Polymer-metal foil structure for neural stimulating electrodes

• US 5,987,361 A
• Filed: 11/13/1998
• Issued: 11/16/1999
• Est. Priority Date: 03/07/1996
• Status: Expired due to Fees

• Current Assignee: AXON Engineering, Inc.
• Original Assignee: AXON Engineering, Inc.
• Inventors: Mortimer, J. Thomas
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/849,774
• Time in Patent Office: 368 Days
• Field of Search: 607/115, 607/116, 607/118, 607/127, 607/142, 607/137, 607/148, 607/152, 600/373, 600/372, 600/377, 29/825, 29/745, 29/746
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A neural stimulating electrode structure includes a sheet of metal foil having portions defining holes. The holes form patterns allowing the metal foil to flex without buckling when subjected to compressive forces. The holes also define discrete electrodes on the metal foil when the foil is cut. A first polymeric base layer covers a first face of the metal foil. A second polymeric base layer covers a second face of the metal foil. The first and second polymeric base layers fill the holes in the metal foil. A third polymeric base layer covers both the first and second polymeric base layers. The third polymeric base layer has portions defining pairs of holes. Each pair of holes is associated with one of the discrete electrodes. Each hole exposes a different portion of the discrete electrode for contacting tissue, passing current and/or measuring voltage.

Claims

1. A neural stimulating electrode structure, comprising:

a sheet of metal foil having a first face and a second face, with holes located within the metal foil, the holes formed in predetermined patterns allowing the metal foil to flex without buckling, metal foil between the holes defining a plurality of discrete electrodes on the metal foil when the foil is cut;

a first polymeric base layer covering the first face of the metal foil;

a second polymeric base layer covering the second face of the metal foil, the first and second polymeric base layers further filling the holes in the metal foil;

a third polymeric base layer covering at least one of the first and second polymeric base layers; and

external connection points, formed at locations where portions of the third polymeric base layer and one of the first and second polymeric base layers have been removed, each of the connection points corresponding to metal foil between a pair of holes associated with one of the discrete electrodes, at least one of the discrete electrodes at least one of contacting tissue, passing current and measuring voltage.

2. The neural stimulating electrode structure as set forth in claim 1 wherein:

the three polymeric base layers include silicone rubber.

3. The neural stimulating electrode structure as set forth in claim 1 wherein:

the three polymeric base layers are laser cutable.

4. The neural stimulating electrode structure as set forth in claim 1 wherein:

the metal foil is annealed for removing residual internal stresses.

5. The neural stimulating electrode structure as set forth in claim 1 wherein:

the metal foil has a thickness between about 10 μ

m and about 75 μ

m.

6. The neural stimulating electrode structure as set forth in claim 1 wherein:

the neural stimulating electrode structure forms a curving surface for conforming to an outside surface of a neural tissue.

7. A neural stimulating electrode structure, comprising:

a sheet of metal foil having a first face and a second face, with holes forming a mesh, the mesh allowing the metal foil to flex without buckling when subjected to compressive forces, the mesh also enabling electrical conduction in a first direction and a second direction across the metal foil, the metal foil mesh between the holes defining at least one electrically isolated region;

a first polymeric base layer covering the first face of the metal foil;

a second polymeric base layer covering the second face of the metal foil, the first and second polymeric base layers filling the holes defined by the mesh;

a third polymeric base layer covering at least one of the first and second polymeric base layers; and

external connection points, formed at locations where portions of the third polymeric base layer and one of the first and second polymeric base layers have been removed, wherein portions of the metal foil are exposed, the exposed metal foil portions corresponding to metal foil between a pair of holes, each pair of holes being associated with one of the electrically isolated regions on the metal foil.

8. The neural stimulating electrode structure as set forth in claim 7 wherein:

the three polymeric base layers include silicone rubber.

9. The neural stimulating electrode structure as set forth in claim 7 wherein:

the three polymeric base layers are laser cutable.

10. The neural stimulating electrode structure as set forth in claim 7 wherein:

the metal foil is platinum foil having a thickness between about 10 μ

m and about 75 μ

m.

11. The neural stimulating electrode structure as set forth in claim 7 wherein:

the metal foil is annealed for removing residual internal stresses.

12. The neural stimulating electrode structure as set forth in claim 7 wherein:

the sheet of metal foil forms a curving surface for conforming to an outside surface of a tissue.

13. An electrode structure, comprising:

a common structure including an electrically conductive material;

at least one lead pad electrode formed within the common structure;

at least one connection pad electrode formed within the structure;

at least one conductive path formed within the common structure, each of the conductive paths defining an electrical connection between a unique one of the lead pad electrodes and a unique corresponding one of the connection pad electrodes, each of the conductive paths including a plurality of voids; and

at least one non-conductive interconnection electrically isolating (i) each of the lead pad electrodes from each of the other lead pad electrodes, (ii) each of the connection pad electrodes from each of the other connection pad electrodes, (iii) each of the lead pad electrodes from each of the connection pad electrodes, and (iv) each of the conductive paths from at least one of the other conductive paths.

14. A method of manufacturing a neural stimulating electrode structure, comprising:

forming holes into a metal foil sheet for forming patterns and allowing the metal foil to flex without buckling when subjected to compressive forces, segments of the metal foil between the holes defining a plurality of discrete electrodes;

filling the holes with a laser cutable polymer, the polymer accommodating the compressive forces;

sandwiching the metal foil between two layers of the polymer;

cutting the sandwiched metal foil to form at least one of the discrete electrodes within the metal foil, each of the discrete electrodes being electrically isolated from each of the other discrete electrodes;

covering the at least two discrete electrodes with a second coating of the polymer; and

,

creating one pair of openings for each of the at least two electrodes, one opening in each of the pairs of openings exposing a respective portion of the metal foil for interfacing the respective portion of the metal foil with one of tissue and an electrical lead.

15. The method of manufacturing a neural stimulating electrode structure according to claim 14, further including:

after the forming step and before the filling step, annealing the metal foil sheet for removing residual internal stresses.

16. The method of manufacturing a neural stimulating electrode structure according to claim 14, wherein the sandwiching step includes:

applying the polymer to a first face of the metal foil; and

,

applying the polymer to a second face of the metal foil.

17. The method of manufacturing a neural stimulating electrode structure according to claim 16, wherein after the step of cutting and before the step of creating, the method further includes:

forming the at least two electrodes into a curved surface for conforming to an outside surface of a neural tissue.