WO2007034639A1

WO2007034639A1 - Stent delivery catheter

Info

Publication number: WO2007034639A1
Application number: PCT/JP2006/316103
Authority: WO
Inventors: Yorito Suzuki; Masumi Yonemitsu; Katsuhiko Shimizu
Original assignee: Terumo Kabushiki Kaisha
Priority date: 2005-09-26
Filing date: 2006-08-16
Publication date: 2007-03-29

Abstract

Stent delivery catheter (1) having a distal-end-side section comprising outer tube (8); inner tube (5) passing through the interior of the outer tube (8); balloon (6) having tubular part (6a), distal-end-side catheter junction part (6d), distal-end-side outside diameter change part (6b), base-end-side catheter junction part (6e) and base-end-side outside diameter change part (6c), the balloon (6) at its distal end side fixed to the inner tube (5) and at its base end side fixed to the outer tube (8); stent (9) fitted to the balloon (6); and imaging marker (18) fitted to the inner tube (5). The outer tube (8) has a distal-end portion positioned in the base-end-side outside diameter change part (6c) of the balloon (6). The distal end of the marker (18) lies in a position corresponding to the base end of the stent (9) or slightly to the base end side. The base end of the marker lies in the region ranging from a position to the base end side by 1/5 of the whole length of the marker from the distal end of the outer tube to a position to the distal end side by 1 mm from the distal end of the outer tube.

Description

Specification

Stent delivery catheter

Technical field

The present invention relates to a stent delivery catheter used for improving a stenosis formed in a living organ such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, and other organs. In particular, it is possible to transport a stent for expanding a living organ after PTCA at a stenotic lesion in endovascular treatment, mainly cardiovascular, to the target living organ site with safe and smooth operability. The present invention relates to a stent delivery catheter.

Background art

[0002] Conventionally, a living organ dilatation method has been performed in which a stent is placed in a narrowed portion of a body lumen or body cavity such as a blood vessel, bile duct, esophagus, trachea, urethra, and other organs to secure the lumen or body cavity space. It has been broken.

Stents used for this include balloon expandable stents and self-expandable stents depending on the function and placement method.

In order to place a stent having no expansion function in the stent itself at the target site, for example, the nora expandable stent is inserted into the target site and then the balloon is expanded. The stent is expanded (plastically deformed) by the expansion force of the balloon, and is fixed in close contact with the inner surface of the target site.

A conventional balloon expandable stent delivery catheter includes, for example, an inner tube, an outer tube provided at a position retracted to a proximal end side by a predetermined length from the inner tube, as disclosed in Japanese Patent Publication No. 10-234860, X-ray fluoroscopy of the balloon with the distal end fixed to the inner tube and the proximal end fixed to the outer tube in a contracted or folded state, the stent placed on the outer surface of the balloon, and the stent position X-ray contrast markers, such as radiopaque materials, are provided near both ends of the stent for visual recognition below.

[0004] However, such a conventional stent delivery catheter has a marker-existing portion and a marker on the proximal side portion of the contrast marker made of a radiopaque material that is a hard material. Only the inner tube and the balloon also have a force. Peripheral When the catheter is configured so as to have a very small diameter so that it can be inserted into the target living organ part, the difference in rigidity between the two is large, so that the catheter (inner tube) is easily kinked in that part. When such a kink occurs, the pushing force applied at the hand of the catheter disappears at this kink, and the pushing force is not transmitted to the distal end of the catheter, making it difficult to carry the catheter to the peripheral target living organ site.

[0005] In addition, since the contrast marker is formed of a very hard radiopaque material such as platinum, when the catheter is pushed forward to a more peripheral living body organ site, a living body such as a bent blood vessel is formed. When passing through the duct, a hard marker may come into contact with the end of the stent through the balloon wall, damaging the stent and balloon wall.

