# US 2024/0188958 A1 · Nerve conduit

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- Number: US 2024/0188958 A1
- Document ID: US20240188958A1
- Status: Published application
- Kind: A1
- Application number: 18/555,318
- Filed: 2022-04-26
- Published: 2024-06-13
- Earliest claimed: 2021-04-26
- Applicants: Tissium S.A.
- Inventors: Marie Malafosse; Simon Menand; Estelle Collin; Maria Pereira
- Web page: https://patentgrep.com/patent/US20240188958A1

## CPC

- A61B 17/1128: {of nerves}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/1132: {End-to-end connections}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Nerve conduits support the repair of nerve lesions by facilitating proper insertion and/or fixation of nerve ends into the nerve conduit. A nerve conduit includes an elongate body with a central portion defining an inner cavity and end portions defining a respective opening to the inner cavity and arranged adjacent to the central portion and at longitudinally opposing ends of the elongate body. A cross-sectional area of at least one opening is larger than the cross-sectional area of the inner cavity of the central portion. A use and a method of treating a nerve lesion using such nerve conduits is also disclosed.

## Claims

### Claim 1

A nerve conduit, comprising:
an elongate body comprising;
a central portion defining an inner cavity; and
end portions each defining a respective opening to the inner cavity and arranged adjacent to the central portion and at longitudinally opposing ends of the elongate body;
wherein a cross-sectional area of at least one of the openings is larger than a cross-sectional area of the inner cavity of the central portion.

### Claim 2 (depends on 1)

The nerve conduit according to claim 1, wherein the central portion is formed as an essentially tubular shape and the elongate body comprises two of the end portions.

### Claim 3 (depends on 1)

The nerve conduit according to claim 1, wherein the openings and inner cavity define a single lumen or continuous through hole.

### Claim 4 (depends on 1)

The nerve conduit according to claim 1, wherein the cross-sectional area of each of the openings is larger than the cross-sectional area of the inner cavity or wherein the cross-sectional area of an opening of only one end portion is larger than the cross-sectional area of the inner cavity.

### Claim 5 (depends on 1)

The nerve conduit according to claim 1, wherein the cross-sectional area of the at least one opening increases in the longitudinal direction and away from the central portion.

### Claim 6 (depends on 5)

The nerve conduit according to claim 5, wherein the at least one end portion and the corresponding opening are formed as a rotationally symmetric shape along a longitudinal axis defined by the elongate body, said shape being an essentially U-shape, sigmoidal shape, conical shape, concave shape, funnel shape, or parabolic shape.

### Claim 7 (depends on 1)

The nerve conduit according to claim 1, wherein the end portions are equally formed.

### Claim 8 (depends on 1)

The nerve conduit according to claim 1, wherein the inner cavity and the openings are formed by a single wall of the elongate body defining an inner diameter and outer diameter of the elongate body.

### Claim 9 (depends on 8)

The nerve conduit according to claim 8, wherein the wall comprises an essentially continuous thickness along the circumferential and longitudinal direction of the elongate body.

### Claim 10 (depends on 8)

The nerve conduit according to claim 8, wherein the inner diameter and outer diameter of the central portion are essentially continuous in the longitudinal direction of the elongate body.

### Claim 11 (depends on 8)

The nerve conduit according to claim 8, wherein the diameter of the at least one opening increases in the longitudinal direction away from the central portion.

### Claim 12 (depends on 11)

The nerve conduit according to claim 11, wherein a ratio between a maximum diameter of the at least one opening and the diameter of the inner cavity is preferably between 1.05:1.0 and 1.5:1.0, or between 1.05:1.0 and 1.2:1.0.

### Claim 13 (depends on 11)

The nerve conduit according to claim 11, wherein a maximum diameter of the at least one opening is smaller than or corresponds to the outer diameter of the central portion.

### Claim 14 (depends on 1)

The nerve conduit according to claim 1, wherein an outer surface of the end portions extending from the central portion is aligned with an outer surface of the central portion and/or is free of steps or edges with the outer surface of the central portion.

### Claim 15 (depends on 1)

The nerve conduit according to claim 1, wherein a ratio between a length of the central portion and a length of one of the end portions in a longitudinal direction is from 1.2:1.0 to 15:1.0; or from 1.2:1.0 to 12:1.0; or from 1.2:1.0 to 10:1.0.

