JP2790617B2 - Hollow fiber blood purification device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hollow-fiber blood purification apparatus, and more particularly, to an interface between a cylindrical casing and a sealant, which is free from cracks or peeling, and has excellent durability against steam sterilization and the like. It has sufficient strength, improves clearance, reduces the amount of sealant used, and prevents incomplete filling of the sealant, and can be downsized to reduce blood leakage, residual blood, coagulation, stagnation, etc. The present invention relates to a hollow-fiber blood purification apparatus which is free from generation, has a simple structure and is easy to manufacture.

[0002]

2. Description of the Related Art As shown in FIG. 3, a conventional hollow fiber type blood purification apparatus 11 is, for example, a cylindrical casing 12 and a hollow casing 13 which projects from an opening 13 of the cylindrical casing 12. A sealant solidifying portion 17 fixed to the sealant 14 and opening the end 16 of the converged hollow fiber bundle 15, and an opening 13 of the cylindrical casing 12.
1 filled between the sealant solidification part 17 and the sealant 1
4, a blood lead-in / out member 18 attached to the opening 13 of the cylindrical casing 12, and an annular elastic member 19 closely attached to the sealant end surface 14a and the inner surface of the blood lead-in / out member 18. Had a structure.

[0003] However, the conventional hollow fiber type blood purification apparatus 11 has the following problems.

[0004] That is, the hollow fiber type blood purification apparatus 11 comprises:
The bundled hollow fiber bundles 15 are inserted into the openings 13 of the cylindrical casing 12, and the uncured sealant is filled into the openings of the cylindrical casing 12 and solidified. FIG.
As shown in FIG. 5, in the sealant 14 filled between the cylindrical casing 12 and the sealant solidifying portion 17, the interface between the cylindrical casing 12 and the solidified sealant 14 on the opening 13 side of the cylindrical casing 12 is formed. Rip 2
Zero often occurred. The split 20 causes a decrease in the strength of the hollow fiber type blood purification apparatus 11, and when the hollow fiber type blood purification apparatus 11 having such a split 20 is steam-sterilized, separation occurs at the interface, and the hollow fiber type blood purification apparatus 11 is separated. The blood purification device 11 becomes unusable. Moreover, since the annular elastic member 19 is located outside the end 16 of the sealant solidifying portion 17 and the opening 13 of the cylindrical casing 12 is located outside the annular elastic member 19, the maximum outer diameter of the cylindrical casing 12 is reduced. It becomes inevitably large in structure. For this reason,
In addition to the need for extra sealant 14, sealant 14
May be incompletely solidified.

An object of the present invention is to solve the above-mentioned conventional problems. The present invention complicates the shape of the adhesive surface between the cylindrical casing and the sealant, and increases the area thereof, so that no cracks or peeling occurs at the interface between the two, and the durability is excellent for steam sterilization and the like, and sufficient. Another object is to provide a hollow fiber type blood purification device having strength. The present invention reduces the maximum outer diameter of the cylindrical casing while increasing the diameter of the hollow fiber bundle,
An object of the present invention is to provide a small-sized hollow fiber type blood purification apparatus capable of reducing the amount of the sealant to be filled, preventing incomplete filling of the sealant, and improving the clearance. An object of the present invention is to provide a hollow fiber type blood purification apparatus which is free from blood leakage, residual blood, coagulation, stagnation and the like, has a simple structure, and is easy to manufacture.

[0006]

According to a first aspect of the present invention, there is provided a cylindrical casing, and hollow fibers protruding from an opening of the cylindrical casing and fixed by a sealant and converged. A sealant solidified portion that opens the end of the bundle, a sealant end face of a sealant that fills the space between the opening of the cylindrical casing and the sealant solidified portion, and covers an end surface of the opening of the cylindrical casing; The blood lead-in / out member attached to the opening, and the O.
-A ring and an opening in the cylindrical casing.
Point a where the inner peripheral surface of the opening intersects the end surface of the opening;
Including a contact point between the O-ring and the sealant end face;
Or on the contact surface between the O-ring and the sealant end face
Line segment in the direction perpendicular to the axis of the cylindrical casing
An imaginary line parallel to the axis of the cylindrical casing including the midpoint is
A distance E between the opening b and a point b intersecting the end face is 0.
More der and Rukoto hollow fiber type blood purification device according to claim, the invention according to claim 2, the contact surface between the O- ring and the sealant end surface, the end surface of the opening portion of the tubular casing The hollow fiber type blood purification apparatus according to claim 1, which is located above the sealant, wherein the sealant end face fills a space between an opening of a cylindrical casing and a sealant solidification part. 3. The hollow according to claim 1, wherein the end surface of the opening portion of the cylindrical casing is a sealant end surface of a sealant covering a portion corresponding to １ ／ to 1/1 of a thickness in a diametric direction. 4. The invention according to claim 4, which is a thread-type blood purification apparatus, wherein the sealant end face is formed to project from the end face at the opening of the cylindrical casing by 0.1 to 3.0 mm. 3 A hollow fiber type blood purification device according to any one.

