JP2011104346A - Dialyzer device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a dialyzer device which reduces burden to be borne by patients and gives reduced side effect. <P>SOLUTION: The dialyzer device is a bag body formed of a dialysis membrane and at least a part thereof indwells in an animal body. The device may be one that a dialysate is stored inside the bag body, one that an absorbent material is stored in the bag body, one that stores an enzyme inside the bag body, or one with a port for communicating the inside of the bag body with the outside. The dialysis membrane may be formed of an ethylene-vinyl alcohol copolymer. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to an artificial dialysis device, and more particularly to an artificial dialysis device that enables artificial dialysis with less patient burden and less side effects.

At present, the number of chronic dialysis patients in Japan is about 275,000 (2007), which is increasing. As an existing treatment method, artificial dialysis using an extracorporeal circulation type dialysis apparatus can be mentioned. However, frequent hospital visits and long dialysis times are necessary, and the burden on the patient is great.
In order to improve this, peritoneal dialysis has been implemented in some areas (for example, Patent Document 1), but it is an effective technique for patients and children who wish to return to society. It is known that peritoneal function is reduced due to complications such as peritoneal sclerosis and peritoneal fibrosis. Due to these complications, the period during which peritoneal dialysis therapy can be performed is limited to about 8 years, and only about 9000 patients (2007) are using peritoneal dialysis.

  On the other hand, even in mammals such as dogs and cats that are companion animals, the prevalence of kidney diseases such as nephritis and renal failure has increased as the lifespan increased, and the third most common disease that affects dogs (9%), It is also ranked second (25%) among the diseases that cats suffer from. Although there are artificial dialysis and peritoneal dialysis using an extracorporeal circulation type device as treatments for kidney disease in these dogs and cats, they are inefficient and more burdensome and difficult to perform than human treatment. In the current situation, there is no good treatment because

JP-A-2003-290341 (for example, paragraph numbers 0001 to 0003 in FIG. 3 in the summary and detailed description of the invention)

  Accordingly, an object of the present invention is to provide an artificial dialysis device that enables artificial dialysis with less patient burden and less side effects.

  As a result of intensive studies in view of the above problems, the present inventors have accommodated components (for example, dialysate, adsorbent, enzyme, etc.) effective for dialysis inside a bag formed of a dialysis membrane. It has been found that by placing the contained bag in the body, artificial dialysis (treatment of kidney disease) can be efficiently performed with less burden on the patient and less side effects, and the present invention has been completed.

That is, the artificial dialysis tool of the present invention (hereinafter referred to as “the present tool”) is a bag formed of a dialysis membrane and is an artificial dialysis tool in which at least a part is indwelled.
This tool may contain a dialysate in the bag.
Further, the present tool may be one in which an adsorbent is accommodated in the bag body.
And this tool may contain an enzyme in the inside of the said bag.

The present tool may include a port for communicating the inside and the outside of the bag body.
The device may be one in which the dialysis membrane is formed of an ethylene-vinyl alcohol copolymer.

  The present invention also provides an artificial dialysis method for mammals other than humans (hereinafter referred to as “the present method”) using the device. That is, this method is an artificial dialysis method for a mammal other than a human, which includes indwelling at least a part of the device in the body of the mammal other than a human.

1 is a schematic view showing a method for producing an artificial dialysis tool (this tool) according to Example 1. FIG. 6 is a schematic view showing a method for producing an artificial dialysis tool (this tool) according to Example 2. FIG. 6 is a schematic view showing a method for producing an artificial dialysis tool (this tool) according to Example 3. FIG. It is a graph which shows a time-dependent change of the creatinine density | concentration inside the bag body in Example 7, and the bag body outside. It is a graph which shows a time-dependent change of the creatinine density | concentration inside the bag body in Example 8, and the bag body outside. It is a graph which shows the time-dependent change of the total protein amount in the bag body in Example 8, and a bag body outside. It is a graph which shows a time-dependent change of the creatinine density | concentration inside the bag body in Example 9, and the bag body outside. It is a graph which shows a time-dependent change of the total protein amount in the bag body in Example 9, and a bag body outside. It is a graph which shows a time-dependent change of the weight of the bag body in Example 10. FIG.

