Kidney dialysis on the go

[okarol]

Kidney dialysis on the go

Studies of a wearable artificial kidney prototype have been promising. It could free patients from the long hours tied to machines.

By Linda Marsa, Special to The Times
November 12, 2007
PEOPLE with chronic kidney failure face a bleak future. Conventional dialysis cleanses the blood of only about 17% of the toxic chemicals that a healthy kidney removes. And donor organs are scarce. The 300,000 Americans who depend on dialysis to stay alive are crippled by an array of complications caused by the buildup of dangerous poisons in their blood, and only one-third survive more than five years.

Experimental devices in development could help turn this situation around. One advance, a battery-powered, wearable dialysis machine, would allow users to have their blood cleansed round the clock instead of being hooked up to machines 12 hours a week, potentially improving quality of life and reducing mortality. Even further ahead, blood-filtering systems created via nanotechnology -- engineering on a scale one-billionth the size of a meter -- may prove more effective than current dialysis and may even lead to miniaturized, implantable artificial organs that mimic the continuous function of healthy kidneys.

The next generation of artificial kidneys
 
"There's been an explosion in innovation in dialysis in the past few years," says Dr. Allen Nissenson, director of the Dialysis Program at UCLA's Geffen School of Medicine. "In the not too far future, this new technology could transform the field. . . . If it works, it could improve people's lives by providing a form of dialysis that is much more like what natural kidneys do."

Round-the-clock treatment

Currently, people suffering from chronic kidney failure must undergo half-day hemodialysis sessions tethered to bulky machines three times a week to have toxic chemicals cleared from their blood. The intensive treatment can be physically and psychologically draining and cause cramps and nausea.

Because their kidneys no longer flush out fluids, patients must restrict their fluid intake. They must avoid foods containing potassium and phosphorous, because their bodies can't metabolize them properly. Patients also take a fistful of medications every day to help their tissues absorb the scant amount of these minerals their bodies can manage and to stave off the collateral damage of kidney failure such as heart disease, anemia, high blood pressure, osteoporosis, severe joint pain and loss of mental acuity.

"These patients are miserable and not infrequently they tell me, 'I can't take it anymore, stop and let me die in peace,' " says Dr. Victor Gura, a nephrologist at Cedars-Sinai Medical Center who has invented a wearable artificial kidney, and chief scientific officer at Xcorporeal Inc., the L.A.-based company developing his device.

Growing scientific evidence suggests that increasing the frequency and duration of dialysis treatments could greatly reduce this suffering. But dialysis is expensive, and there are not enough machines or nurses to give everyone daily treatments. "The exponentially increasing number of patients requiring dialysis -- a population that is growing 10% annually -- coupled with the crisis in heathcare funding in the U.S. is putting immense pressure on us to deliver dialysis in a completely different way," says Dr. William Fissell, a nephrologist at the Cleveland Clinic in Ohio.

A wearable artificial kidney would be an important step toward providing round-the-clock treatment, says Dr. Claudio Ronco, a nephrologist at St. Bortolo Hospital in Vicenza, Italy, who tested Gura's device in early human trials. "Dialyzing patients continuously with a miniaturized wearable device represents a complete paradigm shift from the way we treat patients today," Ronco says.

How it works

The portable artificial kidney consists of a tiny, double-channeled pulsating pump -- one circulates blood, the other water -- a fluid-collection bag, a filtration system to cleanse impurities and disposable cartridges to purify the water so that it can be recirculated.

The device weighs about 10 pounds, uses about 14 ounces of water and is powered by a 9-volt battery. These components are attached to a belt worn around the waist.

(In contrast, conventional dialysis equipment is the size of a washing machine and requires 40 gallons of water and 110 volts of electricity, which means it must be plugged into an electrical outlet.)

"This is an excellent first step," says the Cleveland Clinic's Fissell.

Small pilot studies have been encouraging, the researchers say. Initial tests in May 2006 on six patients in Italy revealed that the device was safe and removed water effectively without complications.

The results of a more recent trial were reported Nov. 3 at the annual meeting of the American Society of Nephrology. Eight patients in London wore the belt for as long as eight hours. The wearable artificial kidney effectively cleansed waste products and excess fluids from the patients' blood, although at a slower rate than conventional dialysis. "But if we could use this 24/7 or even 18 hours a day, it would be as good or better than daily dialysis, and liberate patients from being tied for huge chunks of time to machines," Gura says.

