JPS6336262B2 - - Google Patents

Description

BACKGROUND TECHNICAL FIELD OF THE INVENTION The present invention relates to a hollow fiber type blood processing device that performs mass transfer through a hollow fiber membrane, such as a hollow fiber type oxygenator, a hollow fiber type artificial kidney, and a hollow fiber type heat exchanger. The present invention relates to a method for repairing a hollow fiber blood processing device, such as a hollow fiber plasma separator, in which an opening at the end of a hollow fiber having a leakage portion is closed.

Prior Art In general, a hollow fiber blood processing device, such as a hollow fiber oxygenator 11, is constructed as shown in FIG. That is, an assembly 14 of hollow fiber membranes 13 is housed in the inner space of the cylindrical housing 12 . Both ends of the hollow fiber membrane 13 are fluid-tightly held in the housing 12 via partition walls 15 and 16.
Headers 17, 1 are provided at both ends of the housing 12.
8 is a ring nut-shaped fixing member 19,
20. The inner surface of the header 17 and the partition wall 15 define a blood inflow chamber 21 communicating with the internal space of the hollow fiber membrane 13, and a blood inflow port 22 is formed in the header 17. The inner surface of the header 18 and the partition wall 16 define a blood outflow chamber 23 that communicates with the internal space of the hollow fiber membrane 13, and a blood outflow port 24 is formed in the header 18. That is, in the case of the hollow fiber oxygenator 11,
Blood supplied from the blood inflow port 22 is allowed to flow into the hollow fiber membrane 13.

Further, the partition walls 15 and 16, the inner surface of the housing 12, and the outer surface of the hollow fiber membrane 13 define a gas chamber 25, and at both ends of the housing 12, a gas inlet port 26 and a gas outlet port 26, which communicate with the gas chamber 25, are provided. A port 27 is formed. That is, in the hollow fiber oxygenator 11, gas (oxygen, air, etc.) is allowed to flow around the hollow fiber membrane 13 in the gas chamber 25 in a turbulent state.

Note that the hollow fiber membrane 13 is made of a porous polyolefin resin or the like, and has a large number of pores that communicate between the inside and outside of the wall. The hollow fiber membrane 13 has an inner diameter of 100 to 1000μ, a wall thickness of 10 to 50μ, and an average pore diameter of about 200 to 2000Å. In addition, partition walls 15, 16
is formed from a polymeric potting material that is injected into the housing 12 by centrifugal injection.

In a hollow fiber blood processing device such as the hollow fiber oxygenator 11, the hollow fiber membrane 13 has an internal space, a blood inflow chamber 21, a blood outflow chamber 23, and a gas chamber 25 as an external space of the hollow fiber membrane 13. It is an essential structural condition that there be no so-called leakage between the two. However, in a hollow fiber type blood processing device such as the hollow fiber type oxygenator 11, the hollow fiber membrane 1
In the manufacturing process of 3 or the manufacturing process of the hollow fiber oxygenator 11, as shown in FIG. There is a risk that this may occur. In the case of a hollow fiber type blood processing device in which the leak occurs, the entire module becomes a defective product even if the pinhole portion 28 occurs in only one place.

Therefore, in a hollow fiber blood processing device such as the hollow fiber oxygenator 11 described above, it is recommended to take measures such as clogging the hollow fiber membranes that are involved in the occurrence of leaks, as long as it does not actually affect the performance. It is possible to salvage the whole module as a good product by making it unusable.

FIGS. 3A to 3D are explanatory diagrams showing a method of repair processing for a hollow fiber type blood processing device according to a conventional example. That is, when the gas chamber 25 serving as the external space of the hollow fiber membrane 13 is filled with fluid in the process before attaching the headers 17 and 18 in the manufacturing process of the hollow fiber oxygenator 11, the partition wall 15 (same goes for 16). If the fluid flows out to the outer end surface of the hollow fiber membrane as shown at 30 in FIG. In this way, when the opening in the outer end surface of the partition wall 15 is detected,
As shown in FIG. 3B, a recess 32 is formed by cutting off the periphery of the opening using a drill 31, and then,
As shown in FIG. 3C, a filler 3 is placed in the recess 32.
3 to close the opening, and then Fig. 3D
As shown in FIG. 2, the surfaces of the partition wall 15 and the filling material 33 are sliced to make the outer end surface of the partition wall 15 into a planar shape that does not adversely affect blood flow.

