JPH0458959A - Hollow fiber type blood treating device and production thereof - Google Patents

Abstract

PURPOSE:To sufficiently assure the flow of the material moving fluid to the hollow fiber bundle in a central part and to improve performance by lowering the packing rate of the hollow fiber in the central part of partition walls to the rate lower than the packing rate in the outer peripheral part of the partition walls. CONSTITUTION:An artificial kidney 1 is constituted by mounting the hollow fiber bundle 5 in a cylindrical body having a dialyzate inflow port 2 and a dialyzate outflow port 3 and fixing the partition walls 6, 7 to both ends to seal the body. Headers 10, 11 respectively having the blood inflow port 8 and the blood outflow port 9 are fixed to both opening ends of the cylindrical body 4. The packing ratio A/B of the central part packing rate A in the central part (a) of the hollow fiber of the partition wall 6 (or 7) and the outer peripheral part packing rate B in the central part (b) of the hollow fiber is preferably in a 1.1 to 1.5 range, more particularly preferably a 1.2 to 1.4 range.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Application of the Invention) The present invention relates to a hollow fiber blood processing device and a method for manufacturing the same. More specifically, the present invention relates to a hollow fiber type blood processing device such as an artificial kidney or an artificial lung, in which a sufficient flow of a mass transfer treatment liquid in the center of the hollow fiber bundle is ensured, and a method for manufacturing the same.

(Prior Art) Hollow fiber blood processing devices have been widely used as artificial kidneys, artificial livers, plasma separation devices, artificial lungs, and the like. Taking an artificial kidney as an example, such a hollow fiber type blood processing device has a blood inlet port and a blood outlet port at both ends, and a dialysate inlet and a dialysate outlet on the side wall. A large number of hollow fibers are housed in a cylindrical body, the hollow fibers are fixed to the cylindrical body by partition walls provided at both ends of the hollow fibers, and the hollow fibers are communicated with the respective ports. It is something. However, in the hollow fiber type blood processing apparatus as described above, the blood inlet port and the blood outlet port have different colors, etc., but the internal shapes are the same or are used.

Such a hollow fiber type blood processing device uses the principle of diffusion to remove waste products in the blood M (for example, in the case of artificial dialysis, metabolic products such as urea in the blood) to be processed through the hollow fiber membrane. , has a function of transferring the fluid to the processing fluid side (for example, in the case of artificial dialysis, the dialysate side).

(Problem to be solved by the invention) The rate-limiting factors in this diffusion phenomenon are mainly the resistance of the membrane itself and the membrane resistance generated on both sides of the membrane [blood side and permeable JJi fluid side (in the case of artificial kidneys)]. be. Conventional hollow fiber blood processing apparatuses are designed with the main objective of dispersing the hollow fibers as uniformly as possible and storing them in the housing. For this reason, taking an artificial kidney as an example, the dialysate flowing in from the outer peripheral edge of the hollow fiber bundle contacts the outer peripheral hollow fibers at a high flow rate, and mass transfer occurs. - For hollow fibers near the center, a lower flow velocity tends to be formed. In other words, the membrane resistance on the dialysate side of the hollow fibers at the outer periphery tends to be small, but the membrane resistance on the dialysate side at the center increases, making it difficult to draw out the original diffusion ability of the membrane. There are many things that cannot be done.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide an improved white liquor processing apparatus and method for manufacturing the same. Another object of the present invention is to provide a hollow fiber type blood processing device such as an artificial kidney or an artificial lung, in which the flow of a mass transfer treatment liquid in the center of the hollow fiber bundle is ensured sufficiently, and a method for manufacturing the same. It is in.

(Means for Solving the Problems) These ports include a cylindrical body having a blood inlet port and a blood outlet port at both ends, respectively, and a mass transfer fluid inlet and a mass transfer fluid outlet on the side wall. and a hollow fiber type blood treatment comprising a large number of hollow fibers housed in the cylindrical body, both ends of which are fixed to the cylindrical body by partition walls, and both ends of which are communicated with the two ports. The device is a hollow fiber type blood processing device, characterized in that the filling rate of the central portion of the hollow fiber and the partition wall is sparser than the filling factor of the outer peripheral portion of the partition wall.

