JPH066156B2 - Method for manufacturing hollow fiber blood purification device - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a method for manufacturing a hollow fiber blood purification apparatus, and more particularly, to high efficiency of blood purification or plasma separation without retention of blood or plasma. The present invention relates to a novel method for manufacturing a hollow fiber blood purification device.

[Prior Art and Problems to be Solved by the Invention] FIG. 2 shows a typical hollow fiber blood purification apparatus used in the medical field, for example, used as a hemodialyzer.

This hollow fiber type blood purification device is used as a hemodialyzer for purification of blood by dialysis or as a plasma separator for the purpose of plasma separation.

In the figure, 2 is a tubular casing having both ends having a larger diameter than the other portions, and a hollow fiber bundle 4 made of a thermoplastic resin is loaded in the tubular casing. Reference numerals 6a and 6b denote a pair of supports for fixing both ends of the hollow fiber bundle to both ends of the tubular casing 2, and 8a and 8b are caps attached to both ends of the tubular casing 2.

A dialysate introducing port 10a for introducing dialysate is formed so as to project near the one end on the peripheral side of the tubular casing 2.
A dialysate discharge port 10b for discharging the dialysate is formed so as to project near the other end.

The supports 6a and 6b are made of synthetic resin (hereinafter, simply referred to as “resin”), have a disk shape with a diameter substantially the same as that of the tubular casing 2, and solidify both ends of the hollow fiber bundle 4. .

The open end of the hollow fiber bundle 4 is exposed on the outer surface of the support 6.

One of the caps 8a, 8b has a blood inlet 12a for introducing blood.
And a blood discharge port 12b for discharging blood is formed on the other side 8b.

Blood enters the space in the cap 8a from the blood inlet 12a, that is, the space formed by the cap 8a and the support 6a as shown by the arrow A, passes through the hollow fibers of the hollow fiber bundle 4, and passes through the cap. Space in 8b, ie support 6b and cap
8b enters into the space formed with and is discharged from the blood discharge port 12b as shown by arrow B.

Also, the dialysate is supplied through the dialysate inlet 10a as shown by arrow C.
Enters the cylindrical casing 2 and flows in the direction opposite to the dialyzed blood on the outside of each hollow fiber in the hollow fiber bundle 4, and is discharged from the dialysate outlet 10b as shown by arrow D. The waste products in the blood flowing through the hollow fibers are dialyzed into the outside dialysate through the walls of the hollow fibers.

The hemodialyzer with the above configuration is also used as a plasma separator.

In that case, the dialysate inlet for introducing dialysate functions as a plasma outlet, and the dialysate outlet for discharging dialysate functions as an air vent or a pressure monitor for plasma discharge. In this plasma separator, during the plasma separation process,
The air vent is closed or used as a pressure monitor line. Then, blood is introduced into the hollow fiber type blood purification device from the blood inlet, plasma that permeates the hollow fiber is sucked and discharged from the plasma outlet by a roller pump, etc., and concentrated blood is discharged from the blood outlet. It When this plasma separation process is completed, the plasma discharged from the plasma discharge port is opened to discharge all the plasma stored in the cylindrical casing.

In order to manufacture the above-described hollow fiber blood purification apparatus as a hemodialyzer, first, the hollow fiber bundle 4 is inserted into the tubular casing 2, and both ends 4a and 4b of this bundle are placed at both ends of the tubular casing 2. The support 6 is fixed to the inner wall, and both ends of the tubular casing 2 are closed by caps 8a and 8b. To form the supports 6a and 6b, for example, resin is injected from the dialysate inlet 10a, the tubular casing 2 is rotated, and the resin is moved to both ends of the tubular casing 2 by centrifugal force, and solidified there. Let Then, the surplus portion of this solidified portion is cut to support 6a, 6
form b.

By the way, as described above, when the resin for forming the support is introduced with the hollow fiber bundle inserted in the tubular casing,
Part of the resin enters the hollow fiber from the open end of the hollow fiber bundle, and the open end of the hollow fiber bundle remains blocked even when the surplus portion is cut, an effective membrane area for blood circulation. May decrease.

In order to prevent this, conventionally, before inserting the hollow fiber bundle into the tubular casing, the end portions of the scattered (separated) hollow fiber bundle are melted and solidified by, for example, a heating means to close the opening of the hollow fiber. I am trying.