[0007]

According to the hollow fiber type blood purification apparatus of the present invention,
A sealant is present between the opening of the cylindrical casing and the sealant solidification portion, and covers an end surface at the opening of the cylindrical casing. As a result, the sealant adheres not only to the inner peripheral surface of the cylindrical casing but also to the end surface of the opening. Further, the blood introduction / extraction member is attached to the opening of the cylindrical casing with the O-ring tightly sandwiched between the inner surface and the sealant end surface. As a result, between the blood derivation member and the sealant end surface is liquid-tightly sealed.

[0008]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the hollow fiber type blood purification apparatus of the present invention will be described below with reference to the drawings. FIG. 1 is a schematic partial cross-sectional explanatory view showing one embodiment of the hollow fiber type blood purification apparatus of the present invention.

The hollow fiber type blood purification apparatus 1 of this embodiment is
It comprises a cylindrical casing 2, a sealant solidifying section 7, a blood lead-in / out member 8, and an O-ring 9.

Examples of the cylindrical casing 2 include a casing generally used as an artificial kidney module. The shape of the cylindrical casing 2 is not particularly limited as long as it has a cylindrical shape having open ends at both ends.
For example, shapes such as a cylindrical shape, a rectangular tube shape, a flat cross-sectional shape, and an elliptical cross-sectional shape can be given. The cylindrical casing 2 in this embodiment has a cylindrical shape, and has a large diameter at both ends, and two liquid outflow ports are formed on a peripheral side surface thereof. The structure of the cylindrical casing 2,
The size and the like are not particularly limited, and can be appropriately determined according to the purpose.

The material of the cylindrical casing 2 can be appropriately determined in consideration of pressure resistance, heat resistance and the like that can withstand steam sterilization and the like. Examples of the material include polycarbonate, polystyrene, a copolymer of acrylonitrile and styrene, polymethyl methacrylate, ABS
Resins and the like can be suitably mentioned, and other ordinary polymer materials, metal materials and the like may be appropriately used according to the purpose of use. The tubular casing 2 is preferably formed of a transparent material so that the internal state during use can be observed.

The sealant solidifying section 7 is formed by solidifying both ends of a hollow fiber bundle 5 formed by bundling a large number of hollow fibers with a sealant 4 and integrating them. In addition, the converged hollow fiber bundles 5 are provided on both ends 6 of the sealant solidified portion 7.
Is open.

Examples of the hollow fibers include cellulose derivatives such as cellulose, cellulose diacetate, cellulose triacetate, etc.
Hollow fibers formed of polyamide derivatives, polyester derivatives, methacrylic or acrylic polymers such as polymethyl methacrylate, polyvinyl polymers such as polyvinyl chloride, polyurethane, and polyolefins such as polyethylene and polypropylene. be able to. The outer diameter of the hollow fiber is usually 10 to 600.
μm.

The type of the sealant 4 is not particularly limited as long as it can be firmly bonded to the hollow fiber bundle 5, the cylindrical casing 2 and the like.
For example, a curable polymer composition such as a polyurethane resin, a silicone resin, and an epoxy resin can be used.

[0015] The sealant solidifying section 7 is a cylindrical casing 2
And the openings 3 at both ends of the cylindrical casing 2
And both end portions thereof are integrally fixed to the cylindrical casing 2 with the sealant 4. Specifically, for example, the sealant 4 is transferred to the opening 3 of the cylindrical casing 2.
And filling the gap between the inner peripheral surface and the outer peripheral surface of the sealant solidified portion 7 and covering the end surface of the opening 3 of the cylindrical casing 2. Then, by solidifying the sealant 4, the cylindrical casing 2 and the sealant solidifying portion 7 are formed.
Can be integrally fixed. At this time, the end face formed by the solidified sealant 4 is the sealant end face 4a. The solidified sealant 4 is fixed not only to the inner peripheral surface but also to the end surface of the opening 3 of the cylindrical casing 2 and has a complicated and large fixing surface.

