JP2001017541A - Dialyzer regeneration method and dialyzator device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a dialyzer regeneration method and a dialyzator that can prevent reliably contamination by bacteria and endotoxins as toxins they generate, the most problematic in the reuse of a dialyzer, reduce costs through labor saving regeneration work of medical workers, secure safety through prevention or the like of viral infection in regeneration work of medical workers. SOLUTION: After blood dialysis, by supplying a sterilized dialysate to a dialyzer 20 through a dialysate circuit 12, and reversely filtering the dialysate from a dialysate system to a blood system, the blood system is washed out sterilely. Here the sterilization of the dialysate is carried out by at least removing bacteria and endotoxins, toxins generated by them by filtering the dialysate by a bacteria removing filter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to medical equipment, and more particularly to a method for regenerating a dialyzer after hemodialysis by a dialyzer, and a dialysis apparatus which can easily carry out this method. .

[0002]

2. Description of the Related Art A dialyzer generally called a dialyzer is widely used in a hemodialysis therapy for removing waste products in a patient's blood into a dialysate through a dialysis membrane in the dialyzer. Conventionally, it has been difficult for most dialysers to keep their dialysate system in an aseptic state, so that they are disposable only for one use.

Recently, however, reusing the dialyzer in the same patient rather than disposing it is disposable, because the blood system of the dialyzer is coated with protein components in blood, thereby improving biocompatibility and economical efficiency. However, due to circumstances such as
Overseas, the reuse of dialysers is widespread.

[0004] Regeneration of such a dialyzer for reuse has generally been performed in the following procedure. First, after hemodialysis, heparinized saline is allowed to flow from the blood circuit,
Immediately after returning the blood in the blood circuit and the dialyzer to the patient (blood return), the dialyzer and the blood circuit are removed from the dialyzer, and the blood circuit is disconnected from the dialyzer. Next, reverse osmosis treatment water is poured into the blood system of the dialyzer by the dialyzer regenerating apparatus, and the remaining blood, thrombus, and the like are washed away.

Thereafter, the dialyzer was filled with a chemical disinfectant such as 3% formalin water and stored. Thus, a series of processes from the end of the dialysis to the storage are performed.

[0006] When the dialyzer is reused, it is checked whether or not formalin physiological saline is filled, and then the formalin is washed out, and then the presence or absence of residual formalin is checked.
If there was no problem, the dialyzer was filled with heparinized saline (priming) and reused. Here, priming is a treatment for improving the dialysis properties of the dialyzer.

[0007]

However, the above-mentioned conventional method for regenerating a dialyzer has a problem in that contamination by bacteria and endotoxin, which is a toxin produced by the bacteria, which is a problem in reuse, cannot be prevented.

In addition, formalin, which sterilizes and preserves the dialyzer, is toxic to living organisms, and must be thoroughly washed with sterile water as a pretreatment for dialysis until no residual formalin remains in the dialyzer. However, since formalin is easily adsorbed to the dialysis membrane due to its properties, it takes considerable time and labor to sufficiently remove it, and this has been a factor of cost increase.

[0009] Further, the washing of the dialyzer and the sterilization operation with formalin involve the risk of causing virus infection and phytotoxicity to medical personnel. In the dialyzer, biocompatibility is improved by coating a protein component on the inner wall of the dialysis membrane. However, since the protein is denatured into a heterologous protein by formalin, the biocompatibility is reduced by sterilization.

Furthermore, in the conventional method for regenerating a dialyzer, three steps of processing immediately after dialysis, storage of the dialyzer, and processing immediately before dialysis are performed separately. In particular, washing out formalin, etc., which is a process immediately before dialysis, is extraly necessary because there is a process of filling and storing formalin, etc. in a dialyzer, and there is no way to efficiently perform each process, and regeneration The simplification of the work was eagerly desired.

The present invention has been made in view of the above-mentioned problems of the prior art, and reliably prevents contamination by bacteria and endotoxin, which is a toxin which is the most problematic in reuse of a dialyzer. And a method for regenerating a dialysis machine, which can reduce costs by reducing the labor required for regenerating work by healthcare workers, and can also prevent virus infection and ensure safety in the work of regenerating healthcare workers. It is intended to provide a dialysis device.

[0012]

Means for Solving the Problems The gist of the present invention for achieving the above-mentioned object lies in the following inventions. [1] A dialyzer (20) that filters waste matter in blood into a dialysate through a dialysis membrane (22), and connects a blood system inside the dialysis membrane (22) of the dialyzer (20) with a human body. A blood circuit (11) and a dialysate circuit (12) for supplying a dialysate to a dialysate system outside the dialysis membrane (22) of the dialyzer (20).
A method for regenerating the dialyzer (20) after hemodialysis by a dialysis device (10) having a dialysate circuit (12) after the hemodialysis. A dialyser (2) through which the dialysate is back-filtered from the dialysate system of the dialyzer (20) to the blood system to aseptically wash the blood system.
0) Reproduction method.

[2] The method according to [1], wherein after the hemodialysis, the dialysate is sterilized by a sterilization filter (60) capable of removing at least bacteria and endotoxin which is a toxin produced by the bacteria. A method for regenerating the dialyzer (20).

[3] A dialyzer (20) for filtering waste matter in blood into a dialysate through a dialysis membrane (22), and a blood system and a human body inside the dialysis membrane (22) of the dialyzer (20). And a dialysate circuit (12) for supplying a dialysate to a dialysate system outside the dialysis membrane (22) of the dialyzer (20). After the hemodialysis by the dialysis device (10), the dialyzer (2)
In the dialysis device (10) capable of regenerating the dialysis solution (0), a disinfection filter (60) is interposed in the supply side of the dialysate circuit (12), and the disinfection filter is provided after the hemodialysis. The dialysate sterilized by (60) is supplied to a dialyzer (20), and the dialysate is supplied to the dialyzer (20).
The dialysis apparatus (10), characterized in that the dialysis apparatus is set to back-filter from the dialysate system to the blood system to aseptically wash the blood system.

