JPS61240964A - Body fluid treating device and its production - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION [Technical Field] The present invention relates to a hollow fiber layer body fluid treatment device and a method for manufacturing the same.

More specifically, the present invention relates to a body fluid treatment device and a method for manufacturing the same in which a packing member is installed between tube sheets bonded and solidified with the ends of the hollow fiber bundle left open.

[Prior art]

In recent years, medical techniques using extracorporeal circulation of blood, such as hemodialysis, blood filtration, blood adsorption, and plasma separation, have made remarkable progress, contributing to improving patients' medical conditions and preserving their lives. For example, in hemodialysis, blood is continuously extracted from the body of a patient with chronic renal failure, excess waste products and water are removed to the dialysate side through a dialysis membrane, the electrolyte concentration is adjusted, and the blood is returned to the patient's body. It is something to return.

For example, in the case of a hollow fiber type blood processing device, a blood distribution section is provided where blood enters the hollow fiber membrane separation section of the blood processing device, and the blood is spread in the distribution section and separated by the membrane. The blood enters the blood collection section, is collected in the blood collection section, and exits the blood processing device.

When blood processing is completed, the blood remaining in the blood processing device and the blood circuit connecting the patient and the blood processing device must be returned to the patient's body as completely as possible. A packing member is disposed between the tube sheet surface where the hollow fibers are opened by cutting after adhesion and solidification, and the blood distribution member and collection member to prevent blood leakage and to reduce the positive pressure applied to the blood processing device. The structure maintains positive pressure.

However, in conventional blood processing devices, a packing member 9 is installed at a position away from the opening of the hollow fiber 1 on the surface of the tube plate 7, as shown in FIG. There is a drawback that a dead space is created around the hollow fiber opening in which blood tends to accumulate.

Japanese Unexamined Patent Publication No. 55-158057 discloses a blood processing device in which a tapered annular wall surface constituting a blood distribution member or a collection member is attached to a tapered wall surface of a tube plate in which hollow fiber openings are distributed over the entire surface. In addition, a method is disclosed in which blood stagnation in the distribution section and collection section is reduced. However, such a blood processing device has a very complicated structure, is extremely difficult to manufacture, and has the disadvantage that both tapers are difficult to match well, and when they do not match, blood stagnates.

In addition, the outer wall surface of the hollow fiber is easily exposed over the entire side surface of the tapered tube sheet, and when cutting the end face or joining the taper, the outer periphery of the cut surface is crushed and raised, causing damage to the hollow fiber. There was a major problem in that the cross section was easily deformed. In addition, with this method, when applied to heat sterilization, it was difficult to maintain a seal due to expansion and contraction of the tube sheet due to heat.

[Purpose of the invention]

The present invention aims to solve these problems in conventional hollow fiber blood processing devices. Eliminate dead space, especially in body fluid distribution and collection areas.
It is a body fluid treatment device with a simple structure,
Furthermore, it is an object of the present invention to provide an extremely superior body fluid treatment device that can be manufactured easily and stably, even though some of the hollow fibers may be damaged during manufacturing.

[Structure of the invention]

As a result of intensive research to achieve this object, the present inventors have found an effective method for installing an annular banking member so that the inner side of the annular banking member is substantially in contact with the outermost part of the opening on the tube sheet surface where the hollow fiber is opened. We discovered the structure and arrived at the present invention.

