Expandable LAA Occluder With Positioning Spines for Reliable Sealing
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Solution Overview
Problem
The left atrial appendage in patients with atrial fibrillation experiences stagnant blood pooling, leading to thrombi formation that can enter the bloodstream and cause stroke or heart attack, and existing medical devices are inadequate in effectively sealing and endothelializing the left atrial appendage.
Innovation Solution
A medical device with an expandable member and spine members is designed to seal the left atrial appendage, featuring an expandable balloon with a coating to promote endothelial cell growth and spine members for positioning and anchoring, allowing it to conform to the appendage's geometry and reduce thrombi formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an expandable member is used to seal the left atrial appendage, then the sealing effectiveness is improved, but the device complexity increases
Solution Approach 1:
The expandable member is nested within a delivery catheter system, allowing the complex device to be delivered through a minimally invasive approach while maintaining its complex structure for effective sealing. The nested configuration enables the expandable member to be collapsed for delivery and then expanded at the target site to achieve reliable sealing of the left atrial appendage.
Solution Approach 2:
The sealing device is divided into multiple components including the expandable member, frame structure, and delivery system. This segmentation allows each component to be optimized independently for its specific function while reducing the overall complexity of deployment. The expandable member can be separately designed for sealing effectiveness while the delivery system handles the complex aspects of navigation and deployment.
2Manufacturing precision
If spine members are added for positioning and anchoring, then the positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The spine members are integrated with the expandable member and frame structure, combining multiple functions into a unified structure. The spine members serve both as positioning elements and as structural support for the expandable member, reducing the need for separate components and simplifying the overall device architecture while maintaining positioning accuracy.
Solution Approach 2:
The spine members are strategically positioned at specific locations on the expandable member where positioning and anchoring are most critical. This localized placement provides enhanced positioning accuracy at key interfaces with the left atrial appendage tissue without adding spine members throughout the entire structure, thereby limiting the increase in device complexity.
3Reliability
If the expandable member is made to conform to the appendage geometry, then the sealing effectiveness is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The expandable member is designed with dynamic properties that allow it to adapt its shape after deployment. The material and structural design enable the member to deform and conform to the unique geometry of the left atrial appendage ostium once deployed, achieving effective sealing without requiring extremely tight manufacturing tolerances for complex curved geometries.
Solution Approach 2:
The expandable member utilizes material properties that allow for parameter changes in shape and form after deployment. By using elastomeric or shape-memory materials, the device can transition from a manufactured state with standard tolerances to a deployed state that conforms precisely to the patient-specific anatomy, achieving effective sealing without demanding ultra-precise manufacturing.
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 device effectively seals the left atrial appendage, reducing thrombi formation and promoting endothelialization, thereby lowering the risk of thrombi entering the bloodstream and minimizing the risk of stroke.
Implementation Method 1
an expandable member having a first end region, a second end region and an inflation cavity
Implementation Method 2
featuring an expandable balloon with a coating to promote endothelial cell growth
Data Source
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AI summary
A medical device for occluding the left atrial appendage, comprising an expandable balloon including an outer surface and an inner expansion cavity; a plurality of positioning members coupled to the expandable balloon; a fixation member extending away from the outer surface of the expandable balloon; wherein the plurality of positioning members are configured to position the medical device within an opening of the left atrial appendage; wherein the expandable balloon is configured to expand and seal the opening of the left atrial appendage.