JPH07136253A - Method for repairing hollow yarn type artificial organ and repaired hollow yarn type artificial organ - Google Patents

Abstract

PURPOSE:To rapidly and surely repair the leaking point of an artificial organ without damaging the constituting members of the organ. CONSTITUTION:The repaired hollow yarn type artificial organ is obtd. by packing a radiation curing type resin 8 into the leaking point 7, such as opening of leaking hollow yarn or the spacing between pieces of the hollow yarn generated as a result of forming a hollow yarn supporting body or the spacing between the hollow yarn and a housing at the end face of the hollow yarn supporting body and irradiating the resin with radiations of a specific wavelength and instantaneously curing these materials.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a technique for repairing a leak portion of a hollow fiber type artificial organ for the purpose of dialysis, adsorption, filtration and the like of a substance in a body fluid using a hollow fiber membrane.

[0002]

2. Description of the Related Art In a hollow fiber type artificial organ, generally, a hollow housing is filled with a hollow fiber bundle, and when the hollow fiber bundle is linear, it is at both ends of the housing or the hollow fiber bundle is U-shaped.
In the case of a letter shape, at one end, the hollow fiber end is fixed and supported by the housing by a potting material such as urethane.

In the manufacturing process of hollow fibers used for hollow fiber type artificial organs, it is practically impossible to detect 100% of the generated pinholes and exclude them as defective yarns. In a manufacturing process of an artificial organ using as a raw material a hollow fiber bundle containing a small amount of hollow fibers having defective pinholes, a leak defective hollow fiber module is generated with a certain probability.

In the process of manufacturing a hollow fiber type artificial organ, the potting material enters into the spaces between the hollow fibers or into the gaps between the hollow fibers and the housing and hardens to form a hollow fiber support. , The air couldn't be exhausted,
In the case where the hollow fiber bundle is not completely embedded, a leak failure may occur in the hollow fiber support itself.

In the case of repairing a defective module as described above, conventionally, a method of filling a thermosetting resin such as polyurethane resin into a gap has been generally used, but it is a two-liquid mixing type and has a long curing time. Therefore, the work was difficult and complicated. In addition, as an alternative repair technique, a technique of repairing using hot melt resin has been devised, but the one that can be used relatively easily has the problem that melting and deterioration occur due to high temperature processes such as autoclave sterilization. In addition, the high temperature melting type, which can withstand the autoclave sterilization process, hardens spontaneously due to the temperature drop that occurs during filling, making reliable repair difficult, and raising the surface temperature of the material to an appropriate level makes the hollow fiber There is a possibility that the artificial organ components such as the membrane may be damaged.

[0006]

As described above, the conventional hollow fiber type artificial organ leak point repairing technique has problems in workability, reliability, influence on the artificial organ member itself, and the like. The object of the present invention is to solve the above-mentioned problems of the prior art.
Good workability, without adversely affecting the artificial organ member,
Moreover, it is an object of the present invention to provide a method for repairing a hollow fiber type artificial organ capable of surely repairing a leak location and a repaired hollow fiber type artificial organ.

[0007]

Therefore, the inventors of the present invention have conducted extensive studies to achieve the above object. As a result, by using a radiation-curable resin for leak repair of a hollow fiber type artificial organ, the radiation-curable resin can be reliably filled into the repaired portion and can be cured at any timing, which is surprising. The present invention has been completed by finding that workability and reliability are improved, and confirming that the hollow fiber type artificial organ member is not adversely affected.

That is, the present invention is a method for repairing a leak site of a hollow fiber type artificial organ having a leak site,
After filling the leak-curable resin with the radiation-curable resin or at the same time as filling, irradiating the radiation-curable resin with radiation,
A method for repairing a hollow fiber type artificial organ characterized by curing, and a hollow hollow type artificial organ, characterized in that the leak location is repaired by a radiation curable resin. It is a thread-shaped artificial organ.

The hollow fiber type artificial organ referred to in the present invention is a hemodialyzer represented by an artificial kidney, a plasma separator, a plasma component separator, a hemofilter, a plasma component adsorber, an artificial lung, an endotoxin removal filter, etc. , A module for medical use having a hollow fiber as a main constituent member.

