WO2019155895A1

WO2019155895A1 - Implantable hemodialysis device

Info

Publication number: WO2019155895A1
Application number: PCT/JP2019/002213
Authority: WO
Inventors: 則尚三木; 藍渡邊; 能士大田
Original assignee: 学校法人慶應義塾
Priority date: 2018-02-09
Filing date: 2019-01-24
Publication date: 2019-08-15
Also published as: JPWO2019155895A1

Abstract

[Problem] To provide a hemodialysis device that reduces the risk of accidents and infections and can remove waste products to a sufficient degree. [Solution] A hemodialysis device which includes: a hemodialysis filtration membrane 5 inside a first housing 3; an arterial-side blood circuit 7 for flowing blood into the first housing 3; an intravenous side blood circuit 11 for flowing out the blood from the first housing 3; a dialysate introducing unit 21 that is connected to the first housing 3 and introduces a dialysate into the first housing 3; a dialysate discharging unit 31 that is connected to the first housing 3 and is for discharging the dialysate that has been through the housing; and an extracorporeal first connecting unit 25 for connecting a dialysate feed unit of an extracorporeal dialysate feed device with the dialysate introducing unit 21.

Description

Implant hemodialysis machine

The present invention relates to a hemodialysis apparatus. More specifically, the present invention relates to an in-vivo type hemodialysis apparatus.

Japanese Patent No. 5385663 discloses a hemodialysis apparatus. Patients who require artificial dialysis must go to hospital once every two or three days to perform artificial dialysis. For this reason, dialysis by going to hospital significantly reduces the patient's QOL. For this reason, home dialysis has been proposed in which dialysis is performed while the patient is at home. Home dialysis involves hemodialysis or peritoneal dialysis at home. It is said that home dialysis has a greater freedom of life and a relatively slow decline in kidney function compared to artificial dialysis. On the other hand, even at home dialysis, it is necessary to operate the dialysis machine and puncture it. For this reason, an attendant is always required for home dialysis, and there is a risk of accidents and infectious diseases.

JP-A-2017-158814 describes an implantable blood filtration device artificial kidney. If an artificial kidney is used, dialysis can be performed continuously for 24 hours, and the risk of accidents and infectious diseases is small. On the other hand, an artificial kidney may not have sufficient performance for removing waste components such as urea components and creatinine.

JP 2017-158814 A

Therefore, an object of the present invention is to provide a hemodialysis apparatus that can sufficiently remove waste products with less risk of accidents and infectious diseases.

The hemodialysis apparatus disclosed in this specification is a hemodialysis apparatus implanted in a living body.
This hemodialysis apparatus is a hemodialysis apparatus 1 in which at least a housing is embedded in a living body.
This hemodialyzer includes a first housing 3, a hemodiafiltration membrane 5 present in the first housing 3, an arterial blood circuit 7, a venous blood circuit 11, a dialysate introduction unit 21, And a dialysate discharge unit 31.
The arterial blood circuit 7 is an element that is connected to the first housing 3 and flows blood into the first housing 3.
The venous blood circuit 11 is connected to the first housing 3 and is an element for flowing out blood from the first housing 3.
The dialysate introduction part 21 is connected to the first housing 3 and is an element for introducing dialysate into the first housing 3.
The dialysate discharge part 31 is connected to the first housing 3 and is an element for discharging the dialysate passing through the housing out of the housing.

Since it has the above configuration, this hemodialysis apparatus can perform diafiltration using the hemodiafiltration membrane 5. In addition, this hemodialyzer can connect the dialysate introduction part 21 and the dialysate supply part of the dialysate supply apparatus, and allow the dialysate to flow into the housing through the dialysate introduction part 21. The hemodialyzer can discharge the dialysate passing through the housing through the dialysate discharge portion 31 to the outside of the housing. For this reason, if this hemodialyzer is used, there is no need to puncture when performing artificial dialysis, so accidents and infectious diseases can be remarkably reduced, and waste products can be effectively removed.

It is preferable that this hemodialysis apparatus further has a first connection part 25. The first connection part 25 is an element for connecting the dialysate supply part of the dialysate supply apparatus and the dialysate introduction part 21 that are located outside the living body and exist outside the living body. With this element, the dialysate can be easily flowed into the first housing from the dialysate supply device existing outside the body.

The hemodialyzer preferably has a second connection part 35. The second connection unit 35 is located outside the living body and is an element for connecting the dialysate discharge unit and the dialysate discharge unit 31 of the dialysate supply device.

