JP4922703B2 - Catheter tube manufacturing core and manufacturing method thereof - Google Patents
Catheter tube manufacturing core and manufacturing method thereof Download PDFInfo
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- JP4922703B2 JP4922703B2 JP2006248037A JP2006248037A JP4922703B2 JP 4922703 B2 JP4922703 B2 JP 4922703B2 JP 2006248037 A JP2006248037 A JP 2006248037A JP 2006248037 A JP2006248037 A JP 2006248037A JP 4922703 B2 JP4922703 B2 JP 4922703B2
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- 238000004519 manufacturing process Methods 0.000 title claims description 48
- 239000011162 core material Substances 0.000 claims description 104
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 51
- 239000011347 resin Substances 0.000 claims description 43
- 229920005989 resin Polymers 0.000 claims description 43
- 239000010410 layer Substances 0.000 claims description 36
- 238000007747 plating Methods 0.000 claims description 36
- 229910052742 iron Inorganic materials 0.000 claims description 21
- 239000011247 coating layer Substances 0.000 claims description 19
- 238000009792 diffusion process Methods 0.000 claims description 15
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 13
- 229910052799 carbon Inorganic materials 0.000 claims description 13
- 238000010438 heat treatment Methods 0.000 claims description 10
- 229910001030 Iron–nickel alloy Inorganic materials 0.000 claims description 9
- 229910045601 alloy Inorganic materials 0.000 claims description 9
- 239000000956 alloy Substances 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 9
- 238000005491 wire drawing Methods 0.000 claims description 9
- PXHVJJICTQNCMI-UHFFFAOYSA-N nickel Substances [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 41
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 21
- 238000000034 method Methods 0.000 description 13
- 238000000137 annealing Methods 0.000 description 12
- 238000009713 electroplating Methods 0.000 description 6
- 239000011261 inert gas Substances 0.000 description 6
- 239000004677 Nylon Substances 0.000 description 5
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 5
- 229920001778 nylon Polymers 0.000 description 5
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 4
- 229910052802 copper Inorganic materials 0.000 description 4
- 239000010949 copper Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 description 4
- 206010040844 Skin exfoliation Diseases 0.000 description 3
- -1 polytetrafluoroethylene Polymers 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000012937 correction Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 229910052759 nickel Inorganic materials 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- LNOPIUAQISRISI-UHFFFAOYSA-N n'-hydroxy-2-propan-2-ylsulfonylethanimidamide Chemical compound CC(C)S(=O)(=O)CC(N)=NO LNOPIUAQISRISI-UHFFFAOYSA-N 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000006748 scratching Methods 0.000 description 1
- 230000002393 scratching effect Effects 0.000 description 1
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Description
本発明は、治療や検査のために血管等に導入する薄肉・細径のカテーテルチューブの製造に関し、特に、線状の芯材の外周に樹脂の被覆層を形成した後、芯材を引き抜いてカテーテルチューブを製造するのに使用する芯材およびその製造方法に関する。 The present invention relates to the manufacture of a thin-walled, thin-diameter catheter tube that is introduced into a blood vessel or the like for treatment or examination, and in particular, after forming a resin coating layer on the outer periphery of a linear core material, the core material is pulled out. The present invention relates to a core material used for manufacturing a catheter tube and a manufacturing method thereof.
治療用あるいは検査用の薄肉・細径のカテーテルチューブの製造方法として、例えば銅線を芯材とし、その芯材の外周に押出しあるいは塗布によって樹脂の被覆層を形成し、その後、芯材を引き抜いてカテーテルチューブを製造する方法が従来から知られている（例えば、特許文献１、２参照。）。 As a method for manufacturing a thin or thin catheter tube for treatment or examination, for example, a copper wire is used as a core material, and a resin coating layer is formed on the outer periphery of the core material by extrusion or application, and then the core material is pulled out. A method of manufacturing a catheter tube is conventionally known (see, for example, Patent Documents 1 and 2).
