Long-acting antibacterial anti-stenosis functional urethral stent and preparation method thereof

Patent metadata

Field	Value
Publication number	US-12337129-B2
Application number	US-202218577719-A
Country	US
Kind code	B2
Filing date	Mar 22, 2022
Priority date	Jul 15, 2021
Publication date	Jun 24, 2025
Grant date	Jun 24, 2025

Abstract

A long-acting antibacterial anti-stenosis functional urethral stent and preparation method thereof is provided; the urethral stent is a tubular structure consisting of three layers: inner, middle and outer layers; the middle layer is a fabric tube; the outer layer is a silk fibroin film carrying anti-stenosis drugs; the inner layer is an antibacterial antifouling coating, consisting of chitosan-nanosilica arrays, villi, microvilli and antibacterial drugs; the preparation method includes: after making yarns into the fabric tube by textile molding, preparing the antibacterial and anti-fouling coating on the inner surface, and the silk fibroin film carrying anti-stenosis drugs on the outer surface respectively, to obtain the long-acting antibacterial anti-stenosis functional urethral stent. The method is simple, and the prepared urethral stent has a smooth surface and good biocompatibility, which has excellent properties such as radial compression force, circumferential expansion force, resistance to bending and torsion and elastic recovery.

First claim

The invention claimed is:

1. A long-acting antibacterial anti-stenosis functional urethral stent, wherein the urethral stent is a tubular structure consisting of three layers: inner, middle and outer layers;
wherein the middle layer is a fabric tube; wherein the outer layer is a silk fibroin film carrying anti-stenosis drugs; wherein the inner layer is an antibacterial antifouling coating, consisting of chitosan-nanosilica arrays, villi, microvilli and antibacterial drugs;
wherein the chitosan-nanosilica array arranged on an inner surface of the fabric tube, is a nanosilica array carrying chitosan molecules; one end of the villus is fixed on a surface of the chitosan-nanosilica array while the other end is a free end, and a material of the villus is a polymer containing polyhydroxy functional group, which is bonded with the chitosan in the chitosan-nanosilica array through covalent bonds, and a number of hydroxyl of the polymer containing polyhydroxy functional group is greater than or equal to 2; one end of the microvillus is fixed to the villus while the other end is a free end, and a material of the microvillus is a polymer with antibacterial adhesion function, which is bonded with the villus through covalent bonds; wherein the antibacterial drug is distributed in the whole inner layer,
wherein the fabric tube consists of yarns; wherein the yarn is one or more selected from the group consisting of silk, a polylactide filament, a polydiaxone filament, a polyglycolide acid filament, a poly (lactic-co-glycolic acid) filament and a developing wire;
wherein the fabric tube has a radial compression modulus of 0.03-5.72 MPa, an elastic recovery ratio of 74.53-93.63%, a circumferential expansion breaking strength of 0.03-10.62 MPa, and a yarn coverage rate of 66.67-83.15%;
wherein the anti-stenosis drug is rapamycin and/or curcumin;
wherein the polymer containing polyhydroxy functional group is one or more selected from the group consisting of polyether, polyvinyl alcohol, polyethylene glycol, polyhydroxyethyl methacrylate and acrylic acid-hydroxypropyl acrylate copolymer;
wherein the polymer with antibacterial adhesion function is one or more selected from the group consisting of cationic polymer, anionic polymer, nonionic polymer and zwitterionic hydrophilic polymer;
wherein the antibacterial drug is one or more selected from the group consisting of antibacterial peptide, triclosan, heparin, clarithromycin, berberine, sparfloxacin, amikacin and ketolovic acid.

2. The long-acting antibacterial anti-stenosis functional urethral stent of claim 1 , wherein a wall thickness of the long-acting antibacterial anti-stenosis functional urethral stent is 0.19-0.4 mm, and a wall thickness of the middle layer is 0.06-0.27 mm.

3. The long-acting antibacterial anti-stenosis functional urethral stent of claim 1 , wherein the developing wire is a medical magnesium wire, a medical tantalum wire or a medical silver wire;
wherein the polymer with antibacterial adhesion function is one or more selected from the group consisting of polyvinylpyridine, phosphoylcholine polymer, sulphobetaine polymer, carboxybetaine polymer, polyethylene glycol and poly(2-methyl-2-oxazoline).

Assignees

• Nantong Textile & Silk Industrial Tech Research Institute
• Univ Soochow

Inventors

• Li Gang
• Li Lu
• Li Feng
• Duan Lirong

Classifications

• A61L2400/18

  Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment · CPC title

• A61L2300/416

  Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus · CPC title

• A61L2300/404

  Biocides, antimicrobial agents, antiseptic agents · CPC title

• A61L31/14

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• D03D3/02

  Tubular fabrics · CPC title