Implantable leads with flag extensions

Patent metadata

Field	Value
Publication number	US-2016199638-A1
Application number	US-201314911702-A
Country	US
Kind code	A1
Filing date	Aug 27, 2013
Priority date	Aug 27, 2013
Publication date	Jul 14, 2016
Grant date	—

Abstract

In one example, an implantable lead includes a substrate and an electrically conductive material disposed on the substrate to form a flexible circuit. The flexible circuit includes a proximal end adapted to electrically connect to an implantable processor, a distal portion adapted to stimulate a cochlear nerve, and a lead body extending from the proximal end to the distal portion, the lead body having a longitudinal axis and comprising a plurality of electrical traces adapted to carry electrical signals from the proximal end to the distal portion. A flag extension is formed in the substrate and extends laterally outward from the lead body longitudinal axis. A method for forming a cochlear lead with a flag extension is also provided.

First claim

What is claimed is:

1 . An implantable lead comprising:
a substrate; and an electrically conductive material disposed on the substrate to form a flexible circuit, the flexible circuit comprising: a proximal end adapted to electrically connect to an implantable processor; a distal portion adapted to stimulate a cochlear nerve; a lead body extending from the proximal end to the distal portion, the lead body having a longitudinal axis and comprising a plurality of electrical traces adapted to carry electrical signals from the proximal end to the distal portion; and a flag extension formed in the substrate and extending laterally outward from the lead body longitudinal axis.

2 . The lead of claim 1 , further comprising flexible encapsulant encapsulating at least a portion of the flexible circuit.

3 . The lead of claim 2 , wherein the flag extension is not encapsulated by the flexible encapsulant.

4 . The lead of claim 2 , wherein the flag extension is encapsulated by the flexible encapsulant.

5 . The lead of claim 1 , wherein the flag extension comprises a through hole for receiving a suture.

6 . The lead of claim 1 , wherein the substrate comprises a thermoplastic.

7 . The lead of claim 6 , wherein the flag extension is thermoformed into a predetermined geometry.

8 . The lead of claim 6 , wherein the substrate further comprises a flexible non-thermoformable material bonded to the thermoplastic.

9 . The lead of claim 1 , wherein the flag extension is adapted to be fixed to tissues proximal to the lead body.

10 . The lead of claim 1 , wherein the flag extension comprises a depth marker adapted to show a target insertion depth of the implantable lead into biological tissue.

11 . The lead of claim 10 , wherein the flag extension comprises a radiopaque material.

12 . The lead of claim 10 , wherein the depth marker is thermoformed to lie flat against tissue at a surgical opening in the cochlea when the electrode array is inserted at the target insertion depth.

13 . A method comprising:
forming a flexible circuit by:
forming a conductive pattern on a flexible substrate; and
cutting the flexible substrate to form a flag extension; and
encapsulating the flexible circuit in a flexible body to form an electrode array and a lead body wherein the flag extension extends laterally outward from the lead body.

14 . The method of claim 13 , wherein the flag extension is adapted to be secured to biological tissue.

15 . The method of claim 13 , wherein the flag extension is configured as an insertion depth marker.

16 . The method of claim 13 , wherein the flag is configured to be used as an insertion depth marker and to be secured to biological tissue.

17 . The method of claim 13 , further comprising thermoforming the flexible circuit prior to encapsulating the flexible circuit in the flexible body.

18 . The method of claim 17 , wherein thermoforming the flexible circuit comprises passing a first alignment feature through an aperture in a first flag extension to secure the flexible circuit during thermoforming.

19 . The method of claim 18 , further comprising passing a second alignment feature through an aperture in a second flag extension during thermoforming and then cutting off the second flag extension from the flexible circuit prior to encapsulating the flexible circuit.

20 . An implantable lead comprising:
a flexible circuit having a distal end and a longitudinal axis, the flexible circuit comprising:
a substrate; and
an electrically conductive material disposed on a portion of the substrate forming:
an electrode array on the distal end, the electrode array comprising a plurality of electrodes adapted to stimulate a cochlear nerve; and
a lead body electrically coupled to the electrode array and extending proximally therefrom;

wherein the substrate has at least one flag formed therein, proximal of the electrode array, extending outwardly from the longitudinal axis, and adapted to be affixed to tissue.

Assignees

• Advanced Bionics Ag

Inventors

• Xu Bing
• Koester Kurt J
• Downing Mark B

Classifications

• A61N1/0541 Primary

  Cochlear electrodes · CPC title

• A61N1/3603

  Control systems · CPC title

• A61N1/36036

  of the outer, middle or inner ear · CPC title