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

• US 8,897,893 B2
• Filed: 03/21/2014
• Issued: 11/25/2014
• 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:
  US14/222,496
• Publication Number:
  US 20140207148A1
• Time in Patent Office: 249 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 aim 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 portion 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 portion of the main body portion, and a second stimulation arm extending from the distal end portion of the main body portion;

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

advancing the second stimulation arm through a second intervertebral foramen from inside the epidural space.

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 the first intervertebral foramen and the second intervertebral foramen are disposed along opposing sides of the patient'"'"'s vertebral column.

5. The method of claim 1, wherein the first intervertebral foramen and the second intervertebral foramen are disposed along the same side of the patient'"'"'s vertebral column.

6. 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 first intervertebral foramen.

7. The method of claim 6, wherein guiding the second stimulation arm into and through the second 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.

8. The method of claim 6, wherein guiding the second stimulation arm into and through the second 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.

9. The method of claim 8, 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.

10. The method of claim 1, wherein advancing a distal end portion of a multi-armed lead into an epidural space of the patient comprises advancing the distal end portion of the multi-armed lead into the epidural space of the patient while the first stimulation arm is coupled to the second stimulation arm.

11. The method of claim 10, further comprising uncoupling the second stimulation arm from the first stimulation arm subsequent to advancing the distal end portion of the multi-armed lead into the epidural space of the patient.

12. 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.

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

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

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

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

a plurality of first electrodes disposed along the first stimulation arm,

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

a plurality of second electrodes disposed along the second stimulation arm,

wherein the first stimulation arm is configured and arranged for extending through a first intervertebral foramen when the main body portion is disposed in the epidural space,

wherein the second stimulation arm is configured and arranged for extending through a second intervertebral foramen when the main body portion is disposed in an epidural space;

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

a plurality of conductors electrically coupling the plurality of terminals to the plurality of first electrodes and to the plurality of second electrodes.

14. The lead of claim 13, wherein a first pre-defined bend is formed along the first stimulation arm and a second pre-defined bend is formed along the second stimulation arm.

15. The lead of claim 14, wherein the first pre-defined bend is oriented in an opposite direction from the second pre-defined bend.

16. The lead of claim 14, wherein the first pre-defined bend is symmetric with the second pre-defined bend along an axis of symmetry extending along the longitudinal length of the major body portion.

17. The lead of claim 14, wherein the first pre-defined bend and the second pre-defined bend are each configured and arranged to straighten upon application of force and to reform upon removal of the applied force.

18. The lead of claim 14, wherein the first pre-defined bend and the second pre-defined bend are each no less than 50°

and no greater than 160°

.

19. The lead of claim 13, wherein the first stimulation arm and the second stimulation arm are configured and arranged for being removably coupled to one another during insertion of the lead into the patient.

20. An electrical stimulating system comprising:

the lead of claim 13;

a control module electrically coupled to the plurality of first electrodes of the first stimulation arm of the lead and to the plurality of second electrodes of the second stimulation arm of the lead, 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 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 when the major body portion is received by the at least one port.