Materials, Process/Manufacturing, and

Product Technologies for Configured

Consumer Products
Sorbent Dialysis
At most hemodialysis centers, the rich dialysate from the hemodialysis devices is not regenerated and recycled,
but disposed of through drains and replaced by freshly diluted solution. This process, known as single-pass
dialysis, requires large volumes of ultra-pure water, typically prepared using reverse osmosis, activated carbon,
deionization, and the like. The necessary equipment and holding tanks are expensive and require much space
and, consequently, are not well suited for home hemodialysis products. In the Allient 1 Sorbent Hemodialysis
System (see the Sorbent Dialysis Primer and History of Sorbent Dialysis Web sites), the spent dialysate is
chemically regenerated by passing through a disposable cartridge containing layers of activated carbon, the
urease enzyme, and ionexchange membranes. A small amount of makeup solution, called the infusate,
replenishes any essential ions lost in the filter. Thanks to this regeneration process, only 6 L are required for
each treatment session, compared with greater than 120 L for single-pass dialysis. In addition to removing urea
from the dialysate, the cartridge removes bacteria, heavy metals, and other contaminants from ordinary tap
water, eliminating the need for water-treatment equipment. New devices are completely portable, requiring only
a source of electricity (see the Sorbent Dialysis Primer Web site). The first sorbent dialysis system was
developed in the early 1970s and was sold under the REDY 1 brand name (for REcirculating DYalysis). Its use
continued throughout the 1980s and, in 1993, a portable device was created. FDA approval for this device was
not completed, however, and production was suspended until 1999, when SORB Technology, Inc., obtained the
REDY 1 brand and renewed interest in sorbent dialysis. After merging with Renal Solutions, Inc., in 2001, they
began to develop a system for home use. Renal Solutions, Inc., recently obtained FDA approval to market their
product, the Allient Sorbent Dialysis System, for both in-center and home treatment (see the History of Sorbent
Dialysis Web site). As shown in Figure 16.23, the used dialysate from the hemodialysis unit enters a purification
layer, consisting of activated carbon, to remove particulate matter, heavy metals, etc. Next, the dialysate passes
through a layer of the urease enzyme, which converts urea to ammonium and carbonate ions, that is, ammonium
carbonate. It next passes through a zirconium phosphate layer (cation exchanger), where the dangerous
ammonium ions are exchanged for hydrogen and sodium. A layer of zirconium oxide (anion exchanger) binds
fluorides and phosphates that have been removed from the blood. Because the urease enzyme can break down
unlimited amounts of urea, the main limitation of the cartridge is its capacity to bind ammonia. Current
cartridges (known as SORB TM and HISORB TM ) can process 20–30 g of urea nitrogen before losing their
ability to bind ammonia. A breakthrough of ammonia, when its concentration exceeds 1 TM 2 wt%, indicates that
the capacity has been exceeded and the cartridge must be changed (see the Sorbent Dialysis Primer Web site,
page 6).
b. Technology Protection To protect their technology, prior to designing a new home hemodialysis
product, product-development teams need to be aware of existing patents. In July 2007, an advanced Google
patent search for the term ‘‘home hemodialysis’’ returned 37 patents. The breakdown by decade is as follows:
As seen, far more patents were issued in the 1990s than in the other decades. Many of the inventors cited the
low percentage of patients undergoing dialysis at home and offered solutions they believed would increase the
popularity of this treatment. The following categories were well represented in the search results: On the basis
of this search, it seems clear that the principal technologies associated with the hemodialysis device and the
sorbent dialysis cartridge have been identified (U.S. Patents 3,865,726; 4,276,173; D282,578; 5,783,124;
3,669,878; 4,473,449; 6,878,283; 4,148,314; 6,804,991). Before initiating the design of the home hemodialysis
product in Section 17.3, a more specific search should be carried out for patents associated with devices to
improve safety and for machine disinfection. When significant technologies are located, they can be added to the
innovation map. Other references on hemodialysis devices, in general, include Misra (2005) and Shapiro (2004).