  Embodiments of the present invention will be described below. However, the present invention is not limited by these.

Since the bag body of the present tool is formed of a dialysis membrane (semipermeable membrane), components effective for dialysis (for example, dialysate, adsorbent, enzyme, etc.) are accommodated inside the bag body, Is placed in the body of a mammal so that the sac can be placed between the inside (there is an effective component for dialysis) and the outside (the body fluid present in the body of the mammal). Mass transfer (dialysis) occurs through the dialysis membrane, whereby artificial dialysis can be performed in the body of the mammal. That is, the dialysis membrane does not leak out the components existing inside the bag body to the outside of the bag body, and the urine component facing the outer surface of the dialysis membrane of the bag body (of the mammal in which the bag body is placed). The dialysis membrane is absorbed into the bag.
For this reason, according to this tool, the patient burden accompanying extracorporeal circulation type artificial dialysis can be remarkably reduced, and the QOL can be greatly improved. Furthermore, dialysis efficiency and side effects (for example, occurrence of complications such as peritoneal sclerosis and peritoneal fibrosis), which are disadvantages of peritoneal dialysis, can be solved. In addition, even in mammals with kidney diseases such as dogs and cats, it is possible to provide an effective therapeutic method with less burden on the owner and affected animals.

The dialysis membrane (semi-permeable membrane) forming the bag of the device may be any material that can ensure the performance as a dialysis membrane and safety and stability in the living body, and the material of the dialysis membrane is not limited in any way. For example, cellulose materials such as cellulose acetate, cellulose diacetate, cellulose triacetate, mixed cellulose ester and regenerated cellulose, polyolefins such as polyethylene, polysulfone, polyamide, polymethyl methacrylate, polyacrylonitrile, ethylene-vinyl alcohol A polymer etc. can be mentioned as an example.
It should be noted that the bag body of this device need not be entirely formed of a dialysis membrane as long as dialysis performance and safety and stability in the living body can be ensured, and only a part of the bag body is formed of a dialysis membrane. It may be done.

As the material of the dialysis membrane forming the bag of the present tool, ethylene-vinyl alcohol copolymer may be used because it is excellent in biocompatibility and safety among the above examples.
When an ethylene-vinyl alcohol copolymer is used as the material of the dialysis membrane, if the ethylene unit content of the ethylene-vinyl alcohol copolymer is too small, the hydrophilic or water-solubility becomes too high and the structure of the dialysis membrane is formed. In contrast, if the ethylene unit content of the ethylene-vinyl alcohol copolymer is too high, the hydrophobicity becomes too high, so that proteins and the like are easily adsorbed and it is difficult to maintain the performance of the dialysis membrane. The ethylene unit content of the ethylene-vinyl alcohol copolymer is usually preferably 20 to 80 mol% based on all the structural units of the polymer, and preferably 25 to 60. Mole% is more preferable.

  An additive for imparting hydrophilicity such as polyvinyl pyrrolidone or polyethylene glycol may be added to the material of the dialysis membrane forming the bag of the device.

  The performance of the dialysis membrane that forms the bag of the device, that is, the pore diameter can be used as long as it is a size used in normal artificial dialysis, and is not limited at all. For example, the pore diameter is 1 nm to 20 nm, more preferably. May be in the range of 2.5 nm to 15 nm.

  The film thickness of the dialysis membrane forming the bag of the device is not particularly limited as long as the dialysis performance and in-vivo safety and stability can be ensured. If the thickness is too thick, the safety and the like are improved, but the dialysis performance is lowered. Therefore, it is preferable to make these ranges compatible, for example, 5 μm to 500 μm, and more preferably 10 μm to 200 μm.