[4] When a sterilization filter (60) is interposed in the middle of the supply side of the dialysate circuit (12), a coupler (1) that can be sterilized and cleaned by a separately prepared washer (120).
30) characterized by being interconnected via [3]
A dialysis device as described (10).

[5] The coupler (130) is detachably fitted to one of the tubular ports to be connected.
1) and a lock mechanism (140) for the attachment / detachment port (131).
And a communication port (137) that communicates with the attachment / detachment port (131) on the side opposite to the opening edge of the attachment / detachment port (131) and can connect the other tubular portion to be connected.
0) is an operation ring (141) fitted externally slidably in the axial direction with respect to the outer peripheral portion of the attachment / detachment (131), and movable to the inner peripheral side and the outer peripheral side of the attachment / detachment (131). When the operation ring (141) is held and the inner wall of
31) a ball (133) projecting to the inner peripheral side to fit into a stop groove formed on the outer periphery of the one tubular opening, and an outer peripheral portion of the attaching / detaching opening (131) and an operation ring (141). The operation ring (141) is housed in the gap and the ball (13)
3) a coil spring (145) for urging the cover to cover the outer peripheral portion of the attachment / detachment port (131) and the operation ring (1).
41), a groove (134a, 142a) is formed to communicate with the gap in which the coil spring (145) is housed from the front and rear direction of the operation ring (141). The attachment / detachment port (1
31) forming a fitting margin outer periphery (135) larger than the outer diameter of the operation ring (141) on a part of the outer periphery of the operation ring (141); the washer (120) has a case body (121); The case body (121) is formed in a tubular shape having an inner diameter that matches the fitting margin outer peripheral portion (135) of the coupler (130), and has a pair of openings (122) opened at both ends thereof; When the respective couplers (130) are fitted to the outer periphery (135) of the fitting margin from (122), the internal space (1) in which the mounting / removing openings (131) are separated from each other and can be accommodated.
23), and in the internal space (123) of the case body (121), the communication port (13) of one coupler (130) is provided.
The disinfectant is injected into the internal space (123) from 7), and the disinfectant is discharged from the communication port (137) of the other coupler (130) to the outside, and the internal space (123) is filled and circulated. The disinfectant is supplied to and removed from the opening (13) of each coupler (130).
The dialysis apparatus (10) according to [4], wherein the dialysis apparatus (10) is set so as to be in contact with the entire inner and outer surfaces of the attachment / detachment port (131) including the gap between the outer peripheral portion of (1) and the operation ring (141).

[6] A blood flow path switching means (30) is provided in the blood circuit (11), and the dialysate circuit (1) is provided.
2) A dialysate flow path switching means (40) is provided, and the blood flow path switching means (30) is connected to the arterial inlet (3) connecting the terminal of the arterial blood circuit (11a) of the blood circuit (11).
1) and the venous blood circuit (11) of the blood circuit (11).
b) a venous outlet (32) for connecting the starting end, and a pair of inlets and outlets (33, 34) that can be selectively and alternately connected to the arterial inlet (31) and the venous outlet (32), respectively. The dialyzer (20) is provided at each of the entrances (33, 34).
A pair of blood outflow / inlet ports (23a, 23b) provided at both ends of the dialysate and connected to the blood system are respectively connected, and the dialysate flow path switching means (40) is connected to the supply-side dialysate of the dialysate circuit (12). A supply-side inlet (41) connecting the end of the circuit (12a) and a discharge-side outlet (42) connecting the start of the discharge-side dialysate circuit (12b) of the dialysate circuit (12);
A pair of entrances and exits (43, 4) that can be selectively and alternately connected to the supply-side entrance (41) and the discharge-side exit (42), respectively.
4), wherein a pair of dialysate outlets (24a, 24b) provided at both ends of the dialyzer (20) and connected to the dialysate system are connected to the respective ports (43, 44). [3], [4] or [5].

[7] With respect to the dialyzer (20), the blood flow path switching means (30), the dialysate flow path switching means (40), and the sterilization filter (60) are The dialysis device (10) according to [6], wherein the dialysis device is integrally configured in advance including a middle route of the dialysis.

Next, the operation based on the above-mentioned solution will be described. According to the method for regenerating a dialyzer (20) according to the present invention, after hemodialysis with a dialyzer (10), a sterilized dialysate is passed through a dialysate circuit (12) to a dialyzer (2).
0) and the dialysate is back-filtered from the dialysate system of the dialyzer (20) to the blood system to wash out the blood system aseptically.

By such back filtration, the dialyzer (20)
The blood remaining in the blood system is sufficiently washed away, and the contamination by bacteria and endotoxin, which is a toxin produced by reusing the dialyzer (20), can be surely prevented. In addition, because we do not use drugs such as formalin,
It is possible to omit the labor required for removing the drug, which has been conventionally required before re-use, and also to eliminate anxiety about safety due to the use of the drug.

In order to sterilize the dialysate, for example, a disinfection filter (60) capable of removing at least bacteria and endotoxin, which is a toxin produced by the bacteria, is provided on the supply side of the dialysate circuit (12). The sterilization filter (60) can easily realize the sterilization of the dialysate.

Further, according to the dialysis apparatus (10) of the present invention, a disinfection filter (60) is interposed in the middle of the supply side of the dialysate circuit (12), and after the hemodialysis, the disinfection filter (60) is provided. The dialysate sterilized by (60) is supplied to the dialyzer (20). This dialysate can be back-filtered from the dialysate system of the dialyzer (20) to the blood system to aseptically wash out the blood system.
Can be easily implemented.

In the dialysis device (10), the sterilization filter (60) is provided on the supply side of the dialysate circuit (12).
It is important how to maintain the aseptic condition at the connection portion when interposing. Therefore, by connecting them to each other via a coupler (130) that can be sterilized and cleaned by a separately prepared washer (120), it is possible to more reliably and sufficiently sterilize the dialysate.

Specifically, for example, in the case of the coupler (130) described in the above [5], the aseptic cleaning can be reliably and easily performed by the dedicated washer (120).
In the case of cleaning, first, the opening (131) side of the coupler (130) is fitted into the opening (122) at both ends of the case body (121). Case body (121)
Has an inner diameter that matches the outer peripheral portion (135) of the fitting allowance of the coupler (130), so that the outer peripheral portion (135) of the fitting allowance is pressed against the inner wall of the opening (122) of the case body (121). , Can be maintained in the fitted state.

