Conformable neural interface device with hydrogel adhesion and methods of using the same

Patent metadata

Field	Value
Publication number	US-12576268-B2
Application number	US-201817260203-A
Country	US
Kind code	B2
Filing date	Jul 20, 2018
Priority date	Jul 20, 2018
Publication date	Mar 17, 2026
Grant date	Mar 17, 2026

Abstract

Disclosed are highly compliant bioelectronic neural interface devices with hydrogel adhesion. Example devices include adhesion-promoting functional groups that facilitate enhanced electrical contact with the nerve without the need for continuous application of pressure. A transfer process may be used to fabricate the device using a sacrificial material (e.g., polyacrylic acid (PAA)) that has tunable solubility in aqueous media, helping avoid the need for harsher release chemicals that may affect the properties of the hydrogel. The transfer process also helps achieve electrode contacts that are flush with a surface of the device and facilitate more intimate contact with the nerve. A gradual change in Young's modulus from a stiff contact pad region to a more compliant electrode contact region may be achieved via a varied amount of an epoxy-based material (such as SU-8) and with silicone-based material (such as polydimethylsiloxame (PDMS)) to encapsulate the device cable.

First claim

What is claimed is:

1 . A conformable neural interface system comprising:
(a) a neural interface device for interfacing with a nerve, the neural interface device comprising a probe region having at least one electrode on a nerve-facing surface, at least one conductive trace electrically coupled to the electrode, and at least one insulating polymer layer overlying the conductive trace; and (b) a suture-like anchor device comprising an elongated adhesive hydrogel layer that: (i) is external to the insulating polymer layer of the probe region, (ii) comprises a gel polymer network that comprises a crosslinkable polymer precursor crosslinked with a redox active metal, and (iii) is configured, in use, to be wrapped around the nerve with opposing portions of the elongated adhesive hydrogel layer contacting and adhering to each other to secure the probe region such that the electrode is maintained in non-penetrating contact with the nerve.

2 . The conformable neural interface system of claim 1 ,
(a) for use in stimulating or inhibiting a nerve in a subject in need thereof; (b) for use wherein the subject suffers from a disease or medical condition that affects a system or an organ selected from the group consisting of heart, brain, lungs, an organ of a respiratory system, liver, kidney, stomach, small intestine, large intestine, a muscle of a limb, central nervous system, peripheral nervous system, pancreas, bladder, skin, urinary tract, thyroid gland, pituitary gland, and adrenal cortex; and/or (c) for use in modulating the levels of one or more hormones, neurotransmitters, immune cells, interleukins, cytokines, lymphokines, chemokines, growth factors, and/or enzymes in a subject.

3 . The conformable neural interface system of claim 1 , wherein the redox active metal is Fe 3+ , Au 3+ , V 5+ , or Ag + .

4 . The conformable neural interface system of claim 1 , wherein the gel polymer network has an effective interfacial adhesion of between 0.1 and 10 J/m{circumflex over ( )}2.

5 . The conformable neural interface system of claim 1 , wherein the gel polymer network has a fracture energy between about 100 and about 1,000 J/m{circumflex over ( )}2.

6 . The conformable neural interface system of claim 1 , wherein the gel polymer network comprises a dopamine moiety and/or a stimulus-responsive telechelic Dopa-modified polyethylene glycol-based hydrogel.

7 . The conformable neural interface system of claim 1 , wherein the gel polymer network has a thickness from about 200 microns to about 3.5 mm.

8 . The conformable neural interface system of claim 1 , wherein the gel polymer network comprises a drug, a ligand, or a peptide that binds to a site expressed on a target tissue.

9 . The conformable neural interface system of claim 1 , wherein the gel polymer network is deposited on a detachable surgical support substrate, wherein the detachable surgical support substrate comprises an inert polymer film.

10 . The conformable neural interface system of claim 1 , wherein the Young's modulus of the suture-like anchor device is between 10 kPa and 100 kPa.

11 . The conformable neural interface system of claim 1 , wherein the shear modulus (G) of the suture-like anchor device is between 1 kPa and 100 kPa.

