JP2011255380A - Joint reinforcement method of module header, and reinforced module - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a reinforcement method offering excellent working efficiency and providing joint strength for surely fitting a header to a body vessel without exerting a bad influence on a functional part as an artificial organ, and to provide a module in which the joint strength is reinforced.SOLUTION: This invention relates to the joint reinforcement method for performing ultrasonic welding of the header from the side of the body vessel, as a method for fitting the header fluid-tightly to the body vessel in the module comprising the body vessel 2, the functional part 3 held in the body vessel, and the header 1. The invention also relates to the module comprising the body vessel 2, the functional part 3 held in the body vessel, and the header 1 fitted fluid-tightly to the body vessel, which is a module in which the joint strength is reinforced by performing ultrasonic welding of the header from the side of the body vessel.

Description

  The present invention relates to a method for reinforcing the bonding strength between a main body container and a header, and a module in which the bonding strength is reinforced. More specifically, hollow fiber membrane modules such as hemodialyzers, plasma separators, plasma component separators, water filters, and endotoxin removers using hollow fibers, adsorbent modules, filter modules incorporating leukocyte selective capture filters, etc. The present invention relates to a method for reinforcing the bonding strength between a main body container and a header, and a module having a reinforced bonding strength.

  The prior art will be described by taking a hollow fiber type artificial organ module as an example. In general, a module is used in which a hollow cylindrical body container is filled with hollow fibers and fixed to the body container with a potting agent such as urethane, and then headers are attached to both ends of the body container. In the manufacturing (assembling) process of the hollow fiber type artificial organ module, as a method of attaching the header to both ends of the main body container, (1) a method of liquid-tight joining by screwing the header through a packing such as an O-ring, or (2) There is a method in which a header is ultrasonically welded to a main body container via a seal portion and is joined in a liquid-tight manner.

  In the case of the header attachment method as described above, the attachment method (1) has a problem that the header is loosened and blood leaks when used, and as a prevention method, the organic solvent is poured into the screw portion and bonded. However, when an organic solvent is poured, setting of the application amount, positioning of the application location, inventory management of the organic solvent, and the like may become complicated. In addition, the attachment method (2) has a problem that a case where ultrasonic welding is incomplete occurs and the bonding strength is reduced, and a step of eliminating this is necessary. As a countermeasure for perfecting these, it is conceivable to change the shape of the main body container or the header, but the structure is complicated and the cost is increased.

  As described above, in the conventional header mounting method, there are concerns about the reliability and safety of sealing and joining, and efforts have been made to eliminate defective products. An object of the present invention is to provide a method for reinforcing the bonding strength in order to securely attach the header to the main body container without adversely affecting the functional part as an artificial organ, in view of the above-mentioned problems of the prior art. And providing a module having a reinforced bonding strength.

  Therefore, the present inventor has intensively studied to achieve the above object. As a result, as a method for reinforcing the bonding strength between the main body container and the header, it has been found that an excellent reinforcing effect can be obtained by performing ultrasonic welding from the side of the main body container, and it has an adverse effect on the functional part of the artificial organ. The present invention has been completed by confirming that neither is given. That is, the present invention relates to a method of attaching a main body container and the header in a liquid-tight manner in a module comprising a main body container, a functional part held in the main body container, and a header, and ultrasonicating the header from the side of the main body container. Bonding reinforcement method for welding, and further, a bonding reinforcement method in which the method of attaching the main body container and the header in a liquid-tight manner is ultrasonic welding, and the main body container, the functional part held in the main body container, and the main body container The module is composed of the header attached in a liquid-tight manner, and the joining strength is reinforced by ultrasonically welding the header from the side of the main body container.

