Sterile Fluid Diversion and Metering for Contamination-Free Sampling
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing bodily-fluid collection methods suffer from microbial contamination and inaccurate volume measurement, leading to false positive or negative test results, which can result in misdiagnosis, unnecessary treatments, and increased healthcare costs.
Innovation Solution
A bodily-fluid collection device with a diversion mechanism and flow metering system that isolates a first volume of fluid in a pre-sample reservoir and meters subsequent volumes into separate sample reservoirs, ensuring accurate volume measurement and minimizing external contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual intervention is used to connect fluidic interfaces during sample procurement, then ease of operation is improved, but reliability deteriorates due to contamination from users and ambient environment
Solution Approach 1:
The system is divided into sterile and non-sterile zones with physical barriers. The sterile adapter assembly includes a sterile barrier that segments the fluid path, allowing manual operation while preventing contamination transfer between user contact surfaces and patient sample pathways.
Solution Approach 2:
A sterile adapter assembly acts as an intermediary component between the non-sterile external environment and the sterile patient sample pathway. This adapter includes a sterile barrier that mediates the connection, allowing fluid transfer while blocking contamination from reaching the sample.
2Adaptability or versatility
If multiple fluidic interfaces are used in equipment, then adaptability is improved, but reliability deteriorates due to multiple potential contamination points
Solution Approach 1:
The sterile barrier is extracted as a separate, removable component within the adapter assembly. This allows the barrier to be independently sterilized and replaced, maintaining reliability while allowing the adapter to interface with multiple different containers and equipment.
Solution Approach 2:
The adapter assembly is designed with universal compatibility to interface with various containers (syringes, bags, bottles) while maintaining a consistent sterile barrier interface. This multi-functional design allows adaptability across different equipment while preserving contamination protection through the standardized sterile barrier mechanism.
3Reliability
If pre-assembled sterilized systems are used, then reliability is improved by reducing contamination, but device complexity increases
Solution Approach 1:
The system segments sterilization requirements into two parts: the adapter assembly with sterile barrier can be sterilized separately, and the patient sample pathway remains isolated. This segmentation allows for simpler, more manageable sterilization processes compared to sterilizing an entire complex system as one unit.
Solution Approach 2:
The sterile adapter assembly serves as an intermediary that can be pre-sterilized independently and then connected to non-sterile components. This mediator approach simplifies the overall sterilization process by isolating the critical sterile interface from the rest of the system, reducing the complexity of sterilizing the entire assembly.
Data Source
AI summary
An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.