JPH07213603A - Blood dialyzer - Google Patents

Abstract

PURPOSE:To prevent intrusion of the endotoxin in a dialyzate into blood by providing a dialyzate inflow path with an endotoxin removing filter. CONSTITUTION:The endotoxin removing filter device 6 is disposed in a blood introducing port 1. The endotoxin removing filter device 6 is composed of a filter case 7 having an outer peripheral surface in contact with the inner peripheral surface of the blood introducing port 1 and a filter formed of plural pieces of hollow yarn 9 housed within this filter case 7 by a urethane resin 8. The hollow yarn 9 is formed of an endotoxin impermeable membrane which is bent to a loop shape and is fixed by the urethane resin 8 to the opening at one end of the filter case 7.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hemodialysis device, and more particularly, to a hemodialysis device capable of effectively preventing endotoxin in a dialysate from mixing into blood during hemodialysis by a simple method. Regarding

[0002]

BACKGROUND OF THE INVENTION Hemodialysis technology has made rapid progress with the development of hollow fiber hemodialysis equipment, and urea, which is a waste product in blood even in patients with renal failure, etc. By periodically removing low-molecular-weight metabolites such as creatine and uric acid by dialysis, it has become possible to live a social life similar to that of a healthy person.

However, there are substances (eg, β2 microglobulin) that cannot be removed by ordinary dialysis, and their accumulation in the patient's body has been a problem. Therefore, attempts have been made to remove the β2 microglobulin and the like by a hemodialysis device that employs a dialysis membrane having a larger pore size than the dialysis membrane used in the conventional hemodialysis device.

However, increasing the pore size has caused a new problem that endotoxin existing in the dialysate permeates the dialysis membrane and is mixed into blood.

Therefore, a method has been adopted in which a filter for removing endotoxin is provided in the dialysate supply line to prevent the endotoxin from flowing into the hemodialysis apparatus to prevent the endotoxin from mixing into blood. .

However, according to the above-mentioned method, when disinfecting the dialysate supply line, it is necessary to select a disinfection method that the filter for removing endotoxin used can withstand, for example, hot water disinfection or chemical disinfection. It was necessary and sometimes a simple disinfection method could not be adopted, which was a burden on the medical field.

It is conceivable to disinfect the dialysate supply line after removing the endotoxin removal filter from the dialysate supply line, but it is complicated to remove one by one, and due to various bacteria when removing or installing the dialysate. There is a risk of pollution.

Furthermore, there is a possibility that endotoxin may be contaminated below the mounting position of the filter for removing endotoxin in the dialysate supply line. For example, endotoxin may be mixed in the hemodialysis machine when the hemodialysis machine is attached to the dialysate supply line.

The present invention has been completed based on the above circumstances. An object of the present invention is to provide a hemodialysis device that can easily and efficiently prevent endotoxin in a dialysate from mixing into blood during hemodialysis.

[0010]

