JP5027651B2 - Vascular catheter - Google Patents
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- JP5027651B2 JP5027651B2 JP2007506026A JP2007506026A JP5027651B2 JP 5027651 B2 JP5027651 B2 JP 5027651B2 JP 2007506026 A JP2007506026 A JP 2007506026A JP 2007506026 A JP2007506026 A JP 2007506026A JP 5027651 B2 JP5027651 B2 JP 5027651B2
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- 238000012423 maintenance Methods 0.000 claims description 14
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
本発明は、血管を始めとする脈管内に挿入される脈管カテーテル、およびその製造方法に関する。 The present invention relates to a vascular catheter that is inserted into a blood vessel including a blood vessel, and a method for manufacturing the same.
生体管腔に挿入されるカテーテル（特にＥＰＢＤによる総胆管結石治療用のもの）として、下記特許文献１に記載のものが知られている。このカテーテルでは、結石を把持する把持部を引き込む際、先端が周方向に裂けようとするが、これを防止するため、先端に補強材としての金属リングが付設される（第００１５段落）。
しかし、このようなカテーテルを例えば血管用としてそのまま応用すると、次のような問題を生ずる可能性がある。即ち、血管カテーテルにおいては、血管の損傷を防止するため、最先端部分（チップ）が、特に柔軟性の高いものとして構成される。一方、血管は複雑に屈曲しており、狭窄のため患部の血管内径が狭くなっている場合がある。また、患部が石灰化により硬化している場合がある。このような患部へガイドワイヤーに沿わせて拡張バルーンカテーテルをデリバリーする場合、血管の屈曲半径が小さいと、チップの先端が屈曲半径の外側へ縦長に変形するため、カテーテル先端の裂け防止のためのリングが配設されていたとしても最先端の形状がラジアル方向へ変形し、ガイドワイヤからチップ最先端が浮いた状態になり（図１０の部分Ｘ）、チップの最先端が血管壁に当たりながら進むため、血管壁を削り損傷させる可能性がある。 However, if such a catheter is applied as it is, for example, for blood vessels, the following problems may occur. That is, in the vascular catheter, in order to prevent damage to the blood vessel, the most advanced portion (chip) is configured to be particularly flexible. On the other hand, the blood vessel is bent in a complicated manner, and the inner diameter of the affected blood vessel may be narrow due to stenosis. Moreover, the affected part may be hardened by calcification. When delivering a dilatation balloon catheter along a guide wire to such an affected area, if the bend radius of the blood vessel is small, the tip end of the tip is deformed vertically to the outside of the bend radius. Even if a ring is provided, the most advanced shape is deformed in the radial direction, and the tip is lifted from the guide wire (part X in FIG. 10), and the tip is advanced while hitting the blood vessel wall. Therefore, there is a possibility that the blood vessel wall is scraped and damaged.
また、患部の血管内径が狭くなっている場合や石灰化により硬化している場合には、チップの最先端が患部に当たると、チップの最先端が潰れて引っかかり、患部を通過できなくなる可能性がある。 In addition, when the blood vessel inner diameter of the affected part is narrowed or hardened by calcification, if the tip of the tip hits the affected part, the tip of the tip may be crushed and caught and may not pass through the affected part. is there.
そこで、本発明は、このような事情に鑑みてなされたもので、その目的は、患部へのデリバリー性能を保持しながら、デリバリー中の血管等の脈管壁の損傷を防止することができ、患部の通過も確実に行える脈管カテーテル、およびその製造方法を提供することにある。 Therefore, the present invention was made in view of such circumstances, the purpose of which can prevent damage to the vascular wall such as blood vessels during delivery, while maintaining the delivery performance to the affected area, An object of the present invention is to provide a vascular catheter that can reliably pass through an affected area, and a manufacturing method thereof.
上記目的を達成するため、請求項１の発明は、内部にルーメンを有するカテーテル本体の先端部に、これより基端側と比較して柔軟性の高い筒状のチップを備えた脈管カテーテルにおいて、該チップは、先細となるように形成され、該チップの先端側に、チップの長軸方向の可撓性を損なわない状態で、ラジアル方向の外力に対してチップ最先端のルーメンの開口形状を維持する形状維持体を配置し、前記形状維持体が、リング状またはコイル状であることを特徴とするものである。 In order to achieve the above object, a first aspect of the present invention is a vascular catheter having a tubular tip having a higher flexibility than a proximal end side at a distal end portion of a catheter body having a lumen therein. The tip is formed to be tapered, and the tip of the tip has a lumen opening shape at the tip of the tip against the external force in the radial direction without impairing the flexibility in the major axis direction of the tip. A shape maintaining body that maintains the shape is disposed, and the shape maintaining body is ring-shaped or coil-shaped .
