JP3603207B2 - Method for producing perforated catheter with branch tube - Google Patents

Description

【００２１】
【表２】

【００２２】
実施例３，４
図４に示すポリウレタン（Ｔｈｅｒｍｅｄｉｃｓ Ｉｎｃ．社製、商品名 Ｔｅｃｏｆｌｅｘ ６５Ｄ）製本体部１と、ポリウレタン（Ｔｈｅｒｍｅｄｉｃｓ Ｉｎｃ．社製、商品名 Ｔｅｃｏｆｌｅｘ ８５Ａ）製枝管部２，２′，２″とをポリウレタン（Ｔｈｅｒｍｅｄｉｃｓ Ｉｎｃ．社製、商品名 Ｔｅｃｏｆｌｅｘ ８５Ａ）製連結部３を介して結合した分岐用枝管付き３孔型カテーテル（本体部の断面が図６の形状のもの）を準備し、実施例１，２と同様に表１に示した条件で高周波融着化処理を行った。なお、高周波融着化処理は、各隔壁部６，６について各々１回の融着処理を行った。得られた製品の酵素固定化処理後における各不良品率を表２に示した。吸引不良品率は非常に小さく良好であり、しかも融着処理によるリーク不良品率の増加も見られなかった。
なお、前記融着処理を行わない製品（比較例２）との酵素固定化処理後における各不良品率も表２に示したが、吸引不良品率が極めて大きかった。
【００２３】
実施例５
図４に示す分岐用枝管部付き３孔型カテーテル（本体部の断面が図７の形状のもの）を使用する以外は実施例３，４と同様の条件で高周波融着化処理を行った。得られた製品の酵素固定化処理後における各不良品率を表２に示した。なお、高周波融着化処理は、各隔壁部６，６，６について各々１回の融着処理を行った。吸引不良品率は非常に小さく良好であり、しかも融着処理によるリーク不良品率の増加も見られなかった。
なお、前記融着処理を行わない製品（比較例３）の酵素固定化処理後における各不良品率も表２に示したが、吸引不良品率が極めて大きかった。
【００２４】
【発明の効果】
以上の説明から明らかなように、本発明によれば、従来酵素固定化処理により生じていた連結部内におけるカテーテル形成用の本体部の流路端部内の樹脂被膜の剥離が防止され、吸引不良品率が顕著に低下するとともに、カテーテル形成用の本体部の隔壁部に局所的に熱疲労を与えることにより生ずるリーク不良品率の増加のない分岐用枝管部付き多孔型カテーテルの製造方法を提供することが可能となった。
【図面の簡単な説明】
【図１】本発明による分岐用枝管部付き多孔型カテーテルの一例の正面図である。
【図２】図１の分岐用枝管部付き多孔型カテーテルの要部の断面図である。
【図３】分岐用枝管部付き多孔型カテーテルの連結部の高周波加熱処理要領の説明図である。
【図４】本発明による分岐用枝管部付き多孔型カテーテルの他の例の正面図である。
【図５】本発明による分岐用枝管部付き多孔型カテーテルの本体部の断面形状の一例を示す断面図である。
【図６】本発明による分岐用枝管部付き多孔型カテーテルの本体部の断面形状の一例を示す断面図である。
【図７】本発明による分岐用枝管部付き多孔型カテーテルの本体部の断面形状の一例を示す断面図である。
【図８】本発明による分岐用枝管部付き多孔型カテーテルの本体部の断面形状の一例を示す断面図である。
【図９】連結部形成用の下型の内面図である。
【図１０】連結部形成用の上型の内面図である。
【図１１】連結部の樹脂成型要領の説明図である。
【符号の説明】
１ カテーテル形成用の本体部
２，２′… 分岐用枝管部
３ 連結部
４，… 流路
５，５′ 流路
６ 隔壁部
７ 樹脂被膜
２０ 電極[0001]
[Industrial applications]
The present invention relates to a method for manufacturing a perforated catheter having a branch tube for branching.