The invention according to claim 1 for solving the above-mentioned problems dialyzes blood by bringing dialysate introduced from a dialysate inflow passage into contact with blood through a dialysis membrane. A hemodialysis device, wherein the dialysate inflow path is provided with an endotoxin removal filter. The invention according to claim 2, wherein the hollow fiber is provided at both ends of a tubular case having both ends opened. A hemodialysis device, in which a bundle is fixed with a resin, and a dialysate inflow path for introducing dialysate into the tubular case and a dialysate outflow path for discharging dialysate in the tubular case are provided. A hemodialysis device comprising an endotoxin removal filter provided in the above-mentioned, wherein the invention according to claim 3 has the above-mentioned contract wherein the average pore size of the dialysis membrane is 50 angstroms or more. The hemodialysis device according to claim 1, wherein the endotoxin removal filter comprises an ultrafiltration membrane having an average pore size of 50 angstroms or less, or an endotoxin adsorbent is included therein. The hemodialysis device according to any one of claims 1 to 3, wherein the invention according to claim 5 has openings at both ends, and the dialysate introduction path and the dialysate discharge path are circumferential side surfaces. A cylindrical casing main body formed in the casing, a hollow fiber bundle housed in the casing main body, fixed with resin at the openings at both ends, and having an open end at an end face formed of the resin; In a hemodialysis device having two lid members that are respectively attached to the opening portions at both ends of the main body, the outer peripheral surface having the opening portions at both ends and being in contact with the inner peripheral surface of the blood introducing passage is provided. And an endotoxin removal filter device having an endotoxin removal filter comprising a plurality of hollow fibers that are fixed to the one end opening of the filter case and are housed inside the filter case. Each hollow fiber is bent into a loop,
Blood is characterized in that two ends that are bent in the same direction are fixed to one end opening of the filter case by a resin, and have an opening end on the end face formed by the resin. A dialyzer, wherein the invention according to claim 6 has a tubular casing main body having openings at both ends and having a dialysate introduction passage and a dialysate discharge passage formed on the circumferential side surface, and in the casing body. A hollow fiber bundle that is housed and fixed with resin in the openings at both ends and that has an open end on the end face formed of the resin, and two lid members that are respectively installed in the openings at both ends of the casing body. In a hemodialysis apparatus having, a cylindrical filter case having an opening that can be integrally mounted on the outer circumference of the dialysate inlet at one end side, and is bent and looped in a loop shape, respectively. And an endotoxin removal filter consisting of a plurality of hollow fibers fixed inside the filter case with resin so that the two end openings facing in the same direction face the other end opening side of the filter case. A hemodialysis device comprising an endotoxin removal filter device comprising: the dialysate introduction path and the dialysate discharge path having openings at both ends. A tubular casing body formed on a side surface, a hollow fiber bundle housed in the casing body, fixed with resin at the openings at both ends, and having an open end at an end face formed by the resin, In a hemodialysis device having two lid members that are respectively attached to openings at both ends of the casing body, the hemodialysis apparatus has an opening in a space toward a blood introduction path in the casing body. And an endotoxin removal filter device having an endotoxin removal filter consisting of a plurality of hollow fibers fixed with resin so as to open at the opening of the filter case, and is introduced into the blood introduction path. It is a hemodialysis device in which the dialysate passes from the peripheral surface of the hollow fiber into the hollow fiber and flows from the opening of the hollow fiber into the casing body.

[0011]

The hemodialysis apparatus of the present invention operates as follows.

Since the dialysate inflow path of the hemodialysis apparatus of the present invention is equipped with an endotoxin removal filter, endotoxin in the dialysate is removed by the endotoxin removal filter before reaching the dialysis membrane. Therefore, the permeation of endotoxin into the blood through the dialysis membrane is prevented.

[0013]

EXAMPLES The present invention will be described in detail below with reference to examples.

(Embodiment 1) FIG. 1 is a partial sectional view of the vicinity of a dialysate inlet of a hemodialysis apparatus which is an embodiment of the present invention.

This hemodialysis apparatus 1A has a cylindrical casing body 2 having openings at both ends and having a dialysate inlet 1 and a dialysate outlet (not shown) formed on the peripheral side surface.
A hollow fiber bundle 4 housed in the casing main body 2, fixed at a resin 3 at the openings at both ends, and having an open end on an end face formed by the resin 3, and an opening at each of the ends. A hollow fiber hemodialysis apparatus having two lid members 5 (only one of which is shown) to be mounted. In this embodiment, the dialysate inlet 1 constitutes the blood inlet in the present invention, and the dialysate outlet constitutes the dialysate outlet.

This hemodialysis device comprises an endotoxin removal filter device 6 inside the blood inlet 1.

The endotoxin removal filter device 6
Is a filter case 7 having openings at both ends and having an outer peripheral surface in contact with the inner peripheral surface of the blood introducing port 1, and is fixed to one end opening of the filter case 7 by a resin such as urethane resin, and An endotoxin removal filter including a plurality of hollow fibers 9 housed inside the filter case 7 is provided.