This hemodialyzer preferably has a blood channel layer 43 and a dialysate channel layer 47.
The blood channel layer 43 is a layer provided in the first housing 3 and having the blood channel 41. The blood flow path 41 is a blood flow path for guiding the blood flowing into the first housing 3 to the venous blood circuit 11.
The dialysate flow path layer 47 is a layer provided in the first housing 3 and having the dialysate flow path 45. The dialysate flow path 45 is a dialysate flow path for guiding the dialysate flowing into the first housing 3 to the dialysate discharge section 31.
In this case, the hemodiafiltration membrane 5 is interposed between the blood channel layer 43 and the dialysate channel layer 47 and diafilters the blood flowing through the blood channel 41.

This hemodialysis apparatus further includes a blood filtration membrane 61 present in the first housing 3 and a filtrate discharge portion 63 that discharges the filtrate from the blood filtration membrane 61 to the outside of the first housing 3. Those are preferred.

The hemodialysis apparatus preferably further includes a blood flow path layer 43, a dialysate flow path layer 47, and a filtrate flow path layer 69.
The blood channel layer 43 is a layer provided in the first housing 3 and having the blood channel 41. The blood flow path 41 is a blood flow path for guiding the blood flowing into the first housing 3 to the venous blood circuit 11.
The dialysate flow path layer 47 is a layer provided in the first housing 3 and having the dialysate flow path 45. The dialysate flow path 45 is a dialysate flow path for guiding the dialysate flowing into the first housing 3 to the dialysate discharge section 31.
The filtrate channel layer 69 is a layer provided in the first housing 3 and having a filtrate channel 67. The filtrate channel 67 is a channel for guiding the filtrate from the blood filtration membrane 61 to the liquid discharge part 63.
The hemodiafiltration membrane 5 is a hemodiafiltration membrane that is interposed between the blood channel layer 43 and the dialysate channel layer 47 and diafilters the blood flowing through the blood channel 41.
The blood filtration membrane 61 is a blood filtration membrane that is interposed between the blood channel layer 43 and the filtrate channel layer 69 and filters the blood flowing through the blood channel 41.

This hemodialysis machine preferably further has a filtration device 71 for filtering blood flowing out of the first housing 3. The filtration device 71 includes a second housing 73, a blood filtration membrane 61 and a filtrate discharge part 63 provided in the second housing 73. The second housing 73 is a housing for the filtration device 71. The filtrate discharge part 63 is an element for discharging the filtrate from the blood filtration membrane 61 to the outside of the second housing 73.

It is preferable that this hemodialysis apparatus further includes a filtration device 71 connected to the first housing 3 and for filtering blood flowing into the first housing 3. In this case, the filtration device 71 includes a second housing 73, a blood filtration membrane 61 provided in the second housing 73, and a filtrate discharge part 63.

The hemodialyzer preferably has a filtration device 71 for filtering blood. The filtration device 71 includes a second housing 73, a blood filtration membrane 61, and a filtrate discharge part 63. This blood filtration membrane 61 is connected to the arterial blood circuit 7 and is a membrane for filtering blood that does not flow into the first housing 3 but flows into the second housing 73. *

This hemodialysis apparatus can perform diafiltration using the hemodiafiltration membrane 5. In addition, this hemodialyzer can connect the dialysate introduction part 21 and the dialysate supply part of the dialysate supply apparatus, and allow the dialysate to flow into the housing through the dialysate introduction part 21. The hemodialyzer can discharge the dialysate passing through the housing through the dialysate discharge portion 31 to the outside of the housing. For this reason, if this hemodialyzer is used, there is no need to puncture when performing artificial dialysis, so accidents and infectious diseases can be remarkably reduced, and waste products can be effectively removed.

FIG. 1 is a conceptual diagram showing a configuration of a hemodialysis apparatus disclosed in this specification. FIG. 2 is a conceptual diagram showing a configuration of a hemodialysis apparatus different from that shown in FIG. FIG. 3 is a conceptual diagram showing an example of a hemodialysis apparatus having a layer structure. FIG. 4 is a view showing an example of the appearance of the assembled hemodialysis apparatus. FIG. 5 is a conceptual diagram showing a hemodialysis apparatus having a hemodiafiltration membrane and a hemofiltration membrane in a housing. FIG. 6 is a conceptual diagram showing a hemodialysis apparatus having a blood channel layer, a dialysate channel layer, and a filtrate channel layer. FIG. 7 is a block diagram showing a hemodialysis apparatus further having a filtration device for filtering blood flowing out of the first housing 3. FIG. 8 is a block diagram showing a hemodialysis apparatus further having a filtration device for filtering blood flowing into the first housing. FIG. 9 is a conceptual diagram showing an example of a hemodialysis apparatus further having a filtration device in parallel with the first housing.

Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. The present invention is not limited to the embodiments described below, but includes those appropriately modified by those skilled in the art from the following embodiments.

