Tissue Substitute Delivery Device for Urethral Stricture Treatment

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Solution Overview

Problem

Current treatments for urethral strictures, such as urethrotomy and urethral reconstruction, are either minimally invasive with low success rates or invasive with high risks, and stents used to prevent restenosis are temporary due to encrustation, infection, and rejection issues.

Innovation Solution

A device comprising a carrier with a surface for supporting a tissue replacement and a protective element for safe insertion into a hollow organ, allowing for endoscopic, minimally invasive introduction of an expandable implant that reduces mechanical friction and promotes healthy wound healing without encrustation or rejection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If urethrotomy is performed to treat urethral strictures, then the treatment is minimally invasive with low risk, but the success rate is low and restenosis occurs frequently

Engineering Contradiction:
Improveminimally invasive treatmentVSAvoidsuccess rate
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A tissue substitute is introduced as an intermediary material between the urethral walls to prevent restenosis. The tissue substitute acts as a mediator that promotes healthy wound healing and maintains lumen patency without requiring open surgery, thus achieving both minimally invasive treatment and high success rate

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The tissue substitute is prepared and positioned in advance within a delivery device before insertion into the urethra. The substitute is pre-formed with appropriate dimensions and properties to ensure proper placement and function, allowing for controlled deployment at the target site during minimally invasive procedure

Inventive Principle:
Principle #10Preliminary action

2Reliability

If open urethral reconstruction with native oral mucosa is performed, then the success rate is high, but the treatment requires open surgery with associated complications

Engineering Contradiction:
Improvesuccess rateVSAvoidinvasiveness
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The tissue substitute is extracted from the need for open surgical exposure. Instead of requiring large incisions and direct visualization for tissue placement, the pre-formed tissue substitute is delivered through a minimally invasive endoscopic approach, extracting the invasive surgical component while maintaining the beneficial tissue replacement function

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The complex mechanical process of open surgery for tissue harvesting, preparation, and implantation is replaced by a simplified delivery system. The tissue substitute is pre-prepared outside the body and delivered through a catheter-based device, substituting the complex surgical mechanical process with a less invasive delivery mechanism

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If stents are used to prevent restenosis, then lumen patency is maintained, but encrustation, infection, and rejection occur leading to temporary solution

Engineering Contradiction:
Improvelumen patencyVSAvoidencrustation and infection
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The material properties of the tissue substitute are specifically designed with appropriate porosity, surface characteristics, and biocompatibility parameters to prevent encrustation and infection. The substitute's physical and chemical parameters are optimized to promote healthy tissue integration while resisting bacterial colonization and mineral deposition that plague traditional stents

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The tissue substitute is constructed as a composite material combining biocompatible framework with bioactive components. This composite structure provides both mechanical support for lumen patency and biological functionality to prevent infection and encrustation, overcoming the limitations of traditional inert stent materials

Inventive Principle:
Principle #40Composite materials

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

Enables a high success rate, minimally invasive, and cost-effective treatment of urethral strictures by ensuring the tissue replacement is securely fixed to the wound bed, reducing the need for repeated interventions and minimizing complications like encrustation and infection.

Implementation Method 1

a second tube serving as a carrier, which can be inserted into the first tube and has a first expandable section with a surface for receiving the tissue substitute by supplying a fluid

Methodology Applied
Scientific EffectFluid pressure expansion: Pressure Increase

Implementation Method 2

a third tube which can be guided through the second tube and the open proximal end of the first tube, the third tube having a second expandable section at its proximal end by supplying a fluid

Methodology Applied
Scientific EffectFluid pressure expansion: Pressure Increase

Data Source

PatentEP3165196B1Device for introducing a tissue substitute into a hollow organ
Publication Date: 2021.10.27 MUKOCELL GMBH
  • EP3165196B1 patent drawingFigure 1
  • EP3165196B1 patent drawingFigure 2
  • EP3165196B1 patent drawingFigure 3

AI summary

The invention relates to a device for introducing a tissue substitute (2, 103) into a hollow organ (4). The device (1, 101) comprises a carrier (21, 102) with a surface for supporting the tissue substitute (2, 103) and a protective element (11, 104) for protecting the tissue substitute (2, 103) during the insertion of the device (1, 101) into the hollow organ (4).