Systems and methods for programming a neuromodulation system

• US 9,937,349 B2
• Filed: 04/05/2017
• Issued: 04/10/2018
• Est. Priority Date: 12/12/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Grandhe, Sarvani
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/480,033
• Publication Number:
  US 20170203102A1
• Time in Patent Office: 370 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method of operating an implantable neuromodulator includes calculating an index for each of a plurality of modulation parameter sets, wherein each modulation parameter set includes a respective plurality of modulation parameters from which the respective index is calculated, serially conveying electrical modulation energy to a patient in accordance with each of the plurality of modulation parameter sets, causing the patient to perceive paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with one of the plurality of modulation parameter sets, identifying the calculated index for that one modulation parameter set as a perception threshold index based on the perceived paresthesia, and storing the identified perception threshold index. The method may also include determining a new modulation parameter set based on the identified perception threshold index, and conveying electrical modulation energy to the tissue in accordance with the new modulation parameter set.

Claims

1. A method of modifying a neuromodulation parameter set, comprising:

determining a first index for a first plurality of neuromodulation parameters, wherein the first plurality of neuromodulation parameters are part of a first neurostimulation program;

determining a first normalized value for the first index as a percentage of a first patient perception threshold index;

identifying a second patient perception threshold index;

determining a second index from the identified second patient perception threshold index and the determined first normalized value;

determining a second plurality of neuromodulation parameters from the determined second index; and

modifying at least one of the first plurality of neuromodulation parameters to result in the second plurality of neuromodulation parameters and a second neurostimulation program.

2. The method of claim 1, further comprising:

determining a third index for a third plurality of neuromodulation parameters, wherein the third plurality of neuromodulation parameters are part of a third neurostimulation program;

determining a second normalized value for the third index as a percentage of the first patient perception threshold index;

determining a fourth index from the identified second patient perception threshold index and the second normalized value;

determining a fourth plurality of neuromodulation parameters from the determined fourth index; and

modifying at least one of the third plurality of neuromodulation parameters to result in the fourth plurality of neuromodulation parameters and a fourth neurostimulation program.

3. The method of claim 2, wherein modifying at least one of the first plurality of neuromodulation parameters and modifying at least one of the third plurality of neuromodulation parameters are performed simultaneously.

4. The method of claim 1, wherein the modifying at least one of the first plurality of neuromodulation parameters is performed automatically.

5. The method of claim 1, wherein the modifying at least one of the first plurality of neuromodulation parameters is performed manually.

6. The method of claim 1, further comprising modifying an absolute value of the at least one of the first plurality of neuromodulation parameters.

7. The method of claim 1, wherein the first and second indices are energy indices determined by multiplying respective amplitudes, pulse widths, and frequencies.

8. The method of claim 1, wherein the first index for the first plurality of neuromodulation parameters and the second index for the second plurality of neuromodulation parameters are determined as a function of a corresponding plurality of neuromodulation parameters.

9. The method of claim 8, further comprising determining a new neuromodulation parameter set for a sub-threshold therapy based on an identified patient perception threshold index.

10. The method of claim 9, further comprising delivering a sub-threshold neuromodulation therapy, including conveying sub-threshold electrical neuromodulation energy to tissue in accordance with the new neuromodulation parameter set.

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

determine a first index for a first plurality of neuromodulation parameters, wherein the first plurality of neuromodulation parameters are part of a first neurostimulation program;

determine a first normalized value for the first index as a percentage of a first patient perception threshold index;

identify a second patient perception threshold index;

determine a second index from the identified second perception index and the normalized value;

determine a second plurality of neuromodulation parameters from the determined second index; and

modify at least one of the first plurality of neuromodulation parameters to result in the second plurality of neuromodulation parameters and a second neurostimulation program.

12. The non-transitory machine-readable medium of claim 11, further comprising instructions, which when executed by the machine, cause the machine to:

determine a third index for a third plurality of neuromodulation parameters, wherein the third plurality of neuromodulation parameters are part of a third neurostimulation program;

determine a second normalized value for the third index as a percentage of the first patient perception threshold index;

determine a fourth index from the identified second patient perception index and the second normalized value;

determine a fourth plurality of neuromodulation parameters from the determined fourth index; and

modify at least one of the third plurality of neuromodulation parameters to result in the fourth plurality of neuromodulation parameters and a fourth neurostimulation program.

13. The non-transitory machine-readable medium of claim 12, further comprising instructions, which when executed by the machine, cause the machine to simultaneously modify at least one of the first plurality of neuromodulation parameters and at least one of the third plurality of neuromodulation parameters.

14. The non-transitory machine-readable medium of claim 11, further comprising instructions, which when executed by the machine, cause the machine to automatically modify at least one of the first plurality of neuromodulation parameters.

15. The non-transitory machine-readable medium of claim 11, further comprising instructions, which when executed by the machine, cause the machine to modify the absolute value of the at least one of the first plurality of neuromodulation parameters.

16. The non-transitory machine-readable medium of claim 11, further comprising instructions, which when executed by the machine, cause the machine to determine the first and second indices by multiplying respective amplitudes, pulse widths, and frequencies.

17. The non-transitory machine-readable medium of claim 16, wherein the first and second indices are energy indices.

18. A neuromodulation system for use with a plurality of electrodes to provide therapy to a patient, the neuromodulation system comprising:

an electrical neurostimulator configured to be coupled to the plurality of electrodes; and

an external control device configured to;

determine a first index for a first plurality of neuromodulation parameters, wherein the first plurality of neuromodulation parameters are part of a first neurostimulation program;

determine a first normalized value for the first index as a percentage of a first patient perception threshold index;

identify a second patient perception threshold index;

determine a second index from the identified second patient perception threshold index and the determined first normalized value;

determine a second plurality of neuromodulation parameters from the determined second index; and

modify at least one of the first plurality of neuromodulation parameters to result in the second plurality of neuromodulation parameters and a second neurostimulation program.

19. The neuromodulation system of claim 18 wherein the external control device is further configured to:

determine a third index for a third plurality of neuromodulation parameters, wherein the third plurality of neuromodulation parameters are part of a third neurostimulation program;

determine a second normalized value for the third index as a percentage of the first patient perception threshold index;

determine a fourth index from the identified second patient perception threshold index and the second normalized value;

determine a fourth plurality of neuromodulation parameters from the determined fourth index; and

modify at least one of the third plurality of neuromodulation parameters to result in the fourth plurality of neuromodulation parameters and a fourth neurostimulation program.

20. The neuromodulation system of claim 19 wherein the external control device is further configured to simultaneously modify at least one of the first plurality of neuromodulation parameters and at least one of the third plurality of neuromodulation parameters.