Flow Control Valve With Flexible Saddle for Intermittent Drainage
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Solution Overview
Problem
Existing medical devices fail to provide controlled, periodic, or intermittent fluid communication and access between body lumens, leading to unidirectional flow that may not meet the needs of various medical conditions requiring controlled drainage and access.
Innovation Solution
A medical device with an elongate tubular body that expands into proximal and distal retention members, featuring a saddle region with a flexible member or collar that can constrict or expand in response to force, allowing controlled flow or access between body lumens, and optionally includes a reservoir for therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a medical device provides continuous open flow access between body lumens, then fluid communication is established, but controlled periodic or intermittent drainage cannot be achieved
Solution Approach 1:
The patent employs a flexible member that can dynamically change its configuration between constricted and expanded states. This flexible member is positioned within the saddle region and can be manipulated to constrict the lumen, thereby controlling fluid flow. The dynamic nature of this component allows the device to transition from continuous open flow to controlled periodic or intermittent drainage, resolving the contradiction between establishing fluid communication and enabling controlled flow regulation.
Solution Approach 2:
The patent utilizes changes in the physical state or configuration of the flexible member to control flow. By altering the constrictive force applied by the flexible member, the lumen can be partially or completely closed, enabling controlled periodic drainage. This parameter change approach allows the device to adapt its flow characteristics based on medical needs, transforming a static open flow device into one capable of intermittent controlled access.
2Reliability
If the flexible member completely closes the lumen, then controlled drainage is achieved, but fluid communication is completely blocked
Solution Approach 1:
The patent allows for partial closure of the lumen rather than complete closure. The flexible member can be configured to constrict the lumen to varying degrees, enabling partial blockage that regulates flow while maintaining some fluid communication. This partial action approach resolves the contradiction by providing controlled drainage capability without completely eliminating fluid communication, allowing the system to adapt to different medical requirements.
3Stability of the object's composition
If the flexible member is permanently disposed around the saddle region, then structural stability is improved, but adjustability of flow control is reduced
Solution Approach 1:
The patent describes the flexible member as being capable of movement between different configurations. Even when disposed around the saddle region, the flexible member can be manipulated to change its constrictive state. This dynamic capability allows the structure to maintain stability while preserving flow control adjustability, as the flexible member can be repositioned or reconfigured as needed to regulate fluid flow.
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
Enables controlled delivery of therapeutic agents and suction of fluids or debris, minimizing patient discomfort by allowing flexible and adjustable flow or access between body lumens, suitable for various medical procedures.
Implementation Method 1
A flexible member may be disposed around the saddle region and along at least a portion of the length of the saddle region. The flexible member may be configured to constrict at least a portion of the length of the saddle region.
Implementation Method 2
The flexible member and the constricted portion of the length of the saddle region may be configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force
Data Source
AI summary
The present disclosure relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present disclosure relates to devices and methods for establishing a controlled flow or access passage between body lumens.