[0002]
[Prior art]
Generally, a tube placed in the body for medical treatment (administration of drugs, administration of nutrients, discharge of body fluids such as blood and urine) and diagnosis (measurement of blood pressure and blood flow, angiography, blood collection, etc.) in a medical setting Are widely used. This catheter includes a single-lumen (single-hole) catheter having a single flow channel and a perforated catheter having a plurality of flow channels in a single tube. While injecting the nutrient solution in the channel, injecting a drug that is immiscible with the nutrient solution in the other channel, collecting blood, measuring blood pressure, or in hemodialysis, performing blood removal in one channel, Two or more treatments such as blood return in the other flow path can be simultaneously performed, which has the advantage of greatly reducing the burden on patients as well as doctors and nurses, and has been widely used. .
[0003]
The multi-porous catheter is generally connected via a connecting portion provided with a flow path communicating the main body for forming the catheter to be placed in the body and the branch pipe for branching. The main body for forming a catheter is provided with a plurality of flow paths capable of performing a plurality of treatments, and a branch branch for forming a catheter is branched at a connecting portion to inject a drug, collect blood, and control a blood pressure, respectively. It can be connected to instruments, devices, and the like that can perform different treatments such as measurement. A connecting portion between the main body portion for forming the catheter and the plurality of branching branch portions is resin-molded so as to generate a flow passage in which each flow channel of the main body portion and the flow channel of the branch pipe portion are integrally communicated. However, at the time of the resin molding, a part of the resin for forming the connection portion is also poured into the flow path end of the main body portion for forming the catheter, and a thin film is formed. Leaks between the flow paths of the main body are prevented by avoiding a gap at the boundary. In particular, when an enzyme immobilization treatment or the like is performed to add antithrombotic properties to the catheter, depending on the solvent used, the resin at the connecting portion expands and a gap is likely to be generated, which may cause a leak. In order to prevent this, it is necessary to form a resin film inside the flow path end of the main body.
[0004]
[Problems to be solved by the invention]
However, even in a perforated catheter having a branch tube portion for branching in which a resin coating is formed in the end of the flow path of the main body portion for forming a catheter, when an enzyme immobilization treatment or the like is performed, a leak does not occur, but it is difficult to collect blood. In addition, when suction is performed, there is a drawback that the resin film peels off like a valve only at the time of suction to prevent suction, or that suction efficiency is reduced.
[0005]
An object of the present invention is to provide a method of manufacturing a porous catheter with a branch pipe for branching, which prevents peeling of the resin coating caused by an enzyme immobilization treatment or the like and does not cause suction failure.
[0006]
[Means for Solving the Problems]
The method for producing a perforated catheter with a branch for branch according to the present invention achieves the above object, and comprises a main body for forming a catheter having a plurality of flow paths therein, and a branch for each flow path. When forming a connecting part with a flow path communicating with the part by resin molding, a part of the resin for forming the connecting part is poured into the end of the main body flow path, and a thin resin film is formed and integrally formed Then, a pair of electrodes is separately inserted from each opening end of the branch branch portion until the inside of the main body flow path end portion in the connection portion, and a high-frequency voltage is applied to the electrodes to flow the main body flow in the connection portion. The resin film in the road end is subjected to high-frequency dielectric heating to be fused.
[0007]
Hereinafter, the present invention will be described in detail.
The main body for forming a catheter used in the present invention is a tube made of a thermoplastic resin or the like having a plurality of flow paths therein, and its cross-sectional shape may be any, but its typical cross-sectional shape is Is as shown in FIG. 5 to FIG.
[0008]
Further, the branching branch portion used in the present invention is usually a tube of a thermoplastic resin or the like provided with one (in a special case, a plurality of channels) flow passage therein, and is usually used for forming a catheter. The number corresponding to the number of channels in the main body is used.