更に、上記目的に加えて、安全性や操作性を一層向上する目的を達成するため、請求項２記載の発明は、上記発明において、前記形状維持体が、前記チップにおける先端部の内面または外面に配置されているとともに、前記チップにおける先端部の内側または外側に配置されたカバーによって被覆されていることを特徴とし、請求項３記載の発明は、上記発明にあって、前記形状維持体が、前記チップにおける内部に配置されていることを特徴とする。
Furthermore, in order to achieve the object of further improving safety and operability in addition to the above object, the invention according to
本発明の脈管カテーテルでは、患部へのデリバリーに際して、長さ方向に形状維持体が可撓性を有し、従って屈曲半径の小さな血管においても、チップはガイドワイヤに沿って柔軟に追従することができる一方、ラジアル方向に剛性を有する。よってチップの最先端の広がりを抑制して血管損傷を防止することができ、更には石灰化した硬い患部や狭窄により血管内径が細くなった患部においてチップの最先端が潰れることなく確実に通過することができ、操作性および安全性の高い医療用具として極めて有用である。
In the vascular catheter of the present invention, the shape maintaining body has flexibility in the length direction during delivery to the affected area, and thus the tip can flexibly follow the guide wire even in a blood vessel having a small bending radius. On the other hand, it has rigidity in the radial direction. Therefore, the leading edge of the tip can be suppressed to prevent vascular damage, and the tip of the tip can be reliably passed without being crushed in a hard affected part that has been calcified or an affected part in which the inner diameter of the blood vessel has become narrow due to stenosis. it can, Ru extremely useful der as operability and high safety medical devices.
以下、本発明に係る実施の形態について、適宜図面を参照して説明する。 Hereinafter, embodiments according to the present invention will be described with reference to the drawings as appropriate.
［脈管カテーテルに係る第１実施形態］
図１（ａ）は本発明の第１実施形態に係る脈管カテーテル（の一例としての血管カテーテル）（Ｃ１）の先端側の長手方向断面図、図１（ｂ）はＡ−Ａ線断面図である。[First embodiment according to vascular catheter]
1A is a longitudinal sectional view of the distal end side of a vascular catheter (an vascular catheter as an example) (C1) according to the first embodiment of the present invention, and FIG. 1B is a sectional view taken along line AA. It is.
図１に示すように、脈管カテーテル（Ｃ１）は、インナーチューブ（２）およびこれを内側に含むアウターチューブ（３）からなるカテーテル本体（７）を有している。インナーチューブ（２）外側であってアウターチューブ（３）内側は副ルーメン（１０）となっており、インナーチューブ（２）内側は主ルーメン（１１）となっている。 As shown in FIG. 1, the vascular catheter (C1) has a catheter body (7) including an inner tube (2) and an outer tube (3) including the inner tube (2). Outside the inner tube (2), the inner side of the outer tube (3) is a sub-lumen (10), and the inner side of the inner tube (2) is a main lumen (11).
インナーチューブ（２）先端は、アウターチューブ（３）先端よりも僅かに突出しており、インナーチューブ（２）先端縁外周部からアウターチューブ（３）先端縁外周部にかけて、バルーン（１）が取り付けられている。なお、バルーン（１）の内側におけるインナーチューブ（２）の外周部には、バルーン（１）の有効長を示すＸ線不透過マーカ（９）が設置されている。 The tip of the inner tube (2) protrudes slightly from the tip of the outer tube (3), and the balloon (1) is attached from the outer periphery of the inner tube (2) to the outer periphery of the outer edge of the outer tube (3). ing. An X-ray opaque marker (9) indicating the effective length of the balloon (1) is provided on the outer peripheral portion of the inner tube (2) inside the balloon (1).
また、インナーチューブ（２）先端には、インナーチューブ（２）より柔軟性の高い筒状のチップ（４）が、主ルーメン（１１）をインナーチューブ（２）から連続して有する状態で取り付けられている。チップ（４）は、バルーン（１）の有効長より短い程の短尺な部材であって、外面がインナーチューブ（２）先端から連続するとともに先細となるように形成されている。 Further, a cylindrical tip (4) having higher flexibility than the inner tube (2) is attached to the tip of the inner tube (2) in a state where the main lumen (11) is continuously provided from the inner tube (2). ing. The tip (4) is a short member that is shorter than the effective length of the balloon (1), and has an outer surface that is continuous from the tip of the inner tube (2) and is tapered.