  The module in the present invention is a hemodialyzer represented by a hollow fiber type artificial organ, a plasma separator, a plasma component separator, a blood filter, a plasma component adsorber, an artificial component, the main component of which is hollow fiber. Lungs, medical module such as endotoxin removal filter, adsorption module filled with adsorbent, purification device module, filter module incorporating leukocyte selective capture filter, etc. Say what you want as a requirement. A main body container is a container which fills the function part described below. The functional part is a part necessary for the module to perform its main function as an artificial organ. In the above example, the module includes a hollow fiber, an adsorbent, a leukocyte selection filter, and the like. The header is a lid having a conduit for introducing and / or discharging the liquid to be processed into the functional unit, and is attached to the main body container in a liquid-tight manner. Ultrasonic welding refers to a bonding method in which a certain ultrasonic vibration is applied to the welded portion, so that the material to be welded starts to melt at that portion, and the bonding proceeds instantaneously, and thereafter the practical strength can be maintained. . The frequency at which ultrasonic welding is performed is a sonic frequency exceeding the audible frequency, but is preferably 20 kHz to 40 kHz. When the frequency is about 40 kHz, transmission of ultrasonic vibrations is easy, and the equipment tends to be small and tends to be most preferable. It can be selected depending on the shape of the welded part and the purpose of welding.

Although the ultrasonic welding method is not particularly limited, a method of transmitting ultrasonic vibrations to the welded portion with a horn attached to an actuator including a drive unit is preferable. The amplitude of ultrasonic welding has a great influence on the reinforcing strength of the part. The preferred amplitude is 20 to 80 μm, desirably 40 to 60 μm. Although the optimal transmission method of vibration differs depending on the state of the part before welding, various methods such as the presence / absence of a receiving jig at the part and the state of vertical or horizontal direction can be selected, and a reinforcing effect can be obtained. Further, when the main body container and the header are welded at several places, it is more suitable to perform the welding by rotating the main body container and the header or moving the horn. In addition, the method of using ultrasonic welding to reinforce the bonding strength between the main body container and the header is to narrow the tip of the horn for transmitting the vibration of the ultrasonic welding machine to the site and weld it to the required site. Although a method can be illustrated, when the method of attaching the header to the main body container in a liquid-tight manner is ultrasonic welding, a preferable strength can be obtained by welding at a position other than the welding site. In addition, it is also a good method to have two vibration transmission parts on the tip of the horn for transmitting vibration. In this case, it is necessary to fully consider these two pitches when manufacturing the horn. When ultrasonic welding is performed, an actuator equipped with a horn is used to apply pressure to the welded portion to join the welded portions. This pressure ^{is, 1.0kg / cm 2 ~7.0kg / cm} 2 until it is preferred, the more preferred case of welding is ^{1.0kg / cm 2 ~2.5kg / cm 2} . Further, the ultrasonic welding time refers to a time for transmitting ultrasonic vibration to the welded portion. The ultrasonic welding time is preferably 0.05 to 10 seconds, but more preferably 0.2 to 0.4 seconds in the case of side welding. When the applied pressure and welding time are out of this preferred range, the welded portion is insufficiently melted or excessively melted, making it practically difficult. Furthermore, the reinforcement effect can be obtained even at one location where the ultrasonic side welding is performed, but the reinforcement effect can be obtained more at several locations.

  By using the present invention, the joint strength between the main body container and the header can be reliably reinforced without adversely affecting the artificial organ member with good workability.

The cross-sectional schematic diagram which shows an example of a hollow fiber type artificial organ. The schematic diagram which shows an example of a reinforcement location and the aspect of reinforcement. An example of the apparatus for performing ultrasonic side welding.

  Hereinafter, embodiments of the present invention will be described in more detail with reference to the drawings. FIG. 1 is a schematic cross-sectional view showing an example of a hollow fiber artificial organ. The header 1 is attached to both ends of the main body container 2, and external pressure called ultrasonic vibration is applied to the outer peripheral portions of both ends of the main body container 2 and the inner melting margin of the header 1. The melting part of the header 1 is joined, and the main body container and the header are integrated. A hollow fiber artificial organ will be described below as an example. Hollow fiber type artificial organs generally have a hollow cylindrical bundle of hollow fibers such as polyamide, polypropylene, polymethyl methacrylate, ethylene-vinyl alcohol copolymer, regenerated cellulose, cellulose acetate, polyacrylonitrile, polyethylene, and polysulfone. The hollow fiber bundle is assembled by attaching the end of the hollow fiber bundle to the main body container with a potting agent, opening both ends of the hollow fiber, and then attaching the header in a liquid-tight manner. At this time, the header is fixed to the main body container at both ends when the hollow fiber bundle is linear, or at one end when the hollow fiber bundle is U-shaped. The potting agent 4 is a structure for fixing and supporting the hollow fiber and the body container of the artificial organ module, and a cured product of a thermosetting resin typified by polyurethane resin or epoxy resin is widely used. It has been. By this potting agent, the inner side and the outer side of the hollow fiber are separated in the main body container. Further, the role of the header 1 plays a role for allowing the liquid to be treated to flow inside the hollow fiber 3.

