JP2001314501A - Medical blood purifier and housing - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical blood purifier reduced in cost and waste volume. SOLUTION: This blood purifier is composed of a blood inlet port, a blood outlet port, a hollow thread membrane bundle composed of a large number of hollow thread membranes and a sealing part for liquidtightly fixing the respective ports to outside surfaces of the hollow thread membranes so that the mutual outside surfaces of the respective hollow thread membranes and the inside of the hollow thread membranes and the respective ports are communicated in both end parts of the hollow thread membrane bundle. Since it is a sterilized medical blood purifier having no hard housing for covering the hollow thread membrane bundle by liquidtightly abutting to the sealing part, it can be manually deformed and compressed at disposal after blood purifying treatment so as to sharply reduce the waste volume.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a hollow fiber membrane-type medical blood purifier used in hemodialysis therapy and the like.

[0002]

2. Description of the Related Art Medical blood purifiers such as hemodialyzers used in hemodialysis therapy include disposable products which are used only once and which are disposable or are subjected to blood purification treatment and then disinfected, regenerated and then reused in the same module. There is a so-called reuse product that uses a plurality of times.

[0003] At present, the number of patients with renal failure continues to increase worldwide, and the cost of medical care continues to increase. There is a strong need to reduce the cost of modules in order to reduce the medical costs per kidney failure patient. However, reducing the cost of the module and improving the performance are often incompatible, and there is a limit in reducing the manufacturing cost of the module.

[0004] On the other hand, since the environment is destroyed by landfilling or incineration for disposing of the blood purifier discarded after use, reducing the amount of waste is also a major issue. In this regard, disposable products increase waste volume. In addition, current hemodialyzers have a robust housing that prevents blood and dialysate from leaking during use, and cannot be manually compressed when discarded after use, which increases the volume of waste. Would.

In order to solve these problems, the above-mentioned reuse in the United States and the like has reduced the amount of waste,
Reductions in overall medical costs have been made.
However, in order to reuse the module once used for the same patient without error, the reused product must be sorted for each patient, disinfected, regenerated and stored. Reusable products require more space for disinfection, regeneration, and storage than disposable products, and require extra work for sorting, disinfection, regeneration, and storage, which incurs new costs. Furthermore, the safety of reused products in long-term use is not assured as compared to disposable products, and problems have been pointed out regarding the use of hemodialysis using reused products.

[0006] In the field of water purifiers and industrial ultrafilters using hollow fiber membranes, techniques for easily attaching and detaching the hollow fiber membrane and the housing are widely used. But,
In the medical field such as a hemodialyzer, a hollow fiber membrane that does not leak dialysate that has exchanged substances with the patient's blood through the hollow fiber membrane while maintaining the sterility of the part that comes into contact with the blood is maintained. There is no known housing that can be detached.

[0007]

SUMMARY OF THE INVENTION The present invention solves the above-mentioned problems, and disposes of a blood contact portion comprising a blood inlet port, a hollow fiber membrane, a blood outlet port, and a sealing portion, which are portions that come into contact with blood. Another object of the present invention is to provide a medical blood purifier that achieves cost reduction and waste volume reduction by reusing a housing that does not come into contact with blood.

[0008]

[0009]

The present invention provides the following (1).
To (19).

(1) a blood inlet port into which blood flows,
A blood outlet port through which blood flows out, a hollow fiber membrane bundle composed of a large number of hollow fiber membranes, and between the outer surfaces of the hollow fiber membranes at both ends of the hollow fiber membrane bundle and the lumen of the hollow fiber membrane and A blood purifier comprising a sealing portion in which each port is fixed to the outer surface of the hollow fiber membrane in a liquid-tight manner so that the ports communicate with each other, and abuts the sealing portion in a liquid-tight manner to cover the hollow fiber membrane bundle. A sterilized medical blood purifier characterized by having no rigid housing.

(2) a blood inlet port into which blood flows,
A blood outlet port through which blood flows out, a hollow fiber membrane bundle composed of a large number of hollow fiber membranes, and between the outer surfaces of the hollow fiber membranes at both ends of the hollow fiber membrane bundle and the lumen of the hollow fiber membrane and A blood purifier comprising a sealing portion in which each port is fixed to the outer surface of the hollow fiber membrane in a liquid-tight manner so that the ports communicate with each other, wherein the blood inlet port and the outer surface of the blood outlet port, and / or A sterilized medical blood purifier characterized by having a joint that can be liquid-tightly joined to a hard housing that covers the hollow fiber membrane bundle on the outer surface of the stop.

(3) The medical blood purifier according to the above (2), wherein the joint portion is provided with a dialysate swelling material.

(4) The above-mentioned (2) having a covering material made of a flexible material covering the hollow fiber membrane bundle from the sealing part at one end to the sealing part at the other end of the hollow fiber membrane bundle. ) Or the medical blood purifier according to (3).

(5) The bending strength of the wrapping material is 20
The medical blood purifier according to the above (2) to (4), which has a MPa or less.

(6) The medical blood purifier according to the above (2) to (5), wherein at least a part of the hollow fiber membrane bundle is bundled with a dialysate swelling material.

(7) A housing having a dialysate inlet through which dialysate flows in and a dialysate outlet through which dialysate flows out, wherein the junction of the medical blood purifier according to any one of the above (1) to (6). A blood purifier housing having a contact portion for preventing leakage of a liquid by contacting the housing.

(8) The medical blood purifier housing according to (7), wherein the dialysate swellable material is disposed in the contact portion.

(9) The blood purifier housing according to the above (7) or (8), which is dividable in a substantially longitudinal direction and is freely openable and closable.

(10) The medical blood purifier housing described in (7) to (9) above and the medical blood purifier described in (1) to (6) above. A space through which the dialysate flows is formed between the housings, and between the blood flowing through the lumen of the hollow fiber membrane and the dialysate flowing between the hollow fiber membrane and the housing via the hollow fiber membrane. Assembly for dialysis and filtration.

(11) The housing is 500 mm
The assembly according to the above (10), further comprising a holding jig that is not divided by a housing internal pressure of Hg or less.

(12) A blood inlet port through which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle composed of a large number of hollow fiber membranes, and the outer surface of each hollow fiber membrane at both ends of the hollow fiber membrane bundle A blood purifier comprising a sealing portion in which each port is fixed to the outer surface of the hollow fiber membrane in a liquid-tight manner so that the ports communicate with each other and the lumen of the hollow fiber membrane. From the sealing part at one end of the membrane bundle to the sealing part at the other end, a wrapping material made of a flexible material covering the hollow fiber membrane bundle is provided, and a dialysis solution is provided in the wrapping material internal space. A medical blood purifier having a dialysate inlet for inflow and a dialysate outlet for dialysate outflow.

(13) The medical blood purifier according to (12), which is sterilized. (14) The medical blood purifier according to (12) or (13), wherein the wrapping material has a bending strength of 20 MPa or less. Medical blood purifier.

