Stepped Balloon Occluder for Left Atrial Appendage
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Solution Overview
Problem
Existing left atrial appendage occlusion devices face challenges such as irregular atrial appendage shapes, incomplete occlusion, risk of penetration due to uncontrollable barb insertion, and the need for anticoagulant drugs due to metal contact, limiting their applicability and safety.
Innovation Solution
A replaceable left atrial appendage occluder comprising a stepped balloon and an elastic umbrella-shaped occlusion disc, which are connected and fixed on either side of the atrial appendage, using a clamping mechanism to occlude the appendage without metal contact, reducing thrombosis risk and adapting to varying morphologies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If barbs are provided on the occlusion device to prevent displacement, then the device stability is improved, but the risk of penetrating the atrial wall and causing pericardial effusion increases
Solution Approach 1:
The invention removes the harmful barbs from the occlusion device while maintaining device stability through alternative means. The balloon anchoring mechanism provides stabilization without the need for penetrating barbs, thereby eliminating the risk of atrial wall penetration and pericardial effusion associated with traditional barb designs.
Solution Approach 2:
The balloon acts as an intermediary anchoring mechanism between the occlusion device and the atrial wall. Instead of using barbs that directly penetrate the wall, the balloon provides indirect anchoring through inflation within the atrial cavity, achieving device stability without direct wall penetration.
2Strength
If a large area of nickel-titanium alloy framework is used to contact the bloodstream, then the structural strength is improved, but the risk of thrombus formation increases requiring anticoagulant drugs
Solution Approach 1:
The invention removes the nickel-titanium alloy framework from direct contact with the bloodstream. The occlusion device uses a balloon-based mechanism that minimizes metal exposure to blood, thereby reducing the surface area available for thrombus formation and eliminating the need for prolonged anticoagulant therapy.
Solution Approach 2:
The invention employs a balloon (flexible shell) as the primary occlusion and anchoring mechanism. This flexible membrane structure replaces the rigid metal framework, providing the necessary structural function while presenting a non-thrombogenic surface to the bloodstream.
3Reliability
If the occlusion umbrella is designed to completely seal the left atrial appendage orifice, then the occlusion effectiveness is improved, but the adaptability to irregular atrial appendage shapes decreases
Solution Approach 1:
The invention employs a dynamic balloon that can be inflated to various sizes and shapes to adapt to different atrial appendage geometries. The balloon's flexibility and adjustability allow it to conform to irregular orifices while maintaining complete occlusion, unlike fixed-geometry occlusion umbrellas.
Solution Approach 2:
The invention changes the geometric parameters of the occlusion element by inflating the balloon to match the specific dimensions and shape of the patient's left atrial appendage orifice. This parameter adjustment allows the device to adapt to various morphologies while achieving complete sealing.
Data Source
Figure 1~2
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Figure 5a~5b
AI summary
A replaceable left atrial appendage occlusion assembly and an implanting method thereof are provided. The left atrial appendage occlusion assembly includes a stepped balloon (2) and an occlusion disc (3). The left atrial appendage orifice occlusion portion (211) of the stepped balloon (2) is configured to completely occlude the left atrial appendage orifice. The left atrial anchor portion (212) of the stepped balloon (2) is configured to be clamped on the left atrial wall to prevent the left atrial appendage occlusion assembly from shifting. The occlusion disc (3) is released in the pericardial cavity, and is connected to the stepped balloon (2) by the connecting column (31) of the occlusion disc (3), so that the left atrial appendage is pressed and occluded between the stepped balloon (2) and the occlusion disc (3). The stepped balloon (2) occludes the left atrial appendage orifice. The surface of the stepped balloon is smooth and coated with an anticoagulant coating. The left atrial appendage occlusion assembly can occlude various types of left atrial appendages, and prevent the formation of thrombosis. In this way, patients do not need to take anticoagulant drugs after the procedure.