Self-Expanding Braided Occluder for Secure Atrial Anchoring
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Solution Overview
Problem
Current atrial appendage occlusion devices are inadequate for minimizing thrombus formation in patients with atrial fibrillation, particularly those contraindicated for anticoagulation, as they require large insertion locks and lack secure anchoring without detaching, and existing solutions fail to correctly position or are not flexible enough to accommodate varying atrial appendage sizes and heart movements.
Innovation Solution
A self-expandable occlusion device comprising a network of thin wires or threads, designed with a proximal retention region, central region, and distal retention region, made from shape memory materials like Nitinol or polymers, which can be minimally invasively inserted and expand to securely anchor in the atrial appendage, reducing the risk of thrombus formation and dislodgement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a traditional occlusion device is used for atrial appendage occlusion, then the device can be inserted into the atrial appendage, but it requires large insertion locks which increases device complexity and invasiveness
Solution Approach 1:
The occlusion device is designed to be nested within a delivery catheter in a compressed state during insertion, then self-expands to its functional configuration after deployment. This eliminates the need for large insertion locks by allowing the device to pass through a narrow catheter tip and then expand in situ within the atrial appendage.
Solution Approach 2:
The device transitions from a static, large-sized configuration requiring large locks to a dynamic system that can compress to a small size for insertion and then expand to its functional size after deployment. The self-expanding mechanism allows the device to adapt its size dynamically based on the insertion phase versus the functional phase.
2Reliability
If a traditional occlusion device is used, then it can occlude the atrial appendage, but it lacks secure anchoring which increases the risk of detaching especially in patients on anticoagulation
Solution Approach 1:
The device incorporates a flared distal end with a larger diameter than the body portion, creating a local structural feature that engages with the atrial appendage wall to prevent detachment. This localized geometric modification provides enhanced anchoring security specifically at the distal end without compromising the overall device design.
Solution Approach 2:
The occlusion device features an asymmetric geometry with a flared distal end that is larger in diameter than the proximal end. This asymmetric design creates a mechanical interlock with the atrial appendage tissue, making detachment difficult while allowing straightforward insertion and deployment.
3Stability of the object's composition
If a rigid occlusion device is used, then it provides structural stability, but it cannot accommodate varying atrial appendage sizes and heart movements
Solution Approach 1:
The occlusion device is constructed from a flexible wire mesh or braid structure that can deform and adapt to the contours of the atrial appendage. This flexible construction allows the device to accommodate variations in atrial appendage size and shape while maintaining structural integrity and providing stable occlusion.
Solution Approach 2:
The device incorporates dynamic flexibility through its wire mesh construction, allowing it to move with heart contractions and accommodate varying atrial appendage dimensions. The flexible structure maintains its occlusive function while adapting to the dynamic physiological environment of the beating heart.
4Ease of operation
If a non-self-expanding device is used, then it can be inserted, but it requires additional deployment mechanisms which increases device complexity
Solution Approach 1:
The occlusion device is designed as a self-expanding structure that automatically transitions from its compressed delivery configuration to its functional expanded configuration upon release from the delivery catheter. This self-service mechanism eliminates the need for complex external deployment mechanisms, simplifying the insertion procedure while ensuring reliable deployment.
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 effectively reduces thrombus formation and stroke risk by securely anchoring in the atrial appendage, allowing for complete endothelialization and minimizing material fatigue, with a minimally invasive procedure and reduced risk of complications, even in patients contraindicated for anticoagulation.
Implementation Method 1
made from shape memory materials like Nitinol or polymers
Implementation Method 2
designed with a proximal retention region, central region, and distal retention region, made from shape memory materials like Nitinol or polymers, which can be minimally invasively inserted and expand
Implementation Method 3
A self-expandable occlusion device comprising a network of thin wires or threads, designed with a proximal retention region, central region, and distal retention region
Data Source
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AI summary
An occlusion device (1) and a production process for its manufacture are described. The occlusion device includes a braiding (7) of wire or thread (7a), wherein the occlusion device (1) has a hollow design given by a reshaping and heat-treatment process, is self-expandable, and is configured for secure anchoring in the heart. The occlusion device (1) comprises a retention region and a central region (5) wherein the occlusion device is at least partly hollow.