  As the shape of the bag body of the present tool, any shape can be used as long as the shape can be maintained in vivo and a sufficient amount of dialysate or the like can be injected into the inside. For example, a bag shape such as a polygonal shape or a circular shape by fusing a sheet-like material made of a dialysis membrane by heat sealing, or a seamless bag shape by melt molding, discharge molding, or the like. In order to maintain the shape of the bag, a mesh, nonwoven fabric, sponge, or skeleton formed of a metal material such as titanium or stainless steel, which is safe and biocompatible, or a resin material such as nylon or polyethylene, is placed inside the bag. It is also possible to insert or cover the outside of the bag body with these meshes, non-woven fabrics, sponges or skeletons.

  If the inner volume of the bag of this device is too small, sufficient dialysis performance cannot be ensured, and conversely, if it is too large, the effect on animals that place the device in the body will be great, May be. The preferable range of the inner volume of the bag body depends on the size and type of the mammal and the degree of kidney damage, but is, for example, 0.1 ml / kg to 100 ml / kg, more preferably 1 ml per body weight of the mammal. It is good also as the range of / kg-10 ml / kg.

  Various components can be considered as effective components for dialysis accommodated in the bag body of the device depending on the state and type of the disease. For example, dialysis solution, adsorbent, enzyme and the like should be exemplified. Can do. Note that these may be used alone or in combination of two or more.

  As the dialysate, normal extracorporeal circulation type artificial dialysis, dialysate used for peritoneal dialysis, physiological saline, and the like can be used. The amount of dialysate contained in the bag depends on the internal volume of the bag. However, if the amount is too small, sufficient dialysis performance cannot be ensured. Since the influence is large, it may be set as a range in which these are compatible. The preferable range of the amount of the dialysate accommodated in the bag depends on the size and type of the mammal and the degree of kidney injury, but for example, 0.1 to 100 ml / kg per body weight of the mammal, more preferably It is good also as the range of 1-10 ml / kg.

  Examples of the adsorbent include activated carbon, ion exchange resin, water-absorbing resin, or zeolite in powder form or molecular sieve form. If the amount of adsorbent contained in the bag is too small, sufficient dialysis performance cannot be ensured.On the other hand, if the amount is too large, the effect on animals in which the device is placed in the body is large. May be. The preferable range of the amount of the adsorbent accommodated in the bag depends on the size and type of the mammal, the degree of kidney damage, the type and ability of the adsorbent, etc. The range may be 0.001 g / ml to 1.5 g / ml, more preferably 0.01 g / ml to 1 g / ml.

  As the enzyme, urease, creatinase and the like can be used. If the amount of the enzyme used is too small, sufficient dialysis performance cannot be ensured. Conversely, if the amount of enzyme used is too large, the effect on the animal in which the device is placed in the body is great. The preferred range of enzyme capacity in the bag depends on the size and type of the mammal, the degree of kidney damage, the type and ability of the enzyme, etc., but it efficiently enters the bag and decomposes urea, creatinine, etc. It can be used as long as it can be used, and usually has a weight in the range of, for example, 0.00001 g / ml to 1 g / ml, more preferably 0.0001 g / ml to 0.5 g / ml per inner volume of the bag. Also good.

  As described above, the device is used by storing the components effective for dialysis in a bag and placing it in the body of a mammal. However, before the device is placed in the body, Used after sterilization. Although it does not specifically limit as a sterilization method, For example, gamma ray sterilization, ethylene oxide gas sterilization, etc. can be illustrated.

This tool may be provided with a port for communicating the inside and the outside of the bag body of the tool.
This tool is equipped with a port that allows communication when it is necessary to communicate between the inside and outside of the bag, and prohibits communication when communication between the inside and outside of the bag is not required. Injecting other components into the inside of the bag body through the port, or conversely, using the inside of the bag body, the item to be exchanged (the one that has come to be replaced with a new one) via the port It can also be extracted outside.
The port may be present inside the body in which at least a part of the bag body of the device is placed or may be present outside the body. When the port is placed in the body, it is preferable to place it under the skin in order to facilitate exchange of dialysate from the outside.
The port can be directly connected to the bag body, but the port is disposed at a position away from the indwelling site of the bag body by connecting the port and the bag body using a tube material. This is preferable because the degree of freedom of the port installation position is increased.
As described above, the port needs to be able to allow and prohibit communication. For example, the port can be configured by an openable / closable lid, a valve, etc., but can be opened and closed easily and reliably. From the above, a rubber partition configured so that the internal flow path of the injection needle forms a communication by puncturing with the injection needle (communication is allowed), and the communication is cut off by removing the injection needle (communication prohibited) The port may be formed by As such a port of the rubber partition wall, a port that can withstand a plurality of injections using a syringe or the like is already known.

