Introducer Valve With Inflatable Membrane and Piston
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Solution Overview
Problem
Existing introducer systems with hemostasis valves face challenges in maintaining effective hemostasis and preventing excessive bleeding, especially when medical devices of varying sizes are inserted or removed.
Innovation Solution
The introducer system incorporates a valve assembly with a compliance chamber and a piston assembly, which accommodates inflation media to maintain the valve membrane in an inflated state, ensuring sealing around medical devices and maintaining hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional hemostasis valve is used to seal around medical devices, then hemostasis is maintained, but the valve cannot effectively accommodate medical devices of varying sizes
Solution Approach 1:
The valve assembly incorporates a compliant chamber that dynamically adjusts its volume to accommodate medical devices of different sizes. As a medical device is inserted, the compliant chamber deforms and expands to accommodate the device while maintaining sealing pressure, allowing the valve to adapt to varying device diameters while preserving hemostasis effectiveness
Solution Approach 2:
The system changes the physical state of the valve assembly by introducing inflation media into the compliant chamber, transforming it from a rigid structure to a dynamically adjustable sealing system that can modify its internal pressure and volume parameters to match different medical device sizes
2Adaptability or versatility
If the valve assembly is made rigid to maintain structural integrity, then manufacturing is simplified, but it cannot accommodate devices of different sizes
Solution Approach 1:
The valve assembly is segmented into distinct functional components: a rigid housing that provides structural integrity and manufacturing simplicity, and a compliant chamber that provides adaptability. This segmentation allows each component to be optimized independently - the housing for ease of manufacture and the chamber for size accommodation
Solution Approach 2:
The compliant chamber is constructed using flexible materials that can deform and expand to accommodate medical devices of varying sizes. This flexible shell approach allows the valve assembly to gain adaptability without significantly increasing overall structural complexity, as the flexibility is localized to the chamber portion
3Reliability
If inflation media is added to inflate the valve membrane, then sealing is improved, but there is no mechanism to accommodate displaced inflation media
Solution Approach 1:
The compliant chamber is merged with the inflation media system, serving dual purposes: it provides the sealing force by containing inflation media and simultaneously accommodates displaced inflation media when the valve membrane inflates. This merging eliminates the need for separate accommodation mechanisms and simplifies the overall system
4Reliability
If the valve membrane is kept inflated to maintain hemostasis, then bleeding prevention is effective, but the system cannot easily adapt when devices are inserted or removed
Solution Approach 1:
The compliant chamber automatically adjusts its volume and the valve membrane automatically maintains sealing pressure in response to device insertion or removal. The system serves itself by using the mechanical displacement of inflation media to drive the adaptation process, eliminating the need for external control mechanisms and enabling automatic adaptation while maintaining hemostasis
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 system effectively maintains hemostasis by ensuring the valve membrane seals around medical devices of different sizes and automatically closes when devices are removed, reducing bleeding and improving procedural efficiency.
Implementation Method 1
the biasing member is a spring
Implementation Method 2
the biasing member biases the piston member to reduce a working volume of the compliance chamber
Implementation Method 3
a flexible material within the valve assembly having an inner surface exposed along a portion of the medical device passage and an outer surface at least partially defining a valve membrane chamber
Data Source
AI summary
The present invention discloses an introducer system comprising an introducer sheath, a valve assembly, and a medical device passage. The valve assembly includes a flexible material with an inner surface exposed along a portion of the medical device passage and an outer surface defining a valve membrane chamber. Additionally, a compliance chamber within the valve assembly is in communication with the valve membrane chamber and houses a piston assembly movable between positions to accommodate inflation media.