JPS61170472A - High pressure steam sterilized 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] (Field of technology) The present invention relates to autoclaved artificial organs.

More specifically, when an artificial organ is sterilized using high-pressure steam, at least one of the blood port, plasma port, or dialysate port of the artificial organ has a space of a predetermined volume, and gas permeates through a portion of the space. A high-pressure steam sterilized artificial organ characterized by using a member equipped with a porous membrane that blocks liquid, deaerating the inside of the artificial organ during heat sterilization, and absorbing thermal expansion of the liquid inside the artificial organ. Regarding.

(Prior Art) As a method for sterilizing artificial organs such as artificial kidneys and plasma separators, method 1 involves filling the artificial organs with an aqueous solution containing a disinfectant such as formalin.

Fill with sterilizing gas such as ethylene oxide gas.

Substantially dry sterilization methods are known.

However, in these conventional methods, the sterilizing agent is harmful to the human body, so it is necessary to clean the inside of the artificial organ before use, and even with cleaning, it is difficult to completely remove the sterilizing agent, and some of it is This is not a preferred method as it leaves some residue behind. Therefore, a method of high-pressure steam sterilization is known in which the artificial organ is filled with physiological saline or sterile water without using such a sterilizing agent, and the artificial organ is pressurized and heated using an autoclave.

In this case, there is a risk that the artificial organ may be cracked, destroyed, or deformed due to thermal expansion of the filled physiological saline or the air inside. As an improvement method for this, 9 a buffer device that can be transformed into a blood port, dialysate, or plasma port of an artificial organ (Japanese Patent Application Laid-Open No. 53-84394).

JP-A-57-75656 and JP-A-53-1018
(Refer to Publication No. 90) and hydraulic pressure relief tube (Japanese Patent Laid-Open No. 55-118
757, JP-A-57-49465), a method of connecting a conduit to water or an aqueous solution (see JP-A-53-592),
(see Publication No. 96), etc. have been proposed.

However, in the conventional method, after high-pressure steam sterilization of an artificial organ, it is necessary to completely degas it in advance to prevent air bubbles from entering. In particular, in order to autoclave a hollow fiber dialyzer or porous or hollow fiber plasma separator filled with physiological saline or sterile water, complete deaeration is required. Even if vacuum degassing is performed, a considerable amount of time is required.

(Means for Solving the Problems) The present invention has been made in view of the above problems, and includes:
When sterilizing an artificial organ with high pressure steam, at least one of the blood port, other plasma port, or dialysate port of the artificial organ has a space of a predetermined volume, and gas permeates through a part of the space, A member equipped with a porous membrane that blocks liquids is used to degas the interior of the artificial organ (9) and to absorb the thermal expansion of the liquid (physiological saline, sterile water, etc.) inside the artificial organ during heat sterilization. The present invention relates to a characteristic high-pressure steam sterilized artificial organ.

The material of the space (liquid thermal expansion absorber) having a predetermined volume that absorbs the thermal expansion of the liquid in the artificial organ, such as physiological saline or sterile water, may be any material that can withstand high-pressure steam sterilization9. polypropylene.

Polycarbonate, glass, etc. are preferred, but they do not necessarily have to be rigid, such as silicone rubber.

It may be an expandable material such as natural rubber or synthetic rubber, or a structurally expandable material such as a bellows shape. The volume of the space may be at least one volume capable of absorbing the substantial thermal expansion of the liquid within the artificial organ (the difference between the thermal expansion of the artificial organ and the thermal expansion of the liquid within the artificial organ). The shape may be any shape as long as it can be connected to at least one of the blood port, plasma port, or dialysis port of the artificial organ, and a porous membrane can be attached to a portion thereof.

Further, as the porous membrane that allows gas to pass through but blocks liquid, a hydrophobic microporous membrane that can withstand heat sterilization is used. For example, a porous membrane made of a hydrophobic resin having a melting point higher than the heat sterilization temperature, such as a polypropylene porous membrane or a nylon porous membrane, is preferable. The pore diameter of these porous membranes is preferably 0.01 to 2 μm in view of gas permeability and liquid barrier properties.

When a hydrophobic porous membrane is used, it is only necessary to ensure that the porous membrane is in the highest position during heat sterilization, and there is no need to pay special attention to other positional relationships.
It is also advantageous in that there is no risk of liquid inside the artificial organ leaking to the outside during or after the high-pressure steam sterilization process. However, from the viewpoint of degassing within an artificial organ, the membrane is not limited to hydrophobic porous membranes.

As for the shape of the microporous membrane, either a flat membrane or a hollow fiber membrane can be used. It is also possible to remove the liquid thermal expansion absorber equipped with this porous film for degassing from the artificial organ under sterilization, attach a sealing plug, and package it.

