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Image-Based Evaluation of In Vivo Degradation for Shape-Memory Polymer Polyurethane Foam.

Lance M Graul¹, Staci J Horn^1,2, Landon D Nash³

¹Department of Biomedical Engineering, Texas A&M University, College Station, TX 77843, USA.

|October 14, 2022

Summary

Shape-memory polymer foams used in embolization devices degrade at different rates in vivo. Peripheral embolization devices (PEDs) degrade slowly (~0.11%/day), while neurovascular embolization devices (NEDs) degrade rapidly (~1.01%/day).

Keywords:

embolic devices histopathology in vivo degradation polymeric mass-loss estimation polyurethane foams shape-memory polymers

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Area of Science:

Biomaterials Science
Polymer Chemistry
Medical Device Engineering

Background:

Shape-memory polymer (SMP) polyurethane foams are utilized as embolic devices in various animal models.
These SMP foams undergo oxidative degradation, necessitating detailed characterization for biocompatibility assessments.
Quantifying degradation is crucial for understanding the in vivo performance and longevity of embolic devices.

Purpose of the Study:

To quantitatively assess and characterize the in vivo degradation rates of peripheral embolization devices (PEDs) and neurovascular embolization devices (NEDs).
To compare the degradation behavior of PEDs and NEDs in different anatomical locations and animal models.
To correlate foam microarchitecture and material properties with observed degradation rates.

Main Methods:

An image-based method employing high-resolution histology scans was utilized to estimate mass loss.
Detailed analysis of foam microarchitecture, including struts and membranes, was performed.
Degradation rates were calculated based on explant analysis at 30-, 60-, and 90-day timepoints in porcine and rabbit models.

Main Results:

PED foams in porcine arteries exhibited a slow degradation rate of approximately 0.11% per day.
NED foams in rabbit carotid aneurysms showed a significantly faster degradation rate of approximately 1.01% per day.
Membranes within both device types degraded faster than struts, and NEDs (smaller pore size, more hydrophobic) degraded more rapidly in vivo than suggested by in vitro studies.

Conclusions:

In vivo degradation rates of SMP embolic devices vary significantly based on device type, implant location, animal species, and local tissue environment.
The observed in vivo degradation rates differ substantially from in vitro predictions, highlighting the importance of in vivo studies.
Further investigation into factors influencing degradation, such as implant site characteristics, is warranted for optimizing embolic device design and application.