Each of the plurality of hollow fibers 9 is bent in a loop shape, and the two ends 10 directed in the same direction when bent are formed by the urethane resin 8 into one end opening of the filter case 7. It is fixed and has an open end on the end face formed by the urethane resin 8. The hollow fiber 9 is formed of an endotoxin-impermeable membrane.

The endotoxin impermeable membrane is not particularly limited as long as it is an endotoxin impermeable membrane, but an ultrafiltration membrane can be preferably used. Examples of the material of the ultrafiltration membrane include cellulose-based materials such as cellulose acetate and synthetic polymer-based materials such as polyamide, polysulfone, and polyacrylonitrile.

The average pore size of the ultrafiltration membrane is not particularly limited as long as it is impermeable to endotoxin. For example, the average pore size may be 50 microns or less.

Endotoxin removal filter device 6
Means that one end opening of the filter case 7 on the end face side where the hollow fiber 9 is opened faces the outside (right direction in FIG. 1) of this hemodialysis device, and the other one end opening is inside this hemodialysis device ( It is arranged inside the dialysate inlet 1 of the hemodialysis device so as to face leftward in FIG. 1, and there is no gap between the outer peripheral surface of the filter case 7 and the inner peripheral surface of the dialysate inlet 1. It is adhered by urethane like so.

According to this hemodialysis apparatus 1A, an endotoxin removal filter device 6 formed of an endotoxin-impermeable membrane is provided at the dialysate inlet port 1 which is a dialysate inflow path into the device. The influx of endotoxin into the can be blocked. In this embodiment, dialysate flows in through the opening at one end of the hollow fiber 9,
The hollow fibers 9 flow from the peripheral surface into the tubular casing body 2.

(Embodiment 2) The dialysate inflow passage in the present invention means a space through which the dialysate flows before the dialysate contacts the dialysis membrane. Therefore, the dialysate inflow path provided with the endotoxin removal filter is not limited to the dialysate inlet in Example 1, and may be upstream or downstream of the dialysate flow from the dialysate inlet. good.

FIG. 2 is a partial cross-sectional view of the hemodialysis apparatus 1B according to another embodiment of the present invention in the vicinity of the dialysate inlet 6a.

The hemodialysis apparatus 1B comprises an endotoxin removal filter device 6a mounted outside the dialysate inlet 1.

The endotoxin removal filter device 6a in this embodiment is provided with an opening portion which can be integrally mounted on the outer periphery of the dialysate inlet 1 at one end side and a line connecting member 11 at the other end side. Cylindrical filter case 7
a and a filter case 7a made of a resin such as urethane resin 8 so that the two end openings which are bent in a loop shape and which are bent in the same direction are directed toward the line connecting member 11 side. And an endotoxin removal filter consisting of a plurality of hollow fibers 9 fixed inside. It is preferable that the hollow fiber 9 opening to the side of the line connecting member 11 is mounted in the filter case 7a so as to occupy as much as possible a cross section in the direction orthogonal to the axis inside the filter case 7a.

As the endotoxin-impermeable membrane (hollow fiber), a membrane having pores with an average pore size of 50 microns or less can be preferably used.

In addition, the opening on the one end side of the filter case 7a is attached to the hemodialysis device integrally with the inner circumference 12 and the outer circumference 13 of the dialysate inlet 1 by resin.

Also in this embodiment, since the dialysate inlet 1 which is the inflow path of the dialysate into the device is equipped with the endotoxin removal filter device 6 formed of the endotoxin impermeable membrane, the inside of the device is The inflow of endotoxin can be blocked. Also in this embodiment, the dialysate flows from the one end opening of the hollow fiber 9 and flows from the peripheral surface of the hollow fiber 9 into the cylindrical casing body 2.

(Embodiment 3) FIG. 3 is a partial cross-sectional view of the vicinity of a dialysate inlet of a hemodialysis apparatus 1C which is another embodiment of the present invention.