そして、チップ（４）における先端側（最先端部）には、図２（ａ）にも示す、リング状の形状維持体（５）が配置されている。形状維持体（５）の材質は、金または白金またはこれらを主成分とする合金、ステンレス、ポリイミド等の高強度樹脂（硬質樹脂を含む）、または樹脂にカーボンナノチューブを混合した（カーボンナノチューブをフィラーとした）複合材であり、非常に剛性の高いものであるので、小さな部材であってもラジアル方向に充分な剛性を有し、デリバリー中における屈曲に伴いラジアル方向に外力を受けたとしても、そのリング形状が楕円状につぶれることはなく、元の形状を維持するようになっている。また、形状維持体（５）がつぶれないことにより、チップ（４）における主ルーメン（１１）の先端開口形状が維持されることとなる。一方、形状維持体（５）はリング状であるため、チップ（４）の長軸方向の可撓性は損なわれない。 And the ring-shaped shape maintenance body (5) shown also to Fig.2 (a) is arrange | positioned at the front end side (front-end | tip part) in a chip | tip (4). The material of the shape maintaining body (5) is gold or platinum or an alloy containing these as a main component, stainless steel, polyimide or other high-strength resin (including hard resin), or a resin mixed with carbon nanotubes (carbon nanotubes as fillers) Because it is a composite material and is extremely high in rigidity, even a small member has sufficient rigidity in the radial direction, and even if it receives external force in the radial direction due to bending during delivery, The ring shape is not crushed into an ellipse, and the original shape is maintained. Moreover, when the shape maintaining body (5) is not crushed, the tip opening shape of the main lumen (11) in the tip (4) is maintained. On the other hand, since the shape maintaining body (5) is ring-shaped, the flexibility in the major axis direction of the tip (4) is not impaired.
そして、この形状維持体（５）が次のようにしてチップ（４）に埋設されることで、脈管カテーテル（Ｃ１）の先端が製造される。即ち、チップ（４）の先端部内側には、拡径部が形成されて、筒状のカバー（６）が丁度入り込むようになっており、カバー（６）の外側とチップ（４）の拡径部内側とで形状維持体（５）を挟むことで、形状維持体（５）がカバー（６）で覆われる。 And the front-end | tip of a vascular catheter (C1) is manufactured by embedding this shape maintenance body (5) in a chip | tip (4) as follows. That is, an enlarged diameter portion is formed inside the tip end portion of the tip (4) so that the cylindrical cover (6) just enters, and the outside of the cover (6) and the expansion of the tip (4) are arranged. The shape maintaining body (5) is covered with the cover (6) by sandwiching the shape maintaining body (5) with the inside of the diameter portion.
以上の脈管カテーテル（Ｃ１）では、内部に副ルーメン（１０）および主ルーメン（１１）を有するカテーテル本体（７）の先端部に、これより基端側と比較して柔軟性の高いチップ（４）を備えており、チップ（４）の先端側に、チップ（４）の長軸方向の可撓性を損なわない状態で、ラジアル方向の外力に対してチップ（４）最先端の主ルーメン（１１）の開口形状を維持する形状維持体（５）を配置するため、図６に示すように、屈曲半径の小さな血管（Ｐ）をガイドワイヤ（Ｇ）上において通過する場合でも主ルーメン（１１）開口部が広がり出ることはなく、よって当該突出部による血管損傷を防止することができ、また当該突出部が掛かることによる硬化部分や細径部分の通過不能の事態を防止することができ、安全性および操作性を極めて高くすることができる。 In the vascular catheter (C1) described above, a tip having a higher flexibility than the proximal side than the distal end portion of the catheter body (7) having the auxiliary lumen (10) and the main lumen (11) inside ( 4), and the tip (4) has a leading edge on the tip (4) with respect to the external force in the radial direction without impairing the flexibility in the long axis direction of the tip (4). In order to arrange the shape maintaining body (5) that maintains the opening shape of (11), as shown in FIG. 6, even when the blood vessel (P) having a small bending radius passes on the guide wire (G), the main lumen ( 11) The opening does not spread out, so that it is possible to prevent blood vessel damage due to the protrusion, and it is possible to prevent the hardened portion and the small diameter portion from passing through due to the protrusion. , Safety and operation It can be very high sex.
また、形状維持体（５）が、チップ（４）における先端部の内面に配置されているとともに、チップ（４）における先端部の内側に配置されたカバー（６）によって被覆されているため、剛性の高い形状維持体（５）が露出せず、安全性を更に高めることが可能になる。 In addition, the shape maintaining body (5) is disposed on the inner surface of the tip portion of the chip (4) and is covered with the cover (6) disposed on the inner side of the tip portion of the chip (4). The highly rigid shape maintaining body (5) is not exposed, and the safety can be further improved.
