Multi-functional Occluder with Stretchable Connector
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Solution Overview
Problem
Existing intravascular occlusion devices for treating congenital heart defects often require oversized devices to prevent embolization, leading to complications such as heart blocks and structural damage, and they struggle to adjust to the unique anatomy of each patient.
Innovation Solution
A multi-functional occlusion device comprising two uniform discs with retention screws, connected by a central conical connector section with a stretchable narrow connector, allowing for hemodynamic adjustment to fit various defect sizes and shapes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an oversized occlusion device is used to prevent embolization and residual leak, then the reliability of occlusion is improved, but the risk of complications such as heart blocks and damage to cardiac structures increases
Solution Approach 1:
The occlusion device incorporates a conical connector section with a stretchable narrow connector that allows the device to dynamically adjust its configuration. The narrow connector can stretch and conform to match the specific geometry of the defect, enabling the device to adapt from an oversized state during delivery to a precisely fitted state after deployment, thereby maintaining occlusion reliability while reducing complications
Solution Approach 2:
The device utilizes changes in physical parameters - specifically the stretchability of the narrow connector - to transform from a fixed oversized configuration to an adaptive configuration that matches the defect dimensions. This parameter change allows the device to maintain both safety margins against embolization and precise fit to avoid complications
2Device complexity
If a fixed-size occlusion device is used, then the device complexity is reduced, but the adaptability to various defect sizes and shapes deteriorates
Solution Approach 1:
The occlusion device is segmented into distinct functional components: two discs for occlusion and a conical connector section with a stretchable narrow connector. This segmentation allows each component to perform its specific function - the discs provide the occlusion surface while the narrow connector provides the adaptability - thereby achieving versatility without excessive overall complexity
Solution Approach 2:
The narrow connector is designed with flexible, stretchable material properties that allow it to conform to various defect geometries. This flexibility enables the device to adapt to different sizes and shapes of defects while maintaining a relatively simple overall structure, as the adaptability is achieved through material properties rather than complex mechanical mechanisms
3Reliability
If devices with corners extending to the free wall of the atria are used, then the occlusion effectiveness is improved, but the structural fatigue and fracture risk increases
Solution Approach 1:
The occlusion device employs curved, disc-shaped components without sharp corners. The discs have smooth, rounded edges that conform to the curvature of the atrial septum, eliminating stress concentration points that would lead to fatigue fractures. This curved geometry maintains occlusion effectiveness by providing adequate surface area contact while inherently improving structural integrity
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 provides a secure, leak-proof occlusion with reduced risk of complications like heart blocks, as it automatically adjusts to fit the defect size, allowing for precise placement and minimizing damage to cardiac structures.
Implementation Method 1
a stretchable narrow connector, allowing for hemodynamic adjustment to fit various defect sizes and shapes
Data Source
AI summary
The present invention is related to an occlusion device for occluding an opening in a body tissue and a method of deploying said occlusion device to the site of defect. The occlusion device comprises a flexible proximal high-pressure disc and a flexible distal low-pressure disc, that are centrally connected by a central connector section of varying diameter and length which further comprises a stretchable narrow connector at the tapered end, and retention screws. The design of the occlusion device of the present invention is such that it enables haemodynamic adjustment providing a better-fit to the size of the defect, and reduction of clamping force and stress on the conduction system.