(15) The above (12) to (1) wherein at least a part of the hollow fiber membrane bundle is bundled with a dialysate swelling material.
The medical blood purifier according to 4).

(16) A housing for suppressing excessive expansion of the wrapping material of the medical blood purifier described in (12) to (15) above, wherein the dialysate inlet and the dialysate outlet are provided. A blood purifier housing communicable with the outside of the housing.

(17) It can be divided substantially in the longitudinal direction,
The housing for a blood purifier according to the above (16), which is openable and closable.

(18) A blood purifier covered with the blood purifier housing according to (16) or (17), wherein a dialysate is passed between the hollow fiber membrane and the encapsulating material. (12) to (1), wherein dialysis and filtration are performed between the blood flowing through the lumen of the hollow fiber membrane and the dialysate flowing between the hollow fiber membrane and the encapsulating material via the hollow fiber membrane.
A medical blood purifier according to 5).

(19) The housing is 500 mm
(18) The medical blood purifier according to the above (18), further comprising a holding jig that is not divided by the inner pressure of the encapsulating material of Hg or less.

[0028]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail.

FIG. 1 is a longitudinal sectional view showing an example of the blood purifier according to the first embodiment of the present invention. FIG. 2 is a longitudinal sectional view showing an example of a housing used for the blood purifier according to the first embodiment of the present invention. FIG. 3 is a longitudinal sectional view of a blood purifier assembly in which the blood purifier shown in FIG. 1 and the blood purifier housing shown in FIG. 2 are combined.

The present invention comprises a blood inlet port 21 through which blood flows in, a blood outlet port 22 through which blood flows out, a hollow fiber membrane bundle 3 comprising a number of hollow fiber membranes, and hollows at both ends of the hollow fiber membrane bundle. A blood purifier comprising a sealing portion 4 in which each port is liquid-tightly fixed to the outer surface of the hollow fiber membrane so that the port communicates with the outer surface of the fiber membrane and between the inner cavity of the hollow fiber membrane and the port. A sterilized medical blood purifier characterized by not having a hard housing that abuts the sealing portion in a liquid-tight manner and covers the hollow fiber membrane bundle. With this configuration, compression can be performed manually, and the volume of waste can be reduced. The blood flow space formed by the blood inflow portion 92 of the blood inlet port 21, the hollow fiber lumen 31, and the blood / blood outflow portion 93 of the blood outlet port 22 is separated from the outside by the sealing portion 4.

Further, according to the present invention, the blood is supplied to the blood inlet port 2.
1. In a blood purifier that flows through a hollow fiber lumen 31 and a blood outlet port 22 and a dialysate flows outside each hollow membrane 32, a blood purifier comprising a blood inlet port 21, a hollow fiber lumen 31, and a blood outlet port 22. The channel is freely detachable from the housing 6 forming a part of the dialysate channel, and the portion constituting the blood channel that comes into contact with blood is disposable, and the housing that does not come into contact with blood is reused. By doing so, cost reduction and waste volume reduction are achieved.

In the blood purifier assembly 100 composed of the blood purifier 1 and the housing 6,
By disposing the dialysate swellable material 51 between the joint portion 5 of the blood purifier 1 as a part constituting the disposable blood flow path and the contact portion 8 of the housing 6, Is prevented from leaking from between the joint 5 and the contact 8. The joining portion is, specifically, a urethane, which is generally referred to as a “potting material”, and is usually a liquid-tight seal between the outer surfaces of the hollow fiber membranes and between the outer surface of the hollow fiber membrane and the surrounding material. At the surface 41 of the sealing portion 4 formed of resin or epoxy resin, or at the blood inlet port 21 or the blood outlet port 22 or the like, the member surface 23 which is combined with the contact portion 8 of the housing 6 to obtain liquid tightness And the like, and the joint portion 5 may be configured independently of the sealing portion surface 41 and the member surface 23, or the sealing portion surface 41 and the member surface 23.
May be combined. The contact portions 8 are preferably provided near the openings at both ends of the housing 6.

The contact part 8 of the housing 6 is a part corresponding to the joint part 5 in the blood purifier assembly 100. Polystyrene, polyolefin, polyester, polyurethane, polyamide elastomer, or silicone may be disposed in the contact portion 8 in order to achieve liquid tightness.

By arranging the dialysate swellable material 51 at the joint portion 5, the dialysate flows during dialysis, and the dialysate swellable material 51 comes into contact with the dialysate.
1 swells and tightly joins between the joint 5 and the contact 8 to prevent the dialysate from leaking.

After the blood purification treatment is completed, the dialysate swellable material 51 is contracted, so that the blood purifier 1 and the housing 6 can be easily separated. The contraction of the dialysate swellable material 51 can be performed by, for example, injecting ethanol into the dialysate swellable material 51 with a syringe or the like to dehydrate the dialysate swellable material. Further, the blood purifier 1 can be detached from the housing 6 when the housing 6 is broken and opened in the longitudinal direction. It is preferable to provide a dialysate swellable material at the corresponding contact portion 8 of the housing, for example, when the housing is opened and closed by breaking in the longitudinal direction. At the time of dialysis, the blood purifier 1 is covered with the housing 6,
The housing 6 is closed, the dialysate flows, the swelling material of the dialysate swells, and the dialysate side becomes liquid-tight. At the end of dialysis, the housing 6 is opened to disconnect the blood purifier 1 and the housing 6. Can be separated.

Further, in order to protect each hollow fiber membrane 32 of the hollow fiber membrane bundle 3 of the blood purifier 1 from external force, the hollow fiber membrane bundle 3 is covered with a porous material such as a mesh, a sponge, etc. Mounting / detachment of the hollow fiber membrane bundle 3 to / from the housing while allowing the liquid to flow between the hollow fiber membranes;
Alternatively, the setting operation or the like of the blood purification process can be facilitated.

Further, by covering the entire surface of the hollow fiber membrane bundle 3 with a wrapping material made of a flexible material from the sealing portion at one end to the sealing portion at the other end, the hollow fiber membrane bundle 3 is protected from external force. can do. At this time, the encapsulating material has a communication portion with the outside at a portion where the dialysate flows in and a portion where the dialysate flows out.

Further, by providing a band made of a dialysate swellable material on a part of the hollow fiber membrane bundle 3, mounting and storing the blood purifier 1 in the housing becomes easy. The bundle can be protected from external forces. In particular, it is preferable that the band is located in the middle of the hollow fiber membrane bundle 3.

