Occluder Access Passage With Penetrable Closure
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Solution Overview
Problem
Conventional occluders for atrial septal defects (ASD) prevent subsequent access across the septal wall, limiting procedures like tissue mapping and ablation, and can cause tissue erosion due to high radial forces.
Innovation Solution
A medical occluder with an access passage and a penetrable closure, featuring a frame with annular flanges and a waist portion, allowing access while reducing radial forces and minimizing tissue erosion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional occluders with continuous metal fabric or wire discs are used to close ASD, then the occlusive effect is improved, but subsequent access for medical devices through the septal wall is blocked
Solution Approach 1:
The continuous metal fabric or wire disc is segmented into a mesh structure with openings. The mesh configuration allows medical devices to pass through the occluder while the interconnected wires maintain occlusive function. This segmentation resolves the contradiction by enabling both reliable occlusion and subsequent access capability.
Solution Approach 2:
The occluder employs a porous mesh structure instead of solid continuous material. The mesh openings provide pathways for medical devices to penetrate the occluder and access the left atrium, while the mesh configuration maintains sufficient tissue coverage for effective occlusion. This porous approach simultaneously achieves occlusive reliability and procedural accessibility.
2Strength
If conventional occluders with continuous metal fabric or wire are used, then structural strength is improved, but tissue erosion is caused due to high radial forces
Solution Approach 1:
The mesh structure distributes radial forces across multiple wire contact points rather than concentrating force on a continuous surface. This force distribution reduces peak stress on any single point of tissue contact, minimizing erosion risk while maintaining overall structural integrity through the interconnected wire framework.
Solution Approach 2:
The occluder combines metal wires with different properties or configurations to create a mesh structure that balances strength and tissue compatibility. The wire arrangement and material selection provide sufficient structural strength for occlusion while reducing radial force concentration that causes tissue erosion.
3Reliability
If conventional occluders are deployed to close ASD, then the defect closure is achieved, but access for future procedures like mapping and ablation is prevented
Solution Approach 1:
The mesh configuration segments the occluder surface into interconnected wire elements with openings between them. This segmentation allows catheters and other medical devices to navigate through the mesh structure and access the left atrium for procedures like mapping and ablation, while the wire framework maintains reliable defect closure.
Solution Approach 2:
The mesh occluder performs multiple functions simultaneously: it provides reliable ASD closure while also serving as an access pathway for future interventional procedures. The dual functionality eliminates the need for separate access devices and enables comprehensive patient care through a single implantable structure.
Data Source
Figure 1
Figure 2A~2B
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AI summary
The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.