Dead Volume Reducing Luer Connector Design
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Solution Overview
Problem
The existing Luer connector system often results in unpredictable dead space volume variations due to manufacturing tolerances, leading to inaccuracies in drug delivery and potential dose wastage, as the 6% taper angle causes inconsistent sealing between male and female connectors.
Innovation Solution
A female connector design that includes a receptacle with a distal engagement surface and radial protrusions to securely engage the male Luer lock connector, ensuring a consistent fluid-tight seal and reducing dead space volume by allowing the male Luer tip to bottom out against the seal, thus aligning with ISO 80369-7:2021 standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a standard Luer connector with 6% taper angle is used, then the connector can be manufactured with standard tolerances, but the dead space volume becomes unpredictable and dose accuracy decreases
Solution Approach 1:
The patent changes the critical parameter from a tapered interface to a flat-faced interface with a specific seal surface. The female connector features a flat distal end with a seal surface that contacts the male connector tip, eliminating the 6% taper angle that causes volume variability. This parameter change ensures consistent dead space volume despite standard manufacturing tolerances.
2Measurement precision
If the male Luer tip does not bottom out against the seal, then assembly is easier, but dead space volume increases and dose accuracy decreases
Solution Approach 1:
The female connector is pre-configured with a flat distal end and seal surface positioned at a specific location. When the male connector is inserted, the flat-faced geometry automatically guides the tip to bottom out against the seal surface, ensuring consistent dead space volume. The radial protrusions on the male connector engage with corresponding features in the female connector to ensure proper alignment before sealing occurs.
3Measurement precision
If a flat-faced connector design is used, then dead space volume becomes consistent, but the connector may be more sensitive to misalignment during assembly
Solution Approach 1:
The connector interface is segmented into distinct functional zones: radial protrusions for alignment, a flat distal end for bottoming out, and a seal surface for fluid-tight sealing. This segmentation allows each feature to perform its specific function independently, ensuring reliable seal formation even if minor misalignments occur during assembly.
Solution Approach 2:
The male connector features radial protrusions that are asymmetrically positioned relative to the tip, while the female connector has corresponding asymmetric features. This asymmetric design provides mechanical guidance during assembly, ensuring that the flat-faced tip aligns correctly with the seal surface before engagement, thereby maintaining both consistency and reliability.
Data Source
AI summary
A small bore medical device connector is provided. The small bore medical device connector includes a female connector comprising a fluid path and a receptacle configured to accept a male Luer lock connector protrusion extending from a male Luer lock connector. The female connector is configured for threaded engagement to the male Luer lock connector. The male Luer lock connector protrusion includes a standard Luer tapered protrusion and a flow channel therewithin. The male Luer lock connector terminates at a tip disposed at the distal portion. The tip includes an opening to the flow channel. When the female connector is engaged with the male Luer lock connector, a distal aspect of the tip contactingly engages a distal engagement surface in the receptacle to establish a fluid-tight seal and to establish fluid communication through a combined fluid pathway including the fluid path and the flow channel.