That is, the present invention provides a bundle of hollow fibers having a permselective membrane wall, a container containing the bundle, a tube plate fixed with at least one end of the bundle of hollow fibers left open, and a container containing the bundle of hollow fibers. In a body fluid treatment device having a body fluid distribution member and/or a body fluid collection member facing a tube plate, the inner side of an annular packing member provided between the body fluid distribution member and the tube plate and/or between the body fluid collection member and the tube plate is , a body fluid treatment device characterized in that the body fluid treatment device is located so as to be substantially in contact with the majority of the tube formed by connecting the outermost ends of the openings of the hollow fiber bundles in the shortest distance on the tube plate surface; A bundle of hollow fibers having a membrane wall, a container containing the same, a tube plate fixed with at least one end of the bundle of wrinkled hollow fibers left open, a body fluid distribution member facing the tube plate, and /or In a method for manufacturing a body fluid #11 device having a body fluid collecting member, when molding at least one of the tube plates, the container is made of the hollow fiber bundle with an end of the hollow fiber bundle protruding. The end portion of the hollow fiber bundle is housed in the tube sheet portion using a cover means provided with an annular portion on the inside having a spatial cross-sectional area substantially equal to the thickness of the hollow fiber bundle in the tube plate portion. In the inserted state, the end of the hollow fiber bundle is covered, and with the cover means attached to the end of the container, an adhesive is inserted into the cover means and allowed to solidify, thereby closing the end of the hollow fiber bundle to the container. A body fluid treatment device characterized in that after adhesively solidifying the end portion, the cover means is removed and the adhesively solidified hollow fiber bundle end portion is cut to form a hollow fiber opening to create a tube plate surface. A manufacturing method is provided.

The present invention will be explained in more detail below with reference to the drawings.

That is, in the body fluid treatment device of the present invention, the inside of at least one of the annular packing members of the packing member between the body fluid distribution member and the tube plate surface and the packing member between the body fluid collecting member and the tube plate surface is formed by hollow fibers on the tube plate surface. It is characterized in that the outermost periphery of the opening of the bundle, ie, the outermost part of the opening, is positioned so as to be substantially in contact with the majority of the shortest shoulder.

Here, "substantially in contact" means that the innermost periphery of the packing member is located near the outermost periphery of the opening, specifically, the distance from the outermost periphery of the opening! is 2111
It is ideal to be located at 1 or less, especially 1 or less. still,
The innermost circumferential portion of the packing member may be located inside the outermost circumferential portion of the opening, but it is preferable that the innermost circumferential portion of the packing member be located on the outer side since the entire hollow fiber can be used effectively.

Further, it is desirable that the position where the two substantially contact each other covers most of the innermost circumference of the packing member, particularly preferably one or more portions of the entire circumference.

FIG. 1 shows an example of the body fluid treatment device of the present invention. That is, FIG. 1 shows a bundle of permselective hollow fibers 1, a container 2 containing the bundle having a cylindrical middle and a dialysate outlet 5 and an inlet 6 at both ends, and the hollow fiber bundle. Solidify with adhesive etc. with both ends open.

Sealed tube plates 7, 8 and blood introduction side distribution member 3
and the collection member 4 on the blood outlet side and the annular packing member 9, 10 . provided between them and the tube plate surface. 2 schematically illustrates a hemodialyzer with fixing members 11, 12 for fixing the distribution member and the collection member respectively.

The feature of this hemodialyzer is that the tube sheets 7, 8, the distribution member 3, and the collection member 4 are each provided with an annular recess for inserting the banking member, and packing members 9, 10 are provided, thereby making the hollow space on the tube sheet surface. The outermost periphery of the thread opening is positioned such that it is substantially in fluid contact with the inside of the packing member.

FIG. 2 shows a further enlarged schematic view of the installed state of the packing member 9. As shown in FIG. In the same figure,
The average value of the distance l between the outermost periphery of the opening on the tube plate surface of the bundle of hollow fibers 1 and the inside of the packing member 9 is 2fIIll
It is desirable that the IW be below, more preferably IW1 or less, as this will facilitate the effects of the present invention. FIG. 3 is an enlarged schematic diagram of another installation state of the packing member 9 regarding the body fluid treatment device of the present invention.

