Adjustable Diameter Hemostatic Valve Sealing Mechanism
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Solution Overview
Problem
Current hemostatic valve designs, such as the iris valve, face issues with disengagement of seal ends, recoil, and fluid leakage due to longitudinally extending gaps, making them ineffective for sealing a wide range of medical device diameters and prone to tearing, especially when used for multiple medical devices during procedures.
Innovation Solution
A hemostatic valve device with a valve structure that includes a movable bladder within a housing cavity, capable of changing configuration to accommodate different diameters, using a biocompatible material with elasticity to form a fluid-tight seal, and a locking mechanism to prevent recoil, ensuring a secure seal across various medical device sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an elastomeric sleeve is used to seal the introducer device, then fluid flow can be controlled, but the seal ends are capable of disengagement which destroys sealing ability
Solution Approach 1:
The valve assembly is divided into distinct components: a hub with a bore, an elastomeric sleeve with defined ends, and a cap with engagement features. The segmentation allows each component to be optimized independently while maintaining overall sealing reliability through precise interfacing mechanisms.
Solution Approach 2:
The elastomeric sleeve is positioned within the bore of the hub, and the cap is positioned over the sleeve, creating a nested structure. This nesting ensures that the seal ends are contained and engaged within the valve assembly architecture, preventing disengagement while maintaining sealing capability.
2Reliability
If the rotatable cap is rotated to close the circular opening, then fluid flow is blocked, but the seal can recoil to its original position when rotational pressure is released
Solution Approach 1:
The engagement features (protrusions and recesses) are pre-configured on the cap and sleeve ends before operation. When the cap is rotated, these pre-positioned features automatically engage at specific rotational positions, providing preliminary mechanical action that prevents recoil without requiring continuous rotational pressure.
Solution Approach 2:
The valve assembly uses self-locking engagement features where the cap and sleeve protrusions automatically engage with corresponding recesses when rotated to the closed position. This self-service mechanism maintains seal position stability without requiring external force or pressure to prevent recoil.
3Reliability
If the iris valve is rotated to the closed position, then fluid flow is blocked, but longitudinally extending gaps or channels are formed along the seal which allow fluid leakage
Solution Approach 1:
The elastomeric sleeve acts as a flexible shell that can be radially compressed when the cap is rotated. This flexibility allows the sleeve to conform to the bore surface and eliminate gaps, while the thin film structure enables effective sealing with minimal material and reduced risk of tearing.
Solution Approach 2:
The valve mechanism changes the radial parameter of the elastomeric sleeve by compressing it radially inward when the cap is rotated to the closed position. This parameter change transforms the sleeve from an open-state configuration to a closed-state configuration that eliminates longitudinal gaps and prevents fluid leakage.
4Adaptability or versatility
If a single introducer device is used for multiple medical devices, then device versatility is improved, but the hemostatic valve must seal against devices of different diameters which complicates the sealing mechanism
Solution Approach 1:
The elastomeric sleeve with radially compressible structure serves as a universal sealing interface that can accommodate multiple medical devices of different diameters. The flexible nature of the elastomeric material allows it to adapt to various device sizes without requiring multiple specialized sealing mechanisms.
Solution Approach 2:
The valve mechanism can adjust the radial compression parameter of the elastomeric sleeve to match different device diameters. By changing the degree of radial compression, the same sealing mechanism effectively seals against devices ranging from small wire guides to larger catheters, maintaining simplicity while achieving multi-device compatibility.
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 valve device effectively seals medical devices of varying diameters, prevents fluid leakage, and maintains a secure seal without disengagement or recoil, enhancing the reliability of hemostatic control during medical procedures.
Implementation Method 1
Due to the elastomeric properties of the sleeve, the circular opening of the elastomeric sleeve constricts as the cap is rotated to effect closure
Implementation Method 2
using a biocompatible material with elasticity to form a fluid-tight seal
Data Source
Figure 1
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AI summary
A hemostatic valve device (10) for use in inserting an interventional device into a body lumen of a patient includes a housing (12) that defines a cavity (36) between first and second end openings (30,32). A valve structure (40) is disposed within the cavity, and defines a variable diameter channel for receiving the interventional device. An annular chamber (62) is generally formed between the valve structure (40) and the housing inner surface (12), and can be filled with fluid. The housing (12) is movable between first and second positions so that the volume of the cavity (62) and the diameter of the channel vary to a degree for the valve structure to form a seal along the interventional device inserted within the channel. The valve structure may be configured to seal without substantial twisting.