DISTALLY CURVED ELECTRICAL STIMULATION LEAD AND METHODS OF MAKING AND USING

• US 20130317588A1
• Filed: 05/23/2013
• Published: 11/28/2013
• 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: Howard, Joshua Dale, Leven, Jacob B.
• Granted Patent: US 9,919,148 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable electrical stimulation lead including a lead body having a distal end, a proximal end, and a longitudinal length, wherein the distal end of the lead body is formed into a hook or coil shape; a plurality of electrodes disposed along the hook or coil at the distal end of the lead body; a plurality of terminals disposed on the proximal end of the lead body; and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. The lead can be used to stimulate, for example, a dorsal root ganglion with the hook-shaped or coil-shaped distal end disposed around a portion of the dorsal root ganglion.

Claims

1. An implantable electrical stimulation lead, comprising:

a lead body having a distal end, a proximal end, and a longitudinal length, wherein the distal end of the lead body is formed into a curved hook;

a plurality of electrodes disposed along the curved hook at the distal end of the lead body;

a plurality of terminals disposed on the proximal end of the lead body; and

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals.

2. The electrical stimulation lead of claim 1, wherein the lead body is isodiametric.

3. The electrical stimulation lead of claim 1, wherein the plurality of electrodes are longitudinally spaced apart along the curved hook.

4. The electrical stimulation lead of claim 1, wherein the plurality of electrodes are ring electrodes.

5. The electrical stimulation lead of claim 1, wherein the plurality of electrodes are segmented electrodes, wherein each of the segmented electrodes extends around no more than 75% of a circumference of the lead body.

6. The electrical stimulation lead of claim 1, wherein the curved hook is sized to fit around a dorsal root ganglion.

7. The electrical stimulation lead of claim 6, wherein the curved hook is sized to fit around at least 50% of a circumference of the dorsal root ganglion.

8. A method of implanting an electrical stimulation lead, the method comprising:

providing the electrical stimulation lead of claim 6; and

implanting the electrical stimulation lead with the curved hook disposed around a dorsal root ganglion of a patient, wherein a portion of the lead adjacent to the distal end extends at an angle of at least 45°

with respect to a dorsal root extending from the dorsal root ganglion.

9. An implantable electrical stimulation lead, comprising:

a lead body having a distal end, a proximal end, and a longitudinal length;

a plurality of electrodes disposed along the distal end of the lead body;

a plurality of terminals disposed on the proximal end of the lead body;

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and

a bendable shaping member disposed within at least the distal end of the lead body, wherein the bendable shaping member is reversibly bendable and permits formation of a hook or coil shape in the distal end of the lead body by bending of the distal end of the lead body into the hook or coil shape, wherein the bendable shaping member is configured and arranged to retain the distal end of the lead body in the hook or coil shape without external force being applied.

10. The implantable electrical stimulation lead of claim 9, wherein the bendable shaping member is a metal or plastic wire that is not electrically coupled to any of the plurality of electrodes and plurality of terminals.

11. The implantable electrical stimulation lead of claim 10, wherein the bendable shaping member has a thickness that is at least 1.5 times a thickness of the conductors.

12. The implantable electrical stimulation lead of claim 9, wherein the bendable shaping member comprises a shape memory material.

13. A method of implanting an electrical stimulation lead, the method comprising:

providing the electrical stimulation lead of claim 9;

shaping the distal end of the electrical stimulation lead into a hook or coil shape by bending the bendable shaping member; and

implanting the electrical stimulation lead with the distal end in the hook or coil shape disposed around a dorsal root ganglion of a patient.

14. A method of implanting a lead, the method comprising:

providing a lead comprising a lead body having a distal end, a proximal end, and a longitudinal length, a plurality of electrodes disposed along the distal end of the lead body, a plurality of terminals disposed on the proximal end of the lead body, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals;

inserting a guidewire or stylet into the lead; and

implanting the lead into the patient and around at least a portion of dorsal root ganglion of the patient using the guidewire or stylet to shape the distal end of the lead body into a hook or coil situated around the portion of the dorsal root ganglion.

15. The method of claim 14, wherein the guidewire or stylet comprises an outer sheath and an inner member, wherein the outer sheath and the inner member are slidably engaged.

16. The method of claim 15, wherein the outer sheath is configured and arranged to maintain a portion of the guidewire or stylet containing the outer sheath in a straight configuration.

17. The method of claim 16, wherein the inner member is configured and arranged to curve when exposed outside of the outer sheath.

18. The method of claim 17, wherein implanting the lead comprises retracting the outer sheath to expose a distal portion of the inner member that curves to shape the distal end of the lead body into a hook or coil situated around the portion of the dorsal root ganglion.

19. The method of claim 17, wherein implanting the lead comprises advancing a distal portion of the inner member out of the outer sheath to shape the distal end of the lead body into a hook or coil situated around the portion of the dorsal root ganglion.

20. The method of claim 14, wherein implanting the lead comprises implanting the lead so that a portion of the lead adjacent to the distal end extends at an angle of at least 45°

with respect to a dorsal root extending from the dorsal root ganglion.