The medical blood purifier and the blood purifier housing of the present invention shown in FIG. 3 comprise the blood purifier 1 of FIG. 1 and the housing 6 of FIG. The blood purifier 1 includes a blood inlet port 21 and a blood outlet port 22 and each hollow fiber 32.
Bundle 3 is connected in a liquid-tight manner by a sealing portion 4 and a blood inflow portion 9
2. It is composed of a blood flow path formed by each hollow fiber membrane lumen 31 and a blood outflow portion 93, and a joint portion 5 having a dialysate swellable material 51 disposed on the surface 41 of the sealing portion 4. . The housing 6 includes a contact portion 8 that comes into contact with the joint portion 5,
A dialysate inlet 71 through which dialysate flows in and out, a dialysate outlet 72,
It consists of a torso 81. Dialysate inlet 71 and dialysate outlet 72
Is not fixed with respect to the inflow and outflow of the liquid, and the dialysate may flow out from the dialysate inlet 71. In addition, the liquid flowing in and out is not limited to dialysate,
Depending on the blood purification method to be applied, a blood filtrate, a replacement liquid, etc. may be used.

The housing 6, blood inlet port 21 and blood outlet port 22 are made of, for example, polyethylene, polypropylene, polycarbonate, polymethyl methacrylate, other acrylic resins, hard polyvinyl chloride, styrene-butadiene copolymer resin, polystyrene, polyethylene Various resins such as terephthalate can be used, and it is preferable that the resin is transparent or translucent to secure internal visibility. In addition, the blood inlet port 21 and the blood outlet port 22 may be colored in different colors, for example, in order to easily distinguish the inlet side and the outlet side of the liquid.

In FIG. 3, the hollow fiber membrane bundle 3 is accommodated in the housing 6 over substantially the entire length thereof. The number of hollow fiber membranes 32 used in the blood purifier of the present invention is, for example, about 100 to 70,000.
2 are arranged in parallel along the longitudinal direction of the housing 6. As the hollow fiber membrane 32, for example, regenerated cellulose, a cellulose derivative, polymethyl methacrylate,
Examples thereof include those composed of polyolefins such as polyethylene and polypropylene, polysulfone, polyethersulfone, polyacrylonitrile, polyamide, polyimide, polyether nylon, and polyester polymer alloy. A flammable hollow fiber membrane is more preferable because it can be incinerated.

The effective membrane area of the hollow fiber membrane bundle 3 for blood purification is not particularly limited, but is preferably 100
cm ^{2 to} about 6.0 m ² , more preferably 0.2 to 6.0 m ²
It is about 2.0 m ² .

Both ends of each hollow fiber membrane 32 are
In a state in which the end openings of the two are not closed, the sealing portions 4 at both ends support and fix between the hollow fiber membranes and between the outer surface of each hollow fiber membrane and the blood port (inlet, outlet) in a liquid-tight manner. I have.
The sealing portion 4 is made of, for example, a potting material such as polyurethane, silicone resin, or epoxy resin. As a method for forming the sealing portion 4, a method used when manufacturing a conventional hollow fiber membrane blood purifier can be used. For example, a housing used for a conventional hollow fiber membrane-type blood purifier is made of a polyolefin such as polypropylene or polyethylene to form a temporary housing, and the hollow fiber membrane bundle is inserted into the temporary housing. The liquid potting material is injected from the vicinity of the end of the hollow fiber membrane bundle 3 (for example, the dialysate inlet / outlet of the temporary housing) and cured by a centrifugal injection method in which the potting material is cured while being centrifuged. Cut and open the lumen of each hollow fiber membrane. Finally, by breaking the temporary housing, a hollow fiber membrane bundle having the sealing portion of the present invention is formed.

In the blood purifier of the present invention, a blood inlet port and a blood outlet port are bonded to the above-mentioned hollow fiber membrane bundle having sealing portions at both ends with an adhesive or the like. A blood purifier can be obtained by bonding such as high-frequency fusion.

The blood purifier of the present invention must be sterilized for medical use. For sterilization, conventionally used ethylene oxide gas sterilization, high-pressure steam sterilization, radiation sterilization such as γ-ray or electron beam, and other methods can be used. At the time of sterilization, it is preferable to package the blood purifier with a sterile packaging material suitable for each sterilization method. When using a hollow fiber membrane through which bacteria do not pass, cap the blood inlet port tip and the blood outlet port tip to protect the parts that come into contact with blood from contamination,
It may be only bacterial-impermeable. During the sterilization operation, a reinforcing material for the hollow fiber membrane portion may be applied from outside the sterile packaging material so as not to apply an excessive load to the hollow fiber membrane bundle portion of the blood purifier.

The blood purifier manufactured as described above has a blood flow path through which blood flows in a blood inlet 92 of the blood inlet port 21, a blood outlet 93 of the blood outlet port 22, and the lumen 31 of the hollow fiber membrane 32. Is formed, and a dialysate flow path through which a dialysate flows is formed in a gap between the housing 6 and the hollow fiber membrane bundle 3 and a gap between each adjacent hollow fiber membrane 32. That is, the blood flow path and the dialysate flow path are separated by each hollow fiber membrane 32. In this case, the upstream side of the dialysate flow path is
It communicates with the dialysate inlet 71 and the downstream side communicates with the dialysate outlet 72. With such a configuration, the blood flowing from the blood inlet port 21 flows through the hollow fiber lumen and flows out of the blood outlet port 22, while the dialysate flowing from the dialysate inlet 71 flows through the dialysate flow path. The blood flows in a direction opposite to the blood flow (counter flow) and flows out of the dialysate outlet 72.

The dialysate swellable material 51 can be located at the junction 5 and / or the abutment. For example, it can be arranged at a portion facing the contact portion on the inner surface of the housing 6 on the sealing portion surface 41. Further, it can be arranged at a contact portion on the inner surface of the housing 6. Examples of the dialysate swellable material that can be used in the present invention include (cross-linked) polyacrylate or (cross-linked) acrylic acid-acrylate copolymer (for example, AQUALIC manufactured by Nippon Shokubai Co., Ltd., Arakawa Chemical Co., Ltd.) ARASORB manufactured by Kao Corporation, WONDERGEL manufactured by Kao Corporation, AQUAKEEP manufactured by Iron and Steel Chemical Co., Ltd., DWA.
L. , NationalStarch PARMASORB, Stockausen FA
VOR etc.), isobutylene-maleic acid copolymer (for example, KIGel manufactured by Kuraray Isobutin Co., Ltd.), starch-acrylic acid graft copolymer or a saponified product thereof (for example, SUNWET, GrainProcessin manufactured by Sanyo Chemical Industries, Ltd.)
GPC manufactured by g, SGP manufactured by Henkel, MagicWa manufactured by SuperAbsorbent
terGel, LYOGEL manufactured by Unilever, etc.), saponified vinyl acetate-acrylate copolymer (eg, SUMIKAGEL manufactured by Sumitomo Chemical Co., Ltd.), vinyl acetate-unsaturated dicarboxylic acid copolymer (eg, manufactured by Nippon Synthetic Chemical Industry) GP), carboxymethylcellulose (eg, CLD manufactured by Buckeye Cellulose, AKUCELL manufactured by Enka, etc.), composite fiber of acrylonitrile fiber inner core and acrylate copolymer outer layer (eg, LANSEAL manufactured by Toyobo Co., Ltd.), sodium polyacrylate Salt fiber (for example, BELLOASIS manufactured by Kanebo Co., Ltd.) and the like.

