Interlocked Elastomeric Valve Members for Hemostasis
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Solution Overview
Problem
Existing hemostasis valve systems face challenges with fluid leakage due to gaps created by slitted valve disks, which can lead to air embolism and blood leakage, especially when inserting or removing devices of different diameters, and may result in valve damage or require additional equipment.
Innovation Solution
A hemostasis valve system featuring interlocked elastomeric valve members with shaped faces and edges that form a sealable passageway, providing a yieldable opening for medical devices and maintaining a secure seal upon device removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If slitted valve disks are used to permit device passage, then device insertion is enabled, but gaps are created that permit fluid leakage
Solution Approach 1:
The patent employs elastomeric valve members with flexible membranes that can deform to accommodate device passage while maintaining a fluid seal. The elastomeric material allows the valve to flex open during device insertion and return to its original sealed configuration when the device is removed, preventing fluid leakage through the valve structure.
Solution Approach 2:
The valve design utilizes changes in the physical state and elasticity of the elastomeric material in response to pressure differentials. When pressure is applied during device insertion, the material deforms to allow passage; when pressure equalizes or reverses, the material returns to its sealed state, dynamically adjusting its properties to balance device access and fluid containment.
2Reliability
If multiple valve members are used to reduce leakage, then fluid seal is improved, but device insertion becomes more difficult
Solution Approach 1:
The valve system is divided into multiple elastomeric valve members arranged in series, each capable of independent deformation. This segmentation allows each member to flex and open sequentially during device passage, reducing the overall resistance compared to a single rigid multi-component valve while maintaining multiple sealing surfaces to prevent leakage.
3Ease of operation
If larger slitted valve disks are used, then device passage is easier, but valve damage occurs during insertion
Solution Approach 1:
The elastomeric valve members are designed with sufficient thickness and material strength to resist tearing and damage during device insertion, while their inherent flexibility allows them to deform elastically rather than fracture. The material properties are selected to provide both durability against mechanical stress and compliance to accommodate device passage without permanent deformation or failure.
4Area of stationary object
If smaller slitted valve disks are used, then valve size is reduced, but valve tearing occurs during device passage
Solution Approach 1:
The valve members are constructed from elastomeric composite materials that combine the benefits of flexibility and high tensile strength. These materials allow the valve to maintain a compact size while resisting tearing and mechanical failure during device passage, achieving both miniaturization and enhanced durability through material science advancements.
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 interlocked elastomeric valve system effectively minimizes fluid leakage and prevents valve damage, ensuring a reliable seal during device insertion and removal, regardless of device size, without the need for additional equipment.
Implementation Method 1
The valve members have sufficient elasticity to define a yieldable opening along the engaged inner edge portions upon passage therethrough of a medical interventional device
Data Source
AI summary
A hemostasis valve system for controlling a flow of fluid includes a housing having a chamber therein, and a valve disposed in the chamber. The valve comprises a plurality of elastomeric valve members, each having opposing shaped first and second faces, a shaped inner edge portion, and a shaped outer edge portion. The valve members are collectively structured and arranged in the valve such that the shaped faces and the shaped inner edges are engaged in interlocking relationship. The valve members have sufficient elasticity to define a yieldable opening along the engaged inner edge portions upon passage therethrough of a medical interventional device.