SYSTEMS AND METHODS FOR IDENTIFYING THE CIRCUMFERENTIAL POSITIONING OF ELECTRODES OF LEADS FOR ELECTRICAL STIMULATION SYSTEMS

• US 20130197602A1
• Filed: 01/25/2013
• Published: 08/01/2013
• Est. Priority Date: 01/26/2012
• 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, Carcieri, Stephen
• Granted Patent: US 8,831,742 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: H01R 43/16 for manufacturing contact members, e.g. by punching and by bending
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

A lead assembly for an electrical stimulation system includes terminals disposed along a proximal end of a lead body and electrodes disposed along a distal end of the lead body. The electrodes include segmented electrodes. At least one distal marker is disposed along the distal end of the lead body. The distal marker identifies the circumferential position of at least one of the segmented electrodes along the lead body. The distal marker is aligned with at least one of the segmented electrodes along the longitudinal length of the lead body. At least one proximal marker is disposed along the proximal end of the lead body. The proximal marker is aligned with the distal marker along the longitudinal length of the lead body. The distal marker and the proximal marker are discontinuous with one another along the lead body.

Claims

1. A lead assembly for an electrical stimulation system, the lead assembly 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, 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 at least one of the plurality of electrodes to at least one of the plurality of lead terminals;

at least one distal marker disposed along the distal end of the lead body, the distal marker identifying the circumferential position of at least one of the plurality of segmented electrodes along the lead body, wherein the distal marker is aligned with the at least one of the plurality of segmented electrodes along the longitudinal length of the lead body; and

at least one proximal marker disposed along the proximal end of the lead body, wherein the proximal marker is aligned with the distal marker along the longitudinal length of the lead body;

wherein the at least one distal marker and the at least one proximal marker are discontinuous with one another along the lead body.

2. The lead assembly of claim 1, further comprising a retention sleeve disposed along the proximal end of the lead body, the retention sleeve configured and arranged for facilitating retention of the proximal end of the lead body in a connector.

3. The lead assembly of claim 2, wherein the at least one proximal marker is disposed in or on the retention sleeve.

4. The lead assembly of claim 1, wherein the at least one distal marker is disposed in or on a spacer disposed along the distal end of the lead body.

5. The lead assembly of claim 1, wherein the at least one proximal marker is disposed in or on a spacer disposed along the proximal end of the lead body.

6. The lead assembly of claim 1, wherein at least one of the at least one distal marker or the at least one proximal marker comprises a metallic material.

7. The lead assembly of claim 1, wherein at least one of the at least one distal marker or the at least one proximal marker comprises a radiopaque material.

8. The lead assembly of claim 1, wherein the plurality of electrodes comprises at least one ring electrode.

9. The lead assembly of claim 8, wherein the at least one distal marker is disposed on or in the at least one ring electrode.

10. The lead assembly of claim 1, wherein the at least one proximal marker is disposed on or in at least one of the plurality of terminals.

11. The lead assembly of claim 1, wherein the lead body, the plurality of electrodes, the plurality of terminals, the at least one distal marker, and the at least one proximal marker are each isodiametric with one another.

12. The lead assembly of claim 1, wherein the lead body, the plurality of electrodes, and the plurality of terminals are each isodiametric with one another, and wherein the at least one distal marker and the at least one proximal marker each have outer diameters that are smaller than outer diameters of the lead body.

13. The lead assembly of claim 1, wherein the at least one distal marker comprises a plurality of distal markers, and wherein the plurality of distal markers are each distinct from one another by at least one of color, width, or texture.

14. The lead assembly of claim 1, wherein the at least one proximal marker comprises a plurality of proximal markers, and wherein the plurality of proximal markers are each distinct from one another by at least one of color, width, or texture.

15. The lead assembly of claim 1, wherein neither the at least one distal marker or the at least one proximal marker is disposed directly on or in the lead body.

16. The lead assembly of claim 1, wherein the lead body comprises a multi-lumen conductor guide extending from the proximal end of the lead body to the distal end of the lead body, the multi-lumen conductor guide defining a central lumen and a plurality of conductor lumens disposed around the central lumen, and wherein at least a portion of the multi-lumen conductor guide is twisted and the multi-lumen conductor guide forms at least one helical section with the plurality of conductor lumens forming helical pathways around the central lumen.

17. A deep brain stimulation system comprising:

the lead assembly of claim 1;

a lead extension having a first end and an opposing second end, the lead extension configured and arranged to coupling with the lead body of the lead assembly, the lead extension comprising

a plurality of lead extension terminals disposed on the second end of the lead extension;

a connector disposed at the first end of the lead extension, the connector comprising a connector housing defining a connector port, the connector port configured and arranged to receive the lead body of the lead extension,

a plurality of connector contacts disposed in the connector port, the connector contacts configured and arranged to electrically couple to the lead terminals when the lead body is received by the connector housing, and

a plurality of conductors extending along a length of the lead extension, wherein each of the conductors electrically couples at least one of the lead extension terminals to at least one of the plurality of connector contacts; and

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

18. A method for implanting a lead into a brain of a patient, the method comprising:

inserting the lead assembly of claim 1 into a cranium of the patient with the distal end of the lead body inserted into the patient and the proximal end of the lead body extending outward from the patient;

rotating the lead body until a desired electrical stimulation is achieved by the plurality of segmented electrodes; and

identifying the circumferential orientation of the plurality of segmented electrodes by observing the circumferential orientation of the at least one proximal marker.

19. The method of claim 18, further comprising identifying at least one terminal of the plurality of terminals that is electrically coupled to the plurality of segmented electrodes by observing the location of the at least one distal marker prior to insertion of the lead assembly of claim 1 into the cranium of the patient.

20. A method for marking a lead of an implantable electrical stimulation system, the method comprising:

forming an elongated multi-lumen conductor guide defining a central lumen and a plurality of conductor lumens arranged around the central lumen;

twisting at least a portion of the multi-lumen conductor guide to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the central lumen;

inserting at least one conductor into one of the plurality of conductor lumens;

forming a plurality of segmented electrodes along one end of the multi-lumen conductor guide;

electrically coupling the plurality of segmented electrodes to the at least one conductor; and

forming an ablation along a longitudinal length of the twisted multi-lumen conductor guide, wherein the ablation is aligned along the longitudinal length of the multi-lumen conductor guide with a one of the plurality of segmented electrodes.