Decellularized ECM Matrix for Tympanic Membrane Repair
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current otological repair materials face challenges such as poor biocompatibility, immunogenic reactions, and damage to the patient due to the use of xenobiotic or allogenic materials, and existing ECM products have issues with DNA residues and structural integrity, limiting their effectiveness in repairing the tympanic membrane.
Innovation Solution
An immunogen-removed biological tissue matrix material made from porcine or bovine small intestinal submucosa tissue, processed to reduce DNA residues and enhance cell adherence, with a multi-frequency ultrasonic decellularization and enzymatic treatment to preserve growth factors, and a molding process creating a porous structure for improved tissue integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If xenobiotic materials (paper, egg membrane, gelatin sponge) are used for tympanic membrane repair, then the repair process is simple, but biocompatibility is poor and absorption is difficult causing new problems
Solution Approach 1:
The patent extracts and removes cellular components from animal tissues through decellularization processes, retaining only the extracellular matrix (ECM). This extraction eliminates immunogenic cellular elements while preserving the beneficial structural and biochemical framework of the tissue, resolving the contradiction between simplicity and biocompatibility.
Solution Approach 2:
The patent uses decellularized ECM as an intermediary material between the patient's body and the implant. This intermediary provides a biocompatible interface that promotes native tissue integration while avoiding direct immunogenic reactions, thus improving reliability without significantly complicating the repair process.
2Reliability
If autologous materials (mastoid periosteum, temporal fascia, venous valve) are used for repair, then biocompatibility is excellent, but additional surgery is required causing additional damage and pain
Solution Approach 1:
The patent creates a copy of natural ECM structure and composition from donor tissues that can be processed and sterilized independently. This copied ECM material provides the same biocompatibility benefits as autologous tissue without requiring additional harvesting surgery, thus reducing surgical complexity while maintaining reliability.
Solution Approach 2:
The patent changes the source and processing parameters of the repair material from patient-specific autologous tissue to processed allogeneic decellularized ECM. This parameter change maintains the biocompatibility advantage while eliminating the need for additional harvest surgery, reducing overall surgical complexity.
3Quantity of substance
If xenobiotic or allogenic materials are used, then material availability is high, but thickness is much larger than tympanic membrane affecting hearing recovery
Solution Approach 1:
The patent changes the physical and structural parameters of the repair material through controlled decellularization and processing. This produces an ultra-thin ECM membrane that matches the native tympanic membrane thickness, enabling material availability without compromising hearing recovery.
Solution Approach 2:
The patent employs hydraulic pressure and fluid processing techniques during the decellularization and cleaning stages to thoroughly remove cellular debris and reduce material density, resulting in a thinner, more appropriate final product thickness while maintaining structural integrity.
4Object-generated harmful factors
If conventional decellularization treatments (hydrogen peroxide, hypertonic salts, alkali solution) are used, then cell removal is effective, but extracellular matrix is damaged affecting product quality
Solution Approach 1:
The patent replaces harsh chemical decellularization systems with milder mechanical and enzymatic methods. This substitution achieves effective cell removal while preserving the delicate extracellular matrix structure and composition, resolving the contradiction between removal effectiveness and matrix stability.
Solution Approach 2:
The patent changes the chemical parameters of the decellularization process by using lower concentrations of harsh chemicals or alternative milder reagents. This parameter modification maintains cell removal effectiveness while minimizing damage to the extracellular matrix, improving overall product quality.
5Reliability
If existing ECM products are used, then tissue repair capability is provided, but DNA residues cause immunogenic reactions
Solution Approach 1:
The patent specifically extracts and removes DNA and other immunogenic cellular residues from the ECM material through enhanced decellularization protocols. This extraction eliminates the harmful immunogenic factors while preserving the tissue repair capabilities of the ECM, resolving the contradiction between repair capability and immunogenicity.
Solution Approach 2:
The patent converts the potential harm of residual DNA into a benefit by using controlled decellularization that specifically targets and removes immunogenic elements. The process that initially might seem to compromise tissue integrity actually enhances safety by eliminating harmful residues while maintaining repair functionality.
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 material induces native cell growth, supports tissue reconstruction, and is gradually replaced by host tissue, offering enhanced biocompatibility, reduced immunogenicity, and improved mechanical strength, facilitating effective tympanic membrane repair without additional surgical pain.
Implementation Method 1
multi-frequency ultrasonic decellularization
Implementation Method 2
enzymatic treatment to preserve growth factors
Data Source
AI summary
Disclosed are a biological tissue matrix material, a preparation method therefor and the use thereof in an otological repair material. The biological tissue matrix material comprises an extracellular matrix. The extracellular matrix comprises a collagen fiber, a growth factor and fibronectin. The biological tissue matrix material has a low amount of DNA residue, a low immunogenicity, a high anti-infection ability, and a strong repair capability.