この方法でカテーテルチューブを製造するのに使用される芯材は、従来、ＡｇメッキあるいはＳｎメッキした銅線が一般的であった。銅線は、柔らかく、低荷重で伸びて縮径するため、引き抜き易く、人力による引き抜きも容易であり、また、柔らかいので真直性も出しやすく、カテーテルチューブ製造用芯材として好適である。但し、銅は不安定で酸化しやすく、また酸化した銅は剥落し易いため、そのまま芯材としたのでは、引き抜く時に樹脂である被覆層の内面に酸化した銅が付着する恐れがある。これを防止するためにＡｇメッキあるいはＳｎメッキが施される。 Conventionally, the core material used to manufacture the catheter tube by this method is generally an Ag-plated or Sn-plated copper wire. The copper wire is soft and stretches with a low load to reduce its diameter. Therefore, the copper wire is easy to pull out and can be pulled out easily by human power, and since it is soft, it is easy to produce straightness and is suitable as a core material for manufacturing a catheter tube. However, since copper is unstable and easily oxidized, and oxidized copper is easily peeled off, if the core material is used as it is, oxidized copper may adhere to the inner surface of the coating layer that is a resin. In order to prevent this, Ag plating or Sn plating is performed.
この製造方法では、より具体的には、銅を素材として熱処理、伸線を繰り返して所定の線径を有する長尺の線材（銅線）とした後、その線材を所定条件（温度：３００〜４００℃、時間：１０ｍｉｎ程度）で溶体化処理し、次いで、線材表面にＡｇメッキあるいはＳｎメッキを施し、Ａｇメッキ銅線あるいはＳｎメッキ銅線とする。ここで製造する線材の線径は、治療用であるガイディングカテーテル製造用芯材とする場合は、例えば０．４６ｍｍ、０．７６ｍｍ、１．０８ｍｍであり、検査用である血管造影用カテーテル製造用芯材とする場合は、例えば１．８０ｍｍである。 More specifically, in this manufacturing method, after heat treatment and wire drawing are repeated using copper as a raw material to obtain a long wire (copper wire) having a predetermined wire diameter, the wire is subjected to predetermined conditions (temperature: 300 to 300). (400 ° C., time: about 10 min), and then the surface of the wire is subjected to Ag plating or Sn plating to obtain an Ag plated copper wire or an Sn plated copper wire. The diameter of the wire to be manufactured here is, for example, 0.46 mm, 0.76 mm, and 1.08 mm when the core material for manufacturing a guiding catheter for treatment is used. In the case of a core material, for example, it is 1.80 mm.
そして、このＡｇメッキ銅線あるいはＳｎメッキ銅線を芯材とし、その外周に樹脂を塗布する。塗布する樹脂の厚みは例えば２０〜３０μｍである。塗布する樹脂は、ガイディングカテーテル用芯材の場合は例えばＰＴＦＥ（ポリテトラフルオロエチレン）で、４００℃程度に加熱し液状体として塗布し、血管造影用カテーテル用芯材の場合は、例えばナイロンで、２００℃程度に加熱し液状体として塗布する。 Then, this Ag plated copper wire or Sn plated copper wire is used as a core material, and a resin is applied to the outer periphery thereof. The thickness of resin to apply is 20-30 micrometers, for example. The resin to be applied is PTFE (polytetrafluoroethylene), for example, in the case of a guiding catheter core, and is applied as a liquid by heating to about 400 ° C., and in the case of an angiographic catheter core, for example, nylon. And heated to about 200 ° C. and applied as a liquid.
そして、塗布した樹脂上に網状に編んだブレード線（ＳＵＳ等の丸線あるいは平線）を巻き付け、そのブレード線上にナイロン（又はウレタン）を塗布する。塗布するナイロン（又はウレタン）の厚みは例えば５０〜６０μｍである。 Then, a braided braided wire (round wire such as SUS or flat wire) is wound on the applied resin, and nylon (or urethane) is coated on the braided wire. The thickness of nylon (or urethane) to be applied is, for example, 50 to 60 μm.
その後、真直加工しながら所望の長さに切断する。切断する長さは例えば２ｍである。そして、切断した芯材の両端の樹脂を剥がし、片端をチャッキングして固定し、片端を人力等で引っ張り、芯材を伸ばして縮径し、樹脂から剥離させて芯材を引き抜く。 Thereafter, it is cut into a desired length while being straightened. The length to cut is 2 m, for example. Then, the resin at both ends of the cut core material is peeled off, one end is chucked and fixed, the one end is pulled by human power, the core material is stretched to reduce the diameter, and the core material is pulled out by peeling from the resin.
