Bodily Fluid Sample Reservoir With Dual-Indicator Volume Verification
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Solution Overview
Problem
Existing bodily fluid collection methods suffer from microbial contamination and inadequate volume verification, leading to false positive and negative test results, which can result in misdiagnosis and unnecessary treatments.
Innovation Solution
The use of a transfer device with a sample reservoir and volumetric verification device to ensure accurate collection and verification of bodily fluid volume, reducing contamination and enhancing the reliability of diagnostic tests.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional bodily fluid collection methods are used, then the collection process is simple and quick, but microbial contamination occurs and volume verification is inadequate
Solution Approach 1:
The patent combines multiple functions into a single integrated collection device: the sample collection container, volumetric measurement markings, and contamination prevention features are merged into one unit. This allows the device to maintain simplicity while improving reliability through integrated volume verification and contamination reduction capabilities.
Solution Approach 2:
The patent introduces an intermediary barrier (such as a filter or separator) between the collection environment and the sample reservoir to prevent microbial contamination. This intermediary element blocks contaminants while allowing fluid passage, thereby improving sample reliability without significantly complicating the overall collection process.
2Measurement precision
If volume verification is added to the collection device, then diagnostic test accuracy improves, but the device complexity increases
Solution Approach 1:
The patent incorporates visual indicators such as color-coded markings or changing color elements that indicate when the correct sample volume has been reached. This allows users to verify volume accuracy through simple visual observation without requiring complex electronic sensors or measurement systems, thereby maintaining device simplicity while improving measurement precision.
Solution Approach 2:
The collection device is segmented into functional zones with distinct volumetric markings that divide the total capacity into measurable segments. This segmentation allows for precise volume verification through visual inspection of fluid level against marked intervals, achieving accurate measurement without complex instrumentation.
3Reliability
If contamination prevention measures are implemented, then false positive and negative results are reduced, but the collection process becomes more complex
Solution Approach 1:
The collection device is designed with self-sterilizing features or pre-sterilized components that automatically prevent contamination without requiring additional manual steps from the user. The device performs its own contamination prevention function, maintaining ease of operation while improving diagnostic reliability through reduced false results.
Solution Approach 2:
The device is pre-prepared with contamination prevention features such as pre-sterilized surfaces, pre-installed filters, or pre-sealed barriers before use. This preliminary preparation ensures contamination protection is already in place, eliminating the need for complex user actions during the collection process and maintaining operational simplicity while enhancing reliability.
Data Source
AI summary
A system for verifying a sample volume includes a sample reservoir and a volumetric verification device. The sample reservoir defines an inner volume and is configured to receive a volume of bodily fluid. The inner volume of the sample reservoir contains an additive. The volumetric verification device includes a first indicator and a second indicator. The volumetric verification device is configured to selectively engage the sample reservoir to (1) place the first indicator in a first position along a length of the sample reservoir such that the first indicator is substantially aligned with a surface and/or meniscus of the additive and (2) place the second indicator in a second position along the length of the sample reservoir such that the second indicator is substantially aligned with a predetermined fill volume when bodily fluid is transferred to the inner volume.