Hemostasis Valve Variable-Width Channel Split Housing
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Solution Overview
Problem
Current hemostasis valve assemblies struggle to form a reliable liquid-tight seal across a wide range of medical instrument diameters and often require retraction over the instrument's proximal end for removal, which can be impractical, especially when the instrument is coupled to larger devices.
Innovation Solution
A hemostasis valve assembly with a housing that can be split and an elastomeric member with a variable-width channel and slit configuration, allowing for the passage of instruments with diameters from 1-24 Fr and enabling removal without retracting over the proximal end by breaking or tearing the components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a hemostasis valve assembly uses a fixed-width sealing structure, then it can form a reliable seal for a specific instrument diameter, but it cannot accommodate a wide range of medical instrument diameters
Solution Approach 1:
The sealing structure transitions from a fixed-width design to a dynamic variable-width design. The elastomeric member with variable-width channel can expand and contract to adapt to different instrument diameters (1-24 Fr), maintaining seal reliability across the full range of instrument sizes through its elastic deformation capability
Solution Approach 2:
The sealing structure's width parameter is made variable rather than fixed. The elastomeric member's channel width changes dynamically based on the instrument diameter, allowing the seal to maintain optimal contact pressure and geometry for each specific instrument size while ensuring reliable hemostasis
2Ease of operation
If a hemostasis valve assembly is designed as a single integrated piece, then it is simple in structure, but it requires retraction over the instrument's proximal end for removal which is impractical when the instrument is coupled to larger devices
Solution Approach 1:
The hemostasis valve assembly is divided into separable components: a housing portion and an elastomeric member portion. This segmentation allows the components to be detached from each other and removed from the instrument without requiring retraction over the proximal end, enabling removal from instruments coupled to larger devices while maintaining relatively simple individual component structures
3Strength
If the housing is made thick and robust, then it provides structural strength and support, but it becomes difficult to split or tear for removal
Solution Approach 1:
The housing employs non-uniform thickness distribution with thick regions providing structural strength and support, and thin regions (score lines) providing controlled weakness for splitting. This local quality variation allows the housing to simultaneously achieve robustness where needed and ease of separation where required, with the thin regions acting as predetermined failure points
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 solution provides a versatile and practical hemostasis valve assembly capable of forming liquid-tight seals across various diameters and allows for easy removal from medical instruments, even when they are coupled to larger devices, minimizing blood loss and facilitating medical procedures.
Implementation Method 1
an elastomeric member with a variable-width channel and slit configuration, allowing for the passage of instruments with diameters from 1-24 Fr
Data Source
Figure 1A~1B
Figure 1C
Figure 1D
AI summary
Hemostasis valves and hemostasis valve assemblies can be coupled to a proximal end of an introducer sheath to prevent blood loss through the proximal end of the introducer sheath. Some hemostasis valve assemblies may include an elastomeric member with a variable-width channel that is designed to form a liquid-tight seal over elongate members of different diameter or a single elongate member of variable diameter.