The hemodialysis apparatus 1C is housed in a cylindrical casing body 2 having openings at both ends, is housed in the casing body 2, is fixed with resin 3 at the openings at both ends, and is fixed by the resin 3. A hollow fiber hemodialysis apparatus comprising a hollow fiber bundle 4 having an open end on the formed end surface, and two lid members 5 attached to the openings at both ends. A dialysate inlet 1 and a dialysate outlet are formed on the peripheral side surface of the cylindrical casing body 2, and the endotoxin removal filter device 6b of the present invention is provided near the inside of the dialysate inlet 1. It becomes.

This endotoxin removal filter device 6
b is a filter case 15 having an opening in a space facing the blood inlet 1 in the casing body 2, and a plurality of hollow fibers 9 fixed by a resin 14 so as to open at the opening of the filter case 15. And an endotoxin removal filter consisting of, the dialysate introduced into the blood inlet 1 passes from the peripheral surface of the hollow fiber 9 of the endotoxin removal filter device 6b into the hollow fiber 9, and from the opening of the hollow fiber 9. It circulates into the casing body 2.

In particular, the filter case 15 is formed so as to surround the inner opening of the dialysate inlet 1 in the casing body 2 and passes through the axis of the dialysate inlet 1 and of the casing body 2. The cross section orthogonal to the axis is U-shaped and has one end opening on the resin 3 side and the other end opening on the opposite side. The opening at one end of the filter case 15 is closed with the resin 3. One end opening is buried in the resin 3 inside the filter case 15, and the other end is fixed by the resin 14 at the other end opening of the filter case 15, and the surface of the resin 14 on the casing body 2 side is fixed. A large number of open hollow fibers 9 are mounted. The other end opening of the filter case 15 is closed by the resin and the opening of the hollow fiber bundle.

As the endotoxin-impermeable membrane (hollow fiber), a membrane having pores with an average pore size of 50 microns or less can be preferably used.

With the above structure, the dialysate flowing from the dialysate inlet 1 can come into contact with the hollow fiber for hemodialysis through the passage through the wall surface of the endotoxin-impermeable hollow fiber 9. It flows into the space (dialysis fluid flow is indicated by arrows).

Therefore, since the dialysate after removal of endotoxin is used for hemodialysis, there is no risk of endotoxin being mixed in blood.

(Modification) The present invention is not limited to the above-described embodiments, and various modifications can be made without changing the gist of the invention.

For example, a modification of the endotoxin removal filter is not limited to the hollow fiber type, but may be a flat membrane type. For example, a plurality of flat membrane-like endotoxin-impermeable membranes are stretched in the dialysate inlet 1 of the hemodialysis machine 1A shown in FIG. 1 at right angles to the axis of the dialysate inlet 1. A removal filter can be mentioned.

Similarly, the dialysis membrane for hemodialysis is not limited to the hollow fiber type and may be a flat membrane type.

Further, the endotoxin removing filter in the present invention may be one having an endotoxin adsorbent filled inside. As the endotoxin adsorbent, an endotoxin adsorbent resin known per se can be preferably used.

[0041]

EFFECTS OF THE INVENTION Since the hemodialysis apparatus of the present invention is equipped with the endotoxin removal filter integrated with the hemodialysis apparatus itself, it is possible that contaminants may be mixed into the apparatus when it is installed in the dialysate line. Absent. That is, even if the dialysate line is somewhat contaminated for some reason, bacteria and endotoxin do not mix inside the device.

According to the hemodialysis apparatus of the present invention, since the dialysate from which endotoxin has been removed by the endotoxin removal filter is used for dialysis of blood, endotoxin is prevented from being mixed into blood through the dialysis membrane during dialysis. To be done.

[Brief description of drawings]

FIG. 1 is a partial cross-sectional view in the vicinity of a dialysate inlet of a hemodialysis apparatus that is an embodiment of the present invention.

FIG. 2 is a partial cross-sectional view in the vicinity of a dialysate inlet of a hemodialysis apparatus that is an embodiment of the present invention.

FIG. 3 is a partial cross-sectional view in the vicinity of a dialysate inlet of a hemodialysis apparatus that is an embodiment of the present invention.

