Biodegradable Scaffold Constructs for Bladder Augmentation

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Solution Overview

Problem

Current methods for urinary diversion and bladder augmentation are invasive, costly, and associated with significant complications, including stone formation, infection, and long-term contracture, due to the use of gastrointestinal segments, which require multiple surgeries and do not effectively replicate the bladder's specific muscular and urothelial properties.

Innovation Solution

The use of biodegradable scaffolds seeded with autologous smooth muscle cells derived from peripheral blood or adipose tissue, which are positive for smooth muscle cell markers, to create a neo-urinary conduit that regenerates urinary-like tissue with urothelium, lamina propria, and smooth muscle bundles, eliminating the need for gastrointestinal segments and reducing surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of stationary object

If gastrointestinal segments are used for bladder augmentation and urinary diversion, then bladder capacity and compliance are improved, but complications such as stone formation, infection, and long-term contracture increase

Engineering Contradiction:
Improvebladder capacityVSAvoidcomplications (stone formation, infection, contracture)
Core Design Contradiction:
Volume of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The invention segments the bladder wall into distinct functional layers (urothelium, lamina propria, smooth muscle bundles) and reconstructs each layer separately using tissue engineering, rather than using a single gastrointestinal segment for all functions. This allows optimization of each layer's properties to avoid complications while maintaining bladder capacity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the material parameters by using biodegradable scaffolds with specific porosity, degradation rate, and mechanical properties that mimic native bladder tissue. The scaffolds are seeded with autologous cells that differentiate into bladder-specific tissue, altering the tissue composition parameters to eliminate complications associated with gastrointestinal tissue while preserving compliance and capacity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If multiple surgical procedures are performed for urinary diversion using gastrointestinal segments, then urinary diversion is achieved, but surgical complexity and patient morbidity increase

Engineering Contradiction:
Improveurinary diversion functionVSAvoidsurgical procedures
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention performs preliminary actions by fabricating the engineered bladder construct ex vivo before implantation. The scaffold is pre-seeded with autologous cells and allowed to mature in bioreactors, developing the necessary tissue architecture and vascularization potential before surgical implantation. This eliminates the need for multiple staged procedures required when using gastrointestinal segments.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention merges multiple surgical steps into a single implantation procedure. The engineered bladder construct is designed to be implanted as a complete unit that simultaneously performs urinary diversion, restores bladder function, and integrates with native tissues in one surgical event, rather than requiring separate procedures for each function.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If gastrointestinal segments are used for bladder replacement, then bladder function is restored, but the specific muscular and urothelial properties of the native bladder are not replicated

Engineering Contradiction:
Improvebladder functionVSAvoidtissue structure replication
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The invention applies local quality by creating distinct tissue zones within the engineered bladder, each with properties matched to the corresponding native bladder region. The urothelium layer is optimized for impermeability and secretion, the lamina propria for vascularity and elasticity, and the smooth muscle bundles for contractility, rather than using uniform gastrointestinal tissue throughout.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention uses composite materials by combining biodegradable scaffold materials (such as polyglycolic acid, polylactic acid) with autologous patient cells. This composite structure provides the mechanical strength and architectural framework of the scaffold while the living cells contribute the functional properties of native bladder tissue, achieving superior replication of muscular and urothelial characteristics compared to gastrointestinal segments.

Inventive Principle:
Principle #40Composite materials

4Volume of stationary object

If enterocystoplasty is performed for bladder augmentation, then bladder compliance and capacity are improved, but the procedure is invasive, costly, and associated with chronic complications

Engineering Contradiction:
Improvebladder capacityVSAvoidsurgical invasiveness and cost
Core Design Contradiction:
Volume of stationary objectVSEase of operation

Solution Approach 1:

The invention applies self-service by using autologous patient cells that are harvested from the patient's own body, expanded in culture, and seeded onto the scaffold. These cells self-differentiate and self-organize into functional bladder tissue structures, eliminating the need for complex surgical manipulation of gastrointestinal segments and reducing both surgical invasiveness and long-term complications.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP2352529B1Cell-scaffold constructs
Publication Date: 2018.07.11 INREGEN
  • EP2352529B1 patent drawingFigure 1
  • EP2352529B1 patent drawingFigure 2
  • EP2352529B1 patent drawingFigure 3

AI summary

The present invention relates to the regeneration, reconstruction, repair, augmentation or replacement of organs or tissue structures using scaffolds and autologous cells that are not derived from such organs or tissues.