Flexible Coil Connector for Implantable Medical Devices
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Solution Overview
Problem
Implantable medical devices, such as filters and occluders, face challenges with misalignment and migration in vivo, particularly in curved lumens, due to their rigid structures which can exert straightening forces on vessels, and are often limited in deployment orientation and retrieval direction.
Innovation Solution
A double-ended medical device with a flexible coil connecting element that allows the device to conform to curved vessels without straining the vessel walls, featuring a closure element like a valve or thrombogenic fibers to prevent fluid loss, and made from materials like shape memory alloys for enhanced flexibility and deployment ease.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid double-ended device structure is used, then positional stability and migration resistance are improved, but the device cannot conform to curved lumens and may exert straightening forces on the vessel
Solution Approach 1:
The device is divided into multiple segments: first and second material capture elements connected by a flexible connecting element. This segmentation allows each component to maintain structural integrity while the connection between them provides flexibility to conform to curved vessel geometries without exerting excessive straightening forces.
Solution Approach 2:
The flexible connecting element is constructed from shape memory alloy or other flexible materials that can bend and conform to the curved geometry of blood vessels. This flexible connection maintains the double-ended structure's stability while adapting to curved lumens without causing vessel damage.
2Adaptability or versatility
If a flexible connecting element is used, then adaptability to curved vessels is improved, but device structural stability may be reduced
Solution Approach 1:
The device utilizes composite construction combining rigid material capture elements (for stability and filtration function) with flexible connecting elements made of shape memory alloy or elastic materials (for conformability). This composite approach balances structural stability with adaptability to curved vessel geometries.
Solution Approach 2:
The flexible connecting element provides dynamic adaptability, allowing the device to adjust its configuration to match the vessel's curvature while maintaining overall structural integrity. The shape memory alloy can transition between different states to provide both flexibility and structural support as needed.
3Ease of operation
If the connecting element is a coil with lumen, then ease of delivery over guide wire is improved, but risk of blood or debris loss through the centre increases
Solution Approach 1:
The closure element is positioned within the coil's lumen before deployment. During delivery, the guide wire passes through the open coil structure, and upon deployment, the closure element automatically or manually closes the lumen to prevent blood or debris loss through the center of the device.
Solution Approach 2:
The closure element acts as an intermediary component that seals the central lumen of the coil after delivery. This allows the coil to maintain its open structure for easy delivery over the guide wire while the closure element prevents unwanted passage of blood or debris through the center.
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 device can be securely deployed in either orientation within curved vessels with minimal impact on the vessel walls, maintaining patency and preventing blood or debris loss, while allowing for easy retrieval and reduced migration risks.
Implementation Method 1
a flexible coupling between the two material capture elements, which enables the device to follow the curve of a vessel without imparting unnecessary straightening forces on the vessel
Implementation Method 2
made from materials like shape memory alloys for enhanced flexibility and deployment ease
Data Source
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AI summary
An implantable medical device (10) includes first and second material capture elements (12, 14) which are disposed in opposing orientations and have their narrow ends (18) facing one another. The first and second material capture elements (12, 14) are connected by a flexible connector (26), which enables the implantable medical device (10) to curve within a curved vessel of a patient. The flexible connector (26) is either closed or has a lumen passing therethrough and includes a closure element for closing the lumen after deployment of the device (10) within a patient. The structure enables the device (10) to be positioned reliably within a curved vessel and benefits from the advantage of a double-ended device.