In this way, in the body fluid treatment device of the present invention, one distribution member and/or
Alternatively, only the collecting member may have a recess for inserting a packing member, or only the tube plate surface may have a recess for inserting a packing member, or even there may be no recess at all on both sides. In order to more effectively exhibit the excellent effects of the present invention and to enhance the sealing effect by installing the packing member in a predetermined position, it is desirable that the recess exists on at least one surface. It is preferable that the recesses exist on opposite surfaces. Furthermore, the shape of the packing member insertion recess in the body fluid treatment device of the present invention may be of any shape.

The material for the permselective hollow fiber membrane of the present invention is not particularly limited, and specific examples include cellulose and cellulose acetate.

Polymeryl methacrylate, polyethylene-vinyl alcohol polymer, polyacrylic nitrile, polyethylene, polypropylene.

Examples include polycarbonate and polysulfone.

Further, the shape of the hollow fiber is not particularly limited, but for example, the inner diameter is 10
Hollow fibers of 0 to 400μ and membranes of 45 to 200μ are practically used. Furthermore, any applicable adhesive may be used to bond and solidify these to form a tube sheet.
For example, polyurethane, epoxy resin, etc. are suitable.

The body fluid distribution and collection members may be of any suitable material; for example, polypropylene, polycarbonate, etc. are commonly used. Although any packing member may be used to join the tube plate, on which the ends of the hollow fiber bundles are bonded and solidified, and the body fluid distribution member or collection member, silicone rubber is usually suitably used.

Body fluid treatment devices to which the present invention applies include hollow fiber hemodialyzers, blood filter devices, plasma separators, plasma component separators,
Examples include water exchange separators and artificial lungs. However, it is not limited to these.

Furthermore, the body fluid treatment device of the present invention has the advantage that the sealing performance around the tube plate can be effectively maintained even after heat sterilization.

In the method for manufacturing a hollow fiber body fluid treatment device of the present invention, when forming a tube plate with the ends of the hollow fiber bundle open, the hollow fiber bundle is formed with the ends protruding. The hollow fiber bundle is housed in the container, and the hollow fiber bundle is placed inside the annular part using a cover means provided with an annular part on the inside having a spatial cross-sectional area substantially equal to the thickness of the hollow fiber bundle in the tube plate part. With the end inserted, the end of the hollow fiber bundle is covered, and with the cover means attached to the end of the container, an adhesive is inserted into the cover means and allowed to solidify, thereby closing the end of the hollow fiber bundle. After bonding and solidifying the tube to the end of the container, the cover means is removed and the bonded and solidified hollow fiber bundle end is cut to form a hollow fiber opening, thereby creating a tube plate surface.

In such a method, in particular a spatial cross-sectional area substantially equal to the thickness of the hollow fiber bundle in the tube plate section.

That is, with the end of the hollow fiber bundle inserted into the annular part of the cover means having an annular part having a spatial cross-sectional area perpendicular to the longitudinal direction of the hollow fiber bundle, the end of the hollow fiber bundle is attached to the end of the container. The characteristics include adhesion and solidification, and cutting the adhesion and solidification end of the hollow fiber bundle near the end of the annular portion to form two hollow fibers.

FIG. 5 shows one example of a preferred embodiment of the manufacturing method of the present invention. That is, FIG. 5 shows a state in which a bundle of hollow fibers 1 whose ends are wrapped with tape 20 is stored in a container 2, and then the ends of the bundle of hollow fibers are inserted into a cover means 21 having an annular protrusion 23. Let the adhesive 22 flow in.

The end of the hollow fiber bundle is shown bonded and solidified to the end of the container 2. The manufacturing method of the present invention further includes removing the cover means 21 and cutting the adhesively solidified hollow fiber bundle end with the mark of the annular protrusion 23 remaining at the part A, -4 in FIG. This forms the tube plate surface.

Thereafter, by installing and fixing the distributing member together with a packing member in the form of an O-ring, for example, the hollow fiber melon liquid ripener of the present invention is obtained.