上述のように、芯材の外周に樹脂の被覆層を形成し、その後、芯材を引き抜いてカテーテルチューブを製造するのに使用される芯材は、従来、ＡｇメッキあるいＳｎメッキした銅線が一般的で、ＡｇメッキやＳｎメッキが必要であるためコストが高い。また、Ａｇメッキ銅線やＳｎメッキ銅線は非常に柔らかくて、ハンドリング（取り扱い）時に芯材表面にキズがつきやすい。そして、そのキズは凹状であるため、芯材に樹脂を塗布した後、芯材を取り去って製造したカテーテルチューブの内面に芯材の傷に沿った凸状の膨らみができ、これがガイドワイヤ等のスムーズな挿入を阻害するという問題が生ずる。 As described above, a core material used for manufacturing a catheter tube by forming a resin coating layer on the outer periphery of a core material and then drawing the core material is conventionally an Ag-plated or Sn-plated copper wire. However, since Ag plating or Sn plating is necessary, the cost is high. Further, the Ag-plated copper wire and the Sn-plated copper wire are very soft and are easily scratched on the surface of the core material during handling (handling). And since the scratch is concave, after the resin is applied to the core material, the inner surface of the catheter tube manufactured by removing the core material can form a convex bulge along the wound of the core material, which is a guide wire or the like. The problem of hindering smooth insertion arises.
本発明は、低荷重で伸び、樹脂にくっつきにくく、真直性も容易に出せ、キズがつきにくく、製造が容易で、安価な、線状の芯材の外周に樹脂の被覆層を形成した後、芯材を引き抜いてカテーテルチューブを製造するのに好適なカテーテルチューブ製造用芯材およびその製造方法を提供することを目的とする。 After forming a resin coating layer on the outer periphery of a linear core material, the present invention extends at a low load, hardly sticks to the resin, can be easily straightened, is not easily scratched, is easy to manufacture, and is inexpensive. Another object of the present invention is to provide a catheter tube manufacturing core material suitable for manufacturing a catheter tube by drawing out the core material, and a manufacturing method thereof.
本発明に係るカテーテルチューブ製造用芯材は、線状の芯材の外周に樹脂の被覆層を形成した後、芯材を引き抜いて樹脂からなるカテーテルチューブを製造するのに使用する芯材であって、母材が炭素含有量が０．０２重量％以下の電磁軟鉄で、表面にＮｉメッキが施されてＮｉメッキ層が形成されていることを特徴とする。 The core material for producing a catheter tube according to the present invention is a core material used for producing a catheter tube made of a resin by forming a resin coating layer on the outer periphery of a linear core material and then pulling out the core material. The base material is electromagnetic soft iron having a carbon content of 0.02% by weight or less , and the surface is Ni-plated to form a Ni-plated layer.
この芯材は、母材が軟鉄で、それ自体安価である。そして、柔らかくて低荷重で伸びるため、引き抜き易く、また、柔らかいので真直性も容易に出せる。真直加工は、ロータリー矯正、ローラー矯正、あるいは張力をかけながら溶体化処理をする等、いろいろな方法がある。真直加工しながら所定の長さに切断することもできる。また、軟鉄は容易に酸化するが、Ｎｉメッキにより十分な防錆効果が得られるためコストが安くて済み、被覆した樹脂から芯材を引き抜く際に酸化物が剥がれて樹脂に付着するようなことがなくなる。そして、このカテーテルチューブ製造用芯材は、Ｎｉメッキを施したことにより、芯材表面が硬くなり、キズがつきにくくなる。そのため、芯材表面のキズが原因でカテーテルチューブの内面にガイドワイヤ等のスムーズな挿入を阻害するような膨らみができるのを防止することができる。また、このカテーテルチューブ製造用芯材は、高温強度が大きく、樹脂を加熱し液状体として塗布する際に芯材に負荷する張力を大きくすることができ、チューブ内径の精度を高めることができる。 In this core material, the base material is soft iron, and is itself inexpensive. And since it is soft and stretches with a low load, it is easy to pull out, and since it is soft, straightness can be easily obtained. There are various methods for straight processing, such as rotary correction, roller correction, or solution treatment while applying tension. It can also be cut into a predetermined length while straightening. Soft iron easily oxidizes, but Ni plating provides a sufficient rust-preventive effect, so the cost is low, and the oxide peels off and adheres to the resin when the core is pulled out from the coated resin. Disappears. And since this core material for catheter tube manufacture gave Ni plating, the surface of a core material becomes hard and it becomes difficult to be damaged. Therefore, it is possible to prevent bulges that hinder smooth insertion of a guide wire or the like on the inner surface of the catheter tube due to scratches on the surface of the core material. Moreover, this catheter tube manufacturing core material has high strength at high temperatures, can increase the tension applied to the core material when the resin is heated and applied as a liquid, and the accuracy of the inner diameter of the tube can be increased.
