JOHNSON CITY – The world's first full-body, high-fidelity surgical simulator will soon embark for medical teaching facilities around the globe, and the patented core technologies within this lifelike manikin, who goes by the name of Chloe, were developed and created at East Tennessee State University.
Officially known as Surgical Chloe™, the surgical simulator is an anatomical facsimile of a human woman, developed to train medical residents, students and physicians in obstetrics and gynecological procedures. Surgical Chloe™ is lifelike in the sense that she not only resembles an adult female in outward appearance, but also internally, with a simulated circulatory system, lung sounds, heart sounds, a trachea and different uterine and abdominal wall inserts that can be interchanged to teach a range of medical procedures.
Surgical Chloe™ came about through extraordinary measures of innovative thinking and collaboration among university faculty members from ETSU's James H. Quillen College of Medicine and the College of Business and Technology. Gaumard Scientific, which specializes in manufacturing simulators for health care education, purchased the rights from ETSU to mass produce the Chloe prototype and is marketing Surgical Chloe™ to teaching facilities.
Conceptualizing, developing, engineering, testing and re-testing Chloe were part of a nine-year process that started with Dr. Martin Olsen, a professor and director of the OB/GYN residency program in the ETSU Department of Obstetrics and Gynecology.
"It's been a long road," said Olsen, as he stood next to the Chloe prototype in the Human Patient Simulation Lab at the Quillen College of Medicine. "And it's exciting to see the project come to fruition."
The idea for what would become Surgical Chloe™ came to Olsen in the middle of the night as he pondered a better method to train residents in OB/GYN operative procedures. There is a long history of surgical simulators that goes back hundreds of years as a means of training in obstetrics and other surgical disciplines. Early incarnations would have used such materials as leather to replicate human anatomy, and there have, of course, been advancements with each generation. But even modern versions before Chloe were low-fidelity and virtual reality mechanisms.
Olsen made the first version from a cardboard box, a wooden pear and rubber bands. To fully realize his vision, Olsen needed help. He reached out to Dr. Paul Sims and Bill Hemphill, two faculty members in the College of Business and Technology's Department of Engineering Technology, Surveying and Digital Media, as well as his colleague, Dr. Martin Eason, an associate professor and director of Quillen's Center for Experiential Learning, which operates the Human Patient Simulation Lab.
Olsen's medical expertise and vision for a state-of-the-art training tool came together with the knowledge of Hemphill and Sims in computer-assisted design and engineering. Hemphill took the lead on working with Olsen to develop the anatomy through computer-assisted design, and the resulting body parts – ranging from multiple-form plastic molds for the hard anatomical structures to pliable blood vessels and fallopian tubes – would be realized in full form via the 3-D printer at ETSU.
Olsen's cardboard original gave way to other forebears, including one comprised of organs and tissues mounted within a wooden CD crate. Early in the process, Olsen and Eason realized the need for internal video cameras to record and later evaluate a surgeon's practice in the abdominal cavity. To preserve the darkened environment, Sims suggested infrared cameras and LEDs to provide light that would be invisible to students.
Multidisciplinary teamwork proved essential. Sims and Eason were instrumental in designing and creating a programmable blood supply that could mimic changing blood pressures and heart rates. Likewise, Olsen tasked Hemphill with building new organ pathologies in a lab that would come to be informally known as "the body shop."
In 2008, a more highly developed iteration of the simulator – one with anatomically correct internal organs and tissues as well as articulated lower limbs – was demonstrated at a national simulation conference. That version, known as "Peggy" for peg legs that were made from PVC pipe, convinced Gaumard Scientific to take ETSU's high-fidelity simulator idea and bring it to market.
Surgical Chloe™ simulates a patient down to minute details. After lifting the abdominal wall of the prototype, Olsen pointed out a ruptured ectopic pregnancy that had been removed by an OB/GYN resident. Vessels have been sutured, and if those cuts aren't ligated properly, she will "bleed" internally.
Hysterectomies can be performed on the surgical simulator. Training in many other procedures, such as removal of endometrioma or a dermoid cyst, are possible as well.
"There are heart sounds and lung sounds, and we can cause her to have a heart attack in the operating room or some other crisis that needs to be managed, so we can see how trainees respond," Olsen said. "The arteries have the same blood pressure as the human body, and you can change that pressure depending on the particular scenario."
Hemphill said creating the simulator was an incredibly satisfying process, as well as a learning experience.
"Part of this was going through this long process of teaching myself what I needed to learn to build what we needed to build," Hemphill said. "The doctors helped me understand what we were trying to mold in the way of high-fidelity human organs. We would deploy, test, come back and change. The great thing about using CAD and 3-D printing is it allowed us to make very quick changes once we knew what we wanted; we could change things subtly to make it that much more realistic."
Work by the ETSU team was recognized in January 2011, when a U.S. Patent for a "Surgical Simulator System" was awarded to the four ETSU faculty members and Sheldon Davis, a graduate student studying under Sims who assisted the team.
When Hemphill saw Surgical Chloe™ marketing literature from Gaumard, it was an indelible moment. He also relished the teaching opportunity to show students in tangible form how concept, design and manufacture come together.
Speaking of seeing a photo of a lifelike silicone uterus used in Surgical Chloe™, Hemphill said: "The really great thing is that, after years of work and getting a very high-fidelity model, when I first saw those manufacturing photos, I realized I had created that. That was really a poignant moment for me."
Olsen can identify with that feeling. It's expected that the simulator will be used not only in U.S. teaching facilities, but also in those overseas. Gaumard Scientific sent Olsen a Surgical Chloe™ brochure that had been translated into Russian.
"It's been a gratifying experience," Olsen said. "We think she'll be valuable teaching tool because participants can use their own surgical instruments, in a simulated operating room or even in a real operating room. Chloe will be used in teaching facilities around the world, and she got her start at ETSU."
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East Tennessee State University has invested $500,000 in establishing a simulation center with a Medical Education Technology Incorporated (METI) Human Patient Simulator (HPS). Approximately $100,000 per year is spent by our institution for maintenance of this center. Our residents have an opportunity to spend a significant amount of time in the simulation center and face diagnoses with which they might not otherwise have the opportunity to familiarize themselves.
Additionally, an excellent team of inventors at ETSU continues to develop a vaginal surgery simulator so that the residents will have opportunities to practice skills involved in performing surgical procedures in a confined space in a laboratory setting. A urethral sling procedure trainer and a birthing simulator are also available to help train residents.
Various abstracts, posters and presentations have been conducted regarding our simulation program. Here are a few:
A fetal monitoring teaching web site developed by the department is located at http://www.ob-efm.com and an ultrasound teaching web site is under development.
Our surgical education program includes an ETSU designed surgical simulation unit. These simulation devices (for which patent applications have been submitted) have been used in the simulation lab to instruct the residents in the management of surgical crises. Future growth in the devices will allow the department to assess the competency of a resident in both vaginal and abdominal surgery. Cameras mounted on the resident’s head as well as cameras mounted within the simulation device will record surgical technique and permit subsequent review by residents and faculty. Competency can be assessed not only in vaginal hysterectomy but assessment of complications such as bladder injury or hemorrhage may also take place. This simulation device has a simulated blood supply. The pressure of the blood supply is equivalent to that of the blood pressure in a human being such that knot integrity can be assessed. In 2008, contracts have been signed for production of this surgical simulation as well as a book of simulation scenarios.