### Claim 16 (depends on 1)

The nerve conduit according to claim 1, wherein a ratio between a length of the central portion and a length of one of the end portions in a longitudinal direction is between 1.2:1.0 and 6.0:1.0; or between 1.2:1.0 and 1.4:1.0; or between 1.8:1.0 and 2.2:1.0; or between 4.4:1.0 and 5.4:1.0.

### Claim 17 (depends on 1)

The nerve conduit according to claim 1, wherein a ratio between a length of the central portion and a length of the elongate body in a longitudinal direction is from 0.3:1.0 to 1:1.0, or between 0.3:1.0 and 0.8:1.0.

### Claim 18 (depends on 1)

The nerve conduit according to claim 1, wherein a length of the central portion in a longitudinal direction is from 3 mm to 40 mm, or from 4 mm to 30 mm, or from 4.5 mm to 25 mm.

### Claim 19 (depends on 1)

The nerve conduit according to claim 1, wherein a length of the elongate body in a longitudinal direction is between 5 mm and 50 mm, or from 6 mm to 40 mm, or from 7 mm to 30 mm.

### Claim 20 (depends on 1)

The nerve conduit according to claim 1, wherein a length of one of the end portions in a longitudinal direction is from 1 mm to 8 mm, or between 1.3 mm and 6.5 mm.

### Claim 21 (depends on 1)

The nerve conduit according to claim 1, wherein a length of the central portion in a longitudinal direction is between 5 mm and 10 mm, or between 6.5 mm and 8.5 mm, wherein the length of the elongate body in the longitudinal direction is between 7 mm and 25 mm, or between 9 mm and 22 mm, and/or wherein the length of one of the end portions in the longitudinal direction is between 1 mm and 8 mm, or between 1.3 mm and 6.5 mm.

### Claim 22 (depends on 1)

The nerve conduit according to claim 1, wherein the central portion is defined by an interface region between respective end portions and/or corresponding openings, wherein an extension of the central portion in a longitudinal direction is less than about 10 percent of a smallest extension of a respective opening and/or end portion in the longitudinal direction.

### Claim 23 (depends on 1)

The nerve conduit according to claim 1, wherein a diameter of the inner cavity is from 1 mm to 15 mm, or from 1 mm to 12 mm.

### Claim 24 (depends on 1)

The nerve conduit according to claim 1, wherein a maximum diameter of the at least one opening is from 1 mm to 15 mm, or from 1.5 mm to 13 mm, or from 1.75 mm to 7 mm.

### Claim 25 (depends on 1)

The nerve conduit according to claim 1, wherein the diameter of the inner cavity is between 1 mm and 12 mm, preferably between 1.5 mm and 6.5 mm, and/or wherein the maximum diameter of the at least one opening is between 1.5 mm and 11 mm, preferably between 1.75 mm and 6.5 mm.

### Claim 26 (depends on 1)

The nerve conduit according to claim 1, wherein the inner cavity of the central portion defines a single lumen and the nerve conduit comprises two of the end portions, which are located at either end of the central portion, wherein a maximum outer diameter of the end portions is larger than an outer diameter of the central portion and an outer end of the end portion is provided by a continuous edge.

### Claim 27 (depends on 1)

The nerve conduit according to claim 1, wherein:
a cross-sectional area of the at least one opening increases in a longitudinal direction and away from the central portion;
the at least one end portion and the corresponding opening are formed as a rotationally symmetric funnel and/or parabolic shape along a longitudinal axis defined by the elongate body;
the inner cavity and the openings are formed by a single wall of the elongate body defining an inner diameter and outer diameter of the elongate body and having an essentially continuous thickness along the circumferential and longitudinal direction of the elongate body; and
the inner diameter and outer diameter of the central portion are essentially continuous in the longitudinal direction of the elongate body.

### Claim 28 (depends on 1)

The nerve conduit according to claim 1, wherein;
a cross-sectional area of each of the openings is larger than a cross-sectional area of the inner cavity and increases in a longitudinal direction and away from the central portion;
the at least one end portion and the corresponding opening are formed as a rotationally symmetric funnel and/or parabolic shape along a longitudinal axis defined by the elongate body; and
the inner cavity and the openings are formed by a single wall of the elongate body having an essentially continuous thickness along the circumferential and longitudinal direction of the elongate body.

