System and method of developing a program for providing therapeutic electrical stimulation for treating a patient

• US 9,943,691 B2
• Filed: 03/28/2014
• Issued: 04/17/2018
• Est. Priority Date: 03/28/2014
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Landers, Paul, Iyassu, Yohannes
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US14/229,458
• Publication Number:
  US 20150273216A1
• Time in Patent Office: 1,481 Days
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• 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 stimulation system, such as a spinal cord stimulation (SCS) system, having a programmer for establishing a program to treat a patient. The programmer uses a discretized, interrupted, and safe spatial electrode migration process for establishing the stimulation program.

Claims

1. A method of developing a program for providing therapeutic electrical stimulation for treating a patient with a stimulation system, the stimulation system comprising an electrical stimulation generator, an implanted medical lead coupled to the electrical stimulation generator, the implanted medical lead including a plurality of electrodes, and a programmer configured to communicate with the electrical stimulation generator, the method comprising:

communicating first stimulation parameters to the stimulation generator resulting in a first stimulation with the stimulation generator using the first stimulation parameters, the first stimulation parameters including assigned first amplitude values and first polarities for a first set of the electrodes of the plurality of electrodes;

displaying, on a user interface of the programmer, a first user-controllable input and a second user-controllable input that is different from the first user-controllable input;

determining that a user is attempting to perform a discrete migration from the first set of the electrodes to a second set of electrodes of the plurality of electrodes, the second set being different from the first set, the determining including;

receiving a first input defining a percentage of amplitude change for the migration, wherein the first input is received via a user engagement with the first user-controllable input, and

receiving a second input defining a direction for the migration, wherein the second input is received via a user engagement with the second user-controllable input, wherein the first user-controllable input and the second user-controllable input are simultaneously accessible via a same screen of the user interface,

calculating, in response to the determining that the user is attempting to perform the discrete migration, second stimulation parameters using the first stimulation parameters, the first input, and the second input, wherein the second stimulation parameters include automatically assigned second amplitude values and second polarities for the second set of the electrodes; and

communicating the second stimulation parameters to the stimulation generator resulting in a cessation of the first stimulation and initiation of a second stimulation with the stimulation generator using the second stimulation parameters.

2. The method of claim 1, further comprising repeatedly, discretely revising stimulation parameters with the determining by utilizing the second stimulation parameters as the first stimulation parameters.

3. The method of claim 2, further comprising repeatedly communicating the revised stimulation parameters to the stimulation generator resulting in the cessation of stimulation and initiation of revised stimulation with the stimulation generator using the revised stimulation parameters.

4. The method of claim 1, wherein the implanted medical lead includes a plurality of medical leads.

5. The method of claim 4, and further comprising grouping the plurality of leads according to their identified locations, and identifying a relationship of the plurality of electrodes.

6. The method of claim 1, wherein at least some of the second set of electrodes and the first set of electrodes are the same electrodes, and wherein the second amplitude values and the first amplitude values are different.

7. method of claim 1, wherein the first input defining the percentage of amplitude change includes receiving indication to move an entire electrode configuration from a first electrode to a second electrode based on the second input defining the direction for the migration.

8. The method of claim 1, wherein the first input defining the percentage of amplitude change includes receiving indication to move a granular amount of electrode configuration from a first electrode towards a second electrode based on the second input defining the direction for the migration.

9. The method of claim 1, wherein the first user-controllable input includes a migration discretized selector that, in response to the user engagement, determines the percentage of the amplitude change for the migration.

10. The method of claim 1, wherein the second user-controllable input includes directional arrows that, in response to the user engagement, determine the direction of the migration.

11. The method of claim 1, further comprising finalizing the program for providing therapeutic electrical stimulation using the second stimulation parameters.

12. The method of claim 1, further comprising receiving a third input excluding an electrode of the plurality of electrodes from being considered for migration, and wherein the calculating the second stimulation parameters excludes the excluded electrode from the calculating.

13. The method of claim 1, further comprising capturing implant information including receiving a third input identifying the implanted medical lead and identifying the plurality of electrodes within the implanted medical lead.

14. The method of claim 1, further comprising identifying a spatial relationship among the plurality of electrodes.

15. The method of claim 1, and further comprising assigning the first stimulation parameters for the plurality of electrodes prior to the step of communicating the first stimulation parameters, and assigning the second stimulation parameters for the plurality or electrodes prior to the step of communicating the second stimulation parameters.

