Management of stimulation safety limits in a neurostimulation system

• US 9,358,394 B2
• Filed: 04/03/2014
• Issued: 06/07/2016
• 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): Lavert, Nicole F
• Application Number:
  US14/244,652
• Publication Number:
  US 20140303689A1
• Time in Patent Office: 796 Days
• Field of Search: 607/59
• US Class Current: 1/1
• 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 for use with a plurality of electrodes implanted within a tissue region, comprising:

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 comprising independent contributions of the physical electrode parameter and the electrode source parameter for each electrode in the electrode set, 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.

2. The neurostimulation system of claim 1, wherein performing the corrective action comprises preventing the neurostimulation device from delivering the electrical stimulation energy to the plurality of electrodes.

3. The neurostimulation system of claim 1, wherein performing the corrective action comprises delivering the electrical stimulation energy to the electrode set in accordance with a different set of stimulation parameters.

4. The neurostimulation system of claim 1, wherein performing the corrective action comprises directing the control device to convey a warning signal to the user.

5. The neurostimulation system of claim 1, wherein the controller/processor circuitry is configured for:

directing the neurostimulator to deliver the electrical stimulation energy to the plurality of electrodes in accordance with the modified stimulation parameter set if the computed charge injection metric value does not breach the threshold charge injection metric value; and

performing the corrective action if the computed charge injection metric value breaches the threshold charge injection metric value.

6. 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.

7. 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.

8. The neurostimulation system of claim 1, wherein the physical electrode parameter is an electrode surface area, and the electrical source parameter is a charge.

9. The neurostimulation system of claim 1, further comprising memory storing a plurality of different safety threshold values, and the controller/processor circuitry is configured for selecting the safety threshold value from the different safety threshold values based on a characteristic shared by the electrode set.

10. The neurostimulation system of claim 9, wherein the characteristic is one of the same frequency and the same polarity.

11. The neurostimulation system of claim 1, wherein the controller/processor circuitry is configured for, in response to the user input:

computing at least one other charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for each of at least one other set of the electrodes, wherein the electrode set and each of the at least one other electrode set are different from each other, and each of the at least other electrode set comprises at least two electrodes;

comparing a function of the computed charge injection metric value and the at least one other computed charge injection metric value to the safety threshold value; and

performing the corrective action based on the computed function.

12. The neurostimulation system of claim 11, wherein the function is one of a maximum, a sum, an average, and a minimum of the charge injection metric value and the at least one other charge injection metric value.

13. The neurostimulation system of claim 1, wherein the neurostimulator is implantable.

14. The neurostimulation system of claim 1, wherein the control device comprises the controller/processor circuitry.

15. The neurostimulation system of claim 1, wherein the control device is an external control device.

16. The neurostimulation system of claim 8, wherein the ratios between the injected charge and the surface area for at least two of the electrodes are different.

17. A neurostimulation system for use with a plurality of electrodes implanted within a tissue region, comprising:

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, wherein physical electrode parameter is an electrode surface area, and the electrical source parameter is a charge and the tissue charge injection safety value is computed in accordance with the equation

18. A neurostimulation system for use with a plurality of electrodes implanted within a tissue region, comprising:

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, wherein physical electrode parameter is an electrode surface area, and the electrical source parameter is a charge and the tissue charge injection safety value is computed in accordance with the equation

19. The neurostimulation system of claim 18, wherein the weighting value W_i, is a binary value.

20. The neurostimulation system of claim 18, wherein the weighting value W_i, is a graduated value.

21. The neurostimulation system of claim 18, wherein the controller/processor circuitry is configured for determining the weighting value W_i, for each electrode in the electrode set based on an adjacency of the respective electrode relative to a reference electrode in the electrode set.

22. The neurostimulation system of claim 18, wherein the controller/processor circuitry is configured for determining the weighting value W_i, for each electrode in the electrode set based on a polarity of the respective electrode.