Systems and methods for providing electrical stimulation of multiple dorsal root ganglia with a single lead

• US 8,718,790 B2
• Filed: 05/23/2013
• Issued: 05/06/2014
• Est. Priority Date: 05/25/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/901,158
• Publication Number:
  US 20130317586A1
• Time in Patent Office: 348 Days
• Field of Search: 607/117
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A method for implanting an electrical stimulation lead into a patient includes advancing a distal end of a multi-armed lead into an epidural space of the patient. The multi-armed lead includes first and second stimulation arms extending from a main body portion. The first stimulation arm is guided into and through a first intervertebral foramen. The first stimulation arm is positioned in proximity to a first dorsal root ganglion. The first stimulation arm is positioned with electrodes disposed along the first stimulation arm in operational proximity to the first dorsal root ganglion. The second stimulation arm is guided into and through a second intervertebral foramen. The second stimulation arm is positioned in proximity to a second dorsal root ganglion. The second stimulation arm is positioned with electrodes disposed along the second stimulation arm in operational proximity to the second dorsal root ganglion.

Claims

1. A method for implanting an electrical stimulation lead into a patient, the method comprising:

advancing a distal end of a multi-armed lead into an epidural space of the patient, the multi-armed lead comprising a main body portion, a first stimulation arm extending from a distal end of the main body portion, and a second stimulation arm extending from the distal end of the main body portion;

guiding the first stimulation arm into and through a first intervertebral foramen from inside the epidural space;

positioning the first stimulation arm in proximity to a first dorsal root ganglion that extends through the first intervertebral foramen, the first stimulation arm positioned with a plurality of electrodes disposed along the first stimulation arm in operational proximity to the first dorsal root ganglion;

guiding the second stimulation arm into and through a second intervertebral foramen from inside the epidural space; and

positioning the second stimulation arm in proximity to a second dorsal root ganglion that extends through the second intervertebral foramen, the second stimulation arm positioned with a plurality of electrodes disposed along the second stimulation arm in operational proximity to the second dorsal root ganglion.

2. The method of claim 1, wherein the first intervertebral foramen and the second intervertebral foramen are disposed at a same spinal cord level.

3. The method of claim 1, wherein the first intervertebral foramen and the second intervertebral foramen are disposed at different spinal cord levels.

4. The method of claim 1, wherein guiding the first stimulation arm into and through the first intervertebral foramen from inside the epidural space comprises inserting a first stylet into the first stimulation arm and using the first stylet to guide the first stimulation arm into and through the second intervertebral foramen.

5. The method of claim 4, wherein guiding the second stimulation arm into and through the first intervertebral foramen from inside the epidural space comprises inserting the first stylet into the second stimulation arm and using the first stylet to guide the second stimulation arm into and through the second intervertebral foramen.

6. The method of claim 4, wherein guiding the second stimulation arm into and through the first intervertebral foramen from inside the epidural space comprises inserting a second stylet into the second stimulation arm and using the second stylet to guide the second stimulation arm into and through the second intervertebral foramen.

7. The method of claim 6, wherein the first stylet and the second stylet are simultaneously disposed in the multi-armed lead during at least a portion of the implantation of the multi-armed lead into the patient.

8. The method of claim 1, further comprising

coupling the first stimulation arm of the multi-armed lead to the second stimulation arm of the multi-armed lead prior to guiding the first stimulation arm into and through the first intervertebral foramen;

and

uncoupling the second stimulation arm from the first stimulation arm after guiding the first stimulation arm into and through the first intervertebral foramen and prior to guiding the second stimulation arm into and through the second intervertebral foramen from inside the epidural space.

9. The method of claim 8, wherein the first stimulation arm is coupled to the second stimulation arm by a perforated line.

10. The method of claim 1, further comprising

anchoring the first stimulation arm to the first intervertebral foramen using a pre-defined bend formed along the first stimulation arm;

and

anchoring the second stimulation arm to the second intervertebral foramen using a pre-defined bend formed along the second stimulation arm.

11. An implantable lead for providing electrical stimulation to a patient, the lead comprising:

a lead body having a proximal end, a distal end, and a longitudinal length, the lead body comprising

a main body portion having a proximal end, a distal end, and a longitudinal length,

a first stimulation arm extending from the distal end of the main body portion, the first stimulation arm having a radius of curvature,

a plurality of electrodes disposed along the first stimulation arm,

a second stimulation arm extending from the distal end of the main body portion, the second stimulation arm having a radius of curvature, and

a plurality of electrodes disposed along the second stimulation arm;

a plurality of terminals disposed at the proximal end of the main body portion; and

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes, wherein at least one of the plurality of conductors electrically couples at least one terminal of the plurality of terminals to at least one electrode of the plurality of electrodes disposed along the first stimulation arm, and wherein at least one of the plurality of conductors electrically couples at least one terminal of the plurality of terminals to at least one electrode of the plurality of electrodes disposed along the second stimulation arm.

12. The lead of claim 11, wherein a different pre-defined bend is formed along each of the first stimulation arm and the second stimulation arm.

13. The lead of claim 12, wherein the pre-defined bend of the first stimulation arm is oriented in an opposite direction from the pre-defined bend of the second stimulation arm.

14. The lead of claim 13, wherein the pre-defined bend of the first stimulation arm and the pre-defined bend of the second stimulation arm are configured and arranged for insertion into bilateral intervertebral foramina from inside a patient'"'"'s epidural space.

15. The lead of claim 12, wherein the pre-defined bend of the first stimulation arm is symmetric with the pre-defined bend of the second stimulation arm along an axis of symmetry extending along the longitudinal length of the major body portion.

16. The lead of claim 12, wherein the pre-defined bend of the first stimulation arm and the pre-defined bend of the second stimulation arm are each configured and arranged to straighten upon application of force and to reform upon removal of the applied force.

17. The lead of claim 12, wherein the pre-defined bend of the first stimulation arm and the pre-defined bend of the second stimulation arm are each no less than 50°

.

18. The lead of claim 12, wherein the pre-defined bend of the first stimulation arm and the pre-defined bend of the second stimulation arm are each no greater than 160°

.

19. The lead of claim 11, wherein the major body portion comprises a multi-lumen conductor guide, the multi-lumen conductor guide defining at least one stylet lumen configured and arranged to receive a stylet and a plurality of conductor lumens each configured and arranged to receive at least one conductor of the plurality of conductors.

20. An electrical stimulating system comprising:

the lead of claim 11;

a control module electrically coupled to the plurality of electrodes disposed along the first stimulation arm and to the plurality of electrodes disposed along the second stimulation arm, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector assembly for receiving the lead, the connector assembly comprising

a connector housing defining at least one port at a distal end of the connector housing, the at least one port configured and arranged for receiving the major body portion of the lead, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals disposed along the major body portion.