[0009]
As shown in FIGS. 1, 2, and 4, the main body 1 for forming the catheter and the branch pipes 2, 2 ',... Are connected by a connecting portion 3 formed by resin molding. Are formed with the flow paths 4, 5 ',... Which communicate the flow paths 4,... Of the catheter forming body 1 with the branching branch pipes 2, 2',. A thin resin film 7 is formed in the end of each flow path 4.
[0010]
The resin molding of the connecting portion 3 is performed in the following manner.
As shown, the lower mold 10 shown in FIG. 9 and the upper mold 11 shown in FIG. 10 have a resin injection port 12, a concave portion 13 for forming the connecting portion 3, a concave portion 14 for fixing the main body portion 1 for forming the catheter, Recesses 15, 16 for fixing the branch pipe sections 2, 2 'are formed.
[0011]
As shown in FIG. 11, the main body 1 for forming the catheter and the branch pipes 2 and 2 'are fixed to the recess 14 and the recesses 15 and 16 of the lower mold 10, respectively. The bent ends of the rod-shaped cores 17, 17 inserted from the respective open ends are inserted into the ends of the flow paths 4, 4 of the main body 1 for forming a catheter, and then the upper die 11 is attached to the lower die 10. Then, the molten resin for connecting portion molding is injected from the injection port 12, and after solidification, the molded product is removed from the lower die 10 and the upper die 11, and the rod-shaped cores 17, 17 are removed. The resin films 7, 7 are formed.
[0012]
Next, as shown in FIG. 3, a pair of electrodes 20, 20 are inserted from the respective open ends of the branch pipe sections 2, 2 'until they reach the ends of the flow paths 4, 4 of the main body 1 for forming a catheter. Then, a high-frequency voltage is applied to the electrodes 20, 20, and the thin resin coatings 7, 7 in the end portions of the flow path are subjected to high-frequency dielectric heating to be fused. In this method, since each portion inside the dielectric uniformly generates heat, fusion is performed uniformly. Moreover, since the handling is clean and sanitary, it is an effective means as a method of bonding to medical materials.
[0013]
Here, the material of the electrode 20 to be used is an aluminum alloy such as duramin, or a conductive metal such as iron or stainless steel. The shape of the electrode 20 extends along the inner wall from the open end of the branch pipe portion 2, 2 '. It is preferable that the shape is such that it can be freely inserted and removed, and can be uniformly pressed on a portion to be fused. Since the resin films 7, 7 are formed on the partition 6 in FIG. 5 as shown in FIGS. 2 and 3, the width of the electrodes is adjusted by fusing the entire surface of the resin film and suppressing peeling satisfactorily. It is desirable that the width be substantially the same as that of the longest straight line portion of the partition wall portion 6 in FIG.
[0014]
It is preferable to use a "comb-shaped electrode" in which a plurality of dielectric metal wires are arranged in parallel for one of a pair of electrodes to be used, and to use a thin dielectric metal for the other electrode. It is. The resin coating is often formed on only one surface of the partition 6 depending on the inclination direction of the branching branch portions 2 and 2 'with respect to the main body 1 for forming the catheter. It is desirable to use a comb-shaped electrode for the electrode and to use a thin dielectric metal for the electrode on the partition wall side of the main body for forming the catheter. By using the electrode having the above shape, the heat transfer from the internal heat generated by the high frequency to the two electrodes is biased, the thermal fatigue applied on the partition wall side of the main body is suppressed, and the resin coating 7 is reliably melted on the resin coating side. Can be fused to the partition wall side. In addition, by forming the electrodes in a comb shape, the molten resin can escape between the metal wires, so that the problem of high protrusions around the electrodes can be suppressed.
[0015]
Next, regarding the electrode insertion position, it is preferable that the opposed electrode is positioned at a position where the electrode tip enters at least the tip of the resin film 7. However, care must be taken because if the resin coating 7 is inserted too far into the distal end, the partition wall 6 of the main body 1 for forming a catheter is directly subjected to thermal fatigue, which causes dielectric breakdown or leakage. The reliable fusion of the tip of the resin film 7 is an important point for completely suppressing peeling.
