The coiled envelope, a disposable pre-sterilized insert for coil dialysis, and its associated hardware were developed. In vitro and in vivo characterizations of the dialyzer were carried out and clinical dialyses performed. Clinical studies show the efficacy of the device and indicate advantages in its design. The dialyzer can be assembled in less than 5 minutes. The blood fluid path materials are replaceable in the coiled envelope kidney and can be certified sterile and pyrogen-free for each dialysis. This is a distinct advantage over the reuse of commercial dialyzers which can not be certified after their initial use. The disposable insert could be made available for patient use at a cost about one-half that of present commercial dialyzers.
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