At this time, the attachment / detachment opening (13) of the coupler (130)
1) and the operation ring (1) forming a lock mechanism (140).
41), coil spring (145) and ball (133)
Although it is located in the internal space (123) of the case body (121), the fitting margin outer peripheral portion (135) of the coupler (130) is provided.
The communication port (137) on the rear end side is exposed outside the case body (121). The coil spring (14)
5) is accommodated in a gap between the outer periphery of the attachment / detachment port (131) and the inner periphery of the operation ring (141).

Here, the coil spring (145) is confined in the gap, but the outer periphery of the attachment / detachment port (131) and the operation ring (141) are located before and after the operation ring (141) with respect to the gap. Groove (134
a, 142a) are formed. Therefore, the gap in which the coil spring (145) is stored is not a closed space, but is opened to the outside by the grooves (134a, 142a).

Each coupler (130) is connected to the case body (12).
1), the inner space (123) of the case body (121) is inserted into the pair of couplers (1).
30) to form a closed space that is hermetically closed. A sterilizing solution is injected into the internal space (123) from the communication port (137) of one coupler (130), and the other coupler (13) is injected.
The sterilizing solution is discharged to the outside from the communication port (137) of 0).

Accordingly, the germicidal solution filled and circulated in the internal space (123) is supplied to the entire inner and outer surfaces of the attachment / detachment port (131) of each coupler (130) and the locking mechanism (140).
Each coupler (130) is evenly sterilized as a whole, evenly contacting each component such as the coil spring (145). Moreover, bacteria and their products are stored in the internal space (1).
The pair of couplers (130) is surely and thoroughly washed, because the pair of couplers (130) is constantly washed away by the circulating germicidal solution without remaining in (23).

Further, the blood circuit (11) is provided with a blood flow path switching means (30), and the dialysate circuit (1) is provided.
When the dialysate flow path switching means (40) is provided in 2),
The flow directions of the blood system and the dialysate system of the dialyzer (20) can be switched at predetermined intervals during dialysis.

As a result, the inflow and outflow of blood to and from the blood system end of the dialyzer (20) are repeated, and the coagulated clot at the blood system end is washed out and remains on the dialysis membrane (22). Blood is avoided as much as possible, and the operation of regenerating the dialyzer (20) after dialysis can be further simplified.

Further, the blood flow path switching means (30), the dialysate flow path switching means (40), and the sterilization filter (60) are integrated with the dialyzer (20) in advance. With such a configuration, it is possible to make the entire dialysis apparatus (10) compact, and the assembling work is omitted and the handling is convenient. In addition, bacterial contamination at the time of assembly can be reliably prevented.

[0032]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram showing an embodiment of the present invention. 1 to 6 show one embodiment of the present invention. As shown in FIG. 1, a dialysis apparatus 10 according to the present embodiment includes a dialyzer 20 generally called a dialyzer, a blood circuit 11 connecting the blood system of the dialyzer 20 to a human body, And a dialysate circuit 12 for supplying a dialysate to the dialysate system. In particular, the dialysis apparatus 10 is set so that the dialyzer 20 can be regenerated after hemodialysis.

As shown in FIG. 5, in the dialyzer 20, a bundle of a number of hollow fiber type dialysis membranes 22 is sealed inside a cylindrical tube body 21, and inside the tube body 21, the dialysis membrane 22 , And the dialysate flows outside the dialysis membrane 22. That is, the inside of the tube main body 21 is divided into two systems: a blood system inside the dialysis membrane 22, and a dialysate system outside the dialysis membrane 22.

The blood port portions 21 at both ends of the tube body 21
In a, the dialysis membrane 22 is fixed by potting with both ends open. As the dialysis membrane 22, an asymmetric polysulfone membrane or the like in which the inner side in the film thickness direction is an active layer as a molecular sieve and the outer side is a porous support layer having a high water content may be used. In such a case, the dialyzer 20
Back-filtration of the dialysate during regeneration of
It is possible to prevent deterioration of the substance removal performance due to reuse of the dialyzer 20.

A pair of blood outlets 23a and 23b communicating with the blood system are provided at both ends of the tube body 21 so as to protrude therefrom.
A pair of dialysate outflow ports 24a and 24b communicating with the dialysate system are provided on the side walls at both ends of the tube body 21 so as to protrude therefrom. The directions in which blood and dialysate flow in the tube main body 21 are set so as to be counterflows which are opposite to each other from the viewpoint of dialysis efficiency.

As shown in FIG. 1, the blood circuit 11 includes an arterial blood circuit 11a connected to the artery side of the human body and a venous blood circuit 11b connected to the vein side of the human body. The starting end of the arterial blood circuit 11a is connected to an artery of the human body via an internal shunt or the like during hemodialysis, but the end is connected in advance to a blood flow switching means 30 described later.

In the middle of the arterial blood circuit 11a,
A blood pump 51 and a pulser 52 for pulse generation are interposed. The blood flow rate by the blood pump 51 can be controlled to a desired value. The pulsar 52 may be omitted by using a blood pump having a pulse generation function.

On the other hand, the starting end of the venous blood circuit 11b is previously connected integrally to a blood flow switching means 30, which will be described later, while the end is connected to a vein of the human body via an internal shunt or the like during hemodialysis. . In the middle of the venous blood circuit 11b,
A drip chamber 53 is provided. The drip chamber 53 is mainly for removing bubbles in the circulating blood and detecting the pressure.

The blood flow switching means 30 has an artery-side inlet 31 for connecting the end of the arterial-side blood circuit 11a and a venous-side outlet 32 for connecting the start of the venous-side blood circuit 11b. Further, the blood flow switching means 30 includes an artery-side entrance 31.
The (end of the arterial blood circuit 11a) and the venous outlet 32 (the starting end of the venous blood circuit 11b) have a pair of inlets and outlets 33 and 34 which can be selectively and alternately communicated with each other.

