Modular Fluid Delivery Device Sterilization Segmentation
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Solution Overview
Problem
Conventional methods for delivering biological components like fibrin sealants are prone to cross-contamination and require complex, error-prone multi-step processes, involving transfer of materials between sterile and non-sterile environments, which can lead to leakage and spillage, and do not allow for pre-loaded, sterilized applicators.
Innovation Solution
A modular delivery device comprising separate components for each fluid, including an applicator, fluid housing, and plunger, where each component is sterilized individually and assembled only at the point of use, with a keyfit mechanism ensuring secure and leak-free connection, and exposed to radiation sterilization to maintain sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biological components are delivered in separate sterile and non-sterile packages, then sterility control is improved, but the complexity of the delivery process increases and cross-contamination risk arises
Solution Approach 1:
The delivery device is divided into separate sterile and non-sterile portions that are physically isolated until the moment of use. The sterile portion contains the biological component in a sealed container, while the non-sterile portion contains the delivery mechanism. This segmentation maintains sterility control while simplifying the overall delivery process by eliminating the need for manual transfer between separate packages.
Solution Approach 2:
A sterile barrier or seal acts as an intermediary between the sterile biological component and the non-sterile delivery mechanism. This barrier is broken or opened only at the point of use, allowing the biological component to be delivered without direct contact between sterile and non-sterile elements during storage and transport, thus maintaining sterility while simplifying the delivery process.
2Adaptability or versatility
If manual transfer of materials between packages is performed, then flexibility in delivery is improved, but the risk of leakage and spillage increases
Solution Approach 1:
The sterile biological component and the non-sterile delivery mechanism are merged into a single integrated device at the point of use. The sterile container is designed to interface directly with the delivery mechanism through a sterile barrier that is broken only during the controlled delivery process. This merging eliminates manual transfer steps, maintaining delivery flexibility while preventing leakage and spillage.
3Reliability
If conventional sterilization techniques are used on multi-component materials, then sterilization effectiveness is improved, but the biological materials are compromised or destroyed
Solution Approach 1:
The device is segmented into portions that can be sterilized separately at different times and by different methods. The non-sterile delivery mechanism can be sterilized by conventional techniques, while the sterile biological component is sterilized by gentle methods that preserve its integrity. This segmentation allows each component to be sterilized appropriately without compromising the other.
Solution Approach 2:
The biological component is sterilized and sealed in a sterile container before being combined with the delivery mechanism. This preliminary sterilization action protects the sensitive biological material from exposure to harsh sterilization conditions that would occur if the entire assembled device were sterilized, thus maintaining both sterilization effectiveness and material integrity.
4Reliability
If the entire device exterior is exposed to radiation sterilization, then sterility is improved, but the device design becomes more complex to ensure beam visibility
Solution Approach 1:
The device is segmented into a sterile portion and a non-sterile portion, with the radiation sterilization applied only to the sterile portion or to the entire device in a simplified configuration. The sterile container and its contents are designed to be fully exposed to the radiation beam without shadowing, while the delivery mechanism may have reduced sterility requirements. This segmentation simplifies the radiation sterilization process while ensuring the critical sterile components are properly sterilized.
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
The modular device minimizes cross-contamination risks, allows for pre-loaded and sterilized delivery, and simplifies the application process by ensuring all components are sterile and ready for use, reducing errors and leakage while maintaining the integrity of biological materials.
Implementation Method 1
subject the entire exterior of the device to low level of radiation energy, such as with an electron-beam
Implementation Method 2
exposed to radiation sterilization to maintain sterility
Data Source
AI summary
Apparatuses and methods for delivery of fluid materials, particularly multi-part fluid materials, including modular apparatuses in which various components are maintained separately until ready for use. Each fluid component is maintained in a separate housing until mixing of the fluid components is desired. Maintaining components separately until use allows for proper filling, sterilization, packaging and storing until use.