12 . The conformable neural interface system of claim 1 , wherein the yield strength of the suture-like anchor device is between 1 Pa and 1000 Pa.

13 . The conformable neural interface system of claim 1 , wherein the redox active metal is a metal ion.

14 . The conformable neural interface system of claim 1 , wherein the redox active metal is gold.

15 . A conformable neural interface system, comprising:
(a) a neural interface device for interfacing with a nerve, the neural interface device comprising a probe region having a nerve-facing surface with at least one electrode; and (b) a suture-like anchor device comprising an elongated adhesive hydrogel layer comprising a gel polymer network that is configured to couple with the probe region and that comprises a crosslinkable polymer crosslinked with a redox active metal ion, the adhesive hydrogel layer bonded directly to the nerve-facing surface of the probe region so as to at least partially surround the electrode, the hydrogel layer securing the probe region to the nerve without penetrating the nerve.

16 . The conformable neural interface system of claim 15 , wherein the crosslinkable polymer is cross linked with the redox active metal ion via redox-mediated crosslinking.

17 . The conformable neural interface system of claim 15 , wherein the elongated adhesive hydrogel layer comprises a first portion and a second portion that are not in contact with each other before the elongated adhesive hydrogel layer is wrapped around the nerve, and wherein the elongated adhesive hydrogel layer is configured such that the first portion and the second portion bond together when they make contact with the elongated adhesive hydrogel layer wrapped around the nerve to secure the at least one electrode to the nerve.

18 . The conformable neural interface system of claim 15 , wherein the redox active metal ion is a gold ion.

19 . The conformable neural interface system of claim 1 , wherein the adhesive hydrogel layer is an elongated sheet-like hydrogel layer on a detachable surgical support substrate.

20 . The conformable neural interface system of claim 1 , wherein the neural interface device further comprises a contact pad region and a cable connecting the probe region to the contact pad region, and wherein the neural interface device comprises a gradient of increasing stiffness from the probe region to the contact pad region.

21 . The conformable neural interface system of claim 1 , wherein the at least one electrode has a separation of no more than 25 nm from the nerve-facing surface of the probe region.

22 . The conformable neural interface system of claim 1 , wherein the at least one electrode is configured to protrude or extend out no more than 25 nm from the nerve-facing surface of the probe region.

23 . The conformable neural interface system of claim 1 , wherein the neural interface device further comprises an epoxy-based layer having a patterned array of pores with a pore-density gradient that increases from a contact pad region toward an electrode region, thereby providing variation in stiffness from the probe region to the contact pad region, the variation being achieved at least in part by varying a volume ratio of the epoxy-based layer to the hydrogel via said patterned pores.

24 . The conformable neural interface system of claim 1 , wherein each electrode is electrically connected to a contact pad region by at least two separate wires forming an electrical loop, such that continuity of each electrode can be verified prior to implantation.

25 . The conformable neural interface system of claim 1 , wherein the neural interface device comprises at least two tabs, each tab comprising at least one electrode, and wherein the electrodes are staggered in distance from a spine of the probe to provide circumferentially distributed contact points along the nerve.

26 . The conformable neural interface system of claim 15 , wherein the at least one electrode has a separation of no more than 25 nm from the nerve-facing surface of the probe region.

27 . A conformable neural interface system comprising:
a neural interface device

Assignees

• Univ Pittsburgh Commonwealth Sys Higher Education
• Univ Carnegie Mellon
• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education

Inventors

• Horn Charles C
• Xiao Gutian
• Bettinger Christopher J
• Fedder Gary Keith
• Ong Xiao Chuan
• Huang Wei-Chen
• Fisher Lee Erik Bartholomew
• Gaunt Robert A

Classifications

• A61N1/36135

  using physiological parameters · CPC title

• A61N1/0568

  with drug delivery · CPC title

• A61N1/0539

  Anchoring of brain electrode systems, e.g. within burr hole · CPC title

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title

• A61B5/259

  using conductive adhesive means, e.g. gels · CPC title