ここで、母材である軟鉄は、炭素含有量が０．０３重量％未満（例えば炭素含有量が０．０２重量％以下の電磁軟鉄）であるのがよい。炭素含有量が０．０３重量％以上では伸線前の熱処理（軟化焼鈍）で焼きが入って硬化してしまう可能性があるが、０．０３重量％未満ではその虞が少ない。 Here, the soft iron as the base material may have a carbon content of less than 0.03% by weight (for example, electromagnetic soft iron having a carbon content of 0.02% by weight or less) . If the carbon content is 0.03% by weight or more, there is a possibility that the heat treatment (softening annealing) before wire drawing will cause baking and hardening, but if it is less than 0.03% by weight, there is less concern.
また、芯材表面のＮｉメッキ層の厚みは、１〜５μｍであるのがよい。Ｎｉメッキ層の厚みが１μｍ未満では、防錆効果が十分でなく、衝撃等でキズがつく虞もあるが、Ｎｉメッキ層の厚みが１〜５μｍあれば、十分な防錆効果を確保でき、また、通常の取り扱いでキズがつくことはほぼない。また、Ｎｉメッキ層の厚みが５μｍを超えると、芯材の低荷重での伸びが悪くなる。 The thickness of the Ni plating layer on the surface of the core material is preferably 1 to 5 μm. If the thickness of the Ni plating layer is less than 1 μm, the rust prevention effect is not sufficient, and there is a risk of scratching due to impact or the like, but if the thickness of the Ni plating layer is 1 to 5 μm, a sufficient rust prevention effect can be secured, Also, there is almost no scratch on normal handling. On the other hand, when the thickness of the Ni plating layer exceeds 5 μm, the elongation of the core material at a low load is deteriorated.
そして、この芯材は、Ｎｉメッキ層の内側に、Ｆｅ中にＮｉが拡散してＦｅ−Ｎｉ合金となった拡散層が形成されているのがよい。Ｎｉメッキ層の内側に、Ｆｅ中にＮｉが拡散してなるＦｅ−Ｎｉ合金が形成されていることで、Ｎｉメッキ層と母材である軟鉄との結合が強固となり、Ｎｉメッキ層の剥離が防止される。 In this core material, it is preferable that a diffusion layer in which Ni diffuses in Fe to become an Fe—Ni alloy is formed inside the Ni plating layer. Since the Fe-Ni alloy formed by diffusing Ni in Fe is formed inside the Ni plating layer, the bond between the Ni plating layer and the soft iron as a base material becomes strong, and the Ni plating layer is peeled off. Is prevented.
