Multi-Flap Trough Seal for Leak-Safe Catheter Passage
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Solution Overview
Problem
Existing seals for medical devices, such as catheters, fail to effectively prevent leakage of fluids, particularly blood and air, due to passages remaining separated after device insertion, leading to procedure delays and costs.
Innovation Solution
A seal with an elastic component featuring a slit intersecting an elongated trough, flaps at the distal end, and a longitudinal axis, allowing device passage while forming a fluid seal through flaps and trough sides.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a flexible seal with a slit is used to allow device insertion, then device passage is enabled, but passages on one or more sides of the device remain separated causing fluid leakage
Solution Approach 1:
The seal is divided into multiple independent flaps (first flap, second flap, third flap) that can move independently. Each flap can conform to the device and seal against it separately, ensuring complete sealing even when the device moves or changes position within the seal.
Solution Approach 2:
The flaps are designed to be flexible and dynamic, allowing them to move and adjust their position in response to device insertion and movement. This dynamic behavior enables the flaps to maintain continuous contact with the device, preventing fluid leakage while accommodating device passage.
2Reliability
If excess blood leaks through the seal, then sealing performance is insufficient, but procedure must be aborted and catheter disposed of
Solution Approach 1:
The multi-flap design provides redundant sealing capability built into the seal structure itself. If one flap fails to seal properly, the other flaps continue to provide sealing, preventing complete seal failure and avoiding the need to abort the procedure.
Solution Approach 2:
The flaps are designed with specific material properties and geometric parameters (thickness, length, width) that optimize their sealing performance. The material composition and dimensional parameters are tuned to ensure reliable sealing under varying physiological conditions throughout the procedure.
3Reliability
If air leaks through the seal during aspiration, then sealing is inadequate, but procedure time and cost increase
Solution Approach 1:
The seal is segmented into multiple flaps that create multiple independent sealing interfaces with the device. This segmentation ensures that air cannot bypass the seal through gaps between flaps, maintaining reliable sealing during aspiration operations.
4Reliability
If the seal conforms tightly around the device, then fluid leakage is prevented, but the device cannot be inserted through the seal
Solution Approach 1:
The flaps are designed to be flexible and dynamic, allowing them to move and adjust their position in response to device insertion and movement. This dynamic behavior enables the flaps to maintain continuous contact with the device, preventing fluid leakage while accommodating device passage.
Solution Approach 2:
The seal is constructed from flexible material that can deform and conform to the device shape. This flexibility allows the device to be inserted through the seal while the material maintains its sealing function by conforming tightly around the device.
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 seal significantly reduces fluid leakage, minimizing procedural delays and costs by ensuring a tight seal around medical devices like catheters, guidewires, and dilators.
Implementation Method 1
a seal (26) configured to permit passage of a device (28, 36, 40, 42, 44, 46) through the seal (26). The seal (26) includes an elastic component (40) having a proximal end (42), a distal end (44)... one or more flaps (74a, 74b) of elastic material
Data Source
Figure 1~2
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Figure 5~6
AI summary
A seal to permit the passage of a device through the seal. The seal includes an elastic component having a proximal end, a distal end, and an elongated trough adjacent the distal end. The elastic component has a slit that intersects the elongated trough.