### Claim 29 (depends on 1)

The nerve conduit according to claim 1, wherein at least one of the end portions comprises one or more retention surfaces at an outer surface of the elongate body and being configured for securing a medical adhesive to the respective end portion.

### Claim 30 (depends on 29)

The nerve conduit according to claim 29, wherein the one or more retention surfaces of a respective end portion are formed as a plurality of ellipsoid or circular holes arranged in at least one row in a circumferential direction of the elongate body.

### Claim 31 (depends on 30)

The nerve conduit according to claim 30, wherein the holes are arranged in 2 to 4 rows, wherein each row comprises 4 to 8 holes and wherein the holes of adjacent rows are arranged in a staggered formation.

### Claim 32 (depends on 30)

The nerve conduit according to claim 30, wherein each hole is formed as a cut-out, a recess, or a through-hole in a wall forming the elongate body.

### Claim 33 (depends on 29)

The nerve conduit according to claim 29, wherein the one or more retention surfaces of a respective end portion are formed as at least one groove extending in a helical direction along a longitudinal axis defined by the elongate body.

### Claim 34 (depends on 33)

The nerve conduit according to claim 33, wherein the at least one groove comprises rounded edges and/or wherein the at least one groove defines at least one undercut.

### Claim 35 (depends on 33)

The nerve conduit according to claim 33, wherein the at least one groove defines an outermost edge of the respective end portion in a longitudinal direction of the elongate body.

### Claim 36 (depends on 33)

The nerve conduit according to claim 33, wherein the at least one groove comprises a radial depth varying in accordance with an increase of a cross-sectional area of the at least one opening in the longitudinal direction and away from the central portion.

### Claim 37 (depends on 33)

The nerve conduit according to claim 33, wherein the at least one groove extends between 0.5 and 10 revolutions around a longitudinal axis defined by the elongate body.

### Claim 38 (depends on 37)

The nerve conduit according to claim 37, wherein the at least one groove extends between 2 and 6 revolutions around the longitudinal axis defined by the elongate body.

### Claim 39 (depends on 37)

The nerve conduit according to claim 37, wherein the respective end portion comprises at least two grooves extending in opposing circumferential directions and intersecting each other, each groove extending between 0.5 and 5 revolutions around a longitudinal axis.

### Claim 40 (depends on 29)

The nerve conduit according to claim 29, wherein the one or more retention surfaces of a respective end portion are formed as one or more circumferential ribs extending from an outer surface of the elongate body.

### Claim 41 (depends on 40)

The nerve conduit according to claim 40, wherein the extension of the one or more ribs is linear to a circumferential direction or comprises an offset to the circumferential direction in a longitudinal direction of the elongate body.

### Claim 42 (depends on 1)

The nerve conduit according to claim 1, wherein the elongate body is formed of a biocompatible material, an inert material, a bioimplantable material, and/or biodegradable material.

### Claim 43 (depends on 1)

The nerve conduit according to claim 1, wherein the elongate body is formed of a polymer-based material, or an elastomer.

### Claim 44 (depends on 1)

The nerve conduit according to claim 1, wherein the central portion and the end portions are integrally formed or formed of a single piece.

### Claim 45 (depends on 1)

The nerve conduit according to claim 1, wherein the elongate body is formed of a polymerized and/or crosslinked polymer unit comprising an ester group component and an acid ester group component, the ester group component being a polyol and the acid ester group component being a polyacid.

### Claim 46 (depends on 1)

The nerve conduit according to claim 1 formed by a 3D-printing process.

### Claim 47 (depends on 1)

Use of a nerve conduit according to claim 1 for repairing, supporting, and/or guiding neural tissue, or for repairing a peripheral nerve lesion.

### Claim 48

(canceled)

### Claim 49 (depends on 1)

A method of treating a peripheral nerve lesion, comprising the steps of:
providing a nerve conduit according to claim 1;
inserting one end of the lesioned nerve into the nerve conduit via an opening having a larger cross-sectional area than the inner cavity of the central portion;
inserting another end of the lesioned nerve via an opening at an end portion at a longitudinally opposing end of the elongate body; and
securing the lesioned nerve ends within the elongate body.

### Claim 50 (depends on 49)

The method according to claim 49, wherein the securing of the lesioned nerve ends is performed by applying a medical adhesive outside of the inner cavity and/or into the openings via at least one of the openings and/or around the openings.
