Hemostasis Valve Gasket Segmented Flaps Bidirectional Sealing
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Solution Overview
Problem
Existing hemostasis valve systems for introducer sheaths in vascular access procedures face challenges in minimizing blood loss and air embolism, and in achieving effective sealing during the insertion and withdrawal of medical devices.
Innovation Solution
A valve gasket design featuring an annular wall with radially inward extending ligaments, a membrane with slits dividing it into flaps, and a central protrusion with guiding recesses, which are aligned with positioning protrusions and recesses on the annular wall to enhance sealing and facilitate device insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional valve gasket design is used, then the structure is simple, but the sealing characteristics are insufficient and blood loss cannot be minimized
Solution Approach 1:
The valve gasket is segmented into multiple functional components: an annular wall forming the outer structure, a membrane with radial slits creating multiple flaps, and ligaments with slits that divide them into segments. This segmentation allows each component to contribute to sealing while enabling independent optimization of each element's function.
Solution Approach 2:
The membrane and ligaments are designed as dynamic elements that can deform and move in response to radial expansion forces. The slits in both the membrane and ligaments allow controlled deformation while maintaining structural integrity, enabling the gasket to adapt dynamically to different operational states during catheter insertion and withdrawal.
2Strength
If the membrane is made thicker to improve durability, then strength increases, but the ability to seal effectively during device insertion decreases
Solution Approach 1:
The membrane is divided into multiple flaps by radial slits, and each ligament is divided into segments by slits. This segmentation creates multiple sealing surfaces that work together, providing both durability through distributed stress and effective sealing through multiple contact points with the catheter.
Solution Approach 2:
The membrane is designed as a flexible thin film structure with slits that allow it to deform appropriately during catheter insertion while maintaining sealing capability. The flexibility enables the membrane to conform to the catheter surface, ensuring effective sealing without requiring excessive thickness.
3Reliability
If the valve gasket is designed to seal in one direction, then sealing is effective for that direction, but sealing fails when device insertion direction reverses
Solution Approach 1:
The valve gasket employs asymmetric design elements including the orientation of ligament slits relative to the membrane slits, and the positioning of ligaments at specific angles. This asymmetric configuration creates directional sealing characteristics that effectively seal during both forward insertion and reverse withdrawal of the catheter, providing bidirectional sealing capability.
Solution Approach 2:
The dynamic deformation of the membrane and ligaments during catheter insertion and withdrawal enables adaptive sealing in both directions. The slits allow the structure to flex and reconfigure based on the direction of force applied, maintaining sealing effectiveness regardless of insertion direction.
4Manufacturing precision
If positioning protrusions and recesses are added to align components, then manufacturing precision improves, but device complexity increases
Solution Approach 1:
The positioning protrusions and recesses are integrated into the existing annular wall structure rather than being separate components. This merging approach provides precise alignment functionality while minimizing additional complexity, as the positioning features are formed as part of the overall gasket structure during manufacturing.
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 gasket design improves sealing characteristics, reduces the risk of air embolism, and ensures effective sealing regardless of the direction of medical device insertion, thereby enhancing the safety and efficacy of vascular access procedures.
Implementation Method 1
a membrane surrounded by the annular wall and attached to the plurality of ligaments and to the annular wall, wherein the membrane includes at least one membrane slit that divides the membrane into a plurality of flaps
Implementation Method 2
each ligament of the plurality of ligaments includes a ligament slit that divides the ligament into two ligament segments; and the plurality of ligaments are positioned with the plurality of ligament slits aligned with the at least one membrane slit
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
A gasket for a hemostasis valve includes an annular wall, a membrane, a central protrusion on the membrane, and a plurality of ligaments attached to the central protrusion extending radially to the annular wall. The membrane, central protrusion, and ligaments are divided by slits into a plurality of flaps, with each flap bounded along an outer circumferential edge by the annular wall, along an inner circumferential edge by the central protrusion, and along its radial edges by segments of the ligaments. Two such gaskets can be arranged, back-toback, in a hemostasis valve. To facilitate such assembly, each gasket can include a plurality of positioning protrusions extending axially and a plurality of positioning recesses set into a circumferential surface, with the protrusions and recesses having complementary shapes for proper interconnection and fit between gaskets.