Hemostatic Valve Biaxial Braided Seal for Variable Diameters
Solution Overview
Problem
Existing hemostatic valve devices, such as disk valves and iris valves, face challenges in maintaining a seal across a wide range of diameters, are prone to deformation, dislodgment, and fluid leakage, and require complex rotation mechanisms, making them unsuitable for use with multiple medical devices of varying sizes during procedures.
Innovation Solution
A hemostatic valve device with a contractible biaxial braided structure and a silicone sealing tube, where the sealing tube remains unattached to the contractible structure, allowing independent expansion and contraction to accommodate different diameters, and an operable element moves the valve structure between configurations to adjust the sealing diameter and length, facilitating sealing across a wide range of interventional device sizes without twisting or rotating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a disk valve is used to control fluid flow, then the valve can provide a seal, but the valve deforms over time due to compression set and sterilization, and can tear or become dislodged during device insertion and withdrawal
Solution Approach 1:
The valve is divided into a disk portion and a stem portion as separate functional elements. The disk portion provides the sealing function while the stem portion provides the structural support and attachment function. This segmentation allows the disk to be optimized for sealing without compromising structural stability, and the stem can be optimized for mechanical strength and resistance to tearing and dislodgment.
2Adaptability or versatility
If a disk valve is modified with increased tensile and elongation properties to accommodate a wide range of diameters, then the valve can seal across different sizes, but the resistance increases and thus increases the forces for insertion and withdrawal of interventional devices
Solution Approach 1:
The valve stem is designed with dynamic properties including elongation capability and resilient behavior. The stem can elongate to accommodate different device diameters and then resiliently return to its original position. This dynamic design allows the valve to adapt to various diameters without requiring excessive tensile strength that would increase insertion and withdrawal forces.
3Reliability
If an iris valve with a rotatable cap is used to seal the introducer, then the valve can control fluid flow, but the seal can recoil to its original position when rotational pressure is relaxed, and longitudinally extended gaps can form allowing fluid leakage
Solution Approach 1:
The rotational control mechanism (cap) is separated from the sealing function (disk). The cap provides control over disk movement, but the disk itself performs the sealing function independently. This extraction eliminates the recoil problem because the disk is directly actuated without relying on rotational tension in an elastomeric sleeve, and prevents gap formation because the disk moves as a unified sealing element rather than relying on sleeve constriction.
4Strength
If the sealing structure is attached to the contractible structure, then the valve provides structural support, but the sealing structure cannot independently expand and contract to accommodate different diameters
Solution Approach 1:
The valve is segmented into a disk portion and a stem portion that are connected but can move independently. The stem portion provides structural support while the disk portion provides the sealing function. The disk can independently expand and contract relative to the stem to accommodate different device diameters, while the stem maintains the overall structural integrity of the valve assembly.
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 device provides a reliable and adjustable seal across various diameters, reducing the risk of fluid leakage and deformation, and simplifies the process of using a single introducer device for multiple medical devices, ensuring effective hemostasis during procedures.
Implementation Method 1
The valve structure includes a biaxial braided contractible structure and a sealing structure. The contractible structure is movable between an expanded configuration and a contracted configuration. When the contractible structure moves from the expanded configuration to the contracted configuration, the diameter of the valve structure is reduced and the length of the valve structure is increased.
Implementation Method 2
The sealing structure can remain unattached to the contractible structure at least along the sealing region of the valve structure to permit independent expansion and contraction therebetween in response to movement of the valve structure between the first and second configurations.
Data Source
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AI summary
A hemostatic valve device for use in inserting an interventional device into a body lumen of patient is provided. The valve device includes a housing that defines a cavity between first and second end openings. A valve structure is disposed within the cavity, and defines a variable diameter channel for receiving the interventional device. The valve structure can include discrete layers of material, such as a sealing layer and a contractible layer such as a biaxial braided layer. The end of the valve structure is movable relative to the fixed end so that the longitudinal passageway of the valve structure varies in diameter and axial length to form a seal against an interventional device inserted within the passageway. An operable element is coupled to the movable end and is actuated by the end user to open and close the valve structure.