FIG. 1 is a conceptual diagram showing a configuration of a hemodialysis apparatus disclosed in this specification. This hemodialysis apparatus is a hemodialysis apparatus 1 in which at least a housing 3 is embedded in a living body. As shown in FIG. 1, this hemodialysis apparatus includes a first housing 3, a hemodiafiltration membrane 5 present in the first housing 3, an arterial blood circuit 7, and a venous blood circuit 11. , A dialysate introduction part 21 and a dialysate discharge part 31.

“Housing” means a housing part covering each element. The housing is preferably such that the liquid inside does not leak from the housing. The housing is made of, for example, plastic (for example, acrylic and methacrylic resins) or metal (for example, copper, titanium, stainless steel, aluminum, gold, platinum, and alloys thereof). Since the housing is a concept that means the main body portion of the hemodialysis apparatus, the housing does not necessarily have a cavity inside, and may be an assembly of a plurality of layers.

The hemodiafiltration membrane 5 is for removing unnecessary substances such as waste products from the blood through the dialysate. The hemodiafiltration membrane may be a dialysis membrane in a dialysis machine or a filter-like filtration membrane. The pore diameter of the hemodiafiltration membrane 5 is preferably 0.1 nm or more and 10 nm or less, and may be 0.5 nm or more and 2 nm or less. If it is this size, since a virus and a microbe cannot pass, even if a virus and a microbe mix from the dialysate introduction part 21 or the dialysate discharge part 31, it does not mix in the blood, Therefore Infectious disease can be prevented.

The arterial blood circuit 7 is connected to the first housing 3 and is an element for flowing blood into the first housing 3. The carotid artery side blood circuit 7 is normally connected to an artery or a blood vessel derived from the artery, and can flow blood into the housing. In the example shown in FIG. 1, the arterial blood circuit 7 is connected to the first housing 3 via the arterial port 9. On the other hand, the arterial blood circuit 7 may be integrated with the first housing 3. The arterial blood circuit 7 only needs to be able to flow blood into the first housing 3. The arterial blood circuit 7 may have a tubular or tube shape. If it is tubular or tubular, it can be deformed flexibly in the living body, and blood (such as liquid) can be carried in the tube. Examples of tube materials are polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, polycarbonate, acrylic resin, methacrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, butadiene-styrene copolymer, polyamide ( For example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, seed thermoplastic elastomer, PTFE (polytetrafluoroethylene) , EPTFE (stretched polytetrafluoroethylene), titanium, stainless steel, aluminum, copper, and copper-based alloys. The inner diameter of the tube may be adjusted as appropriate. An example of the inner diameter of the tube is 2 mm to 2 cm (2 mm to 8 mm, 3 mm to 7 mm, 3 mm to 5 mm, or 2 mm to 4 mm).

The venous blood circuit 11 is connected to the first housing 3 and is an element for flowing out blood from the first housing 3. The venous blood circuit 11 is normally connected to a vein. The material and shape of the venous blood circuit 11 are the same as those of the arterial blood circuit 7. In the example of FIG. 1, the venous blood circuit 11 and the first housing 3 are connected via the venous port 13. On the other hand, the venous port 13 does not exist, and the venous blood circuit 11 and the first housing 3 may be integrally formed.

The dialysate introduction part 21 is connected to the first housing 3 and is an element for introducing dialysate into the first housing 3. The dialysate is supplied from outside the body, for example. The dialysate introduction part 21 may be manufactured using the same material as the arterial blood circuit 7 and may have the same shape as the arterial blood circuit 7. In addition, the dialysate introduction part 21 may be embedded in the living body, and the remaining part may be outside the living body. Moreover, the dialysate introduction part 21 may be connected with the 1st connection part 25 provided in the patient's body surface. In this case, if the 1st connection part 25 is made into a closed state, the air outside a body and the 1st connection part 25 will be interrupted | blocked. If the 1st connection part 25 is made into an open state, the air outside a body and the 1st connection part 25 will be conduct | electrically_connected. If the supply liquid is supplied to the first connection part 25, the dialysate can be introduced into the first housing 3 through the dialysate introduction part 21. In the example of FIG. 1, the dialysate introduction part 21 and the first housing 3 are connected via a dialysate introduction port 23. On the other hand, the dialysate introduction part 21 and the first housing 3 are integrally formed, and the dialysate introduction port 23 may not exist. In peritoneal dialysis, a catheter is used. Similarly, the dialysate introduction unit 21 may use a catheter.

The dialysate discharge unit 31 is connected to the first housing 3 and is an element for discharging dialysate that has passed through the housing to the outside of the housing. However, finally, it is preferable that the dialysate is discharged out of the body. The dialysate discharge part 31 may have the same configuration as the dialysate introduction part 21. In the example of FIG. 1, the dialysate discharge portion 31 and the first housing 3 are connected via the dialysate discharge port 33. On the other hand, the dialysate discharge portion 31 and the first housing 3 are integrally formed, and the dialysate discharge port 33 may not exist.

