Deep brain stimulation lead

• US 9,474,894 B2
• Filed: 08/27/2014
• Issued: 10/25/2016
• Est. Priority Date: 08/27/2014
• Status: Active Grant

• Current Assignee: Aleva Neurotherapeutics
• Original Assignee: Aleva Neurotherapeutics
• Inventors: Mercanzini, Andre, Jordan, Alain, Michalis, Alexandre, Boers, Marc, Dransart, Alain
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/470,423
• Publication Number:
  US 20160059004A1
• Time in Patent Office: 790 Days
• Field of Search: 600/377, 600/378
• US Class Current: 1/1
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: H05K 1/118 specially for flexible printed circuits, e.g. using folded portions

Abstract

The present disclosure discusses a system and methods for a deep brain stimulation lead. More particularly, the disclosure discusses a stimulation lead that includes one or more silicon based barrier layers within a MEMS film. The silicon based barrier layers can improve device reliability and durability. The silicon based barrier layers can also improve adhesion between the layers of the MEMS film.

Claims

1. A neurological lead, comprising:

a planar formed, cylindrical film comprising a distal end, a proximal end, and a plurality of electrodes, the planar formed, cylindrical film further comprising;

a ribbon cable extending from the distal end of the planar formed, cylindrical film into a lumen defined by the planar formed, cylindrical film;

a first polymeric layer;

a first silicon based barrier layer at least partially disposed over the first polymeric layer;

a first metal layer at least partially disposed over the first silicon based barrier layer;

a second silicon based barrier layer at least partially disposed over the first metal layer and the first silicon based barrier layer, the second silicon based barrier layer defining a first plurality of through-holes;

a second polymeric layer at least partially disposed over the second silicon based barrier layer and defining a second plurality of through-holes, the first plurality of through-holes substantially aligned with the second plurality of through-holes to define each of the plurality of electrodes; and

a second metal layer disposed on the first metal layer; and

a tube coupled with the proximal end of the planar formed, cylindrical film, the tube comprising one or more orientation marks.

2. The lead of claim 1, the first metal layer forming the plurality of electrodes and a plurality of traces.

3. The lead of claim 1, the first metal layer forming a plurality of contact pads disposed on the ribbon cable, each of the plurality of contact pads electrically coupled with at least one of the plurality of electrodes by a trace formed in the first metal layer.

4. The lead of claim 1, wherein the second metal layer comprises gold and the first metal layer comprises at least one of one of platinum, iridium oxide, and titanium.

5. The lead of claim 1, wherein the first and second silicon based barrier layers comprise at least one of Silicon Nitride, Silicon Oxide, Silicon Carbide, Polysilicon, Amorphous-Silicon, Titanium Dioxide, and Titanium III Oxide.

6. The lead of claim 1, wherein a thickness of the first and second silicon based barrier layers is between about 100 nm and about 2 μ

m.

7. The lead of claim 1, wherein a cylindrical shape of the planar formed, cylindrical film is at least partially maintained by a wire coupling a first side of the planar formed, cylindrical film to a second side of the planar formed, cylindrical film.

8. A method of forming a neurological lead, the method comprising:

forming a planar film comprising a plurality of electrodes and a ribbon cable extending from a distal end of the planar film by;

depositing a first silicon based barrier layer at least partially over a first polymeric layer;

depositing a first metal layer at least partially over the first silicon based barrier layer;

depositing a second silicon based barrier layer over at least partially over the first metal layer and the first silicon based barrier layer;

depositing a second polymeric layer at least partially over the second silicon based barrier layer; and

depositing a second metal layer on the first metal layer;

heating the planar film;

molding the heated planar film into a cylinder, the cylinder defining a lumen;

extending the ribbon cable into the lumen defined by the cylinder; and

coupling the molded planar film to a tube comprising one or more orientation marks.

9. The method of claim 8, further comprising:

forming the plurality of electrodes in the first metal layer;

forming a plurality of contact pads on the ribbon cable in the first metal layer; and

forming a plurality of traces electrically coupling each of the plurality of contact pads to at least one of the plurality of electrodes.

10. The method of claim 9, further comprising depositing the second metal layer on the plurality of contact pads.

11. The method of claim 8, further comprising:

defining each of the plurality of electrodes by etching a plurality of through-holes in the second silicon based barrier layer and the second polymeric layer.

12. The method of claim 8, wherein the first and second silicon based barrier layers comprise at least one of Silicon Nitride, Silicon Oxide, Silicon Carbide, Polysilicon, Amorphous-Silicon, Titanium Dioxide, and Titanium III Oxide.

13. A neurological lead, comprising:

a planar formed, cylindrical film defining a lumen, the planar formed, cylindrical film comprising a distal end and a proximal end, the planar formed, cylindrical film further comprising;

a plurality of electrodes disposed on an outer surface of the planar formed, cylindrical film; and

a ribbon cable extending from the distal end of the planar formed, cylindrical film into the lumen toward the proximal end of the planar formed, cylindrical film; and

an encapsulating polymer filling the lumen of the planar formed, cylindrical film; and

a tube coupled with the proximal end of the planar formed, cylindrical film, the tube comprising one or more orientation marks.

14. The lead of claim 13, comprising a plurality of contact pads disposed on the ribbon cable, each of the plurality of contact pads electrically coupled to at least one of the plurality of electrodes.

15. The lead of claim 14, comprising a gold layer disposed on each of the plurality of contact pads.

16. The lead of claim 15, wherein the gold layer is between about 5 μ

m and about 50 μ

m thick.

17. The lead of claim 13, comprising a peripheral trace partially surrounding each of the plurality of electrodes and coupled with each of the plurality of electrodes at two or more locations.

18. The lead of claim 13, wherein the one or more orientation marks are aligned with at least one of the plurality of electrodes or the ribbon cable.

19. The lead of claim 13, wherein the one or more orientation marks are radiopaque.

20. The lead of claim 13, wherein at least one of the plurality of electrodes comprises a mesh configuration.

21. The lead of claim 13, wherein at least one of the plurality of electrodes comprises rounded corners.

22. A method of manufacturing a neurological lead, the method comprising:

providing a planar film comprising a distal end, a proximal end, a plurality of electrodes, and a ribbon cable extending from the distal end of the planar film;

forming the planar film into a cylinder, the cylinder defining a lumen;

extending the ribbon cable into the lumen defined by the cylinder;

filling the lumen with an encapsulating polymer; and

disposing a radiopaque dye on the planar film.

23. The method of claim 22, comprising heating the planar film.

24. The method of claim 22, comprising coupling the proximal end of the planar film to a catheter.

25. The method of claim 22, comprising coupling a stylet with the ribbon cable.