  Next, a reinforcement location and the aspect of reinforcement are demonstrated using drawing. 2 shows the ultrasonic vibration from the side of the main body container 2 and the header 1 to the hollow fiber type artificial kidney of FIG. 1 in which the ultrasonic vibration is transmitted and the outer peripheral portions of both ends of the main body container 2 and the melting allowance of the header 1 are joined. The joining strength is reinforced by adding several to several places. Next, an apparatus for reinforcing the bonding strength between the main body container of the hollow fiber type artificial organ and the header using an ultrasonic welder will be described. FIG. 3 is a schematic view showing an example of an apparatus for welding the part by ultrasonic side welding, and the horn 6 attached to the ultrasonic welder 5 transmits ultrasonic vibration for a certain period of time to facilitate reinforcement. And it can be done reliably. At this time, in order to transmit ultrasonic vibrations uniformly, it is preferable to perform the module while receiving it with the receiving jig 7. Examples of the present invention are shown below, but the present invention is not limited thereto.

Example 1
As shown in FIG. 2, in order to reinforce the bonding strength between the main body container and the header after the main body container and the header are ultrasonically welded between the outer peripheral portion of the main body container and the inner melting portion of the header. Further, the bonding strength was reinforced by ultrasonic side welding. As the hollow fiber type artificial organ, dialyzer AM-GP-150 (manufactured by Asahi Medical Co., Ltd.) using regenerated cellulose hollow fiber was used. As the ultrasonic side welder, a horn having a frequency of 40 kHz and a horn shape having an ultrasonic vibration transmitting portion with one tip portion was used. A horn with a length of 2.2 mm was used. The output of the ultrasonic welder is 284W. There are two side welds. As conditions for ultrasonic welding applied to the object, the applied pressure is 1.0 kg / cm ² and the welding time is 0.2 seconds. In the tensile test, the main body container and the header were held by each jig, a load was applied vertically, and the load when the fracture point and the measurement limit were reached was read. The results are shown in Table 1.

(Example 2)
The same operation as in Example 1 was performed except that the welding time was set to 0.3 seconds. Table 1 shows the results of the tensile test at this time.

(Comparative Example 1)
The main body container and the header of the hollow fiber type artificial kidney device of Example 1 were merely joined by ultrasonic welding, and the joining strength was not reinforced by ultrasonic side welding. Table 1 shows the results of the tensile test at this time.

(Example 3)
The same operation as in Example 1 was performed except that the applied pressure was 2.0 kg / cm ² and the welding time was 0.4 seconds. Table 1 shows the results of the tensile test at this time.

Example 4
The same operation as in Example 1 was performed except that the pressure was 2.5 kg / cm ² and the welding time was 0.15 seconds. Table 1 shows the results of the tensile test at this time.

上記の実施例では引張荷重が全てにおいて、比較例の１９０ｋｇより充分大きな値になっており、補強がなされていることがわかる。また、作業性においても問題はなく、確実に補強できるようになった。 (Example 5)
The same operation as in Example 1 was performed except that the pressing force was 2.5 kg / cm ² and the welding time was 0.2 seconds. Table 1 shows the results of the tensile test at this time.

In the above examples, the tensile load is a value sufficiently larger than 190 kg of the comparative example, and it can be seen that the reinforcement is made. Also, there is no problem in workability, and it can be surely reinforced.

1 Header 2 Body container 3 Hollow fiber 4 Potting agent 5 Ultrasonic welding machine 6 Horn 7 Receiving jig (anvil)

Claims (3)

  A method of joining and reinforcing ultrasonically the header from the side of the main body container in a method of liquid-tightly attaching the main body container and the header of a main body container, a module comprising a functional part and a header held in the main body container .   The joining reinforcement method according to claim 1, wherein the method of attaching the main body container and the header in a liquid-tight manner is ultrasonic welding.   A module comprising a main body container, a functional part held in the main body container, and a header that is liquid-tightly attached to the main body container, wherein the header is ultrasonically welded from the side of the main body container A module with reinforced strength.

Images