LEADS WITH ELECTRODE CARRIERS FOR SEGMENTED ELECTRODES AND METHODS OF MAKING AND USING

• US 20150360023A1
• Filed: 06/12/2015
• Published: 12/17/2015
• Est. Priority Date: 06/13/2014
• 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, Ulloa, Jose, Pianca, Anne Margaret, Black, James Robert
• Granted Patent: US 9,962,541 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: Y10T 29/49171 with encapsulating

Abstract

A stimulation lead includes an electrode carrier disposed along a distal portion of a lead body. The electrode carrier defines multiple segmented-electrode-receiving apertures extending between an outer surface and a central lumen. Each of the segmented-electrode-receiving apertures includes a ledge disposed around a perimeter of that segmented-electrode-receiving aperture and inset from the outer surface of the electrode carrier. The stimulation lead also includes multiple segmented electrodes, with each of the segmented electrode disposed in a different one of the segmented-electrode-receiving apertures with an outer stimulation surface exposed through the segmented-electrode-receiving aperture and an inner surface abutting the ledge disposed around the perimeter of that segmented-electrode-receiving aperture. Conductive wires extend along the lead body and couple the segmented electrodes to terminals.

Claims

1. A stimulation lead, comprising:

a lead body comprising a longitudinal length, a distal portion, and a proximal portion;

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

an electrode carrier coupled to, or disposed along, the distal portion of the lead body, the electrode carrier having an outer surface, the electrode carrier comprising

a central lumen, and

a stimulation region defining a plurality of segmented-electrode-receiving apertures extending between the outer surface and the central lumen, wherein the stimulation region is formed of a non-conductive material, and wherein, for each of the segmented-electrode-receiving apertures, a ledge is disposed around a perimeter of that segmented-electrode-receiving aperture, the ledge inset from the outer surface of the electrode carrier;

a plurality of electrodes comprising a plurality of segmented electrodes each having an outer stimulation surface, an opposing inner surface, and sidewalls connecting the outer stimulation surface to the inner surface, each of the segmented electrodes extending around no more than 75% of a circumference of the lead, each of the segmented electrodes disposed in a different one of the segmented-electrode-receiving apertures of the electrode carrier with the outer stimulation surface exposed through the segmented-electrode-receiving aperture and the inner surface abutting the ledge disposed around the perimeter of that segmented-electrode-receiving aperture; and

a plurality of conductive wires extending along the lead body and coupling the plurality of electrodes to the plurality of terminals.

2. The lead of claim 1, further comprising a conductor carrier disposed along the central lumen of the electrode carrier, the conductor carrier defining a central lumen, the conductor carrier housing portions of each of the plurality of conductive wires.

3. The lead of claim 2, wherein the conductor carrier defines a plurality of conductor lumens disposed peripherally about the central lumen of the conductor carrier, and wherein the plurality of conductive wires are disposed in the plurality of conductor lumens.

4. The lead of claim 3, wherein the conductor carrier defines an ablated region exposing each of the plurality of conductor lumens to the plurality of segmented-electrode-receiving apertures.

5. The lead of claim 1, wherein the electrode carrier comprises an inner sleeve and an outer sleeve disposed over the inner sleeve, the outer sleeve defining the plurality of segmented-electrode-receiving apertures and the inner sleeve defining a plurality of conductor apertures exposing the central lumen of the electrode carrier to the plurality of segmented-electrode-receiving apertures defined in the outer sleeve.

6. The lead of claim 1, wherein the outer stimulation surfaces of the plurality of segmented electrodes are arc-shaped.

7. The lead of claim 1, wherein at least one of the plurality of segmented electrodes defines at least one coupling groove disposed along the outer stimulation surface of the segmented electrode, the at least one coupling groove attached to the stimulation region of the electrode carrier via adhesive.

8. The lead of claim 1, wherein at least one of the segmented electrodes defines at least one anchoring aperture extending between the outer stimulation surface and the inner surface of the segmented electrode, the at least one anchoring aperture filled with polymeric material.

9. The lead of claim 1, wherein at least one of the plurality of segmented electrodes comprises at least one anchoring tab extending outwardly from at least one of the sidewalls of the segmented electrode.

10. The lead of claim 1, wherein the plurality of electrodes further comprises at least one of a tip electrode or at least one ring electrode.

11. An electrical stimulating system comprising:

the lead of claim 1;

a control module electrically coupled to the plurality of electrodes 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 lead, and

a plurality of connector contacts disposed in the connector housing and configured and arranged to couple to the plurality of terminals disposed along the proximal portion of the lead.

12. A method of making a stimulation lead, the method comprising:

providing a non-conductive electrode carrier defining a plurality of segmented-electrode-receiving apertures, wherein, for each of the segmented-electrode-receiving apertures, a ledge is disposed around a perimeter of that segmented-electrode-receiving aperture, the ledge inset from an outer surface of the electrode carrier;

pressing a plurality of segmented electrodes into the plurality of segmented-electrode-receiving apertures until inner surfaces of the plurality of segmented electrodes abut the inset ledges, each of the segmented electrodes extending around no more than 75% of a circumference of the lead, each of the segmented electrodes disposed in a different one of the segmented-electrode-receiving apertures of the electrode carrier;

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

electrically coupling the plurality of conductors to a plurality of terminals disposed along an opposing end of the lead.

13. The method of claim 12, wherein the plurality of segmented electrodes are retained in the plurality of segmented-electrode-receiving apertures by an interference fit.

14. The method of claim 12, further comprising applying adhesive to at least one coupling groove defined along an outer stimulation surface of at least one of the plurality of segmented electrodes, the adhesive coupling the segmented electrode to the electrode carrier.

15. The method of claim 12, wherein electrically coupling the plurality of conductors to a plurality of terminals comprises extending the plurality of conductors along a longitudinal length of a conductor carrier at least partially disposed along a central lumen of the electrode carrier.

16. The method of claim 15, wherein extending the plurality of conductors along a longitudinal length of the conductor carrier comprises extending the plurality of conductors through conductor apertures defined along a portion of the conductor carrier.

17. The method of claim 15, wherein extending the plurality of conductors along a longitudinal length of the conductor carrier comprises extending the plurality of conductors through an ablated region defined along a portion of the conductor carrier.

18. The method of claim 12, further comprising backfilling the electrode carrier with a polymeric material.

19. The method of claim 12, further comprising reflowing the electrode carrier with a polymeric material.

20. The method of claim 12, wherein pressing the plurality of segmented electrodes into the plurality of segmented-electrode-receiving apertures occurs after electrically coupling a plurality of conductors to the plurality of segmented electrodes.