16. The method of claim 1, wherein the first stimulation parameters further include assigned frequency and pulse width for the first stimulation.

17. A method of developing a program for providing therapeutic electrical stimulation for treating a patient with a stimulation system, the stimulation system comprising an electrical stimulation generator, an implanted medical lead coupled to the electrical stimulation generator, the implanted medical lead including a plurality of electrodes, and a programmer configured to communicate with the electrical stimulation generator, the method comprising:

communicating first stimulation parameters to the stimulation generator resulting in a first stimulation with the stimulation generator using the first stimulation parameters, the first stimulation parameters including assigned first amplitude values and first polarities for a first set of the electrodes of the plurality of electrodes;

displaying, on a user interface of the programmer, a migration discretized amount selector and a directional input device that is different from the migration discretized amount selector, wherein the directional input device includes a plurality of arrows that correspond to different migrational directions;

determining that a user is attempting to perform a migration from the first set of the electrodes to a second set of electrodes of the plurality of electrodes, the second set being different from the first set, the determining including;

receiving, via a user engagement with the migration discretized amount selector, a first input defining a percentage of amplitude change for the migration; and

receiving, via a user engagement with the directional input device that is different from the migration discretized amount selector, a second input defining a direction for the migration, wherein the migration discretized amount selector and the directional input device are simultaneously accessible via a same screen of the user interface;

calculating, in response to the determining that the user is attempting to perform the migration, second stimulation parameters using the first stimulation parameters, the first input, and the second input, wherein the second stimulation parameters include automatically assigned second amplitude values and second polarities for the second set of the electrodes; and

communicating the second stimulation parameters to the stimulation generator resulting in a cessation of the first stimulation and initiation of a second stimulation with the stimulation generator using the second stimulation parameters.

18. The method of claim 17, further comprising receiving a third input excluding an electrode of the plurality of electrodes from being considered for migration, and wherein the calculating the second stimulation parameters excludes the exclude electrode from the calculating.

19. The method of claim 17, further comprising identifying a spatial relationship among the plurality of electrodes.

20. A method, comprising:

communicating, via an electronic programmer, first stimulation parameters to a stimulation generator, thereby resulting in a first stimulation with the stimulation generator using the first stimulation parameters, the first stimulation parameters including first amplitude values and first polarities for a first set of the electrodes of a plurality of electrodes, wherein the first amplitude values and the first polarities are specified by a user;

displaying, on a user interface of the electronic programmer, a first user-controllable input and a second user-controllable input that is different from the first user-controllable input;

determining that the user is attempting to perform a migration from the first set of the electrodes to a second set of electrodes of the plurality of electrodes different from the first set, wherein the migration is performed in a plurality of steps, and wherein the determining comprises;

receiving a first input defining a percentage of amplitude change for each step of the migration, wherein the first input is received via a first user engagement with the first user-controllable input; and

receiving a second input defining a direction for the migration, wherein the second input is received via a second user engagement with the second user-controllable input, wherein the first user-controllable input and the second user-controllable input are simultaneously accessible via a same screen of the user interface; and

calculating, in response to the determining that the user is attempting to perform the migration, second stimulation parameters using, wherein the calculating comprises automatically calculating the second stimulation parameters as a function of the first input, the second input, and the first stimulation parameters.

21. The method of claim 20, further comprising:

communicating, via the electronic programmer, the second stimulation parameters to the stimulation generator, thereby resulting in a cessation of the first stimulation and initiation of a second stimulation with the stimulation generator using the second stimulation parameters.

22. The method of claim 20, wherein the second stimulation parameters include second amplitude values and second polarities for the second set of the electrodes.

23. The method of claim 20, wherein the first user-controllable input and the second user-controllable input are mutually exclusive of each one.

24. The method of claim 20, wherein:

the first user-controllable input includes a variable selector that, in response to the first user engagement, varies the percentage of the amplitude change for each step of the migration; and

the second user-controllable input includes directional arrows that, in response to the second user engagement, determine the direction of the migration.

25. The method of claim 20, wherein at least some of the second set of electrodes and the first set of electrodes are the same electrodes.

26. The method of claim 20, comprising identifying a spatial relationship among the plurality of electrodes.

27. The method of claim 20, further comprising grouping the plurality of leads according to their identified locations, and identifying a relationship of the plurality of electrodes.

28. The method of claim 20, wherein the first and second stimulation parameters each further include stimulation frequency and stimulation pulse width.