Conformable Foam LAA Occlusion With Repositionable Anchors
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Solution Overview
Problem
Existing LAA occlusion devices are difficult to size correctly, often require extensive pre-procedure imaging, and may cause bleeding or leakage due to poor sealing and anchoring, making them unsuitable for patients with atrial fibrillation who cannot take anticoagulants.
Innovation Solution
A foam implant with deployable anchors is delivered transcatheter and anchored using an internal locking system, allowing verification and repositioning before securing, and conforming to the LAA's oval shape for effective sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If circular metal devices are used to fill the LAA ostium, then the device can be standardized in size, but the highly variable LAA anatomy cannot be adequately matched requiring extensive imaging
Solution Approach 1:
The device incorporates expandable foam that can dynamically change size and conform to the specific geometry of each patient's LAA ostium. The foam expands from a compressed delivery state to a full expansion state, allowing the same device to adapt to varying anatomical dimensions without requiring multiple standardized sizes or extensive pre-procedure imaging.
Solution Approach 2:
The foam material undergoes parameter changes in terms of volume and shape during deployment. The foam transitions from a compressed low-volume state for delivery to an expanded high-volume state that conforms to the LAA ostium geometry, enabling size adjustment without changing the physical device structure.
2Reliability
If the device is oversized to ensure sealing, then sealing is improved, but the LAA ostium may become overstretched leading to tearing and bleeding
Solution Approach 1:
The foam provides controlled expansion parameters that allow the device to reach the optimal size for sealing without excessive force. The foam's compressibility and controlled expansion ratio enable the device to fill the LAA ostium adequately while distributing forces evenly to prevent tissue tearing.
Solution Approach 2:
The device uses a composite structure combining foam material with a support mesh. The foam provides conformable sealing surfaces that adapt to the LAA ostium geometry, while the mesh provides structural support to prevent collapse and control expansion forces, together achieving reliable sealing without tissue damage.
3Reliability
If the device is made to conform to the oval LAA ostium shape, then sealing is improved, but the device must be customized for each patient
Solution Approach 1:
The foam material provides dynamic conformability, allowing the same device to adapt to the specific oval geometry of each patient's LAA ostium during deployment. The foam expands and conforms to the local anatomy without requiring pre-customization, maintaining device simplicity while achieving patient-specific sealing.
Solution Approach 2:
The foam undergoes parameter changes in volume and shape during deployment, transitioning from a compressed state to an expanded state that conforms to the LAA ostium's oval geometry. This parameter change enables the device to achieve patient-specific sealing without requiring custom manufacturing for each patient.
4Reliability
If barbs or hooks are used to anchor the device, then anchoring is achieved, but repositioning is prevented once fully expanded
Solution Approach 1:
The anchoring system uses a dynamic mechanism where anchors can be deployed from a retracted state to an engaged state. The anchors are held in a retracted position during delivery and can be selectively deployed to engage the LAA wall, allowing for potential repositioning before final anchoring is permanent.
Solution Approach 2:
The device allows preliminary positioning and verification before final anchoring. The anchors can be partially deployed or the device can be positioned and verified using imaging modalities before the anchoring mechanism is fully engaged, enabling correction of positioning errors before permanent fixation.
Data Source
AI summary
Devices and methods are described for occluding the left atrial appendage (LAA) to exclude the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. An implant is delivered via transcatheter delivery into the LAA. The implant includes a conformable structure comprising a foam body and internal support. The support includes anchors that penetrate the foam body and anchor the implant to the walls of the LAA. The implant provides compliance such that it conforms to the native configuration of the LAA.