Rotating LAA Closure Hub and Hooks for Reliable Sealing
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Solution Overview
Problem
Existing medical devices for closing the left atrial appendage in patients with atrial fibrillation are inadequate in effectively preventing thrombi formation and migration, leading to stroke or heart attack risks.
Innovation Solution
A left atrial appendage closure device featuring a central hub and engagement arms with hooks, a drive mechanism, and a proximal cap, designed to rotate and seal against the atrial appendage tissue, utilizing a Nitinol frame for shape memory and adaptability to various appendage geometries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing medical devices are used to close the left atrial appendage, then the device structure is relatively simple, but the device is inadequate in effectively preventing thrombi formation and migration
Solution Approach 1:
The device is divided into multiple functional components: a delivery catheter for minimally invasive insertion, an occlusion device with expandable frame for sealing the appendage, and a retrieval system for removing thrombi. This segmentation allows each component to perform its specific function efficiently while maintaining overall system reliability.
Solution Approach 2:
The occlusion device is nested within the delivery catheter in a compressed state for insertion, then expanded within the left atrial appendage to perform its sealing function. The retrieval system can also be nested within the occlusion device structure, allowing for compact delivery and retrieval while maintaining device effectiveness.
2Reliability
If the engagement arms are designed to extend radially outwardly for effective sealing, then the sealing effectiveness is improved, but the device complexity increases
Solution Approach 1:
The engagement arms are designed to be dynamic rather than static - they can extend radially outwardly when needed to engage with the left atrial appendage tissue for effective sealing, and can be retracted or adjusted during the procedure. This dynamic configuration allows the device to adapt to varying anatomical conditions while maintaining sealing effectiveness.
Solution Approach 2:
The engagement arms can change their geometric parameters (extension length, radial position, engagement angle) based on the specific anatomical conditions of the patient's left atrial appendage. This parameter adjustment capability allows optimal sealing for different appendage geometries without requiring multiple different device designs.
3Adaptability or versatility
If the device uses shape memory Nitinol frame for adaptability to various appendage geometries, then the adaptability is improved, but the manufacturing complexity increases
Solution Approach 1:
The Nitinol frame is manufactured with specific shape memory parameters that allow it to transform from a compressed delivery configuration to an expanded functional configuration. The material's inherent shape memory properties enable the frame to adapt to various left atrial appendage geometries while maintaining a relatively simple manufacturing process, as the shape memory effect is achieved through controlled thermal or mechanical treatment during fabrication.
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 seals the left atrial appendage, reducing blood stagnation and thrombi formation, thereby minimizing the risk of emboli entering the bloodstream.
Implementation Method 1
utilizing a Nitinol frame for shape memory and adaptability to various appendage geometries
Data Source
AI summary
A left atrial appendage closure (LAAC) device is adapted to pull a left atrial appendage (LAA) closed on itself. The LAAC device includes a central hub and a plurality of engagement arms that are coupled to the central hub. At least some of the plurality of engagement arms include a tissue engaging region having one or more hooks that extend in a first circumferential direction. A drive mechanism is engaged with the central hub and is adapted to rotate the central hub in the first circumferential direction.