By Christine Horan and Allan Cameron
Electrosurgical instruments are used to cut through soft tissue and bone but they also are used to control the bleeding that, consequently, occurs during orthopedic procedures. The problem is that the power that cuts tissue so effectively is actually over-powered for blood vessel sealing and can burn tissue, leaving behind char. This can impact tissue recovery and therefore patient outcomes. It also produces irritating smoke that can impede a surgeon’s visibility and may even be toxic if inhaled.
Medtronic (NYSE: MDT) recently partnered with Continuum to design a new device to eliminate these problems while meeting performance, cost, and usability goals. The Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting combines a powerful cutting function with a coagulation technology called “Transcollation.” This technology uses radiofrequency energy and saline to provide low-temperature blood vessel sealing that controls bleeding without charring or producing smoke.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The Continuum Advanced Systems project team began in the field, with an emphasis on human-centered design, knowing that a deep understanding of the context-of-use would be critical to design the next generation tool. In order to create an intuitive instrument that would perform as needed, our team of designers, strategists, and engineers observed surgeons using existing devices. It became obvious that switching between tools was not only inconvenient with the possibility of a device falling outside the sterile field, but more importantly, it increased surgical durations and impacted the surgical workflow.
In addition, while electrosurgical instruments are not designed to push away at bone and muscle, the team noticed surgeons were using them to do exactly that. For this reason, and because surgeons currently bend electrosurgical pencil tips to improvement cutting shape and angle, we worked to design one that could safely apply pressure to bone and tissue, which resulted in the device’s flexible dual-functioning tip.
We also saw that surgeons had to compensate for the heavy cord attached to the end of some of the existing devices, and to combat that, we created a swivel on the new device. This simple modification made the device more ergonomic, reducing wrist strain and increasing use accuracy.
An unexpected discovery was just how important it was to keep the device familiar. From our interviews, we learned it would be risky to create a device drastically different in design from the tools surgeons were trained on and were used to using. To make our design familiar to surgeons, we incorporated the conventional electrosurgical tools general dimensions — in particular the diameter — and kept the distance between the tip and the cut button the same. The team kept the industry’s standard blue and yellow button colors but the coagulation button was elongated and positioned at 90 degrees so the ergonomics could accommodated the tool rotation needed for the dual use functions. These design decisions eliminated a learning curve for doctors using the new tool.
When considered individually, each observation seems minor, but all led to major design decisions. Every step we took to improve the device was rooted in surgical room observations and testing. The result was an electrosurgical instrument that has improved surgical outcomes and recovery times for patients and led to it recently being chosen for a 2014 IF Design Award.
Christine Horan is a principal of mechanical engineering and Allan Cameron is a principal of industrial design at Continuum.