In FIG. 1, the dialysate introduction part 21 and the dialysate discharge part 31 are drawn as two independent tubes or tubes. On the other hand, for example, only a single tube or a tube may be present by using a double-lumen tube structure or a structure in which another tube exists in the tube. It is preferable to combine the dialysate introduction part 21 and the dialysate discharge part 31 in this way because the burden on the patient can be reduced.

As described above, it is preferable that the hemodialysis apparatus further includes the first connection part 25. The first connection part 25 is located outside the living body and is dialyzed by the dialysate supply apparatus existing outside the living body. This is an element for connecting the liquid supply part and the dialysate introduction part 21. The entire dialysate introduction unit 21 may be embedded in the living body, and the dialysate may be exchanged with the outside of the body via the first connection unit 25. Moreover, the dialysate introduction part 21 may be embedded in the living body partway and extend outside the body. Such connection parts and tube / tube configurations are appropriately adopted from those used in peritoneal dialysis (for example, those described in Japanese Patent No. 6240485, Japanese Patent No. 6170988, and Japanese Patent No. 6161167). Also good. In addition, for example, elements described in Japanese Patent No. 4067419 (closed cell culture system) may be used as appropriate. With this element, the dialysate supply device existing outside the body and the first housing can be easily connected, and the dialysate can flow into the first housing.

In addition, it is preferable that the hemodialysis apparatus further includes a second connection portion 35. It is also possible to drain dialysate containing waste products as urine by connecting to the bladder. On the other hand, the dialysate contaminated by dialysis is preferably discharged out of the body. The second connection unit 35 is located outside the living body and is an element for connecting the dialysate discharge unit and the dialysate discharge unit 31 of the dialysate supply device. The second connection portion 35 is the same as the first connection portion 25. The dialysate after use is discharged out of the body through the dialysate discharge part 31 and the second connection part 35.

In the example of FIG. 1, the blood traveling direction in the first housing 3 from the artery side blood circuit 7 entering the first housing 3 toward the vein side blood circuit 11 is from left to right. On the other hand, in the example of FIG. 1, the dialysate that has entered the first housing 3 via the dialysate introduction part 21 is directed from the right to the left in the first housing 3 in the first housing 3 toward the dialysate discharge part 31. Direction. That is, in FIG. 1, the blood traveling direction and the dialysis fluid traveling direction are drawn so as to be reversed. That is, in this example, the dialysate drainage portion 31 is located closer to the artery side blood circuit 7 or the artery side port 9 than the vein side blood circuit 11 or the vein port 13 in the first housing. ). In this example, the dialysate introduction part 21 is located closer to the venous blood circuit 11 or the venous blood circuit 11 or the venous port 13 than the arterial blood circuit 7 or the arterial port 9 in the first housing. ).

For example, a hemodiafiltration membrane 5 used for a dialysis machine is present in the first housing, and blood is supplied and discharged from one side of the central portion of the first housing. . Water or dialysate is supplied from the other side different from the direction in which blood is supplied, and water or dialysate is discharged through the gap between the inner surface of the cylinder forming the hemodiafiltration membrane and the plurality of narrow cylinders. . The part through which water and dialysate pass and the part through which blood passes are isolated by a thin blood purification membrane. The blood purification membrane can discharge creatinine, which is a uremic toxin, from the blood into water. The blood purification membrane does not allow red blood cells to pass through. From these effects, creatinine, which is a uremic toxin, can be removed from blood, blood can be purified, and blood can be discharged. Thus, it is preferable that there is actually a portion where the traveling directions of blood and dialysate are reversed because hemodialysis is efficiently performed. On the other hand, this drawing is a concept, and the position of the dialysate introduction part 21 and the dialysate discharge part 31, the traveling direction of the blood, and the traveling direction of the dialysate are arbitrary.

FIG. 2 is a conceptual diagram showing the configuration of a hemodialysis apparatus different from that shown in FIG. In this example, the traveling direction of the dialysate is drawn in the housing so as to be the same as the traveling direction of blood.