［脈管カテーテルに係る第２実施形態］
図３は本発明の第２実施形態に係る脈管カテーテル（Ｃ２）の先端側の長手方向断面図である。この脈管カテーテル（Ｃ２）は、第１実施形態に係る脈管カテーテル（Ｃ１）と比べて、形状維持体の配置およびカバーの構成のみが相違する。即ち、脈管カテーテル（Ｃ２）の形状維持体（５）は、チップ（４）における先端縮径部の外面に配置されているとともに、当該先端縮径部の外側に配置された先端縮径部に収まるカバー（６ａ）によって被覆されている。このようなカバー（６ａ）によっても、安全性および操作性の高い脈管カテーテルを形成することができる。[Second embodiment according to vascular catheter]
FIG. 3 is a longitudinal sectional view of the distal end side of the vascular catheter (C2) according to the second embodiment of the present invention. This vascular catheter (C2) differs from the vascular catheter (C1) according to the first embodiment only in the arrangement of the shape maintaining body and the configuration of the cover. That is, the shape maintaining body (5) of the vascular catheter (C2) is disposed on the outer surface of the distal diameter-reduced portion of the tip (4) and is also disposed on the outer side of the distal diameter-reduced portion. Is covered with a cover (6a) that fits in With such a cover (6a), a vascular catheter with high safety and operability can be formed.
［脈管カテーテルに係るその他の実施形態］
続いて、上記実施形態において形状維持体のみを変更してなる各実施形態につき説明する。[Other Embodiments Related to Vascular Catheter]
Subsequently, each embodiment obtained by changing only the shape maintaining body in the above embodiment will be described.
即ち、形状維持体を、図２（ｂ）に示すように、一部途切れたリング形状とする。また、形状維持体を、図４（ａ）に示すように短尺パイプ状としたり、図４（ｂ）に示すように一部途切れた短尺パイプ状としたりする。これらによっても、長軸方向に可撓性がありかつラジアル方向に剛性の高い形状維持体を提供することができる。 That is, as shown in FIG. 2B, the shape maintaining body has a ring shape that is partially interrupted. Further, the shape maintaining body is formed into a short pipe shape as shown in FIG. 4A or a partially cut short pipe shape as shown in FIG. 4B. Also by these, it is possible to provide a shape maintaining body that is flexible in the long axis direction and highly rigid in the radial direction.
あるいは、形状維持体を、図５（ａ）に示すように密に詰まったコイル状としたり、図５（ｂ）に示すように僅かに間のある粗なコイル状としたり、図５（ｃ）に示すように全体が互いに異なる材質からなる複列巻きコイルからなるものとしたり、図５（ｄ）に示すように一部が互いに異なる材質からなる複列巻きコイルからなるものとしたり、図５（ｅ）に示すように互いに異なる材質である複層構造となっているものとしたり、図５（ｆ）に示すように短尺スパイラル状としたりする。これらによっても、長軸方向に可撓性がありかつラジアル方向に剛性の高い形状維持体を提供することができる。また、材質の異なる複数のものを採用したものにあっては、上記可撓性と剛性の調整を、材質の組合せや寸法比等によって調整することができる。 Alternatively, the shape maintaining body may be a tightly packed coil shape as shown in FIG. 5 (a), or a rough coil shape with a slight gap as shown in FIG. 5 (b). ) As shown in FIG. 5 (d), or as shown in FIG. 5 (d), a part of which is composed of a double row winding coil made of different materials. As shown in FIG. 5 (e), a multi-layer structure made of different materials is used, or as shown in FIG. 5 (f), a short spiral shape is used. Also by these, it is possible to provide a shape maintaining body that is flexible in the long axis direction and highly rigid in the radial direction. In addition, in a case where a plurality of different materials are adopted, the flexibility and rigidity can be adjusted by a combination of materials, a dimensional ratio, or the like.
なお、本発明の脈管カテーテルに係る実施形態は上記のものに限られることはなく、上記実施形態は次にそれぞれ例示するように様々に変更可能である。即ち、形状維持体の材質を、ニッケルチタン等の超弾性金属を初めとする他のものに変更する。また、複合樹脂につき、カーボンナノチューブに代えて、炭素繊維やガラス繊維等の高強度繊維や、カーボンパウダー、シリカ粉末を含むセラミック粉末等を混合したり、これらを適宜組み合わせて混合したりする（樹脂のフィラーをこれらのものに変える）。あるいは、チップを先細でなく各部にわたり同径のものとする。また、カバーを、拡径部ないし縮径部に収まらず、単に形状維持体を被覆するものとする。あるいは、形状維持体を、単線または撚り線に係る糸状とする。ここで、糸状の形状維持体として、延伸材または撚り線に係る糸状ポリマーを選択して良い。また、形状維持体やルーメン等の断面形状を楕円や多角形とする。あるいは、主複ルーメンを有するバルーンカテーテル以外の他のバルーンカテーテルないしは他の脈管カテーテルにおいて形状維持体等を導入する。 In addition, embodiment which concerns on the vascular catheter of this invention is not restricted to said thing, The said embodiment can be variously changed so that it may illustrate next, respectively. That is, the material of the shape maintaining body is changed to another material such as a super elastic metal such as nickel titanium. In addition, for the composite resin, instead of carbon nanotubes, high-strength fibers such as carbon fibers and glass fibers, ceramic powders including carbon powder and silica powder, or the like are mixed appropriately or mixed (resin Of these fillers). Alternatively, the tip is not tapered but has the same diameter over each part. Further, the cover does not fit in the enlarged diameter portion or the reduced diameter portion, and simply covers the shape maintaining body. Or let a shape maintenance body be the thread form which concerns on a single wire or a strand wire. Here, as the filamentous shape maintenance body, a filamentous polymer related to a stretched material or a stranded wire may be selected. Further, the cross-sectional shape of the shape maintaining body, the lumen, etc. is an ellipse or a polygon. Alternatively, a shape maintenance body or the like is introduced into another balloon catheter or other vascular catheter other than the balloon catheter having the main multiple lumen.