The switching of the blood flow in the blood flow switching means 30 is performed by driving the switching valve 35. Here, the switching valve 35 is set so that it can be selectively held at the position A and the position B shown in the figure. In addition, each said entrance 33,
Reference numeral 34 denotes a pair of blood outlets 23 in the dialyzer 20.
a and 23b are connected together in advance via communication pipes.

As shown in FIG. 1, a dialysate circuit 12 supplies a dialysate from a tank or the like.
And a discharge dialysate circuit 12 for discharging the returned dialysate.
b. The start end of the supply-side dialysate circuit 12a is connected to a dialysate tank (not shown), but the end is connected to the sterilization filter 60 and the dialysate flow path switching means 40 therethrough via a coupler 130 described later. It is connected.

In the middle of the supply-side dialysate circuit 12a, a dialysate pump 54 and another sterilization filter 6 are provided.
0 is interposed. The dialysate flow rate by the dialysate pump 54 can be controlled to a desired value. The sterilization filter 60 here is basically the same as the sterilization filter 60 connected via the coupler 130.

On the other hand, the starting end of the discharge side dialysate circuit 12b is
It is connected to the blood flow path switching means 30 via a coupler 130 and a check valve 58 described later, and the terminal is connected to a drainage tank (not shown). Also, the discharge side dialysate circuit 12b
A dialysate pump 55 is interposed midway. The dialysate pump 55 is set to be driven at substantially the same output at the same time as the dialysate pump 54 in the supply-side dialysate circuit 12a.

The discharge-side dialysate circuit 12b is provided with a bypass passage 12c straddling the dialysate pump 55. An electromagnetic valve 56 is provided upstream of the bypass passage 12c. An electromagnetic valve 57 is also provided on 12c itself. These operations will be described later.

The sterilizing filter 60 supplies the dialysate, which has been sterilized even after hemodialysis, to the dialyzer 20, whereby the blood system can be aseptically washed out by back-filtration of the dialysate. ing.

More specifically, the germicidal filter 60 is shown in FIG.
As shown in the figure, a large number of filters 62 are sealed in a cylindrical filter case 61. Here, the filter 62 is a material capable of at least removing bacteria and endotoxin, which is a toxin produced by the filter, and specifically, for example, is a polyethylene hollow fiber membrane and has a pore size radius of 40.
Angstrom is suitable.

The inside of the filter case 61 is divided into a feed port side and a feed port side by a filter 62, and a feed port (tubular port) 63 a protrudes from one end communicating with the hollow fiber which is the filter 62. A delivery port 63b protrudes from the other end communicating with the outside of the hollow fiber.

A stop groove 64 is formed at the tip end of the inlet 63a along the outer periphery thereof. Such stop groove 6
Reference numeral 4 denotes a structure for connecting a coupler 130 described later. The outlet 63b is connected to the discharge-side dialysate circuit 12.
Similarly to the intermediate route where the starting end of b is continuous, it is connected to the dialysate flow path switching means 40. Further, a discharge port 63c is protruded from the other end communicating with the hollow fiber. The discharge port 63c is connected to a discharge line 65 for bacteria, endotoxin, and particulate matter after dialysate filtration.

The dialysate flow path switching means 40 is connected to the supply inlet 41 to which the outlet 63b of the sterilizing filter 60 is integrally connected, and to the starting end of the discharge dialysate circuit 12b via a coupler 130 or the like. It has a discharge outlet 42 to be connected. Further, the dialysate flow path switching means 40 includes a supply-side inlet 41.
And the discharge side outlet 42 have a pair of inlets and outlets 43 and 44 which can be selectively and alternately communicated with each other.

The switching of the flow channel in the dialysate flow channel switching means 40 is performed by driving the switching valve 45. Here, the switching valve 45 is set so that it can be selectively held at the position A and the position B shown in the figure. In addition, each said entrance 4
The reference numerals 3 and 44 are respectively connected to a pair of dialysate outlets 24a and 24b of the dialyzer 20 via communication pipes.

Next, the operation of the dialysis apparatus 10 will be described. In the present dialysis device 10, the blood flow path switching means 30, the dialysate flow path switching means 40, and one of the sterilization filters 60 are integrally formed as a unit with the dialyzer 20 in advance. Therefore, it is possible to make the entire dialysis device 10 compact, and to save the labor of assembling,
It is convenient for handling. In addition, bacterial contamination at the time of assembly can be reliably prevented. Hereinafter, the pre-dialysis washing, the actual hemodialysis, and the method of regenerating the dialyzer 20 which forms the basis of the present invention will be described step by step.

I. First, the blood flow switching means 30 integrated with the dialyzer 20
In contrast, the arterial blood circuit 11a and the venous blood circuit 11
b, and further connects the supply-side dialysate circuit 12a and the discharge-side dialysate circuit 12b to the sterilization filter 60 and the dialysate flow path switching means 40 integrated with the dialyzer 20.

At this time, in particular, the end of the supply-side dialysate circuit 12a is connected to the inlet 63a of the sterilization filter 60 via the coupler 130 which has been previously sterilized and washed, and the discharge of the dialysate flow path switching means 40 is performed. The starting end of the discharge-side dialysate circuit 12b is connected to the side outlet 42 via a similar coupler 130. In addition, about the coupler 130 and its aseptic sterilization,
This will be described in detail later.

Next, with the interlocking dialysate pumps 54 and 55 being driven, the solenoid valve 56 being closed and the solenoid valve 57 being open, dialysate from the supply side dialysate circuit 12a, for example, 20
It is sent to the dialysis device 10 at a speed of about 0 to 400 ml / min. Then, the dialyser 20 is sufficiently washed by subjecting the dialysate to reverse filtration in the dialyzer 20.

On the other hand, the blood pump 51 is
The blood circuit 11a, the dialyzer 20, and the venous blood circuit 11b are rotated in reverse at a speed of about 200 ml / min.
The priming is performed to complete the preparation for dialysis while removing the air that has been inside.

The dialysate used for the pre-dialysis washing as described above is first sterilized by a sterilization filter 60 in the middle of the supply-side dialysate circuit 12a, and the sterilization filter connected to the end of the supply-side dialysate circuit 12a is further removed. The filter 60 is again sterilized.

