Septal Occluder Gate Structure for Repeat Transseptal Access
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Solution Overview
Problem
Conventional septal occluders obstruct transseptal puncture sites, preventing subsequent procedures from being performed at different locations, rendering them inadvisable.
Innovation Solution
A septal occluder with a flexible skin attached to a structural framework, featuring membrane and/or mechanical gates, allowing for the occluder to be punctured and reopened for subsequent transseptal procedures without requiring removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional septal occluder is used to close an opening through the inter-atrial septum, then the defect is sealed and blood flow is blocked, but the occluder obstructs the puncture site and prevents subsequent transseptal procedures
Solution Approach 1:
The occluder is divided into functionally distinct segments: fixation wings for anchoring, a central body for sealing, and a gate mechanism for controlled access. This segmentation allows the sealing function to be maintained while the gate portion can be selectively opened to permit subsequent procedures through the same puncture site.
Solution Approach 2:
The occluder incorporates a dynamic gate mechanism that can transition between closed and open states. The gate is initially closed to maintain sealing but can be opened using a recrossing catheter to allow passage of equipment for subsequent procedures, then closed again to restore sealing functionality.
2Reliability
If the septal occluder structure is made solid to ensure reliable sealing, then occlusion effectiveness is improved, but the ability to perform subsequent punctures through the same site is lost
Solution Approach 1:
The gate mechanism provides dynamic control over the occluder's structure, allowing it to transition from a solid sealed state to an open state for procedure access, and back to sealed state. This dynamic capability resolves the contradiction between maintaining solid sealing and enabling subsequent access.
Solution Approach 2:
The gate acts as an intermediary element between the sealed occlusion structure and the need for subsequent access. It provides a controlled pathway that can be opened when needed while maintaining the overall integrity and sealing function of the occluder during normal operation.
3Adaptability or versatility
If a membrane gate is added to the septal occluder to enable recrossing, then subsequent procedures can be performed, but the device complexity increases
Solution Approach 1:
The gate is constructed from a flexible membrane that can be punctured or opened by a recrossing catheter. This flexible membrane approach adds minimal structural complexity compared to rigid mechanical gates, while still providing the necessary functionality for controlled access and sealing.
Data Source
AI summary
A septal occluder includes a structural framework and a flexible skin supported by the structural framework. The structural framework includes a cylindrical section interposed between end sections. Each of the cylindrical section and end sections include interconnected struts that form a mesh. The cylindrical section extends along a centerline axis to define a bore. The flexible skin includes a membrane gate, a mechanical gate, or a membrane gate and mechanical gate spanning the bore.