However, in the case of the hollow fiber type blood processing device formed by the conventional repair treatment described above, there is a step of forming the recess 32 with the drill 31, a step of hardening the filling material 33 to a state that can withstand slicing, a step of forming the partition wall 15 and filling the filling material. A step of slicing the surface of the material 33 is required, and the processing procedure is complicated. Also, drill 3
Foreign matter is generated due to cutting by No. 1, and if removal of this foreign matter is insufficient, there is a risk that it may flow into the bloodstream and cause serious side effects such as cerebral embolism. Further, there is a possibility that the filler 33 may peel off from the recess 32. In addition, the filling range of the filler 33 becomes relatively wide, and a large number of hollow fiber membranes 13 that do not require repair become clogged, making them unusable and reducing performance.

Purpose of the Invention The present invention has simple processing steps, no generation of foreign matter, only the minimum necessary hollow fiber membranes that are unusable, and
It is an object of the present invention to provide a method for repairing a hollow fiber type blood processing device that can reliably close a hollow fiber having a leak portion.

Structure of the Invention In order to achieve the above object, the present invention provides a method in which an end of a hollow fiber membrane is held in a housing via a partition,
The outer wall of the hollow fiber membrane, the inner end surface of the partition wall, and the inner wall of the housing define an external space of the hollow fiber membrane, and the hollow fiber membrane and the partition wall are made of a material that has a property of being softened by heat. A method for repairing a hollow fiber blood processing device includes pressing a heating element against the opening of the outer end surface of the partition wall in which the hollow fiber membrane having the leakage part is opened, and rubbing the opening with the heating element; The opening is closed by forming a film by softening the material constituting the partition wall around the opening.

DETAILED DESCRIPTION OF THE INVENTION Hereinafter, an embodiment in which the present invention is applied to a hollow fiber oxygenator 11 similar to that shown in FIG. 1 will be specifically described. Note that FIGS. 4A to 4C show the headers 17 and 18 in the manufacturing process of the hollow fiber oxygenator 11.
The cylindrical housing 12 and the hollow fiber membrane 1 before installation
3. Partition wall 15 is shown.

First, a fluid that does not originally pass through the wall of the hollow fiber membrane 13 is flowed into the gas chamber 25 as an external space of the hollow fiber membrane 13, and the fluid flows into the hollow fiber through the pinhole or broken part of the hollow fiber. A portion passing through the inside of the hollow fiber and flowing out to the outer end surface of the partition wall 15 as shown at 41 in FIG. 4A is defined as an opening. Here, if pressure is applied to the external space of the hollow fiber membrane 13, the detection sensitivity can be further increased. However, this pressure must not be so high as to destroy the hollow fiber membrane 13. The detection of an opening at the end of a hollow fiber having a leakage portion can be carried out, for example, by filling the outside of the hollow fiber membrane 13 with water and applying pressure with air. Since this occurs, the opening of the hollow fiber having the leakage portion can be easily detected.

Next, a heating element 42 with a small diameter as shown in FIG.
The tip of the hollow fiber is pressed against the opening of the hollow fiber having the leak portion on the outer end surface of the partition wall 15 detected as described above, and the heating body 42 is rotated to cover the opening and a relatively narrow area around it. Rub.

By pressing the heating body 42 against the opening,
As shown in FIG. 5A, the end of the hollow fiber membrane 13 that is open at the outer end surface of the partition wall 15 is melted by the heat of the heating element 42, causing thermal contraction, and as shown in FIG. 5B. Forms its own sealing part 43. This heating body 42
In the pressing step, the tunnel portion 44 that held the hollow fiber membrane 13 of the partition wall 15 remains. In this way, if the end of the hollow fiber membrane 13 that is involved in the leak is in a state where it forms the sealing part 43 by itself, and a pinhole part is generated in the hollow fiber membrane 13, the pinhole part is formed. Leakage based on the hole portion can be eliminated for the time being.

At the stage where the heating body 42 presses against the opening and rubs the opening in a rotating manner, the constituent material on the outer end surface side of the partition wall 15 softens, and the partition wall 1
A coating portion 45 as shown in FIG. 5C is formed in the opening area of the tunnel portion 44 of No. 5. As a result, the opening on the outer end surface of the partition wall 15 is completely closed by the sealing part 43 of the hollow fiber membrane 13 and the coating part 45 of the partition wall 15, and is formed into a substantially planar shape as shown in FIG. 4C. This is to obtain an outer end surface of the partition wall 15 with the opening portion closed.

It goes without saying that the leakage portion on the outer end surface of the other partition wall 16 of the hollow fiber oxygenator 11 is also repaired by the same method as described above.

