Bioabsorbable Atrial Septal Defect Occluder with Nested Delivery
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Solution Overview
Problem
Existing methods for treating atrial septal defects, such as surgical operations and catheterization, face challenges including invasive procedures, long hospitalization, and complications like anchor entanglement in biological tissue and long-term presence of metal occluders which may cause issues.
Innovation Solution
A medical material with a tubular body having a mesh structure formed of bioabsorbable linear material, designed to be set in a catheter, featuring a shape with a smaller middle portion and larger end portions, allowing easy deployment and retrieval, and equipped with connecting parts for secure manipulation and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical operation (patching operation) is performed to close the hole in the atrial septum, then the hole can be reliably closed, but the procedure becomes highly invasive and requires long hospitalization
Solution Approach 1:
The occluder is divided into two separate anchors (first anchor and second anchor) that are deployed on opposite sides of the atrial septum defect. Each anchor independently engages with the tissue, allowing the defect to be closed by bringing the two anchors together rather than using a single large patch requiring open surgery.
Solution Approach 2:
The occluder components are delivered through a catheter in a compressed, nested state. The first and second anchors are collapsed within the catheter lumen during delivery, then expanded at the target site to close the defect, enabling percutaneous access without open chest surgery.
2Loss of time
If catheterization with metal occluder is used to close the hole, then hospitalization time is reduced, but metal anchors remain in the body long-term which may cause issues
Solution Approach 1:
The material composition of the anchors is changed from permanent metal to bioabsorbable materials such as polymers or biodegradable metals. This parameter change allows the anchors to perform their function initially, then gradually degrade and be absorbed by the body over time, eliminating long-term foreign body presence while maintaining short-term effectiveness.
3Reliability
If anchors are extended in the living body to close the hole, then the occlusion function is achieved, but it becomes difficult to return the anchors to their original folded state
Solution Approach 1:
A delivery catheter serves as an intermediary device that maintains the anchors in a compressed, navigable state during insertion. The catheter provides mechanical support and confinement, allowing the anchors to be positioned accurately through blood vessels without premature expansion. Once positioned, the anchors are released and expand to close the defect, while the catheter can be withdrawn.
4Ease of operation
If a dedicated takeout device with complicated structure is used to fold the anchor, then the anchor can be retrieved, but the device is difficult to operate from outside the living body
Solution Approach 1:
The anchors are designed with dynamic shape-memory properties that allow them to transition between compressed and expanded states. The anchors can be autonomously deployed from the catheter and can be controlled to change shape through simple external manipulation, eliminating the need for complex mechanical folding devices.
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
Enables less invasive catheterization with easy and reliable operation, reduces the risk of complications during deployment, and minimizes long-term issues since the bioabsorbable material is eventually absorbed by the body.
Implementation Method 1
a tubular body (100) having a mesh structure formed of a bioabsorbable linear material
Data Source
AI summary
A hole closing material achieves less invasive treatment for atrial septal defect with no or little possibility of problems in the late post-treatment period. The hole closing material includes two tubular bodies (first tubular portion and second tubular portion) having a mesh structure formed of a bioabsorbable linear material, and includes: a proximal connecting part connected to a first end; and a distal connecting part connected to a second end and screwed to a delivery cable. The proximal connecting part and the distal connecting part are capable of selectively achieving: “locked” in which the proximal connecting part and the distal connecting part remain united; and “unlocked” in which the proximal connecting part and the distal connecting part do not remain united. The delivery cable passes through the substantially middle portion, is inserted into a hollow tube of the proximal connecting part, and passes out of the hole closing material in a direction from the second end to the first end.