Hollow fiber type artificial organs are generally made of polyamide, polypropylene, polymethylmethacrylate, ethylene-vinyl alcohol copolymer, regenerated cellulose, cellulose acetate, polyacrylonitrile, polyethylene,
It is assembled by housing a hollow fiber bundle of polysulfone or the like in a tubular housing, adhering and fixing the end portion of the hollow fiber bundle to the housing with a potting material, opening the hollow portion, and then attaching a header.

At this time, the hollow fiber bundle is fixed to the housing at both ends when it is linear, or at one end when the hollow fiber bundle is U-shaped. The potting material is a structure containing the hollow fiber for fixing and supporting the hollow fiber and the housing of the artificial organ module, and a cured product of a thermosetting resin typified by polyurethane resin or epoxy resin is widely used. It is commonly used. The potting material separates the inside and the outside of the hollow fiber inside the housing.

The term "leakage point" as used in the present invention refers to a point where the inside and outside of the hollow fiber cannot be separated from each other in the housing, such as the pinhole part of the hollow fiber, the part where the housing and the potting material are separated, and the hollow part. This is the case where the potting material is not properly injected between the threads.

The radiation-curable resin refers to a resin that starts to cure upon irradiation with radiation and progresses to practical strength, and thereafter can maintain practical strength even if irradiation with radiation is stopped. However, the radiation referred to in the present invention is an electromagnetic wave having a shorter wavelength than visible light (not including visible light).
It is defined as Examples of the radiation curable resin of the present invention include ultraviolet curable resin, X-ray curable resin, γ-ray curable resin and the like.

Of the radiation, the longer the wavelength, the shorter the reach of the radiation, but the easier it is to shield the radiation, and the smaller the equipment. Conversely, the shorter the wavelength, the larger the equipment but the ultraviolet rays. It has the feature that it can bond deep places that cannot reach, and it can be selected according to the purpose.

The viscosity of the radiation-curable resin before curing affects the workability of repairing the leaked portion. The optimum viscosity varies depending on the size of the leak point, but 1 cp at room temperature (28 ° C)
It is possible to use from s to paste. However, in the case where the hollow fiber is blocked, 100
From about 100,000 cps is easy to use. More preferred is 1,000 to 10,000 cps, and more preferred is 3,000 to 7,000 cps.

In terms of workability, a radiation-curable resin which is a one-component type, which does not need to care about the pot life and which is cured in seconds after radiation irradiation, is preferable. From the viewpoint of safety, durability, and heat resistance, it withstands the sterilization conditions used for medical devices and does not easily deteriorate.
A radiation-curable resin having characteristics such as not showing mutagenicity is preferable.

Among the radiation curable resins, when an ultraviolet curable resin is used, the ultraviolet curable resin containing a photopolymerization initiator having a reaction wavelength between 100 and 400 nm avoids the influence of visible light (indoor scattered light). For that reason, it can be preferably used, and in addition, the UV curable resin utilizing the photoinitiator having the maximum absorption in the vicinity of 366 nm, which has the most light intensity in the commonly used high pressure mercury lamp, is the most efficient and the cost is low. It is most preferably used from the viewpoint of resource saving.

When an ultraviolet curable resin is used, the penetration length of the resin into the hollow fiber openings and / or the voids present in the hollow fiber support depends on the film thickness curing performance of the resin. Then, the upper limit is determined, while the lower limit is determined by the materials of the hollow fiber support and the hollow fiber and the adhesive strength of the resin. Generally, the value of film thickness hardening performance is about 7
The penetration limit is preferably 10 mm or less, and the penetration length is preferably about 7 mm or less, and the reaching limit of the light beam changes depending on the inner diameter of the hollow fiber and the degree of verticality with respect to the light source.
It can be said that 5 mm or less is more preferable. And, most preferably, by setting the penetration length to 3 mm or less, reliable curing can be expected by short-time irradiation, and proper repair can be performed. The lower limit of 0.3 mm is sufficient, but 0.5 mm is more preferable, and 1 mm is desirable.

