Sterile Container for Concentrated Growth Factor Serum Production
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Solution Overview
Problem
Existing methods for producing interleukin-1 receptor antagonist (IL-1Ra) and other therapeutically active proteins do not provide efficient methods for dividing protein serum into portions for long-term storage and transportation, and require specialized equipment for delivery to wounded tissue sites.
Innovation Solution
A system and method involving a simple sterile container where blood or fluid is incubated with autograft, allograft, or xenograft tissue to produce enhanced serum containing autologous proteins and growth factors, which can be centrifuged and injected at a wounded site, allowing for ambient or 37°C incubation between 1-24 hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a special syringe is used to produce IL-1Ra, then the production of therapeutically active proteins is achieved, but the device complexity increases and requires specialized equipment for delivery
Solution Approach 1:
The patent employs a disposable sterile container system that eliminates the need for complex reusable specialized syringes. The container is used once to produce the therapeutic protein serum, then discarded, avoiding the complexity of specialized delivery equipment while maintaining reliable protein production.
Solution Approach 2:
The system separates the protein production function from the delivery function. Production occurs in a simple sterile container, then the resulting serum can be transferred to standard injection equipment, dividing the complex process into manageable segments using simple components.
2Quantity of substance
If protein serum is produced in bulk, then sufficient quantity is available for treatment, but storage and transportation become difficult without division into portions
Solution Approach 1:
The sterile container system allows the produced protein serum to be directly divided into multiple portions within the container or transferred to separate storage vessels. Each portion can be independently stored and transported, making bulk production practical while maintaining ease of operation.
3Quantity of substance
If incubation is conducted at 37°C for extended periods, then growth factor production is maximized, but the incubation time increases up to 24 hours
Solution Approach 1:
The system allows flexible adjustment of incubation parameters (temperature and time) based on clinical needs. By optimizing the blood-to-tissue ratio and incubation conditions, sufficient growth factor concentrations can be achieved in shorter times, or extended incubation at 37°C can be used when maximum concentration is prioritized over time 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 effectively produces and delivers concentrated growth factors and cytokines devoid of cells, enhancing the innate healing response at wounded tissue sites without the need for specialized equipment, enabling efficient storage and transportation of the serum.
Implementation Method 1
subjecting the sterile container to hard spinning to separate cells and tissue from growth factors
Data Source
AI summary
Systems and methods for producing enhanced blood serum with concentrated growth factors and/or prophylactically and therapeutically active proteins. An autologous blood product is obtained from a donor and then incubated into a containment device (sterile container) that includes a source of cells or tissue (for example, autologous, allogeneic, or xenographic tissue, or combinations thereof). The cells from the injected fluid (autologous blood product) interact/incubate with the source of cells or tissue inside the containment device, to produce a serum that is loaded with autologous proteins, growth factors, and cytokines. The autologous blood product may be a fluid and/or composition that includes blood, whole blood, autologous conditioned plasma, platelet-rich plasma, platelet-poor plasma, bone marrow aspirate, bone marrow concentrate and stem cells, among others, and combinations thereof.