FIG. 3 is a conceptual diagram showing an example of a hemodialysis apparatus having a layer structure. As shown in FIG. 3, this hemodialyzer preferably has a blood channel layer 43 and a dialysate channel layer 47. The basic structure of the device having this layer structure is described in Japanese Patent Application Laid-Open No. 2017-158814 (Patent Document 2). This hemodialysis apparatus has a main body (first housing 3) having a hexagonal outer shape. The main body has a laminated structure formed by laminating a plurality of plate-like members. A blood inlet 9a and a blood outlet 13a, a dialysate inlet 23a and a dialysate outlet 33a (and a filtrate outlet) are provided on one surface of the main body in the stacking direction. The blood inlet allows blood to flow into the main body, and the blood outlet causes blood within the main body to flow out. The dialysate inlet allows the dialysate to flow into the main body, and the dialysate outlet allows the dialysate inside the main body to flow out. Then, the filtrate outlet discharges the filtrate that has been filtered in the main body and taken out from the blood. It is preferable that the blood inlet and the blood outlet, the dialysate inlet and the dialysate outlet (and the filtrate outlet) each have a connector shape to which a tube can be connected.

FIG. 3 shows a configuration example in which one blood flow path layer 43 and one dialysate flow path layer 47 are prepared and laminated in order to easily understand the structure of the hemodialysis apparatus. However, the artificial kidney 41 may have a configuration in which a plurality of blood flow path layers 43 and dialysate flow path layers 47 are alternately stacked to form several tens or hundreds of layers. The number of layers can be appropriately changed according to the mammal. The main body is sandwiched by the first end plate 49 and the second end plate 51 from both sides in the stacking direction, integrated using fastening means (for example, bolts and nuts), and held in a compressed state in the stacking direction. May be.

The blood channel layer 43 is a layer provided in the first housing 3 and having the blood channel 41. The blood flow path 41 is a blood flow path for guiding the blood flowing into the first housing 3 to the venous blood circuit 11. The dialysate flow path layer 47 is a layer provided in the first housing 3 and having the dialysate flow path 45. The dialysate flow path 45 is a dialysate flow path for guiding the dialysate flowing into the first housing 3 to the dialysate discharge section 31. The dialysate channel 45 may be connected to the dialysate inlet and the dialysate outlet. In this case, the hemodiafiltration membrane 5 is interposed between the blood channel layer 43 and the dialysate channel layer 47 and diafilters the blood flowing through the blood channel 41.

The blood channel 41 and the dialysate channel 45 may be designed with reference to, for example, Japanese Patent Application Laid-Open No. 2017-158814 (Patent Document 2). The width of the channel is preferably from 0.01 mm to 1 cm, from 0.1 mm to 5 mm, and from 0.5 mm to 4 mm. The thickness of the flow channel is adjusted as appropriate according to the thickness of the device and the number of layers. If the flow channel is too thick, the blood flow rate will be too high, and if the flow channel is too thin. In addition to stagnation of the blood flow, there is an increased risk of impurities accumulating and blocking the flow path. From such a viewpoint, the thickness of the flow path is preferably 0.01 mm or more and 1 cm or less, may be 0.05 mm or more and 5 mm or less, and may be 0.1 mm or more and 3 mm or less.

Further, in order to obtain an appropriate blood filtration devices, the total area of the flow path is important, the total area of the passage is preferably 1 cm ² or more 100000 ² below, may be a 2 cm ² or more 10000 cm ² or more, 10 cm ² It may be 5000 cm ² or less.

FIG. 4 is a diagram showing an example of the appearance of the assembled hemodialysis apparatus. In the example of FIG. 4, the arterial connection port 9, the vein connection port 13, the dialysate introduction port 23, and the dialysate discharge port 33 are provided on the first end plate 49. When there is a filtrate connection port connected to the filtrate outlet, if the filtrate connection port is also provided on the first end plate 49, various ports can be concentrated on one side, so that blood It becomes easy to implant a dialysis device in the body. In the example shown in FIG. 4, the arterial connection port 9, the vein connection port 13, the dialysate introduction port 23, and the dialysate discharge port 33 are in the shape of connectors, and the column part and the connection located at the tip of the column part Has a part. Of the connecting parts, the part connected to the column part has a diameter larger than that of the column part, and the connection part becomes thinner toward the tip so that it can be connected to a tube such as a tube. By covering the tube, etc., beyond the connection part up to the column part, the tube etc. are connected to each connection element, so that the tube etc. is not easily detached from the connection element. In the example shown in FIG. 4, a plurality of layers are united by being compressed from above and below by bolts 2 and nuts. In the example shown in FIG. 4, the upper surface shape of the first end plate 49 is a hexagonal shape, and the bolts 2 are provided at six locations correspondingly. The actual shape of the upper surface of the hemodialysis apparatus may be a circle or an ellipse, or may be an octagon, a decagon, or a dodecagon other than a rectangle or a hexagon. It is preferable that the bolt position is usually provided at a position that is point-symmetric about the center of gravity of the first end plate. Examples of the number of bolt positions are 4, 6, 8, 10, and 12.