According to such two sterilizing filters 60, bacteria contaminated in the dialysate and endotoxin, which is a product thereof, can be removed by the filter 62 in the filter case 61. Aseptic dialysate can be supplied to the dialyzer 20 side.

Accordingly, the sterilizing operation of the dialyzer 20 with a chemical such as formalin becomes unnecessary. As a result, the dialyzer 20
The protein component of the blood coating the surface of the dialysis membrane 22 inside is not transformed into a heterologous protein by the drug,
Does not impair biocompatibility.

In addition, it is possible to eliminate the risk of virus infection and chemical injury of medical staff involved in the cleaning operation and the sterilization operation of the dialyzer 20. Such a disinfection filter 60
The sterilization treatment of the dialysate by the above method has the same effect in the hemodialysis and the regeneration method of the dialyzer described below.

II. Hemodialysis First, in FIG. 3, blood taken out of the artery of the human body from the beginning of the arterial blood circuit 11 a is driven by the blood pump 51, passes through the blood flow switching means 30, and passes through the dialyzer 20.
Sent to Here, the blood is supplied to the blood flow switching means 30.
The artery-side entrance 31 of the entrance and exit 3
3, the blood enters the blood system of the dialyzer 20 through the blood outlet 23a of the dialyzer 20.

The blood outlet 23b of the dialyzer 20
The blood that has flowed out again passes through the blood flow switching means 30. Here, the blood passes through the entrance 34 of the blood flow path switching means 30.
And exits through the venous outlet 32 with which it communicates.
The blood is returned to the vein of the human body through the drip chamber 53 through the venous blood circuit 11b.

On the other hand, the dialysate supplied from the start end of the supply-side dialysate circuit 12a passes through the two sterilization filters 60 by the driving of the dialysate pumps 54 and 55, and then passes through the dialysate channel switching means 40. It is sent to the dialyzer 20. Here, the dialysate is supplied to the supply-side inlet 4 of the dialysate flow path switching means 40.
The dialyser 20 enters the dialysate system 20 through the dialysate outlet port 24a of the dialyser 20, and enters the dialysate system of the dialyser 20 via the dialysate outlet 43a.

The dialysate outlet 24 of the dialyzer 20
The dialysate coming out of b passes again through the dialysate channel switching means 40. Here, the dialysate enters the inlet / outlet 44 of the dialysate flow path switching means 40, exits through the discharge side outlet 42 communicating therewith, and is discharged from the discharge side dialysate circuit 12b via the check valve 58 and the like.

The circulation of blood and dialysate during hemodialysis is as described above. In the dialyzer 20 in such a circulating process, waste in blood is filtered through the dialysis membrane 22 to the dialysate side in contact therewith. It is purified. During such hemodialysis, the blood flow switching means 30 and the dialysate flow switching means 40 are simultaneously switched, so that the dialyzer 20 is switched.
It is possible to intermittently switch the flow direction of the blood flow toward and to the flow direction of the dialysate.

FIG. 4 shows the direction in which blood and dialysate flow in the dialyzer 20 by switching the switching valves 35 and 45 of the blood flow path switching means 30 and the dialysate flow path switching means 40 to position B, respectively. Shows the state opposite to that of FIG.

By switching the flowing direction of the blood and the dialysate, the inflow and outflow of the blood to and from the blood system end of the dialyzer 20 are repeated, and the coagulated mass at the blood system end is washed out. In addition, residual blood on the dialysis membrane 22 is also avoided as much as possible, and the operation of regenerating the dialyzer 20 after dialysis described below can be further simplified.

III. Regeneration method of dialyzer After the above-mentioned hemodialysis, about 200 to 300 ml of physiological saline is poured, and blood in blood circuit 11 and dialyzer 20 is returned. Here, instead of the physiological saline, the dialysate may be back-filtered to return blood.

After the blood return is completed, the solenoid valve 56 as shown in FIG.
Is closed and the solenoid valve 57 is opened, the dialysate pump 54 and the dialysate pump 55 are simultaneously driven, and dialysate is supplied from the supply-side dialysate circuit 12a at a speed of, for example, about 200 to 400 ml / min. Send to On the way, the dialysate is first sterilized by a sterilization filter 60 in the middle of the supply side dialysate circuit 12a, and further sterilized by the sterilization filter 60 connected to the end of the supply side dialysate circuit 12a. .

[0086] The thus-dialyzed dialysate is back-filtered by the dialyzer 20, so that blood and impurities remaining in the blood system of the dialyzer 20 can be aseptically and sufficiently washed away. In particular, since the dialysate passes in the thickness direction of the dialysis membrane 22 from the dialysate system to the blood system, it is possible to reliably peel off fine coagulated mass adhered to the blood-side surface of the dialysis membrane 22.

As a result, it is possible to reliably prevent bacteria which are a problem when the dialyzer 20 is reused and contamination with endotoxin which is a toxin produced by the bacteria. Further, at the time of back filtration, the blood pump 51 is reversely rotated at a speed of, for example, about 100 to 200 ml / min, so that residual blood and coagulated clots in the arterial blood circuit 11a, the dialyzer 20, the venous blood circuit 11b, and the like. Is also removed.

The dialyzer 20 regenerated by the above-described reverse filtration may be stored by, for example, intermittent low-temperature sterilization by heating and storing. Here, since it is not necessary to use a drug such as formalin, it is possible to omit the labor required for removing the drug, which is conventionally required before re-use, and it is also possible to eliminate anxiety about safety due to the use of the drug.

Next, the coupler 13 according to the present embodiment
0 and its washer 120 will be described in detail. As shown in FIG. 7, the coupler 130 is connected to the sterilizing filter 60.
131 which is detachably fitted to the inlet 63a of the vehicle.
And a lock mechanism 140 for the opening 131, and a communication port 137 communicating with the inside of the opening 131 on the side opposite to the opening edge of the opening 131. The cleaning device 120 includes a tubular case body 121.

