LAA Occluder Anchor Penetration System for Embolization Prevention
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Solution Overview
Problem
Current LAA occluder devices face challenges in reliably anchoring within the left atrial appendage without embolizing or migrating, especially due to varying LAA sizes and configurations, and existing solutions cause damage to the endocardium layer and neighboring structures during placement and retrieval.
Innovation Solution
An anchoring system comprising an outer sheath, delivery catheter, and anchor that penetrates the LAA wall to deploy an occluder device through the pericardial space, anchoring it via all three layers of the LAA wall to prevent embolization and facilitate easy retrieval and adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current LAA occluder devices are used to seal off the left atrial appendage, then the procedure can be performed with existing technology, but the devices fail to reliably anchor within the LAA and cause damage to the endocardium layer and neighboring structures
Solution Approach 1:
The patent introduces an anchor as an intermediary component that penetrates through the LAA wall to provide secure anchoring of the occluder device. The anchor acts as a mediator between the occluder device and the LAA wall, distributing mechanical stresses and preventing direct damage to the endocardium layer while ensuring reliable anchoring.
Solution Approach 2:
The occluder device is divided into multiple functional components: the occluder element for sealing, the anchor for anchoring, and the delivery system for deployment. This segmentation allows each component to perform its specific function optimally - the anchor provides secure anchoring without requiring the entire device to cause tissue damage.
2Reliability
If LAA occlusion procedures are performed to seal off the left atrial appendage, then thrombus formation can be prevented, but the devices may embolize or migrate out of the LAA into the systemic circulation
Solution Approach 1:
The anchor is designed to penetrate and secure the occluder device within the LAA wall before the device is fully deployed. This preliminary anchoring action prevents embolization or migration of the device into the systemic circulation, ensuring device stability before the occlusion function is activated.
Solution Approach 2:
The anchor features a curved or angled penetration path that follows the natural geometry of the LAA wall. This curved design allows the anchor to engage the tissue more effectively and prevent device migration, while the occluder element maintains its sealing function against the LAA ostium.
3Ease of operation
If existing occluder devices are deployed in the left atrial appendage, then the procedure can be completed, but retrieval and adjustment of the device is difficult or impossible
Solution Approach 1:
The anchor and occluder device are designed with dynamic characteristics that allow for controlled deployment and retrieval. The anchor can be partially or fully retracted into the delivery catheter, and the occluder device can be adjusted or removed if needed, providing operational flexibility without excessive structural complexity.
Solution Approach 2:
The anchor is designed to nest within the delivery catheter during the procedure, and the occluder device can be nested within or attached to the anchor structure. This nesting design facilitates easy retrieval and adjustment while minimizing the complexity of the overall device structure during the procedure.
4Adaptability or versatility
If occluder devices are placed within the left atrial appendage, then LAA occlusion can be achieved, but the devices cannot be optimally positioned due to varying LAA sizes and configurations
Solution Approach 1:
The anchor is designed with a universal structure that can adapt to varying LAA sizes and configurations. The anchor's penetration mechanism and anchoring geometry are designed to work across different anatomical variations, providing precise device placement without requiring multiple specialized device versions.
Solution Approach 2:
The delivery system and anchor design allow for adjustable parameters such as penetration depth, anchor expansion size, and occluder device positioning. These parameter changes enable the device to adapt to different LAA anatomies while maintaining precise placement and optimal sealing function.
Data Source
AI summary
The present invention relates in general to anchoring systems for occluder devices, and more specifically, to an anchoring system and method for implanting an occluder device within a left atrial appendage (“LAA”) of the heart. The anchoring system is configured so that an anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of an LAA wall. The purpose of the present invention is to provide an occluder device anchor that has a low risk of embolization and/or causing injury to neighboring valve structures. An additional purpose of the present invention is to provide an anchoring system and method for implanting an occluder device within the LAA that allows for the occluder device to be retrievable after initial placement, reusable, and repositionable for an optimal final placement within the LAA.