Moreover, this method is convenient for smoothly inserting the hollow fiber bundle into the tubular casing.

However, when the end of the hollow fiber bundle is melted and solidified in this way, the end of the hollow fiber bundle has to be smaller than the inner diameter of the end of the tubular casing.

Therefore, as described above, when the support 6a, 6b is formed by cutting the excess portion of the solidified portion, the diameter of the hollow fiber bundle that appears on the end surface is also smaller than the inner diameter of the end of the tubular casing. Become.

As a result, when blood is allowed to flow into the hollow fiber blood purifying apparatus, blood is likely to stay at the end faces of the supports 6a and 6b and outside the ends of the hollow fiber bundles, and blood clots easily occur.

Moreover, since the flow of the dialysate becomes non-uniform, the blood purification efficiency also decreases in the hemodialyzer, and the plasma separation efficiency decreases in the plasma separator.

Although an end of the hollow fiber bundle is hardened by using an adhesive outside the heating means, the same problem as described above occurs.

The present invention has been made to improve the above circumstances.

That is, an object of the present invention is to provide a method for producing a hollow fiber blood purification apparatus which does not cause blood retention and has high efficiency of blood purification or plasma separation.

MEANS FOR SOLVING THE PROBLEM The present invention for achieving the above-mentioned object is to insert a hollow fiber bundle made of a thermoplastic resin into a tubular casing, and insert each end of the hollow fiber bundle into a tubular casing. In a method for manufacturing a hollow fiber blood purification apparatus in which each end of a hollow fiber type blood purification device is fixed with a resin, an end of a hollow fiber bundle that is inserted into an upright cylindrical casing and spreads at an upper opening end of the cylindrical casing. The method for producing a hollow fiber blood purification apparatus is characterized in that it includes a step of melting the part by a heating means in a non-contact state with the heating means.

Hereinafter, the present invention will be described in detail.

[Operation] When the hollow fiber fiber bundle is inserted into the upright tubular casing, or when the tubular casing is upright with the hollow fiber fiber bundle still inserted, the upper end of the hollow fiber fiber bundle is above the tubular casing. It projects from the opening and spreads out.

In the present invention, the end portion of the spread portion is melted by the heating means and in a state of not contacting the spread portion.

The melted resin is cooled and solidified, the openings of the hollow fibers are surely closed, and the ends of the hollow fiber bundles are projected from the cylindrical casing and fixed in a dispersed state.

When the heating means is brought into contact with the ends of the hollow fiber bundles, the molten state becomes non-uniform and the object of the present invention cannot be achieved.

After that, the desired hollow fiber blood purification apparatus can be obtained by performing a predetermined post-process.

EXAMPLES Next, the present invention will be specifically described based on examples in the order of steps with reference to the drawings.

As shown in FIG. 1A, first, the hollow fiber fiber bundle 4 is inserted into the tubular casing 2.

In order to smoothly perform this insertion, it is advisable to tie the hollow fiber fiber bundle 4 with a thread or wind it with a sheet or the like and insert it.

The inserted hollow fiber fiber bundle 4 has its one end 4a projected from the cylindrical casing 2 to the outside, as shown in FIG. Similarly, the other end of the hollow fiber bundle is also projected outside from the tubular casing 2.

Next, as shown in FIG. 1C, the tubular casing 2 in this state is stood up.

Of course, instead of this, the hollow casing 2 may be stood up and then the hollow fiber bundle 4 may be inserted.

Examples of the material of the hollow fiber include cellulose type (cellulose diacetate, cellulose triacetate, cellulose ether, etc.), polymethyl methacrylate, polyacrylonitrile, polyethylene vinyl alcohol, polycarbonate, polysulfone, polyamide type, polyurethane, polyethylene, polypropylene, polyvinyl type. And so on. The outer diameter of the hollow fiber is usually about 10 to 600 μm.

The material of the tubular casing 2 can be widely selected from general synthetic resins and metals in consideration of pressure resistance.

Also, although the shape of the tubular casing is generally cylindrical,
Other than this, for example, a rectangular tube or the like can be adopted.

