Pangolin Medical produces biomimicry systems that imitate clinical reality for physicians and researchers, enabling hands-on practice of complex, high risk, and novel procedures in safe, accurate non-clinical setups.  Their team comprises medical device engineers, radiologists, and catheterization physicians—professionals in stenting, catheter placement, and other endovascular procedures.

Pangolin medical simulators can be used in physician training centers, and by medical device producers developing medical devices for the deployment of stents, heart valves, and more.

Pangolin Medical’s challenge was to create a biomimetic simulator—a medical ‘phantom’—that would include a beating ‘heart’ and a ‘brainstem’, that part of the human brain that autonomously controls heartbeat and blood pressure.

To enable physicians, trainers, and students to practice endovascular procedures such as stenting, catheterization, and valve replacement in a realistic clinical setting, Pangolin created a replica of the four-chambered human heart in flexible silicone, including the right and left atria and ventricles, the coronary arteries and veins that feed into the heart. This allows physicians to carry out procedures that require trans-aortic, transseptal access via veins or femoral arteries.

The ‘brainstem’ needed to exactly replicate the pulsing—the actual beating—of the human heart. In essence, the heart is a pump, and therefore contains valves just like any pump. The human brainstem controls the flow of blood at specific pressures; the challenge was therefore to control this pressure to replicate varying patient states; for example the changing states of a patient with heart failure who is undergoing different procedures.

Another critical aspect of the system was the absolute requirement to support the sensors of standard medical devices such as catheters.

Pangolin Medical teamed with RDT, a Unitronics distributor located in Petah Tikva. Pangolin provided a simulated use silicone ‘phantom’—medical phantoms are devices specifically designed to mimic human anatomy and tissue properties—as well as necessary medical instrumentation such as sensors that are familiar to physicians. RDT provided the hardware controls and control expertise; together they were able to rapidly develop the system within 2 weeks.

The functionality of the ‘brainstem’ is replicated by a Unitronics UniStream PLC and a 7” touch screen, along with a Unitronics EtherCAT Servo drive with built-in STO. The outputs of sensors commonly used in hospitals during cardiac procedures, for example pressure sensors, are fed to the PLC and servo. The servo is connected to a linear actuator, which functions as a Pulse Pump.

The pulse pump models a sinusoidal wave, based on Pulse frequency, Pulse volume, and Diastolic / Systolic pressure; the PLC controls the valves to set the ‘blood’ pressure and volume flow quantity throughout the simulated use model. This allows Pangolin’s biomimetic simulation to accurately replicate the systolic and diastolic blood pressure of varying patient states.

The data ‘readouts’ reflecting the patient’s hemodynamic status during the procedures are received by the PLC and displayed on the HMI.

Pangolin required that this data be displayed just as it would be in an operating room during cardiac procedures; therefore the UniStream HMI screens are designed to display all of the data that is normally provided on medical displays—animations, live graphs showing pressure, stroke volume, cardiac output values, diastolic duty cycle, total flow, beats per minute and more.
The end user can easily use the HMI screen to program complex wave forms, for example by altering the duty cycle.

Since users are able to access historical data, users can easily review status at different stages of the procedure. All data is collected and stored, and can be exported at will.

In addition to the Pulse Pump, cardiac procedures require specific instruments. The heart catheters used to perform these procedures are thin, flexible, tubes that are introduced into a patient’s circulatory system, for example into the femoral artery, and gently guided to the heart using fluoroscopy (x-ray).

The catheters themselves are fluid-filled conduits that transmit pressures to pressure transducers, enabling the physician to measure pressure in any part of the heart that a catheter can be maneuvered into; these pressures were also displayed on the UniStream’s HMI screen.

Unitronics PLCs enable Pangolin Medical to develop features more easily and to rapidly modify existing features. For example, modifying a wave form is a simple task of modifying the wave’s duty cycle, to influence the function of the simulator’s valves to replicate conditions such as atrial fibrillation, backflow, tachycardia, bradycardia.

By using a PLC to control their system, Pangolin Medical gains a competitive edge over companies in the medical device sector that rely on older technologies, which tends to limit feature development.

The CEO of Pangolin Medical, Ohad Shafran, reported:

“Using Unitronics, we were able to complete development of our biomimetic simulator—including motion control and user interface application—in just two weeks!”