゛The present invention also provides the formula I filling ratio=B/A (I) [however,
In the formula, A and B are respectively expressed by the following formula A=([π(0,5d
)2 XII8 ]/(D/6) 2 πl X1
00(%)B= is π(0,5d)2XnB ]/[(0
, 5) 2π-(D/'6)2 π1X100(%) (where, D is the diameter of the circle occupied by the hollow fiber bundle in the partition wall cross section (Cm
), d is the outer diameter of the hollow fiber (cm), nA is the number of hollow fibers in the center, nB is the number of hollow fibers in the outer periphery, and are the filling rate at the center and the filling rate at the outer periphery] Filling ratio B/A expressed as 1°1~1.5
This is a hollow fiber type blood processing device in which the central filling rate is in the range of 20 to 50%. The present invention further includes:
This is a hollow fiber type blood processing device in which the filling ratio B/A expressed by the formula (2) is 1.2 to 1.4, and the central filling ratio A is 30 to 40%. The present invention is also a hollow fiber blood processing device in which the blood processing device is an artificial kidney.

These ports include a cylindrical body having a blood inlet port and a blood outlet port at both ends, and a mass transfer fluid inlet and a mass transfer fluid outlet in the side wall, and a cylindrical body housed within the cylindrical body. A method for manufacturing a hollow fiber type blood processing device comprising a large number of hollow fibers, both ends of which are fixed to the cylindrical main body by partition walls, and both ends of which are in communication with the two ports, the hollow fibers comprising: A hollow fiber bundle made of a mixture of water-soluble fibers corresponding to a predetermined filling rate is fixed to the cylindrical body at the partition walls at both ends, and then water or an aqueous solution is passed through it to dissolve and flow. This can also be achieved by a method for manufacturing a hollow fiber type blood processing device, characterized in that the filling rate of the central portion of the hollow fiber is less dense than the filling rate of the outer peripheral portion of the dividing wall.

The present invention also provides a method for manufacturing a hollow fiber type surface M treatment device in which water-soluble fibers are mixed only in the hollow fiber bundle forming the center portion.

(Function) The hollow fiber blood processing device in the present invention includes an artificial kidney,
Refers to artificial livers, plasma separators, artificial lungs, etc. Therefore, the hollow fiber blood processing device according to the present invention will be described below by taking an artificial kidney as an example with reference to the drawings.

FIG. 1 shows a hollow fiber artificial liver according to the present invention. That is, the artificial kidney 1 consists of a cylindrical body 4 having a transparent liquid flow type port 2 and a transparent liquid outlet 3 near opposite ends (=J), and a hollow body inside the cylindrical body 4. A yarn bundle 5 is built in, and both ends thereof are sealed by fixing partition walls 6 and 7 formed of a potting agent such as polyurethane to the cylindrical body 4. At both open ends of the cylindrical body 4, In this case, headers 10.11 each having a blood inlet 8 and a blood outlet 9 are each fixed by a threaded ring 12.13.

Therefore, if we take a cross section of the partition wall 6.7 along the line ■-■, as shown in FIG.
), it is preferable that the filling ratio B/A between the center filling rate A at the center a of the hollow fiber and the outer peripheral filling rate B at the center a of the hollow fiber is in the range of 1.1 to 1°5,
In particular, it is preferably in the range of 1.2 to 1°4. In other words, if the filling ratio is less than 1.1, the effect will hardly be expressed, whereas if it exceeds 1.5, blood will mainly flow to the center and no effect will be observed. be.

Here, the center filling rate A is expressed by the following formula % formula % (), and the outer peripheral filling IB is expressed by the following formula B-([π (
0,5d)2XnB]2'[(0,5)2π
−(D, '6)2 π lX100(%) (where, D is the diameter of the circle occupied by the hollow fiber bundle in the partition wall cross section (cm
), d is the outer diameter of the hollow fiber (cm), n is the number of hollow fibers in the center, and nH is the number of hollow fibers in the outer periphery. ) Furthermore, the center filling rate A is preferably in the range of 20 to 50%, particularly preferably in the range of 30 to 40%. In other words, if the center filling rate A is less than 20%, a biased flow will occur in the center contrary to the purpose, and the purpose may be achieved. On the other hand, if it exceeds 50%, the sparse filling effect in the center will not occur. This is because there is not much difference from conventional products.

The rArfi of the hollow fiber is not particularly limited; for example, in the case of artificial kidneys, there are conventionally used regenerated cellulose, polyacrylonitrile, polymethyl methacrylate, etc., but amphiphilic cellulose is usually used. .

