Atrial Appendage Plug Assembly for Recanalization-Resistant Occlusion
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Solution Overview
Problem
Current methods for occluding the left atrial appendage (LAA) during open heart surgery have high failure rates due to recanalization and lack of an easily deployable internal occluder device, posing a risk of blood clots and stroke.
Innovation Solution
A surgical occluder system comprising a biocompatible patch, strip, and delivery mechanism, which includes a base, guide rod, and shell, allowing secure deployment and occlusion of the LAA using biocompatible materials like bovine pericardium, facilitating endothelial integration and reducing thrombosis risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical closure is used to occlude LAA, then the procedure can be performed during open heart surgery, but the occlusion has high failure rate due to recanalization
Solution Approach 1:
The occlusion device is divided into multiple components: a delivery catheter for minimally invasive insertion, an expandable occluder element that segments into radial struts, and a separate anchoring mechanism. This segmentation allows the device to be delivered through a simple catheter while achieving complex occlusion functionality, resolving the contradiction between reliability and surgical complexity.
Solution Approach 2:
The device performs preliminary actions by first deploying an anchoring element at the LAA base to secure positioning, then expanding the occluder element to fill the cavity before final suturing. This staged preliminary action ensures proper positioning and initial stabilization before permanent fixation, improving occlusion reliability while maintaining procedural simplicity.
2Ease of operation
If percutaneous catheter-delivered devices are used to occlude LAA, then the procedure is less invasive, but the devices cannot be easily deployed during open heart surgery
Solution Approach 1:
The device is designed with multi-functionality to serve dual purposes: it can be delivered percutaneously like catheter devices but also deployed during open heart surgery with direct visual guidance and manual manipulation. The occluder element can be expanded and secured both percutaneously and with surgical assistance, making the device universally applicable to different surgical approaches while maintaining reliability.
Solution Approach 2:
The delivery catheter serves as an intermediary that facilitates minimal invasive delivery, while surgical instruments and direct visualization act as intermediaries during open heart surgery to assist deployment. This dual intermediary system allows the device to be easily deployed during surgery while maintaining the reliability benefits of both percutaneous and surgical approaches.
3Reliability
If external LAA occlusion devices are used, then the occlusion can be achieved with simple clipping, but the closure may not prevent recanalization effectively
Solution Approach 1:
The occluder element is nested within the delivery catheter in a compressed state, then expanded radially within the LAA cavity like a nested doll unfolding. This nesting allows the complex expandable structure to be delivered through a simple catheter, reducing delivery complexity while maintaining the reliable recanalization prevention provided by the expandable occlusion element.
Solution Approach 2:
The occluder element utilizes flexible thin-film struts that can be compressed for delivery and then expanded to fill the LAA cavity, creating an effective barrier against recanalization. These flexible films conform to the LAA geometry while maintaining structural integrity, achieving reliable occlusion without requiring complex rigid structures.
Data Source
AI summary
A system, method, and device for occluding an anatomical cavity, such as an atrial appendage are provided. The system includes a biocompatible plug assembly comprising a patch and strip made of, for example, bovine pericardium, where the strip is flexible and foldable on itself to reduce its vertical profile, as well as a surgical occlusion device configured to deliver the strip into an anatomical cavity to pack the anatomical cavity. The patch may be secured to an opening of the anatomical cavity, to create a secure plug preventing fluid or material passage. Applied to a left atrial appendage, the system and method reduce the risk of cardioembolic strokes from atrial fibrillation.