また、本発明に係るカテーテルチューブ製造用芯材の製造方法は、線状の芯材の外周に樹脂の被覆層を形成した後、芯材を引き抜いて前記樹脂からなるカテーテルチューブを製造するのに使用する芯材の製造方法であって、炭素含有量が０．０２重量％以下の電磁軟鉄を、熱処理後、伸線加工して所定の線径（０．４〜２ｍｍ）を有する線材とし、該線材表面にＮｉメッキを施し、次いで、熱処理してＦｅ中にＮｉを拡散させることにより、表面にＮｉメッキ層が形成され該Ｎｉメッキ層の内側にＦｅ−Ｎｉ合金が形成されたカテーテルチューブ製造用芯材を製造することを特徴とする。 The method for manufacturing a core material for manufacturing a catheter tube according to the present invention is a method for manufacturing a catheter tube made of the resin by forming a resin coating layer on the outer periphery of a linear core material and then pulling out the core material. A method for producing a core material to be used, in which electromagnetic soft iron having a carbon content of 0.02% by weight or less is subjected to a wire drawing process after heat treatment to have a predetermined wire diameter (0.4 to 2 mm), Manufacturing of a catheter tube in which Ni is plated on the surface of the wire and then Ni is diffused in Fe by heat treatment to form a Ni plated layer on the surface and an Fe-Ni alloy formed on the inner side of the Ni plated layer It is characterized by manufacturing a core material.
軟鉄は、炭素含有量が０．０３重量％未満（例えば炭素含有量が０．０２重量％以下の電磁軟鉄）であるのがよい。また、Ｎｉメッキ層の厚みは、１〜５μｍであるのがよい。そして、伸線前の熱処理は、軟化焼鈍で、不活性ガス中、７００℃以上で行うのがよい。伸線加工後の線材の線径は、０．４〜２ｍｍとするのが好適である。また、メッキ後の熱処理は、拡散焼鈍で、不活性ガス中、６００〜１０００℃で行うのがよい。 The soft iron may have a carbon content of less than 0.03% by weight (for example, electromagnetic soft iron having a carbon content of 0.02% by weight or less) . The thickness of the Ni plating layer is preferably 1 to 5 μm. The heat treatment before wire drawing is preferably performed by softening annealing at 700 ° C. or higher in an inert gas. The wire diameter of the wire after drawing is preferably 0.4 to 2 mm. The heat treatment after plating is preferably performed by diffusion annealing at 600 to 1000 ° C. in an inert gas.
この方法で、母材が軟鉄で、表面にＮｉメッキが施され、Ｎｉメッキ層の内側に、Ｆｅ中にＮｉが拡散してＦｅ−Ｎｉ合金が形成されたカテーテルチューブ製造用芯材を容易に製造できる。 By this method, a catheter tube manufacturing core material in which the base material is soft iron, Ni plating is applied to the surface, and Ni is diffused into Fe inside the Ni plating layer to form an Fe—Ni alloy. Can be manufactured.
このように本発明によれば、線状の芯材の外周に樹脂の被覆層を形成した後、芯材を引き抜いてカテーテルチューブを製造するのに使用する芯材を、安価で、低荷重で伸びて、樹脂塗布後に芯材を容易に引き抜くことができ、柔らかくて、容易に真直性を出すことができ、錆び難くて、樹脂から芯材を引き抜く際に樹脂に酸化物が付着するのを防止でき、芯材表面が硬くてキズが付き難く、カテーテルチューブの内面にガイドワイヤ等のスムーズな挿入を阻害するような膨らみができるのを防止することができ、また、高温強度が大きく、樹脂を塗布する際の芯材に負荷する張力を大きくしてチューブ内径の精度を高めることができるものとすることができる。そして、特に、軟鉄を母材とする芯材の表面のＮｉメッキ層の内側に、Ｆｅ中にＮｉが拡散してなるＦｅ−Ｎｉ合金が形成されているものとすることで、Ｎｉメッキ層と母材である軟鉄との結合を強固とし、Ｎｉメッキ層の剥離を防止することができる。 As described above, according to the present invention, after forming the resin coating layer on the outer periphery of the linear core material, the core material used for manufacturing the catheter tube by pulling out the core material can be manufactured at low cost and with low load. The core material can be easily pulled out after applying the resin, it is soft, can be easily straightened, is not easily rusted, and the oxide adheres to the resin when the core material is pulled out from the resin. It is possible to prevent the core material surface from being hard and difficult to be scratched, and to prevent the inner surface of the catheter tube from bulging so as to hinder the smooth insertion of a guide wire or the like. It is possible to increase the tension applied to the core material when applying the coating to increase the accuracy of the tube inner diameter. And in particular, it is assumed that an Fe-Ni alloy formed by diffusing Ni in Fe is formed inside the Ni plating layer on the surface of the core material having soft iron as a base material. The bond with soft iron, which is a base material, can be strengthened, and the Ni plating layer can be prevented from peeling off.
