Cross-Slit Gasket Structure for Leak-Safe Introducer Sheaths
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Solution Overview
Problem
Conventional introducer sheaths with hemostasis valves often fail to ensure effective sealing for a wide range of interventional device diameters, leading to leakage issues during procedures like percutaneous transluminal coronary angioplasty, especially when dealing with varying blood pressures and device sizes.
Innovation Solution
A single-piece, disk-shaped gasket with opposing slits is used in the introducer sheath, providing a universal seal that accommodates different device diameters and reduces friction during insertion and withdrawal, ensuring hemostasis without air or blood leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single proximal input port hemostasis valve is used, then the device complexity is reduced, but the sealing reliability for various device diameters deteriorates
Solution Approach 1:
The gasket is segmented with multiple slits (first slit, second slit, third slit) oriented at different angles, allowing each slit to accommodate devices of different diameters independently while maintaining overall sealing integrity
Solution Approach 2:
The gasket with multiple slits serves multiple functions: it seals around devices of various diameters, maintains hemostasis, and allows device insertion/withdrawal through different orientations, replacing the need for multiple specialized valves
2Manufacturing precision
If a doughnut-shaped gasket with a hole slightly smaller than the catheter diameter is used, then the sealing precision for specific device sizes is improved, but the adaptability to different device diameters deteriorates
Solution Approach 1:
The gasket features slits rather than fixed circular holes, allowing the opening to dynamically adjust its effective diameter and orientation to accommodate devices of varying sizes and shapes while maintaining contact for sealing
Solution Approach 2:
The gasket design changes the sealing parameter from fixed circular geometry to flexible slit geometry, enabling the seal to adapt to different device diameters by adjusting which portions of the slit edges contact the device surface
3Adaptability or versatility
If a Y-shaped slit gasket is used, then the adaptability to different device shapes is improved, but the sealing reliability for small diameter devices deteriorates
Solution Approach 1:
The gasket is divided into multiple separate slits (first, second, and third slits) rather than a single Y-shaped slit, with each slit providing independent sealing capability that can effectively contact small diameter devices
Solution Approach 2:
Each slit is designed with specific local characteristics (orientation, width, position) optimized for sealing around devices of particular dimensions, with the combination of multiple slits providing comprehensive coverage for various device types
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 effectively prevents leakage and provides a smooth, reliable sealing mechanism for various interventional devices across a range of diameters, enhancing procedural safety and efficiency by maintaining hemostasis during interventions.
Implementation Method 1
a resilient gasket material... when the interventional device is inserted through the gasket, the gasket deforms elastically to seal around the device
Implementation Method 2
reduces friction during insertion and withdrawal
Data Source
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AI summary
A sheath introducer system including a sheath introducer defining a lumen therethrough and having a proximal valve housing in fluid communication with a distal tubular sheath, wherein a proximal end of the valve housing defines a proximal opening of the lumen of the sheath introducer. A gasket seated within the valve housing has a first surface, a second surface and an outer periphery extending between the first and second surfaces. A first slit is formed into the first surface having an inner surface defining a first gap. A second slit formed into the second surface having an inner surface defining a second gap. A notch extends into the first gap of the first slit forming a bump on the inner surface of the first slit, wherein the second slit intersects the first slit at the notch such that the notch prevents the first and second slits from being in fluid communication.