Automated search to identify a location for electrical stimulation to treat a patient

• US 9,067,074 B2
• Filed: 07/09/2013
• Issued: 06/30/2015
• Est. Priority Date: 09/07/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Polefko, Richard J., Wilder, Steven E.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US13/937,463
• Publication Number:
  US 20130296972A1
• Time in Patent Office: 721 Days
• Field of Search: 607/46, 607/45, 607/59
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• 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 1/37235 Aspects of the external programmer
• 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 an automated search to establish a program to treat a patient with electrical stimulation. The stimulation system includes an electrical stimulation generator, a medical lead coupled to the electrical stimulation generator, and a programmer with a communication interface, a display screen, and a user interface. The display screen displays an image of a spinal column and a position of the medical lead relative to the spinal column. The system includes an automated search that stimulates a series of regions and receives patient feedback via the user interface. The system then stimulates a series of subregions within a subset of the regions based on the feedback, receives additional feedback, and identifies a subset of the subregions location for stimulation based on the additional feedback.

Claims

1. An automated search method to identify a location for electrical stimulation to treat a patient with a stimulation system, the stimulation system comprising an electrical stimulation generator, a medical lead implanted in the patient and coupled to the electrical stimulation generator, a programmer with a display screen, and a feedback device configured to communicate with the programmer, the method comprising:

displaying an image of a spinal column on the display screen of the programmer;

displaying a portion representing the medical lead on the image of the spinal column;

displaying a first plurality of regions on the image of the spinal column with respect to the portion representing the medical lead, each of the first plurality of regions specifying a respective location for targeting of electrical stimulation within the patient;

initiating electrical stimulation with the electrical stimulation generator and the medical lead according to the first plurality of regions;

receiving feedback indicating the effectiveness of the electrical stimulation to the first plurality of regions;

displaying a second plurality of regions on the image of the spinal column with respect to the portion representing the medical lead, the second plurality of regions including subregions on the image within one of the first plurality of regions, wherein the second plurality of regions is displayed based on the feedback from the patient, and wherein each of the second plurality of regions specify a second respective location for targeting of electrical stimulation within the patient;

initiating electrical stimulation with the electrical stimulation generator and the medical lead according to the second plurality of regions; and

receiving additional feedback indicating the effectiveness of the electrical stimulation to the second plurality of regions.

2. The automated search method of claim 1, further comprising identifying a subset of the second plurality of regions for targeted electrical stimulation based on the additional feedback from the patient.

3. The automated search method of claim 1, wherein each region of the first plurality of regions is a quadrilateral.

4. The automated search method of claim 3, wherein the first plurality of regions form a grid.

5. The automated search method of claim 1, wherein each region of the first plurality of regions shares a boundary with another region of the first plurality of regions.

6. The automated search method of claim 1, wherein the initiating the electrical stimulation according to the first plurality of regions includes initiating electrical stimulation to a first region, then initiating electrical stimulation to a second region adjacent to the first region, and then initiating electrical stimulation to a third region adjacent to the second region.

7. The automated search method of claim 1, further comprising, driving, with the electrical stimulation generator, the medical lead to provide targeted electrical stimulation to the second plurality of regions.

8. The automated search method of claim 1, further comprising, displaying, on the display screen, an initial stimulation field overlaid on the second plurality of regions, wherein the initial stimulation field includes an initial boundary.

9. The automated search method of claim 8, further comprising,

receiving graphical manipulations of the initial boundary to define an altered stimulation field, wherein the graphical manipulations at least one of move and alter the shape of the initial boundary;

determining stimulation parameters to drive the medical lead to generate the altered stimulation field; and

driving, with the electrical stimulation generator, the medical lead according to the determined stimulation parameters.

10. The automated search method of claim 8, further comprising,

receiving, by the programmer, manual adjustments to stimulation parameters;

and

driving, with the electrical stimulation generator, the medical lead according to the stimulation parameters as manually adjusted.

11. A programmer for programming an electrical stimulation generator that provides electrical stimulation to treat a patient via a medical lead, the programmer comprising:

a first interface for communicating with the electrical stimulation generator;

a display screen for displaying images;

a second interface for receiving feedback; and

programming means for

causing the display screen to display an image of a spinal column and a position of a portion of the medical lead relative to the spinal column,

causing the display screen to display a first plurality of regions on the image of the spinal column with respect to the position of the medical lead, each of the first plurality of regions specifying a respective location for targeting of electrical stimulation within the patient;

causing the electrical stimulation generator to drive the medical lead according to the first plurality of regions;

receiving feedback via the second interface indicating the effectiveness of the electrical stimulation to the first plurality of regions;

causing the display screen to display a second plurality of regions on the image of the spinal column with respect to the position of the medical lead, the second plurality of regions including subregions on the image within one of the first plurality of regions, wherein the second plurality of regions is displayed based on the feedback, and wherein each of the second plurality of regions specify a second respective location for targeting of electrical stimulation within the patient;

causing the electrical stimulation generator to drive the medical lead according to the second plurality of regions; and

receiving feedback via the user interface indicating the effectiveness of the electrical stimulation to the second plurality of regions.

12. The stimulation system of claim 11, wherein the programming means further identifies a subset of the second plurality of regions for targeted electrical stimulation based on the additional patient feedback.

13. The stimulation system of claim 11, wherein each region of the first plurality of regions is a quadrilateral.

14. The stimulation system of claim 13, wherein the first plurality of regions form a grid.

15. The stimulation system of claim 11, wherein each region of the first plurality of regions shares a boundary with another region of the first plurality of regions.

16. The stimulation system of claim 11, wherein causing the electrical stimulation generator to drive the medical lead according to the first plurality of regions includes causing the medical lead to provide electrical stimulation to a first region, then provide electrical stimulation to a second region adjacent to the first region, and then provide electrical stimulation to a third region adjacent to the second region.

17. The stimulation system of claim 11, wherein the programming means further causes the display screen to display an initial stimulation field overlaid on the second plurality of regions, wherein the initial stimulation field includes an initial boundary.

18. The stimulation system of claim 17, wherein the programming means further receives graphical manipulations of the initial boundary to define an altered stimulation field, determines stimulation parameters to drive the medical lead to generate the altered stimulation field, and causes the electrical stimulation generator to drive the medical lead according to the determined stimulation parameters.

19. The stimulation system of claim 11, wherein the programming means further receives manual adjustments to stimulation parameters and causes the electrical stimulation generator to drive the medical lead according to the stimulation parameters as manually adjusted.