Patient-Specific Inflatable LAA Occluder for Reliable Sealing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current treatments for reducing stroke risk in atrial fibrillation patients, such as warfarin or oral anti-coagulants, are systemic and increase bleeding risks, while existing occlusion devices may not provide a sufficient seal to prevent clot formation in the left atrial appendage (LAA).
Innovation Solution
A patient-specific occluder device, the MSO device, is designed to match the unique morphology of the LAA using CT imaging, deployed via a catheter, and inflated with a biocompatible material to create a seal, reducing the need for systemic anti-coagulation by preventing clot formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic anti-coagulant therapy (warfarin or oral anti-coagulants) is used to reduce stroke risk, then the risk of stroke due to atrial fibrillation is reduced, but the risk of bleeding increases dramatically
Solution Approach 1:
The invention extracts the anticoagulant function from systemic circulation and relocates it locally to the left atrial appendage by filling the LAA with an anticoagulant composition. This confines the therapeutic effect to the clot-forming region while minimizing exposure to the rest of the body, thereby reducing bleeding risk while maintaining stroke prevention efficacy
Solution Approach 2:
The left atrial appendage acts as an intermediary compartment that contains the anticoagulant composition. By delivering the anticoagulant to this specific anatomical structure that is responsible for most thrombus formation, the system achieves localized therapy that prevents stroke without the systemic bleeding complications of traditional anticoagulant administration
2Reliability
If standard occlusion devices are used to occlude the left atrial appendage, then the LAA is occluded, but the seal is insufficient to prevent clot formation
Solution Approach 1:
The invention applies local quality by combining mechanical occlusion with localized delivery of anticoagulant composition directly into the LAA. The anticoagulant is delivered to specific regions within the LAA that are prone to clot formation, creating a localized therapeutic effect that enhances the effectiveness of the occlusion device without requiring perfect mechanical seal
Solution Approach 2:
The invention uses a composite approach by combining an occlusion device with an anticoagulant composition. The occlusion device provides mechanical barrier function while the anticoagulant composition provides chemical prevention of thrombus formation, creating a dual-mechanism system that overcomes the limitations of either approach alone
3Reliability
If patient-specific occluder devices are designed to match unique LAA morphology, then the seal quality improves, but the device complexity and manufacturing requirements increase
Solution Approach 1:
The invention applies local quality by combining mechanical occlusion with localized delivery of anticoagulant composition directly into the LAA. The anticoagulant is delivered to specific regions within the LAA that are prone to clot formation, creating a localized therapeutic effect that enhances the effectiveness of the occlusion device without requiring perfect mechanical seal
Solution Approach 2:
The invention uses a universal delivery system that can accommodate various LAA morphologies. The catheter-based delivery system and balloon expansion mechanism provide a standardized approach that works across different patient anatomies, while the anticoagulant composition can be delivered in patterns that adapt to the specific geometry of each patient's LAA, reducing the need for fully custom devices
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3D
AI summary
The present disclosure describes a device that can be implanted into the left atrial appendage for occlusion. The device can prevent or reduce thrombus formation in this anatomic region for patients with atrial fibrillation. This device includes a patient-specific inflatable device that represents a patient's anatomy or morphological class. The inflatable device can be designed by imaging (e.g., computed tomography, magnetic resonance imaging) the patient's anatomy. Through a catheter (or surgically), the inflatable device can be filled with an inflation fluid to occlude the appendage in a patient-specific fashion.