This device is used after transplanted and placed in the body, and examples of the transplanted portion of the bag include intraperitoneal and subcutaneous.
Transplantation of this device into the body can be performed according to a normal transplantation procedure, although it varies depending on the transplantation site. For example, the skin and peritoneum are incised by a midline incision, and the bag of the device is inserted at a position along the inner wall of the peritoneum. If necessary, the peripheral part of the bag of the tool and the peritoneum are sutured and fixed in several places using thread. When the port is placed in the body, the port is placed between the peritoneum and the skin, and the peritoneum is sutured and closed. Finally, the port can be implanted by leaving the port under the skin and closing the skin with sutures. With the same procedure, the bag of the device can be implanted subcutaneously, or the skin can be sutured by taking the port out of the body.

  If the device has a port, exchange of components effective for dialysis (eg, dialysate, adsorbent, enzyme, etc.) can be performed through the port. For example, a syringe with a needle is inserted into a port (rubber partition port) from outside the body, and used components (for example, dialysate, adsorbent, enzyme, etc.) inside the bag body of this device are sucked out and newly It can be carried out by injecting components (for example, dialysate, adsorbent, enzyme, etc.) with a syringe. The exchange time of such components (for example, dialysate, adsorbent, enzyme, etc.) varies depending on the type and size of mammal, the symptoms of kidney disease, and the site of transplantation. It may be once, more preferably once every 1 to 7 days.

  EXAMPLES Hereinafter, although an Example demonstrates this invention further in detail, this invention is not limited to these, unless it deviates from the meaning and application range.

Example 1
FIG. 1 is a schematic view showing a method for producing an artificial dialysis tool (present tool) 11 according to the present invention according to Example 1. With reference to FIG. 1, the manufacturing method of this tool 11 is demonstrated.
First, an ethylene-vinyl alcohol copolymer (ethylene unit content: 32 mol%) was dissolved in dimethyl sulfoxide to prepare a 15% solution. This solution was kept at 40 ° C., formed into a film by casting, and then poured into water kept at 40 ° C. to prepare a dialysis membrane.
Then, as shown in FIG. 1, two 1 × 2 cm dialysis membranes 13 a and 13 b were overlapped, and four sides were fused to produce a bag body 13. On the other hand, a polyvinyl chloride tube (outer diameter 3 mm, length 2.5 cm) 17 having a port 15 with a silicon stopper attached to one end was prepared. Thereafter, a punch hole is made in one side of the obtained bag 13, and the other end of the tube 17 connected to the port 15 with the silicon stopper is inserted into the punch hole and connected with an epoxy adhesive. 11 was produced. In addition, the silicone plug of the port 15 is formed so that the internal flow path of the injection needle is connected by puncturing with the injection needle (communication is allowed), and the communication is cut off (removal is prohibited) by removing the injection needle. It is a rubber septum configured and can withstand multiple injections using a syringe.

(Example 2)
FIG. 2 is a schematic view showing a method for producing the artificial dialysis tool (the present tool) 21 according to the second embodiment of the present invention. With reference to FIG. 2, the manufacturing method of this tool 21 is demonstrated.
Two 1.5 × 2 cm dialysis membranes 13a and 13b prepared in the same manner as in Example 1 were prepared, and two 1 × 1.5 cm polyester meshes (305 mesh) 24 were sandwiched therebetween (in FIG. 2). When two sheets overlap each other), four sides are fused to produce a bag body 23. On the other hand, similarly to Example 1, a vinyl chloride tube (outer diameter 3 mm, length 2.5 cm) 17 having a port 15 with a silicon stopper attached to one end was prepared. A punch hole is made in one side of the obtained bag body 23, the other end of the tube 17 connected to the port 15 with a silicon stopper is inserted into the punch hole, and connected with an epoxy adhesive, and the tool 21 is attached. Manufactured.

