Expandable Foam Gap Sealing for Left Atrial Appendage
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Solution Overview
Problem
Existing left atrial appendage closure devices often leave leaks around the margins due to irregular shapes of the left atrial appendage, leading to potential thrombus formation and migration, which can cause stroke or heart attack.
Innovation Solution
A gap sealing system comprising a piece of expandable foam that expands in vivo to fill gaps between the occlusive implant and the atrial appendage wall, with optional anchoring elements to secure the foam in place, using materials like shape memory polymers and metallic components for enhanced fit and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing left atrial appendage closure devices are used, then the procedure can be performed with standard devices, but leaks occur around the margins due to irregular shapes of the left atrial appendage
Solution Approach 1:
The patent employs a foam sealant that can deform and conform to irregular surfaces. The foam is delivered in a compressed state and expands to fill gaps between the occlusive device and the irregular left atrial appendage wall, creating a flexible seal that adapts to the unique anatomy of each patient rather than requiring a rigid geometric match
Solution Approach 2:
The foam sealant undergoes a parameter change from a compressed, low-volume delivery state to an expanded, high-volume deployed state. This transformation allows the sealant to be delivered through a catheter and then expand to fill irregular gaps, changing its volume and shape parameters to adapt to the irregular anatomy
2Adaptability or versatility
If the left atrial appendage has irregular shape, then anatomical variability is accommodated, but gaps form between the occlusive implant and the appendage wall
Solution Approach 1:
The foam sealant is applied locally at the gap interfaces between the occlusive device and the appendage wall. It provides localized filling and sealing precisely where gaps exist, rather than requiring the entire device to be redesigned. The sealant's properties are optimized for the specific local condition of irregular geometry
Solution Approach 2:
The foam sealant acts as an intermediary material between the occlusive device and the irregular appendage wall. It mediates the interface by filling the voids and gaps that form due to geometric mismatch, creating a continuous seal that connects the rigid occlusive device to the irregular tissue surface
3Reliability
If expandable foam is used to fill gaps, then sealing effectiveness is improved, but device complexity increases
Solution Approach 1:
The foam sealant is integrated with the occlusive device as a combined system. The sealant is delivered through the same catheter infrastructure used for the occlusive device, and the anchoring elements serve both the occlusive device and the sealant. This merging reduces the need for separate delivery systems and simplifies the overall procedure
4Stability of the object's composition
If anchoring elements are added to secure the foam, then seal stability is improved, but manufacturing complexity increases
Solution Approach 1:
The anchoring elements are pre-formed and attached to the foam sealant before delivery. This preliminary preparation allows the foam to be ready for immediate deployment without requiring complex assembly procedures during the intervention. The anchoring elements are integrated into the foam structure in advance, simplifying the manufacturing process
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 effectively seals gaps in the left atrial appendage, reducing the risk of thrombus formation and migration by providing a secure, conformable seal that adapts to the irregular anatomy, thereby minimizing the risk of leaks.
Implementation Method 1
The piece of expandable foam may be formed from a shape memory polymer
Data Source
AI summary
A gap sealing system may include a piece of expandable foam configured to expand in vivo, and an anchoring element extending from the piece of expandable foam. The anchoring element may include at least one arm extending distally from the foam. The foam may be configured to be disposed proximal of an occlusive implant to occlude an ostium of the left atrial appendage. The at least one arm may be configured to extend into an interior of the implant in vivo to anchor the foam to the implant. A kit may include the piece of expandable foam, a second piece of expandable foam configured to expand in vivo, wherein the second piece of expandable foam has an overall volume different from the piece of expandable foam, a tubular member configured to deliver the piece of expandable foam, and a second tubular member configured to deliver the second piece of expandable foam.