Of these, composite fibers of an inner core of acrylonitrile fiber and an outer layer of an acrylate copolymer, which are super absorbent fibers, and sodium polyacrylate fiber are most preferred. In addition, the dialysate swelling material is, for reasons of production, etc.,
It is preferable to use materials having water swellability, and the dialysis solution ratio of these materials is 10% by weight or more, preferably 10% by weight.
22,600% by weight, more preferably 50-2,000% by weight. It is the dialysate, not water, that is absorbed by the dialysate swellable material in the module. Various types of dialysate are known. Different types of dialysate have different dialysate rates, and the dialysate rate of the dialysate swellable material is affected by the ionic strength of the solution. Since the concentration difference is small, the difference in weight increase rate is small even if the dialysate is replaced.

In the blood purifier of the present invention, it is preferable that the hollow fiber membrane bundle 3 is covered with a porous material 35 as shown in FIG. As the porous material, a mesh, a sponge, a nonwoven fabric, or the like can be used. The material is stainless steel, titanium and other low corrosive metal materials, polyethylene, polypropylene, polycarbonate, acrylic resin, styrene butadiene copolymer, polystyrene, polyethylene terephthalate, polyamide, ethylene vinyl alcohol copolymer, polyphenylene sulfide, poly Sulfone, polyethersulfone, or the like, or in the case of an elastomer material, a plastic material such as a polystyrene-based, polyolefin-based, polyester-based, polyurethane-based, or polyamide-based elastomer can be used. Any material can be used as long as it is substantially free of harm to the living body due to eluate and the like when it comes into contact with the dialysate. The porous material can be used as long as the dialysate can flow between the hollow fiber membranes 32.

In the blood purifier of the present invention, as shown in FIG. 7, the entire surface of the hollow fiber membrane bundle 3 is covered with a flexible material from the sealing portion 37 at one end to the sealing portion 38 at the other end. By covering with 36, the hollow fiber membrane bundle 3 can be protected from external force. At this time, the encapsulating material 36 has a communication part with the outside at a part 308 where the dialysate flows in and a part 307 where the dialysate flows out.

The material bending strength of the wrapping material 36 is preferably 20 MPa or less, more preferably 2 to 20 MPa. Preferred materials are polystyrene, polyolefin, polyester, polyurethane, and polyamide elastomers. Any material can be used as long as it is substantially free of harm to the living body due to eluate and the like when it comes into contact with the dialysate. Here, the measurement of the material bending strength is based on JIS K7
Follow the 203 bending test.

Further, as shown in FIG. 5, the blood purifier of the present invention has a band 48 made of a dialysate swellable material listed as a material to be disposed at the above-mentioned joint in a part of the hollow fiber membrane bundle 3.
By providing the blood purifier 1, the blood purifier 1 can be easily attached to and housed in the housing, and the hollow fiber membrane bundle can be protected from external force. In particular, it is preferable that the band 48 is located in the middle of the hollow fiber membrane bundle 3.

FIG. 6 is a schematic view showing the appearance of the band 48 when the blood purifier shown in FIG. 5 is filled with a dialysate. When the dialysate is filled, the joint portion 51, which is a dialysate swellable material, and the band 48 swell. Band 48
Swells to form band 49.

It is preferable that the housing of the present invention can be opened and closed by breaking in the longitudinal direction. FIG. 10 shows an example of a housing that can be opened and closed in the longitudinal direction. The housing 6 is provided with a back portion 82, an opening / closing portion 84, a fixing portion 83, a stopper 86, and an abutment portion 8 to enable attachment / detachment of the blood flow path and to make the dialysate side liquid-tight. Is possible. Back 82
May have, for example, a hinge structure,
The rubber elasticity of the elastomer may be used. When the back has a hinge structure, stainless steel, polyethylene, polypropylene, polycarbonate, acrylic resin, styrene butadiene copolymer, polystyrene, polyethylene terephthalate, polyamide, ethylene vinyl alcohol copolymer, polyphenylene sulfide,
Polysulfone and polyether sulfone are preferred.
When the back portion 82 is an elastomer, a polystyrene-based, polyolefin-based, polyester-based, polyurethane-based, or polyamide-based elastomer is preferable. The contact portion 8 is preferably made of polystyrene, polyolefin, polyester, polyurethane, polyamide elastomer, or silicone for liquid tightness. Further, it is preferable that a dialysate swellable material is disposed in the contact portion 8. Any structure may be used for the fixing portion 83 as long as it can hold the outer cylinder, and a stopper structure is preferable.

It is preferable that the housing of the present invention has a holding jig such as the packing portion and the fixing portion which are not divided at an internal pressure of 500 mmHg or less. With this characteristic, the same safety as a conventional blood purifier can be obtained.

FIG. 8 is a longitudinal sectional view of the blood purifier according to the second embodiment of the present invention. FIG. 9 is a longitudinal sectional view of a housing used together with the blood purifier of FIG.

The present invention provides a blood inlet port 201 into which blood flows, a blood outlet port 202 through which blood flows, a hollow fiber membrane bundle 300 composed of a large number of hollow fiber membranes, and hollow fibers at both ends of the hollow fiber membrane bundle. The blood purifier 101 includes a sealing portion 400 in which each port is liquid-tightly fixed to the outer surface of the hollow fiber membrane so that the port communicates between the outer surfaces of the fiber membrane and between the inner cavity of the hollow fiber membrane and the port. Then, from the sealing portion 401 at one end of the hollow fiber membrane bundle 300 to the sealing portion 402 at the other end,
There is a wrapping material 605 made of a flexible material that covers the hollow fiber membrane bundle, and a dialysate chamber 191 is formed by the sealing portions 401 and 402, the wrapping material 605, and the outer surface of each hollow fiber membrane 300. The encapsulating material 605 has a dialysate inlet 701 through which dialysate flows into the dialysate chamber 191 and a dialysate outlet 702 through which dialysate flows out. With this configuration, the blood purifier of the present invention can be easily compressed manually, and the waste volume can be reduced.

The material 605 of the wrapping material 605 has a bending strength of 20 MPa.
It is particularly preferred that: Further, as the material, the same material as the above-mentioned wrapping material 36 can be selected.

The material and shape of the dialysate inlet 701 and dialysate outlet 702 are not limited as long as they can be connected to external dialysate supply means and dialysate recovery means. , It is easy to obtain a firm connection. Stainless steel, titanium, polyethylene, polypropylene, polycarbonate, acrylic resin, styrene butadiene copolymer,
Examples thereof include polystyrene, polyethylene terephthalate, polyamide, ethylene vinyl alcohol copolymer, polyphenylene sulfide, polysulfone, and polyether sulfone.

