Polymeric Occlusion Device for Anatomical Defects
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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 allergy, toxicity, friction lesions, perforations, and thromboembolism, and obstruct trans-septal access, necessitating an alternative solution.
Innovation Solution
A polymeric occlusion device with a scaffold comprising proximal and distal support structures and a waist portion, which can be deployed through a sheath to close anatomical defects from both sides, using biodegradable or non-biodegradable polymers to minimize long-term toxicity and improve biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If metal frame occluders are used to close anatomical defects, then the closure effectiveness is improved, but the risk of metal allergy, toxicity, and thromboembolism increases
Solution Approach 1:
The invention changes the material parameter from metal (Nitinol, Phynox) to polymeric material, fundamentally altering the chemical composition to eliminate metal-related allergies and toxicity while maintaining the structural functionality of the occluder device
Solution Approach 2:
The invention uses composite polymeric structures combining different polymer properties - the frame structure provides mechanical support while the insert material (collagen matrix or synthetic fabric) provides sealing functionality, creating a composite device that addresses both structural integrity and biocompatibility requirements
2Reliability
If metal frame occluders with synthetic fabrics are used, then the occlusion capability is improved, but the risk of friction lesions, perforations, and thromboembolism increases
Solution Approach 1:
The invention changes the material parameter from metal to polymeric material for the frame structure, eliminating the hard, rigid properties that cause friction lesions and perforations while maintaining sufficient structural support through polymer elasticity and flexibility
Solution Approach 2:
The invention employs flexible polymeric frame structures that can conform to tissue surfaces without creating rigid edges that cause friction lesions, and the thin film insert materials provide gentle sealing that reduces perforation risk
3Reliability
If metal occluders are deployed to close defects, then the defect closure is achieved, but trans-septal access for future treatments is obstructed
Solution Approach 1:
The invention changes the material parameter from metal to biodegradable polymeric material, allowing the occluder to degrade over time and eventually be absorbed by the body, thereby restoring trans-septal access for future treatments while maintaining defect closure during the critical healing period
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. More particularly the present invention refers to occlusion devices for closing septal abnormalities such as atrial septal defects and patent foramen ovale, and to methods of closing an anatomical defect in a tissue.