Medical

Wearable Artificial Kidney gets green light for US trials

Wearable Artificial Kidney get...
John Kundzins of the Kidney Research Institute in Seattle models the Wearable Artificial Kidney that will undergo human trials in the US
John Kundzins of the Kidney Research Institute in Seattle models the Wearable Artificial Kidney that will undergo human trials in the US
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From left, developers of the WAK, Jonathan Himmelfarb, Victor Gura and Larry Kessler
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From left, developers of the WAK, Jonathan Himmelfarb, Victor Gura and Larry Kessler
Detail of the Wearable Artificial Kidney
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Detail of the Wearable Artificial Kidney
The Wearable Artificial Kidney features miniaturized components that perform kidney hemodialysis
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The Wearable Artificial Kidney features miniaturized components that perform kidney hemodialysis
Demo version of the Wearable Artificial Kidney
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Demo version of the Wearable Artificial Kidney
John Kundzins of the Kidney Research Institute in Seattle models the Wearable Artificial Kidney that will undergo human trials in the US
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John Kundzins of the Kidney Research Institute in Seattle models the Wearable Artificial Kidney that will undergo human trials in the US
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In 2009, we had a look at the Wearable Artificial Kidney (WAK) concept that promised patients suffering from kidney failure an alternative to conventional dialysis. Now the tool-belt sized prototype has been granted approval for human testing in the United States by the FDA with clinical trials scheduled to take place in Seattle later this year.

The result of over a decade of development, the WAK was conceived by a team led by Victor Gura at the Cedars-Sinai Medical Center, Los Angeles and the David Geffen School of Medicine at UCLA. It’s a miniature dialysis machine small enough to be worn like a tool belt and is connected to the patient by means of a catheter. According to the team, with such a device, patients would no longer be spending time in long, boring static sessions, but could be out and about working or playing while the wearable unit cleaned their blood on the go.

Like a conventional dialysis machine, the WAK filters out waste products from the patient’s blood after their own kidneys have failed. But while a conventional dialysis machine is the size of a filing cabinet, and even a portable version is as large as a computer printer, the WAK weighs only 10 lb (4.5 kg).

The Wearable Artificial Kidney features miniaturized components that perform kidney hemodialysis
The Wearable Artificial Kidney features miniaturized components that perform kidney hemodialysis

This is very important because dialysis takes up to four hours at a time, three times a week, during which the patient is attached to the machine. And because conventional and portable machines need to hooked to the mains and need large amounts of water, that means the patient can do little more than sit in a chair the entire time.

In terms of its design, WAK is almost identical to larger dialysis machines, but by taking advantage of recent advances in batteries, materials, and miniaturization, the WAK team has been able to radically reduce the size of the wearable machine and the amount of water needed from 40 gal (151 L) to a pint (0.5 L).

So far, the WAK device is at the prototype stage and has undergone limited human testing in Italy and the UK, and is one of three proposals out of 32 candidates chosen for the FDA’s Innovation Pathway program aimed at streamlining the development of medical products. The tests will involve up to 16 patients with 10 to be selected for the full trial. This will involve 24 -hour tests during which the patients will be allowed to move around. During this, blood samples will be drawn and there will be a 28-day follow-up observation period.

Detail of the Wearable Artificial Kidney
Detail of the Wearable Artificial Kidney

If the current test series proves successful, the team plans to work on a lighter and more streamlined version of the WAK. Future tests will aim at developing a method of slow, steady, round-the-clock dialysis to mimic the working of a normal kidney. According to the team, this would not only be a more natural routine, but would also free patients from some diet restrictions.

The Wearable Artificial Kidney is discussed in the video below.

Source: University of Washington

Wearable Artificial Kidney: first U.S. clinical trial

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6 comments
Bob Flint
Admirable effort, however I still doubt that one would be out and about playing or working with the potential for tangling and stares alone.
I would like to try and help get this down to the size of a small fanny pack.
bobflint@excite.com
Nicole Hafezzi
Seems like a wasted effort. A 3D printed kidney from a patients own stem cells is a 100 time better option than this archaic and bulky tool. Unless they can design a fully implantable artificial kidney than a wearable dialysis machine is quite pointless.
Slowburn
Why is a three hour sit three days a week seen as such problem? The real value that that could provide is washing the blood daily. I would want the thing in a hard case.
Rfrstormer
I think there is value in their device. As a current dialysis patient I know the time in the chair often feels wasted. While this option is not as good as the replacement kidney, I do not see that happening any time soon. This would be great for medical centers and home patients as the smaller size and the need for considerably less water improves the efficiency of the process considerably over the current machines.
WAK Fund
​The device shown here is​​​ only a BASIC RESEARCH PROTOTYPE. We have no plans to go with this to the market for public use,​ and we'll surely make it much smaller and lighter, so folks can wear it under their clothes. Normal kidneys filter blood 24 hours a day 7 days a week which is 168 hours of filtration per week, instead of 9 hours of dialysis. Obviously dialyzing for only 3 hours 3 times a week is not sufficient. This is exactly why patients are so sick, their quality of life on dialysis is so poor and the mortality so high. Printing a kidney or stem cells regenerating kidneys would be great, but those would be a decade away or more and a lot of folks would be sick or dead by then. The WAK has already worked in bench, animal and human trials.
Sandi Goodell
Is this device meant to replace peritoneal dialysis in the sense that it needs to run every day, or is it more akin to hemo, in which case it would require the patient or caregiver to actually self-perform puncture, or is it only for those patients who have an existing catheter port? And how incredibly tight will the filter have to be in order to necessitate filtering over and again with the same fluid? And is there more of a chance of the blood clotting in that type of filter?