Electrode devices for neurostimulation

Patent metadata

Field	Value
Publication number	US-11559692-B2
Application number	US-201816634620-A
Country	US
Kind code	B2
Filing date	Jul 23, 2018
Priority date	Jul 28, 2017
Publication date	Jan 24, 2023
Grant date	Jan 24, 2023

Abstract

An extravascular neural interface is disclosed containing electrodes for neurostimulation of the vessel. The devices are housed in flexible substrates, each substrate having a spinal portion for routing leads/conductors into the device for connection to the electrodes. Extending from opposite sides of the spinal portion is a self-sizing inner flap that supports and positions the electrodes to be inward facing, i.e., extravascular designs, and one more rigid outer flap. The electrodes may be flexible multifilar coil electrodes.

First claim

What is claimed is:

1. A neural interface for interfacing with a target, the neural interface comprising:
a spinal portion configured to house electrical leads for one or more electrodes;
a flexible inner flap connected to at least a first side of the spinal portion and configured to house and position the one or more electrodes such that the one or more electrodes are provided around the target; and
an outer flap connected to a second side of the spinal portion and configured to overlap at least partially around the flexible inner flap and the target, wherein the first side is opposite the second side, wherein the outer flap is more rigid than the flexible inner flap, wherein the outer flap and the flexible inner flap are configured to create a mechanical lock between the outer flap and the flexible inner flap.

2. The neural interface of claim 1 , wherein a first portion of the flexible inner flap is connected to the second side of the spinal portion and includes one or more protrusions on an outer surface of the first portion, and wherein a second portion of the flexible inner flap is connected to the first side of the spinal portion and includes the one or more electrodes.

3. The neural interface of claim 2 , wherein one or more holes are formed in the outer flap and configured to receive the one or more protrusions.

4. The neural interface of claim 1 , wherein the one or more electrodes is a coil electrode that extends orthogonal to a length of the target when positioned around the target, wherein at least one of:
the one or more coil electrodes are connected to a lead of the electrical leads by a crimp/weld sleeve; or
the one or more coil electrodes include one or more filar wound around a central portion and terminated at a distal end of the central portion at a plug.

5. The neural interface of claim 1 , wherein the one or more electrodes are configured to be exposed to the target from an inside surface of the flexible inner flap.

6. The neural interface of claim 1 , wherein the flexible inner flap has a first hardness and the outer flap has a second hardness, and wherein the second hardness is greater than the first hardness.

7. The neural interface of claim 1 , wherein the spinal portion and the flexible inner flap are molded from a silicone-based material, and wherein the silicone-based material is at least one of:
doped with a steroid drug; or
coated with a hydrophilic polymer.

8. A method of manufacturing a neural interface, the method comprising:
covering a length of a lead with a tube except for a first end of the lead;
connecting the first end of the lead to an elongated electrode;
placing at least a portion of the length of the lead, the first end of the lead and the elongated electrode in a first mold;
molding via the first mold a first material over at least the portion, the first end of the lead and the elongated electrode to create a flexible inner flap and a spinal portion of the neural interface, wherein at least a portion of a length of the elongate electrode is exposed from the first material on an inside surface of the flexible inner flap such that the one or more electrodes can be provided at least partially around a target; and
molding via a second mold a second material to create an outer flap of the neural interface, the outer flap provided at least partially around at least a portion of the flexible inner flap and the target, wherein the outer flap and the flexible inner flap are configured to create a mechanical lock between the outer flap and the flexible inner flap.

9. The method of claim 8 , wherein the first mold forms one or more protrusions in an outer surface of the flexible inner flap, wherein the second mold forms one or more holes in the outer flap that match the one or more protrusions, and further comprising fitting the one or more protrusions in the one or more holes.

10. The method of claim 8 , wherein the flexible inner flap has a first hardness and the outer flap has a second hardness, and wherein the second hardness is greater than the first hardness.

11. The method of claim 8 , wherein the first material is a silicone based material, and the method further comprises at least one of:
doping the silicone-based material with a steroid drug; or
coating the silicone-based material with a hydrophilic polymer.

12. The neural interface for interfacing with a target of claim 1 , wherein the one or more electrodes are provided at least partially around the target such that the entire circumference of the target is covered by the one or more electrodes.

Assignees

• Galvani Bioelectronics Ltd

Inventors

• Zaidi Faisal
• Ouchouche Sebastien

Classifications

• A61N1/372 Primary

  Arrangements in connection with the implantation of stimulators · CPC title

• A61N1/0556 Primary

  Cuff electrodes · CPC title

• A61K31/56

  Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids · CPC title

• A61N1/05

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title

• A61N1/375

  Constructional arrangements, e.g. casings · CPC title