(Example 3)
FIG. 3 is a schematic view showing a method for producing the artificial dialysis tool (the present tool) 31 of the present invention according to Example 3. With reference to FIG. 3, the manufacturing method of this tool 31 is demonstrated.
Two 1.5 × 2 cm dialysis membranes 33a and 33b prepared in the same manner as in Example 1 were prepared using an ethylene-vinyl alcohol copolymer (ethylene unit content: 47 mol%), with 1 × 1 in between. A bag body 33 was manufactured by sandwiching a melamine resin sponge 34 having a size of 5 × 0.3 cm and fusing the four sides. On the other hand, as in Examples 1 and 2, a vinyl chloride tube (outer diameter 3 mm, length 2.5 cm) 17 having a port 15 with a silicon plug attached to one end was prepared. A punch hole is made in one side of the obtained bag 33, the other end of the tube 17 connected to the port 15 with a silicon stopper is inserted into the punch hole, and connected with an epoxy adhesive, and the tool 31 is attached. Manufactured.
The dialysis membranes (13a, 13b, 33a, 33b) of Examples 1 to 3 each had a pore diameter of about 5 nm and a film thickness of about 100 μm.

Example 4
A midline incision was made in the abdomen of a 14 week old Wistar rat under anesthesia with diethyl ether. 0.6 ml of physiological saline was injected into the bag 13 prepared in Example 1 previously sterilized with ethylene oxide gas using a syringe through the port 15 and inserted into the abdominal cavity. The tube 17 and the port 15 were taken out of the abdominal cavity, and the peritoneum was sutured and closed with only the bag 13 remaining in the abdominal cavity. Next, the tube 17 and the port 15 were placed under the skin, and the skin was sutured closed. After 6 days and 11 days, the internal fluid of the bag 13 was collected from outside the body through the port 15 using a syringe, and a new dialysate (physiological saline 0.6 ml) was injected. When the collected internal solution was analyzed, after 6 days, the urea nitrogen concentration in the internal solution was 16.8 mg / dl (using urease indophenol method. Urea nitrogen concentration in serum; 17.7 mg / dl), The creatinine concentration was 0.8 mg / dl (Jaffe method used; serum creatinine concentration; 0.7 mg / dl). After 11 days (5 days after reinfusion of physiological saline), the urea nitrogen concentration in the internal solution was 18 mg / dl. 4 mg / dl (using urease / indophenol method; urea nitrogen concentration in serum; 17.7 mg / dl), creatinine concentration being 0.63 mg / dl (using Jaffe method; creatinine concentration in serum; 0.7 mg / dl) It was sufficient performance for artificial dialysis.

(Example 5)
Under anesthesia with diethyl ether, the flank of an 8-week-old Wistar rat was incised. 0.6 ml of physiological saline was injected into the bag body 23 prepared in Example 2 previously sterilized with ethylene oxide gas using a syringe through the port 15 and inserted into the abdominal cavity. The tube 17 and the port 15 were taken out of the abdominal cavity, and the peritoneum was sutured and closed with only the bag 23 remaining in the abdominal cavity. Next, the tube 17 and the port 15 were placed under the skin, and the skin was sutured closed. Five days later, the internal solution of the bag body 23 was collected from outside the body through the port 15 using a syringe, and a new dialysate (0.6 ml of physiological saline) was injected. When the collected internal solution was analyzed, the urea nitrogen concentration in the internal solution was 17 mg / dl (using urease / indophenol method; urea nitrogen concentration in serum; 17.7 mg / dl), and the creatinine concentration was 0 0.027 mg / dl (Jaffe method used; serum creatinine concentration; 0.028 mg / dl), which was sufficient for artificial dialysis.