［脈管カテーテルの製造方法に係る実施形態］
図７は、図１、図３で示される脈管カテーテル（Ｃ１、Ｃ２）に係る上記製造方法とは異なる脈管カテーテルの製造方法の説明図である。この製造方法において、まず芯材（２１）に、これより融点の低い熱溶融樹脂製の被覆材（２２）を被覆し、被覆芯材（２３）を形成する。次に、図７（ａ）に示すように、軸（２４）に沿う状態で被覆芯材（２３）を密に巻き付ける。続いて、被覆芯材（２３）に、樹脂製の熱収縮チューブ（２５）を外挿する。なお、芯材（２１）は、例えば金属、樹脂、複合樹脂（フィラーを混合した樹脂）の延伸材あるいはこれらの撚り線、またはこれらの組合せ（複数材質の撚り線等）が選択されるが、単線または撚り線から成る糸状であることが好ましい。また、被覆芯材（２３）の巻き付けは、例えば手巻きや、一般のスプリング製造装置ないしコイル製造装置に係る巻き付け装置による。[Embodiment related to manufacturing method of vascular catheter]
FIG. 7 is an explanatory view of a manufacturing method of a vascular catheter different from the manufacturing method according to the vascular catheters (C1, C2) shown in FIGS. In this manufacturing method, first, the core material (21) is covered with a coating material (22) made of a hot-melt resin having a lower melting point to form a coated core material (23). Next, as shown to Fig.7 (a), a coating | coated core material (23) is wound tightly in the state along an axis | shaft (24). Subsequently, a resin heat-shrinkable tube (25) is extrapolated to the coated core material (23). As the core material (21), for example, a metal, a resin, a stretched material of a composite resin (a resin mixed with a filler), or a stranded wire thereof, or a combination thereof (a stranded wire of a plurality of materials) is selected. It is preferably a filament made of a single wire or a stranded wire. The coated core material (23) is wound by, for example, manual winding or a winding device according to a general spring manufacturing apparatus or coil manufacturing apparatus.
そして、熱収縮チューブ（２５）を、その外側に配置した電熱線（２６）により、被覆材（２２）の融点（ガラス転移点）以上、芯材（２１）の融点未満の温度を呈するように加熱する。熱収縮チューブ（２５）は、この加熱により、被覆材（２２）に熱を与えて被覆材（２２）を溶融させるとともに、自ら収縮して被覆材（２２）に圧力を加える。この後、熱収縮チューブ（２５）への加熱を停止し、熱収縮チューブ（２５）等が被覆材（２２）の融点未満の温度となるようにし、熱収縮チューブ（２５）を除去する。すると、図７（ｂ）に示すように、軸（２４）とほぼ同径のルーメンを有する筒状となった被覆材（２２）の内部に、螺旋状の芯材（２１）即ち形状維持体が位置するチップ（２７）が形成される。そしてこのチップ（２７）を、脈管カテーテルの先端に配置する。 The heat-shrinkable tube (25) exhibits a temperature not lower than the melting point (glass transition point) of the covering material (22) and lower than the melting point of the core material (21) by the heating wire (26) disposed on the outside thereof. Heat. The heat-shrinkable tube (25) heats the coating material (22) by this heating to melt the coating material (22), and contracts itself to apply pressure to the coating material (22). Thereafter, heating to the heat-shrinkable tube (25) is stopped so that the heat-shrinkable tube (25) or the like has a temperature lower than the melting point of the covering material (22), and the heat-shrinkable tube (25) is removed. Then, as shown in FIG. 7 (b), a spiral core material (21), that is, a shape maintaining body is formed inside the cylindrical covering material (22) having a lumen having the same diameter as the shaft (24). A chip (27) in which is located is formed. This tip (27) is then placed at the tip of the vascular catheter.
