JP2002011094A - Coupler for hemodialyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a coupler connecting the coupling part of the nozzle for dialysis liquid with the dialysis feed hose of a hemodialyzer that prevents bacteria and toxins originated from bacteria from entering the hemodialyzer by equipping the coupler with a structure which removes the bacteria and the toxins originated from the bacteria and hence purifies the dialysis liquid. SOLUTION: This is a coupler for hemodialyzer in which the opening at one end is constructed as a hose connecting end for connecting the dialysis liquid hose and the opening at the other end is constructed as a coupling section to the dialysis liquid nozzle of the hemodialyzer, and the removal device of the bacteria and/or the toxius originated is provided between the both openings.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a coupler for a hemodialyzer used for connecting a dialysate hose to a dialysate joint tube of a hemodialyzer when supplying the dialysate to the dialyzer.

[0002]

2. Description of the Related Art Recently, since a large amount of fluid has been exchanged in hemodialysis therapy, the purification of dialysate requires R
Improvements in the O equipment and piping method, cleaning of the B stock solution tank, installation of a filter for removing endotoxin (toxin components derived from Gram-negative bacteria), and other improvements have been made, and the water quality has been dramatically improved (Kanesei Yasushi, "Dialysate" Water Quality Management & Online HDF "
Medical Review, 1996).

[0003] That is, the water for hemodialysis is supplied water such as tap water, (1) removal of polyvalent cations such as Ca ions, magnesium ions and aluminum ions by an ion exchange column (softening), and (2) activated carbon. After adsorption and removal of free chlorine by treatment and (3) removal of ions etc. by reverse osmosis membrane, temporarily store in reverse osmosis tank (above, reverse osmosis system). To make dialysis water,
Next, the dialysis water is mixed with a stock solution which is a commercially available electrolyte concentrate to prepare a dialysate (dialysate preparation system).

Normally, in the case of a sodium bicarbonate dialysis solution, it is prepared in the ratio of reverse osmosis water: stock solution A: stock solution B = 32.74: 1: 1.2.

[0005] Under such circumstances, the contamination contained in each of them is brought into the dialysate in the prepared ratio, so that the degree of contamination of the dialysate is most strongly reflected by the degree of contamination of the reverse osmosis water. . Also, in the B stock solution tank, the baking soda solution itself sometimes becomes a hotbed where various germs grow, so that it tends to be a pollution source.

Here, it is difficult to completely remove bacteria and toxin components derived from bacteria in the reverse osmosis system.
In addition, it is difficult to eliminate any secondary contamination in the subsequent process of dialysate preparation.

Therefore, conventionally, in order to finally supply a dialysate having a high degree of cleanliness, as a filtration step for removing toxin components derived from bacteria, a hollow fiber was used immediately before the dialysate was supplied to the hemodialyzer. A type of bacterial toxin removal filter was installed.

The conventional hollow fiber type bacterial toxin component removal filter has two filters on both sides of the header and two filters on the outer cylinder side, for a total of 4 filters.
Although there are two nozzles, dead space where dialysate does not flow is likely to occur near the blinded nozzle and it is likely to eventually become a contamination source, so it is a rule to connect all four nozzles to avoid blind ends. However, there is a disadvantage that the piping becomes complicated.

Although the conventional filter for removing bacterial toxin components is installed immediately before a hemodialyzer, a pipe is required to supply a dialysate to the hemodialyzer. It was not installed just before.

[0010] Considering a coupler for a hemodialyzer, a conventional coupler for a hemodialyzer has one end configured as a hose connection end for connecting a dialysate hose, and the other end connected to a dialysate nozzle of the dialyzer. This is configured as a joint pipe section. FIG. 1 shows such a state, in which the dialysate nozzle joint pipe section 26 of the dialyzer whose outline shape is stipulated by international standards and schematically shown in FIG. When the O-ring 2 is inserted into the portion 26, the sealing O-ring 2 is provided in the annular groove inside the coupler.
2 is pressed against the distal end of the hemodialyzer joint tube 26 by a ball-lock connection function to achieve liquid tightness.
Reference numeral 20 denotes a dialysate hose connection, reference numeral 22 denotes a sealing O-ring, and reference numeral 24 denotes a locking ball.