The blood processing device of the present invention can be manufactured by various methods, but for example, it can be manufactured as follows. That is, the hollow fibers used are mixed with water-soluble fibers corresponding to a predetermined filling rate to form a hollow fiber bundle, the hollow fiber bundle is housed in a cylindrical body, and a potting agent such as polyurethane resin is applied. A module is formed by fixing the hollow fibers to the partition wall using a conventional method, cutting the partition wall and opening both end faces of the hollow fibers to the end faces of the partition wall, and then opening the dialysate inlet (or dialysate outlet) It is produced by dissolving water-soluble fibers by flowing water or an aqueous solution through the dialysate outlet (or the dialysate inlet). In this case, the fibers at the portion where the water-soluble fibers are fixed by the potting agent will not be eluted even if they are in contact with water over a long period of time. The reason for this is thought to be that the potting agent penetrates between the molecules of the fiber and is fixed. That is, there is no need to actively perform insolubilization treatment, and modules can be easily manufactured by the method of the present invention.

Water-soluble fibers include fibers made of water-soluble polymers such as polyvinyl alcohol, polyacrylic acid, polyacrylates, polyacrylamide, polymethacrylamide, and carboxymethylcellulose, and their shapes can be either hollow fiber or solid base. Good, but usually solid base type. Alternatively, the water-soluble polymer may be a naturally occurring water-soluble polymer.

The amount of water-soluble fibers mixed into the hollow fibers should be adjusted to correspond to the filling of the hollow fibers used. If it is large, reduce the amount of water-soluble fiber mixed. Therefore, for example, a corresponding amount of water-soluble fibers can be mixed in the center part, while no water-soluble fibers or only a small amount of water-soluble fibers can be mixed in the outer peripheral part.

(Example) Next, the present invention will be described in further detail by giving examples.

The following confirmation experiment was conducted using typical polyvinyl alcohol, polyacrylic acid, and carboxymethyl cellulose as sulfurized fruit and experimental water-soluble fibers.

(1) A bundle of water-soluble fibers (solid yarn) (approximately 2,000 fibers) is placed in a polypropylene cup using a polyurethane potting agent used for module assembly, filled to the bottom, and immersed for hardening. Ta. After curing (approximately 24 hours), the potting agent layer was cut perpendicular to the fibers.

(2) Next, this cut tube was immersed in reverse osmosis water (RO water) used as filling water for the module, and heated at 12]-'C for 20
Steam sterilized under conditions for 1 minute. The sample was left in an oven at 60° C. for 3 minutes while being immersed in RO water.

(3) Using an SEM (electron microscope) to examine the cut surface after leaving it,
The fiber-urethane fixed part was observed, and it was found that either the part of the fiber that had come out into the water had completely dissolved, or the urethane had invaded the urethane fixed part, and no changes such as swelling were observed.

Examples 1 to 3 and Comparative Example 1 When forming a hollow fiber bundle, a predetermined amount of solid fibers made of polyvinyl alcohol were mixed into the cuprammonium regenerated cellulose hollow fibers corresponding to the central part of P, and the outer peripheral part After forming a hollow fiber bundle of copper ammonia regenerated cellulose hollow fibers corresponding to the above without mixing polyvinyl alcohol solid fibers, the hollow fiber bundle is housed in a cylindrical body, and both ends are fixed with a polyurethane potting agent. and the cylindrical body were fixed, then the partition walls at both ends formed by the potting agent were cut to open the hollow fibers at the end faces, and predetermined headers etc. were fixed to form the module of the artificial kidney.

The module was cleaned using reverse osmosis water before sterilization.

At this time, an appropriate amount of reverse osmosis water was passed through until the polyvinyl alcohol fibers were dissolved.

Also, if the water temperature is lower than 40°C, the polyvinyl alcohol fibers will dissolve into the reverse osmosis water more quickly. Then, it was steam sterilized or gamma ray sterilized, and its performance was tested using creatinine diffusion performance as an index. The results are shown in Table 1.

Note that the clearance here is defined by the following formula.

