Multifunctional LAA Occluder with Conformable Foam Frame
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Solution Overview
Problem
Existing LAA occlusion devices face challenges in achieving effective sealing due to variability in LAA size and anatomy, leading to issues like overstretching, residual leakage, and complications in delivery and repositioning, particularly in patients with atrial fibrillation who cannot use anticoagulants due to bleeding risks.
Innovation Solution
A multifunctional LAA occluder with a conformable frame and foam design that conforms to the oval shape of the LAA, allowing for superior sealing without extensive pre-procedure imaging and enabling off-axis delivery, equipped with sensors and electronic systems for additional functionalities like pacing and drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If existing LAA occlusion devices are used to seal the LAA ostium, then occlusion is achieved, but the device forces the oval LAA ostium to take the round shape of the device resulting in residual leakage at the edges due to poor sealing
Solution Approach 1:
The device employs an asymmetric oval-shaped occlusion element that matches the natural oval geometry of the LAA ostium rather than forcing a round shape. This asymmetric design allows the device to conform to the native anatomy, eliminating residual leakage at the edges while maintaining effective occlusion.
2Manufacturing precision
If the occlusion device is significantly oversized to ensure sealing, then sealing coverage is improved, but the LAA ostium may become overstretched leading to tearing, resulting in bleeding into the pericardial space
Solution Approach 1:
The device utilizes a compliant frame structure that can dynamically adjust its dimensional parameters to match the actual LAA ostium size. This parameter adaptability allows the device to achieve complete sealing coverage without being significantly oversized, thereby preventing ostium overstretching and tissue tearing while maintaining adequate seal.
3Device complexity
If the occlusion device is too small to match variable LAA size, then device simplicity is maintained, but it will not adequately seal the ostium and may be prone to embolization
Solution Approach 1:
The device incorporates a dynamic sizing mechanism where the occlusion element can expand or contract to match the variable LAA ostium dimensions. This dynamic adaptability ensures adequate sealing across different LAA sizes without requiring multiple fixed-size devices, maintaining device simplicity while achieving proper seal.
4Strength
If existing devices require sufficient spring force or stiffness to seal and anchor to surrounding tissue, then anchoring strength is improved, but these devices may lead to leaking of blood through the tissue into the pericardial space which may lead to cardiac tamponade
Solution Approach 1:
The device employs a compliant frame constructed from flexible materials that can conform to and gently anchor against the LAA ostium tissue. This flexibility allows the device to achieve sufficient anchoring strength through adaptation to tissue contours rather than through rigid stiffness, preventing blood leakage into the pericardial space while maintaining secure positioning.
5Ease of operation
If existing devices require positioning in the LAA coaxial to the axis of the LAA, then device alignment is simplified, but delivery complexity increases and repositioning is limited once the implant is fully expanded
Solution Approach 1:
The asymmetric oval-shaped occlusion element provides inherent directional orientation that guides correct positioning during delivery. This asymmetric geometry allows the device to be delivered off-axis relative to the LAA while still achieving proper alignment upon deployment, simplifying the delivery procedure and enabling repositioning capability after full expansion.
Data Source
AI summary
Devices and methods for occluding the left atrial appendage (LAA) with a device having multifunctional capability. The device is delivered via transcatheter delivery into the LAA and anchored using a compliant frame and scaffold, which may be foam. The device further includes one or more electronic systems to provide a multitude of features related to sensing, electrical stimulation, pacing, communication, etc. The device may have an open configuration where an opening in the proximal end of the device allows for delivery of one or more sensors into and/or through the device. The device may be manipulated into a closed configuration to secure the electronic systems therein and close off the proximal end to provide the occlusive effects. The electronic systems therein may then be used for the various electronic and other functions.