The crude prototype used in these tests was constructed with existing equipment off the shelf. But now that they've proven the concept works, engineers at Xcorporeal are fabricating a customized version with turbo-charged pumps and more efficient filters that would clear toxins and fluids more rapidly, Gura says. They hope to put all the components together in a streamlined package that weighs about 5 pounds, so that it can be worn comfortably all day.

"We're still a long way from having an FDA-approved product," Gura says. "But we've demonstrated this is doable."

http://www.latimes.com/features/health/la-he-lab12nov12,1,6584708.story?coll=la-headlines-health

[rose1999]

I always read your posts and yet never say thank you for all the time you put into researching and posting these items. Without you I wouldn't know half the things I do.

So THANK YOU okarol       

Rose xx

[paris]

OK,they can use me an a guinea pig!  I will gladly be an experiment.  The article mentioned Cleveland Clinic which is also the hospital that received the grant for research on an artificial kidney.  My sister use to work there and my brother-in-law is treated there for liver failure.  Think I need to move back home!

[KT0930]

I like the sounds of it, but it sounds like it may be quite cumbersome to carry all day. It's hard enough concealing the PD cath and belly all day at work...plus how noisy is it? But if they can assure me no one else will see or hear it, count me in!

[okarol]

Here are photos that accompanied the news story:

Photo #1 -  Dr. Victor Gura of Cedars-Sinai Medical Center shows the prototype kidney dialysis device he created. An FDA-approved product is still a long way away, he says, “but we’ve demonstrated this is doable.”  (Anne Cusack, Los Angeles Times)

Photo#2 -  The prototype was assembled with existing equipment off the shelf. Gura hopes that the final product will be faster and lighter, down from the current 10 pounds to 5, so that it can be worn all day.  (Anne Cusack, Los Angeles Times)

[okarol]

And here is additional info that accompanied the main article:

The next generation of artificial kidneys

November 12, 2007

Nanotechnology -- precision tooling at the micro-molecular level -- is being used to create the next generation of artificial kidneys, ones that would be small enough to be implanted and engineered to more closely simulate the function of human kidneys than current equipment.

Scientists at Cleveland Clinic's Lerner Research Institute in Ohio have completed some key initial steps in this process. Employing technology used to make computer chips, they've fabricated synthetic membranes with pores engineered to filter the blood with exquisite selectivity: trapping the bad stuff -- toxic metabolic waste products such as urea, plus excess fluids and salts -- without robbing the body of critical proteins and blood cells.

The micro-machining enables researchers to etch precise patterns of pores onto ultra-thin silicon wafers, creating sponge-like filters with more than 10,000 pores per square centimeter.

"The trick is to refine the holes and build a membrane with an easy flow so you don't need a huge pump," says Shuvo Roy, a biomedical engineer at the Cleveland Clinic who is involved in this research.

The research is still in the preliminary stages -- researchers are refining the membranes -- but the ultimate goal is to exploit the capabilities of nanotechnology and shrink the filtration and pump system down to the size of a soda can. This would open the pathway toward the development of a truly implantable artificial kidney, one inserted right in the body, much akin to pacemakers. "What we're aiming for is a quantum leap forward -- a device that would operate 24/7 without human intervention," says Dr. William Fissell of the Cleveland Clinic, who is also working on this technology.

UCLA researchers also are using nanotechnology to fashion a device that functions more like a normal kidney does. It would have a dual membrane system: one would filter impurities from the blood and the other would reabsorb blood components that are needed, then excrete the rest as urine, as flesh-and-blood kidneys do. "By mimicking nature, we have the best chance of getting the best outcome," says nephrologist Dr. Allen Nissenson, director of the Dialysis Program at UCLA. "It's still very early, but so far so good."

-- Linda Marsa

http://www.latimes.com/features/health/la-he-labbox12nov12,1,788915.story?ctrack=4&cset=true

[boxman55]

Well I wish they would hurry up. According to the article only a third of us are going to be around after 5 years of dialysis or in my case 45 more months...Its encouraging to hear about these things, but at the same time it is a little depressing when they give life expectency on dialysis and in the same breath say it is going to be awhile before it is ready to use...Boxman

[RichardMEL]

Boxman.. remember some folks have been on dialysis 20+ years.. I think 5 is just an average.. likely skewed by the advanced age of the majority of dialysis patients (though this is likely not going to be the case much longer - sadly).

I do like the sound of nanotechnology... that would really help out so many people... just imagine... an artificial kidney in your body doing all that work... freedom from dialysis and no reliance on transplants..... is it really a dream or something we might see in 20 years? who knows!

[paddbear0000]

Yikes! That thing is huge! It looks so much like a strap-on bomb, it might induce panic! Great idea as a starting point tho.

[okarol]

Yikes! That thing is huge! It looks so much like a strap-on bomb, it might induce panic! Great idea as a starting point tho.

  Yeah, forget passing through airport security!! 

[okarol]

Nov 23, 2007 04:11 AM
Xcorporeal's Wearable Artificial Kidney Prototype Device Featured in Los Angeles Times Article

LOS ANGELES - Xcorporeal, Inc. (OTCBB:XCPL) announced today that The Los Angeles Times has featured the company's Wearable Artificial Kidney prototype device (WAK) in a story following a presentation delivered by Victor Gura M.D., the company's Chief Scientific Officer, at The American Society of Nephrology's (ASN) Renal Week. The presentation, titled, "Continuous Renal Replacement Therapy with a Wearable Device," discussed the first human study conducted in London earlier this year with a prototype of the company's WAK. The article may be viewed at: http://www.latimes.com/features/health/la-he-lab12nov12,1, 6584708.story?coll=la-headlines-health&ctrack=1&cset=true (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

The ASN is organized and operated exclusively for scientific and educational purposes, including enhancing the field of nephrology by advancing the scientific knowledge and clinical practice of that discipline through stimulation of basic and clinical investigation, providing access to new knowledge through the publication of journals and the holding of scientific meetings, advocating for the development of national health policies to improve the quality of care for renal patients, cooperating with other national and international societies and organizations involved in the field of nephrology, and using other means as directed by the Council of the Society.

About Xcorporeal

Xcorporeal, Inc. is a medical device company developing an innovative extra-corporeal platform technology that may be used in devices to replace the function of various human organs. The platform leads to three initial products; a device for home hemodialysis, another device for hospital Renal Replacement Therapy (RRT) and the WAK, being presented today, for continuous ambulatory hemodialysis. These devices will seek to provide patients with improved, efficient and cost effective therapy. The RRT markets represent multibillion dollar opportunities.

For the RRT market, Xcorporeal is developing a portable, multifunctional renal replacement device that will offer cost effective therapy for those patients suffering from Acute Renal Failure (ARF) which causes a rapid decline in kidney function. In the U.S., the disease affects more than 200,000 patients annually, with a mortality rate of 50%. The Xcorporeal platform technology is a natural fit for the hospital market of renal replacement therapy since the technology is designed to provide cost-effective, continuous therapy without the need for expensive replacement fluids. The projected 2007 market opportunity for the U.S. is approximately $1.4 billion. The disposable market is expected to grow at 10% per year. The devices typically need to be replaced every five years. The Company intends to commercialize this device during the first half of 2009.

Xcorporeal also plans to commercialize a home hemodialysis machine and the WAK for the End Stage Renal Disease (ESRD) market, which includes patients with severe kidney disease in which the kidneys cease to function. Xcorporeal's devices will combine the best attributes of currently marketed home hemodialysis machines to create hemodialysis devices which offer patients convenient, durable and truly portable devices for home use. The Company believes its machines will provide a cost-effective alternative to current home treatment modalities, due to their ability to offer hemodialysis without the need for dialysate fluids. The WAK is in addition a revolutionary device intended to enable patients with ESRD to achieve a quality of life closer to that of healthy individuals.

Additional Company information may be found on the Internet at: www.xcorporeal.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and substantial regulation in the medical device industry; and additional risks factors as discussed in the reports filed by the company with the Securities and Exchange Commission, which are available on its website at http://www.sec.gov.

Xcorporeal, Inc. Robert Weinstein, 310-424-5738 Chief Financial Officer
Copyright Business Wire 2007

http://www.newsobserver.com/1566/story/788671.html