An engineer and a surgeon working together in a University of Michigan spin-off, FlexDex Surgical, have developed a new low-cost surgical instrument that replaces the $2 million daVinci Surgical System for certain minimally invasive procedures.
The FlexDex is a simple, ergonomic and intuitive "needle driver" for stitching inside the body, and is being used for the first time in a series of operations. The low-cost platform is expected to expand the use of minimally invasive surgery, an approach that allows patients to recover faster.
The FlexDex was developed over a period of 10 years. It is an all-mechanical platform that mounts to the surgeon's arm, and its unique engineering approach enables the tip of the instrument to mimic the direction of movement of the surgeon's hand. This breakthrough in engineering amounts to remote control without electronics.
FlexDex was invented by pediatric surgeon Jim Geiger and associate professor of mechanical engineering Shorya Awtar.
The needle driver has already been used in several laparoscopic and thoracic procedures, and the device will be applied to other types of operations, including hernia repairs, hysterectomies and prostatectomies.
Minimally invasive procedures are much less traumatic than traditional open surgeries. Surgeons make smaller incisions. They use laparoscopic cameras to see inside the body, and specialized, smaller instruments to perform the operation. As a result, patients recover faster and healing hurts less. However, these procedures require cumbersome or expensive instruments.
"FlexDex provides the functionality of robots at the cost of traditional hand-held laparoscopic instruments. We've disrupted the paradigm where surgeons and hospitals had to choose between high cost/high function and low cost/low function," Awtar said.
According to Awtar, there are currently a number of other options open to surgeons when they need to stitch internally.
The first is the high-tech daVinci Surgical System, a robot-assisted approach that can cost millions, and therefore not widely available at all hospitals. The system also takes considerable training to learn to use.
The second is old-fashioned straight-stick instruments that can be ergonomically challenging and difficult to learn, especially for complex tasks like suturing and knot tying.
"One of the fundamental challenges in existing instruments is that they have no dexterity. They are tool shafts, handles, and jaws that open and close," Awtar explained.
This lack of ergonomics makes it difficult to execute delicate movements. While they have been some innovations in instruments that allow the surgeon to rotate the tip of the tools, those solutions have been sub-optimal.
[The FlexDex demonstrating suturing.]