Aseptic PD Transfer Set with Helical Slider Isolation
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Solution Overview
Problem
The existing peritoneal dialysis transfer sets are prone to touch contamination at the connection interface between the male luer patient line connector and the female luer connection end, leading to a high risk of Peritonitis, which is a common infection and a major cause of treatment failure.
Innovation Solution
A peritoneal dialysis transfer set design featuring a base, slider, shroud barrel, and minicap, where the slider translates through translational movement guided by the base's slots and shroud barrel's helical grooves, ensuring a sterile connection between the male and female luer connectors, reducing direct contact and contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional transfer set design is used, then the device structure is simple, but the connection interface is prone to touch contamination leading to Peritonitis
Solution Approach 1:
The transfer set is divided into distinct functional components: a base body, a movable slider with connector, and a shroud barrel. This segmentation allows the connector to be isolated on the slider while the base remains stationary, creating a sterile barrier between the connection interface and the external environment. The segmented design enables the connector to move independently through the shroud barrel without compromising sterility.
Solution Approach 2:
The shroud barrel acts as an intermediary protective barrier between the connector and the external environment. The slider serves as an intermediary carrier that moves the connector through the sterile field. These intermediary components allow the connection interface to be protected from direct exposure to non-sterile surfaces while maintaining connectivity functionality.
2Ease of operation
If the connector is exposed for easy connection, then ease of operation is improved, but the risk of touch contamination increases
Solution Approach 1:
The connector is made dynamic by mounting it on a movable slider that can be positioned along the base body. The slider moves the connector into and out of the connection zone, allowing the connector to be exposed only when needed for connection while remaining protected during storage and transport. This dynamic positioning enables easy operation without permanent exposure to contamination risks.
3Productivity
If direct connection between male and female luer connectors is allowed, then connection speed is fast, but the risk of Peritonitis increases
Solution Approach 1:
The shroud barrel functions as a flexible protective shell that encloses the connection interface. This shell-like structure allows the male and female luer connectors to be brought into direct contact for rapid connection while the shroud barrel maintains a sterile barrier between the connection zone and the external non-sterile environment. The flexible shell protects without impeding the connection action.
Data Source
AI summary
A peritoneal dialysis (“PD”) transfer set includes a base having at least one slot; a slider extending within the base and including an elongated tube configured to carry PD fluid, the elongated tube extending to a head of the slider, the head including at least one lug extending through the at least one slot and further including a connector for connecting to a mating patient line connector; and a shroud barrel including at least one helical groove and extending around a portion of the base so that the at least one helical groove receives the at least one lug, wherein a user may rotate the shroud barrel including the at least one helical groove such that the at least one lug extends along the at least one helical groove, the at least one slot constraining movement of the at least one lug and the slider to being a translational movement.