The blood purifier 101 is used together with the housing 601. The housing 601 is made of a hard material, and prevents the wrapping material 605 from being excessively expanded when the dialysate flows into the dialysate chamber 191.

The properties, materials and other members of the hollow fiber membrane of the blood purifier 101 of the second embodiment shown in FIGS. 8 and 9 and the material of the housing 601 are the same as those of the first embodiment of the present invention. Can be used.

The blood fluid purifier of the second embodiment can employ the same sterilization method as that of the first embodiment.

Further, the blood fluid purifier of the second embodiment can be covered with the same porous material as that of the first embodiment.
The housing 601 used in the embodiment is provided with the dialysate inlet 70 provided in the enclosing material 605 of the blood purifier 101.
1 and the dialysate outlet 702 allow the mouth part 70 to communicate with the outside when the housing 601 is mounted.
3, 704.

The housing 601 is not divided by the internal pressure of the encapsulating material 601 (pressure of the dialysate chamber 191) of 500 mmHg or less, and is similar to the back portion, the fixing portion and the like used in the housing of the first embodiment. It is preferable to have a holding jig of the following. With this characteristic, the same safety as a conventional blood purifier can be obtained. Hereinafter, an example of the dialyzer of the present invention will be described in detail.

[0065]

Example 1 A bundle of about 10,000 hollow fiber membranes (effective membrane area: 1.5 m ² ) made of polysulfone having an outer diameter of 280 μm and an inner diameter of 200 μm was prepared, and this bundle of hollow fiber membranes was 235 mm in effective length. It was inserted into a urethane potting temporary housing made of cylindrical polypropylene having an inner diameter of 36 mm. Next, a polyurethane resin potting agent is injected into both ends of each hollow fiber membrane inserted in the temporary housing, cured, sealed and fixed at both ends of each hollow fiber membrane, and both ends are sliced. The lumen of each hollow fiber membrane was opened. Since the temporary housing made of polypropylene has no adhesiveness to the urethane resin, it was easily peeled off from the urethane resin. Therefore, the temporary housing was peeled off from the sealing portion, and the hollow fiber membrane and the sealing portion were taken out from the temporary housing.

A blood inlet port (outermost diameter 36 mm) and a blood outlet port (outermost diameter 36 mm) made of polycarbonate were bonded to the potting sealing portions at both ends with an adhesive. 5000 denier water-absorbent fiber made of polyacrylate as a dialysate swellable material (BELLOASl manufactured by Kanebo Co., Ltd.)
S, a dialysate-containing rate of 1,963%) was wound around the surface of the outer periphery of the sealing portion and adhered to form a joint, thereby obtaining a blood purifier as a hemodialyzer.

Then, the blood purifier was placed in a sterilization bag made of a polyester / polyethylene composite film on one side and a nonwoven fabric of polyethylene on the other side, the bag was sealed, and steam sterilization was performed at 121 ° C. for 20 minutes. After sterilization, it was placed in an oven at 80 ° C. and dried with hot air.

On the other hand, a housing made of polycarbonate having an effective length of 235 mm and an inner diameter of 38 mm and having a dialysate inlet and a dialysate outlet was prepared.

The sterilized blood purifier described above was taken out of the sterilization bag, and inserted into the prepared housing to obtain a blood purifier assembly.

A dialysate supply circuit and a dialysate recovery circuit of a dialyzer used for general hemodialysis treatment are connected to a dialysate inlet and a dialysate outlet of a blood purifier assembly, respectively, and the dialysate is supplied to the dialysate inlet. And filled the blood purifier assembly.

The water-absorbing fibers arranged at the junction of the blood purifier swell instantly upon contact with the dialysate, and flow the dialysate at a flow rate of 500 ml / min and a housing internal pressure of 480.
After 4 hours of circulation at mmHg, no apparent leakage of dialysate from the junction was observed.

[0072]

Example 2 About 10,000 bundles (effective membrane area: 1.5 m ² ) of regenerated cellulose hollow fiber membranes having an outer diameter of 252 μm and an inner diameter of 200 μm were prepared, and a dialysate was placed at the center of the bundle of hollow fiber membranes. 5000 denier water absorbent fiber made of polyacrylate as a swellable material (BELLOASl manufactured by Kanebo Co., Ltd.)
S, 6g of band consisting of dialysate (1,963%) (width 5c)
m). This hollow fiber membrane bundle has an effective length of 235 m
m, and inserted into a temporary housing for urethane potting made of cylindrical polypropylene having an inner diameter of 31 mm.

In the same manner as in Example 1, a module having a hollow fiber membrane opening at both ends of the sealing portion was obtained. A blood inlet port (outermost diameter of 33 mm) and a blood outlet port (outermost diameter of 33 mm) made of polycarbonate were bonded to the outer peripheral surface of the sealing portion of the module with an adhesive.

On the outer periphery of the outermost diameter portion of each of the blood inlet port and the blood outlet port, 5000 deniers of water-absorbing fiber made of polyacrylate as a dialysate swelling material (BELLOASlS, manufactured by Kanebo Co., 963%) was wound and adhered to form a joint, and a blood purifier was obtained as a hemodialyzer.

Next, this blood purifier was placed in a sterilization bag made of a polyester / polyethylene composite film on one side and a non-woven fabric of polyethylene on the other side, the bag was sealed, and steam sterilization was performed at 121 ° C. for 20 minutes. After sterilization, it was placed in an oven at 80 ° C. and dried with hot air.

On the other hand, the housing is made of polycarbonate and has an effective length of 235 mm and an inner diameter of 3 which is opened and closed in the longitudinal direction.
An 8 mm diameter dialysate inlet and dialysate outlet was prepared.

The above-mentioned sterilized blood purifier was taken out of the sterilization bag and inserted into the prepared housing to obtain a blood purifier assembly.

The dialysate supply circuit and the dialysate recovery circuit of the dialyzer used for general hemodialysis treatment are connected to the dialysate inlet and dialysate outlet of the blood purifier assembly, respectively, and the dialysate is supplied to the dialysate inlet. And filled the blood purifier assembly.

The water-absorbing fibers arranged at the junction of the blood purifier swell instantaneously upon contact with the dialysate, flow the dialysate at a flow rate of 500 ml / min and a housing internal pressure of 500.
After 4 hours of circulation at mmHg, no apparent leakage of dialysate from the junction was observed.

[0080]

Example 3 About 10,000 bundles (effective membrane area: 1.5 m ² ) of regenerated cellulose hollow fiber membranes having an outer diameter of 252 μm and an inner diameter of 200 μm were prepared, and the entire circumference of the hollow fiber membrane bundle was made of polyester. Mesh (70 mesh, wire diameter 1
20 μm, and an average mesh thickness of 182 μm). Further, a band 6 g (width: 5 cm) made of 5000 denier water-absorbing fiber made of polyacrylate (BELLOASlS manufactured by Kanebo Co., Ltd., containing 1,963% of dialysate) was attached to the central portion thereof as a dialysate swelling material. This hollow fiber membrane bundle was inserted into a urethane potting temporary housing made of cylindrical polypropylene having an effective length of 235 mm and an inner diameter of 31 mm.