FIG. 8 of Japanese Patent Laying-Open No. 2003-102844 (US Publication 2004267280) shows a stent delivery catheter in which the distal end of the outer tube 2 extends into the balloon 1 and is close to the proximal end of the marker 4. According to this, the area of the portion formed only by the inner tube and the balloon is reduced, and the kink prevention effect at that portion can be expected.

Disclosure of the invention

Problems to be solved by the invention

[0006] In the stent delivery catheter shown in FIG. 7 of Japanese Patent Laid-Open No. 2003-102844 (US Publication 2004267280), as shown in FIG. In addition, the stent 11 is attached to the entire cylindrical portion 1A of the balloon 1. For this reason, the marker 4 is located within the proximal end portion of the stent 11, and both are overlapped in the axial direction. For this reason, the proximal end portion of the stent 11 is considerably hard, and further, the distal end of the outer tube is positioned close to the proximal end portion of the stent, and the proximal end portion force of the stent is applied to the distal end portion of the outer tube. As a result, parts that are difficult to bend are formed, and the operability may be degraded. Furthermore, the proximal end of the stent 11 that is crimped as shown in FIG. 13 of Japanese Patent Laid-Open No. 2003-102844 (US Publication 2004267280) is close to the proximal end of the marker via a balloon. As a result, the proximal end of the stent, the proximal end of the force, and the balloon are close to closing the distal end opening of the outer tube, and there is a high possibility that the inflow of the balloon expansion fluid will be inhibited. [0007] An object of the present invention is to solve the above-mentioned problems of the prior art, generate kinks between the distal end of the outer tube and the proximal end of the stent, and partially harden the catheter by overlapping the marker and the stent. And a stent delivery catheter that can be reliably expanded with a stent that is excellent in pushability to a target living organ site in the periphery and that has no inflow failure of the expansion liquid into the cell.

Means for solving the problem

[0008] What achieves the above object is as follows.

(1) An outer tube, an inner tube having a tip portion that is inserted through the outer tube and protrudes from the tip of the outer tube for a predetermined length, and a cylindrical portion that has a substantially uniform outer diameter when expanded. A distal-side catheter joint, a distal-side outer diameter changing portion located between a distal end of the tubular portion and a proximal end of the distal-side catheter joint, a proximal-side catheter joint, and the proximal end A proximal-side outer diameter changing portion located between the distal end of the side catheter joint and the proximal end of the tubular portion, the distal catheter joint is fixed to the distal end of the inner tube, A balloon in which a proximal catheter joint is fixed to the outer tube, a stent attached to the outer surface of the balloon and expanded by expansion of the balloon, and a position in the balloon and on the proximal side of the balloon A contrast marker provided on the outer surface of the inner tube and having contrasting material force A stent delivery catheter having a distal portion comprising:

The outer tube includes a distal end portion that extends to a distal end side from the proximal catheter coupling portion of the balloon, and is positioned within the proximal outer diameter changing portion.

The proximal end of the stent is located at the proximal end of the tubular portion of the nolane, and the distal end of the marker is at a position corresponding to the stent proximal end in the axial direction of the catheter or slightly from the position. Located at the base end side, the base end of the marker is one-fifth of the total length of the marker from the tip of the outer tube, and is lmm from the tip of the outer tube from the position of the base end side. Stent delivery catheter located within range.

Brief Description of Drawings

FIG. 1 is a front view of one embodiment of a stent delivery catheter of the present invention.

FIG. 2 is an enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. is there.

FIG. 3 is an enlarged cross-sectional view of the stent delivery catheter shown in FIG. 1 in the vicinity of the proximal end portion of the stent.

FIG. 4 is a partially omitted enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. 1 when the balloon is expanded.

FIG. 5 is an enlarged cross-sectional view of the distal end portion of a stent delivery catheter according to another embodiment of the present invention.

FIG. 6 is an enlarged cross-sectional view of the stent delivery catheter shown in FIG. 5 in the vicinity of the proximal end portion of the stent.

FIG. 7 is a partially omitted enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. 5 at the time of balloon expansion.

