Management of stimulation safety limits in a neurostimulation system

• US 9,744,362 B2
• Filed: 05/31/2016
• Issued: 08/29/2017
• Est. Priority Date: 04/04/2013
• Status: Active Grant

• 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:
  US15/168,511
• Publication Number:
  US 20160271396A1
• Time in Patent Office: 455 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 neurostimulator configured to deliver electrical stimulation energy via a plurality of electrodes; and

controller circuitry configured to;

define a set of stimulation parameters for the plurality of electrodes as a function of independent contributions of a physical electrode parameter and an electrical source parameter for each electrode in the plurality electrodes; and

instruct the neurostimulator to deliver the electrical stimulation energy based on the defined set of stimulation parameters.

2. The neurostimulation system of claim 1, wherein the controller circuitry is configured to define the set of stimulation parameters in response to computing a charge injection metric value as a function of the physical electrode parameter and the electrical source parameter.

3. The neurostimulation system of claim 2, wherein the controller circuitry is further configure to compare the computed charge injection metric value to a safety threshold value and define the set of stimulation parameters below the safety threshold value.

4. The neurostimulation system of claim 3, wherein the controller circuitry is configured to modify the set of stimulation parameters in response to the computed charge injection metric value exceeding the safety threshold value.

5. The neurostimulation system of claim 3, wherein the controller circuitry is configured to compute the charge injection metric value in response to a user input.

6. The neurostimulation system of claim 5, further comprising a control device configured to receive the user input.

7. The neurostimulation system of claim 6, wherein the user input comprises a modification of the set of stimulation parameters.

8. 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.

9. 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.

10. A neurostimulation system comprising:

a neurostimulator configured to deliver electrical stimulation energy via a plurality of electrodes; and

controller circuitry configured to;

calculate a safety value of electrical stimulation energy for delivery by at least one of the plurality of electrodes as a function of independent contributions of a physical electrode parameter and an electrical source parameter for each electrode in the plurality electrodes.

11. The neurostimulation system of claim 10, wherein the controller circuitry is further configured to instruct the neurostimulator to deliver the electrical stimulation energy based on the calculated safety value.

12. The neurostimulation system of claim 11, wherein the controller circuitry is configured to calculate the safety value in response to computing a charge injection metric value as a function of the physical electrode parameter and the electrical source parameter.

13. The neurostimulation system of claim 12, wherein the controller circuitry is further configure to compare the computed charge injection metric value to a safety threshold value.

14. The neurostimulation system of claim 13, further comprising memory storing a plurality of different safety threshold values, and the controller circuitry is configured to determine a safety threshold value from the different safety threshold values.

15. The neurostimulation system of claim 10, wherein the physical electrode parameter is at least one of an electrode surface area, an electrode surface shape, and an electrode material.

16. The neurostimulation system of claim 11, wherein the electrical source parameter is at least one of a current, a voltage, a charge, charge density, and an impedance.

17. A method of defining a set of stimulation parameters for delivery of stimulation energy by a neurostimulator configured to deliver the stimulation energy via a plurality of electrodes, the method comprising:

defining a set of stimulation parameters as a function of independent contributions of a physical electrode parameter and an electrical source parameter for each electrode in the plurality electrodes; and

instructing the neurostimulator to deliver the stimulation energy based on the defined set of stimulation parameters.

18. The method of claim 17, further comprising comparing a computed charge injection metric value to a safety threshold value to define the set of stimulation parameters below a safety threshold value.

19. The method of claim 17, wherein the physical electrode parameter is at least one of an electrode surface area, an electrode surface shape, and an electrode material.

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