LAA Isolator Inversion for Clot Containment
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Solution Overview
Problem
The left atrial appendage (LAA) is prone to forming blood clots in patients with atrial fibrillation, leading to thrombotic stroke, as existing methods are inadequate in effectively preventing clot release into the left atrium.
Innovation Solution
A system comprising a mesh body with anchors and a catheter-based isolator that isolates the LAA from the left atrium, using a self-collapsing or expandable mechanism to prevent clot release, and includes tools for manipulating and reshaping the LAA to secure the closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a plug is placed inside the LAA or a lasso loop is fastened around it, then the LAA closure is achieved, but the effectiveness in preventing clot release is inadequate
Solution Approach 1:
The LAA is inverted inside the left atrium, and a closure device is positioned around the inverted portion. This inversion approach allows the closure device to engage the LAA from the outside, creating a more secure seal that prevents clot release while maintaining a relatively simple device structure.
Solution Approach 2:
The closure device is delivered through a catheter in a compressed state, then expanded within the LAA. The nested delivery system allows the complex closure mechanism to be delivered through a simple catheter, reducing the apparent device complexity while maintaining high reliability for preventing clot release.
2Ease of operation
If the LAA is manipulated to close it, then closure is achieved, but blood clots may be released into the left atrium during manipulation
Solution Approach 1:
An isolator is deployed before LAA manipulation to create a protective barrier. This preliminary action prevents clot release during subsequent manipulation steps, allowing safe inversion and closure of the LAA while eliminating the harmful effect of clot embolization.
Solution Approach 2:
The isolator acts as an intermediary between the manipulation tools and the LAA contents. It allows manipulation to proceed while blocking the harmful effect of clot release, enabling safe closure operations.
3Reliability
If an isolator is used to prevent clot release, then clot containment is improved, but the device complexity increases
Solution Approach 1:
The isolator serves multiple functions: it contains clots during manipulation, provides a stable platform for closure device deployment, and can be integrated with the closure mechanism itself. This multi-functionality reduces the need for separate components, thereby reducing overall system complexity while maintaining high clot containment effectiveness.
Solution Approach 2:
The isolator and closure device are combined into a single integrated system. This merging eliminates the need for separate deployment steps and reduces the number of components, thereby reducing device complexity while maintaining reliable clot containment throughout the procedure.
Data Source
AI summary
A left atrium appendage (LAA) isolator, including:a body sized and shaped to fit an at least partially inverted LAA of a human adult, wherein a distal end of said body defines a two-state sealing adaptor interface configured in a first state to apply a radially outward force against a wall of said LAA or against a wall of said LAA opening sufficient to anchor said body to the LAA wall, and in a second state the sealing adaptor interface is configured to apply a radially inward force on a portion of the inverted LAA positioned within said body.