FIG. 8 is a partially omitted enlarged cross-sectional view of a distal end portion of a stent delivery catheter according to another embodiment of the present invention when the balloon is expanded.

FIG. 9 is an enlarged view of the vicinity of the joint between the distal shaft and the base shaft in the catheter shown in FIG. 1.

FIG. 10 is an enlarged cross-sectional view of the vicinity of the joint between the distal shaft and the base shaft in the catheter shown in FIG.

FIG. 11 is a cross-sectional view taken along line BB in FIG.

FIG. 12 is a cross-sectional view taken along line CC of FIG.

FIG. 13 is a perspective view of the distal end portion of the base side shaft used in the catheter of FIG. 1.

FIG. 14 is a cross-sectional view taken along line AA in FIG.

FIG. 15 is an enlarged cross-sectional view of the proximal end portion of the catheter shown in FIG. 1.

FIG. 16 is a front view of an example of a stent used in the stent delivery catheter of the present invention.

FIG. 17 is an external view of another embodiment of the stent delivery catheter of the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION [0010] The stent delivery catheter of the present invention will be described with reference to the embodiments shown in the drawings. FIG. 1 is a front view of an embodiment of the stent delivery catheter of the present invention. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. FIG. 3 is an enlarged cross-sectional view of the stent delivery catheter shown in FIG. 1 in the vicinity of the proximal end portion of the stent. FIG. 4 is a partially omitted enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. 1 when the balloon is expanded. FIG. 5 is an enlarged cross-sectional view of the distal end portion of a stent deli catheter of another embodiment of the present invention. FIG. 6 is an enlarged cross-sectional view of the vicinity of the proximal end of the stent of the stent delivery catheter shown in FIG. FIG. 7 is an enlarged cross-sectional view of the distal end portion of the stent delivery catheter shown in FIG. FIG. 8 is a partially omitted enlarged sectional view of the distal end portion of the stent delivery catheter according to another embodiment of the present invention when the balloon is expanded. 14 is a cross-sectional view taken along line AA in FIG. FIG. 15 is an enlarged cross-sectional view of the proximal end portion of the catheter shown in FIG.

[0011] The stent delivery catheter 1 of the present invention includes an outer tube 8, an inner tube 5 having a distal end projecting from the distal end of the outer tube 8 through a predetermined length, and a substantially uniform outer tube when expanded. A cylindrical portion 6a having a diameter, a distal-side catheter joint 6d, and a distal-end outer diameter changing portion located between the distal end of the tubular portion 6a and the distal-side force tatel joint 6d 6b, a proximal catheter joint 6e, and a proximal outer diameter changing portion 6c positioned between the distal end of the proximal catheter joint 6e and the proximal end of the tubular portion 6a. The distal catheter joint 6d is fixed to the distal end of the inner tube 5, the proximal catheter joint 6e is fixed to the outer tube 8, and the balloon 6 is attached to the outer surface of the balloon 6. Contrast material provided on the outer surface of the stent 9 to be expanded and the inner tube 5 at a position in the balloon 6 and on the proximal end side of the balloon A stent delivery catheter having a distal portion and a contrast marker 18 consisting of. The outer tube 8 extends to the distal end side from the proximal catheter joining portion 6e of the balloon 6 and includes a distal end portion located in the proximal outer diameter changing portion 6c. The proximal end of the stent 9 is The distal end of the marker 18 is located at a position corresponding to the proximal end of the stent 9 in the axial direction of the catheter 1 or slightly closer to the proximal end than the position. Yes. The proximal end of the marker 18 extends from the proximal end position by one fifth of the total length of the marker 18 from the distal end of the outer tube 8 to the lmm distal end position from the distal end of the outer tube 8. Located within range.

[0012] Therefore, the stent delivery catheter 1 of the present invention is referred to as a so-called rabbit exchange type, and will be described using a catheter provided with a guide wire introduction port 52 in the middle part of the catheter. The catheter of the present invention is not limited to the rabbit exchange type having the guide wire introduction port 52 in the intermediate portion.

