Sealed Phage Culturing Device with Tangential Flow Filtration
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Solution Overview
Problem
Current methods for phage therapy in Western European countries face hurdles due to lengthy approval procedures for cultured phages as medicinal products, making it difficult to provide clinically traceable, autologous phage preparations for therapeutic use, and there is a need for a device that can produce phages safely and hygienically on a scale suitable for medical practices.
Innovation Solution
A sealed phage culturing device with a fluid line system, filtration device, and method for culturing phages from a specific individual's sample, ensuring phages are exclusively attributed to that person, using a hermetically sealed system with Luer lock connectors, inlet and outlet ports, and a filtration device with a filter membrane to separate phages from bacteria, allowing for autologous production and use without complicated approval procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sealed hermetic system is used for phage culturing, then safety and hygiene are improved, but device complexity increases
Solution Approach 1:
The device is divided into separate sealed modules: a sample vessel for phage collection, a culturing chamber for phage multiplication, and a filtration unit for separation. Each module maintains hermetic sealing independently, allowing complex safety functions to be achieved through modular segmentation rather than a single complex sealed system.
Solution Approach 2:
A filter membrane acts as an intermediary element between the culturing chamber and the output, enabling selective passage of phages while blocking bacteria. This intermediary component maintains the hermetic seal while achieving the safety function of pathogen separation, reducing the need for complex sealing mechanisms throughout the entire device.
2Reliability
If phages are cultured in a sealed system, then contamination is prevented, but manufacturing complexity increases
Solution Approach 1:
The device employs disposable sealed components, particularly the sample vessel and filter unit, which are pre-sealed and discarded after single use. This approach prevents contamination through factory sealing while avoiding the need for complex manufacturing and sterilization processes for reusable components, thereby reducing overall manufacturing complexity.
Solution Approach 2:
Critical sealing and filtration components are pre-prepared and pre-sealed during manufacturing before the device reaches the user. The filter membrane is pre-attached in a sterile sealed state, and the sample vessel is pre-closed with Luer lock connectors already in place. This preliminary action ensures contamination prevention without requiring complex assembly procedures or sterilization steps at the point of use.
3Reliability
If autologous phage production is enabled, then therapeutic safety is improved, but production time increases
Solution Approach 1:
The device combines multiple functions into a single integrated system: sample collection, phage culturing, and filtration occur in one continuous sealed process without intermediate handling or transfer steps. This merging of functions maintains therapeutic safety through continuous hermetic sealing while reducing production time by eliminating sequential processing steps that would require separate operations and potential contamination risks.
Solution Approach 2:
The hermetic seal maintains continuous isolation of the phage culture from the external environment throughout the entire production process. This continuous sealing ensures therapeutic safety by preventing contamination at all times, while the uninterrupted culturing process without opening or re-sealing operations minimizes production time compared to batch processes with multiple handling steps.
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
Enables the production of autologous phages that can be traced back to a specific individual, ensuring safety and hygiene, facilitating their use in medical settings without complex approval processes, and allowing for scalable production suitable for medical practices.
Implementation Method 1
a filtration device with a filter membrane to separate phages from bacteria
Data Source
AI summary
A device and a method for clinically providing a preparation of autologous phages, namely, those that can verifiably be traced back to originating from a very specific person and preferably are also only intended for use in this one specific person includes a phage culturing device which is a fluid line system that is sealed off with respect to the outside environment The phages in the fluid line system obtained after at least one-time culturing are separated from bacteria by way of filtration, and preferably by way of tangential flow filtration. The phages separated by way of filtration are transferred into a collection vessel that is connected to the fluid line system and are preferably removed from the fluid line system, using the collection vessel, as a usable, preferably autologous preparation.