Malchesky P S, Surovy R, Kiraly R, Carse C, Nakamoto S, Hulsman A, Vidt D, Nosé Y
Med Instrum. 1975 May-Jun;9(3):129-32.
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.
开发了一种用于盘管透析的一次性预消毒插入物——盘管包膜及其相关硬件。对透析器进行了体外和体内表征,并进行了临床透析。临床研究表明了该装置的有效性,并指出了其设计优势。该透析器可在不到5分钟的时间内组装完成。在盘管包膜肾脏中,血液流动路径材料是可更换的,并且每次透析都可保证无菌和无热原。这与商用透析器再利用相比具有明显优势,商用透析器在初次使用后无法保证无菌和无热原。这种一次性插入物可供患者使用,成本约为目前商用透析器的一半。