Multi-Port Inflatable Hemostatic Valve for Vascular Sealing
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Solution Overview
Problem
Conventional hemostatic valve systems in medical devices are not well-suited for procedures involving interventional devices of different diameters or simultaneous placement of multiple devices, leading to leakage challenges during percutaneous insertion into vascular systems.
Innovation Solution
A hemostatic valve system comprising an elongate tubular member with a body, pouches, and disks, where the pouches have a first unexpanded and second expanded configuration, and the disks span the device ports to create a seal, allowing for efficient passage of interventional devices while minimizing fluid leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional hemostatic valve members are used, then the valve structure is simple, but the valve cannot effectively seal around interventional devices of different diameters or multiple devices, leading to fluid leakage
Solution Approach 1:
The hemostatic valve is divided into multiple independent pouches (first pouch, second pouch, third pouch) that can expand independently to seal around different devices. Each pouch can be inflated separately to adapt to the specific configuration of interventional devices, whether single or multiple devices of varying diameters.
Solution Approach 2:
Multiple pouches are nested within the valve body structure, with each pouch capable of containing and sealing around interventional devices. The pouches can be nested within one another or positioned adjacently to accommodate multiple devices simultaneously passing through the valve.
2Adaptability or versatility
If elastomeric hemostatic valves are used to seal around interventional devices, then fluid leakage is minimized during device exchange, but the valves are not well-suited for procedures involving devices of different diameters or simultaneous placement of multiple devices
Solution Approach 1:
The hemostatic valve incorporates inflatable pouches that can dynamically change their configuration from deflated to inflated states. This dynamic capability allows the valve to adapt its internal geometry to accommodate different device diameters and configurations, maintaining sealing performance across diverse procedural requirements.
Solution Approach 2:
The multi-pouch valve structure is designed to universally accommodate various interventional device configurations, including single devices of different diameters, multiple devices simultaneously, and different device types. The inflatable pouches can be selectively deployed to match the specific procedural needs.
3Loss of substance
If conventional hemostatic valves are used, then the device structure is simple, but fluid leakage occurs during insertion and withdrawal of interventional devices of varying diameters or multiple devices
Solution Approach 1:
The valve system is segmented into multiple functional pouches (first pouch for initial sealing, second pouch for device passage sealing, third pouch for additional device accommodation) that work together to prevent fluid leakage. Each pouch addresses specific leakage scenarios, providing comprehensive sealing coverage.
Solution Approach 2:
The pouches can be pre-inflated or selectively inflated in advance of device insertion to establish sealing barriers before fluid leakage can occur. This preliminary action ensures that the sealing mechanism is already in place when interventional devices are inserted or withdrawn.
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 provides a leak-free passage for interventional devices of varying diameters and multiple devices, enhancing the effectiveness of medical procedures by maintaining a secure seal during insertion and withdrawal, thus reducing fluid loss and improving procedural efficiency.
Implementation Method 1
The one or more pouches are disposed within the chamber and have a first unexpanded configuration and a second expanded configuration
Data Source
AI summary
A medical device is provided having a hemostatic valve system that allows substantially leak-free passage of one or more medical interventional devices, such as a catheter, for insertion into a body vessel. The medical device comprises a hemostatic valve system and an elongate tubular member. The hemostatic valve system comprises a body, one or more pouches, and one or more disks.