Foam LAA Occluder with Tissue Ingrowth Anchoring
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Solution Overview
Problem
Existing LAA occlusion devices face challenges in accurately sizing to match variable LAA anatomy, often leading to overstretching, leakage, and bleeding complications due to their circular design and reliance on hooks or barbs for anchoring, which limits their effectiveness in preventing blood clots from embolizing.
Innovation Solution
A self-expandable open cell foam device with a skin covering, capable of tissue ingrowth anchoring, that can be delivered through a catheter and conforms to the LAA shape, reducing the need for extensive pre-procedure imaging and minimizing the risk of emboli formation, using ePTFE or other materials for strength and tissue integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a circular metal device is used to occlude the LAA, then the device can be manufactured with standard geometry, but the device cannot conform to the variable LAA anatomy leading to poor sealing and residual leakage
Solution Approach 1:
The patent employs a flexible fabric or mesh material that can be delivered in a compressed state and then expanded to conform to the LAA ostium. This flexible structure adapts to the variable anatomy of different patients without requiring precise pre-matching, eliminating residual leakage while maintaining ease of manufacture through standardized delivery systems.
Solution Approach 2:
The device utilizes shape memory alloys or phase-change materials that allow the occluder to transition from a compressed delivery state to an expanded functional state. This parameter change enables the device to automatically adapt to the LAA geometry upon deployment, achieving both manufacturing simplicity and anatomical conformity.
2Reliability
If the device is oversized to ensure adequate sealing, then sealing is improved, but the LAA ostium becomes overstretched leading to tearing and bleeding into the pericardial space
Solution Approach 1:
The device is designed with dynamic expansion capabilities, allowing it to be delivered in a compressed state through a catheter and then gradually expanded to the appropriate size. This dynamic approach enables the operator to adjust the final device size to match the actual LAA ostium dimensions, achieving reliable sealing without overstretching or tearing the tissue.
Solution Approach 2:
The occluder is divided into multiple expandable segments or struts that can be deployed in a controlled sequence. This segmentation allows for gradual expansion and adjustment, enabling the device to conform to the LAA ostium without exerting excessive force that could cause tissue damage, while still achieving adequate sealing.
3Object-affected harmful factors
If the device is too small to avoid overstretching, then tissue damage is reduced, but the device cannot adequately seal the ostium and becomes prone to embolization
Solution Approach 1:
The device maintains a compressed small size during delivery to avoid tissue damage, then dynamically expands to the appropriate larger size upon deployment to achieve adequate sealing. This dynamic size adjustment resolves the contradiction by allowing the device to be small during insertion and large during function.
4Reliability
If an array of radially disposed barbs or hooks is used for anchoring, then the device can be secured in place, but the device cannot be repositioned once fully expanded and may cause bleeding into the pericardial space
Solution Approach 1:
The patent removes the problematic barbs or hooks from the device design entirely. Instead, anchoring is achieved through the friction fit of the expanded fabric or mesh structure against the LAA ostium, or through tissue ingrowth over time. This extraction of harmful anchoring elements maintains reliability while enabling repositioning if needed.
Solution Approach 2:
A separate delivery catheter or positioning mechanism serves as an intermediary that allows the device to be secured and repositioned during the procedure. The intermediary provides the anchoring function temporarily during deployment, then can be removed or left in place without causing tissue damage, enabling both secure anchoring and repositioning capability.
5Manufacturing precision
If multiple device sizes are offered to match variable LAA anatomy, then anatomy matching is improved, but extensive pre-procedure imaging is required increasing device complexity and procedure time
Solution Approach 1:
The patent describes a universal device design that can accommodate a wide range of LAA ostium sizes through dynamic expansion. Instead of offering multiple fixed-size devices, a single multi-functional device is provided that can be expanded to match various anatomies, eliminating the need for extensive pre-procedure imaging and complex sizing decisions.
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
The foam device effectively occludes the LAA, reduces the risk of bleeding and embolization, and allows for repositioning without hooks or barbs, providing a secure seal that adapts to the native LAA configuration, thereby addressing the limitations of prior devices.
Implementation Method 1
The body is compressible within a delivery catheter and can self expand to a larger diameter when released from the delivery catheter
Implementation Method 2
Anchoring of these plugs are made by tissue ingrowth from the LAA into the foams, adhesives, barbs or distal anchoring elements
Data Source
AI summary
Devices and methods for occluding the left atrial appendage (LAA) to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. A foam implant encapsulated with a tough thromboresistent membrane is placed via transvascular means into the LAA and anchored with adhesives and/or mechanical anchors. Tissue over- and in-growth are optimized to anchor the implant in place and provide a permanent occlusion.