Next, as shown in FIG. 1D, the heating means 1 melts the end 4a of the hollow fiber bundle 4 protruding from the upper opening 2a of the tubular casing 2.

However, the heating means 1 at this time is the end portion of the hollow fiber bundle 4.
Do not make direct contact with 4a. If you touch this,
The hot plate and the end face of the hollow fiber are in close contact, making it difficult to peel off,
Further, even if it is attempted to forcibly peel it off, it cannot be peeled off because the tubular casing and the hollow fiber bundle are not fixed. In addition, the gap between the hollow fibers disappears, and urethane for fixing may not enter, which is not preferable.

In the present invention, this heating means is not particularly limited,
Practically, for example, the heating plate 1 is preferable, and it is preferable to heat the heating plate 1 at a distance of about 1 to 10 mm from the end 4a of the hollow fiber bundle 4 and facing the end 4a of the hollow fiber bundle 4.

The heating temperature is usually determined in the range of 100 to 500 ° C in consideration of the melting point of the thermoplastic resin forming the hollow fiber bundle.

It is not recommended to heat for too long, generally 10
It may be in the range of up to 50 seconds.

In addition, when the ends 4a of the hollow fiber bundles 4 are not sufficiently dispersed and opened during this heating, it is preferable to loosen them by hand or blow air or the like to disperse them before heating.

Subsequently, although not shown, the hollow fiber bundle 4
The other end of the is also melted by the heating means.

The end 4a of the melted hollow fiber bundle 4 is naturally cooled or forcedly cooled, and the latter is preferable.

Specifically, it is preferable to cool quickly using cold air.

After cooling and solidifying in this way, a cap 8 is then fitted to the end of the tubular casing 2 while the hollow fiber bundle 4 is still inserted as shown in FIG. The resin is injected, the tubular casing 2 is rotated, and the resin is moved to both ends of the tubular casing 2 by centrifugal force, and is solidified there (e).

Then, the cap 8 is removed, and the excess portion of the solidified portion 7 is cut along the alternate long and short dash line in FIG. 1 (f) to form the support 6.

After forming the support body 6, the cap 8 is attached to the end portion 2a of the tubular casing 2 again as described above.

In the present invention, since the ends of the hollow fiber bundle are heated as described above, the openings of the hollow fibers are surely closed, and the melting length of the hollow fibers is uniform.

Therefore, when the support is formed of resin, the hollow fibers can be completely prevented from being clogged by the support-forming resin, and the effective membrane area does not decrease.

Moreover, since the melting length of the hollow fibers is short, there is no sticking of the hollow fibers to each other, and the ends of the hollow fiber bundles are spread wider than the inner diameter of the central part of the tubular casing. There is no gap between the edges.

Therefore, blood does not stay there and clotting does not occur.

[Effect of the Invention] According to the production method of the present invention, it is possible to completely prevent the hollow fibers from being blocked by the resin for forming the support of the hollow fiber bundle, and furthermore, the hollow fiber bundle end portion and the tubular casing end portion are provided. Since the space between them can be eliminated, it is possible to provide a hollow fiber type blood purification device with high purification efficiency that does not cause blood retention and blood clotting.

[Brief description of drawings]

FIG. 1 is an explanatory view showing a process in one embodiment of the present invention,
FIG. 2 is a vertical cross section of a typical hollow fiber blood purification apparatus. 1 ... Hot plate, 2 ... Cylindrical casing, 2a, 2b ...
..Ends of tubular casings, 4 ... Hollow fiber bundles, 6
... Support, 7 ... Resin solidification part, 8 ... Cap.

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Toshihiko Fukushima 3-5-5 Tsutsujigaoka, Tarumi-ku, Kobe-shi, Hyogo (56) References JP-A-59-137062 (JP, A) JP-A-62-84771 (JP) , A)

Claims (1)

[Claims] 1. A hollow fiber blood purification apparatus in which a hollow fiber bundle made of a thermoplastic resin is inserted into a tubular casing, and each end of the hollow fiber bundle is fixed to each end of the tubular casing with a resin. In the manufacturing method, the end of the hollow fiber fiber bundle that is inserted into the upright tubular casing and spreads at the upper opening end of the tubular casing is in a non-contact state with the heating means by the heating means, A method for manufacturing a hollow fiber type blood purification device comprising a step of melting.