図１および図２は本発明の実施形態の一例を示している。図１はカテーテルチューブ製造用芯材および該芯材を用いたカテーテルチューブ製造方法の説明図（ａ）〜（ｃ）、図２はカテーテルチューブ製造用芯材の製造方法の説明図である。 1 and 2 show an example of an embodiment of the present invention. FIG. 1 is an explanatory diagram (a) to (c) of a catheter tube manufacturing core material and a catheter tube manufacturing method using the core material, and FIG. 2 is an explanatory diagram of a manufacturing method of a catheter tube manufacturing core material.
図１の（ａ）は、この実施形態のカテーテルチューブ製造用芯材（以下、単に芯材という）１の断面構造を示している。この芯材１は、炭素含有量が０．０３重量％未満の軟鉄、例えば炭素含有量が０．０２重量％以下の電磁軟鉄（ＪＩＳ）の線材２の表面に、Ｎｉ（ニッケル）電解メッキにより厚みが１〜５μｍのＮｉメッキ層３が形成されたものであり、芯材表面のＮｉメッキ層３の内側に、Ｆｅ中にＮｉが拡散してＦｅ−Ｎｉ合金となった拡散層４が形成されている。
FIG. 1A shows a cross-sectional structure of a catheter tube manufacturing core material (hereinafter simply referred to as a core material) 1 of this embodiment. The core material 1 is made of Ni (nickel) electrolytic plating on the surface of soft iron having a carbon content of less than 0.03% by weight, for example, electromagnetic soft iron (JIS)
この芯材１は、図２に示すように、軟化焼鈍、伸線加工、Ｎｉ電解メッキ、拡散焼鈍の順に各工程ａ〜ｄの処理を行って製造する。製造方法の詳細は次のとおりである。 As shown in FIG. 2, the core material 1 is manufactured by performing the processes a to d in the order of softening annealing, wire drawing, Ni electrolytic plating, and diffusion annealing. The details of the manufacturing method are as follows.
まず、軟化焼鈍の工程ａで、軟鉄（例えば、炭素含有量が０．０２重量％の電磁軟鉄）の線材を、不活性ガス中、７００℃以上で軟化焼鈍し、伸線加工の工程ｂで、伸線（伸線加工）を繰り返し、所定の線径（０．４〜２ｍｍ）を有する長尺の線材２を製造する。
First, in softening annealing step a, soft iron (for example, electromagnetic soft iron with a carbon content of 0.02 wt%) is annealed at 700 ° C. or higher in an inert gas, and in wire drawing step b. Then, wire drawing (drawing process) is repeated to produce a
そして、Ｎｉ電解メッキの工程ｃで、所定の線径（０．４〜２ｍｍ）となった線材２の表面にＮｉ電解メッキを施し、厚み１〜５μｍのＮｉメッキ層３を形成する。
Then, in the Ni electroplating step c, Ni electroplating is applied to the surface of the
そして、拡散焼鈍の工程ｄで、不活性ガス中、６００〜１０００℃での拡散焼鈍を行って、芯材表面のＮｉメッキ層３の内側に、Ｆｅ中にＮｉが拡散してＦｅ−Ｎｉ合金となった拡散層４を形成する。
Then, in the diffusion annealing step d, diffusion annealing is performed in an inert gas at 600 to 1000 ° C., and Ni diffuses in Fe inside the
こうして製造した線状の芯材１は、外周に樹脂を塗布して被覆層を形成し、その後、芯材１を引き抜いてカテーテルチューブを製造するのに使用する。そのカテーテルチューブの製造方法の詳細は次のとおりである。 The linear core material 1 manufactured in this manner is used to manufacture a catheter tube by applying a resin to the outer periphery to form a coating layer, and then pulling out the core material 1. The details of the manufacturing method of the catheter tube are as follows.
