Left Atrial Appendage Occlusion Device with Two-Way Anchoring Stent

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Solution Overview

Problem

Conventional percutaneous left atrial appendage occlusion devices struggle to achieve stable fixation and complete occlusion due to the complex anatomy of the left atrial appendage, leading to incomplete sealing and potential abrasion between the appendage and the pericardium, with existing occluders often failing to fit securely and causing trauma.

Innovation Solution

A left atrial appendage occlusion system featuring a plum blossom-shaped metal stent released via a catheter, which is firmly fixed at the entrance of the left atrial appendage, and a double-disc occluder is deployed on the stent to completely occlude the passage between the left atrium and the left atrial appendage, utilizing two-way anchoring thorns and a delivery system for precise placement and adjustment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a conventional occluder is used to occlude the left atrial appendage, then the procedure is minimally invasive, but the occluder cannot fully fit the complicated anatomic structure and cannot be stably fixed

Engineering Contradiction:
Improveminimally invasive procedureVSAvoidstable fixation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device is divided into two functional parts: a stent component for providing a stable base and anchoring structure, and an occluder component for sealing the appendage opening. This segmentation allows each component to optimize its function independently while working together to solve both the minimally invasive requirement and the stable fixation requirement

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stent is deployed first to establish a stable foundation and anchoring structure at the appendage opening before the occluder is released. This preliminary action ensures that the subsequent occluder placement is supported by a pre-formed stable structure, enabling reliable fixation while maintaining the minimally invasive approach

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the occluder is positioned within the left atrial appendage, then occlusion is achieved, but the support force may expand the left atrial appendage leading to abrasion between the appendage and the pericardium

Engineering Contradiction:
Improveocclusion effectVSAvoidabrasion between appendage and pericardium
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By separating the occlusion function (occluder) from the support function (stent), the device allows the stent to provide structural support that prevents appendage expansion, while the occluder focuses on sealing without bearing the full support load, thereby reducing the risk of pericardial abrasion

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stent acts as an intermediary structure between the occluder and the left atrial appendage wall. It provides a supportive framework that distributes forces evenly, preventing direct expansion of the appendage by the occluder's support force, thus eliminating the harmful abrasion effect while maintaining effective occlusion

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a hard anchoring thorn is used to stab into the wall of the left atrial appendage, then stable fixation is achieved, but it may pierce the left atrial appendage and hinder recovery and replacement

Engineering Contradiction:
Improvestable fixationVSAvoidpiercing and trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The anchoring thorns are designed with non-uniform characteristics: they have a sharp tip for easy penetration and stable fixation, but the shaft and base are softer and more compliant. This local quality variation allows the thorn to achieve stable fixation at the tip while the softer body minimizes trauma and allows for potential recovery and replacement if needed

Inventive Principle:
Principle #3Local quality

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 system ensures secure and precise fixation of the stent and occluder, preventing stroke-causing thrombi while avoiding enlargement of the left atrial appendage, thus minimizing the risk of abrasion and facilitating easy relocation or replacement of the occluder.

Implementation Method 1

the stent is formed by laser-cutting a nickel-titanium alloy tube or heat shaping braided nickel-titanium alloy wires

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

the stent is formed by laser-cutting a nickel-titanium alloy tube or heat shaping braided nickel-titanium alloy wires

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Implementation Method 3

utilizing two-way anchoring thorns and a delivery system for precise placement and adjustment

Methodology Applied
Scientific EffectMechanical interlocking: Mechanical Fastener

Data Source

PatentUS9763666B2Left atrial appendage plugging device and delivery system
Publication Date: 2017.09.19 APT MEDICAL INC
  • US9763666B2 patent drawing
  • US9763666B2 patent drawing
  • US9763666B2 patent drawing

AI summary

A left atrial appendage occlusion device and a delivery system are provided, wherein the left atrial appendage occlusion device includes a stent and an occluder. Firstly, the stent is implanted and fixed at the entrance of the left atrial appendage; then, a double-disc occluder is released on the stent to occlude the left atrial appendage. The left atrial appendage occlusion device includes a self-expandable nitinol stent, which is firmly fixed at the entrance of the left atrial appendage via a two-way anchoring thorn, and then an occluder is released on the stent. The left atrial appendage occlusion device is delivered to the left atrial appendage by the delivery system. Compared with the prior art, the delivery system improves the releasing accuracy and the implanting stability of the occluder. After being released, both the stent and the occluder can be withdrawn into a catheter to be relocated or replaced.