Floating Hemostasis Valve With Elastic Bellows for Off-Axis Catheter Sealing
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Solution Overview
Problem
Current sheath introducers for catheter delivery face issues with valve leaks when retracting devices due to off-axis forces disturbing the seal, as they have fixed valves centered on the longitudinal axis.
Innovation Solution
Incorporating a floating hemostasis valve with elastic bellows that can move orthogonally to accommodate off-axis movements of the catheter shaft, allowing the seal to deform and maintain a fluid-tight seal even when the device is inserted or retracted at an angle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed valve centered on the longitudinal axis is used, then the valve structure is simple and stable, but off-axis forces during device retraction disturb the seal and cause valve leaks
Solution Approach 1:
The patent applies the dynamics principle by making the valve body movable relative to the sheath instead of fixed. The valve body can move axially within the sheath to accommodate off-axis forces during device retraction, allowing the seal to maintain contact with the catheter shaft while the valve body adjusts its position dynamically in response to applied forces, thereby preventing valve leaks without compromising structural simplicity
Solution Approach 2:
The patent applies parameter changes by allowing the valve body position parameter to vary in response to off-axis forces. The valve body can shift axially along the longitudinal axis within controlled limits, changing its position parameter to accommodate varying insertion angles and off-axis movements during device retraction while maintaining seal integrity
2Ease of operation
If the seal is made fixed to maintain stability, then the structure is simpler, but it cannot accommodate orthogonal movement of the catheter shaft causing seal disturbance
Solution Approach 1:
The seal is integrated with the movable valve body, allowing it to move dynamically with the valve body in response to off-axis forces. This dynamic coupling enables the seal to maintain proper alignment with the catheter shaft during angled insertion and device retraction without requiring complex independent adjustment mechanisms
Solution Approach 2:
The patent merges the seal function with the movable valve body structure. Instead of having a separate fixed seal mechanism, the seal is positioned on or integrated with the valve body, combining the sealing function with the movement accommodation function in a single integrated component, thereby reducing overall device complexity
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 floating hemostasis valve effectively prevents valve leakage by allowing orthogonal movement of the seal, maintaining hemostasis during catheter insertion and retraction without disturbing the seal, thus enhancing the reliability of the sheath introducer system.
Implementation Method 1
The floating hemostasis valve can have elastic bellows which can allow the seal to move orthogonal to the longitudinal axis of the sheath introducer in response to an orthogonal movement of the shaft of the catheter. The elastic bellows can be configured to deform to allow the orthogonal movement of the floating hemostasis valve.
Data Source
AI summary
Disclosed herein is a system for treatment including a sheath introducer and a catheter or other device. The system can have a floating hemostasis valve comprising a seal through which the shaft of the catheter can extend. The floating hemostasis valve can have elastic bellows which can allow the seal to move orthogonal to the longitudinal axis of the sheath introducer in response to an orthogonal movement of the shaft of the catheter. The elastic bellows can be configured to deform to allow the orthogonal movement of the floating hemostasis valve.