The sealant end face 4a is usually flat, but may be formed as a curved surface in some cases. Further, an annular concave portion for disposing the annular elastic member 9 may be formed on the sealant end face 4a. In this embodiment, the sealant end face 4a and the end 6 of the sealant solidified portion 7 are located on the same plane.

In this embodiment, the sealant end face 4
Although a is formed when the cylindrical casing 2 and the sealant solidified portion 7 are fixed with the sealant 4, it may be formed as follows, for example. First, the cylindrical casing 2
, A hollow fiber bundle 5, and a molding form having a storage portion for converging the end of the hollow fiber bundle 5 and being attachable to the cylindrical casing 2 are prepared. Next, the hollow fiber bundle 5 is housed and arranged in the cylindrical casing 2 such that its ends project from the openings 3 at both ends of the cylindrical casing 2. The end portion of the hollow fiber bundle 5 is stored in the storage portion of the forming mold so as to converge the protruding end portion of the hollow fiber bundle 5, and the forming form is attached to the opening end of the cylindrical casing. . After that, the liquid sealant 4 is put into the cylindrical casing 2,
By rotating the cylindrical casing 2 on which the forming mold is mounted at a high speed, the liquid sealant 4 is removed from the cylindrical casing 2.
To both ends. After the movement, the sealant 4 is solidified. After the sealant 4 has solidified, the molding form is removed from the cylindrical casing 2. In the vicinity of the opening 3 of the cylindrical casing 2, the solidified portion of the hollow fiber bundle 5 solidified by the sealant 4 is cut along a direction orthogonal to the axis of the hollow fiber bundle 5. Thus, the hollow fiber bundle 5 having an open end
Can be fixed to the cylindrical casing 2 with the sealant 4. In this case, the sealant solidified portion 7 and the sealant end face 4a are formed at the same time. The sealant solidification unit 7
The formation of the sealant end face 4a may be performed according to a known method such as a standing method or a centrifugal molding method.

In the present invention, the sealant end face 4a formed as described above is the end face of the opening 3 of the cylindrical casing 2 and is 1 / (thickness) of the thickness in the diameter direction.
A mode in which a portion corresponding to 5 to 1/1 is covered is preferable. Further, the sealant end surface 4a is preferably 0.1 to 3.0 m from the end surface of the opening 3 of the cylindrical casing 2.
m, particularly preferably 0.5 to 1.5 mm. In the case of these embodiments, the object of the present invention can be effectively achieved.

The blood lead-in / out member 8 is provided with a blood lead-out port 8a through which blood can be led into and out of the hollow fiber bundle 5 fixed to the cylindrical casing 2, and can be attached to the opening 3 of the cylindrical casing 2. There is no particular limitation so long as it is a member generally used as an artificial kidney module. The inner surface of the blood introduction / inlet member 8 has O
A pressing portion capable of pressing the ring 9 may be formed, and an annular concave portion capable of accommodating the O-ring 9 may be formed.

The blood lead-in / out member 8 is formed, for example, by screwing a thread formed on the outer peripheral surface of the opening 3 of the cylindrical casing 2 with a thread formed on the inner peripheral surface at the end of the blood lead-in / out member 9. Or the opening 3 of the cylindrical casing 2
Is attached to the cylindrical casing 2 by ultrasonically fusing the outer peripheral surface of the member and the inner peripheral surface of the end of the blood introduction / inlet member 8 with ultrasonic waves.
In addition, as the mounting means, in addition to the screwing or ultrasonic fusion, a method of bonding with an adhesive can be adopted.

The O-ring 9 is an elastic member formed in an annular shape, and is not particularly limited as long as the space between the blood introduction / inlet member 8 and the sealant solidified portion 4a can be sealed in a liquid-tight manner. O-rings and packings formed of rubber, butadiene rubber, neoprene rubber, and the like can be given. In this embodiment, the O-ring 9 is a silicone rubber O-ring.

The O-ring 9 has an inner diameter of the hollow fiber bundle 5.
Is designed to be larger than the outer diameter of the end face of the opening 3 of the cylindrical casing 2 so as to be larger than the outer diameter of the cylindrical casing 2. The cross-section of the O -ring 9 when the O -ring 9 is cut in the diameter direction is, for example, a circle, an ellipse, or a square. The O-ring 9 may be solid or tubular. The thickness of the O-ring 9 can be appropriately determined according to the purpose.

