Resilient Mesh LAA Occlusion Device for Stable, Tissue-Integrated Sealing
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Solution Overview
Problem
Current LAA occlusion devices face challenges such as pericardial effusion, device dislodgement, blood clot formation, and anatomical incompatibilities, necessitating improved occlusion devices that promote effective endothelialization and minimize the need for additional materials in the left atrial space.
Innovation Solution
An occlusion device with a substantially solid marker band and a resilient mesh body, featuring a dual-layer mesh configuration and a bolus of additional mesh material, designed to expand in a low profile manner to seal the LAA opening and promote endothelialization, reducing the need for additional materials and enhancing compatibility with varying anatomies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current expandable nitinol frame devices are used for LAA occlusion, then device deployment is achieved, but pericardial effusion and device dislodgement occur
Solution Approach 1:
The patent employs a flexible polymer coating applied to the nitinol frame, creating a thin film layer that reduces direct contact between the metal frame and pericardial tissue. This flexible shell minimizes pericardial effusion while maintaining device stability and preventing dislodgement through the underlying nitinol structure.
Solution Approach 2:
The device combines nitinol frame with polymer coating materials to create a composite structure. The nitinol provides mechanical strength and stability, while the polymer coating reduces harmful interactions with surrounding tissues, thereby preventing pericardial effusion and maintaining device reliability.
2Reliability
If current occlusion devices are used, then LAA occlusion is achieved, but blood clot formation occurs on the device surface
Solution Approach 1:
The polymer coating acts as a flexible shell that creates a smooth, non-thrombogenic surface on the device. This thin film layer prevents blood clot formation on the device surface while maintaining the occlusion effectiveness of the nitinol frame structure.
Solution Approach 2:
The patent modifies the surface parameters of the device through polymer coating, changing the surface properties from metallic to polymeric. This parameter change reduces thrombogenicity and prevents blood clot formation while preserving the device's occlusion function.
3Reliability
If current devices with solid structure are used, then occlusion is achieved, but tissue integration is limited
Solution Approach 1:
The patent incorporates a porous polymer coating on the nitinol frame, creating a porous structure that allows tissue ingrowth. This porous material enhances tissue integration and stability while maintaining the occlusion stability provided by the underlying nitinol frame.
Solution Approach 2:
The composite structure combines nitinol frame with porous polymer coating, where the porous polymer facilitates tissue integration and stabilization. This composite approach maintains occlusion stability through the nitinol while enhancing biological compatibility through the porous polymer material.
4Reliability
If multiple coils or framing wires are used to achieve occlusion, then occlusion effectiveness is improved, but device complexity and procedure time increase
Solution Approach 1:
The patent merges the functions of multiple separate components (coils, framing wires, nitinol cage) into a single integrated device. The polymer-coated nitinol frame combines occlusion, stabilization, and tissue integration functions in one component, reducing device complexity and procedure time while maintaining occlusion effectiveness.
Solution Approach 2:
The nitinol frame with polymer coating serves multiple functions simultaneously: it provides occlusion, stabilization, tissue integration, and prevents pericardial effusion. This multi-functional design eliminates the need for separate coils or framing wires, reducing device complexity while maintaining occlusion effectiveness.
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 occludes the LAA by minimizing blood flow, traps clots, and facilitates endothelial growth, while being compatible with diverse LAA morphologies, reducing the risk of clot emboli and minimizing the need for anticoagulation therapy.
Implementation Method 1
a resilient mesh body attached within the marker band, wherein the resilient mesh body has a length y... the resilient mesh body has a first delivery shape and a second expandable deployed shape
Implementation Method 2
promoting more effective endothelialization around the device... facilitates endothelial growth
Data Source
Figure 1
Figure 2
AI summary
Provided herein is an occlusion device comprising: (a) a substantially solid marker band (40) having an inner and outer diameter, a proximal end, and a distal end; and (b) a resilient mesh body (20) attached within the marker band (40), wherein the body (20) has a length y, and wherein the device comprises a bolus (30) of additional resilient mesh material of a length x arranged within said body (20) and, and wherein the body (20) extends distally from the marker band (40) and wherein the body (20) has a first delivery shape and a second expandable deployed shape.