Further, FIG. 6 shows another example of the manufacturing method of the present invention, and relates to a case where the cover means 24 does not have a protruding annular portion. In the same figure, after removing the cover means 24, the adhesively solidified hollow fiber bundle end is gt gt
The tube plate surface can be formed by cutting at the section.

In the manufacturing method of the present invention, any method may be used for adhesion and solidification, such as a method using centrifugal force.

Further, the method of installing the packing member is not particularly limited, and for example, a pre-formed member may be inserted, or a method may be used in which a material capable of forming the packing member is introduced and solidified during assembly.

Further, the cutting method for forming the tube plate surface may be any method, and it is preferable to cut the tube plate surface in the vicinity of the mark of the tip of the annular member that is created when the cover means is removed. When a cover means having a protrusion is used, it is preferable to leave a mark at the tip of the annular protrusion when cutting.

In particular, in the production of the body fluid treatment device of the present invention, it is advantageous to easily reduce the distance 1iii in the case of bulky hollow fiber bundles such as finned hollow fibers, crimped hollow fibers, and hollow fibers with cover yarns.

〔Example〕

The present invention will be described in more detail with reference to Examples below, but the present invention is not limited to these Examples.

Example 1 A bundle of cellulose hollow fibers for hemodialysis with an inner diameter of 200 μm and a membrane thickness of 20 μm and a polycarbonate container with a cylindrical central portion and an inlet and an outlet for dialysate were used. After bonding and solidifying both ends of the hollow fiber with a polyurethane adhesive using a centrifugal force using a cover means having an annular protrusion as shown in FIG. A tube sheet with an open hollow fiber was formed by cutting along the A and -A planes, leaving a trace of the tip. Using a silicone rubber O-ring that fits the annular recess formed on the tube plate surface, separate the polypropylene distribution member and collection member each having an annular recess for the packing member, as shown in Figure 1. It was fixed with a cover. In the thus obtained hollow hemodialyzer, the average distance between the outermost periphery of the opening of the hollow fiber on the tube plate surface and the inside of the O-ring member is about 0.5 mm.
The characteristics of residual blood, etc. were as shown in Table 1.

Example 2 Made of cellulose diacetate, inner diameter 200μ.

Using a hemodialysis hollow fiber bundle having a membrane thickness of 14 μm, the ends of the hollow fiber bundle were bonded and solidified in the same manner as in Example 1 using a cover means as shown in FIG. B,
After both tube sheets were formed by cutting at a plane, a distribution member and a collection member were installed via silicone rubber O-rings.

In the obtained dialyzer, the average distance between the outermost periphery of the open hollow fiber bundle on the tube plate surface and the inside of the O-ring was about 1-5w1. The obtained 956L characteristics are also shown in Table 1.

Example 3 A cell p-s hollow fiber with fins for hemodialysis has an inner diameter of 200μ, a membrane thickness of 20μ at the part without fins, a height of 30μ, and a width (width at the height of T) of 20μ. Using a bundle of hollow fibers with six longitudinally extended fins,
A hollow fiber hemodialyzer was produced in the same manner as in Example 1.

The average distance between the outermost periphery of the opening of the hollow fiber bundle and the inside of the O-ring member on the tube plate surface of this dialyzer is approximately 1111, and its sealing performance and residual blood characteristics are as shown in Table 1. there were.

Comparative Examples 1 to 3 φ Using the same hollow fiber bundles as those used in Examples 1 to 3, dialyzers with packing members installed as shown in FIG. 4 were prepared by a conventional method. The average distance between the outermost periphery of the open hollow fiber bundle on the tube plate surface and the inside of the Q-ring was about 3 fins each.

The dialysis properties, etc., were as shown in Table 1.

