High Hydrostatic Pressure Tissue Processing
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Solution Overview
Problem
Current tissue processing methods often damage biologic properties or require harsh conditions that can alter tissue extracellular matrix proteins, and existing sterilization techniques may not effectively reduce bioburden without compromising tissue integrity.
Innovation Solution
Applying high hydrostatic pressure to tissue samples in a liquid to decellularize, thaw, and reduce bioburden, while maintaining controlled temperature below 30°C to preserve tissue integrity and biologic properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If harsh processing conditions are applied to remove cells and reduce bioburden, then decellularization and sterilization effectiveness is improved, but tissue integrity and biologic properties are damaged
Solution Approach 1:
The patent applies high hydrostatic pressure (a physical parameter change) to achieve decellularization and bioburden reduction without using harsh chemical treatments. By controlling pressure parameters (e.g., 300-1000 MPa) and treatment time, the method effectively removes cells and reduces bacterial load while preserving the extracellular matrix structure and biologic properties of the tissue.
2Reliability
If high pressure is applied for sufficient time to destroy cells, then decellularization effectiveness is improved, but treatment time increases
Solution Approach 1:
The patent employs periodic or cyclic pressure application patterns, where high pressure is applied in cycles rather than continuously. This allows for effective cell destruction through repeated stress cycles while reducing the total treatment time compared to continuous prolonged pressure application. The cyclic nature enhances penetration and disruption efficiency.
3Productivity
If pressure is applied rapidly to achieve decellularization, then processing speed is improved, but temperature elevation occurs which may damage tissue
Solution Approach 1:
The patent implements temperature control measures beforehand and during the high pressure treatment process. Cooling systems or temperature monitoring are integrated to prevent excessive temperature rise that would occur with rapid pressure application. This cushioning approach allows for fast processing speeds while maintaining tissue temperature within safe limits to avoid thermal damage.
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
Achieves efficient decellularization, thawing, and bioburden reduction with minimal tissue damage, maintaining desired biologic properties and reducing bacterial load by at least 95% and temperature elevation, thus enhancing the safety and efficacy of tissue products.
Implementation Method 1
applying a pressure to the liquid of at least 200 MPa for a time sufficient to destroy substantially all of the native tissue cells within the soft tissue, wherein destroying substantially all of the cells includes disrupting the cell membrane of the cells
Implementation Method 2
applying a pressure to the liquid sufficient to thaw the frozen tissue sample
Implementation Method 3
applying a pressure to the liquid for a time sufficient to cause at least a 5 log reduction in the bacterial concentration within the soft tissue, wherein during application of the pressure, the temperature of the tissue sample does not exceed 30° C.
Data Source
AI summary
Methods for processing tissue are provided. In some embodiments, the methods comprise methods for decellularizing tissue samples by applying high hydrostatic pressure to the tissues samples. In some embodiments, the methods comprise methods for thawing tissue samples and/or reducing the bioburden in a sample by applying high hydrostatic pressure to the tissue samples.