Rotating Infusion Sideport for Steerable Sheath Sealing
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Solution Overview
Problem
Current medical introducer sheaths face challenges in effectively navigating complex anatomies and preventing fluid leakage during medical procedures, particularly when used with deflectable or steerable devices.
Innovation Solution
A deflectable introducer sheath assembly with a tubular sheath member, a handle assembly, and a hemostasis valve assembly that includes a side port member axially rotatable relative to the sheath member and handle assembly, allowing for fluid communication and easy navigation while inhibiting fluid leakage through the use of seal rings and a mechanism for altering the shape of the distal end portion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed side port is used in the hemostasis valve assembly, then the structure is simple, but the device cannot be rotated relative to the handle assembly, limiting its adaptability for different procedural needs
Solution Approach 1:
The side port member is designed to be rotatable relative to the handle assembly and sheath member, transforming a static structure into a dynamic one. This allows the side port to be positioned at different orientations during the procedure, providing adaptability without requiring multiple separate components, thus managing complexity while improving versatility.
Solution Approach 2:
The hemostasis valve assembly is segmented into distinct rotatable components (side port member, body member, hub) that can move independently relative to each other. This segmentation allows the side port to rotate independently while maintaining sealing through the hemostasis valve mechanism, enabling versatility without compromising structural integrity.
2Adaptability or versatility
If a rotatable side port member is implemented, then the device can navigate complex anatomies better, but the risk of fluid leakage increases
Solution Approach 1:
The hemostasis valve assembly acts as an intermediary mechanism between the rotatable side port member and the sheath lumen. It maintains fluid sealing through seal rings and valve mechanisms that prevent leakage while allowing the side port to rotate, thus enabling navigation capability without compromising fluid sealing reliability.
Solution Approach 2:
The sealing mechanism parameters are designed to accommodate rotation. The seal rings and hemostasis valve are configured to maintain effective sealing contact throughout the rotation range, allowing the side port to change orientation for navigating complex anatomies while preventing fluid leakage through maintained sealing parameters.
3Difficulty of detecting and measuring
If the side port member is made transparent, then fluid flow and air bubbles are more visible, but the mechanical strength may be reduced
Solution Approach 1:
The side port member and body member are made of transparent materials that provide both optical clarity for visualizing fluid flow and air bubbles, and sufficient mechanical strength to withstand procedural forces. The transparency allows detection of fluid dynamics while the material properties maintain structural integrity.
Data Source
AI summary
An introducer sheath assembly comprises a tubular sheath member having a deflectable distal end portion and a sheath member lumen, a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member, and a hemostasis valve assembly. The hemostasis valve assembly includes a side port member configured to be connected to a fluid source for introducing fluid into the sheath member lumen. The side port member is axially rotatable relative to the handle assembly and the sheath member such that the side port member can remain rotationally fixed relative to the fluid source as the handle assembly and the sheath member are rotated relative to the fluid source. The side port member may also be made transparent to allow for easy visualization of air bubbles, and is also configured to allow for evacuation of any visualized air bubbles.