The mesh and the bundle of hollow fiber membranes were simultaneously potted in the same manner as in Example 2, the lumens of the hollow fiber membranes were opened at both ends of the sealing portion, and the blood inlet port and blood outlet port were bonded with an adhesive. did.

On the outer periphery of the outermost diameter portion of each of the blood inlet port and the blood outlet port, 5,000 denier water-absorbing fibers made of polyacrylate as a dialysate swelling material (BELLOASlS, manufactured by Kanebo Co., 963%) was wound and adhered to form a joint, and a blood purifier was obtained as a hemodialyzer.

Next, this blood purifier was placed in a sterilization bag made of a polyester / polyethylene composite film on one side and a nonwoven fabric of polyethylene on the other side, the bag was sealed, and steam sterilization was performed at 121 ° C. for 20 minutes. After sterilization, it was placed in an oven at 80 ° C. and dried with hot air.

On the other hand, the housing is made of polycarbonate and has an effective length of 235 mm and an inner diameter of 3
An 8 mm diameter dialysate inlet and dialysate outlet was prepared.

The sterilized blood purifier described above was removed from the sterile bag and inserted into the prepared housing to obtain a blood purifier assembly.

A dialysate supply circuit and a dialysate recovery circuit of a dialyzer used for general hemodialysis treatment are connected to a dialysate inlet and a dialysate outlet of a blood purifier assembly, respectively, and the dialysate is supplied to the dialysate inlet. And filled the blood purifier assembly.

The water-absorbing fibers arranged at the junction of the blood purifier swell instantly when they come in contact with the dialysate, and flow the dialysate at a flow rate of 500 ml / min and a housing internal pressure of 450.
After 4 hours of circulation at mmHg, no apparent leakage of dialysate from the junction was observed.

[0088]

Example 4 About 10,000 bundles (effective membrane area: 1.5 m ² ) of regenerated cellulose hollow fiber membranes having an outer diameter of 252 μm and an inner diameter of 200 μm were prepared, and a dialysate was placed at the center of the bundle of hollow fiber membranes. 5000 denier water absorbent fiber made of polyacrylate as a swellable material (BELLOASl manufactured by Kanebo Co., Ltd.)
S, 6g of band consisting of dialysate (1,963%) (width 5c)
m). This hollow fiber membrane bundle has an effective length of 235 m
m, made of a cylindrical polyurethane having an outer diameter of 36 mm (thickness: 200 μm), and inserted into a housing having a dialysate inlet and an outlet made of polycarbonate.
It was covered with a cylindrical polypropylene reinforced housing that could be split in the longitudinal direction.

A potting operation was performed using a urethane resin in the same manner as in Example 1. After the urethane resin was cured, the reinforcing housing was divided and removed, and the hollow fiber membrane openings were opened at both ends of the sealing portion. Got a module. A blood inlet port (outermost diameter of 36 mm) and a blood outlet port (outermost diameter of 36 mm) made of polycarbonate were adhered to the outer peripheral surface of the sealing portion of this module with an adhesive to obtain a blood purifier as a hemodialyzer.

Next, the blood purifier was placed in a sterilization bag made of a polyester / polyethylene composite film on one side and a non-woven fabric of polyethylene on the other side, and the bag was sealed, followed by steam sterilization at 121 ° C. for 20 minutes. After sterilization, it was placed in an oven at 80 ° C. and dried with hot air.

On the other hand, the housing is made of polycarbonate and has an effective length of 235 mm and an inner diameter of 3 which is opened and closed in the longitudinal direction.
An 8 mm diameter dialysate inlet and dialysate outlet was prepared.

The sterilized blood purifier described above was taken out of the sterilization bag and inserted into the prepared housing.

A dialysate supply circuit and a dialysate recovery circuit of a dialyzer used for general hemodialysis treatment are connected to a dialysate inlet and a dialysate outlet of a blood purifier assembly, respectively, and the dialysate is supplied to the dialysate inlet. And filled the blood purifier assembly.

The water-absorbing fibers arranged at the junction of the blood purifier swell instantly when they come in contact with the dialysate, and flow the dialysate at a flow rate of 500 ml / min and a housing internal pressure of 500.
Circulation for 4 hours at mmHg could be performed without any problem.

[0095]

Comparative Example 1 A bundle of about 10,000 polysulfone hollow fiber membranes (effective membrane area: 1.5 m ² ) having an outer diameter of 280 μm and an inner diameter of 200 μm was prepared, and this bundle of hollow fiber membranes was made of cylindrical polycarbonate. Effective length 235mm, inner diameter 3
It was inserted into a housing with a dialysate inlet and dialysate outlet at 8 mm.

Next, a polyurethane resin potting agent was injected into both ends of each hollow fiber membrane inserted into the housing and cured to seal both ends of each hollow fiber membrane in the same manner as in Example 1. Then, both ends were sliced to open the lumen of each hollow fiber membrane.

A blood inlet port (outermost diameter of 38 mm) and a blood outlet port (outermost diameter of 38 mm) made of polycarbonate are adhered to the potting sealing portions at both ends with an adhesive.
A blood purifier was obtained as a hemodialyzer.

[0098]

Comparative Example 2 About 10,000 bundles (effective membrane area: 1.5 m ² ) of regenerated cellulose hollow fiber membranes having an outer diameter of 252 μm and an inner diameter of 200 μm were prepared, and a dialysate was placed at the center of the bundle of hollow fiber membranes. 5000 denier water absorbent fiber made of polyacrylate as a swellable material (BELLOASl manufactured by Kanebo Co., Ltd.)
S, 6g of band consisting of dialysate (1,963%) (width 5c)
m). This hollow fiber membrane bundle was inserted into a housing made of polycarbonate having an effective length of 235 mm and an inner diameter of 38 mm and having a dialysate inlet and a dialysate outlet.

Next, a polyurethane resin potting agent was injected into both ends of each hollow fiber membrane inserted into the housing and cured to seal both ends of each hollow fiber membrane in the same manner as in Example 1. Then, both ends were sliced to open the lumen of each hollow fiber membrane.

A blood inlet port (outermost diameter of 38 mm) and a blood outlet port (outermost diameter of 38 mm) made of polycarbonate are adhered to the potting sealing portions at both ends with an adhesive.
A blood purifier was obtained as a hemodialyzer.

