Decellularized Serosal ECM Barrier for Post-Operative Adhesion Prevention
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Solution Overview
Problem
Post-operative peritoneal adhesions pose a significant challenge in gastrointestinal surgery, leading to complications such as chronic abdominal pain, recurrent intestinal obstructions, infertility, and high healthcare costs, with existing treatments being ineffective and costly.
Innovation Solution
A barrier material comprising multiple layers of decellularized extracellular matrix (dECM) from porcine small intestine serosa, chemically modified with carboxylic acids, amines, and hydrophilic polymers, is developed to prevent post-operative adhesions by preserving the serosal tissue's anti-adhesive properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If decellularization process is used to remove cells and DNA/RNA from serosal tissue, then purity of extracellular matrix is improved, but manufacturing complexity increases
Solution Approach 1:
The decellularization process is divided into distinct sequential stages: (1) degreasing with chloroform-methanol solution, (2) enzymatic digestion with trypsin-EDTA, (3) detergent treatment with SDS, and (4) sterilization with peracetic acid. Each stage targets specific cellular components systematically, making the complex process manageable and reproducible while achieving complete decellularization.
Solution Approach 2:
The patent optimizes specific parameters at each decellularization stage: chloroform-methanol ratio (1:1 v/v), trypsin concentration (0.05-0.5%), SDS concentration (0.1-1%), and incubation times (8-16 hours). These parameter optimizations ensure effective cell removal while preserving ECM integrity, resolving the contradiction between thorough decellularization and process complexity.
2Reliability
If multiple layers of dECM are stacked to enhance anti-adhesive properties, then effectiveness against post-operative adhesions is improved, but device complexity increases
Solution Approach 1:
Multiple decellularized serosal layers are stacked and chemically crosslinked together to form a unified multi-layer barrier membrane. The crosslinking merges individual layers into a cohesive structure that maintains the anti-adhesive properties of serosa while providing enhanced mechanical strength and durability for surgical application.
Solution Approach 2:
The barrier membrane is constructed as a composite material system combining multiple dECM layers with chemical crosslinks. This composite structure integrates the biological functionality of decellularized serosa with the structural advantages of layered architecture, achieving both anti-adhesive effectiveness and mechanical integrity.
3Strength
If chemical crosslinking is applied to stabilize dECM layers, then mechanical strength is improved, but potential cytotoxicity increases
Solution Approach 1:
The patent employs glutaraldehyde crosslinking, a well-established and inexpensive chemical method, to stabilize the dECM layers. The crosslinking is controlled to achieve adequate mechanical strength while the final product is sterilized and ready for single-use surgical application, eliminating long-term cytotoxicity concerns.
Solution Approach 2:
The crosslinking process parameters are optimized including glutaraldehyde concentration, incubation time, and pH conditions. These parameter controls ensure sufficient mechanical stabilization of the barrier membrane while minimizing residual chemical toxicity, resolving the contradiction between strength enhancement and cytotoxicity reduction.
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 dECM barrier material effectively reduces post-operative intestinal adhesions, offering a cost-effective solution with improved anti-adhesive qualities and potential therapeutic applications.
Implementation Method 1
A barrier material comprising multiple layers of decellularized extracellular matrix (dECM) from porcine small intestine serosa... to prevent post-operative adhesions by preserving the serosal tissue's anti-adhesive properties
Implementation Method 2
incubating the isolated serosal layer in a solution including chloroform and methanol for at least 8 hours to produce a degreased serosal layer
Implementation Method 3
incubating the degreased serosal layer with an enzyme solution for at least 8 hours to produce a partially decellularized serosal layer... the enzyme solution includes 0.05-0.5% trypsin
Implementation Method 4
incubating the partially decellularized serosal layer with a detergent solution under agitation for at least two hours to produce decellularized serosal layer... the detergent solution includes 0.1-1% sodium dodecyl sulfate (SDS)
Implementation Method 5
incubating the decellularized serosal layer with peracetic acid solution followed by ethanol solution to produce a dECM from porcine small intestine serosa
Implementation Method 6
the sheet is lyophilized
Data Source
AI summary
The present disclosure relates to an extracellular matrix-based biomaterial that allows for the prevention of post-operative adhesions. The disclosed extracellular matrix-based biomaterial is produced from decellularized porcine small intestinal serosa. Methods of producing the extracellular matrix-based biomaterial from decellularized porcine small intestinal serosa are also disclosed.