Endocardial Left Atrial Appendage Inversion and Excision
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Solution Overview
Problem
Current methods for managing the left atrial appendage in patients with atrial fibrillation are invasive, costly, and carry risks, such as bleeding complications and the need for open-heart surgery, as they often involve foreign objects that can leak or obstruct, failing to effectively prevent stroke risk.
Innovation Solution
A minimally invasive endocardial method and device for inverting and excising the left atrial appendage using a percutaneous trans-septal catheter, which engages the appendage, inverts it, secures it with closure devices, and separates it from the heart using a separation apparatus, allowing for removal without leaving medical devices behind, thereby reducing stroke risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endocardial procedures use appendage occlusive devices, then stroke risk is reduced, but the devices can leak into the LAA and cause complications
Solution Approach 1:
The patent removes the LAA entirely from the body through excision, rather than attempting to occlude it with a device that remains in place. The extraction process involves engaging the LAA with a grasping device, pulling it into the left atrium, cutting it free from the left atrial wall, and removing it completely through the transseptal puncture site, thereby eliminating the source of clot formation without leaving any occlusive device behind
Solution Approach 2:
The patent inverts the conventional approach by not trying to seal the LAA opening but rather by removing the entire appendage structure. Instead of placing something inside the LAA to block it, the procedure pulls the LAA inside out and excises it, turning the occlusion problem into a removal problem that eliminates the harmful structure entirely
2Reliability
If surgical suturing or pericardial clips are used for LAA closure, then stroke risk is reduced, but the procedures are expensive and carry additional surgical risks
Solution Approach 1:
The patent replaces complex surgical mechanical systems (suturing devices, pericardial clips, open-heart surgery equipment) with a simpler catheter-based mechanical system that can be delivered percutaneously. The excision device uses basic mechanical actions of grasping, pulling, and cutting that can be performed through a catheter rather than requiring sophisticated surgical instrumentation
Solution Approach 2:
The patent changes the access parameter from open surgical access to percutaneous transseptal catheter access. This parameter change transforms the procedure from complex open-heart surgery to a less invasive catheter-based procedure, reducing surgical risks and costs while maintaining effectiveness in removing the LAA
3Reliability
If foreign objects are placed within the LAA by trans-septal catheter, then stroke risk is reduced, but long-term risks of complications increase
Solution Approach 1:
The patent extracts the LAA entirely from the body rather than leaving foreign objects within it. By removing the appendage completely through the transseptal puncture site, the procedure eliminates the source of clot formation while avoiding the long-term complications associated with having permanent foreign devices embedded in the cardiac structure
Solution Approach 2:
The patent discards the LAA structure entirely rather than retaining it with occlusive devices. The excised LAA is removed from the body, and the transseptal puncture site is closed, leaving no permanent foreign objects. This discarding approach eliminates long-term complications while maintaining stroke prevention benefits
Data Source
AI summary
Disclosed are methods and devices for endocardial left atrial appendage management (LAAM) by inversion and excision. The methods may comprise inserting an inverter apparatus into an interior cavity of the left atrial appendage (LAA) of a subject and inverting the LAA, closing the base portion of the inverted LAA with the one or more closure devices, separating the inverted LAA from the left atrium with a separation apparatus positioned at the base portion of the inverted LAA adjacent to the one or more closure devices, and removing the separated LAA from the subject.