[0101]

Comparative Example 3 About 10,000 bundles (effective membrane area: 1.5 m ² ) of regenerated cellulose hollow fiber membranes having an outer diameter of 252 μm and an inner diameter of 200 μm were prepared, and a dialysate was placed at the center of the bundle of hollow fiber membranes. 5000 denier water absorbent fiber made of polyacrylate as a swellable material (BELLOASl manufactured by Kanebo Co., Ltd.)
S, 6g of band consisting of dialysate (1,963%) (width 5c)
m). This hollow fiber membrane bundle was inserted into a housing made of polycarbonate having an effective length of 235 mm and an inner diameter of 38 mm and having a dialysate inlet and a dialysate outlet.

Next, a polyurethane resin potting agent was injected into both ends of each hollow fiber membrane inserted into the housing and cured to seal both ends of each hollow fiber membrane in the same manner as in Example 1. Then, both ends were sliced to open the lumen of each hollow fiber membrane.

A blood inlet port (outermost diameter of 38 mm) and a blood outlet port (outermost diameter of 38 mm) made of polycarbonate are adhered to the potting sealing portions at both ends with an adhesive.
A blood purifier was obtained as a hemodialyzer.

[Test Example 1] Airtight leak test: According to the airtight leak test specified in the approval standard for dialysis-type artificial kidney devices, the dialysate inlet / outlet and blood outlet port of the dialyzer were closed, and air was sent from the blood inlet port. After the working pressure was around 500 mmHg, it was lowered to 400 mmHg and the vicinity of the blood inlet port was closed. The pressure after standing for 5 minutes was read. Pass if the pressure drop after 5 minutes is within 10% (50mmHg) of the maximum working pressure. The test was performed at n = 3. Table 1 shows the results.

[0105]

[Table 1] All of the examples passed, and there was no problem in airtightness.

[Test Example 2] Clearance measurement: According to the clearance measurement method determined by the Japanese Society of Artificial Organs, the blood was flowed at a blood flow rate (Qb) of 200 m1 / min and a dialysate flow of 500 m1 / min.
TMP: 0 mmHg (filtration flow rate: Oml / min). A 100 mg / dl solution of urea was used on the blood side, and after waiting for at least 5 minutes in a steady state, sampling was performed on the blood-side inlet, outlet, and dialysate-side outlet. The test was performed at n: 3. The clearance CL is calculated from equation (1).

CL = ((CBi−CBo) / CBi) × Qb
(1) Here, CBi: blood-side inlet concentration, CBo: blood-side outlet concentration. Table 2 shows the results.

[0108]

[Table 2] There was no difference between Example 1 and Comparative Example 1, Example 2 and Comparative Example 2, and Example 3 and Comparative Example 3, and good clearance was obtained.

[Test Example 3] Waste capacity: In Example 1, after use, ethanol was injected into the swelling material of the dialysate and contracted, and the blood port and the bundle of hollow fibers were taken out of the housing. In Examples 2 to 3, after use, the housing was opened and the blood port and the bundle of hollow fibers were taken out. The waste capacity is
Container of fixed capacity (27.5 cm long x 37.5 cm wide x 20.0 depth)
cm) was evaluated as the reciprocal of the number of modules. Exam n: 3
I went in. Disposal capacity of modules of comparative examples (Comparative Examples 1-3
Table 3 shows the waste capacity ratio when 1 is the same capacity.

[0110]

[Table 3] The waste capacity was reduced to about 30-50% compared to the comparative example. In Examples 2 and 3, incineration was possible.

[0111]

As described above, the present invention provides a blood inlet port through which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle comprising a large number of hollow fiber membranes, and a hollow fiber membrane bundle comprising the hollow fiber membrane bundle. Blood comprising a sealing portion in which each port is liquid-tightly fixed to the outer surface of the hollow fiber membrane so that the port communicates with the outer surface of each hollow fiber membrane at both ends and the lumen of the hollow fiber membrane communicates with the port. The purifier is a sterilized medical blood purifier that does not have a hard housing that abuts the sealing portion in a liquid-tight manner and covers the hollow fiber membrane bundle. Since it can be manually deformed and compressed, the waste volume can be greatly reduced.

The present invention also relates to a blood inlet port into which blood flows, a blood outlet port from which blood flows out, a hollow fiber membrane bundle comprising a number of hollow fiber membranes, and hollow fibers at both ends of the hollow fiber membrane bundle. A blood purifier comprising a sealing portion in which each port is liquid-tightly fixed to the outer surface of the hollow fiber membrane such that the ports communicate with each other between the outer surfaces of the membranes and the lumen of the hollow fiber membrane, A sterilized medical blood purifier having, on the outer surface of the blood inlet port and the blood outlet port, and / or the outer surface of the sealing portion, a joint that can be liquid-tightly joined to a hard housing covering the hollow fiber membrane bundle. Therefore, the waste volume can be reduced, and the rigid housing can be easily reused.

The present invention also provides a housing having a dialysate inlet through which dialysate flows in and a dialysate outlet through which dialysate flows out, wherein the housing is in contact with the junction of the medical blood purifier to leak liquid. It is a housing for a blood purifier having a contact portion for preventing the blood purifier, so that it can be combined with the medical blood purifier.

Further, according to the present invention, a space for allowing a dialysate to flow between the hollow fiber membrane and the housing is formed by the blood purifier housing, and the lumen of the hollow fiber membrane is formed through the hollow fiber membrane. Since it is a medical blood purifier assembly that performs dialysis and filtration between flowing blood and dialysate flowing between the hollow fiber membrane and the housing, the waste volume can be reduced, and blood can be safely collected. Purification can be performed.

The present invention also provides a blood inlet port into which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle comprising a number of hollow fiber membranes, and hollow fibers at both ends of the hollow fiber membrane bundle. A blood purifier comprising a sealing portion in which each port is liquid-tightly fixed to the outer surface of the hollow fiber membrane such that the ports communicate with each other between the outer surfaces of the membranes and the lumen of the hollow fiber membrane, A wrapping material made of a flexible material covering the hollow fiber membrane bundle is provided from the sealing portion at one end of the hollow fiber membrane bundle to the sealing portion at the other end. Is a medical blood purifier having a dialysate inlet through which dialysate flows in and a dialysate outlet through which dialysates flow out, so that the volume of waste can be reduced.

[0116]

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view showing an example of a blood purifier according to a first embodiment of the present invention.

FIG. 2 is a longitudinal sectional view showing an example of a housing used for the blood purifier according to the first embodiment of the present invention.

3 is a longitudinal sectional view of an example of a blood purifier assembly obtained by combining the blood purifier shown in FIG. 1 and the blood purifier housing shown in FIG. 2;

FIG. 4 is a longitudinal sectional view showing an example in which the hollow fiber membrane bundle of the blood purifier of the present invention is covered with a porous material.

FIG. 5 is a longitudinal sectional view of an example in which a band made of a dialysate swellable material is provided in a part of the hollow fiber membrane bundle of the blood purifier of the present invention.

FIG. 6 is a schematic diagram showing a band when the blood purifier shown in FIG. 5 is filled with a dialysate.

