Injectable Polyurethane Tissue Filler for Irregular Void Integration
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Solution Overview
Problem
Existing filler materials for treating tissue voids, such as those used in complex anal fistulae, face challenges in resisting migration, maintaining structural integrity, integrating with surrounding tissue, and promoting cell in-growth and tissue regeneration, while also being clinically safe.
Innovation Solution
A composition comprising a polyurethane precursor and a particulate acellular tissue matrix, which can be polymerized in situ to form a biocompatible filler material that conforms to irregular geometries, retains volume, and promotes tissue integration and regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If cyanoacrylate glue is used as infill material, then the fistula is occluded and inflammation is reduced, but it acts as a barrier to host tissue integration and causes chronic inflammatory response
Solution Approach 1:
The patent introduces a biocompatible intermediate material that mediates between the host tissue and the infill requirement. This material allows tissue integration while providing structural support, avoiding the barrier effect of cyanoacrylate glue. The intermediary material facilitates host tissue ingrowth rather than blocking it.
Solution Approach 2:
The patent changes the chemical and physical parameters of the infill material from cyanoacrylate-based adhesives to biocompatible polymers with specific properties. The material is designed to be non-toxic, non-inflammatory, and conducive to tissue integration, fundamentally altering the parameters that cause harmful effects in traditional glues.
2Reliability
If BIOGLUE is used as infill material, then fistula occlusion is achieved, but acute sepsis rates are unacceptable and nerve injury may occur
Solution Approach 1:
The patent employs a biodegradable infill material that serves its occlusion function temporarily and then degrades safely. This short-living approach allows the material to provide necessary structural support during healing while eventually being absorbed by the body without causing long-term harmful effects like sepsis or nerve injury.
Solution Approach 2:
The patent converts the potential harm of permanent foreign material presence into a benefit by using biodegradable materials. The temporary presence of the infill material provides necessary occlusion and structural support, then degrades into harmless byproducts, turning the potential long-term harm of permanent implants into a beneficial temporary solution.
3Object-affected harmful factors
If polyurethane is used as filler material, then biocompatibility is improved, but cell in-growth and tissue regeneration are insufficient
Solution Approach 1:
The patent modifies polyurethane to create a porous structure that maintains biocompatibility while enabling cell infiltration and tissue regeneration. The porous architecture provides pathways for cell migration and vascular ingrowth, transforming the non-porous polyurethane that previously inhibited tissue integration into a material that actively promotes regeneration.
Solution Approach 2:
The patent creates a composite material combining polyurethane with other components that enhance cell in-growth and tissue regeneration properties. This composite approach retains the biocompatibility of polyurethane while adding functional properties that promote active tissue integration and regeneration.
4Adaptability or versatility
If filler material is injected into irregular tissue voids, then the voids are filled, but migration resistance and structural integrity are compromised
Solution Approach 1:
The patent uses a material with dynamic rheological properties that allows it to be injected as a fluid that conforms to irregular void geometries, then transforms into a solid with high structural integrity. This dynamic state change enables the material to adapt to complex shapes while maintaining strength, resolving the contradiction between conformability and structural stability.
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 polyurethane-based filler material effectively integrates with surrounding tissue, maintains structural integrity, and promotes cell in-growth and regeneration, addressing the limitations of existing materials.
Implementation Method 1
a polyurethane precursor and a particulate acellular tissue matrix, which can be polymerized in situ to form a biocompatible filler material
Data Source
AI summary
Polyurethane-based tissue fillers useful for treating and/or augmenting tissue, as well as acting as a biological scaffold that promotes cell in-ingrowth and tissue integration, are disclosed, as are quick-setting, injectable precursors of such tissue fillers. Such tissue fillers generally comprise (1) a polyurethane and (2) a particulate acellular tissue matrix. Also disclosed are methods of treating and/or augmenting tissues using such tissue fillers, particularly voids in human tissue such as anal fistulae or hernias.