Physiological flow systems are changing the landscape of simulation and creating new opportunities for endovascular research and training, and we’re excited to be pioneers.

Flow systems serve to further enhance tactile feedback experienced in traditional simulation, allowing operators to overcome many more challenges within device development, clinical training, and education. Follow along as we introduce flow systems, its mechanics, and its vast impact on simulation training and medical research in this blog.

What are physiological flow systems? 

Physiological flow systems, or replicators, are life-like platforms that replicate human vascular anatomy and hemodynamic functioning for the application of device or procedural research, training, and education. This replication results in an extraordinarily realistic experience in which operators can get a sense of a device’s true haptic feedback, as it would feel in a real patient.   

Envision a patient on the operating table. Imagine you could 3D-print this patient’s endovascular pathology to exact specifications and create a silicone model from it. Then, configure that replicated anatomy to a platform that is designed to look and function just as a patient would. Within the center of the platform, envision a silicone heart functioning just like a real heart would. This heart-like pump helps to sustain a life-like flow of real fluid into the vessels from the system, much like the clinical human waveform. The result is a high-fidelity replica of specific endovascular cases, as seen in the rendering below:

Flow systems consist of two distinctive qualities that yield enhanced tactile feedback:

1. Patient-specific silicone models are designed to produce the exact feel and resistance of real vessels during minimally invasive procedures.
2. Replicated hemodynamics, or realistic flow, provide matched clinical waveforms over a variety of relevant case scenarios.

This high fidelity feedback gives physicians, clinical trainers, and researchers a great boost in confidence, insight, and overall operator efficiency. 

How do physiological flow systems differ from and complement VR simulation?

High fidelity VR simulation recreates the catheterization lab to allow for structured and deliberate training of endovascular skills in a safe environment. Operators become well-immersed in the clinical environment under VR simulation. Flow systems additionally enhance the tactile feedback by replicating hemodynamic elements otherwise not seen in traditional simulation. Replicated flow elements, or hemodynamics, of the system, such as blood viscosity and the clinical waveform, provide a life-like enhancement to the simulated deployment experience. 

This combination creates an all-around robust platform, especially for specific cases, complex procedural problems, and novel devices. Together, these systems complement each other in such a way that supports medical device development from concept, to market roll-out, and beyond toward continuous training and medical education. 

What is the impact of enhanced haptic feedback and realistic flow across medical device development, training, and education?

Flow systems allow operators to get the most realistic idea of what the device at hand feels like, and how it behaves during a procedure. This is accomplished through the replicated hemodynamic environment of the system created by a variety of matched physiological factors of the system:

• Matched vessel geometric properties and patient-specific anatomies
• Matched blood viscosity and device resistance via vessel coating and Replicator Fluid  
• Ability to replicate rapid pacing and other complex scenarios via manipulation of heart rate, blood pressure, and cardiac outputs

These enhanced qualities allow health care professionals to experiment with new techniques and investigate ideas in a safe environment, away from real patients or animal models. In the long run, this can significantly reduce the learning curve of novel devices: 

"This model helps physicians and the treating team give patients the best outcome, especially with new technologies that are novel and innovative, where there’s a very steep learning curve."

Vascular Surgeon   

In 2016, a flow system was utilized in a study comparing the efficacy of two different flow diversion devices. The system provided a life-like and risk-free testing bench to investigate each device’s flow diverting capabilities in varying anatomical cases:

"Replicator practice sessions are feasible as long as the replicator model is a functional and faithful representation of the patient’s vasculature. In many cases, the replicator session provided an opportunity to correctly size the endovascular device, and avoid resheathing devices during the actual procedure."

Nickele C, et al. - British Medical Journal Publishing Group (2016)

In cases like these, clinical trainers and corresponding teams are able to get an extraordinarily real experience and deal with potential challenges ahead of time, especially for novel devices, all within a risk-free setting. Trainers can then expedite to clinical trials with less cost and more confidence.

In 2019, a flow system was used to support the rollout of a new and unique aortic device. The system provided the clinical trainer and his team a seamless experience and more device insight before using it in real patients:  

“I feel much more confident relaying to physicians exactly what each step feels like. You can get a very good idea of what the device feels like as you push it through tortuous anatomy, and the resistance you feel as you deploy the device.” 

Clinical Trainer 

With enhanced tactile feedback, you also have a unique demonstrative platform from which to showcase a device’s true behavior, as well as educate, in real time, with full visibility, and active pulsatile flow. One medical device company has utilized this to demonstrate their novel left ventricular assist device and how it behaves in a life-like setting: 

   Click to play full video

Other operators have even replicated procedures live in front of audiences at key conference events. This involves only a simple set-up of the system, from which the operator is able to replicate any number of times for his or her audience. This is a more feasible alternative to the popular live cases taking place during scientific events, especially considering the COVID-19 pandemic.  

What’s Next?

This synergy of virtual and 3D solutions will support all stages of medical device development, from concept to final adoption worldwide. It will provide an unparalleled realism that will raise the standard for medical simulation towards improving clinical performance and patient outcomes. Mentice clients will now have the possibility to deploy and test real medical devices in a physical model under x-ray guidance with much more experimental capability and research insights. Operators can not only train for proficiency on a VIST simulator, but also deploy a real medical device under x-ray in the same exact anatomy within a flow system, and utilize the flow system for the rehearsal of specific cases.

Want to learn more? Check out the associated research publications from peers like you.

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