The stent delivery catheter 1 includes a distal side shaft 3 including a balloon 6, a proximal side shaft 2, and a stent 9 mounted on the balloon 6. The distal side shaft 3 and the base side shaft 2 are joined by a fixing portion 42 as shown in FIGS.

In particular, in the catheter 1 of this embodiment, the outer tube 8 and the inner tube disposed in the outer tube 8 and fixed to the outer tube 8 at the proximal end and having the guide wire introduction port 52 at the proximal end. 5 and a connecting pipe part that is arranged in parallel with the base end part of the inner pipe 5 and is fixed to the base end part of the inner pipe 5 and whose tip part is liquid-tightly fixed to the base end part of the outer pipe 8 4 and a proximal shaft 2 having a distal end portion inserted and fixed in the connecting pipe portion 4 of the distal shaft 3, and the outer tube 8 or the connecting tube portion 4. A distal-end shaft lumen 31 formed between the inner surface and the outer surface of the inner tube 5 communicates with a proximal-side shaft lumen 20 formed in the proximal-side shaft 2.

Furthermore, the base side shaft 2 includes a main body 21, a distal end 22 that is thinner than the main body 21 and enters the lumen 45 of the connecting pipe 4, and between the main body 21 and the distal end 22. And a lumen 45 of the connecting tube portion 4 is provided on the proximal end side of the connecting tube portion 4 and is directed toward the distal end to reduce the lumen cross section. The base-side shaft inclined portion 23 and the lumen changing portion 46 are in contact with each other, and the pushing force applied to the main body portion 21 of the base-side shaft 2 passes through the contact portion between the two. It is transmitted to the tip side shaft 3.

As shown in FIGS. 1, 9, 10, and 14, the distal shaft 3 includes an outer tube 8, an inner tube 5, and a connecting tube portion 4. Specifically, the shaft 3 on the distal end side is parallel to the outer tube 8, the inner tube 5 disposed in the outer tube 8 and fixed to the outer tube 8 at the base end, and the base end of the inner tube 5. Is fixed to the proximal end of the inner tube 5 and the distal end of the outer tube 8 is liquid-tight. A fixed connecting pipe 4 is provided. Note that the outer tube 8 and the connecting tube portion 4 fixed to the base end portion of the outer tube 8 are not limited to such a configuration in which two members are fixed, but can be a single member. Anyway!

The outer tube 8 is a tube body penetrating from the distal end to the proximal end, and the inner tube 5 can be inserted therein. The outer tube 8 has an outer diameter of 0.6 to 1.5 mm, preferably 0.8 to 1. lmm, and an inner diameter force of 0.5 to 1.4 mm, preferably 0.7 to 1.0 mm. .

[0015] As shown in the figure, the inner tube 5 is a tube body having a guide wire lumen 51 penetrating to the proximal end as well as being inserted into the outer tube 8, as shown in Figs. As shown in FIG. 2, the tip of the inner tube 5 protrudes from the tip of the outer tube 8 by a predetermined length.

The inner pipe 5 has an outer diameter force of 0.35 to: L Omm, preferably 0.45 to 0.8 mm, and an inner diameter force of O. 2 to 0.9 mm, preferably 0.35 to 0.7 mm. . Further, the protruding length of the inner tube 5 at the tip of the outer tube 8 is a force 5 to about LOOmm, preferably 10 to 60 mm, which varies depending on the length of the balloon used.

The balloon 6 expands the stent 9 to be mounted by expanding. The stent 9 is fitted onto the balloon 6 by being fitted onto the cylindrical portion 6a of the balloon 6 and compressed. Nolane 6 is folded by the compressed stent 9 and is in contact with the outer surface of the inner tube. When the expansion fluid flows into the balloon 6, the balloon 6 expands and the stent mounted on the balloon expands.