この脈管カテーテルの製造方法では、芯材（２１）の外部に、当該芯材（２１）より融点の低い被覆材（２２）を被覆して、被覆芯材（２３）を形成するとともに、当該被覆芯材（２３）を螺旋状に巻き、被覆材（２２）の融点以上、芯材（２１）の融点未満の温度となるように前記被覆芯材（２３）を加熱して、チップ（２７）を、螺旋状の芯材（２１）としての形状維持体を含む状態で形成するため、形状維持体を内部に含む筒状のチップ（２７）を効率良く形成することができ、よって患部へのデリバリー性能を保持しながら、デリバリー中の脈管壁の損傷を防止することができ、患部の通過も確実に行える脈管カテーテルを効率良く提供することができる、という効果を奏する。 In this method for manufacturing a vascular catheter, a coating material (23) having a melting point lower than that of the core material (21) is coated on the outside of the core material (21) to form a coated core material (23). The coated core material (23) is wound in a spiral shape, and the coated core material (23) is heated to a temperature not lower than the melting point of the cover material (22) and lower than the melting point of the core material (21). ) In a state including the shape maintaining body as the spiral core material (21), it is possible to efficiently form the cylindrical tip (27) including the shape maintaining body therein, and thus to the affected area. While maintaining the delivery performance, it is possible to prevent damage to the vascular wall during delivery and to efficiently provide a vascular catheter that can reliably pass the affected part.
また、上記製造方法では、螺旋状の被覆芯材（２３）に熱収縮チューブ（２５）を被せて加熱することで、被覆芯材（２３）に対して加圧しながら加熱しているので、被覆芯材（２３）の溶融や凝集を調整することができ、従って、上記効果に加えて、組成の面でより強靱かつ柔軟なチップ（２７）ないしは脈管カテーテルを提供することができる、という効果を奏する。更に、上記製造方法によって、前記チップにおける内部に形状維持体が配置されるようになり、即ち安全性および操作性の高い脈管カテーテルを形成することができる。 Moreover, in the said manufacturing method, since it coat | covers and heats with respect to a coating | coated core material (23) by covering a helical coating | coated core material (23) with a heat-shrinkable tube (25), it is covered. The effect that the melting or aggregation of the core material (23) can be adjusted, and therefore, in addition to the above effects, a tip (27) or a vascular catheter that is more tough and flexible in terms of composition can be provided. Play. Furthermore, by the above manufacturing method, a shape maintaining body is arranged inside the tip, that is, a vascular catheter with high safety and operability can be formed.
［脈管カテーテルの製造方法に係るその他の実施形態］
なお、本発明の脈管カテーテルの製造方法に係る実施形態は、上記のものに限られることはなく、次にそれぞれ例示するように様々に変更可能である。即ち、軸や熱収縮チューブを用いずに、被覆芯材を巻き、あるいは加熱する。被覆芯材を粗に巻き付ける。互いに異なる芯材を有する複数の被覆芯材を、交互に巻く。熱源につき、軸を加熱するものとしたり、電熱線に代えて、ノズルからの熱風、加熱した金型、加熱槽、レーザーとしたり、これらの適宜の組合せとしたりする。あるいは、軸、形状維持体、熱収縮チューブ、芯材、被覆材につき、断面形状を楕円や多角形としたり、断面の大きさを大きくあるいは小さくしたりする。熱収縮チューブを除去せずそのまま残してチップの一部とする。また、被覆材を金属製とする。被覆材や軸が金属である場合の熱源として、誘導加熱によるものまたは上記のものとの適宜の組合せを選択する。[Other Embodiments Related to Manufacturing Method of Vascular Catheter]
In addition, embodiment which concerns on the manufacturing method of the vascular catheter of this invention is not restricted to said thing, It can change variously so that it may illustrate next, respectively. That is, the coated core material is wound or heated without using a shaft or a heat shrinkable tube. Wrap the coated core material roughly. A plurality of coated core materials having different core materials are alternately wound. For the heat source, the shaft is heated, instead of the heating wire, hot air from a nozzle, a heated mold, a heating tank, a laser, or an appropriate combination thereof is used. Or about a shaft, a shape maintenance body, a heat contraction tube, a core material, and a covering material, the section shape is made into an ellipse or a polygon, or the size of a section is made large or small. Leave the heat-shrinkable tube as it is without removing the heat-shrinkable tube. The covering material is made of metal. As a heat source in the case where the covering material and the shaft are made of metal, a heat source by induction heating or an appropriate combination with the above is selected.
