Multi-electrode assembly for an implantable medical device

• US 8,483,846 B2
• Filed: 04/08/2010
• Issued: 07/09/2013
• Est. Priority Date: 07/26/2006
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Byerman, Bryan P.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US12/757,002
• Publication Number:
  US 20100192374A1
• Time in Patent Office: 1,188 Days
• Field of Search: 607/116, 607/118, 607/127, 607/131
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: Y10T 29/49218 with deforming

Abstract

A method, system, and apparatus are provided for an electrode assembly comprising a plurality of electrodes for use with an implantable medical device for conducting an electrical signal between the implantable medical device and a target tissue. The electrode assembly includes a helical member and first and second electrodes formed upon the helical member. The first and second electrodes are adapted to deliver the electrical signal. The electrode assembly also includes a first conductive element formed upon the helical member and operatively coupled to the first electrode. The electrode assembly also includes a second conductive element formed upon the helical member and operatively coupled to the second electrode.

Claims

1. A method for forming a helical electrode assembly for carrying a signal associated with an implantable medical device, comprising:

forming a first layer on a generally flat substrate;

forming a first conducting structure as a second layer upon said first layer, said second layer comprising a first electrode and a first conductive strip operatively coupled to said first electrode;

forming a third, non-conductive layer above said first and second layers;

forming a second conducting structure as a fourth layer upon said third layer, said fourth layer comprising a second electrode and a second conductive strip operatively coupled to said second electrode; and

forming at least a portion of said generally flat substrate and the first, second, third and fourth layers into a helical structure,

wherein forming said third layer comprises forming the third layer at an offset position on the second layer such that the third layer does not overlap the region in which the first electrode resides, such that a stair step of layers that contain electrodes and conductive strips is generated.

2. The method of claim 1, wherein forming said first and second conducting structures comprises:

performing a photolithography process to imprint said first conducting structure upon said first layer and said second conducting structure upon said third layer; and

performing an etch process to control at least one dimension relating to each of said first and second conducting structures within respective predetermined tolerances.

3. The method of claim 1, wherein forming said first and second conducting structures comprises:

performing a metal deposition process to deposit a conductive material for forming said first and second conducting structures; and

performing an etch process to control at least one dimension relating to each of said first and second conducting structures within predetermined tolerances.

4. The method of claim 1, further comprising:

forming a fifth, non-conducting layer above said third and fourth layers, and forming a third conducting structure as a sixth layer upon said fifth layer, said third conducting structure comprising a third electrode and a third conducting strip operatively coupled to said third electrode; and

forming a seventh non-conducting layer above said fifth and sixth layers, and forming a fourth conducting structure as an eighth layer upon said seventh layer, said fourth conducting structure comprising a fourth electrode and a fourth conducting strip operatively coupled to said fourth electrode.

5. The method of claim 1, further comprising:

forming a first connection pad on the surface of said electrode assembly, said first connection pad being electrically coupled to said first conductive strip; and

forming a second connection pad on the surface of said electrode assembly, said second connection pad being electrically coupled to said second conductive strip.

6. A method for forming a helical electrode assembly for carrying an electrical signal associated with an implantable medical device, comprising:

forming a plurality of layers on a generally flat substrate, including a first conducting structure and a second conducting structure as two of the plurality of layers; and

forming at least a portion of said generally flat substrate into a helical structure,

wherein said first conducting structure comprises a first electrode and a first conductive strip operatively coupled to said first electrode, and said second conducting structure comprises a second electrode and a second conductive strip operatively coupled to said second electrode,

wherein said first and second conducting structures are formed to be electrically isolated from one another, such that said first and second electrodes may be operated independently of one another, and

wherein forming said first and second conducting structures comprises offsetting said first conducting structure from said second conducting structure such that the second conducting structure does not overlap the region in which the first electrode resides, such that a stair step of layers that contain electrodes and conductive strips is generated.