Ql,: Dialysate flow it (ml/m1n) C+r+: Dialysate artificial side solute concentration (mg/old) QB,: Blood side inlet flow rate (ml/m1n) QBQ: Blood side outlet flow rate (ml)
/m1n) CB: Blood, fluid inlet side solute concentration (mg/dl
) C10°: Blood outlet side solute concentration (mg/dl) (ni
l/m1n) Examples 4 to 10 and Comparative Example 2 The performance of modules assembled and manufactured in the same manner as in Example 1 was tested using creatinine clearance as an index. The results are shown in Table 2.

(Effects of the Invention) As described above, the present invention provides a cylindrical body having a blood inlet port and a blood outlet port at both ends, and a mass transfer fluid inlet and a mass transfer fluid outlet on the side wall. and a hollow fiber type blood processing device with a large number of hollow fibers housed in the cylindrical body, both ends of which are fixed to the cylindrical body by partition walls, and both ends of which are in communication with the two ports, Since the hollow fiber type blood processing device is characterized in that the filling rate of the central portion of the partition wall of the hollow fiber is sparser than the filling rate of the outer peripheral portion of the partition wall, the substance in the central hollow fiber bundle is The flow of the moving fluid is sufficiently anchored, the membrane resistance is small (and the performance is improved by 1.
, 5, preferably 1.2 to 1.4, and the above effect is significantly increased by setting the hollow fiber filling rate A in the center to 20 to 50%, preferably 30 to 40%.

[Brief explanation of drawings]

FIG. 1 is a partial cross-sectional view of a hollow fiber artificial kidney according to the present invention, and FIG. 2 is a cross-sectional view taken along the line ■--■ in FIG. DESCRIPTION OF SYMBOLS 1... Jinnokenzou, 4... Cylindrical body, 5... Hollow fiber bundle, 6.7... Partition wall, 8... RFU liquid inlet, 9...
...Self-performance outlet, 1],,12...Header a...
・Central part, b...outer part.

Claims (6)

[Claims] (1) A cylindrical body having a blood inlet port and a blood outlet port at both ends, respectively, and a mass transfer fluid inlet and a mass transfer fluid outlet on the side wall; In a hollow fiber type blood processing device comprising a large number of hollow fibers whose both ends are fixed to the cylindrical main body by a partition wall and whose both ends communicate with the ports, filling the central portion of the partition wall of the hollow fibers. A hollow fiber type blood processing device characterized in that the filling ratio of the outer peripheral portion of the partition wall is sparser than the filling ratio of the outer peripheral portion of the partition wall. (2) Formula I Filling ratio = B/A (I) [However, A and B in the formula are respectively the following formula, A = {[
π(0.5d)^2×n_A]/(D/6)^2π}×
100(%)B={[π(0.5d)^2×n_B]/
[(0.5)^2π-(D/6)^2π]}×100(
%) (where, D is the diameter of the circle occupied by the hollow fiber bundle in the partition wall cross section (cm
), d is the outer diameter of the hollow fiber (cm), n_A is the number of hollow fibers in the center, n_B is the number of hollow fibers in the outer periphery, and the center filling rate B/A and the outer peripheral filling rate are The filling ratio expressed by 1.1 to 1.5
The hollow fiber type blood processing device according to claim 1, wherein the central filling rate A is in the range of 20 to 50%. (3) The filling ratio B/A expressed by formula I is 1.2 to 1
．． 4, and the center filling rate A is 30 to 40%. (4) Claims 1 to 3, wherein the blood processing device is an artificial kidney.
The hollow fiber blood processing device according to any one of the above. (5) a cylindrical body having a blood inlet port and a blood outlet port at both ends and a mass transfer fluid inlet and a mass transfer fluid outlet on the side wall; In a method for manufacturing a hollow fiber type blood processing device comprising a large number of hollow fibers whose both ends are fixed to the cylindrical main body by partition walls and whose both ends communicate with the both ports, the hollow fibers are filled with a predetermined amount. A hollow fiber bundle consisting of a mixture of water-soluble fibers corresponding to the same amount as the fibers is fixed to the cylindrical body at the partition walls at both ends, and then water or an aqueous solution is passed through it to dissolve it and flow it away. A method for producing a hollow fiber type blood processing device, characterized in that the filling rate of the central portion of the partition wall of the hollow fiber is sparser than the filling factor of the outer peripheral portion of the partition wall. (6) The method for manufacturing a hollow blood processing device according to claim 5, wherein water-soluble fibers are mixed in the hollow fiber bundle forming the center portion.