Indego Exoskeleton Gives Hope to Paraplegic Patients

Earlier this year, Parker Hannifin Corporation announced that it formalized clinical trial agreements with five of the top-tier U.S. rehabilitation centers for its Indego exoskeleton device. Indego is a wearable lower limb orthotic that allows paraplegic patients or patients with similar immobilizing conditions to walk and gain some measure of independence—hence the name, which is a portmanteau of “independent” and “go.”

“Indego is a powered exoskeleton, which in essence operates like a legged Segway,” Achilleas Dorotheou, vice president and head of the human motion and control business unit for Parker Hannifin, told ODT. “We like to use that phrase to relate that it mimics natural human movement by using postural cues to provide legged mobility for people with paraplegia and people with other mobility impairments of the lower limbs. The idea is that it helps a paraplegic get up and walk with the aid of just plain crutches.”

The system works via “vibratory feedback,” controlled by the subject’s posture, Dorotheou explained. If a subject wishes to stand up from a seated position, all she has to do is lean forward. Indego will register her posture and vibrate in order to signal that it is ready to help her stand up. If the patient did not mean for that action, she just needs to lean back again. Otherwise, Indego will move mechanically to bring her into a standing position. Then, if she wants to walk forward, she leans forward again. If she wants to stop, she leans back. In this way, Parker Hannifin has tried to make its design as intuitive as possible.

The system has a modular design which means that it can be disassembled into five pieces and stored in a case about the size of an airplane carry-on luggage allowance.

“The subject can take those components and then attach the calf pieces, thigh pieces and back piece around his body,” Dorotheou said. “Between the pieces are ‘quick connects.’ We paid special attention to these over the past year to make them particularly user friendly and forgiving, so that the user can connect ‘blind’—i.e. they don’t even have to look at them to assemble them.”

Dorotheou’s relationship with Indego began in 2012, three years after the system had been conceived at Vanderbilt University. At the time, Dorotheou was the vice president of business development at another Parker Hannifin group, and had already gained experience commercializing medical devices in collaboration with Cleveland Clinic. Parker Hannifin’s chief technology officer asked him to negotiate an agreement with Vanderbilt, and he was able to obtain an exclusive license for commercializing the device globally. He and Parker Hannifin, which is a motion control technology company, then hired co-inventor of the technology Ryan Farris, Ph.D., as engineering manager for human motion and control. Farris was still a doctoral student when he brought the exoskeleton to life under the instruction of Michael Goldfarb, PhD., the H. Fort Flowers Chair in mechanical engineering and professor of physical medicine and rehabilitation at Vanderbilt. Since 2012, Dorotheou’s team along with several new hires, worked on a second generation of the exoskeleton, making it lighter, more modular, extending its battery life, and all in all getting it ready for the clinical trial stage. Now, the team is ready to hand the system over to the Shepherd Center, a highly regarded Atlanta, Ga.-based spinal cord and traumatic brain injury rehabilitation and research center, for three months of pilot clinical trials. Following this, the system will move into the clinical trials previously announced.

“Some of Indego’s competing devices use very sophisticated, lightweight aerospace materials in order to make the device light. That really adds to the cost of the device,” Dorotheou said. “The genius of our device, which we recognized from the beginning, is that its light weight is not due to any material, but the mechanical design itself. Therefore it allowed us to use quite standard materials. We have spent a lot of time and money on optimizing the battery so it can basically snap on. The external pieces are made from basic plastic resin, and there are some internal metal components. The original design was 3-D printed, and the current design is formed plastic material.”

Currently in trials, Parker has secured partnerships with five out of the top 10 rehabilitation institutions in the United States to work with it on the trials, which will last between 12 and 14 months to reflect protocols desired by the U.S, Food and Drug Administration (FDA) and payers. Following that, Parker will apply for FDA approval which is projected to take a year. By mid-2016, Parker hopes to have Indego on the U.S. market ready for clinical and personal use. Meanwhile, Parker is also pursuing ISO 13485 and CE mark approval in Europe, and Indego should be on the European market by early 2015.

“We see [Parker] as truly being a leader in the human motion control space not in the sense of not only being the largest company, but by enriching and enabling the field,” Dorotheou said. “Nobody really has done rigorous clinical studies on exoskeletons so far. There were some pilot studies here and there, but here we are engaging and attracting the interest of some of the leading clinical institutions in the industry to work with us as we go through clinical trials while being transparent with the FDA in what we’re doing. We’re trying to bring a level of professionalism and rigor. We are aiming to be the first with FDA approval and we want to be the true leader in the field.”

“Intelligent, powered, connected devices that enhance the quality of life for the mobility impaired.” That, said Dorotheou, is the theme for how Parker will approach this field.

Parker Hannifin is based in Cleveland, Ohio. The company focuses on motion control technology, and Indego is its first foray into the human motion control space.