(Example 6)
Under anesthesia with diethyl ether, the flank of an 8-week-old Wistar rat was incised. 0.6 ml of dialysate (peritoneal dialysate, manufactured by Baxter, Die anneal PD-4 2.5) was injected into the bag body 23 prepared in Example 2 previously sterilized with ethylene oxide gas using a port 15. Injected and inserted into the abdominal cavity. The tube 17 and the port 15 were taken out of the abdominal cavity, and the peritoneum was sutured and closed with only the bag 23 remaining in the abdominal cavity. Next, the tube 17 and the port 15 were placed under the skin, and the skin was sutured closed. Five days later, the internal solution of the bag body 23 was collected from outside the body through the port 15 using a syringe, and a new dialysate (peritoneal dialysate, manufactured by Baxter, Die anneal PD-4 2.5, 0.6 ml) was added. Injected. When the collected internal solution was analyzed, the urea nitrogen concentration in the internal solution was 17.5 mg / dl (urease / indophenol method used; urea nitrogen concentration in serum; 17.7 mg / dl), and creatinine concentration Was 0.030 mg / dl (Jaffe method used; serum creatinine concentration; 0.028 mg / dl), which was sufficient for artificial dialysis.

  As described above, the bag body containing the dialysate of the embodiment is left in the body of the rat, thereby forming the bag body between the inside of the bag body (dialysate) and the outside (rat body fluid). Mass transfer (dialysis) occurred through the dialysis membrane (semi-permeable membrane), which revealed that sufficient artificial dialysis can be performed in the rat body (the concentrations of urea and creatinine in the body and in the bag) ) Indicates that dialysis is sufficient.

(Example 7)
An ethylene-vinyl alcohol copolymer (ethylene unit content: 47 mol%) was dissolved in dimethyl sulfoxide to prepare a 15% solution. This solution was kept at 40 ° C., formed into a film by casting, and then poured into water kept at 40 ° C. to prepare a dialysis membrane. In addition, the pore diameter of the dialysis membrane of Example 7 was about 5 nm, and the film thickness was about 100 μm.
Two 3 × 4 cm dialysis membranes were stacked and fused on all sides to produce a bag. On the other hand, a tube made of vinyl chloride (outer diameter 3 mm, length 2.5 cm) was prepared. A punch hole was made in one side of the obtained bag, and one end of the tube was inserted into the punch hole and connected with an epoxy adhesive. The other end of the tube was sealed with a pinch cock.
The obtained bag was immersed in 100 ml of a physiological saline solution containing 10 mg / dL of creatinine and 5 g / dl of bovine serum albumin (BSA), and the creatinine concentration inside and outside the bag was measured over time (using the Jaffe method). The measurement results are shown in FIG. As shown in FIG. 4, the creatinine concentrations inside and outside the bag became uniform in about 3 hours, and the performance was sufficient for artificial dialysis.

(Example 8)
An ethylene-vinyl alcohol copolymer (ethylene unit content: 47 mol%) was dissolved in dimethyl sulfoxide to prepare a 15% solution. This solution was kept at 40 ° C., formed into a film by casting, and then poured into water kept at 40 ° C. to prepare a dialysis membrane. The dialysis membrane of Example 8 had a pore diameter of about 5 nm and a film thickness of about 100 μm.
Two 3 × 4 cm dialysis membranes were stacked and fused on all sides to produce a bag. On the other hand, a tube made of vinyl chloride (outer diameter 3 mm, length 2.5 cm) was prepared. A punch hole was made in one side of the obtained bag, and one end of the tube was inserted into the punch hole and connected with an epoxy adhesive. Through the tube, 1.0 g of activated carbon (GLC, manufactured by Kuraray Chemical Co., Ltd.) was added, and the tube was sealed with a pinch cock.
The obtained bag containing activated carbon was immersed in 100 ml of a physiological saline solution containing 10 mg / dL of creatinine and 5 g / dl of bovine serum albumin (BSA), and the creatinine concentration inside and outside the bag was measured over time (Jaffe method). use). The measurement results are shown in FIG. As shown in FIG. 5, the creatinine concentration outside the bag body was remarkably reduced, and creatinine was efficiently removed, which was sufficient for artificial dialysis. At the same time, the total amount of protein inside and outside the bag was measured (total protein II-HA test Wako), and it was confirmed that the total protein amount had not changed (see FIG. 6), and adverse effects such as protein adsorption. It turned out that there was not.

