Automated Classified Reactor for Sterile Tissue Matrix Production
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Solution Overview
Problem
Current methods for producing decellularized bone matrix for allografts are labor-intensive, costly, and limited by manual handling, requiring extensive sterile workspace, and are prone to handling errors, which restricts patient access to this reliable bone reconstruction technique.
Innovation Solution
An automated process within a classified reactor for tissue processing, including classification, treatment, and packaging, utilizing robotic means to maintain sterile conditions and minimize human intervention, ensuring efficient production and traceability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual processing methods are used in classified sterile enclosures, then sterile conditions are maintained, but production time increases and costs become prohibitive
Solution Approach 1:
The patent combines multiple separate sterile enclosures into a single integrated classified reactor that can perform multiple processing steps (centrifugation, cutting, chemical treatment, lyophilization, packaging) sequentially within the same sterile environment, eliminating the need to transfer tissue between multiple isolators and thereby reducing production time while maintaining sterile conditions
Solution Approach 2:
The automated system enables continuous processing where each step flows directly into the next without interruption or transfer between enclosures, allowing the tissue to remain in the classified reactor throughout the entire process from receipt to packaged product, thus eliminating idle time and accelerating production
2Reliability
If multiple separate sterile enclosures are used for each processing step, then sterility is maintained, but workspace requirements increase significantly
Solution Approach 1:
The patent consolidates multiple separate sterile enclosures (each required for centrifugation, cutting, chemical treatment, lyophilization, and packaging) into a single classified reactor with integrated processing chambers, dramatically reducing the total workspace required while maintaining sterile conditions throughout all processing steps
Solution Approach 2:
The design nests multiple processing functions within a single reactor structure, where each processing step occurs in a dedicated chamber or zone within the overall classified reactor, allowing multiple operations to be performed in a compact integrated system rather than requiring separate enclosures for each function
3Ease of operation
If manual handling by hospital staff is used, then flexibility is maintained, but handling errors occur and traceability becomes difficult
Solution Approach 1:
The system employs automated robotic manipulation for all handling operations, where the tissue is transferred between processing zones and handled by automated mechanisms rather than human operators, eliminating handling errors while the centralized control system maintains flexibility and ensures complete traceability through automated recording of all processing steps
4Reliability
If extensive classified sterile enclosures and dedicated space are provided, then production reliability is improved, but production costs become prohibitive
Solution Approach 1:
The patent consolidates multiple separate sterile enclosures and processing stations into a single integrated classified reactor, reducing the amount of dedicated classified space required and associated infrastructure costs while maintaining production reliability through automated processing and centralized sterile environment control
Solution Approach 2:
The system is designed to efficiently use and recycle resources within the classified reactor, including recovery and reuse of chemical treatments and optimization of space utilization, thereby reducing overall production costs while maintaining reliable sterile processing
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 approach reduces handling errors, optimizes space and cost, and allows for continuous production with improved traceability, making decellularized bone matrix more accessible and reducing production time, enabling efficient and reliable tissue matrix production for allografts and xenografts.
Implementation Method 1
Centrifugation of tissue taken from the donor to remove blood and fat
Implementation Method 2
Chemical treatment, in order to eliminate traces of cells, and to inactivate viruses and/or bacteria
Implementation Method 3
Lyophilization, in order to obtain stable demineralised bone matrix
Data Source
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AI summary
The invention relates to a method for producing a tissue matrix for an allotransplantation or a xenotransplantation, according to which, once a biological tissue has been obtained, said tissue is classified, said tissue is treated and the tissue matrix produced is conditioned, all of said steps being implemented in an automated manner inside the same "classified" reactor. The invention also relates to the reactor allowing the implementation of the method of the invention.