The O-ring 9 is disposed on the sealant end face 4 a. In the present invention, the contact surface between the O-ring 9 and the sealant end face 4 a is located above the end face of the opening 3 of the cylindrical casing 2. O-phosphorus
It is preferable to arrange the plug 9 on the sealant end face 4a.
In this case, the object of the present invention can be effectively achieved.

When the blood lead-in / out member 8 is mounted on the cylindrical casing 2, the O-ring 9 receives a pressing force by the inner surface of the blood lead-in / out member 8 and the sealant end face 4 a, and is sandwiched in a deformed state. . At this time, the inner wall of the blood introduction / inlet member 8 and the O-ring 9 come into close contact with each other, and the sealant end face 4a and the O -ring 9
Since the ring 9 is in close contact, the cylindrical casing 2 and the blood lead-in / out member 8 are connected in a liquid-tightly sealed state.

Hereinafter, an actual design example of the hollow fiber type blood purification apparatus in this embodiment will be compared with a reference example of a conventional hollow fiber type blood purification apparatus.

FIG. 2 is a partially enlarged explanatory view of a portion surrounded by a circle in FIG. In FIG. 2, A to G are as follows. A: O-ring 9 and sealant end face 4a
And the diameter (mm) connecting the middle points of the contact surfaces with each other, and means the inner diameter of the seal ring. B is
It is the outer diameter (mm) of the hollow fiber bundle 5 and means the hollow fiber dispersion diameter. C means the protruding length (mm) of the surface of the flange portion of the solidified sealant 4 that is in contact with the end surface of the opening 3 of the cylindrical casing 2. D is sealant end face 4
a is the length (mm) protruding from the end face of the opening 3 of the cylindrical casing 2, and means the thickness of the flange portion of the solidified sealant 4. E is the point of contact or the midpoint of the contact surface between the O-ring 9 and the sealant end surface 4a from the inner peripheral surface of the opening 3 of the cylindrical casing 2 in a direction perpendicular to the axis of the hollow fiber blood purification device 1. Distance (m sometimes referred to as “effective seal surface position”)
m). When the value of E is positive, it means that the effective seal surface is located outside the inner peripheral surface of the opening 3 of the cylindrical casing 2, and when the value of E is negative, the opening 3 of the cylindrical casing 2 is Means that the effective seal surface is located inside the inner peripheral surface of the first seal. F means the thickness (mm) at the opening 3 of the cylindrical casing 2. G means an outer diameter (mm) at the opening 3 of the cylindrical casing 2.

The hollow fiber type blood purification apparatus was designed so that the above-mentioned A to G became the values shown in Table 1. In the hollow fiber type blood purification apparatus of the present invention, C> 0, 3.0 ≧ D ≧ 0.1,
The feature is that E ≧ 0.

The hollow fiber blood purification devices of Design Examples 1 and 2 and Reference Example 1 were compared for the clearance of creatinine (molecular weight: 113), which is a uremic substance. In addition,
The length of the cylindrical casing 2 in the hollow fiber blood purification device is 255 mm, the effective membrane area is 1.8 m ² ,
Regenerated cellulose membrane (AKZO NOB) as a hollow fiber bundle
A bundle of EL; Cuprophan was used.

As a result, the clearances are 180, 183, and 180 in Design Example 1, Design Example 2, and Reference Example 1, respectively.
175. In Design Example 1 and Design Example 2,
It was confirmed that the clearance was improved as compared with Reference Example 1.

The hollow fiber type blood purification devices of Design Examples 3 to 5 and Reference Examples 2 to 3 were subjected to a filling test with a urethane resin as a sealant. The number of tests was 100 for each. The length of the cylindrical casing 2 in the hollow fiber type blood purification device is 255 mm, the effective membrane area is 1.5 m ² , and the hollow fiber bundle is a PEPA membrane hollow fiber (polyarylate resin with polyether sulfone resin). And a hollow fiber bundle formed using the same.

As a result, in Design Examples 3 to 5, incomplete filling of the urethane resin was not confirmed. On the other hand, in Reference Examples 2 and 3, incomplete filling of the urethane resin was confirmed for two and ten samples, respectively.

For each of the 20 hollow fiber type blood purification apparatuses of Design Example 5 and Reference Example 3, 40
Steam sterilization for one minute. As a result, peeling of the urethane resin as a sealant did not occur in Design Example 5, but occurred in Reference Example 3 three times.

