Peripheral Endovascular Interventions using Human Thiel embalmed cadavers with extracorporeal flow for medical device testing, development and training

Purpose: The numerous benefits of the Thiel method of embalming human cadavers over alternative methods of preservation include a patent vascular system. A femoral artery model was used to demonstrate peripheral interventions within the anatomy of the human arterial system with the texture, tactile feel, and additional function of extracorporeal driven flow. Applied to clinical training simulations and pre-clinical testing, this model is designed to offer a superior alternative to benchtop and virtual simulations.

Material and methods: In six cadavers, extracorporeal flow was introduced into the femoral artery of both legs. A distal port was most commonly located within the dorsalis pedis artery to form a circuit. Antegrade pulsatile flow introduced within the circuit (200–400 mL/minute) facilitated fluoroscopically guided endovascular interventions such as angioplasty and stenting at various arterial locations. Interventions are assessed using fluoroscopic, CT imaging, and ultrasound imaging.

Results: The results demonstrated that this model can be used to effectively assess the delivery, device apposition, and device induced effects on flow patterns to the extracorporeal perfused circuit.

Conclusion: The model’s versatility and robust preparation and durable over long periods provide the basis to repeatedly assess devices in numerous leg positions, such as knee bend, facilitating options not viable in fresh cadaveric models or animal models. In addition to multimodal imaging providing the tools to assess the device, it also provides the basis for the application of this model for training purposes in full simulation of clinical interventions.