Next, the flow of dialysate and blood will be described. The dialysate flows through the dialysate inlet 23 a provided in the first end plate 49. Then, the dialysate passes through the dialysate through-hole 23 b provided in the blood flow path layer 43 and the dialysate through-hole 23 c provided in the hemodiafiltration membrane 5, and then the inlet portion of the dialysate flow path 45. 23d. After that, the dialysate proceeds along the dialysate flow path 45 and diafilters the blood flowing through the blood flow path 41 through the hemodiafiltration membrane 5. In the example of FIG. 3, the dialysate flow path 45 and the blood flow path 41 are meandered. However, the dialysate channel 45 and the blood channel 41 are not limited to those illustrated. In the dialysate flow path layer 47, the dialysate that has passed through the dialysate flow path 45 to the dialysate outlet 33 d passes through the dialysate through-hole 33 c and the blood flow path layer 43 provided in the hemodiafiltration membrane 5. It is discharged from a dialysate outlet 33 a provided in the first end plate 49 through a through-hole 33 b for dialysate provided in the first end plate 49. The dialysate outlet 33 a functions as the dialysate outlet 33 and is connected to the dialysate outlet pipe 31. Moreover, the element which functions as the dialysate discharge port 33 may be attached to the dialysate outlet 33a, and the element and the dialysate discharge pipe 31 may be connected. In this way, the dialysate flows into the first housing 3 and circulates in the first housing, and then is discharged from the first housing. An arterial blood circuit 7 that is a blood flow path connected to an arterial blood vessel is connected to the housing 3 via, for example, an arterial connection port 9. The arterial connection port 9 flows into the housing 3 through the blood inlet 9 a provided in the first end plate 49. The blood that flows in from the blood inlet 9 a reaches the inlet portion 9 b of the blood channel 41 provided in the blood channel layer 43. The blood travels along the blood channel 41 from the inlet portion 9 b of the blood channel layer 43 and reaches the outlet portion 13 b of the blood channel 41 provided in the blood channel layer 43. The blood that has reached the outlet portion 13 b of the blood channel 41 is output from the housing 3 through the blood outlet 13 a provided in the first end plate 49. The blood outlet 13a may function as the vein connection port 13 or may be connected to an element functioning as the vein connection port 13. The vein connection port 13 is connected to the vein side blood circuit 11 which is a flow path corresponding to the downstream side of blood.

FIG. 5 is a conceptual diagram showing a hemodialysis apparatus having a hemodiafiltration membrane and a hemofiltration membrane in a housing. The hemodialysis apparatus shown in FIG. 5 includes a blood filtration membrane 61 existing in the first housing 3, and a filtrate discharge portion 63 that discharges the filtrate from the blood filtration membrane 61 to the outside of the first housing 3. , Is further provided.

The blood filtration membrane 61 filters blood to remove harmful substances and excess water. The blood filtration membrane 61 may be constituted by a polymer membrane having many nanoscale pores, for example. As a specific blood filtration membrane 61, a PES (polyether sulfone e) membrane is used. The PES membrane can selectively filter only blood components having a low molecular weight through nanoscale pores, and can extract harmful substances and excess water from the blood. Examples of known blood filtration membranes include those of low molecular weight polysulfone (for example, JP-A-4-338224 and JP-A-11-309355) and those of high molecular weight type polysulfone (JP-A-9-70524). Issue gazette).

FIG. 6 is a conceptual diagram showing a hemodialysis apparatus having a blood channel layer, a dialysate channel layer, and a filtrate channel layer. The blood flow path layer 43, the dialysate flow path layer 47, and the filtrate flow path layer 69 are preferably included in a plurality of layers. In this case, it is preferable that the blood flow path layer 43 and the dialysate flow path layer 47 and the blood flow path layer 43 and the filtrate flow path layer 69 are adjacent to each other. In the example of FIG. 6, the blood filtration membrane 61 has the same shape (here, hexagonal) as each layer. In the example of FIG. 6, there is a portion where the blood flow path layer 43 and the dialysate flow path layer 47 are adjacent to each other through the diffusion film 4. Further, there is a portion where the blood flow path layer 43 and the filtrate flow path layer 69 are adjacent to each other through the blood filtration membrane 61.
The blood channel layer 43 is a layer provided in the first housing 3 and having the blood channel 41. The blood flow path 41 is a blood flow path for guiding the blood flowing into the first housing 3 to the venous blood circuit 11.
The dialysate flow path layer 47 is a layer provided in the first housing 3 and having the dialysate flow path 45. The dialysate flow path 45 is a dialysate flow path for guiding the dialysate flowing into the first housing 3 to the dialysate discharge section 31.
The filtrate channel layer 69 is a layer provided in the first housing 3 and having a filtrate channel 67. The filtrate channel 67 is a channel for guiding the filtrate from the blood filtration membrane 61 to the liquid discharge part 63.
The hemodiafiltration membrane 5 is a hemodiafiltration membrane that is interposed between the blood channel layer 43 and the dialysate channel layer 47 and diafilters the blood flowing through the blood channel 41.
The blood filtration membrane 61 is a blood filtration membrane that is interposed between the blood channel layer 43 and the filtrate channel layer 69 and filters the blood flowing through the blood channel 41. The outlet of the filtrate channel 67 is discharged from the housing 3 via a filtrate outlet 65 a provided in the second end plate 51. At this time, the filtrate outlet 65a may be connected to the filtrate connection port 65, or the filtrate outlet 65a may function as the filtrate connection port 65. The filtrate discharged from the filtrate connection port 65 is connected to the filtrate discharge part 63. And the filtrate discharge | emission part 63 is connected with the inflow pipe | tube to the bladder or a bladder, for example, and the filtrate discharged | emitted from the housing 3 is discharged | emitted outside the body through the bladder.

