OUR TECHNOLOGY vs DIALYSIS
"Helping a patient live his normal life span while not limiting his quality of life is the prime objective."
Hemodialysis (HD) and peritoneal dialysis (PD) are passive diffusion based modalities that were first developed and used clinically in the 1940’s and 1970’s respectively. Both HD and PD require the use of dialysate solutions to generate the chemical gradients for passive flux of ions and organic molecules across either an artificial dialysis membrane (HD) or the peritoneal membrane (PD). HD therapy uses a significant amount of water. Here in the US, this results in approximately 6.6 billion gallons of waste water being discarded into the drainage system yearly.
Since the original description of HD and the widespread use of disposable hollow fiber dialyzers, technical developments have led to improvements in dialyzer design, materials and clearances. Hemodialysis machines have incorporated changes in blood circuit design, safety controls and have been miniaturized. Safety and miniaturization have also been a focus of modifications in PD cyclerrs.
Despite these improvements, the basic technology used to treat patients with HD and PD has remained essentially unchanged since its origins. Given the number of patients on the transplant waiting list and the known drawbacks of current dialysis therapy, it has become increasingly apparent that fundamental technological advances in renal replacement therapy are needed to improve the health outcomes and quality of life of patients with ESRD.
US Kidney's Waterless EDI Technology
Our technology was motivated by the following considerations.
It would be desirable to develop a technology (standalone,
wearable or implantable format) that for the first time did not
require the use of an external dialysate solution to drive the
passive flux of ions and water across a semipermeable
membrane. Secondly, it would be very advantageous to have
the capability of adjusting the transport of ions and water under
feedback/sensor control to prevent the changes in blood
chemistry that result from alterations in dietary food and fluid
intake. Thirdly, a dialysate- and cell-free technology that could
potentially function continuously either in an external or
implantable format would more closely mimic the native kidney.
Here we introduce a novel technological advance in the field of renal replacement therapy that allows for the first time, the two key functional properties of the kidney i.e. filtration of blood and specific transport of ions and water to be simulated by a device that does not utilize biological-based components or a dialysate. Importantly, the components that mediate the transport of ions do not rely on the presence of chemical gradients and passive diffusion to function per se. Accordingly, dialysate solutions currently used in HD and PD are not required. Moreover, sorbent systems being developed to regenerate dialysate solutions are also not needed.
The technology described herein has been in development over the past four years. A Non-Provisional patent application describing this technology has been filed (September 27, 2017; published April, 2018) and is currently awaiting review by the US government.
Although the technology borrows certain functional principles from the physiology of the kidney, the device does not use living cells but rather completely synthetic engineered components. Our innovative approach combines new multiple mesh electrodeionization technology with pressure driven ultrafiltration, nanofiltration, and reverse osmosis modules. Each of the components performs unique functions that can be thought of as simulating key aspects of the native kidney's filtration and transport functions.
The ultrafiltration module simulates the function of glomeruli by preventing the filtration of blood cell components and proteins. The nanofiltration module prevents the excretion in the “urine” stream of large quantities of glucose while allowing urea permeation. A key feature of the technology is the new electrodeionization technology that has been developed and custom designed to allow modulation and specificity of ion transport. The amount of water excretion in the final “urine” stream is controlled by the reverse osmosis unit. Feedforward and feedback sensor systems are being incorporated that will allow the device to respond under customizable software control to changes in blood chemistry (e.g. K+ and other ions).
US Kidney Research Corporation's technological research has resulted in the world's first completely new blood purifying technology since the invention of dialysis over 75 years ago.