[0016] The balloon 6 used in this embodiment is provided on the distal end side of the tubular portion 6a (in other words, a stent mounting portion) that becomes a tubular shape having a substantially uniform outer diameter when expanded. Tip side taper part (constitutes tip side outer diameter changing part) 6b, base end side taper part provided on the base end side of cylindrical part 6a (forms base end side outer diameter changing part) 6c , Tip side taper

It has a distal catheter joint 6d continuous with 6a and a proximal catheter joint _6e continuous with the proximal taper 6c. As the size of the balloon 6, the outer diameter force of the tubular portion 6a (specifically, the cylindrical portion) when expanded is preferably 1.5 to 5. Omm force, and particularly preferably 2.5 to 4. Omm force ^ I like it! Further, the length of the cylindrical portion 6a is preferably 5 to 50 mm, particularly preferably 10 to 40 mm. Also, the length of the tip side turret 6b is up to ί, 2. 0 to 6. Omm force is preferable, especially 3.0 to 5.0 mm force ^ is preferable! The length of the proximal end side tapered portion 6c is preferably 2.0 to 6. Omm, and particularly preferably 3.0 to 5. Omm. The outer diameter of the distal catheter joint 6d is preferably from 0.5 to 1.5 mm, particularly preferably from 0.7 to 1. Omm. The length of the distal catheter joint 6d is preferably 1 to 5 mm, and particularly preferably 1.0 to 1.3 mm. The outer diameter of the proximal catheter joint 6e is preferably 0.8 to 1.6 mm, and particularly preferably 1.0 to 1.5 mm. The length of the proximal end catheter joint 6e is preferably 1 to 5 mm, particularly preferably 2 to 4 mm.

A material having a certain degree of flexibility is preferably used as the material for forming the nolane 6, for example, heat such as polyolefin, polychlorinated bur, polyamide, polyamide elastomer, polyester elastomer, polyurethane, polyester, polyarylene sulfide, etc. Plastic resin, silicone rubber, latex rubber, etc. can be used. In particular, the balloon 6 which is preferably a stretchable material is preferably biaxially stretched having high strength and expansion force. The balloon may be either a single layer or a multilayer structure.

The distal catheter joint 6d of the balloon 6 is fixed to the distal end of the inner tube 5. It should be noted that the distal end side catheter joint 6d of the balloon 6 is fixed so as to be located on the proximal end side with respect to the distal end of the inner tube 5 at a predetermined distance. The distance between the distal end catheter joint 6d of the balloon 6 and the distal end of the inner tube 5 is preferably 1.0 to 4. Omm.

Further, the proximal end side catheter joint 6 e of the balloon 6 is fixed to the distal end portion of the outer tube 8. The outer tube 8 is provided with a distal end portion 8b that extends to the distal end side from the proximal end side catheter joint 6e of the balloon 6 and is positioned in the proximal end tapered portion 6c of the balloon 6. In other words, the proximal end side catheter joint 6e of the balloon 6 is fixed so that the distal end thereof is closer to the proximal end side by a predetermined distance than the distal end 8a of the outer tube 8. The length of the distal end portion 8b (in other words, the distal end of the proximal end catheter joint portion 6e of the balloon 6 and the outer tube 8 is fixed to the proximal end catheter joint portion 6e of the balloon 6 of the outer tube 8. As the distance between the tips 8a), 2.0 to 6. Omm force S is preferable, and 3.0 to 5. Omm force S is particularly preferable.

As shown in FIG. 4, the distal end 8a of the outer tube 8 is located in the proximal end side tapered portion 6c of the balloon 6 and does not reach the cylindrical portion 6a. Specifically, as shown in FIG. 4, the proximal-side outer diameter changing portion (proximal-side tapered portion) 6c of the balloon 6 extends from the distal end 8a of the outer tube 8 to the distal end side. In other words, the distal end 8a of the outer tube 8 is inside the proximal end side tapered portion 6c of the balloon 6. Located at a predetermined distance from the proximal end of the tubular portion 6a to the proximal end side of the catheter. Then, all or most of the markers 18 (all in the embodiment shown in FIG. 4), which will be described later, are located within the base end side outer diameter changing portion (base end side tapered portion) 6c of the balloon 6. RU

In the catheter of this embodiment, almost all or most of the marker 18 is disposed between the distal end 8a of the outer tube 8 and the proximal end of the balloon tubular portion 6a. Even if the balloon tubular portion 6a, which is the stent expansion region, is arranged so as to be at the base end, the stent and the marker do not overlap.