FIG. 7 is a block diagram showing a hemodialysis apparatus further having a filtration device for filtering blood flowing out of the first housing 3. In the example shown in FIG. 7, the filtration device 71 includes a second housing 73, a blood filtration membrane 61 provided in the second housing 73, and a filtrate discharge part 63. The second housing 73 is a housing for the filtration device 71. The filtrate discharge part 63 is an element for discharging the filtrate from the blood filtration membrane 61 to the outside of the second housing 73.
The second housing 73 has a blood discharge path 75 for discharging the filtered blood, and the blood discharge path 75 is connected to, for example, a vein. In the example of FIG. 7, the second housing 73 and the blood discharge path 75 are connected via a blood discharge port 77. In the example of FIG. 7, the second housing 73 and the filtrate discharge part 63 are connected via the filtrate port 65.

FIG. 8 is a block diagram showing a hemodialysis apparatus further having a filtration device for filtering blood flowing into the first housing.
This hemodialysis apparatus is preferably connected to the first housing 3 and further has a filtration device 71 for filtering blood flowing into the first housing 3. In this case, the filtration device 71 includes a second housing 73, a blood filtration membrane 61 provided in the second housing 73, and a filtrate discharge part 63.

FIG. 9 is a conceptual diagram showing an example of a hemodialysis apparatus further having a filtration device 71 in parallel with the first housing. The filtration device 71 includes a second housing 73, a blood filtration membrane 61, and a filtrate discharge part 63. This blood filtration membrane 61 is connected to the arterial blood circuit 7 and is a membrane for filtering blood that does not flow into the first housing 3 but flows into the second housing 73.

An operation example of the hemodialysis apparatus will be described using the hemodialysis apparatus of FIG.
First, when the dialysate is not circulated, the first connecting portion 25 and the second connecting portion 35 are in a closed state (closed state). The dialysate introduction part 21 and the dialysate discharge part 31 are disconnected from the outside air. The blood derived from the artery flows into the first housing through the arterial blood circuit. At this time, even if a virus or the like is mixed from the dialysate introduction part 21 or the dialysate discharge part 31, if the pore diameter of the hemodiafiltration membrane 5 is sufficiently small, the virus or the like causes the blood in the housing to Contamination and prevention of infections can be prevented. On the other hand, the blood whose waste product has been scraped by the blood filtration membrane 61 is discharged to the venous blood circuit 11. Further, the filtrate filtered by the blood filtration membrane 61 is discharged to a liquid discharge portion 63 (for example, a tube). The liquid discharge part 63 is connected to a tube connected to the bladder, for example. Then, the filtrate accumulates in the bladder and is appropriately released outside the body.

Next, the case of performing artificial dialysis will be described. Check the dialysate supply device. Thereafter, the second connecting portion 35 is opened, and the dialysate can be discharged. When the second connection portion 35 is not present, the dialysate is discharged. Therefore, a container for receiving the dialysate is prepared so that the discharged dialysate does not contaminate the surroundings. Next, the first connection portion is opened. The open state means that the first connecting portion can be connected to the outside world. The dialysate supply unit of the dialysate supply apparatus is connected to the first connection unit. In this state, the dialysate can be introduced into the dialysate introduction section. The dialysate is discharged from the dialysate supply device. Then, the dialysate flows into the first housing 3 via the first connection part 25 and the dialysate introduction part 21. The blood flowing in the first housing and the dialysate flowing in the first housing pass through the hemodiafiltration membrane 5. Then, waste products such as urea components and creatinine contained in blood are mixed into the dialysate through the hemodiafiltration membrane 5. The dialysate mixed with the waste is discharged outside the body through the dialysate discharge part 31. The dialysate discharge unit 31 may be connected to a dialysate supply device, and may be reused by filtering the dialysate.

