JPS6158662A - Sterilization of artificial organ - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION (Industrial Application Field) The present invention relates to a method for obtaining a gamma-ray sterilized artificial organ such as an artificial kidney, the interior of which is filled with water or an aqueous solution.

(Prior Art and Problems) Sterilization methods for artificial organs are broadly divided into dry and wet methods, and are classified into EOG sterilization, heat sterilization, gamma ray sterilization, etc. depending on the method used.

Each of these methods has its advantages and disadvantages, and currently there is no established method.

The gamma ray sterilization method involves irradiating artificial organs with gamma rays in a dry or wet state, and if gamma ray radiation equipment is available, it is a promising method that has excellent sterilization effects and is easy to operate.

However, this method also has the following problems.

That is, regardless of the dry method or the wet method, equipment such as hollow fibers is decomposed by γ rays, and the elution of decomposition products becomes a problem.

(Object of the invention) The present invention is a novel sterilization method that improves the above problems, and
Various decomposition products caused by gamma rays are washed away aseptically to provide a wet-type artificial organ with less eluate.

(Structure of the Invention) The gist of the present invention is a gamma ray sterilization method for artificial organs, which comprises the following steps (a) to (d).

(a) Filling the artificial organ with water or an aqueous solution; (b) opening one or more sets of inlets and outlets of the artificial organ; the inlets are filled with water or an aqueous solution; connection,
An empty container for receiving the filling liquid is connected to the outlet via a closed channel opening/closing means, and the other ports are tightly plugged; (c) the artificial organ is sterilized with gamma rays; (d) after sterilization, each channel is The opening/closing means is opened to replace the filling fluid in the artificial organ with the replacement fluid.

The artificial organ used in the present invention is an embodiment using an artificial kidney in the drawings, but is not limited to this. Any type of material may be used as long as it can be filled with water, physiological saline, or other aqueous solution and sterilized with gamma rays. Specific examples include artificial kidneys, ascites treatment equipment, artificial livers,
There are artificial lungs, blood cells, plasma separation equipment, etc.

The container containing the replacement liquid connected to the inlet and the empty container connected to the outlet are made of a material that is difficult to decompose by γ-rays, such as polyethylene, polypropylene, polystyrene, or glass. The container does not need to be rigid and may be bag-shaped.

As the filling liquid and the replacement liquid, sterile water or an aqueous solution such as physiological saline is used.

There are usually 1 to 2 sets of inlets and outlets connecting containers (people
In terms of an engineered kidney, only the blood side or the blood side and the dialysate side)
In terms of liquid flow, it is preferable to use the two openings as the inlet and the lower opening as the outlet.The size of the container varies depending on the artificial organ, but a container with a capacity of 100 to 500 cc is suitable for handling. be.

The containers on the inlet and outlet sides may be the same, but different containers may also be used.

The artificial organ and the container are connected by a pipe via a wave opening/closing means such as a cock.

Examples of the flow path opening/closing means include a pinch cock, a Pean, a clamp, a clamp, and an electric valve.

In addition, elastic rubber plugs are provided at the entrance and exit of the artificial organ, and a hollow needle that communicates with the inside of the container is provided, and instead of opening and closing the cock, the hollow needle can be inserted into or pulled out of the rubber plug. can also be adopted.

The artificial organ with each container connected to the inlet and outlet is 1.0~
3.5 Mrad (Mega Rad) It is sterilized by irradiation with gamma rays of 2.5 Mrad. At this time, if the whole thing is placed in a transparent or translucent bag and sterilized with gamma rays, all post-sterilization work (sealing, removing the container, etc.) can be done visually inside the bag, so a special sterile room, etc. It is simple and does not require

Next, embodiments of the present invention will be described with reference to the drawings.

Figure 1 is an explanatory diagram showing the state of the artificial kidney before sterilization. An empty container (3) is connected to the two openings of the tank, and a container (2) containing a replacement liquid is connected to the upper two openings of the tank via a closed cock (0).In the state shown in Fig. 1, For example, sterilize by irradiating with 2.5 Mrad gamma rays. After sterilization, open the cock (4) and pour the filling liquid in the artificial kidney (1) into the empty container (3).
3) Container (2) with replacement liquid poured into it (2)
The replacement fluid inside is allowed to flow into the artificial kidney (1).

FIG. 2 shows the state after the replacement. Then the module (
1) Remove pipes, cocks, containers, etc. in a sterile room,
Place the prepared appropriate stopper (5) at the entrance and exit to prevent water from leaking as shown in Figure 3.

Ship as a product. As shown in Fig. 4, if γ-ray irradiation is performed with the module, stopper (7), etc. placed in the transparent bag (6), the container etc. can be visually removed from the outside of the transparent bag after sterilization. Works such as sealing can be performed. FIG. 5 shows the sealed module and the removed containers (2) and (3) separated by heat-sealing the bag (8). The L part of the bag containing only the module is cut and shipped as a product.

(Effects of the Invention) The sterilization method of the present invention has the following advantages over known methods.

(a) Decomposition products generated by γ-ray irradiation can be sufficiently removed by liquid replacement, resulting in a highly safe module.

(b) Since the replacement liquid is also sterilized with gamma rays, sterile cleaning is sufficiently achieved.

(c) The amount of air remaining in the module is low.

[Brief explanation of drawings]

1 to 3 are explanatory diagrams showing one embodiment of the present invention, in which FIG. 1 shows the arrangement state of the artificial kidney before sterilization, and FIG.
FIG. 3 is a diagram showing the arrangement of an artificial kidney in which filling water has been replaced after sterilization. FIG. 3 is a diagram showing an artificial kidney with the container etc. removed and sealed tightly. 4 to 5 are explanatory diagrams showing other embodiments in which γ-ray sterilization is performed in a bag, and FIG. 4 shows the arrangement state before sterilization, and FIG.
This is a diagram showing a state in which the product is heat-sealed after sterilization. 1 Artificial kidney 5 Closed stoppers 2 containers (replacement fluid) 6 Transparent bags 3 Empty containers 7 stoppers

Claims (2)

[Claims] (1) A method for sterilizing an artificial organ having one or more sets of inlets and outlets, the method comprising: (a) filling the artificial organ with water or an aqueous solution; and (b) opening one or more sets of inlets and outlets of the artificial organ. A container containing the replacement liquid is connected to this inlet via a closed channel opening/closing means, an empty container for receiving the filling liquid is connected to the outlet via a closed channel opening/closing means, and other A sterilization method comprising the following steps: (c) gamma ray sterilization of the artificial organ; (d) after sterilization, open each channel opening/closing means to replace the filling liquid in the artificial organ with a replacement liquid. (2) The method according to claim 1, in which the artificial organ is placed in a transparent or translucent bag and subjected to gamma ray sterilization.