一方、図８に示す方法によっても、本発明に係る形状維持体入りのチップを製造することができる。即ち、図８（ａ）に示すように、軸（３０）の周りに、形状維持体となるリング（３２）を配置し、その外側に、熱または圧力により溶融する溶融チューブ（３４）を配置する。また、適宜、更に外側に収縮チューブ（３６）を配する。そして、電熱線（３８）で加熱する等して、溶融チューブ（３４）を溶かし、リング（３２）を溶融チューブ（３４）に入れ込んで、加熱を停止する。すると、図８（ｂ）に示すように、リング（３２）を含む溶融チューブ（３４）、即ち形状維持体を含むチップが形成される。 On the other hand, the chip containing the shape maintaining body according to the present invention can also be manufactured by the method shown in FIG. That is, as shown in FIG. 8 (a), a ring (32) serving as a shape maintaining body is disposed around the shaft (30), and a melting tube (34) that melts by heat or pressure is disposed outside the ring (32). To do. In addition, a contraction tube (36) is disposed on the outer side as appropriate. Then, the melting tube (34) is melted by heating with a heating wire (38), the ring (32) is put into the melting tube (34), and the heating is stopped. Then, as shown in FIG. 8B, a melting tube (34) including a ring (32), that is, a chip including a shape maintaining body is formed.
また、図９に示す方法によっても、本発明に係る形状維持体入りのチップを製造することができる。即ち、図９（ａ）に示すように、軸（４０）の周りに、チップ（４１）の大部分を構成し先端側に窪み（４２）を有するチップ本体（４３）を配置し、窪み（４２）の外側に、形状維持体となるリング（４４）を配置し、窪み（４２）ないしリング（４４）の外側に、窪み（４２）に入り、熱または圧力により溶融する溶融チューブ（４５）を配置する。また、適宜、更に外側に収縮チューブ（４６）を配する。そして、電熱線（４８）で加熱する等して、溶融チューブ（４５）を溶かし、リング（４４）を溶融チューブ（４５）と窪み（４２）に入れ込んだ状態で溶融チューブ（４５）をチップ本体（４３）に密着させ、加熱を停止する。ここで、チップ本体（４３）は、ともに溶融するものとしても良いし、当該加熱を行っても溶融しないものとしても良い。すると、図８（ｂ）に示すように、リング（３２）を含むチップ本体（４３）ないしは溶融チューブ（４５）、即ち形状維持体を含むチップ（４１）が形成される。なお、図８、図９の製造方法において、リングを、上記の他の形状維持体に代えても良い。そして、上記各製造方法による芯材あるいはリング等の埋め込みを、カテーテル本体の基端側（チップ以外）において施すことができ、形状を維持する以外の目的（例えば強度向上目的）で芯材などの埋め込みをすることができる。 Moreover, the chip | tip containing the shape maintenance body which concerns on this invention can be manufactured also by the method shown in FIG. That is, as shown in FIG. 9A, a chip body (43) that constitutes most of the chip (41) and has a depression (42) on the tip side is arranged around the axis (40). 42) A ring (44) serving as a shape maintaining body is arranged on the outside, and a melting tube (45) which enters the depression (42) outside the depression (42) or the ring (44) and melts by heat or pressure. Place. In addition, a contraction tube (46) is disposed on the outer side as appropriate. Then, the melting tube (45) is melted by heating with a heating wire (48) or the like, and the melting tube (45) is inserted in a state where the ring (44) is inserted into the melting tube (45) and the recess (42). Close contact with the main body (43) and stop heating. Here, the chip body (43) may be melted together, or may not be melted even if the heating is performed. Then, as shown in FIG. 8 (b), the tip body (43) or the melting tube (45) including the ring (32), that is, the tip (41) including the shape maintaining body is formed. In addition, in the manufacturing method of FIG. 8, FIG. 9, you may replace a ring with said other shape maintenance body. Then, the core material or ring or the like can be embedded by the above manufacturing methods on the proximal end side (other than the tip) of the catheter body, and the core material or the like can be used for purposes other than maintaining the shape (for example, strength improvement purposes). Can be embedded.
４、２７、４１ チップ
５ 形状維持体
６ カバー
７ カテーテル本体
１０ 副ルーメン
１１ 主ルーメン
２１ 芯材
２２ 被覆材
２３ 被覆芯材
２５ 熱収縮チューブ4, 27, 41
Claims (3)
該チップは、先細となるように形成され、該チップの先端側に、チップの長軸方向の可撓性を損なわない状態で、ラジアル方向の外力に対してチップ最先端のルーメンの開口形状を維持する形状維持体を配置し、
前記形状維持体が、リング状またはコイル状であることを特徴とする脈管カテーテル。In the vascular catheter provided with a cylindrical tip with a higher flexibility than the proximal end side at the distal end portion of the catheter body having a lumen inside,
The tip is formed to be tapered, and the tip of the tip has a lumen opening shape at the tip of the tip against the external force in the radial direction without impairing the flexibility in the major axis direction of the tip. Place the shape maintenance body to maintain ,
The vascular catheter according to claim 1 , wherein the shape maintaining body has a ring shape or a coil shape .
