Irisable Aperture Valve for Off-Axis Hemostasis Sealing
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Solution Overview
Problem
Existing hemostasis valves struggle to maintain a fluid seal when medical devices make sharp turns within patient vasculature, leading to potential blood leakage during procedures like cardiac catheterization.
Innovation Solution
An aperture valve with a proximal and distal ring connected by a flexible cylinder, irisable through rotation, and a locking mechanism to secure the rings, allowing the valve to constrict and maintain a seal despite off-axis device insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional hemostatic seals are used, then the device structure is simple, but the seal fails when sharp turns are made in the vasculature
Solution Approach 1:
The valve is segmented into multiple functional components: a flexible cylinder for sealing, proximal and distal rings for structural support and actuation, and a locking mechanism for position maintenance. This segmentation allows each component to perform its specific function optimally while working together to achieve reliable sealing during sharp turns.
Solution Approach 2:
The valve employs dynamic elements including the flexible cylinder that can deform with vessel movement, the irisable aperture that can constrict to maintain seal, and the rotatable distal ring that enables active control. These dynamic features allow the valve to adapt to sharp turns and maintain reliability.
2Reliability
If the valve aperture is constricted to maintain seal, then hemostasis is maintained, but the device complexity increases due to locking mechanism
Solution Approach 1:
The locking mechanism is designed to maintain the valve in its hemostatic state without requiring continuous external actuation. Once the aperture is constricted to the desired position, the locking mechanism automatically engages to maintain this state, allowing the valve to self-maintain hemostasis during the procedure.
Solution Approach 2:
The valve controls hemostasis by changing the aperture parameter from open to constricted state. The locking mechanism then maintains this parameter change without requiring continuous energy input or complex control systems, achieving reliable hemostasis through parameter stabilization.
3Adaptability or versatility
If the distal ring is made rotatable to enable iris action, then the valve can adapt to off-axis insertion, but the device complexity increases
Solution Approach 1:
The distal ring is designed to be rotatable rather than fixed, enabling the valve to adapt its orientation to accommodate sharp turns in the vasculature. This dynamic capability allows the valve to maintain effective sealing even when the medical device follows a non-linear path through the vessels.
Solution Approach 2:
The rotatable distal ring changes the orientation parameter of the valve aperture, allowing it to align with off-axis insertion paths. This parameter adjustment enables the valve to adapt to various insertion angles and sharp turns without requiring multiple valve designs.
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 aperture valve effectively maintains hemostasis by forming a fluid seal around medical devices, even when they are not coaxial with the central axis, reducing blood leakage and ensuring patient safety during vascular procedures.
Implementation Method 1
The friction between the flexible cylinder and the medical device maintains the fluid seal during sharp turns in the vasculature
Implementation Method 2
The locking mechanism is engageable to retain the flexible cylinder in an irised state by locking the proximal ring to the distal ring
Data Source
AI summary
An aperture valve for maintaining hemostasis extends from a proximal end to a distal end along a primary axis. The aperture valve includes a proximal ring situated at the proximal end and formed of rigid material, a distal ring situated at the distal end and formed of rigid material, a flexible cylinder surrounding the primary axis, attached to and axially overlapping with the proximal ring and the distal ring, and a locking mechanism selectively anchoring the proximal ring to the distal ring. The flexible cylinder is irisable by rotation of the proximal ring relative to the distal ring. The locking mechanism is engageable to retain the flexible cylinder in an irised state by locking the proximal ring to the distal ring while the proximal ring is rotated relative to the distal ring.