In the present invention, the preferred voltage is 1 KV or less, optimally 40-600 V, and the preferred high frequency is the frequency band of 1-100 MHz, optimally 40-50 MHz.
[0016]
[Action]
In the present invention, a pair of electrodes from the open end of the branch branch portion to the connecting portion between each flow channel end of the catheter forming body portion having a plurality of flow channels inside and each branch branch portion is provided. Specially inserted, high-frequency voltage is applied to the electrodes, and the resin coating in the end of the main body flow path in the connecting portion is subjected to high-frequency dielectric heating and fusion, so that the heat generated by high-frequency dielectric heating is applied only to the desired resin coating. Are uniformly generated and fused without being scorched or melted, and are clean and sanitary.
[0017]
【Example】
Hereinafter, the present invention will be described in detail with reference to examples.
In addition, the inspection and evaluation methods in the examples are as follows.
(1) Defective Suction Rate The distal end opening of the main body for forming a catheter was immersed in warm water at 37 ° C., and suction was continuously performed at a reduced pressure of about 700 mmHg sequentially from each opening of the branch branch. As a result of the inspection from all the branch branch opening ends, a product that can secure 70% or more of the design flow rate in all the inspection results was regarded as a non-defective product, and the inspection result from all the branch branch opening ends was determined. Either one failed to secure 70% or more of the design flow rate as a defective product, and the defective product ratio was defined as a suction defective product ratio. The designed flow rate varies depending on the inner diameter of the flow path in the main body for forming the catheter and the length of the main body.
[0018]
(2) Leakage defect rate Close the tip opening of the main body part for forming the catheter, immerse the connecting part in water, and pressurize three times with air of about 700 mmHg from each opening end of the branching branch part. In all tests, the product in which no bubbles were observed from the connection part immersed in water was regarded as a good product, and the product in which bubbles were observed in any of the tests was regarded as a defective product. And
[0019]
Examples 1 and 2
A polyurethane (Thermedics Inc., trade name Tecoflex 60D) main body 1 and a polyurethane (Thermedics Inc., trade name Tecoflex 85A) branch pipe part 2, 2 'shown in FIG. Each branching branch 2 of a double-lumen catheter (with a main body having a cross section of FIG. 5) with a branching branch connected via a connecting portion 3 made by Themedics Inc. (trade name: Tecoflex 85A) , 2 ′, a pair of electrodes 20, 20 (electrode width: the same width as the longest part of the partition wall portion of the main body) is inserted, and as shown in FIG. The tip of the electrode was positioned at the tip of the resin coating 7, 7 in the road end. Next, a high frequency voltage was applied under the conditions shown in Table 1 to fuse the resin coatings 7 and 7 together. Table 2 shows the percentage of defective products after the enzyme immobilization treatment of the obtained products. The defective suction rate was very small and good, and no increase in the defective leak rate due to the fusion treatment was observed.
In addition, Table 2 also shows the percentage of defective products after the enzyme immobilization treatment with the product not subjected to the fusion treatment (Comparative Example 1), but the suction defective product ratio was extremely large.
[0020]
[Table 1]

[0021]
[Table 2]

[0022]
Examples 3 and 4
A polyurethane (Thermedics Inc., trade name Tecoflex 65D) main body 1 and a polyurethane (Thermedics Inc., trade name Tecoflex 85A) branch pipe 2, 2, 2 ′, 2 ″ shown in FIG. Example 1 A three-hole catheter (with a main body having a cross-sectional shape shown in FIG. 6) with a branching branch connected via a connecting portion 3 made of (Themedics Inc., trade name: Tecoflex 85A) was prepared. The high-frequency fusion treatment was performed under the conditions shown in Table 1 in the same manner as in Examples 1 and 2. In the high-frequency fusion treatment, each of the partition walls 6 and 6 was subjected to one fusion treatment. The percentage of each defective product after the enzyme immobilization treatment is shown in Table 2. The defective defective product ratio is very small and good, and the defective defective product ratio due to the fusion process is high. Increase was not observed.
