Granted Patent B2

US 12,296,162 · App. 17/595,169 · Granted May 13, 2025

Inventor: Cindy Au (Brentford, GB)

Assignee: GALVANI BIOELECTRONICS LIMITED

A61N1/0551B29C45/14344B29C45/1671B29K2083/00B29L2031/753

Abstract

Claims (29)

1. A method for use in making an implantable electrode assembly for neuromodulation, comprising:

forming a first layer of material including a hole formed therein;

positioning an electrode in the hole in the first layer of material;

connecting an electrical lead to the electrode;

applying a backfill material over the electrode, the electrical lead connection, and a portion of the first layer sufficient to seal any gap between the electrode and the hole; and

applying a second layer of material over the backfill material.

2. The method of claim 1 , wherein one or more of the first layer of material and the second layer of material is formed by a first-shot and a second-shot of a heated and pressurized polymer material.

3. The method of claim 1 , wherein the backfill material comprises adhesive silicone.

4. The method of claim 1 , further comprising, prior to connecting, applying a second backfill material between an edge of the electrode and the hole to hold the electrode in place for connecting.

5. The method of claim 4 , further comprising, prior to applying the backfill material, curing the second backfill material.

6. The method of claim 1 , further comprising, prior to applying the second layer of material, curing the backfill material.

7. The method of claim 1 , wherein the backfill material blocks any leakage path between the electrode and the second layer of material.

8. The method of claim 1 , wherein the first layer of material has a first hardness and the second layer of material has a second hardness, and wherein the first hardness and the second hardness are different.

9. The method of claim 1 , wherein the backfill is softer than the first layer and the second layer.

10. An electrode assembly for neuromodulation, comprising:

a first layer of material comprising an opening;

an electrode connectable to a lead provided at least partly in the opening;

a backfill provided over the electrode, the backfill covering an edge of the electrode; and

a second layer of material provided over the backfill and a portion of the first layer, wherein the backfill blocks any gap between the electrode and the first layer for reducing leakage path between a target contact surface of the electrode and the second layer.

11. The electrode assembly according to claim 10 , further wherein the backfill covers at least a part of an electrical connection between the electrode and the lead.

12. The electrode assembly of claim 10 , wherein the backfill comprises adhesive silicone.

13. The electrode assembly of claim 10 , wherein the backfill covers a peripheral edge of the electrode.

14. The electrode assembly of claim 10 , wherein the first layer of material, the backfill, and the second layer of material are formed from one or more of silicone, a polymer, and a biocompatible thermoplastic elastomer.

15. The electrode assembly of claim 10 , wherein the first layer of material and the second layer of material are the same.

16. The electrode assembly of claim 10 , wherein the first layer of material has a first hardness and the second layer of material has a second hardness, and wherein the first hardness and the second hardness are different.

17. The electrode assembly of claim 10 , further comprising a second adhesive backfill material applied to a second edge of the electrode and the opening.

18. The electrode assembly of claim 10 , further comprising multiple electrodes, wherein the electrodes are connected by a flexible interconnection lead.

19. The electrode assembly of claim 18 , wherein the backfill covers the flexible interconnection lead.

20. The electrode assembly of claim 19 , wherein the backfill is softer than the first layer and the second layer.

Assignments (2)

Continuity (2)

References Cited (17)