[Explanation of symbols]

1A, 1B, 1C ... Hemodialysis device, 1 ... Dialysate inlet, 2 ... Casing body, 3 ... Resin, 4 ...
..Hollow fiber bundle, 5 ... Lid member, 6, 6a, 6b ...
Endotoxin removal filter, 7, 7a ... Filter case, 8 ... Urethane resin, 9 ... Hollow fiber,
10 ... Hollow fiber end, 11 ... Line connecting member, 12 ... Outer surface, 13 ... Inner surface, 14 ... Resin, 15 ... Filter case.

Claims (7)

[Claims] 1. A hemodialysis apparatus for dialyzing blood by bringing dialysate introduced from a dialysate inflow path into contact with blood through a dialysis membrane, wherein an endotoxin removal filter is provided in the dialysate inflow path. A characteristic hemodialysis machine. 2. A dialysis device in which hollow fiber bundles are fixed with resin at both ends of a tubular case with both ends open, and a dialysate inflow passage for introducing dialysate into the tubular case and a dialysate in the tubular case are discharged. A hemodialysis apparatus having a liquid outflow passage, wherein an endotoxin removal filter is provided in the dialysate inflow passage. 3. The hemodialyzer according to claim 1, wherein the average pore size of the dialysis membrane is 50 angstroms or more. 4. The endotoxin removal filter according to claim 1, wherein the endotoxin removal filter comprises an ultrafiltration membrane having an average pore size of 50 angstroms or less, or an endotoxin adsorbent is included therein. Hemodialysis machine. 5. A cylindrical casing main body having openings at both ends and having a dialysate introduction passage and a dialysate discharge passage formed on the circumferential side surface, and a casing body housed in the casing main body, wherein the openings at both ends are provided. In a hemodialysis device, which is fixed with a resin, and has a hollow fiber bundle having an open end on an end face formed of the resin, and two lid members respectively attached to both end openings of the casing body, A filter case having openings on both ends and having an outer peripheral surface in contact with the inner peripheral surface of the blood introducing passage, and a plurality of hollows fixed to the one end opening of the filter case and housed inside the filter case. An endotoxin removal filter device having an endotoxin removal filter made of a thread is provided, and each of the plurality of hollow fibers is bent in a loop shape and bent. As a result, the two end portions facing in the same direction are fixed to one end opening portion of the filter case by a resin, and the opening end is formed on the end face formed by the resin. 6. A cylindrical casing main body having openings at both ends and having a dialysate introduction passage and a dialysate discharge passage formed on the peripheral side surface, and a casing body housed in the casing main body, wherein the openings at both ends are provided. In a hemodialysis device, which is fixed with a resin, and has a hollow fiber bundle having an open end on an end face formed of the resin, and two lid members respectively attached to both end openings of the casing body, A cylindrical filter case having an opening that can be integrally mounted on the outer periphery of the dialysate inlet on one end side, and two ends that are bent in the same loop and are bent in the same direction. An endotoxin removal filter comprising a plurality of hollow fibers fixed to the inside of the filter case with a resin so that the opening of the part faces the other end opening side of the filter case. A hemodialysis device comprising a filter for removing xin. 7. A cylindrical casing body having openings at both ends and having a dialysate introduction passage and a dialysate discharge passage formed on the peripheral side surface, and a casing body housed in the casing body, wherein the openings at both ends are provided. In a hemodialysis device, which is fixed with a resin, and has a hollow fiber bundle having an open end on an end face formed of the resin, and two lid members respectively attached to both end openings of the casing body, An endotoxin having a filter case having an opening in a space toward the blood introduction path in the casing body, and an endotoxin removal filter composed of a plurality of hollow fibers fixed with resin so as to open at the opening of the filter case. Equipped with a removal filter device, the dialysate introduced into the blood introducing passage passes through the peripheral surface of the hollow fiber into the hollow fiber, and from the opening of the hollow fiber, the case A hemodialysis device that is adapted to flow into the main body.