Acellular Tissue Matrix Sterilization via Peracetic Acid and E-Beam
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Solution Overview
Problem
Current methods for preparing acellular tissue matrices are inadequate for effectively sterilizing and preserving tissues for medical applications, particularly in maintaining structural and biological integrity while ensuring safety from microbial contamination.
Innovation Solution
A method involving the use of peracetic acid solutions and low-dose E-beam irradiation to sterilize tissues, combined with decellularization and treatment with DNA nuclease and alpha-galactosidase to create acellular tissue matrices, which are then preserved using specific solutions and freeze-drying techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods are used, then sterilization is achieved, but structural and biological integrity of the tissue is compromised
Solution Approach 1:
The patent changes the parameters of sterilization by using peracetic acid at specific concentrations (0.01-2%) and controlled pH levels (4.0-7.5), combined with low-dose E-beam irradiation (6-60 kGy). This multi-parameter approach achieves effective sterilization while preserving the structural and biological integrity of the tissue matrix, avoiding the damaging effects of conventional high-temperature or high-dose radiation methods.
Solution Approach 2:
The patent introduces peracetic acid as an intermediary sterilizing agent between the tissue and the sterilization process. Peracetic acid acts as a mediator that provides effective microbial kill while being tissue-compatible, and its action is enhanced by the synergistic effect of low-dose E-beam irradiation, achieving sterilization without direct tissue damage.
2Reliability
If decellularization is performed to remove cells, then safety from microbial contamination is improved, but structural integrity may be compromised
Solution Approach 1:
The patent extracts and removes cells from the tissue using DNA nucleases and other decellularization agents, achieving complete cell removal for safety. This extraction process is performed in a controlled manner that preserves the extracellular matrix structure, allowing the tissue to maintain its structural integrity despite the absence of cells.
Solution Approach 2:
The patent controls the parameters of decellularization by using specific enzymes (DNA nucleases, alpha-galactosidase) at optimized concentrations and exposure times. This controlled parameter approach ensures complete cell removal while minimizing damage to the structural components of the tissue matrix.
3Reliability
If multiple treatment steps are applied to sterilize and preserve tissue, then safety and shelf life are improved, but process complexity increases
Solution Approach 1:
The patent merges multiple treatment steps into a coordinated sequence where peracetic acid treatment, E-beam irradiation, and decellularization are performed in an integrated manner. This combining of steps achieves comprehensive sterilization and preservation while managing process complexity through a logical sequence of operations that build upon each other.
Solution Approach 2:
The patent performs preliminary decellularization and stabilization steps before the final sterilization and preservation. This preliminary action prepares the tissue in advance, making the subsequent sterilization and preservation steps more effective and reducing the need for additional complex processing steps.
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 method effectively sterilizes tissues, maintains structural and biological integrity, and extends the shelf life of acellular tissue matrices, making them suitable for various medical applications such as tissue repair and regeneration.
Implementation Method 1
contacting a tissue sample from a mammal with a solution comprising peracetic acid
Implementation Method 2
exposing the tissue sample to low-dose E-beam irradiation
Implementation Method 3
contacting the decellularized tissue with a DNA nuclease that removes all, or substantially all, of the DNA from the decellularized tissue
Implementation Method 4
contacting the decellularized tissue with an agent (such as alpha-galactosidase) that removes all, or substantially all, of the DNA or terminal galactose-α-1-3-galactose moieties
Implementation Method 5
The method can also include the step of freeze-drying the ATM
Data Source
AI summary
The present disclosure provides a variety of methods and compositions e.g., solutions) useful for making, sterilizing, and preserving tissues (e.g., acellular tissue matrices). The disclosure also features the acellular tissue matrices made by the methods, which matrices can be used for a variety of applications such as, but not limited to, treating an injury to, or repairing, a large number of tissues and/or organs (e.g., fascia, bones, and/or cartilage) in a mammal (e.g., a human).