Sterile Fluid Filtration Modules for Lower-Cost Medical Filling
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Solution Overview
Problem
Existing medical fluid purification systems require complex and costly setups for continuous purification, involving separate diafiltration/purification apparatuses and high-rate filtration, which are expensive and complicated, especially for high-flow applications like hemofiltration, and often necessitate frequent sterilization and replacement of components.
Innovation Solution
A fluid preparation apparatus with a combination of permanent and semi-permanent modules that include redundant filtration stages and a controller to ensure sterility and prevent contamination, allowing for repeated use of pretreatment components and periodic replacement of disposable elements, reducing costs and complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous purification processes with separate diafiltration/purification apparatus are used, then sufficient constant flow of sterile replacement fluid is provided, but the system becomes complicated and requires expensive filters and separate pumping systems
Solution Approach 1:
The patent combines the pretreatment module with the dialysis device into an integrated system. The pretreatment module includes filtration elements and fluid pathways that are directly connected to the dialysis device, eliminating the need for separate diafiltration apparatus and pumping systems. This merging maintains reliable sterile fluid flow while significantly reducing system complexity.
Solution Approach 2:
The integrated pretreatment module serves multiple functions: it filters the dialysate, provides sterile replacement fluid, and integrates with the dialysis device's fluid pathways. This multi-functionality eliminates the need for dedicated separate apparatus for each function, reducing overall system complexity while maintaining reliability.
2Productivity
If high-rate filtration is used for hemofiltration applications, then sufficient fluid supply rate is achieved, but expensive filters are required
Solution Approach 1:
The filtration system is segmented into multiple stages with different filtration elements operating at different rates. The pretreatment module uses lower-rate filtration for bulk fluid preparation, while only critical pathways require higher-rate filtration. This segmentation allows the system to achieve sufficient overall fluid supply rate without requiring expensive high-rate filters throughout the entire system.
Solution Approach 2:
Different portions of the filtration system have different filtration rates matched to their specific functional requirements. The pretreatment module operates at lower filtration rates where high purity is sufficient, while only specific critical pathways require higher rates. This local optimization reduces the overall cost of filtration components while maintaining adequate fluid supply rate for hemofiltration.
3Ease of manufacture
If permanent pretreatment modules are used, then sterilization frequency is reduced and costs are lowered, but ensuring sterility becomes more challenging
Solution Approach 1:
The permanent pretreatment module is designed with continuous sterilization capability through integrated sterilizable pathways and elements. The system maintains sterility continuously through the permanent module's design that allows for periodic sterilization cycles without interruption of the overall dialysis process, ensuring reliability while reducing the frequency of complete system replacement.
Solution Approach 2:
The permanent pretreatment module utilizes parameters such as temperature and chemical treatment during sterilization cycles to ensure sterility. By changing these parameters during controlled sterilization periods, the system maintains reliable sterility assurance for permanent components without requiring frequent replacement, thereby reducing costs while maintaining safety.
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 provides a cost-effective and simplified method for producing pure medical fluids by minimizing the need for frequent sterilization and reducing the expense of disposable components, while maintaining sterility and ensuring consistent fluid quality.
Implementation Method 1
a filter cartridge that filters a portion of the water to produce a filtered water
Implementation Method 2
a first deionization cartridge that contains a cation exchange resin and an anion exchange resin, the first deionization cartridge filtering the filtered water to produce a first deionized water
Implementation Method 3
a second deionization cartridge that contains a cation exchange resin and an anion exchange resin, the second deionization cartridge filtering the filtered water to produce a second deionized water
Data Source
AI summary
A system for filling multiple sterile containers includes a filter with an inlet port and multiple outlet ports, the outlet ports being pre-attached to sterile containers by respective filling lines of each container. Each container has an interior and each of the respective filling lines are connected to a respective container interior. The respective filling lines are sealed to the outlet ports and the containers such that the container interiors are isolated from an external environment except the inlet port, via the filter, forming a combined interior volume which is sterile. A container that is connectable to an outlet port the system has a bladder, a first tube and a second tube connected to the bladder, and a sterilizing filter. The container, the first tube and the second tube, and the sterilizing filter are sterile before water is flowed through the sterilizing filter into the bladder.