Vascular Access Device Valve Plate Segmentation
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Solution Overview
Problem
Existing vascular access devices are difficult to manufacture, assemble, and are often ineffective in preventing backflow contamination during medical procedures, particularly when using splittable sheaths and hemostatic valves.
Innovation Solution
A vascular access device featuring a splittable sheath with a flexible and rigid plate body design that forms a central cavity, allowing for the alignment and sealing of a needle and dilator, and includes a locking mechanism to secure the guidewire, dilator, and sheath, facilitating efficient insertion and removal while minimizing backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hemostatic valve is included in the vascular access device to prevent backflow, then the reliability of preventing contamination is improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The valve is divided into two separate plate bodies (first plate body and second plate body) that can be manufactured independently and then assembled together. This segmentation allows each plate to be simpler in design while the combination provides the complete valve function, reducing individual component complexity and manufacturing difficulty.
Solution Approach 2:
The valve plates are positioned within the sheath hub structure, with the first plate body and second plate body nested in relation to each other. This nesting arrangement integrates the valve mechanism into the existing sheath hub without requiring separate housing structures, thereby reducing overall device complexity while maintaining effective backflow prevention.
2Ease of operation
If a splittable sheath is used to facilitate removal after catheter insertion, then the ease of operation is improved, but the manufacturing precision and assembly difficulty increase
Solution Approach 1:
The first plate body and second plate body are pre-positioned and secured to the sheath hub before final assembly. This preliminary positioning ensures proper alignment is established early in the manufacturing process, and subsequent assembly steps maintain this alignment, thereby achieving the required manufacturing precision without excessive complexity.
Solution Approach 2:
The valve plate assembly is integrated with the sheath hub structure, combining multiple functions (sealing, valve operation, and structural support) into a unified component system. This merging reduces the number of separate parts that require precise alignment, thereby improving manufacturability while maintaining the splittable sheath functionality for easy removal.
3Reliability
If the valve plates overlap to seal the central cavity, then the reliability of sealing is improved, but the device complexity increases
Solution Approach 1:
The sealing function is extracted as a distinct feature of the valve plate assembly, where the overlapping edges of the first and second plate bodies create the seal. This separation of sealing function from other valve functions allows for simpler plate body structures that achieve reliable sealing through their geometric arrangement rather than requiring complex sealing mechanisms.
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A sheath can include a sheath body and a sheath hub. The sheath body can have a generally flexible tubular structure, a proximal end, and a distal end. The sheath body can further define a longitudinal axis. The sheath hub can attach to the proximal end of the sheath body and define a longitudinal axis generally aligned with the axis of the sheath body. The sheath body and sheath hub can also form a central cavity along their respective axes. The sheath hub can include two plates: a flexible plate and a rigid plate. The rigid plate can have a relief generally centered on the sheath body's axis. Advantageously, the flexible plate and rigid plate can overlap to substantially seal the central cavity.