Extracellular Matrix Sterilization via Supercritical CO2
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Solution Overview
Problem
Conventional methods for sterilizing and decellularizing extracellular matrix compositions for treating cardiac arrhythmias often alter the tissue properties, fail to completely sterilize, or leave residual contaminants, necessitating separate processes that are time-consuming and inefficient.
Innovation Solution
A method involving the harvesting and processing of extracellular matrix tissue through freezing, thawing, incubation, rinsing, and exposure to supercritical carbon dioxide with rapid depressurization, allowing for simultaneous sterilization and decellularization while enhancing the incorporation of additives, such as growth factors, to create a sterilized, acellular composition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization techniques (ethylene oxide, steam, gamma radiation) are used on extracellular matrix compositions, then sterilization is achieved, but the tissue properties are altered and important components such as growth factors are damaged or destroyed
Solution Approach 1:
The patent changes the physical state parameters of carbon dioxide to supercritical conditions (temperature above 31.1°C and pressure above 73.8 atm), which allows the fluid to penetrate tissue pores effectively for sterilization while avoiding the damaging chemical effects of conventional sterilization methods. The composition remains stable because supercritical CO2 is non-reactive with tissue components.
Solution Approach 2:
The patent utilizes the phase transition of carbon dioxide between supercritical and gaseous states. During sterilization, CO2 is maintained in supercritical state for penetration and sterilization effect. During rapid depressurization, it transitions to gaseous state, creating the popping sound and enhancing additive incorporation. This phase transition enables effective sterilization without leaving residual contaminants that could damage tissue composition.
2Reliability
If separate sterilization and decellularization processes are used, then both functions are achieved, but the process becomes time-consuming and inefficient
Solution Approach 1:
The patent merges sterilization and decellularization into a single integrated process using supercritical carbon dioxide. The supercritical fluid simultaneously kills microorganisms and removes cellular material from the extracellular matrix, achieving both sterilization and decellularization objectives in one step rather than requiring separate sequential processes.
Solution Approach 2:
Supercritical carbon dioxide serves multiple functions simultaneously: it acts as a sterilizing agent, a decellularizing agent, and a vehicle for delivering growth factors and other additives to the tissue. This multi-functionality eliminates the need for multiple separate processing steps.
3Reliability
If conventional decellularization techniques are used, then partial decellularization is achieved, but native cells remain in the tissue compositions
Solution Approach 1:
The patent uses extreme parameter changes - rapid depressurization from supercritical to atmospheric conditions - to enhance the decellularization process. This sudden pressure change creates physical forces that more effectively remove native cells from the tissue matrix, achieving more complete decellularization than conventional gradual methods.
4Quantity of substance
If rapid depressurization is applied during or after sterilization, then additive incorporation is enhanced, but the process complexity increases
Solution Approach 1:
The patent applies preliminary action by incorporating growth factors and other additives into the supercritical carbon dioxide before it contacts the tissue. This pre-loading of the supercritical fluid ensures that additives are delivered directly to the tissue during the sterilization/decellularization process, maximizing incorporation efficiency.
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
This method maintains the native properties of the extracellular matrix, achieves effective sterilization and decellularization, and enhances the incorporation of additives, providing a more efficient and effective treatment for cardiac arrhythmias.
Implementation Method 1
exposure to supercritical carbon dioxide with rapid depressurization, allowing for simultaneous sterilization and decellularization
Implementation Method 2
exposure to supercritical carbon dioxide with rapid depressurization, allowing for simultaneous sterilization and decellularization while enhancing the incorporation of additives
Implementation Method 3
The methods include harvesting of a selected ECM tissue, freezing the selected ECM tissue, thawing the selected ECM tissue
Implementation Method 4
freezing the selected ECM tissue, thawing the selected ECM tissue
Data Source
AI summary
Disclosed herein are compositions and methods for treating or preventing a cardiac arrhythmia in a subject.