LEADS WITH X-RAY FLUORESCENT CAPSULES FOR ELECTRODE IDENTIFICATION AND METHODS OF MANUFACTURE AND USE

• US 20130261684A1
• Filed: 03/06/2013
• Published: 10/03/2013
• Est. Priority Date: 03/30/2012
• 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
• Granted Patent: US 8,744,596 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

An implantable lead for an electrical stimulation system includes a lead body having a distal end, a proximal end, a longitudinal length, and a circumference; a plurality of electrodes disposed along the distal end of the lead body in an electrode array; a plurality of terminals disposed along the proximal end of the lead body; a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals; and at least one capsule including an x-ray fluorescent material and disposed along the distal end of the lead body relative to the electrode array to indicate, when viewed fluoroscopically, an orientation of the electrode array. The plurality of electrodes includes a plurality of segmented electrodes. Each of the plurality of segmented electrodes extends partially around the circumference of the lead body.

Claims

1. An implantable lead for an electrical stimulation system, the lead comprising:

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

a plurality of electrodes disposed along the distal end of the lead body in an electrode array, the plurality of electrodes comprising a plurality of segmented electrodes, wherein each of the plurality of segmented electrodes extends partially around the circumference of the lead body;

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

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals; and

at least one capsule comprising an x-ray fluorescent material and disposed along the distal end of the lead body relative to the electrode array to indicate, when viewed fluoroscopically, an orientation of the electrode array.

2. The lead of claim 1, wherein the at least one capsule comprises a plurality of capsules.

3. The lead of claim 1, wherein the x-ray fluorescent material comprises sodium iodide and thallium.

4. The lead of claim 1, wherein the plurality of segmented electrodes are arranged into a plurality of sets of segmented electrodes, wherein each set comprises a plurality of the segmented electrodes and the segmented electrodes of each set are disposed at a same longitudinal position along the distal end of the lead body.

5. The lead of claim 4, wherein the at least one capsule comprises a plurality of capsules and the plurality of sets of segmented electrodes comprises a first set of segmented electrodes disposed at a first longitudinal position along the distal end of the lead body and a second set of segmented electrodes disposed at a second longitudinal position along the distal end of the lead body.

6. The lead of claim 5, wherein at least two capsules of the plurality of capsules are disposed so that, when viewed fluoroscopically, the at least two capsules appear at least partially disposed between segmented electrodes of the first set of segmented electrodes.

7. The lead of claim 6, wherein the at least two capsules of the plurality of capsules are disposed so that, when viewed fluoroscopically, the at least two capsules appear entirely disposed between segmented electrodes of the first set of segmented electrodes.

8. The lead of claim 6, wherein at least one capsule of the plurality of capsules is disposed so that, when viewed fluoroscopically, the at least one capsule appears at least partially disposed between segmented electrodes of the second set of segmented electrodes.

9. The lead of claim 6, wherein the first and second sets of segmented electrodes each comprise at least three segmented electrodes.

10. The lead of claim 1, wherein the at least one capsule is disposed within the lead body.

11. The lead of claim 1, wherein the at least one capsule is attached to the lead body.

12. A stimulation system comprising:

the lead assembly of claim 1;

a control unit coupleable to the lead, the control unit configured and arranged for providing stimulation to the plurality of electrodes of the lead.

13. The stimulation system of claim 12, further comprising a lead extension having a first end and an opposing second end, the lead extension configured and arranged to coupling the lead to the control unit.

14. A method for making an implantable lead, the method comprising:

disposing a plurality of electrodes along a distal end of a lead body and arranged in an electrode array, the plurality of electrodes comprising a plurality of segmented electrodes, wherein each of the plurality of segmented electrodes extends partially around a circumference of the lead body;

disposing a plurality of terminals along a proximal end of the lead body;

electrically coupling the plurality of electrodes to the plurality of terminals using a plurality of conductors disposed within the lead body; and

disposing at least one capsule along the distal end of the lead body and relative to the electrode array to indicate, when viewed fluoroscopically, an orientation of the electrode array, each of the at least one capsule comprising an x-ray fluorescent material.

15. The method of claim 14, wherein disposing at least one capsule comprises molding the at least one capsule into the lead body.

16. The method of claim 14, wherein disposing at least one capsule comprises attaching the at least one capsule to the lead body.

17. The method of claim 14, wherein the plurality of segmented electrodes are arranged into a plurality of sets of segmented electrodes, wherein each set comprises a plurality of the segmented electrodes and the segmented electrodes of each set are disposed at a same longitudinal position along the distal end of the lead body,

wherein the at least one capsule comprises a plurality of capsules and the plurality of sets of segmented electrodes comprises a first set of segmented electrodes disposed at a first longitudinal position along the distal end of the lead body and a second set of segmented electrodes disposed at a second longitudinal position along the distal end of the lead body, and

wherein disposing at least one capsule comprises disposing at least two capsules of the plurality of capsules along the lead body so that, when viewed fluoroscopically, the at least two capsules appear at least partially disposed between segmented electrodes of the first set of segmented electrodes.

18. The method of claim 17, wherein disposing at least one capsule further comprises disposing at least one capsule of the plurality of capsules so that, when viewed fluoroscopically, the at least one capsule appears at least partially disposed between segmented electrodes of the second set of segmented electrodes.

19. The method of claim 14, further comprising forming the at least one capsule by molding the at least one capsule.

20. The method of claim 14, wherein the x-ray fluorescent material comprises sodium iodide and thallium.