As shown in FIGS. 7 and 9, the coupler 13
The detachable opening 131 of 0 is set to an inner diameter that fits just outside the inlet 63a of the sterilization filter 60 or the like. In the vicinity of the opening edge 131a on the outer periphery of the attachment / detachment port 131,
2 are formed, and the operation ring 14 described later is formed in the concave groove 132.
A ring-shaped retaining stopper 133 for preventing the 1 from falling out is fitted outside.

A sliding outer peripheral portion 134 is formed at the rear end side of the outer peripheral portion of the attachment / detachment 131 so that the rear half of the operation ring 141 is slidably fitted to the outside. Grooves 134a arranged in the circumferential direction at predetermined intervals in the circumferential direction are recessed in the radial direction from the reference outer peripheral surface. Such a groove 13
Reference numeral 4a allows the inside of the gap between the outer periphery of the attachment / detachment opening 131 where the coil spring 145 described later is housed and the inner periphery of the operation ring 141 to communicate with the outside from the rear end side of the operation ring 141.

Further, on the rear end side of the sliding contact outer peripheral portion 134, the fitting allowance outer peripheral portion 13 larger than the outer diameter of the operation ring 141 is provided.
5 are formed. The fitting margin outer peripheral portion 135 is a portion that is set to have a size that matches the inner diameter of the case main body 121 described later, and that is maintained to be pressed into the opening 122 of the case main body 121. On the other hand, an O-ring 136 that presses against an edge of the inlet (tubular port) 63 a of the sterilization filter 60 is provided inside the inside of the attachment / detachment port 131.

The locking mechanism 140 of the opening 131 is
It is composed of an operation ring 141, a ball 143, and a coil spring 145. The operation ring 141 is fitted to the outer peripheral portion of the attachment / detachment port 131 so as to be slidable in the axial direction. A sliding inner peripheral portion 142 that slides on the outer peripheral front end of the attachment / detachment port 131 is formed at the inner peripheral front end of the operation ring 141.

As shown in FIGS. 11 and 12, the sliding contact inner peripheral portion 142 has grooves 1 arranged at predetermined intervals in the circumferential direction.
Reference numeral 42a is recessed in the radial direction from the reference inner peripheral surface. The groove 142a is formed in a gap between the outer periphery of the attachment / detachment port 131 in which the coil spring 145 is housed and the inner periphery of the operation ring 141.
The operation ring 141 is communicated with the outside from the front end side.

The front end of the sliding inner peripheral portion 142 is formed with a taper.
, The operation ring 141 is prevented from coming out of the front of the attachment / detachment port 131. On the other hand, the rear end side of the inner peripheral portion of the operation ring 141 is slidably fitted to the outer peripheral portion 134 of the sliding contact. The rear end of the operation ring 141 is in contact with the front end of the fitting allowance outer peripheral portion 135, so that the operation ring 141 does not fall out behind the attachment / detachment port 131.

The ball 143 is held in the holding hole 144 so as to be movable to the inner and outer peripheral sides of the attachment / detachment port 131. The ball 143 is connected to the operation ring 14.
When the inner walls 1 overlap, they protrude toward the inner peripheral side of the attachment / detachment port 131,
It is set so as to fit into a stop groove 64 formed on the outer periphery of the inlet 63a of the sterilization filter 60 shown in FIG.

The coil spring 145 is housed in a gap between the outer periphery of the attachment / detachment port 131 and the inner periphery of the operation ring 141. The coil spring 145 is housed in the gap in a contracted state, and urges the operation ring 141 to a position (leftward in FIG. 8) covering the ball 143.
When the operation ring 141 is moved toward the rear end (to the right in FIG. 8) against the urging force of the coil spring 145, the ball 1
43 is released.

As shown in FIG. 7, the communication port 137 is formed in a tubular shape at the rear of the attachment / detachment 131 so as to be bent substantially at right angles to the axis of the attachment / detachment 131. The communication port 137 is for connecting the dialysate circuit 12, and has a tapered retaining jaw 13 on the outer periphery on the distal end side.
8 are formed.

As shown in FIGS. 7, 13 and 15,
The case body 121 of the cleaning device 120 is
Is formed in a tubular shape having an inner diameter matching the outer periphery 135 of the fitting allowance, and both ends thereof are opened as a pair of openings 122, 122 as they are. Internal space 1 of case body 121
23, when the couplers 130 are fitted into the fitting margin outer peripheral portions 135 through the respective openings 122, the respective attaching / detaching openings 131
Are set to a length that allows them to be stored in a state of facing each other at a distance from each other.

At the approximate center of the internal space 123, each of the couplers 130 is connected to the outer periphery 1 of each fitting through an opening 122.
When inserted up to 35, a partition plate 124 with which the front end side of each operation ring 141 is engaged is provided. Such a partition plate 124
Is provided with a stepped portion 125 that rotates in the circumferential direction on the front and back sides thereof. The stepped portion 125 engages with the front end of the operation ring 141 to move the operation ring 141 in the unlocking direction (in FIG. 8). (Right) Hold it moved to the closer position.

The operating ring 141 is provided on the partition plate 124.
A communication hole 126 for guiding the sterilizing solution passing through the outer periphery of the outer periphery of the operation ring 141 on the opposite side is formed. A plurality of communication holes 126 are formed at predetermined intervals along the peripheral side of the partition plate 124. The sterilizing solution is set to communicate from the end of the step portion 125 to the gap between the outer periphery of the attachment / detachment port 131 and the inner periphery of the operation ring 141.

Next, a method of sterilizing the coupler 130 by the washer 120 will be described. As shown in FIG. 7, when the pair of couplers 130, 130 is cleaned by the cleaning device 120, first, the openings 122, 122 at both ends of the case body 121 are cleaned.
Accordingly, the side of the attachment / detachment port 131 of the coupler 130 is fitted. Since the inside of the case main body 121 has an inside diameter that exactly matches the fitting margin outer peripheral portion 135 of the coupler 130, the fitting margin outer peripheral portion 135 is pressed against the inner wall of the opening 122 of the case main body 121, so that the fitting margin is changed. Can be maintained.

