Modular LAA Occluder Assembly for Consistent Double Sealing
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Solution Overview
Problem
Existing occluders for left atrial appendage (LAA) closures offer limited sizing options, leading to inconsistent sealing and potential blood flow stagnation or thrombus formation due to anatomical variations among patients.
Innovation Solution
A kit of interchangeable proximal discs and distal lobes with varying diameters, allowing for customizable assembly to fit specific patient anatomies, combined with a connector system for adjustable length and shape, ensuring a double-seal occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed-size occluder is used for LAA closure, then the device structure is simple, but the sealing consistency deteriorates due to anatomical variations among patients
Solution Approach 1:
The occluder is divided into multiple independent size components: proximal discs in different sizes and distal lobes in different sizes. This segmentation allows selection of appropriately sized components for individual patient anatomies, improving sealing consistency while maintaining relatively simple individual component structures.
Solution Approach 2:
The invention changes the size parameters of the occluder by providing multiple proximal discs and distal lobes with varying diameters. This parameter variation enables customization to match diverse LAA anatomical sizes, ensuring reliable sealing without requiring a completely complex adaptive structure.
2Adaptability or versatility
If an occluder with limited sizing options is used, then the manufacturing process is simple, but the adaptability to different patient anatomies deteriorates
Solution Approach 1:
The occluder system is segmented into interchangeable proximal discs and distal lobes, each manufactured in different standard sizes. This segmentation allows each component to be manufactured using standardized processes, while the combination of components provides extensive sizing adaptability for different patient anatomies.
Solution Approach 2:
The connecting portion serves multiple functions: it connects the proximal disc to the distal lobe, allows for size variation in both components, and enables assembly of different size combinations. This multi-functionality increases adaptability without proportionally increasing manufacturing complexity.
3Manufacturing precision
If a customizable occluder assembly system is implemented, then the sizing precision is improved, but the device complexity increases due to multiple components
Solution Approach 1:
The occluder is segmented into proximal discs, distal lobes, and connecting portions, each with standardized size variations. This segmentation enables precise sizing of each component independently, improving overall sizing precision while keeping individual component designs relatively simple.
Solution Approach 2:
The invention systematically varies the diameter parameters of proximal discs and distal lobes across multiple size options. This parameter change strategy allows precise matching to patient anatomy through component selection rather than requiring complex adjustable mechanisms.
4Adaptability or versatility
If interchangeable components are used for occluder assembly, then the adaptability to anatomical variations is improved, but the assembly complexity increases
Solution Approach 1:
The occluder system is segmented into modular proximal discs, distal lobes, and connecting portions that can be independently selected and assembled. This segmentation provides anatomical adaptability through component selection while maintaining relatively simple assembly operations through standardized connection interfaces.
Solution Approach 2:
The connecting portion acts as an intermediary element that joins the proximal disc and distal lobe. This intermediary component standardizes the connection interface, enabling easy assembly of different size combinations without requiring complex joining 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
Enhances the ability to appropriately size the occluder for individual patients, providing consistent and stable sealing, reducing blood flow stagnation and thrombus formation, and accommodating diverse anatomical variations.
Implementation Method 1
the distal lobe is formed as a laser cut tube of shape memory material
Data Source
AI summary
A kit for assembling a collapsible and expandable occluder for occluding a left atrial appendage (“LAA”) may include a plurality of proximal discs and a plurality of distal lobes. Each proximal disc may be configured to cover an ostium of the LAA in an implanted condition of the occluder, and each of the plurality of proximal discs may have a different diameter in an expanded condition than other ones of the plurality of proximal discs. Each distal lobe may be configured to be received within a cavity of the LAA in the implanted condition of the occluder, and each of the plurality of distal lobes may have a different diameter in an expanded condition than other ones of the plurality of proximal discs. Each of the plurality of proximal discs may be configured to couple to any one of the plurality of distal lobes to form the occluder.