まず、図１の（ｂ）に示すように、芯材１の外周に樹脂を塗布し、樹脂の内側被覆層５を形成する。内側被覆層５の厚みは例えば２０〜３０μｍである。塗布する樹脂は、例えばＰＴＦＥ（ポリテトラフルオロエチレン）等のフッ素樹脂で、４００℃程度に加熱し液状体として塗布する。その際、カテーテルチューブの内径精度を上げるために芯材１に所定の張力を負荷する。
First, as shown in FIG. 1B, a resin is applied to the outer periphery of the core material 1 to form an
そして、この内側被覆層５の樹脂上に、網状に編んだブレード線６（ＳＵＳ等の丸線あるいは平線）を巻き付け、そのブレード線６上に樹脂（ナイロン又はウレタン）を塗布し、樹脂（ナイロン又はウレタン）の外側被覆層７を形成する。外側被覆層７の厚みは例えば５０〜６０μｍである。
Then, a braided braided wire 6 (SUS or other round wire or flat wire) is wound on the resin of the
その後、真直加工しながら所定の長さ（例えば２ｍ）に切断する。そして、切断した芯材１の両端の被覆層５，７の樹脂とブレード線６を剥がし、芯材１の一端をチャッキングで固定し、他端を人力等で引っ張って芯材１を伸ばし、縮径して芯材１を引き抜く。
Then, it cut | disconnects to predetermined length (for example, 2 m), carrying out straight processing. Then, the resin and the
こうして、図１の（ｃ）に示す、被覆層５，７の樹脂とブレード線６とからなる中空状のカテーテルチューブ８が得られる。
In this way, a
この実施形態の芯材１は、母材が軟鉄で、低荷重で伸びるため、樹脂塗布後に芯材１を容易に引き抜くことができ、また、柔らかいので容易に真直性を出すことができる。そして、Ｎｉメッキを施しているため、錆び難く、芯材１を引き抜く際に樹脂５に酸化物が付着するのを防止でき、また、表面が硬くてキズが付き難く、カテーテルチューブの内面にガイドワイヤ等のスムーズな挿入を阻害するような膨らみができるのを防止することができる。また、この芯材１は、高温強度が大きく、樹脂５，７を塗布する際の芯材１に負荷する張力を大きくしてチューブ内径の精度を高めることができるものとすることができる。また、Ｎｉメッキ層３は、内側に、Ｆｅ中にＮｉが拡散してＦｅ−Ｎｉ合金となった拡散層４が形成されているため、結合が強固で、剥離の虞が少ない。
Since the base material 1 of this embodiment is made of soft iron and stretches with a low load, the core material 1 can be easily pulled out after application of the resin, and since it is soft, straightness can be easily obtained. Since the Ni plating is applied, it is difficult to rust, and it is possible to prevent the oxide from adhering to the
以上、実施形態の一例を説明したが、本発明はこれに限定されるものではなく、様々な態様で実施することができる。 As mentioned above, although an example of embodiment was demonstrated, this invention is not limited to this, It can implement in various aspects.
表１は、線径０．４ｍｍの０．０２Ｃ電磁軟鉄線材（炭素含有量が０．０２重量％）を、不活性ガス中、７００℃以上での軟化焼鈍した後、伸線加工して、線径１．８ｍｍの線材２とし、それをスルファミン酸浴でＮｉ電解メッキして、表面に厚み２μｍのＮｉメッキ層３を形成し、それを不活性ガス中で７００℃×５分のインライン拡散焼鈍を行って拡散層４を形成した本発明の芯材１の試料について、物性試験を行った結果を、従来の芯材（線径１．８ｍｍのＡｇメッキ銅線）の物性と対比して示している。なお、この実施例では拡散焼鈍をインラインで行っているが、この熱処理はピット型でもよい。
従来のＡｇメッキ銅線の芯材は、引張強度：２９９ＭＰａ、破断伸び：２２％、４００℃での強度：１４３ＭＰａであるのに対し、本発明の芯材試料は、引張強度：３１０ＭＰａ、破断伸び：２４％、４００℃での強度：２４３ＭＰａである。 The core material of the conventional Ag-plated copper wire has a tensile strength: 299 MPa, a breaking elongation: 22%, and a strength at 400 ° C .: 143 MPa, whereas the core material sample of the present invention has a tensile strength: 310 MPa, a breaking elongation. : 24%, strength at 400 ° C .: 243 MPa.
