Hemostasis Valve Seal Stack for Bleed-Back and Catheter Movement
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Solution Overview
Problem
Existing bleed-back control valves, such as the Tuohy-Borst adapter, allow blood backflow during catheter placement, increasing the risk of exposure to blood-borne pathogens and blood loss, as they require the catheter to be partially loosened to prevent bleed-back, which is undesirable.
Innovation Solution
A hemostasis valve with a seal stack comprising conical gaskets and a frustoconical structure that slideably engages the catheter while blocking bleed-back, using flexible and rigid components to maintain a seal without fully locking the catheter, allowing for real-time pressure measurements and fluid communication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the catheter is locked in place using a traditional Tuohy-Borst adapter, then bleed-back is prevented, but the catheter cannot be repositioned or adjusted
Solution Approach 1:
The seal member is designed with dynamic characteristics, allowing it to transition between a locked state that prevents bleed-back and a loosened state that allows repositioning. The conical geometry enables progressive engagement and disengagement along the axial direction, providing both stability when engaged and mobility when needed.
Solution Approach 2:
The sealing interface is segmented into multiple contact zones along the conical surface, allowing partial engagement that can prevent bleed-back while still permitting limited catheter movement or repositioning when necessary.
2Ease of operation
If the catheter is loosened to allow repositioning, then catheter mobility is improved, but blood backflow increases
Solution Approach 1:
The seal member can be engaged partially along its conical surface, providing sufficient sealing action to prevent blood backflow while allowing limited catheter movement. The engagement level can be adjusted to achieve the minimum necessary sealing without complete locking.
Solution Approach 2:
The conical geometry allows changing the engagement parameter (axial position) to adjust between full sealing (preventing backflow) and partial engagement (allowing repositioning), providing continuous control over the sealing effectiveness versus mobility trade-off.
3Device complexity
If a traditional compression gasket is used, then the structure is simple, but it requires full compression to prevent bleed-back which limits catheter adjustment
Solution Approach 1:
The conical seal member provides dynamic engagement where the sealing force progressively increases with axial compression, allowing the system to maintain sealing with varying degrees of engagement rather than requiring a single fixed compression level.
Solution Approach 2:
The conical geometry distributes the sealing force along a curved surface rather than a flat interface, allowing progressive engagement that maintains sealing effectiveness while permitting catheter adjustment within a range of positions.
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 blood backflow during catheter placement by maintaining a seal while allowing catheter movement, reducing exposure risks and blood loss, and enabling real-time pressure monitoring without interrupting procedures.
Implementation Method 1
a first sealing member comprising a flexible conical structure... a second sealing member comprising a flexible conical structure
Data Source
AI summary
A seal for a hemostasis valve is provided as well as a novel seal stack for use in hemostasis valves. The seal stack includes a plurality of conical or frustoconical members including an anti-prolapse member, and a sealing member. The seal stack may optionally include a diaphragm and/or a second sealing member. The valve body may include a pressure sensing member which may be located in a sidearm.