"We couldn't have found a better partner for this collaboration. Cyth took our concepts and developed a workable prototype quickly and with remarkable accuracy. In addition, by using Circaflex they have made it possible to add sensors or actuators in a seemingly effortless way, facilitating expansion and evolution of our product."
Richard Tallman Ph.D.
CEO BioMed Simulation, Inc.
The client needed to simulate a human cardiovascular system attached to an actual heart-lung machine. The simulator needed to cover a wide range of patient sizes from neonate to adult and react to a wide range of uniquely scripted or pre-programmed clinical scenarios during cardiopulmonary bypass. The simulator needed to be compact, programmable, upgradable, and customizable, which required a number of components and precise control of every sensor and device while keeping within size constraints.
Cyth engineers designed and built the bypass simulator around Circaflex 540 embedded control platform chosen for its small size and instant sensor control, as well as for its modular features. The expansion modules of Circaflex 540 provided the flexibility needed to add and change out a wide variety of sensors and I/O at any point during development. Additionally, Circaflex 540 gave the client a proof of concept within a matter of days, saving the client time and money. Once up and running, the client was able to use National Instruments LabVIEW software to program cardiopulmonary bypass scenarios, which can be generated automatically with the push of a button or edited manually via a text editor.
BioMed Simulation, Inc. is an innovative medical simulation developer. The bypass simulator (BPS) and extracorporeal membrane oxygenation (ECMO) patient simulator are the only developments in which a programmable, customizable and upgradeable system simulates a patient’s cardiopulmonary system before, during and after cardiopulmonary bypass (CPB) and total or partial ECMO support. CPB is a technique in which the patient’s heart and lungs are controlled and monitored, typically by a perfusionist, during surgical procedures to ensure the continuous circulation of blood and oxygen throughout a patient’s body. There are numerous scenarios and different circumstances, which can occur to individual patients, from which medical staff in the operating room need as much practice as possible before performing surgery on a live patient. Instead of practicing on patients, simulators like the BPS and ECMO provide an excellent apparatus for the essential training and performance evaluation of perfusionists, nurses, or respiratory therapists.
During the development phase, the client had several criteria for Cyth that required more control of the system and additional options to make the system customizable, upgradeable, and programmable while still maintaining high fidelity and effectiveness. One major criterion was to develop an accurate simulation of a functional human heart and its heartbeat. Circaflex and LabVIEW software were used to control the peristaltic pump and perform the high pulse, low pulse, and pause pattern of a heart. The system used a 2-liter tank of water with an inlet and outlet valve for the water to pump in and drain out, much like a heart does with blood. The simulator can also simulate the lungs during different clinical scenarios. Additional devices controlled by Circaflex to perform other characteristic heart/lung functions included:
· Flow control valves
· Flow meters
· Level sensors
· Pressure transducers
· Peristaltic pumps
Cyth chose to work the Circaflex 540 system due to its small size, customizability with 10 ports for Circaflex expansion modules, and instant sensor control. After gaining control of all the devices on the first day, Cyth Systems and BioMed Simulation worked together to define different scenarios. The system was programmed and performed at a variety of different blood loss rates and heart beat pulses, which were recorded and stored for later use at the push of a single button to practice or edit these scenarios for creating other unique situations. This is a major benefit for evaluation, testing, practice, training and accreditation purposes. Cyth also wrote software to provide the simulator the ability to test how the body will respond to certain drugs during surgery, to call up lab results, and to print out data analyses.
The final design of the simulator is comprised of four main components: the patient module, the OR monitor, CPU, and controller display. It provides connection to any heart-lung machine (HLM) circuit and allows an instructor to effectively interact with an HLM and operator during a simulated surgery. Cyth Systems is proud to be involved in the development of a product that helps save lives in the operating room. We look forward to seeing this technology spread to universities nationwide.