本発明の芯材１（試料）は、引張強度および破断伸びについては従来のＡｇメッキ銅線の芯材と大差がなく、樹脂塗布後の芯材の抜き易さはＡｇメッキ銅線の芯材と同等である。そして、本発明の芯材試料は、４００℃での強度が従来のＡｇメッキ銅線の芯材に比べて大幅に大きい。このように４００℃での強度が大きいことで、カテーテルチューブ製造時のフッ素樹脂コーティング温度（約４００℃）において芯材１に高い張力を負荷することができ、チューブ内径の精度を高めることができる。 The core material 1 (sample) of the present invention is not much different from the core material of conventional Ag-plated copper wire in terms of tensile strength and elongation at break, and the ease of removal of the core material after resin application is the core material of Ag-plated copper wire Is equivalent to And the core material sample of this invention has a significantly larger strength at 400 ° C. than the core material of a conventional Ag-plated copper wire. Since the strength at 400 ° C. is large as described above, a high tension can be applied to the core material 1 at the fluororesin coating temperature (about 400 ° C.) at the time of manufacturing the catheter tube, and the accuracy of the tube inner diameter can be increased. .
また、この本発明の芯材試料について、温度４０℃、湿度８０％での恒温恒湿試験（２４時間）で防錆効果を試験した。その結果、錆は発生していなかった。 The core material sample of the present invention was tested for rust prevention effect by a constant temperature and humidity test (24 hours) at a temperature of 40 ° C. and a humidity of 80%. As a result, no rust was generated.
１ カテーテルチューブ製造用芯材
２ 軟鉄の線材
３ Ｎｉメッキ層
４ 拡散層
５ 内側被覆層（樹脂）
６ ブレード線
７ 外側被覆層（樹脂）
８ カテーテルチューブ
ａ 軟化焼鈍の工程
ｂ 伸線加工の工程
ｃ Ｎｉ電解メッキの工程
ｄ 拡散焼鈍の工程
DESCRIPTION OF SYMBOLS 1 Core material for
6
8 Catheter tube a Softening annealing process b Drawing process c Ni electroplating process d Diffusion annealing process
Claims (4)
母材が炭素含有量が０．０２重量％以下の電磁軟鉄で、表面にＮｉメッキが施されてＮｉメッキ層（３）が形成されていることを特徴とするカテーテルチューブ製造用芯材（１）。 After forming the resin coating layers (5, 7) on the outer periphery of the linear core material (1), the core material (1) is pulled out and used to manufacture the catheter tube (8) made of the resin. The core (1),
Catheter tube manufacturing core material (1) characterized in that the base material is electromagnetic soft iron having a carbon content of 0.02% by weight or less and Ni plating is applied to the surface to form a Ni plating layer (3). ).
炭素含有量が０．０２重量％以下の電磁軟鉄を、熱処理後、伸線加工して所定の線径を有する線材とし、該線材表面にＮｉメッキを施し、次いで、熱処理してＦｅ中にＮｉを拡散させることにより、表面にＮｉメッキ層（３）が形成され該Ｎｉメッキ層（３）の内側にＦｅ−Ｎｉ合金となった拡散層（４）が形成されたカテーテルチューブ製造用芯材（１）を製造することを特徴とするカテーテルチューブ製造用芯材（１）の製造方法。 After forming the resin coating layers (5, 7) on the outer periphery of the linear core material (1), the core material (1) is pulled out and used to manufacture the catheter tube (8) made of the resin. A manufacturing method of the core material (1),
Electromagnetic soft iron having a carbon content of 0.02% by weight or less is subjected to a heat treatment, followed by wire drawing to obtain a wire having a predetermined wire diameter. Ni wire is applied to the surface of the wire, and then heat treatment is performed to add Ni in Fe. The core material for manufacturing a catheter tube in which the Ni plating layer (3) is formed on the surface and the diffusion layer (4) made of Fe—Ni alloy is formed inside the Ni plating layer (3) ( 1) is manufactured, The manufacturing method of the core material for catheter tube manufacture (1) characterized by the above-mentioned.
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