Looking at the hollow fiber type blood purification apparatus of the design example 5 and the reference example 1, A and B are equal to 43 in both cases. In Example 1, it was 48. This is because the value of E is 1.0 in the design example 5 and −1.0 in the reference example 1. That is, in the design example 5, since E ≧ 0, the value of G could be reduced as compared with the reference example 1 in which E <0. Further, in the hollow fiber type blood purification apparatus of Reference Example 1, when the urethane resin as the sealant was solidified, the generation of a tear 20 as shown in FIG. 4 was observed.

[0034]

[Table 1]

[0035]

According to the present invention, the above-mentioned conventional problems can be solved. In other words, a hollow fiber type blood purification apparatus is provided which has a large adhesion area between the cylindrical casing and the sealant, does not cause a crack or peeling at the interface between the two, has excellent durability by steam sterilization or the like, and has sufficient strength. can do. In addition, while reducing the maximum outer diameter of the cylindrical casing, the diameter of the hollow fiber bundle is increased, thereby reducing the amount of the sealant to be filled, preventing incomplete filling of the sealant, and improving the clearance. Can be provided.
Further, it is possible to provide a hollow-fiber blood purification apparatus which is free from blood leakage, residual blood, coagulation, stagnation and the like, has a simple structure and is easy to manufacture.

[Brief description of the drawings]

FIG. 1 is a schematic partial cross-sectional view showing one embodiment of a hollow fiber type blood purification apparatus of the present invention.

FIG. 2 is a partially enlarged explanatory view of a portion surrounded by a circle in FIG. 1;

FIG. 3 is a schematic partial cross-sectional view showing an example of a conventional hollow fiber blood purification device.

FIG. 4 is a partially enlarged explanatory view of a portion surrounded by a circle in FIG. 3;

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Hollow fiber blood purification apparatus, 2 ... Cylindrical casing, 3 ... Opening, 3a ... End face, 4 ... Sealant, 4a ... Sealant end face, 5 ... Hollow Fiber bundle, 6.
··· End, 7 ··· Sealant solidification section, 8 ··· Blood lead-in / out member, 8a ··· Blood lead-in / out port, 9 ··· O-ring , 11 ··· Hollow fiber blood purifier ... Cylindrical casing, 13 ... Opening, 14 ... Sealant, 14a ...
・ Sealant end face, 15 ・ ・ ・ Hollow fiber bundle, 16 ・ ・ ・ End, 17 ・ ・ ・ Sealant solidified part, 18 ・ ・ ・ Blood lead-in / out member, 19 ・ ・ ・ Circular elastic member,
20 ... rip,

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁶ , DB name) A61M 1/18 510

Claims (4)

(57) [Claims] 1. A cylindrical casing, a sealant solidifying portion projecting from an opening of the cylindrical casing, fixed with a sealant, and opening an end of the converged hollow fiber bundle, an opening of the cylindrical casing, and a sealant. A sealant end face of the sealant that fills the space between the solidified portion and covers the end face at the opening of the cylindrical casing, a blood lead-in / out member attached to the opening of the cylindrical casing, and a sealant end face and a blood lead-in / out member. An O-ring adhered to the inner surface, and an inner peripheral surface at an opening of the cylindrical casing;
A point a at which the opening intersects the end face;
The contact between the sealing and the sealant end face, or
-The contact surface between the ring and the sealant end face;
Including the midpoint of the line segment in the direction perpendicular to the axis of the cylindrical casing
An imaginary line parallel to the axis of the cylindrical casing corresponds to the opening.
Distance E between the point b intersecting the end surface of the hollow fiber blood purification device according to claim der Rukoto 0 or more. 2. The hollow fiber blood purification device according to claim 1, wherein a contact surface between the O-ring and the sealant end surface is located above an end surface at an opening of the cylindrical casing. 3. An end face of the sealant, which fills a space between an opening of the cylindrical casing and a sealant solidified portion, and is an end face of the opening of the cylindrical casing, and is 1/5 to 1/5 of a thickness in a diameter direction thereof. The hollow fiber blood purification device according to claim 1 or 2, wherein the sealant is a sealant end face that covers a portion corresponding to 1/1. 4. The hollow fiber blood purification according to claim 1, wherein the end face of the sealant is formed so as to protrude from the end face of the opening of the cylindrical casing by 0.1 to 3.0 mm. apparatus.