Systems and methods for programming a neuromodulation system

• US 9,616,230 B2
• Filed: 12/12/2014
• Issued: 04/11/2017
• 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:
  US14/569,155
• Publication Number:
  US 20150165202A1
• Time in Patent Office: 851 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 operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:

calculating an index for each of a plurality of modulation parameter sets to provide each of the plurality of modulation parameter sets with a respective calculated index, wherein each modulation parameter set includes a respective plurality of modulation parameters, and wherein the respective calculated index for each of the plurality of modulation parameter sets is calculated as a function of the respective plurality of modulation parameters;

serially conveying electrical modulation energy to the tissue 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 respective calculated index for the one of the plurality of modulation parameter sets as a perception threshold index based on the perceived paresthesia;

storing the identified perception threshold index;

determining a new modulation parameter set for a sub-threshold therapy based on the identified perception threshold index; and

delivering the sub-threshold therapy, including conveying sub-threshold electrical modulation energy to the tissue in accordance with the new modulation parameter set.

2. The method of claim 1, wherein determining a new modulation parameter set based on the identified perception threshold index comprises

selecting a new index by applying a function to the identified perception index;

and

determining a plurality of modulation parameters based on the new index.

3. The method of claim 1, further comprising modifying a modulation parameter set based on the identified perception threshold index, and conveying electrical modulation energy to the tissue in accordance with the modified modulation parameter set, wherein modifying a modulation parameter set based on the identified perception threshold index comprises

selecting a new index by applying a function to the identified perception index;

and

determining a plurality of modulation parameters based on the new index.

4. The method of claim 1 , wherein the plurality of modulation parameters used to calculate the index includes two or more modulation parameters selected from the group consisting of amplitude, pulse width, duty cycle, frequency, lead location, electrical field locus, electrical field focus, and electrical field center point size.

5. The method of claim 1, wherein:

each of the plurality of modulation parameter sets directs the implantable neuromodulator to convey electrical modulation energy at a first axial level, the method further comprising identifying another perception threshold index for electrical modulation energy conveyed at a second axial level.

6. The method of claim 1, wherein each of the plurality of modulation parameter sets directs the implantable neuromodulator to convey electrical modulation energy through a first electrode, the method further comprising identifying another perception threshold index for electrical modulation energy conveyed through a second electrode.

7. The method of claim 1, further comprising:

causing the patient to perceive paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with more than one of the plurality of modulation parameter sets; and

identifying the lowest calculated index for the more than one of the plurality of modulation parameter sets as the perception threshold index based on the perceived paresthesia.

8. The method of claim 1, wherein the index is an energy index calculated by multiplying respective an amplitude, a pulse width, and a frequency.

9. The method of claim 2, wherein conveying electrical modulation energy to the tissue in accordance with the new modulation parameter set comprises conveying super-threshold electrical modulation energy.

10. A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:

calculating an index for each of a plurality of modulation parameter sets to provide each of the plurality of modulation parameter sets with a respective calculated index, wherein each modulation parameter set includes a respective plurality of modulation parameters, and wherein the respective calculated index for each of the plurality of modulation parameter sets is calculated as a function of the respective plurality of modulation parameters, wherein calculating the index includes;

calculating an energy index as a product of amplitude, pulse width and frequency;

or

calculating a charge index as a product of amplitude and pulse width;

serially conveying electrical modulation energy to the tissue 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 respective calculated index for the one of the plurality of modulation parameter sets as a perception threshold index based on the perceived paresthesia;

storing the identified perception threshold index;

determining a new modulation parameter set for a subthreshold therapy based on the identified perception threshold index; and

delivering the sub-threshold therapy, including conveying sub-threshold electrical modulation energy to the tissue in accordance with the new modulation parameter set.

11. The method of claim 10, further comprising 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.

12. The method of claim 11, wherein determining a new modulation parameter set based on the identified perception threshold index comprises

selecting a new index by applying a function to the identified perception index;

and

determining a plurality of modulation parameters based on the new index.

13. The method of claim 11, wherein conveying electrical modulation energy to the tissue in accordance with the new modulation parameter set comprises conveying sub-threshold electrical modulation energy.

14. The method of claim 11, wherein conveying electrical modulation energy to the tissue in accordance with the new modulation parameter set comprises conveying super-threshold electrical modulation energy.

15. The method of claim 11, further comprising modifying a modulation parameter set based on the identified perception threshold index, and conveying electrical modulation energy to the tissue in accordance with the modified modulation parameter set, wherein modifying a modulation parameter set based on the identified perception threshold index comprises

selecting a new index by applying a function to the identified perception index;

and

determining a plurality of modulation parameters based on the new index.

16. The method of claim 10, wherein:

each of the plurality of modulation parameter sets directs the implantable neuromodulator to convey electrical modulation energy at a first axial level, the method further comprising identifying another perception threshold index for electrical modulation energy conveyed at a second axial level.

17. The method of claim 10, wherein each of the plurality of modulation parameter sets directs the implantable neuromodulator to convey electrical modulation energy through a first electrode, the method further comprising identifying another perception threshold index for electrical modulation energy conveyed through a second electrode.

18. The method of claim 10, further comprising:

causing the patient to perceive paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with more than one of the plurality of modulation parameter sets; and

identifying the lowest calculated index for the more than one of the plurality of modulation parameter sets as the perception threshold index based on the perceived paresthesia.