JP3381741B2 - Hemodialysis machine - Google Patents

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 a hollow fiber hemodialysis machine, 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 carry out 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 has an opening at both ends,
Cylindrical shape with fluid inlet and dialysate outlet on the peripheral side
And the casing body of the
Are fixed with resin at the openings at both ends, and
Hollow fiber bundle having an open end on the end face formed of the resin
And attached to the openings at both ends of the casing body.
A hemodialysis device having two lid members
Have openings at both ends, and the inner peripheral surface of the dialysate introduction path is
A filter case having an outer peripheral surface in contact with the film;
The filter is fixed to the opening at one end of the
-Enclosure consisting of multiple hollow fibers housed inside the case
Endotoxin removal with dotoxin removal filter
A filter device for removing the hollow fibers
Each is looped and is identical by being bent
The two ends facing in the direction are made of resin and
Fixed to the opening at one end of the base and made of the resin
Blood penetrating characterized in that it has an open end on the end face.
The present invention as set forth in claim 2 is an analyzing device , and an opening is provided at each end.
With a dialysate inlet and a dialysate outlet on the peripheral side.
Formed cylindrical casing body, and the casing body
It is housed inside and fixed with resin at the openings at both ends.
And has an open end on the end face formed of the resin.
Hollow fiber bundle and the
Hemodialysis device having two lid members attached to each
Can be installed integrally with the outer circumference of the dialysate inlet in
Cylindrical filter case with a large opening on one end
And each is bent in a loop and
The two end openings in the same direction
This filter is made of resin so that the other end of the filter faces the opening side.
An end consisting of multiple hollow fibers fixed inside the case
Endotoxin removal with toxin removal filter
Blood filter characterized by having a filter device
The present invention as set forth in claim 3 is an analyzing device , and an opening is provided at each end.
With a dialysate inlet and a dialysate outlet on the peripheral side.
Formed cylindrical casing body, and the casing body
It is housed inside and fixed with resin at the openings at both ends.
And has an open end on the end face formed of the resin.
Hollow fiber bundle and the
Hemodialysis device having two lid members attached to each
At the stand, head to the dialysate introduction path in the casing body
Provided in the dialysate introduction path with an opening in the space
With the filter case and the opening of this filter case
From multiple hollow fibers fixed with resin so that they open
And an endotoxin having a filter for removing endotoxin
Equipped with a thin removal filter device and introduced into the dialysate introduction path
The dialysed liquid that has passed through the hollow fiber from the peripheral surface into the hollow fiber,
It will flow from the hollow fiber opening into the casing body.
According to another aspect of the present invention, the hollow fiber has an average pore size of 50 angstroms.
Or more than 4 ohms, according to any one of claims 1 to 3.
It is a hemodialysis machine .

[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 its 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 dialysate inlet of the present invention, and the dialysate outlet constitutes the dialysate outlet.

This hemodialyzer is equipped with the dialysate inlet 1 described above.
An endotoxin removal filter device 6 is provided inside.

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 dialysate inlet port 1, and is fixed to one end opening of the filter case 7 by a resin such as urethane resin 8, 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 comes into contact with 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 line connecting member 11 side 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 an end face to be formed, 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 dialysate inlet 1 in the casing body 2, and a plurality of hollow fibers fixed with a resin 14 so as to open at the opening of the filter case 15. An endotoxin removal filter consisting of 9 is provided, and the dialysate introduced into the dialysate introduction port 1 passes from the peripheral surface of the hollow fiber 9 of the endotoxin removal filter device 6b into the hollow fiber 9 and the opening of the hollow fiber 9 is formed. To flow into the casing main 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.

─────────────────────────────────────────────────── ─── Continuation of front page (58) Fields surveyed (Int.Cl. ⁷ , DB name) A61M 1/02-1/36

Claims (4)

(57) [Claims] 1. A dialysate introduction path and an opening are provided at both ends.
And a cylindrical casing with a dialysate discharge passage formed on the peripheral side surface
The main body and the casing main body are housed in the both ends of the casing.
It is fixed with resin at the opening and is shaped by the resin.
A hollow fiber bundle having an open end on the end face to be formed;
Two lids attached to the openings on both ends of the main body
And a hemodialysis device having a material
And has an outer peripheral surface in contact with the inner peripheral surface of the dialysate introduction passage.
Filter case and one end of the filter case
Fixed in the opening and inside the filter case
An endotoxin removal flap consisting of multiple hollow fibers to be housed
Filter for removing endotoxin with filter
And each of the plurality of hollow fibers has a loop shape.
Two that go in the same direction by being bent and bent
The end of the filter case is made of resin and one end opening of the filter case
Fixed to the open end on the end face formed by the resin
A hemodialysis apparatus comprising: 2. A dialysate introduction path and a dialysate introduction path having openings at both ends.
And a cylindrical casing with a dialysate discharge passage formed on the peripheral side surface
The main body and the casing main body are housed in the both ends of the casing.
It is fixed with resin at the opening and is shaped by the resin.
A hollow fiber bundle having an open end on the end face to be formed;
Two lids attached to the openings on both ends of the main body
A hemodialysis machine comprising a material,
Provided with an opening that can be integrally attached to the outer circumference of the inlet at one end side
And a cylindrical filter case, and fold each in a loop.
By bending and bending, two
The end opening should face the other end opening of the filter case.
It was fixed inside this filter case with resin
With an endotoxin removal filter consisting of multiple hollow fibers
Having an endotoxin removal filter device that has
A hemodialysis device characterized by: 3. A dialysate introduction path and an opening are provided at both ends.
And a cylindrical casing with a dialysate discharge passage formed on the peripheral side surface
The main body and the casing main body are housed in the both ends of the casing.
It is fixed with resin at the opening and is shaped by the resin.
A hollow fiber bundle having an open end on the end face to be formed;
Two lids attached to the openings on both ends of the main body
In a hemodialysis device having a
With openings to the space toward the translucent 析液introduction passage in the body, before
The filter case installed in the dialysate inlet and
Fixed with resin so that it opens at the opening of the filter case
An endotoxin removal fiber consisting of multiple hollow fibers
An endotoxin removal filter device with a filter
The dialysate introduced in the dialysate inlet is installed around the hollow fiber.
From the surface into the hollow fiber, and from the opening of this hollow fiber, the cable
Hemodialysis device that is made to flow into the main body
Place 4. The hollow fiber has an average pore size of 50 on.
4. The method according to any one of claims 1 to 3, which is Gstrom or more.
The hemodialysis device according to.