Uncoupled LAA Occlusion Device with Articulated Joint
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Solution Overview
Problem
Existing LAA occlusion devices struggle with deployment in anatomies with irregular shapes or angles, often distorting the LAA and causing irritation, and are not readily redeployable, leading to increased costs due to the need for replacement.
Innovation Solution
A flexible LAA occlusion device with an articulated joint between the bulb and cap structure, allowing for greater angulation and a unique three-layer cap structure that conforms to the LAA ostium, providing superior sealing performance and adaptability to various anatomies without distorting the LAA.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid occlusion device is used to seal the LAA, then sealing effectiveness is improved, but the device cannot adapt to irregular LAA shapes and angles, causing distortion and irritation
Solution Approach 1:
The device is divided into separate components: a delivery catheter, an occlusion device with a self-expanding frame, and a sealing membrane. This segmentation allows the frame to expand to provide structural support while the membrane conforms to irregular surfaces, resolving the contradiction between rigid sealing and anatomical adaptability.
Solution Approach 2:
The occlusion device transitions from a compressed delivery state to an expanded deployed state. The self-expanding frame dynamically adjusts to the LAA geometry, providing both the rigidity needed for sealing and the flexibility to adapt to irregular shapes and angles.
2Adaptability or versatility
If the device is made flexible to adapt to various anatomies, then adaptability is improved, but the device may lack the structural support needed for reliable occlusion
Solution Approach 1:
The device combines a self-expanding metallic frame (providing structural rigidity) with a flexible sealing membrane (providing conformability). This composite structure resolves the contradiction by integrating both rigid and flexible components that work together to achieve reliable occlusion while adapting to various anatomies.
3Ease of operation
If the device is deployed once and left in place, then the procedure is simple, but the device cannot be retrieved or redeployed if placement is incorrect, increasing costs
Solution Approach 1:
The device is designed with a retrieval mechanism that allows it to be recaptured and redeployed before final release. This preliminary design consideration enables correction of placement errors without requiring a second procedure, resolving the contradiction between procedural simplicity and the ability to correct mistakes.
4Adaptability or versatility
If existing devices are used in LAA with sharp angles or irregular shapes, then deployment is attempted, but the device distorts the LAA causing irritation and potential complications
Solution Approach 1:
The sealing membrane is designed as a thin, flexible film that can conform to irregular LAA surfaces including sharp angles without forcing the anatomy to conform to the device shape. This resolves the contradiction by allowing deployment in challenging geometries while avoiding tissue distortion and irritation.
Data Source
AI summary
A medical device for treating an LAA is presented. The device includes a cap, a bulb and a joint assembly therebetween. The cap is a three layer mesh structure with a retaining hub securing the layers together. A plurality of proximal wire loops extend from the base layer to a proximal post of the joint assembly. The bulb has a plurality of distal wire loops that extend between a terminal post and a distal post of the joint assembly. The joint assembly comprises a first ball joint, a second ball joint and a housing. Each ball joint is retained in the housing independent ball and socket relationships. Each ball joint and post defines a longitudinal axis. The housing defines a housing longitudinal axis. By way of the ball and socket relationship each ball joint longitudinal axis may form an angle of between about 0 to about 35 degrees with the housing longitudinal axis in any direction.