Hemostatic Valve Assembly Radial Flexure Sealing
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Solution Overview
Problem
Prior art iris valves for medical devices face issues with disengagement of ends, lack of ergonomic design, and inefficiency in sealing smaller diameter devices, leading to potential fluid leakage during medical procedures.
Innovation Solution
A hemostatic valve assembly featuring a rotatable valve control member with an ergonomic outer surface, a flexible valve member, and a valve collar capable of radial flexure, which provides a tactile sensation upon rotation, ensuring effective closure of the valve passageway and preventing fluid leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a disk-like gasket with slits is used to seal the passageway, then large diameter devices can be sealed effectively, but smaller diameter devices cannot be sealed effectively
Solution Approach 1:
The valve member is designed to be movable relative to the valve body, transitioning between open and closed positions. This dynamic configuration allows the valve to adapt its sealing surface to match different device diameters, effectively sealing both small and large diameter interventional devices whereas static disk gaskets fail with smaller devices
Solution Approach 2:
The valve assembly changes the configuration parameter of the valve member position to achieve different sealing states. By adjusting the valve member to the closed position, the sealing surface area and configuration are modified to effectively seal around devices of varying diameters, resolving the contradiction between sealing effectiveness and adaptability
2Device complexity
If the valve ends are engaged in a simple manner, then the structure is simple, but the ends are capable of disengagement which destroys sealing ability
Solution Approach 1:
A retention mechanism acts as an intermediary between the valve member and valve body, preventing disengagement while maintaining the simplicity of the overall structure. This intermediary feature ensures the valve member remains properly positioned to maintain sealing reliability without requiring complex assembly structures
Solution Approach 2:
The retention mechanism provides beforehand protection against disengagement, cushioning against the potential failure mode of the valve ends separating. This preventive design ensures sealing reliability is maintained throughout the device lifecycle without requiring complex corrective mechanisms
3Device complexity
If the outer housing of the valve is cylindrical, then the structure is simple, but it does not provide an ergonomic surface for optimal manipulation
Solution Approach 1:
The outer housing transitions from a simple cylindrical shape to an ergonomic configuration with localized features such as flattened portions or contours. These local modifications provide optimal manipulation surfaces for physician control while maintaining the overall simplicity of the housing structure, resolving the contradiction between structural simplicity and operational ease
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The valve assembly effectively seals both larger and smaller diameter devices, providing a secure and ergonomic interface that minimizes fluid leakage and facilitates easy manipulation during medical procedures.
Implementation Method 1
a flexible valve member (20) having an opening therethrough... Upon rotation of the rotatable valve control member in a first direction relative to the valve collar, the mechanism of the rotatable valve control member engages the valve collar portion in a manner such that the valve collar portion flexes in a radial direction... and such that the flexible valve member longitudinal opening constricts from an open position to a position wherein the flexible valve member opening is at least partially closed
Implementation Method 2
the valve collar portion capable of flexure is defined by said generally U-shaped cut-out... the valve collar portion flexes in a radial direction and a tactile sensation is produced thereby
Data Source
Figure 1~2
Figure 3
Figure 4~8
AI summary
A valve assembly includes a valve collar (14), a rotatable valve control member (16), and a flexible valve member (20) disposed therebetween. The valve control member and the valve collar are aligned to define an elongated passageway, and the flexible valve member is disposed along the passageway. The valve collar is structured such that at least a portion -thereof (41) is capable of radial flexure upon engagement with a mechanism (51) on the rotatable valve control member. One end of the valve member (62) is secured to the valve collar, and the other end (64) is secured to the rotatable valve control member. Upon rotation of the rotatable valve control member relative to the valve collar, the mechanism of the rotatable valve control member engages the valve collar portion in a manner such that the valve collar portion flexes in a radial direction and a tactile sensation is produced thereby, and the flexible valve member constricts from an open position to a position wherein the flexible valve member opening is at least partially closed to passage of fluid therethrough.