JPS5982868A - Heat pasturized hollow yarn type mass transfer apparatus - 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 The present invention relates to a hollow fiber mass transfer device that is heat sterilized in a high temperature, high pressure steam atmosphere.

The hemodialysis machine mentioned here, Q, has a semi-permeable membrane interposed between the blood and the dialysate, and utilizes the difference in osmotic pressure to transfer waste products from the blood to the dialysate. It is used to remove water from the blood through external filtration, and is generally called an artificial kidney. Currently, hemodialysis devices C can be generally classified into coil type, flat plate type, and hollow fiber type depending on their structural characteristics. It is essential that these items must be provided in a sterile state, and currently sterilization methods include ethylene oxide gas, gamma rays, and formalin sterilization, and they can be roughly divided into dry and wet states. be.

Hollow fiber hemodialysis equipment uses cellulose acetate, etc. with an inner diameter of approximately 2
Since hemodialysis is performed by bundling i o, o o o hollow fibers of about 00 to 300 microns back and forth, blood flows inside the hollow fibers, and dialysate flows outside the hollow fibers, the hollow fibers When it comes to sterilization during use, various problems arise compared to the coil type and flat plate type. i.e. in a dry state (ethylene oxide gas) when used in hospitals.

Those sterilized with gamma rays have very thin capillary tubes inside the hollow fibers, making it difficult for liquid to pass through and making it difficult to remove air. For this reason, if the fibers are provided in a moist state if possible, there will be no trouble such as inflowing liquid or venting air during use, and even minor damage to the hollow fibers can be prevented. Therefore, some devices are sterilized by filling formalin inside the device, but this is not recommended for use.
Another problem arises, such as cleaning. Formalin cannot be completely washed away even after washing with large H4 water for about an hour and remains. As described above, there are advantages and disadvantages to sterilization methods for hollow fiber hemodialysis devices, and at present there is no established method.

In view of the above-mentioned circumstances, the present invention aims to provide a vc at the time of use.
,i? It is an object of the present invention to provide a heat-sterilized hollow fiber hemodialysis device that eliminates the trouble of inflowing liquid or venting air, and eliminates the trouble of cleaning.

That is, the present invention has two chambers, a blood chamber and a dialysate or oxygen chamber, an inlet passage and a discharge passage for blood leading to the blood chamber, and a dialysate or oxygen passage leading to the dialysate or oxygen chamber. A hollow fiber mass transfer device comprising an inflow passage and an outflow passage for the purpose of a hollow fiber mass transfer device, wherein the blood chamber and the dialysate or oxygen chamber of the device are substantially filled with an evaporable filling substance that is harmless to the human body; The discharge passage, the inflow passage and the outflow passage are sealed with a sealing member,
The entire device is a heat-sterilized hollow fiber type mass transfer device characterized by being subjected to high-temperature, high-pressure steam treatment.

Hereinafter, the present invention will be explained along with the drawings. In the drawings, the same reference numerals indicate the same things. FIG. 1 shows a general hollow fiber type hemodialysis apparatus l.

Blood is introduced through the introduction passage 2, passes through the hollow fiber 3, and is discharged from the loss passage 4. The cutting L, the dialysate flows into the inflow passage 5, passes through the outside of the hollow fiber 3, and passes through the outflow passage 6.
, and dialysis is performed through the hollow fiber 3. The device 1 is divided into two chambers Q, a 1111 fluid chamber 7 through which blood passes, and a dialysate chamber 8 (in the case of an artificial lung, this would be an oxygen chamber) through which dialysate passes, to ensure that there is no leakage.

In the present invention, first, the blood chamber 7 is filled with an evaporative filling substance that is harmless to the human body, such as physiological saline, water, etc., by reducing the pressure inside the blood chamber 7 using a vacuum filling method, and filling the blood chamber 7 with almost 100% filling. do. By using the reduced pressure filling method, it is possible to easily fill liquid even in very narrow places such as the inside of hollow fibers. Next, the dialysate chamber 8 is filled with 10 [similar to the liquid chamber 7, with an evaporative filling substance, VJ, l (1, which is 10%).

In this case, it is not necessary to use a vacuum filling method.

After filling is complete, go to Hiroto Passage 2. Discharge passage 4. The inflow passage 5 and the outflow passage 6 are sealed in the sealed part 23+ 4a+ 5a+63(
After the device 1 is covered with a rubber plug (for example, a rubber stopper) to prevent leakage of the evaporative filling material inside the device 1, the entire device 1 is placed in high-temperature 86-pressure steam in a supercrepe to perform dtA. J[+
1. Inside the autoclave: 100'~] 30'C
It has the conditions of a temperature of about 1 to 3 and a vapor pressure of 9/cnI, and the temperature and pressure can be freely adjusted within this range.

The container g, 1 can be reliably sterilized by leaving it in an autoclave at 117°C and 1°5 kg/crl for about 30 minutes. In this case, the outer cylinder 9, the fixed cap 10. The cap 11 only needs to be able to withstand the temperature inside the autoclave, and is preferably made of synthetic resin such as polycarbonate or polypropylene. The hollow fiber 3 itself also needs to be selected so that it does not change due to heat.
Regenerated cellulose and the like are preferred.

In short, there is no particular limitation on the material forming the device 1 as long as it can withstand the temperature inside the autoclave.

By sterilizing a hollow fiber mass transfer device in this way, the inside of the device can be reliably sterilized, eliminating the need for cleaning or removing air at the start of dialysis, and since the device is pre-filled with liquid, blood can be removed immediately. It has the advantage of being able to be introduced into hollow fibers.

[Brief explanation of the drawing]

Figure 1e shows a partially broken side curved view of a general hollow fiber hemodialysis device. 1. Hollow fiber hemodialysis device, 2... 7n person passage, 4
...tIli output jQ path, 5... inflow passage, 6...
Outflow passage, 7... blood chamber, 8... dialysate chamber, 2a+ 4a+ 5a+ CIa... sealed section. Source) Ji person Terumo Corporation

Claims (1)

[Claims] 1. Having two chambers: a blood chamber and a dialysate or oxygen chamber,
An inlet passage and an outlet passage for blood leading to the blood chamber, and a dialysate or Qi passageway leading to the dialysate or oxygen chamber.
A hollow fiber type device q' (transfer device QCi) consisting of an inflow passage and an outflow passage for oxygen is provided, and the blood chamber and oxygen chamber of the device are filled with evaporative gas that is harmless to the human body.
jA said introduction passage substantially filled with a substance; The discharge passage, the inflow passage and the outflow passage are honeymoon ff1.
- phase sealed, the whole equipment & 1 high temperature high pressure steam processing BH
A heat sterilized hollow fiber type article f
lf mobile transfer device