Here, as mentioned above, in order to form the own sealing part 43 at the end of the hollow fiber membrane 13 by thermal contraction, the material of the hollow fiber membrane 13 must be softened and melted by heat. It must have the property of being resistant to heat and return to almost its original state upon cooling. For this purpose, it is preferable to use thermoplastic plastic, such as polyethylene, polypropyline, polycarbonate, etc., as the material for the hollow fiber membrane 13.

In addition, as described above, in order to form the coating portion 45 on the outer end surface of the partition wall 15, the potting material forming the partition wall 15 must also have the property of softening with heat, but it is not necessary to use thermoplastic plastic. There is no need to limit it. That is, the material of the partition wall 15 may be any material that partially softens immediately before decomposition, and for example, polyurethane can be used.

According to the above-mentioned embodiment, the leak portion can be reliably removed simply by pressing the heating body 42 against the opening at the end of the hollow fiber having the leak portion and rubbing the opening portion so as to be rotated by the heating body 42. It becomes possible to close the opening at the end of the hollow fiber, and the processing procedure required for repair processing becomes simple, for example, the processing time from several hours to several minutes can be shortened. In addition, the hollow fiber membrane 13,
There is no need to scrape or slice the surfaces of the partition walls 15, 16, and no foreign matter is generated during the process, so the safety of the apparatus is not compromised. In addition, by pressing the small-diameter heating element 42 against the opening at the end of the hollow fiber having the leakage part and making the rubbing area in a rotating manner a relatively narrow range, many hollow fiber membranes 13 are rendered unusable. There is no such thing as Further, the opening of the hollow fiber having a leakage portion based on the pinhole portion of the hollow fiber membrane 13 is located at the sealing portion 4 of the hollow fiber membrane 13.
3. The double closing portion of the coating portion 45 of the partition wall 15 provides more reliable closing.

Specific Effects of the Invention As described above, in the present invention, the ends of the hollow fiber membranes are held in the housing via the partition walls, and the hollow fiber membranes are In a method for repairing a hollow fiber type blood processing device, the hollow fiber membrane and the partition wall are made of a material that has a property of softening with heat,
A heating element is pressed against the opening of the outer end surface of the partition wall where the hollow fiber membrane having the leakage part is opened, and the opening is rubbed by the heating element to form a coating by softening the partition wall constituent material around the opening. The opening is closed by forming the opening. Therefore, there is no risk of embolization as there is no foreign material such as cutting, and since only the minimum necessary hollow fiber membrane is made unusable, there is almost no deterioration in performance, and the ends of hollow fibers with leakage parts can be reliably removed. It becomes possible to obtain a hollow fiber type blood processing device in which the opening of the section is closed.

Further, in the present invention, the hollow fiber membrane is made of thermoplastic plastic, so that the end of the hollow fiber membrane having the pinhole portion seals itself by heat shrinkage, thereby preventing the leakage portion. The blockage becomes more secure.

[Brief explanation of the drawing]

Fig. 1 is a cross-sectional view showing a general hollow fiber oxygenator, Fig. 2 is a cross-sectional view showing the state of leakage in the same hollow fiber oxygenator, and Figs. 3 A to D are hollow fiber oxygenators according to the conventional example. 4A to 4C are cross-sectional views showing a method for repairing a thread-type oxygenator, and FIG. 5A is a cross-sectional view showing a method for repairing a hollow-fiber oxygenator according to an embodiment of the present invention.
-C are cross-sectional views showing enlarged processing conditions in the same example. 11... Hollow fiber oxygenator, 12... Cylindrical housing, 13... Hollow fiber membrane, 15, 16... Partition wall,
42... Heating body, 43... Sealing part, 45... Coating part.

Claims (1)

[Scope of Claims] 1. An end portion of the hollow fiber membrane is held in the housing via a partition wall, and an outer space of the hollow fiber membrane is defined by the outer wall of the hollow fiber membrane, the inner end surface of the partition wall, and the inner wall of the housing. , in a method for repairing a hollow fiber type blood processing device in which the hollow fiber membrane and the partition wall are made of a material that has the property of softening with heat, the hollow fiber membrane having a leak part is outside the partition wall where the hollow fiber membrane is opened. The opening is closed by pressing a heating element against the opening of the end face, rubbing the opening with the heating element, and forming a film by softening the material constituting the partition wall around the opening. How to repair hollow fiber blood processing equipment. 2. The method for repairing a hollow fiber type blood processing device according to claim 1, wherein the constituent material of the hollow fiber membrane is thermoplastic plastic.