7. The method of claim 6, wherein said first and second conducting structures are formed by (i) a photolithography process or a metal deposition process, and (ii) an etch process to control at least one dimension relating to each of said first and second conducting structures within respective predetermined tolerances.

8. The method of claim 7, further comprising performing a chemical-mechanical polishing process.

9. The method of claim 6, wherein said first and second conducting structures are formed to be electrically isolated from one another by forming a non-conductive layer therebetween.

10. The method of claim 6, wherein said plurality of layers comprises alternating non-conductive and conductive layers.

11. The method of claim 10, wherein said plurality of layers comprises four or more layers.

12. The method of claim 6, wherein said first and second electrodes are formed to lie on an interior surface of said helical structure, in a linear or staggered arrangement.

13. The method of claim 6, wherein said helical structure includes an elastomeric body portion comprising a material selected from the group consisting of silicone rubbers, siloxane polymers, polydimethylsiloxanes, polyurethane, polyether urethane, polyetherurethane urea, polyesterurethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethylmethacrylate, polyethylene, and polyvinylacetate, and each of said first and second electrodes comprises a material selected from the group consisting of platinum, iridium, platinum/iridium alloys, and oxides thereof.

14. The method of claim 6, wherein said helical structure is coupled to a lead assembly via an interface, said lead assembly being coupled to the implantable medical device.

15. The method of claim 6, further comprising:

forming a first connection pad on the surface of said electrode assembly, said first connection pad being electrically coupled to said first conductive strip; and

forming a second connection pad on the surface of said electrode assembly, said second connection pad being electrically coupled to said second conductive strip.

16. The method of claim 6, further comprising:

forming a first via to electrically couple said first conductive strip to said first electrode; and

forming a second via to electrically couple said second conductive strip to said second electrode.

17. An electrode assembly for conducting electrical signals between an implantable medical device and a target tissue, comprising:

a helical member;

a first layer formed on the helical member;

a first conducting structure as a second layer formed upon said first layer, said second layer comprising a first electrode and a first conductive strip operatively coupled to said first electrode;

a third, non-conductive layer formed above said first and second layers;

a second conducting structure as a fourth layer formed upon said third layer, said fourth layer comprising a second electrode and a second conductive strip operatively coupled to said second electrode; and

wherein said third layer is formed at an offset position on the second layer such that the third layer does not overlap the region in which the first electrode resides, such that a stair step of layers that contain electrodes and conductive strips is generated.

18. The electrode assembly of claim 17, wherein said first and second conductive strips are positioned in at least a partially parallel configuration along the length of at least a portion of said helical member.

19. The electrode assembly of claim 17, further comprising a fifth, non-conductive layer formed above said first to fourth layers and a third conducting structure as a sixth layer formed upon said fifth layer, said sixth layer comprising a third electrode and a third conductive strip operatively coupled to said third electrode, wherein said first, second, and third electrodes form an electrode array.

20. The electrode assembly of claim 19, wherein said first electrode is adapted to carry a first electrical signal, said second electrode is adapted to carry a second electrical signal different from said first electrical signal, and said third electrode is adapted to carry a third electrical signal different from said first and second electrical signals.

21. The electrode assembly of claim 17, further comprising a first lead wire operatively coupled to said first conductive strip and a second lead wire operatively coupled to said second conductive strip.

22. The electrode assembly of claim 21, further comprising a lead interface operatively coupled to said helical member, said first and second lead wires being operatively coupled to said first and second conductive strips via said lead interface.

23. The electrode assembly of claim 17, wherein said helical material comprises a material selected from the group consisting of siloxane polymers, polydimethylsiloxanes, silicone rubbers, polyurethane, polyether urethane, polyetherurethane urea, polyesterurethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethylmethacrylate, polyethylene, and polyvinylacetate, and said first and second electrodes comprises a material selected from the group consisting of platinum, iridium, and platinum/iridium alloys.

24. The electrode assembly of claim 17, wherein said helical member is capable of being wrapped around a nerve, wherein said first and second electrodes come into electrical contact with said nerve to deliver a stimulation signal in a cascading manner.