Adjustable Tether Occlusion Device for Septal Defect Adaptation
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Solution Overview
Problem
Existing occlusion devices for congenital heart diseases, such as PFO and ASD, face challenges in adapting to unique patient anatomy, leading to incomplete closure and thrombus formation due to fixed disc configurations and difficulty in precise defect sizing.
Innovation Solution
An occlusion device with adjustable length tether and interlocking discs, where the left disc is covered with membranes and made of radially-extending skeletons with heat-treated nitinol wire, allowing adaptive angulation and complete deployment to fit the septal defect closely, reducing thrombus formation and improving closure reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the left disc is made as a whole metal structure, then the device has good mechanical strength, but it directly contacts blood and forms thrombus easily
Solution Approach 1:
The left disc is constructed using thin membrane materials that form a flexible shell structure. These membranes cover the skeletal framework to create a disc shape that contacts blood minimally while maintaining structural integrity. The membrane construction reduces thrombus formation compared to solid metal discs while preserving necessary mechanical strength through the underlying skeleton.
Solution Approach 2:
The left disc employs composite construction combining skeletal frameworks with membrane materials. This composite structure integrates the strength of the skeleton with the blood-compatible properties of the membranes, creating a device that achieves both mechanical strength and reduced thrombus formation through material combination.
2Device complexity
If the two discs are made as a whole fixed structure, then the device has simple construction, but it cannot automatically adjust the angle to adapt to the unique anatomy of the patient
Solution Approach 1:
The occlusion device is segmented into two independent discs (right disc and left disc) that can move and adjust independently relative to each other. This segmentation allows each disc to adapt to the unique anatomical contours of the patient's heart defect while maintaining overall device coherence. The skeletal frameworks of each disc can be configured separately to match specific defect geometries.
Solution Approach 2:
The device transitions from a fixed rigid structure to a dynamic configuration where the two discs can adjust their relative angles and positions. The skeletal frameworks with adjustable tethers enable the discs to move and orient themselves automatically to match the patient's anatomy, providing adaptability while maintaining construction simplicity through the modular design.
3Reliability
If an oversized device is selected to ensure complete coverage, then the occlusion effect is improved, but the device forms a cucurbit shape and results in imperfect closing
Solution Approach 1:
The device allows for parameter changes in disc size and shape through the adjustable tether mechanism. The skeletal frameworks can be configured with specific dimensions that match the patient's defect, and the tethers can be adjusted to optimize the disc geometry. This enables precise sizing to avoid cucurbit formation while ensuring complete coverage for reliable occlusion.
Solution Approach 2:
The dynamic adjustment capability allows the device to adapt its final configuration to match the patient's anatomy precisely. The two discs can adjust their relative positions and angles to achieve optimal contact with the defect margins, preventing cucurbit shape formation and ensuring perfect closing while maintaining reliable occlusion effect.
4Ease of operation
If the left disc is not deployed completely, then the operation becomes more complicated, but it indicates insufficient device selection
Solution Approach 1:
The device incorporates self-deployment characteristics where the skeletal frameworks and adjustable tethers automatically expand and position the discs to match the patient's anatomy upon release. This self-service mechanism eliminates the need for complex manual deployment maneuvers and ensures complete disc deployment when the device is properly sized, simplifying the operation while maintaining accurate defect sizing.
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 adapts to the unique anatomy of each patient, enhances closure reliability, and reduces thrombus formation by allowing the discs to adjust and deploy fully, minimizing the risk of cucurbit shape formation and improving the occlusion effect.
Implementation Method 1
the left disc is made from at least two skeletons covered with membranes, and the two discs are adaptively interlocked together by the skeletons passing through the mesh of the right disc
Implementation Method 2
the left disc is made from several radially-extending skeletons by heat treatment
Data Source
AI summary
The present invention relates to heart septal defect occlusion devices with adjustable length tether which can adapt the interseptal length of the device to the unique anatomy of the patient. The right disc as recited in the present invention is made from a double-deck metal mesh with contraction function, and the left disc is made from at least two skeletons covered by membranes. The two discs are active linked together. Because the connection of the two discs has gimbal function and the distance between the two discs may expand and contract suitably, the device can adapt to the unique anatomy of the patient. Therefore the two discs may attach to the heart valves closely and increase its closing ability. Furthermore it can reduce the thrombus and operate more easily.