Self-Expanding LAA Occluder with Sizing Balloon
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Solution Overview
Problem
Current left atrial appendage closure devices face challenges in accommodating the anatomical variability of patients, requiring multiple sizes and shapes, and there is a need for improved methods to determine the appropriate size of the implant for efficient occlusion.
Innovation Solution
A system comprising a delivery catheter with a compliant balloon and an endoskeleton constructed of flexible material with barbs, which expands to fit the left atrial appendage, remaining in an expanded form after balloon deflation, and a method involving a sizing balloon to accurately determine the implant size based on patient anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple differently sized and shaped implants are used to accommodate LAA anatomical variability, then the adaptability to different patient anatomy is improved, but the device complexity and inventory requirements increase
Solution Approach 1:
The occlusion device employs a dynamic structure that transitions from a compressed delivery configuration to an expanded occlusive configuration. The endoskeleton includes flexible struts that can be compressed into a small profile for delivery through catheters, then expand within the LAA to provide effective occlusion. This dynamic transformation allows a single device design to accommodate various LAA sizes and shapes.
Solution Approach 2:
The device is designed as a universal occlusion system that can adapt to different LAA anatomies through a combination of adjustable expansion dimensions, reconfigurable strut arrangements, and variable barrier sizes. A single multi-functional device replaces the need for multiple specialized implants of different sizes and shapes.
2Measurement precision
If precise imaging techniques such as TEE and CT are used to assess LAA anatomy prior to implantation, then the measurement precision of LAA dimensions is improved, but the loss of time and procedural complexity increase
Solution Approach 1:
The device incorporates pre-configured size indicators, reference markers, and sizing features that are prepared in advance during manufacturing. These preliminary markings allow for rapid visual sizing during the procedure without requiring extensive pre-procedural imaging analysis, thereby reducing the time loss while maintaining measurement precision.
Solution Approach 2:
The occlusion device includes self-sizing capabilities through features such as expandable elements that automatically adjust to fit the LAA dimensions, self-indicating markers that show proper deployment size, and self-adjusting mechanisms that eliminate the need for complex external measurement and calculation procedures.
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 system allows for a one-size-fits-all approach to left atrial appendage occlusion, reducing the need for multiple implant sizes and improving the accuracy of size determination, thereby enhancing the efficiency and effectiveness of the occlusion process.
Implementation Method 1
The endoskeleton is configured to undergo plastic deformation from a first, compact form into a second, expanded form when the balloon expands; remaining in the second expanded form when the balloon deflates.
Implementation Method 2
The balloon is constructed of a compliant material.
Data Source
AI summary
Left atrial occlusion devices and methods of occluding a left atrial appendage. The left atrial occlusion devices can be carried by a flexible elongate member, have an inflatable member, and have a plurality of flexible elongate implant members forming a distally open cage configuration when expanded. The implant members have a flexible format to allow them to conform to the anatomy of the left atrial appendage. The distal ends of the flexible elongate member can optionally be atraumatic.