FIG. 7 is a longitudinal sectional view of an example showing a case where the entire surface of the hollow fiber membrane bundle of the blood purifier of the present invention is covered with a wrapping material made of a flexible material.

FIG. 8 is a longitudinal sectional view showing an example of the blood purifier according to the second embodiment of the present invention.

FIG. 9 is a longitudinal sectional view showing an example of a housing used for the blood purifier according to the second embodiment of the present invention.

FIG. 10 is an example of a housing that can be opened and closed by being broken in the longitudinal direction of the present invention, and has a partially cutout.

[Explanation of symbols]

 1 Blood Purifier 21 Blood Inlet Port 22 Blood Outlet Port 23 Blood Port Member Surface 3 Hollow Fiber Membrane Bundle 31 Hollow Fiber Membrane Lumen 32 Hollow Fiber Membrane 33,34 Porous Material End 35 Porous Material 36 Encapsulating Material 37, 38 End of wrapping material 4 Sealing part 41 Sealing part surface 48 Band (when dry) 49 Band (when swelling) 5 Joining part 51 Dialysate swellable material 6 Housing 71 Dialysate inlet 72 Dialysate outlet 8 Contact part 81 Housing body 82 Back 83 Fixing part 84 Opening / closing part 86 Stopper 91 Dialysate chamber 92 Blood inflow part 93 Blood outflow part 101 Blood purifier 191 Dialysate chamber 192 Blood inflow part 193 Blood outflow part 201 Blood inlet port 202 Blood outlet Port 203 Blood port surface 300 Hollow fiber membrane bundle 307 Site where dialysate flows in 308 Site where dialysate flows out 400 Sealing Parts 401, 402 End of wrapping material 605 Enclosing material 701 Dialysate inlet 702 Dialysate outlet 703, 704 Port

 ──────────────────────────────────────────────────続 き Continued on the front page F-term (reference) 4C077 AA05 BB01 BB02 CC04 GG12 KK23 LL05 PP18 4D006 GA13 HA02 JA13A JA13Z JA22A JA22C JA25A JA25B JA25C JA30A JA30C JB01 JB06 KC21 KC22 KC23 LA10 MA01 MC22 MC37 MC42 MC42 MC42 MC42 MC42 MC42 MC39 PC47

Claims (19)

[Claims] 1. A blood inlet port through which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle composed of a large number of hollow fiber membranes, and outer surfaces of each hollow fiber membrane at both ends of the hollow fiber membrane bundle. A blood purification device comprising a sealing portion in which each port is fixed to an outer surface of the hollow fiber membrane in a liquid-tight manner so that the port communicates with the inner cavity of the hollow fiber membrane. A sterilized medical blood purifier, which does not have a hard housing that abuts on the hollow fiber membrane bundle in a liquid-tight manner. 2. A blood inlet port through which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle comprising a large number of hollow fiber membranes, and outer surfaces of each hollow fiber membrane at both ends of the hollow fiber membrane bundle. A blood purification device comprising a sealing portion in which each port is fixed to the outer surface of the hollow fiber membrane in a liquid-tight manner such that the ports communicate with each other and the lumen of the hollow fiber membrane. And sterilizing medical blood purification having a joint which can be liquid-tightly joined to a hard housing covering the hollow fiber membrane bundle on the outer surface of the blood outlet port and / or the outer surface of the sealing portion. vessel. 3. The medical blood purifier according to claim 2, wherein the joint is provided with a dialysate swellable material. 4. A wrapping material made of a flexible material covering the hollow fiber membrane bundle from the sealing part at one end to the sealing part at the other end of the bundle of hollow fiber membranes. Claim 2
Or a medical blood purifier according to item 3. 5. The wrapping material has a bending strength of 20 MPa.
The medical blood purifier according to any one of claims 2 to 4, wherein: 6. The medical blood purifier according to claim 2, wherein at least a part of the hollow fiber membrane bundle is bundled with a dialysate swelling material. 7. A housing having a dialysate inlet through which dialysate flows in and a dialysate outlet through which dialysates flow out,
A housing for a blood purifier, comprising a contact portion for preventing leakage of a liquid by contacting the joint portion of the medical blood purifier according to any one of claims 1 to 6. 8. The medical blood purifier housing according to claim 7, wherein a dialysate swellable material is disposed at the contact portion. 9. The blood purifier housing according to claim 7, wherein the housing can be divided in a substantially longitudinal direction and can be opened and closed. 10. A medical blood purifier housing according to any one of claims 7 to 9 and a medical blood purifier according to claims 1 to 6, wherein a dialysate is supplied between the hollow fiber membrane and the housing. Forming a space to be circulated, and performing dialysis and filtration between the blood flowing through the lumen of the hollow fiber membrane and the dialysate flowing between the hollow fiber membrane and the housing via the hollow fiber membrane. The featured assembly. 11. The assembly according to claim 10, wherein the housing has a holding jig that is not divided by a housing internal pressure of 500 mmHg or less. 12. A blood inlet port through which blood flows in, a blood outlet port through which blood flows out, a hollow fiber membrane bundle composed of a number of hollow fiber membranes, and outer surfaces of each hollow fiber membrane at both ends of the hollow fiber membrane bundle. A blood purification device comprising a sealing portion in which each port is fixed to an outer surface of the hollow fiber membrane in a liquid-tight manner such that the ports communicate with each other and the lumen of the hollow fiber membrane. A wrapping material made of a flexible material covering the hollow fiber membrane bundle is provided from the sealing portion at one end of the bundle to the sealing portion at the other end, and the dialysate flows into the inner space of the wrapping material. A medical blood purifier having a dialysate inlet for dialysate and a dialysate outlet for dialysate to flow out. 13. The medical blood purifier according to claim 12, which is sterilized. 14. The wrapping material has a bending strength of 20MP.
14. The medical blood purifier according to claim 12, wherein a is equal to or less than a. 15. The medical blood purifier according to claim 12, wherein at least a part of the hollow fiber membrane bundle is bundled with a dialysate swellable material. 16. A medical blood purifier according to claim 12, wherein the dialysis fluid inlet and the dialysis fluid outlet are outside the housing. A housing for a blood purifier characterized by being able to communicate with a blood purifier. 17. The blood purifier housing according to claim 16, wherein the housing can be divided in a substantially longitudinal direction and can be opened and closed. 18. A blood purifier covered with the blood purifier housing according to claim 16 or 17,
A dialysis solution is allowed to flow between the hollow fiber membrane and the encapsulant, and blood flows through the hollow fiber membrane through the hollow fiber membrane, and flows between the hollow fiber membrane and the encapsulant. The dialysis and filtration are performed with a dialysate, and are characterized in that:
A medical blood purifier according to claim 1. 19. The medical blood purifier according to claim 18, wherein the housing has a holding jig that is not divided by the internal pressure of the encapsulating material of 500 mmHg or less.