.

17. The method of claim 11, wherein the electrical source parameter is at east one of a current, a voltage, a charge, charge density, and an impedance.

18. The method of claim 11, wherein physical electrode parameter is an electrode surface area, and the electrical source parameter is a charge and the charge injection metric value is computed in accordance with an equation

19. The method of claim 11, wherein physical electrode parameter is an electrode surface area, and the electrical source parameter is a charge and the charge injection metric value is computed in accordance with an equation

20. The method of claim 19, wherein the weighting value is a binary value.