Flexible Endoskeleton LAA Occluder Balloon Expansion
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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 based on individual anatomy, as well as addressing the issue of LAA rupture during implantation procedures.
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 LAA anatomy, and a method involving inflation, plastic deformation, and barb insertion to occlude the LAA, along with a sizing balloon to determine the optimal implant size, and a sealant for sealing leaks.
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 adaptability to different patient anatomies is improved, but device complexity and the number of available implant options increase
Solution Approach 1:
The endoskeleton is designed to be dynamically expandable from a compressed delivery configuration to an expanded deployed configuration. The flexible material allows the endoskeleton to adapt its shape and size to match the patient's LAA anatomy, eliminating the need for multiple pre-formed implant sizes and shapes while maintaining full adaptability.
Solution Approach 2:
The implant utilizes changes in physical parameters (shape, volume, configuration) through the expansion process. The endoskeleton transitions from a compact state suitable for delivery through catheters to an expanded state that conforms to the LAA geometry, achieving adaptability without requiring multiple different implant designs.
2Adaptability or versatility
If a compliant balloon is used to expand the endoskeleton, then the ability to fit varying LAA anatomies is improved, but the risk of LAA rupture during inflation increases
Solution Approach 1:
A compliant balloon made of flexible material is used to expand the endoskeleton. The balloon's compliance allows it to deform and conform to the LAA geometry during inflation, distributing pressure evenly and reducing stress concentration points that could lead to rupture, while still achieving adequate expansion for proper implant fitting.
Solution Approach 2:
The system includes a sealant delivered through the balloon catheter that is applied to the LAA tissue before or during the expansion process. This sealant acts as a protective layer that reinforces the tissue, cushioning it against the inflation pressure and reducing the risk of rupture while allowing the endoskeleton to expand to the appropriate size.
3Stability of the object's composition
If barbs are inserted into the LAA wall during expansion, then anchoring stability is improved, but the risk of tissue damage and rupture increases
Solution Approach 1:
The sealant is applied to the LAA tissue before the barbs are inserted during expansion. This creates a protective barrier that reduces friction and mechanical stress on the tissue, allowing the barbs to penetrate and anchor the device securely while minimizing tissue damage and the risk of rupture.
4Ease of operation
If the endoskeleton is made of flexible material for balloon expansion, then ease of delivery through catheters is improved, but the structural strength required to maintain occlusion after deployment may be compromised
Solution Approach 1:
The flexible material exhibits dynamic mechanical properties that allow it to be compliant during delivery and expansion, then transition to a stable configured state that maintains structural strength for long-term occlusion. The material's flexibility enables navigation through the delivery catheter and expansion by the balloon, while the resulting deployed configuration provides sufficient strength to maintain permanent occlusion of the LAA.
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 efficient deployment of a left atrial appendage occlusion device that accommodates varying anatomies, reduces the need for multiple implant sizes, and effectively seals the LAA to prevent blood clots and leaks, enhancing stroke risk reduction for atrial fibrillation patients.
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
an endoskeleton constructed of a flexible material and having barbs
Implementation Method 3
a sealant for sealing leaks
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.