In addition, Table 2 also shows the percentage of defective products after the enzyme immobilization treatment with the product not subjected to the fusion treatment (Comparative Example 2), but the suction defective product ratio was extremely large.
[0023]
Example 5
The high-frequency fusion treatment was performed under the same conditions as in Examples 3 and 4, except that the three-hole catheter with a branch tube portion shown in FIG. 4 (the cross section of the main body portion had the shape shown in FIG. 7) was used. . Table 2 shows the percentage of defective products after the enzyme immobilization treatment of the obtained products. In the high-frequency fusion treatment, each of the partition portions 6, 6, and 6 was subjected to one fusion treatment. The defective suction rate was very small and good, and no increase in the defective leak rate due to the fusion treatment was observed.
In addition, Table 2 also shows the percentage of defective products after the enzyme immobilization treatment of the product not subjected to the fusion treatment (Comparative Example 3), but the suction defective product ratio was extremely large.
[0024]
【The invention's effect】
As is apparent from the above description, according to the present invention, peeling of the resin film in the flow path end of the catheter forming main body in the connecting portion, which has been conventionally caused by the enzyme immobilization treatment, is prevented, and a defective suction product is obtained. Provided is a method of manufacturing a perforated catheter having a branch branch for branching, which has a remarkably reduced rate and does not increase the rate of leaky defective products caused by locally applying thermal fatigue to a partition wall of a main body portion for forming a catheter. It became possible to do.
[Brief description of the drawings]
FIG. 1 is a front view of an example of a perforated catheter having a branch tube portion for branching according to the present invention.
FIG. 2 is a cross-sectional view of a main part of the perforated catheter with a branch tube part shown in FIG. 1;
FIG. 3 is an explanatory view of a high-frequency heating process of a connecting portion of a perforated catheter having a branch tube portion for branching.
FIG. 4 is a front view of another example of the perforated catheter having a branch tube portion for branching according to the present invention.
FIG. 5 is a cross-sectional view showing an example of a cross-sectional shape of a main body of a perforated catheter having a branch tube portion for branching according to the present invention.
FIG. 6 is a cross-sectional view showing an example of a cross-sectional shape of a main body of a perforated catheter having a branch tube for branching according to the present invention.
FIG. 7 is a cross-sectional view showing an example of a cross-sectional shape of a main body of the perforated catheter with a branch tube according to the present invention.
FIG. 8 is a cross-sectional view showing an example of a cross-sectional shape of a main body of the perforated catheter with a branch tube according to the present invention.
FIG. 9 is an inner view of a lower mold for forming a connecting portion.
FIG. 10 is an inner view of an upper mold for forming a connecting portion.
FIG. 11 is an explanatory diagram of a resin molding procedure of a connecting portion.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Body part 2 for catheter formation, 2 '... Branch pipe part 3 for branching 3 Connection part ...... Flow path 5, 5' Flow path 6 Partition wall part 7 Resin coating 20 Electrode

Claims (1)

In forming a connecting portion having a flow path that communicates the main body portion for forming a catheter having a plurality of flow paths therein and a branch pipe portion for each flow path by resin molding, A part of the resin is poured into the end of the main body flow path, a thin resin film is formed and integrally formed, and then each of the open ends of the branch branch pipe portion is extended to the inside of the main body flow path end in the connecting portion. A pair of electrodes is separately inserted, and a high-frequency voltage is applied to the electrodes to apply high-frequency dielectric heating to the resin coating in the end portion of the main body flow path in the connection portion, and to fuse the resin coating. A method for producing a porous catheter.

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