Example 9
An ethylene-vinyl alcohol copolymer (ethylene unit content: 47 mol%) was dissolved in dimethyl sulfoxide to prepare a 15% solution. This solution was kept at 40 ° C., formed into a film by casting, and then poured into water kept at 40 ° C. to prepare a dialysis membrane. In addition, the pore diameter of the dialysis membrane of Example 9 was about 5 nm, and the film thickness was about 100 μm.
Two 3 × 4 cm dialysis membranes were stacked and fused on all sides to produce a bag. On the other hand, a tube made of vinyl chloride (outer diameter 3 mm, length 2.5 cm) was prepared. A punch hole was made in one side of the obtained bag, and one end of the tube was inserted into the punch hole and connected with an epoxy adhesive. Through the tube, 1.0 g of activated carbon (bead activated carbon, adsorbent taken out from Kuraray Medical's blood purification adsorber DHP-1 and dried) was put, and the tube was sealed with a pinch cock.
The obtained bag containing activated carbon was immersed in 100 ml of a physiological saline solution containing 10 mg / dL of creatinine and 5 g / dl of bovine serum albumin (BSA), and the creatinine concentrations inside and outside the bag were measured over time (Jaffe method). use). The results are shown in FIG. As shown in FIG. 7, the creatinine concentration outside the bag body was significantly reduced, and creatinine was efficiently removed, which was sufficient for artificial dialysis. At the same time, the total amount of protein inside and outside the bag was measured (total protein II-HA test Wako), and it was confirmed that the total protein amount had not changed (see FIG. 8), and adverse effects such as protein adsorption. It turned out that there was not.

(Example 10)
An ethylene-vinyl alcohol copolymer (ethylene unit content: 47 mol%) was dissolved in dimethyl sulfoxide to prepare a 15% solution. This solution was kept at 40 ° C., formed into a film by casting, and then poured into water kept at 40 ° C. to prepare a dialysis membrane. In addition, the pore diameter of the dialysis membrane of Example 10 was about 5 nm, and the film thickness was about 100 μm.
Two 3 × 4 cm dialysis membranes were stacked and fused on all sides to produce a bag. On the other hand, a tube made of vinyl chloride (outer diameter 3 mm, length 2.5 cm) was prepared. A punch hole was made in one side of the obtained bag, and one end of the tube was inserted into the punch hole and connected with an epoxy adhesive. Through the tube, 50 mg of a water absorbing material (Aquakeep 10SH-PF, manufactured by Sumitomo Seika Co., Ltd.) was added, and the tube was sealed with a pinch cock.
The obtained bag containing the water-absorbing material was immersed in 100 ml of physiological saline, and the water absorption was measured by measuring the weight of the bag over time. The results are shown in FIG. As shown in FIG. 9, water was rapidly absorbed in about 3 hours, and artificial dialysis was possible efficiently.

11 Tools (Example 1)
13 Bag 13a, 13b Dialysis membrane 15 Port 17 Tube 21 This tool (Example 2)
23 bags 24 polyester mesh 31 tools (Example 3)
33 Bag 33a, 33b Dialysis membrane 34 Melamine resin sponge

Claims (7)

    An artificial dialysis tool, which is a bag formed of a dialysis membrane, at least a part of which is indwelled in the body.     The artificial dialysis tool according to claim 1, wherein a dialysis solution is accommodated in the bag body.     The artificial dialysis tool according to claim 1, wherein an adsorbent is accommodated in the bag body.     The artificial dialysis tool according to claim 1, wherein an enzyme is accommodated in the bag body.     The artificial dialysis tool according to any one of claims 1 to 4, comprising a port for communicating the inside and the outside of the bag body.     The artificial dialysis tool according to any one of claims 1 to 5, wherein the dialysis membrane is formed of an ethylene-vinyl alcohol copolymer.     An artificial dialysis method for a mammal other than a human, comprising placing at least a part of the artificial dialysis device according to any one of claims 1 to 6 in the body.

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