Biodegradable Occlusion Device for Septal Defect Closure
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Solution Overview
Problem
Current occluders for closing anatomical defects like atrial septal defects and patent foramen ovale pose risks due to metal presence, including allergy, toxicity, friction lesions, perforations, and thromboembolism, and obstruct trans-septal access, necessitating an alternative solution.
Innovation Solution
A catheter-deliverable occlusion device with a scaffold and foldable section, comprising a head tube, tail tube, and engaging means, made from biodegradable or non-biodegradable polymers, which can be folded to securely close defects from both sides, reducing long-term metal presence and associated risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If metal frame occluders are used for closing anatomical defects, then the occlusion effectiveness is improved, but the risk of allergy, toxicity, friction lesions, perforations, and thromboembolism increases
Solution Approach 1:
The patent removes the metal frame component entirely from the occlusion device, extracting the harmful metallic elements while retaining the occlusion function through alternative materials (polymers, shape memory alloys, or biodegradable materials) that do not cause allergy, toxicity, or thromboembolism risks
Solution Approach 2:
The device employs composite material construction, combining shape memory alloys with polymer coatings or biodegradable materials, creating a multi-material structure that provides both mechanical functionality and biocompatibility, eliminating the harmful effects of pure metal frames
2Strength
If metal frame occluders are used for closing anatomical defects, then the structural strength is improved, but the trans-septal access is obstructed
Solution Approach 1:
The device incorporates dynamic shape memory materials that can change their physical state between deployed and compressed configurations, allowing the structure to be compact during delivery (enabling trans-septal access) and then transform into a strong, stable occlusion device after deployment
Solution Approach 2:
The occlusion device uses flexible polymer shells and thin film structures that can be compressed into a small profile for catheter delivery through the septum, then expand to provide sufficient structural strength for defect closure without obstructing future access procedures
3Object-affected harmful factors
If the occlusion device is made fully biodegradable, then the long-term safety is improved, but the structural stability during deployment may be reduced
Solution Approach 1:
The device is divided into segments with different material properties: a biodegradable polymer framework provides initial structural stability during deployment, while metal-free shape memory alloy components provide mechanical strength, and the structure is designed to progressively biodegrade over time after the defect is closed
Solution Approach 2:
The device utilizes temperature-dependent shape memory effects where the material transitions from a flexible state during delivery to a rigid state at body temperature, providing structural stability during deployment while maintaining biodegradability for long-term safety
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 occlusion device effectively seals anatomical defects with minimal long-term metal presence, reducing complications like allergy and toxicity, while allowing for trans-septal access preservation, facilitating safer and more effective closure procedures.
Implementation Method 1
The occlusion device may comprise a scaffold (i.e., a shape memory alloy scaffold)
Implementation Method 2
scaffold wherein the head tube and the tail tube are movable along a direction towards and away from each other
Implementation Method 3
made from biodegradable or non-biodegradable polymers
Data Source
AI summary
The present invention generally relates to the field of transcatheter device closure techniques for closing an opening in a tissue and more particularly, to occlusion devices for closing anatomical defects in tissue such as defects consisting of an opening connecting a front side and a back side of a tissue. More particularly the present invention relates to occlusion devices for closing septal abnormalities such as atrial septal defects and patent foramen ovale, delivering systems for such occlusion devices, kits comprising the occlusion devices and the delivering systems and to methods of closing an anatomical defect in a tissue consisting of an opening connecting a front side and a back side of a tissue.