Sterilization of an artificial organ

Details Sterilization of an artificial organ Sterilization of an artificial organ

1980-10-31

1983-03-08

Sadowski, David R.

Liquid purification or separation

Casing divided by membrane into sections having inlet

Energy recovery from treated liquid

422 25, 422 38, B01D 3100

Patent

active

043760511

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates to an artificial organ and a method of thermally sterilizing said artificial organ which is adapted to thermally sterilize said artificial organ, for example, in an autoclave and eliminates the necessity of carrying out an aftertreatment following said thermal sterilization.


BACKGROUND OF THE INVENTION

The known processes of sterilizing an artificial organ, for example an artificial kidney, includes the step of filling such artificial organ with an aqueous solution of a sterilizer, such as formalin, or the step of filling said artificial organ with a sterilizing gas of, for example, ethylene oxide. Since the sterilizer is harmful to the human body, the prior art process of sterilizing an artificial organ makes it necessary to wash the interior of an artificial organ before it is applied to the human body. In this case, various difficulties arise that where a solution of a sterilizer, for example, formalin filled in an artificial organ is replaced by a physiological sodium chloride solution, then formaldehyde is left, and moreover harmful substances such as chlorohydrin are produced, and complete elimination of a sterilizer, for example, involves a great deal of time and work. Consequently, the conventional process of sterilizing an artificial organ has not been regarded as satisfactory.
To avoid the above-mentioned problems, a process has been proposed which comprises fully filling the interior of an artificial organ with a physiological sodium chloride solution, instead of applying any of the abovementioned chemical sterilizers and sterilizing the artificial organ with pressure and heat in an autoclave. However, this proposed sterilizing process still has the drawbacks that the artificial organ tends to be cracked or broken due to the thermal expansion of the physiological sodium chloride solution filled in the artificial organ; and these difficulties have to be resolved, before said proposed sterilizing process can be satisfactorily put to practical use.
Processes proposed to date for resolution of the aforementioned problems include, for example, the step of conducting a cannula-bearing buffer bag through the blood port or dialyzate port of an artificial organ, sterilizing the artificial organ under such condition in an autoclave, removing the buffer bag after sterilization, packing the sterilized artificial organ in a wrapper, and again sterilizing the wrapped artificial organ with an ethylene oxide gas. Another proposed process comprises fitting a deformable bag-shaped cap to the blood port or dialyzate port of an artificial organ, sterilizing the artificial organ under such condition in an autoclave, removing the bag-shaped cap, fitting the ordinary rubber cap instead, and packing the assembly in an aseptic atmosphere. However, the above-mentioned proposed processes have the drawbacks that steps extending from the sterilization of an artificial organ in an autoclave to the production of a sterilized packed artificial organ are complicated and consume a great deal of time and work, and further during the aftertreatment following sterilization, the artificial organ is likely to be again contaminated by septic or other harmful microbes. With the former proposed artificial organ-sterilizing process based on the application of a cannula-bearing buffer bag, that portion of an artificial organ which is pierced by a cannula tends to be contaminated, for example, by molds, or bacteria. With the latter proposed artificial organ-sterilizing process based on the application of a bag-shaped cap, tremendous difficulties are encountered in replacing the bag-shaped cap with the ordinary cap and packing a sterilized artificial organ in an aseptic condition. With the above-mentioned proposed artificial organ-sterilizing processes, an artificial organ sterilizer in an autoclave is cooled by water before said organ is packed in the succeeding step. Therefore, care should be taken against the possible contamination of the artificial organ during the water-cooling step.
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REFERENCES:
patent: 3880759 (1975-04-01), Van Assendelft
patent: 4176156 (1979-11-01), Asanuma et al.
Technical Article Entitled, "Tests on the Influence of the .gamma.-Irradiation and the Ethylene Oxide Sterilisation Over Cuprophan", Dr. Kr./Dr. Schl./Lu. Fr/w, Wuppertal, Aug. 30, 1976, pp. 2-9.

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