Table 1 [Effects of the Invention] According to the present invention, the body fluid distribution section or collection section of the hollow fiber type body fluid treatment device and the hollow fiber bundle end section can be airtightly joined,
Therefore, the leakage force of body fluid)' is prevented, and the pressure applied to the body fluid treatment device can be completely maintained. Furthermore, it has become clear that the body fluid processing efficiency is high (and there is almost no residual body fluid such as residual blood), which can greatly contribute to improving the quality of heavy fluid processing equipment. In this case, there is an advantage that local blood stagnation in the distribution section and collection section is less likely to occur, and blood clots are extremely less likely to occur.

Further, the method for manufacturing a body fluid treatment device of the present invention has the advantage that the above-mentioned extremely excellent body fluid treatment device can be manufactured with good reproducibility and extremely easily. It is particularly advantageous for bulky hollow fiber bundles such as finned yarns and crimped yarns.

[Brief explanation of drawings]

FIG. 1 shows a schematic cross-sectional structural diagram of one example of the body fluid treatment device of the present invention, and FIG. The vicinity of the packing member 9 is shown in an enlarged view. FIG. 3 shows another example of the body fluid treatment device of the present invention.
It shows an enlarged view of the vicinity of the packing member. FIG. 4 relates to a conventional body fluid treatment device. Further, Fig. 35 and Fig. 6 are illustrative cross-sectional structural views of the hollow fiber bundle ends in a state in which they are bonded and solidified in relation to the method of manufacturing a body fluid treatment device of the present invention. 111Figure 2Figure 3Figure II 4Figure 5Figure 6

Claims (8)

[Claims] (1) A bundle of hollow fibers having a permselective membrane wall, a container containing the bundle, a tube sheet fixed with at least one end of the bundle open, and the tube sheet. In a body fluid treatment device having a body fluid distribution member and/or a body fluid collection member facing the body fluid, the inner side of an annular packing member provided between the body fluid distribution member and the tube plate and/or between the body fluid collection member and the tube plate is A body fluid treatment device characterized in that the body fluid treatment device is located so as to be substantially in contact with most of the circumference formed by connecting the outermost ends of the openings of the hollow fiber bundles in the shortest length on the tube plate surface. (2) The body fluid treatment device according to claim 1, wherein at least a portion of one surface of the packing member is inserted into an annular recess provided on the tube plate surface. . (3) The annular recess is characterized in that its innermost periphery is substantially in contact with most of the periphery formed by connecting the outermost ends of the opening of the hollow fiber bundle in the tube sheet surface in the shortest possible length. A body fluid treatment device according to claim 2. (4) At least a portion of the other surface of the packing member is inserted into an annular recess provided in the body fluid distribution member and/or the body fluid collection member. The body fluid treatment device according to item 1 or 2. (5) A bundle of hollow fibers having a permselective membrane wall, a container containing the bundle, a tube sheet fixed with at least one end of the bundle of hollow fibers left open, and the tube sheet. In the method of manufacturing a body fluid treatment device having a body fluid distribution member and/or a body fluid collection member facing the tube plate, when molding at least one of the tube sheets, the hollow fiber bundle is The fiber bundle is housed in the container, and the hollow fiber bundle is placed inside the annular portion using a cover means having an annular portion on the inside having a spatial cross-sectional area substantially equal to the thickness of the hollow fiber bundle in the tube plate portion. With the fiber bundle end inserted, the hollow fiber bundle end is covered, and with the cover means attached to the container end, an adhesive is inserted into the cover means and allowed to harden. After the end portion is bonded and solidified with the container end portion, the cover means is removed and the bonded and solidified end portion of the hollow fiber bundle is cut to open the hollow fibers, thereby creating a tube plate surface. A method for manufacturing a body fluid treatment device. (6) The manufacturing method according to item 5, characterized in that the cutting is performed in the vicinity of a mark of the tip of the annular portion created by removing the cover means. (7) A fifth aspect characterized in that the annular portion has an annular protrusion extending in a direction away from the cover means.
Manufacturing method described in section. (8) The manufacturing method according to item 7, characterized in that the cutting is performed while leaving a mark of the annular protrusion formed by removing the cover means.