Modular LAA Occluder Assembly for Double Sealing and Anchoring
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Solution Overview
Problem
Existing occlusion devices for the left atrial appendage (LAA) lack sufficient sizing options and double sealing functionality, leading to inconsistent anchoring and sealing, particularly in anatomically variable patients, due to limited size and shape combinations of the disc and lobe components.
Innovation Solution
A kit of interchangeable proximal discs and distal lobes with varying diameters and shapes, allowing for customizable assembly based on patient-specific measurements, ensuring proper fit and double sealing by combining different components via connectors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size occlusion device is used, then the device structure is simple, but the device cannot accommodate diverse anatomical variations and provides inconsistent anchoring and sealing
Solution Approach 1:
The occlusion device is divided into separate interchangeable components: proximal discs with different diameters and distal lobes with different sizes. This segmentation allows clinicians to select and combine appropriate components based on patient-specific anatomical measurements, providing customized sizing without requiring entirely different device designs.
Solution Approach 2:
The standardized connection mechanism enables a single proximal disc to interface with multiple distal lobe sizes, and vice versa. This universal coupling system creates multiple sizing combinations from a limited set of components, enhancing adaptability while controlling device complexity through standardized interfaces.
2Reliability
If a single-size occluder is used, then manufacturing is simple, but anchoring and sealing consistency is poor in anatomically variable patients
Solution Approach 1:
By segmenting the occluder into modular components with standardized connections, the system achieves reliable anchoring and sealing through proper sizing selection while managing the quantity of components through a limited set of interchangeable parts rather than requiring unique customized devices for each patient.
Solution Approach 2:
The system varies the diameter and size parameters of the proximal disc and distal lobe components to match patient-specific anatomical measurements. This parameter customization ensures optimal anchoring and sealing consistency without requiring a large inventory of completely different device configurations.
3Adaptability or versatility
If interchangeable components with varying diameters are used, then the ability to size the occluder is improved, but the device assembly complexity increases
Solution Approach 1:
The standardized connection mechanism serves as a universal interface that simplifies assembly despite component variety. The consistent coupling method across all proximal disc and distal lobe combinations reduces assembly complexity compared to having unique assembly procedures for each sizing configuration.
Solution Approach 2:
The components are designed with pre-configured connection features (protrusions and receptacles) that guide proper alignment and assembly. This preliminary design of connection interfaces reduces the complexity of the assembly process by providing intuitive, self-aligning coupling mechanisms.
4Reliability
If multiple sized components are provided, then patient-specific fitting is improved, but the risk of blood stagnation and thrombus formation increases due to improper fit
Solution Approach 1:
By varying the diameter and size parameters of the proximal disc and distal lobe components, the system achieves proper anatomical fit for different patients. This customized sizing ensures adequate sealing that prevents blood stagnation in gaps while avoiding excessive compression that could cause tissue damage or thrombus formation.
Solution Approach 2:
The modular component design allows independent optimization of the proximal disc and distal lobe sizes to match specific anatomical features. This segmentation enables precise fitting that eliminates gaps where blood could stagnate while maintaining appropriate sealing pressure throughout the LAA closure.
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 anchoring and sealing, reducing the risk of blood stagnation and thrombus formation, and accommodating diverse anatomical variations.
Implementation Method 1
the enlarged head being compressible and having a diameter that is larger than a diameter of the channel when the enlarged head is in an uncompressed condition
Implementation Method 2
Each first connection portion may include a ratchet pawl, and each second connection portion may include a plurality of serrations so that each second connection portion is configured to pass through any one of the first connection portions in a first direction, but not in a second direction opposite the first direction
Implementation Method 3
each of the plurality of distal lobes may be formed of a laser cut tube of shape memory material
Data Source
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AI summary
A kit for assembling a collapsible and expandable occluder (156dc) for occluding a left atrial appendage (LAA) may include a plurality of proximal discs (156a-c) and a plurality of distal lobes (158a-e). 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.