Shape Memory Polymer Foam for Endovascular Occlusion
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Solution Overview
Problem
Current endovascular therapies for occluding vascular anomalies, such as aneurysms and arteriovenous malformations, are inefficient, requiring extensive time, risk of hematoma, and limited precision due to high blood flow and multiple tissue layers, and existing closure methods are costly and carry risks of trauma and complications.
Innovation Solution
A shape memory polymer foam system that can be delivered endovascularly via a catheter, expanding from a small secondary shape to a larger primary shape to occlude anomalies, using electromagnetic actuation for rapid and controlled expansion, and designed for precise placement and biocompatibility, with options for additional support and retrieval if needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied for puncture site closure, then hemostasis is achieved, but procedural time increases and patient comfort decreases
Solution Approach 1:
The closure device is pre-formed and ready for deployment, eliminating the need for time-consuming manual compression procedures. The device is prepared in advance with the exact shape and size needed for the specific vascular anomaly, allowing immediate deployment once positioned.
Solution Approach 2:
The manual mechanical compression method is replaced with a self-expanding memory alloy device that uses shape memory effect to achieve closure. The device automatically expands to the predetermined shape upon deployment, substituting the need for prolonged external pressure application.
2Adaptability or versatility
If catheterization is performed to access femoral artery, then vascular procedures can be performed, but tissue trauma and blood loss increase
Solution Approach 1:
The closure device acts as an intermediary element that seals the puncture site immediately after catheter removal. It serves as a mediator between the catheterization procedure and the closure process, preventing tissue trauma and blood loss that would otherwise result from the invasive access method.
Solution Approach 2:
The closure device is self-expanding and self-positioning within the puncture site. Once deployed, it automatically expands to the correct shape and size to seal the vessel, requiring no additional manual intervention or support structures, thereby minimizing tissue trauma.
3Reliability
If IVALON foam plug is used for ductus closure, then occlusion is achieved, but fixation difficulty increases due to high pressure differential
Solution Approach 1:
The device utilizes phase transition and shape memory effects to change its mechanical properties dynamically. At deployment temperature, the material is soft and compliant for easy insertion, then undergoes a phase transition to become rigid and self-expanding, automatically adapting to the high pressure differential without requiring complex fixation mechanisms.
Solution Approach 2:
The closure device employs composite material structure combining shape memory alloy with porous foam material. This composite construction provides both the shape memory effect for automatic expansion against pressure differentials and the porous structure for thrombus formation and secure anchoring within the vascular anomaly.
4Productivity
If shape memory polymer foam is used for occlusion, then procedural time is reduced and precision is improved, but device complexity increases
Solution Approach 1:
The shape memory polymer foam device integrates multiple functions into a single component: it serves as the delivery mechanism, the expansion actuator, and the occlusion element simultaneously. This multi-functionality reduces the number of separate components needed, thereby simplifying the overall device structure while improving procedural efficiency.
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
The shape memory polymer foam system allows for precise, rapid, and controlled occlusion of vascular anomalies, reducing procedural time, minimizing tissue damage, and enhancing biocompatibility, with the ability to stay in place without external support, thus addressing the inefficiencies and risks of current methods.
Implementation Method 1
the foam is made of a shape memory polymer that has been compressed into a smaller secondary shape and then delivered to the vascular anomaly
Implementation Method 2
using electromagnetic actuation for rapid and controlled expansion
Data Source
AI summary
A system for occluding a physical anomaly. One embodiment comprises a shape memory material body wherein the shape memory material body fits within the physical anomaly occluding the physical anomaly. The shape memory material body has a primary shape for occluding the physical anomaly and a secondary shape for being positioned in the physical anomaly.