A new medical invention, a wearable artificial kidney, could drastically change the lives of countless people dealing with renal failure now and in the future. The device, created by nephrologist Victor Gura, has shown a great deal of promise in recent clinical trials. Recently Dr. Gura presented on the project for the second time in two years at the American Nephrology Nurses Association 47th National Symposium.
Individuals with renal failure have few options today besides dialysis. Fortunately, the future looks bright for patients who struggle with dialysis due to advances in at-home machines and an implantable artificial kidney that researchers at the University of California, San Francisco are developing. However, it is likely that Dr. Gura’s device will hit the market before these solutions are affordable and viable.
The kidneys are responsible for cleansing the blood of a variety of toxins and, when these organs fail, individuals must have their blood filtered through a machine, a process which is known as dialysis. Dr. Gura believes that slow, gentle dialysis over the course of the day is better than rapid dialysis because it more closely mimics the natural function of the kidneys. Not much research has been done to develop new dialysis methods, as the medical community has largely accepted the status quo.
Home dialysis has been offered as a solution for slower, gentler dialysis, but Dr. Gura remains unconvinced. As he explains, patients have little desire to store dialysis supplies and then set up the machine for frequent sessions. On an institutional level, longer and more frequent dialysis session are not feasible due to nursing shortages, as well as demand on dialysis centers.
The Road to a Wearable Artificial Kidney Option
Last year, Dr. Gura and his team announced that the Food & Drug Administration (FDA) approved a proof-of-concept trial involving a wearable artificial kidney. The device weighs 10 pounds and is powered by nine-volt batteries. Patients wear the device around their waist, benefiting from constant dialysis without the need to go to clinics daily or go through the hassle of setting up machines in their homes. The preliminary study included seven patients, six of whom were ambulatory. All patients experienced fluid removal consistent with the rates achieved by ultrafiltration. The device successfully cleared blood of all typical waste products, including urea, phosphorus, and creatinine, as well as excess blood and sodium chloride.
While the initial trial was promising, it also showed Dr. Gura that improvements were necessary. One subject experienced clotting after a matter of hours and two others had to stop treatment due to issues with the dialysate. After a redesign and remanufacture, the device was ready for another clinical trial. The FDA approved additional trials after redesign, citing the device’s potential for reducing patient mortality while also mitigating the high costs of traditional dialysis.
Another Side to the Artificial Kidney Study
Nancy Colobong Smith, a nurse practitioner at the University of Washington Med Center, conducted a different trial from the point of view of nurses. She worked with 14 patients who received access to the device. Six patients used the device for up to six hours, while a second group of eight used it for up to eight hours.
From the two trials, she found that the wearable kidney is safe. Participants were able to walk, and even dance, with very few side effects. However, she also found that the dialysate regeneration process needed to be fine-tuned and that carbon dioxide bubbles sometimes became trapped due to kinks in the tubing.
Another consideration is that starting participants on the device proved much more involved than getting individuals started with in-center dialysis. The entire process involves a number of checklists and diagrams. Also, three different labs were required to process blood samples from participants to track progress.
At the same time, patients responded very well to the device. One participant, a 70-year-old man, had struggled with diabetes for 40 years and had to go to the clinic for three four-hour dialysis sessions weekly. With the device, he was able to eat an unrestricted diet and consistently achieved normal blood test results. He said that the device was heavy, but that it made him feel much more free than he had with traditional dialysis.
The Future of the Wearable Device
Both Nurse Colobong Smith and Dr. Gura are now pushing for yet another trial with a new smaller and lighter prototype that has been developed to improve comfort. With this new, 24-hour approach to dialysis, they both feel that rates of hypertension will lower and patients may no longer need phosphate binders.
In addition, the device could reduce the need for anemia drugs while giving patients back their active lives. Plus, the ability to not have to adhere to a strict dialysis diet could remarkably improve the quality of life that patients experience after kidney failure.
The results of the initial study were published in early June in Journal of Clinical Investigation Insight. Since then, the buzz surrounding the device has only grown, and it may not be long before another trial takes place and artificial kidneys become commercially available.