THE HISTORY OF SORBENT DIALYSIS Introduced in the early 1970s, sorbent dialysis has been utilized for over 35 years. Renal Solutions, Inc. currently is the only company to take advantage of this proprietary, patented technology, which was developed from NASA research programs. Sorbent technology is safe and proven; backed by over six million clinical treatments.
Development of Sorbent Technology The Marquardt Corporation, an aerospace company in Van Nuys, California, employed sorbent technology in its government-funded aerospace programs for NASA in the early 1960s. The goal of these programs was to use sorbent chemistry to purify waste and drinking water. In 1966, Lou Reynolds, a retired Vice President of Marquardt Corporation, envisioned using this technology to purify blood. Reynolds visualized applying sorbent chemistry to the development of an inexpensive, portable dialysis machine. In July 1967, a new dialysis project was begun with the primary goal of removing toxic waste material from the blood, while maintaining a proper blood balance. It was theorized that a sorbent chemical compound known as zirconium phosphate (ZP) could provide an answer: research had found that ZP removed ammonia from a test solution. This discovery was a giant step toward the completion of a sorbent artificial kidney. A very simple “dialysis machine,” which consisted of a pump, beaker, and heating element was set up in a laboratory at Mt. Sinai Hospital in Los Angeles. In one of the first experiments performed at Mt. Sinai, researchers tested whether a porous bag containing ZP could remove ammonia from a test solution. The experiment failed as the test solution did not penetrate the bag to come into direct contact with the ZP. This “failure” led to the design of the first sorbent cartridge to ensure that the test solution would contact the ZP. Sorbent cartridges provide dialysate regeneration by chemically reprocessing used dialysate into fresh dialysate by passing it through a unique column of patented chemicals. Each cartridge contains four separate layers: an activated carbon purification layer, a urease layer, a zirconium phosphate layer, and a zirconium oxide and zirconium carbonate layer. Used dialysate enters the bottom of the cartridge and is purified as it rises through each succeeding layer. The cartridge effluent is then mixed with a proportioned volume of infusate containing calcium, potassium, and magnesium to produce fresh dialysate. The fresh dialysate is returned to the dialyzer; this cycle is repeated continuously throughout the treatment. For an in-depth look at sorbent cartridge operation, click here. Resulting dialysate is of very high purity and is continually improved during treatment. Only 6 liters of ordinary drinking water is needed to produce dialysate for an entire treatment. There is no need for water or drain hookups, and no complex water treatment system is required because a sorbent system does not continuously send used dialysate down the drain. Sorbent systems can be used anywhere a standard electrical outlet is available.
Sorbent Dialysis Systems The REDY (REcirculating DYalysis) machine, manufactured by CCI Life Systems, was the first dialysis system to use sorbent technology. In January 1973, the first REDY machine, the URS model, was launched. The REDY® URS System Organon Teknika B.V. of Holland purchased CCI Life Systems in 1978. Organon Teknika developed the successor hemodialysis systems that were widely used. In April of 1980, the Sorbsystem SSD was introduced. In 1982, The REDY® 2000 Sorbent Dialysis machine was launched.
The REDY® 2000 System Cartridge development continued refinements made to every throughout the 1980s, with active layer of the
cartridges and improvements made to the canister design. In October 1992, Organon Teknika agreed to sell its dialyzer manufacturing plant and its renal division - including sorbent technology - to Gambro. For a short time after the purchase, sorbent dialysis development continued, and in May 1993, the first REDY® 1000 portable dialysis systems were produced and sold in Australia. However, FDA approval was never completed, and sales were discontinued in part because Gambro had multiple dialysis equipment platforms. Manufacturing of the REDY 2000s was also discontinued in 1993, but that did not spell the end of sorbent dialysis. Support was continued with the sale of cartridges and other disposable supplies for the REDY systems in use. In March 1999, a new company, SORB™ Technology, Inc. purchased all rights to the REDY® 2000 product line from Gambro. In January 2000, SORB Technology began development of an improved sorbent hemodialysis system for the acute care environment. A project to improve and add additional features to the SORB™ and HISORB™ sorbent cartridges was also started. Four new cartridges were developed with improved sodium, bicarbonate, and pH dynamics: SORB+, HISORB+, SORB HD, and HISORB HD cartridges.
SORB+ and HISORB+ Cartridges The Allient System Simultaneously, sorbent dialysis therapy continued to evolve in another location. In the late 1990s, Dr. Steven Ash and his colleagues at HemoCleanse in Lafayette, Indiana, began development of an updated sorbent dialysis system based upon the BioLogic-HD™, a sorbent hemodialysis system Dr. Ash had developed in the late 1980s. Through the leadership of co-founder Peter M. DeComo, the group was successful in obtaining investment capital and formed a new company, Renal Solutions, Inc., to begin the long process of developing a new sorbent system for the home hemodialysis market. On April 30, 2001, Renal Solutions, Inc., and SORB Technology merged - integrating their home and acute care development projects into one platform, the Allient® Sorbent Hemodialysis System. SORB Technology Division continues to manufacture sorbent cartridges in Oklahoma City, while Renal Solutions, Inc. moved to the Pittsburgh, Pennsylvania, area in 2002. The Allient® Sorbent Hemodialysis System From 2002 to 2005, a focused development team at Renal Solutions worked to create a technologically advanced, yet simple to use and flexible system, to meet the growing need to provide dialysis wherever and whenever needed. The Allient® Sorbent Hemodialysis System resulted - combining sorbent dialysis technology and a new Pulsar™ Blood Pump with a unique, pressure-limited, two-chamber design. The system received FDA clearance to market in mid-2005. For more information about the Allient System, click here. For more information about the Pulsar pump, clickhere. The nearly 40-year history of sorbent dialysis has shown the adaptability of this innovative technology. Today the need for a selfcontained, transportable system that produces fresh dialysate utilizing a sorbent cartridge and only 6 liters of drinking water is greater than ever. Renal Solutions is committed to ensuring wider use of this important technology by developing revolutionary products coupled with superior customer service.