Supercritical CO2 Acellular Soft Tissue Processing
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Solution Overview
Problem
Current methods for cleaning and sterilizing soft tissues for allografts often impair biomechanical properties, lead to incomplete sterilization, and result in residual contaminants, causing rejection and inflammatory responses, while existing sterilization techniques like steam and gamma radiation damage tissue integrity.
Innovation Solution
A process using supercritical carbon dioxide to solubilize and remove contaminants from soft tissues, maintaining mechanical properties by agitating the fluid with the tissue in a sealed package, followed by rapid depressurization and rinsing with a sterile solution to achieve acellular, infection-free, and cosmetically acceptable grafts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional cleaning and sterilization methods are used on soft tissues, then microbial contaminants are removed, but biomechanical properties and tissue integrity are impaired
Solution Approach 1:
The patent employs supercritical carbon dioxide, changing the physical state parameter of CO2 from gaseous to supercritical by applying high pressure (73-300 atm) and elevated temperature (31-50°C). This parameter change enables the fluid to penetrate tissue pores effectively while maintaining tissue integrity, achieving both sterilization and preservation of biomechanical properties
Solution Approach 2:
The patent replaces traditional mechanical sterilization methods (steam autoclaving, gamma radiation) with a chemical-solvent-based supercritical fluid extraction system. This substitution eliminates the mechanical damage caused by high-temperature steam and radiation while achieving effective sterilization through solubilization of contaminants in the supercritical CO2 medium
2Reliability
If extensive cleaning steps are performed to remove contaminants, then safety is improved, but processing time and cost increase
Solution Approach 1:
The patent combines multiple separate cleaning and sterilization steps into a single integrated supercritical fluid extraction process. The supercritical CO2 simultaneously performs cleaning, sterilization, and dehydration functions that traditionally required multiple sequential steps, thereby reducing processing time while maintaining safety
Solution Approach 2:
The supercritical fluid extraction process operates continuously, with the CO2 circulating through the tissue material in a closed system. This continuous action allows for complete penetration and extraction of contaminants throughout the entire processing cycle, achieving thorough cleaning and sterilization in a single uninterrupted operation
3Reliability
If aggressive cleaning treatments are applied to remove antigenic matter, then biocompatibility is improved, but mechanical properties and appearance are damaged
Solution Approach 1:
The patent uses moderate temperature (31-50°C) and high pressure conditions to achieve supercritical state of CO2, which allows gentle yet effective extraction of antigenic matter and discoloration. This parameter regime is sufficiently mild to preserve collagen network integrity and mechanical properties while effectively removing harmful substances
Solution Approach 2:
The supercritical carbon dioxide acts as an intermediary solvent that mediates between the tissue material and the extraction process. It selectively solubilizes and removes antigenic matter, lipids, and discoloration while leaving the structural collagen framework intact, thus improving biocompatibility without damaging mechanical properties
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 process preserves the mechanical properties of soft tissues, achieving greater than 6 log reductions in microbial contaminants without cross-linking, reducing processing time, and enhancing the commercial viability of allografts by ensuring safe and effective implantation.
Implementation Method 1
a supercritical fluid such as carbon dioxide is employed as a penetrating fluid used to extract antigenic matter such as cells living or not living
Implementation Method 2
solubilize contaminants contained in the soft tissue and separate the contaminants from the soft tissue by absorption into the absorbent material
Implementation Method 3
separate the contaminants from the soft tissue by absorption into the absorbent material
Implementation Method 4
rapidly depressurizing the pressure vessel at an uncontrolled rate
Data Source
AI summary
A process for creating acellular donor soft tissue by removing contaminants such as cells by extraction using a fluid at supercritical temperature and pressures while preserving the integrity of the soft tissue. The soft tissue is maintained in contact with the fluid in a pressure vessel at supercritical temperature and pressures for a period of time and then the pressure vessel is rapidly depressurized.