[0019]

Embodiments of the present invention will be described in more detail below with reference to the drawings. FIG. 1 is a schematic sectional view showing an example of a hollow fiber type artificial organ. A large number of hollow fibers 1 are bundled and housed in a housing 3 having fluid inlets and outlets 2 and 2 ', and potting materials 4 are provided at both ends of the housing 3.
It is fixed to the housing 3. The container on the open end side of the hollow fiber 1 has a body fluid inlet / outlet 5, 5 ', a header 6,
6'is attached. In this state, the inside of the hollow fiber 1 is open to the headers 6, 6 ′ side, and the outside of the hollow fiber 1 is exposed inside the housing 3. That is, the inside and the outside of the hollow fiber 1 are separated by the hollow fiber 1, the housing 3 and the potting material 4.

Next, the leak location and the mode of repair will be described with reference to the drawings. FIG. 2 is a schematic diagram showing a case where the hollow fiber 1 has a leak part 7 in the hollow fiber type artificial organ. In this case, the radiation curable resin 8 is provided at the open end of the hollow fiber having the leak part 7. Is injected and cured by irradiation with radiation.

FIG. 3 is a schematic view showing a case where the potting material 4 does not sufficiently enter between the hollow fibers 1 and a leak site 7 is formed. In this case, the leak site 7 is radiation-curable. Resin 8 is injected and cured by irradiation with radiation.

FIG. 4 shows the potting material 4 and the housing 3.
It is a schematic diagram showing a case where there is a leak point 7 between
In this case, the radiation curable resin 8 is injected into the leaked portion 7 and is cured by irradiation with radiation. Next, a curing device for repairing a hollow fiber type artificial organ using an ultraviolet curable resin will be described. FIG. 5 is a schematic diagram showing an example of an apparatus for curing an ultraviolet curable resin by irradiating ultraviolet rays. By irradiating ultraviolet rays for a certain period of time with an ultraviolet lamp 9, leak repair can be performed easily and reliably. . At this time, in order to avoid an increase in the surface temperature of the artificial organ 10, blower 11 blows air,
And / or it is preferable to attach an infrared cut filter. The heat generated by the ultraviolet lamp 9 is applied to the fan 12
It is likewise preferred to exhaust with.

[0023]

Examples 1 to 3 A case in which a hollow fiber had a pinhole as shown in FIG. 2 was repaired using an ultraviolet curable resin. As the hollow fiber type artificial organ, a dialyzer AMFP15 (manufactured by Asahi Medical Co., Ltd.) using a regenerated cellulose hollow fiber was used. As the ultraviolet curable resin, a modified urethane acrylate resin containing a photoinitiator having an absorption maximum at 365 nm was used. UV intensity is 25
0 (mw / cm ² ) and the penetration length of the ultraviolet curable resin into the hollow fiber was 7 (mm) ... Examples 1 and 5 (mm) ... Examples 2 and 3 (mm) ... Example 3 did. The minimum curing time at this time was measured, and a pressure resistance test after curing was performed. In the pressure resistance test, an air pressure of 1.5 (kg / cm ² ) was applied to the inside of the hollow fiber, and the presence or absence of leakage was confirmed in water. The results are shown in Table 1.

[0024]

[Table 1]

It can be seen that in each of the examples, the composition cures in a short time and has sufficient pressure resistance. The workability was good and the curing could be started at my own timing, so I was able to repair it without fail.

[0026]

EFFECTS OF THE INVENTION By using the present invention, it has become possible to reliably repair the leak location of a hollow fiber type artificial organ without affecting the artificial organ members with good workability.

[Brief description of drawings]

FIG. 1 is a schematic sectional view showing an example of a hollow fiber type artificial organ.

FIG. 2 is a schematic diagram showing an example of a leak location and a repair mode.

FIG. 3 is a schematic diagram showing another example of a leak location and a repair mode.

FIG. 4 is a schematic diagram showing another example of a leak location and a repair mode.

FIG. 5 shows an example of an apparatus for curing an ultraviolet curable resin.

[Explanation of symbols]

 1 hollow fiber 2,2 'fluid inlet / outlet 3 housing 4 potting material 5,5' body fluid inlet / outlet 6,6 'header 7 leak location 8 radiation curable resin 9 ultraviolet lamp 10 hollow fiber artificial organ 11 blower 12 fan

Claims (2)

[Claims] 1. A method for repairing a leak tube of a hollow fiber type artificial organ having a leak point, which comprises: A method for repairing a hollow fiber type artificial organ, which comprises irradiating and curing the material. 2. A repaired hollow fiber type artificial organ, characterized in that the leaked part is repaired with a radiation curable resin.