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| JP2007506026A JP5027651B2 (en) | 2005-03-03 | 2006-03-03 | Vascular catheter |
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| JP2005203201 | 2005-07-12 | ||
| PCT/JP2006/304106 WO2006093274A1 (en) | 2005-03-03 | 2006-03-03 | Vascular catheter and method of producing the same |
| JP2007506026A JP5027651B2 (en) | 2005-03-03 | 2006-03-03 | Vascular catheter |
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| WO2011070844A1 (en) * | 2009-12-11 | 2011-06-16 | 株式会社グッドマン | Catheter |
| US10342570B2 (en) | 2014-02-03 | 2019-07-09 | Medinol Ltd. | Device for traversing vessel occlusions and method of use |
| WO2011098911A1 (en) | 2010-02-09 | 2011-08-18 | Medinol Ltd. | Catheter tip assembled with a spring |
| JP5659788B2 (en) * | 2010-12-28 | 2015-01-28 | 住友ベークライト株式会社 | catheter |
| JP5732259B2 (en) * | 2011-01-12 | 2015-06-10 | 株式会社グッドマン | catheter |
| JP6004611B2 (en) * | 2011-04-21 | 2016-10-12 | 株式会社グッドマン | Balloon catheter |
| JP5829833B2 (en) * | 2011-04-21 | 2015-12-09 | 株式会社グッドマン | Balloon catheter |
| US9789283B2 (en) | 2014-02-03 | 2017-10-17 | Medinol Ltd. | Catheter tip assembled with a spring |
| WO2015119075A1 (en) * | 2014-02-05 | 2015-08-13 | テルモ株式会社 | Medical catheter and method for producing medical catheter |
| WO2019146171A1 (en) * | 2018-01-29 | 2019-08-01 | 住友電気工業株式会社 | Balloon catheter |
| WO2022190700A1 (en) * | 2021-03-09 | 2022-09-15 | テルモ株式会社 | Catheter and method for manufacturing same |
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| JP2001190681A (en) * | 2000-01-12 | 2001-07-17 | Terumo Corp | Catheter |
| JP2002275774A (en) * | 2001-03-21 | 2002-09-25 | Asahi Intecc Co Ltd | Tube body for medical treatment, balloon catheter, and guide wire for medical treatment |
| JP2005501613A (en) * | 2001-08-31 | 2005-01-20 | ボストン サイエンティフィック リミテッド | Microcatheter with improved distal tip and transition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4921483A (en) * | 1985-12-19 | 1990-05-01 | Leocor, Inc. | Angioplasty catheter |
| US4896669A (en) * | 1988-08-31 | 1990-01-30 | Meadox Medicals, Inc. | Dilatation catheter |
| US6017323A (en) * | 1997-04-08 | 2000-01-25 | Target Therapeutics, Inc. | Balloon catheter with distal infusion section |
| US6623504B2 (en) * | 2000-12-08 | 2003-09-23 | Scimed Life Systems, Inc. | Balloon catheter with radiopaque distal tip |
| US6962597B2 (en) * | 2001-10-24 | 2005-11-08 | Scimed Life Systems, Inc. | Inner member support block |
| JP2004261299A (en) * | 2003-02-28 | 2004-09-24 | Nippon Zeon Co Ltd | Balloon catheter |
-
2006
- 2006-03-03 WO PCT/JP2006/304106 patent/WO2006093274A1/en active Application Filing
- 2006-03-03 JP JP2007506026A patent/JP5027651B2/en active Active
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2011
- 2011-08-03 JP JP2011169941A patent/JP2011212493A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000513235A (en) * | 1991-09-05 | 2000-10-10 | メヨ・ファウンデーション・フォ・メディカル・エジュケーション・アンド・リサーチ | Flexible tube device for use in medical applications |
| JPH07178176A (en) * | 1993-12-24 | 1995-07-18 | Terumo Corp | Catheter |
| JP2001190681A (en) * | 2000-01-12 | 2001-07-17 | Terumo Corp | Catheter |
| JP2002275774A (en) * | 2001-03-21 | 2002-09-25 | Asahi Intecc Co Ltd | Tube body for medical treatment, balloon catheter, and guide wire for medical treatment |
| JP2005501613A (en) * | 2001-08-31 | 2005-01-20 | ボストン サイエンティフィック リミテッド | Microcatheter with improved distal tip and transition |
Also Published As
| Publication number | Publication date |
|---|---|
| JPWO2006093274A1 (en) | 2008-08-07 |
| WO2006093274A1 (en) | 2006-09-08 |
| JP2011212493A (en) | 2011-10-27 |
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