Researchers at The Universities of Washington and California at Los Angeles have just been given the green light by the Food and Drug Administration to begin clinical trials on a "wearable" kidney dialysis machine, per a press release today.
Patients with kidney issues can require an outside device to clean their blood in the place of their body's natural filtration system. Some form of chronic kidney disease affects one in ten American adults -- though dialysis is typically only used when a significant portion of the tissue has becomes non-functional.
The key issue the team wanted to solve was that dialysis machines are stationary and so require patients to remain at home or in the clinic as they undergo treatment. With sessions occurring three times each week, and for up to a few hours at a time, dialysis eats up a huge chunk of people's time and of their ability to live a normal life.
"Wearable" is often a term we use for machinery like smartwatches and fitness bands but as computing and hardware shrink, the applications in medicine grow. It's no secret that healthcare eats up far too much of our budget and time. Finding new ways to treat patients without physician involvement or ensuring people stay compliant with their treatments has been one of the targets for lowering those costs.
The idea behind the Wearable Artificial Kidney (WAK) is allowing patients to undergo treatment while going about their day -- untethering them from a stationary machine. The device is currently the size of a very large tool belt with an attached filtration system and auxiliary pumps.
"Much of it is not fundamentally different than dialysis today, just with improved technology," says Dr Jonathan Himmelfarb of the University of Washington. The WAK runs continuously on batteries and does not require attaching to an outlet or water pipes. "The biggest challenge in making portable hemodialysis is how to handle water."
Typically, dialysis requires many liters of pure water to filter a patient's blood. With the WAK, Himmelfarb says the onboard water filter allows the recycling of just a half liter of water to perform the treatment -- resolving the issue of carrying around all that heavy liquid.
The next phase of the WAK study will involve sixteen patients with the hope that at least ten complete the full clinical trial. Blood samples will be tested every 24 hours and patients will need to participate for 28 days. Like all early stage treatments, safety must be determined before any sort of plans for commercial rollout.
In April of 2012, the FDA launched its second "Innovation Pathway" program designed to fund cures and treatments for "unmet public health needs." The WAK was one of the three applications selected out of 32 submissions that focus on end stage renal disease. The other two were an implantable artificial kidney being developed at the University of California at San Francisco and an artificial on/off valve for the arteries tapped when dialysis is performed, developed by a South Carolina biotech firm.