Thermoformed electrode arrays

• US 10,058,697 B2
• Filed: 08/27/2013
• Issued: 08/28/2018
• Est. Priority Date: 08/27/2013
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics AG (Sonova Holding AG)
• Inventors: Xu, Bing, Koester, Kurt J., Downing, Mark B.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/911,683
• Publication Number:
  US 20160193460A1
• Time in Patent Office: 1,827 Days
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: B29C 51/02 Combined thermoforming and manufacture of the preform

Abstract

A cochlear lead includes a thermoformed circuit with a substrate with electrodes formed on the substrate and shaped to curve around a longitudinal axis of the cochlear lead. Traces are also formed on the substrate and connected to the electrodes. Intermediate sections between the electrodes may be curved about an axis that is orthogonal to the longitudinal axis.

Claims

1. A cochlear lead comprising:

a thermoformed circuit comprising;

a substrate;

electrodes formed on the substrate, wherein the electrodes are shaped to curve around a longitudinal axis of the cochlear lead;

traces formed on the substrate and connected to the electrodes; and

intermediate sections between the electrodes, wherein, when the lead is straight prior to implantation in a cochlea, at least a portion of the intermediate sections are curved around an axis that is orthogonal to the longitudinal axis.

2. The cochlear lead of claim 1, wherein the thermoformed circuit further comprises a basal extension formed into a tube, an interior of the tube forming a lumen to receive a stylet.

3. The cochlear lead of claim 1, wherein proximal intermediate sections curve around the longitudinal axis and distal intermediate sections curve around the axis that is orthogonal to the longitudinal axis.

4. The cochlear lead of claim 1, wherein the electrodes comprise a curled left edge and a curled right edge, wherein the curled left edge and the curled right edge curl into an interior of the cochlear lead and are surrounded by a flexible encapsulant.

5. The cochlear lead of claim 1, wherein the electrodes comprise a three dimensional surface with a compound curvature about two different axes.

6. The cochlear lead of claim 1, further comprising cutouts between the electrodes to increase flexibility of the cochlear lead, wherein the cutouts are larger between distal electrodes and smaller between proximal electrodes to make a distal portion of the cochlear lead more flexible than a proximal portion of the cochlear lead and wherein the cutouts on a first side of the cochlear lead are larger than the cutouts on a second side of the cochlear lead to make the cochlear lead bend into an ascending spiral.

7. The cochlear lead of claim 6, further comprising flexible silicone that fills cutouts between electrodes.

8. The cochlear lead of claim 7, wherein the flexible silicone filling the cutouts is in tension when the cochlear lead is straight.

9. The cochlear lead of claim 1, further comprising tabs extending from the electrodes, in which the tabs are joined to form rings around a central lumen of the cochlear lead.

10. The cochlear lead of claim 1, wherein the substrate comprises:

a flexible substrate in which the electrodes are formed on a first surface of the flexible substrate and traces are formed on a second surface of the flexible substrate; and

a thermoplastic layer adhered to the thermoformed circuit to cover the traces.

11. A method comprising:

patterning traces and electrodes on a substrate;

bonding the substrate to a thermoplastic layer;

thermoforming the substrate and thermoplastic layer into a predetermined shape to form a thermoformed circuit, wherein the predetermined shape comprises electrodes curved around a first longitudinal axis and intermediate portions joining the electrodes, the intermediate portions curved about a second axis that is orthogonal to the longitudinal axis when the circuit is straightened along the longitudinal axis; and

liquid injection molding silicone around the thermoformed circuit.

12. The method of claim 11, further comprising removing silicone flash from the electrodes using a laser operation, wherein the laser operation also forms a predetermined surface texture on the electrodes.

13. The method of claim 11, wherein thermoforming comprises:

aligning the circuit and thermoplastic layer by passing an alignment feature in a thermoforming mold through an aperture in a flag extension formed in the thermoplastic layer; and

pressing the substrate and thermoplastic layer into a mold cavity.

14. The method of claim 11, wherein thermoforming comprises joining a first edge of the thermoplastic layer to a second edge of the thermoplastic layer to form a continuous tube.

15. The method of claim 11, wherein thermoforming comprising joining a first tab extending from a first side of an electrode with a second tab extending from a second side of the electrode.