Multi-Leaflet Valve Gasket for Surgical Port Fluid Seal
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Solution Overview
Problem
There is a need for improved fluid seals in medical devices, such as instrument ports, to prevent contamination and infection by bodily fluids while allowing surgical instruments to be inserted and removed effectively.
Innovation Solution
A gasket with a flexible base and a multi-leaflet valve that transitions between a relaxed and compressed state, requiring different threshold forces and pressure differentials to open in distal and proximal directions, effectively operating as a one-way valve to maintain a fluid seal and secure itself to the conduit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional fluid seal is used in an instrument port, then bodily fluids can be kept out, but the seal cannot allow surgical instruments to be inserted and removed effectively
Solution Approach 1:
The gasket incorporates a dynamic multi-leaflet valve structure that can transition between open and closed states. The leaflets are designed to be flexible and movable, allowing the valve to automatically open when an instrument is inserted (due to force application) and automatically close when the instrument is removed (due to elastic recovery). This dynamic behavior resolves the contradiction by providing both instrument accessibility and fluid sealing at different operational states.
Solution Approach 2:
The gasket utilizes pressure differential as a controlling parameter. When an instrument is inserted, it creates a pressure difference that forces the leaflets open. When the instrument is removed, the pressure differential reverses, causing the leaflets to close. This parameter-based control mechanism allows the seal to adapt its state based on operational conditions, enabling both instrument passage and fluid containment.
2Ease of operation
If a valve mechanism is added to allow instrument passage, then instruments can be inserted and removed, but the device complexity increases
Solution Approach 1:
The multi-leaflet valve is designed as a self-actuating mechanism that requires no external control systems. The leaflets automatically open in response to instrument insertion forces and automatically close when the instrument is removed, utilizing the natural pressure differentials and elastic properties of the materials. This self-service capability adds functionality without requiring complex control mechanisms, actuators, or external power sources.
Solution Approach 2:
The valve leaflets are constructed from flexible materials that can deform and return to their original shape. This flexibility allows the leaflets to function as both the sealing surface and the actuating mechanism, eliminating the need for rigid mechanical components, hinges, or complex linkages. The thin-film structure provides both the sealing function and the mechanical response to pressure changes.
3Ease of operation
If the gasket is made highly compliant to allow instrument passage, then instruments can be inserted easily, but the seal strength decreases
Solution Approach 1:
The gasket is segmented into multiple functional zones: a highly compliant region with the multi-leaflet valve that allows instrument passage, and a more rigid peripheral region that provides structural support and sealing against the instrument port wall. This segmentation allows different parts of the gasket to have different mechanical properties optimized for their specific functions, maintaining both instrument accessibility and seal integrity.
Solution Approach 2:
The gasket utilizes composite construction combining materials with different mechanical properties. The valve leaflets use highly elastic, compliant materials for flexibility, while the base gasket structure incorporates more rigid materials for structural support. This composite approach allows the gasket to simultaneously provide the compliance needed for instrument passage and the strength needed for maintaining the fluid seal.
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 gasket effectively prevents bodily fluids from entering the medical device while allowing surgical instruments to pass through, maintaining a secure seal and reducing the risk of contamination and infection, with the multi-leaflet valve's unique configuration ensuring efficient operation under varying pressure conditions.
Implementation Method 1
a flexible hollow body extending along an axis from the hole, wherein the flexible hollow body is configured to have a relaxed state in which a cross section of the flexible hollow body has a first shape and a compressed state in which the cross section of the flexible hollow body has a second shape
Implementation Method 2
the compressed state causes the multi-leaflet valve to close to increase (a) a first threshold force or a first threshold pressure differential needed to open the multi-leaflet valve in a distal direction and (b) a second threshold force or a second threshold pressure differential needed to open the multi-leaflet valve in a proximal direction
Data Source
AI summary
A gasket for creating a fluid seal in a medical device includes a flexible base, a flexible hollow body, and a multi-leaflet valve. The flexible hollow body extends along an axis from a hole defined in the flexible base. The flexible hollow body is configured to have a relaxed state in which a cross section of the flexible hollow body has a first shape and a compressed state in which the cross section of the flexible hollow body has a second shape. The multi-leaflet valve is disposed in the flexible hollow body. The compressed state causes the multi-leaflet valve to close to increase (a) a first threshold force or a first threshold pressure differential needed to open the multi-leaflet valve in a distal direction and (b) a second threshold force or a second threshold pressure differential needed to open the multi-leaflet valve in a proximal direction.