At this time, the inside and outside of the attachment / detachment opening 131 of the coupler 130, the operation ring 141, the coil spring 145, and the ball 133 forming the lock mechanism 140 are completely contained in the internal space 123 of the case main body 121. However, the coupler 130
The communication port 138 on the rear end side of the fitting margin outer peripheral portion 135
Are exposed outside the case body 121.

The coil spring 145 of the lock mechanism 140
Is accommodated in a gap between the outer periphery of the attachment / detachment 131 and the inner periphery of the operation ring 141.
The operation ring 141 has a groove portion 134a formed in the sliding inner peripheral portion 142 thereof. Therefore, the gap in which the coil spring 145 is housed is not a closed space, and the operating ring 14 is formed by the grooves 134a and 142a.
1 is open to the outside from the front-back direction.

Further, in this embodiment, when the coupler 130 is fitted into the opening 122 of the case main body 121, the front end side of each operating ring 141 is engaged with the step 125 of the partition plate 124 substantially at the center of the internal space 123. I do. Therefore, the operation ring 141 is maintained in a state where it is shifted toward the unlocking direction against the urging force of the coil spring 145, that is, moved to a position where it does not overlap with the ball 143.

Due to such a displacement of the operation ring 141, the gap between the outer periphery of the attachment / detachment port 131 and the inner periphery of the operation ring 141 is slightly opened in the axial direction, so that the sterilizing liquid can more easily enter the gap. Especially the locking mechanism 14
0 can penetrate the sterilizing solution to each part.

The inner space 123 of the case body 121 is formed by a pair of couplers 130, 1 fitted through the openings 122 on both sides.
The closed space is closed by 30. Therefore, a sterilizing liquid is injected into the internal space 123 from the communication port 138 of one coupler 130, and the sterilizing liquid is discharged from the communication port 138 of the other coupler 130 to the outside. Here, the germicidal solution corresponds to a general germicidal solution or a liquid having an excellent germicidal effect, such as weakly electrolytic oxidized water.

More specifically, the sterilizing solution injected into the communication port 138 of the coupler 130 on the left side in FIG.
From the opening edge 131a of the partition plate 124, it goes into the internal space 123, passes through the groove 142a from the end of the step portion 125 of the partition plate 124,
It is guided to the gap between the outer periphery of the attachment / detachment 131 and the inner periphery of the operation ring 141. Then, after passing through the groove 134a, the sterilizing liquid flows outside the outer periphery of the operation ring 141 and flows again to the partition plate 124 side.

Further, the sterilizing solution passes through the communication hole 126 in the partition plate 124 and passes through the operating ring 141 of the right coupler 130.
Is guided to the outside of the outer circumference. The sterilizing solution then enters the gap between the outer periphery of the attachment / detachment port 131 and the inner periphery of the operation ring 141 from the groove portion 134a, passes through the groove portion 142a, and passes through the partition plate 124.
Flows into the inside of the attachment / detachment port 131 from the end of the step 125.
Then, it is discharged to the outside through the communication port 137 as it is.

As described above, the inside space 123 of the case main body 121 is reliably filled with the sterilizing solution.
A sterilizing liquid filled and circulated in the inside of each of the couplers 130
The couplers 130 are evenly sterilized as a whole because the entire surface of the inside and outside of the attachment / detachment port 131 and the components such as the coil spring 145 of the lock mechanism 140 are evenly contacted.

Moreover, since the bacteria and their products are washed away by the circulating sterilizing solution without staying in the internal space 123 of the case body 121, the pair of couplers 130, 130 is formed by the simple and compact structure described above.
Can be reliably and sufficiently washed. In addition, the regeneration method of the dialyzer 20 and the dialysis device 10 according to the present invention are not limited to the above-described embodiment.

[0095]

According to the method for regenerating a dialyzer and the dialysis apparatus according to the present invention, the dialysate that has been sterilized after hemodialysis is used.
The bacteria are supplied to the dialyzer through the dialysate circuit, and the dialysate is back-filtered from the dialysate system of the dialyzer to the blood system to wash out the blood system aseptically. And
Contamination by endotoxin, which is a produced toxin, can be reliably prevented, and since no drug such as formalin is used, labor required for drug removal conventionally required before reuse can be omitted. Problems such as safety anxiety associated with the use of the drug and virus infection of medical staff engaged in the reprocessing can be solved.

[Brief description of the drawings]

FIG. 1 is a schematic diagram schematically showing a dialysis device according to one embodiment of the present invention.

FIG. 2 is a schematic diagram for explaining a pre-dialysis washing method and a method for regenerating a dialyzer in a dialysis device according to an embodiment of the present invention.

FIG. 3 is a schematic diagram for explaining hemodialysis in the dialysis device according to one embodiment of the present invention.

FIG. 4 is a schematic diagram for explaining flow path switching of hemodialysis in the dialysis device according to one embodiment of the present invention.

FIG. 5 is a sectional view showing a dialyzer constituting the dialysis device according to one embodiment of the present invention.

FIG. 6 is a schematic diagram showing a sterilization filter constituting a dialysis device according to one embodiment of the present invention.

FIG. 7 is a cross-sectional view showing a use state of the cleaning device according to one embodiment of the present invention.

FIG. 8 is a side view showing a coupler used in the cleaning device according to one embodiment of the present invention.

FIG. 9 is a side view showing a coupler used in the cleaning device according to the embodiment of the present invention, from which an operation ring is removed.

FIG. 10 is a front view showing a coupler used in the cleaning device according to one embodiment of the present invention, from which an operation ring is removed.

FIG. 11 is a side view showing an operation ring of a coupler used in the cleaning device according to one embodiment of the present invention.

FIG. 12 is a front view showing an operation ring of a coupler used in the cleaning device according to one embodiment of the present invention.

FIG. 13 is a side view showing a cleaning device according to one embodiment of the present invention.

FIG. 14 is a front view showing a cleaning device according to one embodiment of the present invention.