Alternatively, the connecting portion may be fused or fused and cut and then packaged. When using a liquid thermally expandable absorber equipped with a degassing porous membrane having a frame for sealing a blood port, plasma port, or dialysate port, the liquid thermally expandable absorber is attached to an artificial organ, and then the ports are sealed. Open the container, tightly package it in a package that can withstand high-pressure steam sterilization, perform high-pressure steam sterilization, and close the orange from the outside of the package.

With this method, heat sterilization can be performed while still packaged, so there is no post-process to remove the liquid thermal expansion absorber (in the conventional method, the liquid pressure relief tube) and there is no risk of re-contamination.
It will be extremely advantageous.

The blood port, plasma port, or dialysate port sealing stopper may be provided as a stopcock or push-in type sealing orange at the connection between the artificial organ body and the liquid thermal expansion absorber equipped with the porous membrane for degassing, Further, a push-in type sealing plug can be provided in the hole of the port.

(Example) The present invention will be explained with reference to the drawings.

Figure 1 shows a porous polypropylene hollow fiber plasma separator 1.
The plasma port 2 has a plug 8 for sealing the port and a porous polypropylene hollow fiber membrane part 4 for degassing connected by a connecting part 3 at the other end. This is an example equipped with an expansion absorbing section 5. 2 and 3 show different connection examples and port sealing examples (9, 10) equipped with a liquid thermal expansion absorber 5 having a porous membrane portion 4. FIG.

After making the porous polypropylene of the porous polypropylene hollow fiber plasma separator 1 hydrophilic with alcohol, physiological saline is filled into the plasma separator, and a porous polypropylene hollow fiber membrane ( This hollow fiber membrane is not made hydrophilic) and is connected to a liquid thermal expansion absorbing section 5 that can withstand high-pressure steam sterilization. It was tightly packaged and heat sterilized at 121° C. for 20 minutes with the porous membrane at the highest position.

Thereafter, the port sealing function of the connecting portion 3 was closed from the outside of the package. The porous polypropylene hollow fiber plasma separator 1 thus obtained was not cracked or deformed, and the thermally expanded physiological saline returned to the main body of the plasma separator. Moreover, the physiological saline filled inside did not contain air bubbles.

In the artificial organ according to the present invention, the physiological saline 2 can be simply filled with sterile water without any particular consideration for deaeration.

Completely degassed autoclaved artificial organs can be easily obtained.

In addition, it was taken out from the package of the porous polypropylene hollow fiber plasma separator that had been sterilized by high-pressure steam.

A physiological saline circulation device was connected to each blood port, and a saline circulation experiment was conducted, but no visible bubbles were observed in the circulating fluid.

The present invention is not limited to the illustrated drawings, and naturally includes other combinations of porous membrane shapes, connection methods, and types of port sealing plugs.

[Brief explanation of drawings]

1 to 3 show a plasma separator for high-pressure steam sterilization according to the present invention. Symbols 1 to 11 respectively indicate the following parts. l...Porous polypropylene hollow fiber plasma separator. 2... Plasma port, 3... Connection part, 4... Porous membrane part for degassing (hollow fiber membrane or flat membrane), '5... Liquid thermal expansion absorption part. 6...Blood port, F...Sealing stopper, 8...Port sealing stopper (push type), 9...Connecting part sealing stopper (stopcock type), 1
0... Connecting part sealing plug (push type), 11... Hollow fiber type porous membrane botting part for degassing

Claims (4)

[Claims] (1) When autoclaving an artificial organ at 70 to 130°C, a space with a predetermined volume is provided in at least one of the blood port, plasma port, or dialysate port of the artificial organ; The inside of the artificial organ is degassed using a member equipped with a porous membrane that allows gas to pass through but blocks liquid.
Further, an artificial organ sterilized by high pressure steam is characterized in that thermal expansion of a liquid within the artificial organ is absorbed during heat sterilization. (2) When performing high-pressure steam sterilization of an artificial organ at 70 to 130°C, at least one of the blood port, plasma port, or dialysate port of the artificial organ is equipped with a plug for sealing the port, and a predetermined volume is Using a member that has a space and is equipped with a porous membrane that allows gas to pass through a part of the space but blocks liquid,
A high-pressure steam sterilized artificial organ characterized by deaerating the inside of the artificial organ and absorbing thermal expansion of a liquid inside the artificial organ during heat sterilization. (3) The high-pressure steam sterilized artificial organ according to claim 1 or 2, wherein the porous membrane is a porous polypropylene hollow fiber with a pore diameter of 0.01 to 2 μm. (4) The high-pressure steam sterilized artificial organ according to claim 1 or 2, wherein the porous membrane is a porous polypropylene film with a pore diameter of 0.01 to 2 μm.