Design and verification of a shape memory polymer peripheral occlusion device

Area of Science:

• Biomaterials Science
• Medical Devices
• Polymer Engineering

Background:

• Shape memory polymer foams have demonstrated safety and efficacy in aneurysm treatment.
• Their biocompatibility and catheter-based delivery make them suitable for embolic applications, especially in the peripheral vasculature.

Purpose of the Study:

• To investigate the material properties, safety, and efficacy of a novel shape memory polymer peripheral embolization device in vitro.
• To analyze the tunability of the polymer's glass transition temperature (Tg) and expansion rate for optimal catheter delivery.
• To assess the mechanical properties and flow migration to ensure vessel safety and prevent thromboembolism.

Main Methods:

• Material characterization including Tg and expansion rate analysis.
• Mechanical testing and flow migration studies.
• In vitro blood flow studies and ultrasound phantom experiments to assess thrombus formation, blood penetration, flow stagnation, and collateral pathway diversion.

Main Results:

• The shape memory polymer device exhibited tunable material properties, allowing for controlled expansion post-catheter delivery.
• Mechanical and flow studies indicated a low risk of vessel perforation and thromboembolism.
• Blood flow studies confirmed the device's affinity for thrombus formation and effective blood diversion, leading to flow stagnation.

Conclusions:

• The shape memory polymer peripheral embolization device is a safe and effective embolic agent in vitro.
• Its tunable properties and performance in flow studies support its potential for peripheral vascular embolization applications.
• Further in vivo studies are warranted to validate its clinical utility.