In such a coupler for a hemodialyzer, the internal shape of the coupler incorporating the O-ring 22 is complicated, contamination from the bypass connector used for cleaning the coupler, and stagnation of the liquid from the end of the treatment to the transition to the cleaning step. Due to problems, the problem of contamination of the inside of the coupler has been studied (Tetsuya Maeda et al., “Kidney and Dialysis”, 199
7 years, 43 volumes, 74-77).

[0012] From such a point, as a means for preventing the occurrence of contamination inside the coupler, a rubber-like elastic body is used instead of a ball-lock type connecting function, so that the outside of the dialysate nozzle joint pipe of the dialyzer is used. A coupler that achieves liquid-tightness by making close contact (JP-A-8-317972) and an antibacterial coupler containing an antibacterial agent (silver zeolite) in its rubber-like elastic body (Kana Inoue et al., "Kidney and Dialysis", 1997 , 43 volumes,
78-82) or a coupler in which the O-ring is moved to the bypass connector side (Japanese Patent Laid-Open No. 9-51945) has been studied and proposed.

[0013] However, these are merely measures for making it difficult to cause germ contamination inside the coupler and for making the generated contamination easy to clean.

Furthermore, a hemodialyzer has been proposed in which an endotoxin removal filter or the like is fixedly provided in the dialysate inflow passage (Japanese Patent Application Laid-Open No. 7-213603). However, in the case of this proposal, it is cumbersome to remove the filters from the hemodialyzer one by one, and in order to avoid the risk of contamination by germs and the like when removing or attaching, the filter is usually used only once. There is also a problem that the endotoxin filter is fixed to a hemodialyzer that does not have to be used, and the endotoxin filter provided must be disposable.

[0015]

SUMMARY OF THE INVENTION In view of the foregoing, it is an object of the present invention to solve the problems of bacteria and toxin components produced by bacteria that enter the hemodialyzer through the dialysate.

[0016]

That is, according to the present invention, one end opening is formed as a hose connection end for connecting a dialysate hose, and the other end opening is a joint pipe portion to a dialysate nozzle of a dialyzer. And a device for removing germs and / or toxin components derived from germs is provided between the two openings.

That is, conventionally, there was no technical idea that the coupler had a function of preventing contaminating bacteria from invading the hemodialyzer through the dialysate. Just before being fed into the vessel,
It has been found that it is most effective to realize a coupler for a hemodialyzer equipped with a device for removing such bacteria and toxin components produced by the bacteria.

[0018]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the coupler for a hemodialyzer according to the present invention will be described in more detail.

[0019] The coupler of the present invention is used for removing germs and toxin components derived from germs contained in the dialysate flowing into the hemodialyzer from the dialysate nozzle between the two openings. A removal device is provided.

That is, whether the coupler has a conventional general ball-lock type connection function or a coupler using a rubber-like elastic body, one end of the coupler serves as a hose connection portion for connecting a dialysate hose. The other end has an opening at both ends as a joint tube to the dialysate nozzle of the dialyzer. By providing a removing device for removing germs or toxin components derived from germs between the two openings, germs or toxin components derived from germs flowing into the coupler can be efficiently removed.

The removal device for removing various bacteria or toxin components derived from various bacteria which can be used in the present invention includes:
Hollow fiber type or flat type filtration device, ion exchange,
A substance removing device based on hydrophobic interaction or various affinity interactions can be used.

Hereinafter, an embodiment of the coupler for a dialyzer of the present invention will be described with reference to the drawings. A dialyzer using the coupler of the present invention has, for example, a configuration as schematically shown in FIG. There are a blood inflow nozzle 30 and a blood outflow nozzle 30 ′ at both ends of the dialyzer, and the inflowing blood flows inside the thousands to tens of thousands of hollow fibers built in the dialyzer. It flows out and is returned to the patient.
On the other hand, the dialysate flowed from the dialysate inflow nozzle 34 flows outside the hollow fibers in the dialyzer, and after the dialysate is performed with the blood flowing inside the hollow fibers, the dialysate flows out. 34 '.

The coupler for a hemodialyzer according to the present invention is attached to the joint tube portion 34 of the dialysate inflow nozzle, and serves to connect the dialysate supplied from the dialysate hose to the dialyser. Similar to the conventional coupler, the dialysis operation can be performed by joining the joint pipes of each other and maintaining the liquid tightness by, for example, establishing a ball lock mechanism, and then injecting the dialysate. is there.

