Crosslinkable Biomaterial LAA Occlusion via In Situ Polymerization
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Solution Overview
Problem
Current methods for occluding the left atrial appendage (LAA) in patients with atrial fibrillation are inadequate, as existing occlusion implants fail to completely seal the LAA in many patients, leading to incomplete closure and risks such as thrombus formation and life-threatening perforations, while pharmacological therapies have undesirable side effects and compliance issues.
Innovation Solution
A method involving the injection of a crosslinkable biomaterial into the LAA, which forms a biocompatible polymeric matrix that occludes the cavity without impairing cardiac function, using a delivery catheter that can accommodate the irregular shape of the LAA and ensure complete occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous occlusion implants are used in the LAA, then the procedure is less invasive compared to surgical techniques, but the implants cannot completely seal the LAA in all patients due to non-uniform shape, resulting in incomplete closure
Solution Approach 1:
The patent employs shape-memory alloys that change their physical state from a compressed delivery configuration to an expanded deployed configuration through temperature or mechanical triggers. This parameter change enables the implant to adapt to the non-uniform LAA geometry, achieving complete closure while maintaining percutaneous delivery minimality
Solution Approach 2:
The implant utilizes dynamic shape-memory materials that can transition between different shapes and sizes. The device is delivered in a compressed state through a catheter, then dynamically transforms to an expanded conforming shape within the LAA, allowing it to adapt to varying patient anatomies and achieve reliable occlusion
2Ease of operation
If existing occlusion implants are used, then the procedure can be performed percutaneously, but the implants cause life-threatening perforations of the LAA during placement
Solution Approach 1:
The patent incorporates radiopaque markers and imaging guidance capabilities that allow real-time visualization of the implant during deployment. This beforehand detection and monitoring prevents malpositioning and perforation by allowing the operator to adjust the implant position before full deployment, cushioning against the harmful effect of perforation
Solution Approach 2:
The implant utilizes a flexible, self-expanding mesh structure that can conform to the LAA geometry without exerting excessive localized force. This flexible construction distributes pressure evenly across the LAA opening, preventing perforation while maintaining the percutaneous delivery advantage
3Reliability
If anticoagulant therapy is administered to prevent thrombus formation, then stroke prevention is achieved, but medication side effects such as hemorrhage and lack of patient compliance occur
Solution Approach 1:
The patent extracts the thrombus prevention function from systemic pharmacological therapy and relocates it to a localized mechanical solution. By completely occluding the LAA, the device eliminates the thrombus formation site, removing the need for anticoagulant medication and its associated side effects while maintaining stroke prevention efficacy
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
This approach effectively reduces thromboembolic events by providing a durable and biocompatible occlusion that minimizes adverse cardiac impacts and avoids the limitations of existing therapies, including anticoagulant use and surgical risks.
Implementation Method 1
The crosslinkable biomaterial can crosslink in situ in the LAA, forming a biocompatible polymeric matrix
Data Source
AI summary
Provided herein are methods, compositions, and devices for occluding cavities or passageways in a patient, in particular cavities or passageways in the cardiovascular system of a patient, such as the LAA of a patient's heart. The methods, compositions, and devices can be used to percutaneously occlude the LAA, decreasing the risk of thromboembolic events associated with AF.