The present invention can be used in the field of medical equipment.

DESCRIPTION OF SYMBOLS 1 Hemodialysis apparatus 3 1st housing 5 Hemodialysis filtration membrane 7 Arterial side blood circuit 11 Vein side blood circuit 21 Dialysate introduction part 25 First connection part 31 Dialysate discharge part 35 Second connection part 41 Blood flow path 43 Blood channel layer 45 Dialysate channel 47 Dialysate channel layer 61 Blood filtration membrane 63 Filtrate outlet 69 Filtrate channel layer 71 Filtration device 73 Second housing

Claims

A hemodialysis device (1) embedded in a living body,
A first housing (3);
A hemodiafiltration membrane (5) present in the first housing (3);
An arterial blood circuit (7) connected to the first housing (3) for flowing blood into the first housing (3);
A venous blood circuit (11) connected to the first housing (3) for draining blood from the first housing (3);
A dialysate introduction part (21) connected to the first housing (3) and introducing the dialysate into the first housing (3);
A dialysate discharge part (31) connected to the first housing (3) and for discharging dialysate passing through the housing;
A first connection part (25) for connecting the dialysate supply part of the dialysate supply apparatus and the dialysate introduction part (21) located outside the living body and existing outside the living body;
A hemodialysis machine.
The hemodialysis apparatus according to claim 1, wherein
A hemodialysis apparatus further comprising a second connection part (35) located outside the living body for connecting the dialysate discharge part of the dialysate supply apparatus and the dialysate discharge part (31).
The hemodialysis apparatus according to claim 1, wherein
A blood channel layer (43) provided in the first housing (3) and having a blood channel (41) for guiding the blood flowing into the first housing (3) to the venous blood circuit (11). )When,
A dialysate flow path provided in the first housing (3) and having a dialysate flow path (45) for guiding dialysate flowing into the first housing (3) to the dialysate discharge section (31). And further comprising a layer (47),
The hemodiafiltration membrane (5) is interposed between the blood flow channel layer (43) and the dialysate flow channel layer (47), and blood that diafilters blood flowing through the blood flow channel (41). A diafiltration membrane,
Hemodialysis machine.
The hemodialysis apparatus according to claim 1, wherein
A blood filtration membrane (61) present in the first housing (3);
A filtrate discharge part (63) for discharging the filtrate from the blood filtration membrane (61) to the outside of the first housing (3),
Hemodialysis machine.
The hemodialysis apparatus according to claim 4, wherein
A blood channel layer (43) provided in the first housing (3) and having a blood channel (41) for guiding blood flowing into the first housing (3) to the venous blood circuit (11) When,
A dialysate flow path provided in the first housing (3) and having a dialysate flow path (45) for guiding dialysate flowing into the first housing (3) to the dialysate discharge section (31). Layer (47);
A filtrate channel layer provided in the first housing (3) and having a filtrate channel (67) for guiding the filtrate from the blood filtration membrane (61) to the liquid discharge part (63). (69),
Further comprising
The hemodiafiltration membrane (5) is interposed between the blood flow channel layer (43) and the dialysate flow channel layer (47), and blood that diafilters blood flowing through the blood flow channel (41). A diafiltration membrane,
The blood filtration membrane (61) is interposed between the blood channel layer (43) and the filtrate channel layer (69), and filters the blood flowing through the blood channel (41). Is,
Hemodialysis machine.
The hemodialysis apparatus according to claim 1, wherein
A filtration device (71) for filtering blood flowing out of the first housing (3);
The filtration device (71)
A second housing (73) which is a housing of the filtration device (71);
A blood filtration membrane (61) provided in the second housing (73);
A filtrate discharge section (63) for discharging the filtrate from the blood filtration membrane (61) to the outside of the second housing (73);
Have
Hemodialysis machine.
The hemodialysis apparatus according to claim 1, wherein
A filtration device (71) connected to the first housing (3) for filtering blood flowing into the first housing (3);
The filtration device (71)
A second housing (73) which is a housing of the filtration device (71);
A blood filtration membrane (61) provided in the second housing (73);
A filtrate discharge section (63) for discharging the filtrate from the blood filtration membrane (61) to the outside of the second housing (73);
Have
Hemodialysis machine.
The hemodialysis apparatus according to claim 1, wherein
A filtration device (71) for filtering blood;
The filtration device (71)
A second housing (73) which is a housing of the filtration device (71);
A blood filtration membrane (61) connected to the arterial blood circuit (7) and filtering blood that does not flow into the first housing (3) but flows into the second housing (73);
A filtrate discharging part (63) for discharging the filtrate from the blood filtration membrane (61) out of the second housing (73);
Have
Hemodialysis machine.