FIG. 3 shows one embodiment of the coupler for a hemodialyzer according to the present invention. A hollow fiber type bacteria removing filter device is provided between both joint pipes of the coupler of the present invention. Is built-in. That is,
The hollow fibers 42 for removing bacteria in the bacteria removing device are composed of a plurality of fibers, each of which is bent in a loop shape, and the filter case is made of resin 44, for example, urethane resin, in the filter case so that the hollow fiber openings form the same surface. The coupler is installed so as to open to the dialysis nozzle joint tube side 46 of the coupler, for example. The dialysate supplied from the dialysate hose side 40 is filtered from the outside of the hollow fiber 42 into the hollow fiber, passed through the hollow fiber, released from the hollow fiber opening, and passed through the dialysis nozzle joint tube 46. The blood is supplied to the hemodialyzer 34. When filtration is performed from the outside of the hollow fiber to the inside of the hollow fiber, various bacteria and toxin components derived from various bacteria contained in the dialysate are removed.

As the hollow fiber membrane for removing bacteria, any membrane can be used without particular limitation as long as it is a membrane which is substantially impermeable to bacteria. The hollow fibers that have been used can be used as suitable ones.

In particular, when a hollow fiber is used for the purpose of removing toxin components (endotoxin) of Gram-negative bacteria in a dialysate, washing and disinfection can be performed by the hollow fiber and the membrane material satisfying the following requirements. And can be used repeatedly. (1) High endotoxin inhibition rate and endotoxin adsorption ability. (2) The molecular weight cut off is 6000 dal or less. (3) Permeability coefficient per bed is more than 300 ml / hr / mmHg. (4) Chemicals (hypochlorous acid, peracetic acid,
Acetic acid). (5) The endotoxin-blocking ability is maintained for 3 months or more even if it is disinfected by the above-mentioned agent every day. (6) The film and the case member have excellent physical strength. The membrane and case members have a pressure resistance of 1.5 kg / cm or more.

FIG. 4 shows another embodiment of the coupler for a hemodialyzer according to the present invention, in which a filter for removing bacteria of a flat membrane type is incorporated. A flat membrane for removing a derived toxin component, 52 is an O-ring for fixing the flat membrane.

FIG. 5 shows another embodiment of the coupler for a hemodialyzer of the present invention, in which a flat membrane type filter for removing bacteria is incorporated. It is.

[0029]

According to the present invention, various bacteria or toxin components derived from various bacteria conventionally contained in the dialysate are removed immediately before flowing into the hemodialyzer, so that the dialysate can be removed. The cleanliness of the inflowing dialysate can be significantly increased.

In particular, even if various bacteria grow in any of the feed water system and the dialysate preparation system,
If the coupler of the present invention is used, bacteria and toxin components derived from bacteria can be reduced in the dialysate supplied during hemodialysis, whereby the inflammatory reaction of dialysis patients based on these can be suppressed, and various symptoms can be improved. And improve quality of life.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view schematically showing the structure of a conventional coupler for a hemodialyzer.

FIG. 2 is a schematic side view schematically showing a hemodialyzer in which the hemodialyzer coupler of the present invention is used.

FIG. 3 is a cross-sectional view schematically showing an example of an embodiment of the coupler for a hemodialyzer according to the present invention.

FIG. 4 is a cross-sectional view schematically illustrating another embodiment of the coupler for a hemodialyzer according to the present invention.

FIG. 5 is a cross-sectional view schematically showing another embodiment of the coupler for a hemodialyzer according to the present invention.

[Explanation of symbols]

 20: dialysate hose connection part 22: O-ring for sealing 24: ball for locking 26: dialysate nozzle side joint tube of dialyzer 30: blood side nozzle 32: header 34: dialysate side nozzle 36: body case 40: Dialysate hose connection part 42: Hollow fiber for removing germs or toxins derived from germs 44: Resin 46: Fitting tube on dialysate nozzle side of dialyzer 50: Flat membrane for removing germs or toxins derived from germs 52: O for fixing flat membrane Ring 60: Endotoxin-removed beads

Claims (1)

[Claims] 1. A hemodialyzer coupler, wherein one end opening is formed as a hose connection end for connecting a dialysate hose, and the other end opening is formed as a joint pipe to a dialysate nozzle of a dialyzer. A coupler for a hemodialysis machine, wherein a device for removing various bacteria and / or toxin components derived from various bacteria is provided between the two openings.