Left Atrial Appendage Closure Implant With Passive Radial Fixation
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Solution Overview
Problem
Existing medical devices for closing the left atrial appendage in patients with atrial fibrillation fail to provide effective and secure closure without causing tissue damage, leading to potential thrombus formation and embolization.
Innovation Solution
A self-expandable occlusive medical implant with an expandable framework and occlusive element that exerts increasing radial force upon deployment, securing itself within the left atrial appendage without the need for piercing anchoring elements, and optionally includes a rotatable beam mechanism for enhanced securement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional closure devices are deployed to close the left atrial appendage, then closure is achieved, but tissue damage occurs and secure anchoring is insufficient
Solution Approach 1:
The device divides the closure function into two independent parts: a self-expanding stent framework that provides structural support and anchoring without tissue penetration, and a separate occlusive element that seals the appendage opening. This segmentation allows each component to perform its function effectively while avoiding the need for piercing anchoring elements that cause tissue damage.
Solution Approach 2:
The patent introduces an intermediary occlusive element between the stent framework and the left atrial appendage tissue. This intermediary component seals the appendage without requiring the stent to directly penetrate or damage the tissue, thereby achieving effective closure while minimizing harmful effects on the tissue.
2Stability of the object's composition
If piercing anchoring elements are used to secure the device, then secure anchoring is achieved, but tissue damage and thrombus formation risk increase
Solution Approach 1:
The patent replaces the mechanical piercing anchoring system with a self-expanding stent framework that achieves anchoring through radial expansion force. The stent expands to press against the appendage wall, creating secure anchoring without penetration, thereby eliminating the source of tissue damage and thrombus formation risk associated with piercing elements.
3Device complexity
If a self-expanding stent is used without mechanical expansion capability, then device simplicity is maintained, but securement force is insufficient
Solution Approach 1:
The patent introduces dynamic mechanical expansion capability to the stent framework, allowing it to transition from an expanded configuration to a securement configuration. This dynamic feature enables the stent to increase its radial force on demand while maintaining relative structural simplicity, as the expansion mechanism is integrated into the stent's own framework rather than requiring separate complex components.
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 implant provides secure closure of the left atrial appendage, reducing thrombus formation and embolization risks by exerting a strong radial force for anchoring, while minimizing tissue damage and allowing for reversible deployment.
Implementation Method 1
the expandable framework may exert a first radial force on the left atrial appendage in the expanded configuration and the expandable framework may exert a second radial force on the left atrial appendage in the securement configuration
Data Source
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AI summary
An occlusive medical implant for implantation within a left atrial appendage may include an expandable framework configured to self-expand from a collapsed configuration to an expanded configuration, and an occlusive element disposed on a proximal portion of the expandable framework. At least a portion of the expandable framework may be mechanically expandable from the expanded configuration to a securement configuration. When the occlusive medical implant is disposed within the left atrial appendage, the expandable framework exerts a first radial force on the left atrial appendage in the expanded configuration and the expandable framework exerts a second radial force on the left atrial appendage in the securement configuration. The second radial force is greater than the first radial force.