Urinary Drainage Prosthesis Coating for Tissue Integration and Leak Control

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Solution Overview

Problem

Existing urinary drainage prostheses face issues with biocompatibility, leading to insufficient tissue healing, local leakages, and defensive reactions, posing risks such as peritonitis and multi-organ disorders, especially after radical cystectomy.

Innovation Solution

A urinary drainage prosthesis composed of a polypropylene or polyester mesh tube modified with cold oxygen plasma, coated with cross-linked sodium hyaluronate and type I collagen layers, and seeded with mesenchymal stem cells, featuring a cone-shaped collar made of micro/nanofiber nonwoven fabric, enhances biocompatibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an artificial urinary bladder or tubular prosthesis is used for urinary drainage, then urine transport function is restored, but biocompatibility is insufficient leading to tissue healing problems and local leakages

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidtissue healing insufficiency and local leakages
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The prosthesis uses a composite structure combining a polypropylene/polyester mesh tube with multiple functional coatings: cold oxygen plasma modification on the surface, cross-linked sodium hyaluronate layer on the internal surface, and nanofiber collagen layer on the external surface. This composite material system provides both mechanical strength for urine transport and biocompatible interfaces for tissue integration, resolving the contradiction between functional reliability and biocompatibility.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The invention modifies the physical and chemical parameters of the prosthesis surface through cold oxygen plasma treatment, which changes surface energy and hydrophilicity. The plasma treatment creates reactive groups that enhance bonding between the synthetic mesh and the biological coating layers, improving tissue healing and reducing leakage risks while maintaining the structural integrity needed for urine drainage.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If natural tissue is connected to artificial systems, then urine drainage function is achieved, but defensive reactions of the human body occur posing life-threatening risks

Engineering Contradiction:
Improveurine drainage functionVSAvoiddefensive reactions and peritonitis risk
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The prosthesis introduces intermediate biological layers between the artificial mesh and natural tissue: cross-linked sodium hyaluronate on the internal surface facing urine and tissue, and nanofiber collagen on the external surface for tissue integration. These intermediary layers act as biocompatible mediators that reduce immune recognition and defensive reactions, allowing urine drainage function while minimizing life-threatening inflammatory responses.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

Different regions of the prosthesis are given different local qualities through selective coating: the internal surface receives cross-linked sodium hyaluronate for urine contact and epithelialization, while the external surface receives nanofiber collagen for connective tissue integration. This local differentiation reduces overall defensive reactions by providing appropriate biological interfaces in each region, preventing systemic complications like peritonitis.

Inventive Principle:
Principle #3Local quality

3Ease of manufacture

If conventional artificial materials are used, then manufacturing is simple, but tissue integration is poor resulting in insufficient healing

Engineering Contradiction:
Improveprosthesis fabricationVSAvoidtissue integration quality
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The prosthesis undergoes preliminary surface modification with cold oxygen plasma before coating, and the collagen and hyaluronate layers are pre-cross-linked and prepared as nanofiber mats. These preliminary actions are performed during manufacturing to ensure optimal tissue integration properties are built into the prosthesis structure before implantation, achieving high tissue integration quality without excessive manufacturing complexity.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The prosthesis ensures improved biocompatibility, reduces urine leakage, promotes natural tissue growth, and integrates well with animal tissue, shortening recovery time and minimizing complications.

Implementation Method 1

a tube which is made of a hydrophilic matrix made of polypropylene or polyester mesh modified with the use of cold oxygen plasma to increase its hydrophilicity

Methodology Applied
Scientific EffectPlasma treatment: Plasma

Implementation Method 2

a mat in the form of a cone-shaped collar attached to the distal end, produced by electrospinning of a polyester solution

Methodology Applied
Scientific EffectElectrospinning: Electrohydrodynamics

Data Source

PatentEP4570276B1A urinary drainage prosthesis for patients without a bladder and method for manufacturing it
Publication Date: 2025.12.31 UNIV MIKOLAJA KOPERNIKA
  • EP4570276B1 patent drawingFigure 1~2

AI summary

A urinary drainage prosthesis for patients following radical cystectomy, characterized in that it comprises a tube which is made of a hydrophilic matrix made of polypropylene or polyester mesh in the shape of a tube, ended with a collar on one side made of micro and/or nanofiber nonwoven fabric prepared from a synthetic fiber-forming polymer or copolymers, natural polymers such as esters and ethers of cellulose, collagen, gelatin, fibrinogen, natural silk, coated on the internal surface with a layer of cross-linked sodium hyaluronate of the average molecular weight from 2000 kD to 2 500 kD in the form of a film with an addition of the plasticizer - a polyol and on the external surface with a layer of type I collagen of the animal origin of the average molecular weight from 250 kD to 350 kD in the form of a nanofiber layer, whereby the sodium hyaluronate layer amounts from 15% w/w to 25% w/w, preferably 20% w/w of the mass of the prosthesis, and the collagen layer - from 20% w/w to 40% w/w, preferably 30% w/w of the mass of the prosthesis.