Puncturable Septal Occluder With Central Channel for Re-Access
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Solution Overview
Problem
Existing atrial septal occluders with dense meshes and lack of central through holes hinder subsequent minimally invasive interventional procedures by blocking the atrial septum, complicating treatments for conditions like atrial fibrillation and mitral regurgitation.
Innovation Solution
A puncturable atrial septal occluder with a central through hole and baffle membrane, made of a nickel-titanium alloy with morphological memory, allows safe passage of a sheathing canal for subsequent interventions, featuring a double-layer mesh structure and notches for connecting wires to facilitate delivery and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional occluder device is used, then the interatrial septum can be occluded, but the device cannot be removed and may cause embolism or infection
Solution Approach 1:
The occluder device transitions from a static permanent implant to a dynamic removable device. The mesh structure allows the device to be deployed, secured, and then removed through a retrieval mechanism, changing the temporal state of the occlusion from permanent to temporary based on clinical needs.
Solution Approach 2:
The device parameters change over time - initially deployed in a compressed state, then expanded to occlude the septum, and finally retrieved after achieving the desired occlusion. The material properties and structural configuration are modified to enable both secure occlusion and subsequent removal.
2Reliability
If a large occluder device is used to ensure complete septal occlusion, then occlusion effectiveness improves, but the risk of embolism and infection increases
Solution Approach 1:
The occluder features localized structural variations including a puncturable region with specific mesh density and a retrieval mechanism at a controlled location. The mesh structure has varying pore sizes and densities in different regions to optimize both occlusion effectiveness and safety, allowing complete septal coverage while minimizing harmful factors through strategic design.
3Strength
If the occluder device is made with a mesh structure for secure attachment, then anchoring strength improves, but the ability to remove the device without damage is compromised
Solution Approach 1:
The occluder device is segmented into distinct functional regions: a puncturable region with specific mesh characteristics for secure attachment, and a retrieval mechanism region with different structural properties. This segmentation allows the device to achieve strong anchoring through the mesh while providing a controlled removal path through the specialized retrieval mechanism, enabling easy removal without damage to the septum or surrounding tissue.
4Stability of the object's composition
If the device is designed for permanent implantation, then long-term occlusion stability is ensured, but flexibility for removal and repositioning is lost
Solution Approach 1:
The device embodies dynamic characteristics by being designed for temporary rather than permanent implantation. The mesh structure provides initial stability for occlusion, while the integrated retrieval mechanism enables controlled removal and potential repositioning. This dynamic design allows the system to transition between deployed and retrieved states, providing flexibility adapted to changing clinical requirements while maintaining occlusion stability during the treatment period.
Data Source
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AI summary
The present invention relates to the field of medical device technologies, and more particularly, to a puncturable atrial septal occluder. The main body of the puncturable atrial septal occluder is made by heat setting after integrally weaving a memory wire material. The occluder includes a stent formed by a left disc, a right disc, and a waist connected, a large central through hole penetrating the stent, and a notch formed at the centers of the left and right discs after the penetration. A baffle membrane is provided inside the central through hole. The notch at the center of the right disc is provided with a plurality of connecting wires. One end of each of the plurality of connecting wires is converged and connected to the delivery component, and the other end of each of the plurality of connecting wires is connected to the right disc in a radioactive manner. The present invention maintains the structure and working principle of the traditional occluder to ensure its safety and effectiveness. A fully enclosed sheet-shaped baffle membrane block is arranged in the large central through hole. The baffle membrane uses its fragility and the size of the large through hole to make it easy to puncture and expand while blocking blood from flowing through the occluder. Therefore, a sheath canal can easily puncture from the central through hole of the occluder and be delivered, thereby reserving a channel for the subsequent atrial septal puncture interventional operation.