[Explanation of symbols]

 Reference Signs List 10: dialyzer 11: blood circuit 11a: arterial blood circuit 11b: venous blood circuit 12: dialysate circuit 12a: supply-side dialysate circuit 12b: discharge-side blood circuit 12c: bypass path 20: dialyzer 21: tube body Reference numeral 21a: blood port section 22: dialysis membrane 24a: dialysate outflow port 24b ... dialysate outflow port 30 ... blood flow path switching means 35 ... switching valve 40 ... dialysate flow path switching means 41 ... supply side inlet 42 ... discharge side outlet 43 ... Doorway 51 ... Blood pump 52 ... Pulser 53 ... Drip chamber 54 ... Dialysate pump 55 ... Dialysate pump 56 ... Solenoid valve 57 ... Solenoid valve 58 ... Check valve 60 ... Sterilization filter 61 ... Filter case 62 ... Filter 63a ... Sending port 63b ... Sending port 64 ... Stop groove 120 ... Washer 130 ... Coupler 120 ... Washer 121 ... Case body 1 2 ... Opening 123 ... Internal space 124 ... Partition plate 125 ... Step 126 ... Communication hole 130 ... Coupler 131 ... Removable opening 131a ... Opening rim 132 ... Concave groove 133 ... Prevention stopper 134 ... Sliding contact outer periphery 134a ... Groove 135 Fitting margin outer circumference 136 O-ring 137 Communication port 140 Lock mechanism 141 Operating ring 142 Sliding inner circumference 142 a Groove 143 Ball 144 Holding hole 145 Coil spring

Claims (7)

[Claims] 1. A dialyzer for filtering waste matter in blood into a dialysate through a dialysis membrane, a blood circuit connecting a blood system inside the dialysis membrane of the dialyzer and a human body, and a dialysis membrane of the dialyzer. A method for regenerating the dialyzer after hemodialysis with a dialyser having a dialysate circuit for supplying a dialysate to the outer dialysate system, wherein after the hemodialysis, a sterilized dialysate is used. Supplying a dialyser through the dialysate circuit, back-filtrating the dialysate from the dialysate system of the dialyzer to the blood system, and aseptically washing the blood system, wherein the method for regenerating the dialyzer is performed. . 2. The regeneration of the dialyzer according to claim 1, wherein after the hemodialysis, the dialysate is sterilized by a sterilizing filter capable of removing at least bacteria and endotoxin, which is a toxin produced by the bacteria. Method. 3. A dialyzer for filtering waste matter in blood into a dialysate through a dialysis membrane, a blood circuit connecting a blood system inside the dialysis membrane of the dialyzer and a human body, and a dialysis membrane of the dialyzer. A dialysate circuit that supplies a dialysate to an outer dialysate system, wherein the dialyser can regenerate the dialyzer after hemodialysis by the dialyser. A sterilizing filter is interposed in the middle of the supply side, and after the hemodialysis, the dialysate sterilized by the sterilizing filter is supplied to the dialyzer, and the dialysate is collected from the dialysate system of the dialyzer. A dialysis apparatus characterized in that the blood system is aseptically washed out by back-filtration into the system. 4. When a sterilization filter is interposed in the middle of the supply side of the dialysate circuit, they are connected to each other via a coupler which can be sterilized and cleaned by a separately prepared washer. 3. The dialysis device according to 3. 5. A detachable port detachably fitted to one of the tubular ports to be connected, a locking mechanism for the detachable port, and a detachable port on a side opposite to an opening edge of the detachable port. A communication port through which the other tubular portion to be connected and connected can be connected; the lock mechanism includes an operation ring fitted externally slidably in an axial direction with respect to an outer peripheral portion of the attachment / detachment port; It is movably held on the inner peripheral side and the outer peripheral side of the opening, and when the inner wall of the operation ring overlaps, it protrudes toward the inner peripheral side of the attachment / detachment port and fits into a stopper groove formed on the outer periphery of the one tubular port. A ball, a coil spring that is housed in a gap between an outer peripheral portion of the attachment / detachment port and an operation ring and biases the operation ring to a position covering the ball; and an outer peripheral portion of the attachment / detachment port and the operation ring, Externally communicates with the gap in which the coil spring is housed from the front and rear direction of the operation ring. Forming a groove portion, a fitting margin outer peripheral portion larger than the outer diameter of the operation ring is formed in a part of the outer peripheral portion of the attachment / detachment port located on the rear end side of the operation ring, A main body, the case main body is formed in a tubular shape having an inner diameter matching the outer periphery of the fitting allowance of the coupler, and a pair of openings formed at both ends thereof; An inner space in which each of the attachment / detachment ports can be housed in a state of facing each other while being separated from each other when fitted to the outer periphery of the joint, and an antiseptic solution from the communication port of one of the couplers to the interior space in the interior space of the case body. And disinfecting liquid is discharged from the communication port of the other coupler to the outside, and the disinfecting liquid filled and circulated in the internal space includes a gap between the outer peripheral portion of the attaching / detaching port of each coupler and the operation ring. 5. The device according to claim 4, wherein the opening is set so as to be in contact with all inner and outer surfaces of the opening. The placement of the dialysis machine. 6. A blood flow path switching means is provided in said blood circuit, and a dialysate flow path switching means is provided in said dialysate circuit, wherein said blood flow path switching means is an end of an arterial blood circuit of said blood circuit. An arterial-side inlet, a venous-side outlet connecting the beginning of the venous-side blood circuit of the blood circuit, and a pair of inlets and outlets capable of selectively communicating with the arterial-side inlet and the venous-side outlet, respectively. A pair of blood outflow / inlet ports provided at both ends of the dialyzer and communicating with a blood system are connected to each of the ports, and the dialysate flow path switching means includes a supply-side dialysate circuit of the dialysate circuit. A feed-side inlet connecting the end of the dialysate circuit, and a discharge-side outlet connecting the start of the discharge-side dialysate circuit of the dialysate circuit,
A pair of inlets and outlets that can selectively communicate with the supply-side inlet and the discharge-side outlet, respectively, and a pair of dialysate outlets provided at both ends of the dialyzer and communicating with a dialysate system at each of the inlets and outlets; 6. The dialysis apparatus according to claim 3, wherein the dialysis apparatus is connected to the dialysis apparatus. 7. The dialyzer, wherein the blood flow path switching means, the dialysate flow path switching means, and the germicidal filter are integrally formed in advance, including their intermediate paths. The dialysis device according to claim 6, wherein: