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Wearable & Implantable Renal Assist Devices
Wearable Artificial Kidney Devices
Today’s dialysis machines are far from perfect. Their efficiency is only around 10% of that of a functioning kidney, and when used three times per week, they are incapable of controlling unhealthy fluctuations in the concentrations of metabolites such as urea in the blood. Many researchers are seeking to design an artificial, wearable kidney that would make dialysis a more effective therapy.
Researchers in Italy have developed a semi-autonomous system called the Vicenza Wearable Artificial Kidney for Peritoneal Dialysis (ViWAK PD). See video of Prof. Claudio Ronco interviewed about Wearable artificial kidney: Dream or Reality? below.
The ViWAK PD is a fully electronic system with a belt and waterproof chamber that houses the replaceable sorbent tubes. Patients replace the sorbent cartridges a couple times a day on a schedule in conjunction with overnight peritoneal dialysis. Patients can monitor and control their therapy wirelessly via a handheld remote or a computer.
In 1997, researchers at UCLA detailed a peritoneal-based Automated Wearable Artificial Kidney, (AWAK) that can provide continuous filtration, mimicking the functions of the normal kidneys. The system would never need patient intervention except during cartridge replacement every 8 or 12 hours. This device is able to regenerate and reuse fluid, and protein components in the spent dialysate - the fluid that has extracted toxins from the patient through the peritoneal cavity, and which is discarded in current, traditional dialysis protocols. The regenerated dialysate is pumped into the patient for the next cycle of dialysis. As such, protein loss is minimized or eliminated and minimum amount of dialysate is required, making a wearable kidney possible. The technology has been licensed for production.
The Wearable Artificial Kidney (WAK), designed by Dr. Victor Gura, an Associated Clinical Professor from the David Geffen School of Medicine at the University of California in Los Angeles working at Cedars Sinai Hospital has been built and successfully tried in laboratory and animal experiments at Cedars Sinai Hospital.
This device underwent two successful human trials in dialysis patients, one in Vicenza, Italy in cooperation with Dr. Claudio Ronco and the other one in the Royal Free Hospital, University of London College, in association with Dr. Andrew Davenport. All laboratory, animal and human trials were reported in peer reviewed scientific journals and numerous prestigious scientific meeting such as the world Congress of Nephrology, the American Society of Nephrology, the European Dialysis and Transplantation Association, the International Society of Hemodialysis and the International Society of Hemodialysis, the International Society of Blood Purification, the Annual Dialysis Conference and many others.
The initial prototype of this device weights approximately 5 kg, is worn as a belt and works on batteries. In addition it is the only device that affords water quality equal to that used for intravenous fluids, while currently used devices use water with some bacterial and endotoxins content. The device is now ready for clinical trials in order to obtain regulatory approval and made available to the public.
Click here to read about theWAK V1.0 and its advanced versions V 1.1 and 1.2.
"Wearable artificial kidney: Dream or Reality?"
The artificial kidney will be the size of a coffee cup. Blood will be pumped through microscopic filters using the body's own blood pressure.
Researchers Announce First Implantable Artificial Kidney Prototype
Public release date: Sep 2, 2010
Posted on AARS: April 7, 2012
UCSF researchers today unveiled a prototype model of the first implantable artificial kidney, known as the implantable renal assist device (iRAD), in a development that one day could eliminate the need for dialysis.
The device, which would include thousands of microscopic filters as well as a bioreactor to mimic the metabolic and water-balancing roles of a real kidney, is being developed in a collaborative effort by engineers, biologists and physicians nationwide, led by Shuvo Roy, PhD, in the UCSF Department of Bioengineering and Therapeutic Sciences.
The treatment has been proven to work for the sickest patients using a room-sized external model developed by a team member in Michigan. Roy's goal is to apply silicon fabrication technology, along with specially engineered compartments for live kidney cells, to shrink that large-scale technology into a device the size of a coffee cup. The device would then be implanted in the body without the need for immune suppressant medications, allowing the patient to live a more normal life.
"This device is designed to deliver most of the health benefits of a kidney transplant, while addressing the limited number of kidney donors each year," said Roy, an associate professor in the UCSF School of Pharmacy who specializes in developing micro-electromechanical systems (MEMS) technology for biomedical applications. "This could dramatically reduce the burden of renal failure for millions of people worldwide, while also reducing one of the largest costs in U.S. healthcare.
"The team has established the feasibility of an implantable model in animal models and plans to be ready for clinical trials in 2016. The device could be on the market by the end of the decade, with a price tag that’s comparable to what it currently costs to maintain a transplant (about $30,000 a year)......read more
From the Biomedical Microdevices Laboratory at UCSF
Nanoporous membranes for renal replacement therapy - the implantable bioartificial kidney
The UCSF Biomedical Microdevices Laboratory is using MEMS technology to miniaturize a bioartificial kidney that performs many of the functions of the natural kidney (beyond the filtering provided by dialysis alone) is surgically implanted into a patient, requires no tethers to machines outside the body, and requires no pumps or electrical devices to operate.
The bioartificial kidney project as a whole is led by Shuvo Roy, PhD, associate professor, UCSF Department of Bioengineering and Therapeutic Sciences and director of the UCSF Biomedical Microdevices Laboratory. Dr. Roy also leads the membrane research component of the work.
Phase 1 of the comprehensive project has been funded by a $3.2 M Quantum Grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to assess feasibility and identify best approaches.
As of September 2010, results have demonstrated proof of concept for the essential components of the device, including high performance membranes for hemofiltration, surface coatings for enhanced biocompatibility, and cell isolation, propagation and preservation techniques for bioreactor development, and efficacy in animals.
Phase 2 of the project, will integrate the Phase 1 successes made possible by the Quantum Grant by continuing engineering and development to show additional efficacy of the device in animals and functionality in end stage renal disease patients.
Artificial kidney may replace dialysis
From ABC7 Eyewitness News, Feb. 23, 2011
Half-a-million Americans suffer from chronic kidney failure each year, and that number keeps going up. The best available treatment is a transplant, but many have to wait years to get one if they get one at all. Now, an artificial kidney may be medicine's next big thing........Eyewitness News Health specialist Denise Dador reports
Click on Image for AWAK Technologies Pte Ltd. Company Profile
The Automated Wearable Artificial Kidney by AWAK Technologies Pte Ltd
The Automated Wearable Artificial Kidney (AWAK) is a wearable dialysis machine that is “bloodless” as it uses the patient’s own peritoneal membrane as a filter. Because the spent dialysate is continuously regenerated from AWAK and reused in perpetuity, it is considered “waterless”.
AWAK, like the natural kidneys, function on a 24/7 basis, it maintains steady-state metabolic and fluid regulation. This is in marked contrast to the current dialytic practice which provides intermittent rather than continuous function with a consequent “see-saw” pattern regulation.
Round-the-clock cycling of dialysate through the peritoneal cavity and the use of sterile connection are expected to reduce the incidence of infections. Finally, dialysis-on-the-go is made possible by AWAK’s wearability and automation. This enhances the lifestyle of ESRD patients as they are free from the servitude of current dialysis regimentations.
Image Copyright AWAK Technologies
AWAK, which stands for Automated Wearable Artificial Kidney, is an ambulatory (portable) form of peritoneal dialysis.
In peritoneal dialysis, dialysis fluid (or dialysate) is pumped into the peritoneal cavity, a space in the abdomen that surrounds the abdominal organs. Toxins and wastes are then cleared from the blood through the peritoneal membrane, the lining of the abdomen (or the peritoneum). The peritoneal membrane acts as a filter to remove impurities from the blood while at the same time preventing important components of the blood, such as the red and white blood cells and proteins, from leaking out into the dialysate. In essence, the peritoneal membrane serves the same function as the normal kidneys, which act to selectively filter out impurities from the blood and remove them in the urine (1).
Spent dialysate is automaticaly drained from the peritoneal cavity and filtered through the sorbent cartridge where toxins are removed to produce regenerated dialysate (2). The regenerated dialysate is enriched with electrolytes & glucose from the Enrichment Module, before it is returned to the peritoneal cavity (3). Steps 1—3 are repeated until the Sorbent Cartridge is exhausted. The exhausted Disposable Module is replaced with a new Disposable Module and the cycle is repeated. In ultra filtration mode, the dialysate from the peritoneal cavity is emptied into the UF bag and a pre-determined amount of dialysate is returned to the peritoneal cavity (4). AWAK returns to the dialysis mode.....read more
From the Implantable Artificial Kidney Corporation
Implantable Artificial Kidney - Shown without filters or cover plates installed
The Implantable Artificial Kidney (IAK) also reffered to as the Human Kidney Replacement Unit (HKRU)
Our kidney research has resulted in producing a device that is designed to function in the same manner as a human kidney. It is intended to extract waste, and keep the nutrients needed by the body. It is designed to not be rejected by the body, eliminating the post-operative immunosuppressants and frequent patient monitoring that a human kidney transplant patient would require for the rest of his life. It is designed to create urine immediately after being implanted. It is our goal to design the device to last 10+ years, and to not require any maintenance during its lifespan..........read more
September 4, 2013: We are upgrading our prototype
We are upgrading the original prototype and have made some improvements to the design. Instead of waiting to design new filters for longevity of 10 years plus, to speed things along, we will use the improved prototype for ONE animal test. We are about 1-2 months away from lab testing the newly redesigned prototype, and when the laboratory tests are successfully completed, we will begin the animal test with the improved prototype. The redesigned prototype will have new filter material that has improved strength, and better filtration. When the test with one animal (pig) is successfully completed, we will then upgrade the filters for longevity, and all future animal testing will be done with the final model to prepare for future human testing.
September 12, 2013: Next week we will have our upgraded prototype finished.
We will then refit it with new filters and lab test their efficiency. Since the upgraded model is slightly longer at 4.25”, we expect some slight adjustments will need to be made to the filters. We estimate that this phase of the project should be completed within a month. We will report our progress on the filter testing phase as soon as the results are in.
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