Specimen Collection Container With Segmented Sterile Design
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Solution Overview
Problem
Conventional capillary specimen collection containers are not sterile, nor are they compatible with automated clinical laboratory processes, which can compromise specimen quality and hinder efficient diagnostic testing.
Innovation Solution
A specimen collection container design featuring an inner tube with a funnel for directing specimens and an outer tube for protection, along with a sealing mechanism that maintains sterility and compatibility with automated processes, including a self-sealing elastomeric stopper and annular protrusions for secure sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional capillary specimen collection containers are used, then they are simple in structure and easy to manufacture, but they are not sterile and not compatible with automated clinical processes
Solution Approach 1:
The container is divided into an inner tube and an outer tube as separate components. The inner tube contains the specimen and can be sterilized independently, while the outer tube provides structural support and automation compatibility. This segmentation allows each component to be optimized for its specific function without compromising the other.
Solution Approach 2:
The inner tube is nested within the outer tube, creating a hierarchical structure where the sterile inner container is protected by the non-sterile outer container. This nesting arrangement maintains sterility of the specimen while providing the structural integrity needed for automated handling.
2Reliability
If the container structure is simplified for ease of manufacture, then production is easier and faster, but the sealing mechanism cannot maintain sterility effectively
Solution Approach 1:
The inner tube is pre-sterilized and sealed within the outer tube before use. The sealing mechanism is designed to maintain this pre-established sterility without requiring complex real-time sterilization processes during normal operation.
Solution Approach 2:
The outer tube acts as an intermediary barrier that protects the sterile inner tube from contamination during handling and transport. This intermediary structure allows the inner tube to maintain sterility without direct exposure to the external environment.
3Productivity
If the container is designed for automated process compatibility, then clinical workflow efficiency improves, but the device complexity increases
Solution Approach 1:
The outer tube is designed with universal features that enable compatibility with multiple automated processes including sorting, centrifugation, and analysis. Standardized dimensions and interface features allow the same container design to work across different automated systems without modification.
Data Source
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AI summary
A specimen collection container includes inner and outer tubes. The inner tube includes a bottom end, a top end, and a sidewall extending therebetween defining an interior. The sidewall includes an inner surface and an outer surface having at least one annular protrusion extending therefrom. The inner tube includes at least one funnel portion adjacent the top end for directing a specimen into the inner tube interior, and an annular ring disposed about a portion of the outer surface of the sidewall adjacent the top end. The outer tube includes a bottom end, a top end, and a sidewall extending therebetween, the sidewall having an outer surface and an inner surface defining an annular recess adapted to receive a portion of the annular protrusion therein. The inner tube is disposed within the outer tube and a portion of the top end of the outer tube abuts the annular ring.