By disposing the proximal end of the stent close to the proximal end of the tubular portion of the balloon, the balloon tubular portion protruding from the stent can be made extremely small. The balloon tubular portion that protrudes from the stent does not have the stent on the outside, so it expands excessively (expands) during expansion, and the normal lumen of the body or the inner wall of the body cavity near the stenosis There is a fear of expanding and damaging the inner wall.

In the catheter of this embodiment, even if the proximal end of the stent 9 is arranged so as to be just below the proximal end of the balloon tubular portion 6a that is the stent expansion region, the stent and the marker do not overlap each other. . For this reason, the outer diameter (profile) in the stent and marker placement portion during insertion into the living body can be made small. Also, the outer tube and the marker do not overlap.

In Japanese Patent Laid-Open No. 2003-102844 (US Publication No. 2004267280), in order to prevent the formation of a balloon tubular portion that also protrudes the stainless steel force, the end of the stent is overlapped with the marker. Must be placed. For this reason, the outer diameter (profile) of the stent and marker placement portion during insertion into the living body is large. If the outer diameter (profile) of the catheter becomes larger at the end of the stent, it is feared that it will be caught on the tip of the guiding catheter, lesion (especially calcified stenosis), and other devices. Such pulling leads to a decrease in operability of insertion of the catheter into the living body and an obstacle to insertion into the target site in the living body.

The stent 9 used in the stent delivery catheter 1 of the present invention is formed in a substantially tubular body, has a diameter for insertion into a living body, and has a wide force radially outward from the inside of the tubular body. Can be expanded when the balloon 6 is expanded, in other words when the balloon 6 is expanded It is a so-called balloon expandable stent. The proximal end of the stent 9 is located at the proximal end portion of the cylindrical portion 6a of the balloon 6. The proximal end of the stent 9 is mounted so as not to protrude from the proximal end of the tubular portion 6a of the nolane 6, and the distance between the proximal end of the stent 9 and the proximal end of the tubular portion 6a of the balloon 6 is 1. It is preferable that it is 5 mm or less. Further, the distal end of the stent 9 is located at the distal end portion of the cylindrical portion 6 a of the balloon 6. The distal end of the stent 9 is mounted so as not to protrude from the distal end of the tubular portion 6a of the balloon 6. The distance between the distal end of the stent 9 and the distal end of the tubular portion 6a of the balloon 6 is 1.5 mm or less. It is preferable that it exists.

[0019] The stent 9 may be any balloon expandable stent. For example, the stent 9 shown in FIG. 16 has a first wavy annular body 92a formed in a ring shape by a wavy element having a large number of bent portions 85a, and a peak portion close to a valley portion of the first wavy annular body 92a. A second corrugated annular body 92b that is arranged in the axial direction of the stent 9 so as to be in contact with each other and is annularly formed by a corrugated element having a linear bent portion 85a, and a valley portion of the first corrugated annular body 92a 2 is composed of an annular unit 84 comprising a plurality of connecting portions 86 connecting the peaks of the corrugated annular body 92b, and the annular units 84 are arranged in the axial direction of the stent 9 and are adjacent to each other. A connecting portion 87 for connecting the units at the connecting portion forming portion is provided. Further, a plurality of connecting portions 87 are provided between the adjacent annular units 84 so as to have a plurality of opposing positions or substantially equiangular positions with respect to the central axis of the stent. As shown in FIG. 16, the stent 9 in this example is arranged so as to be substantially linear in the axial direction of the plurality of annular units 84 force stent 9, and the corrugated elements (corrugated annular bodies) of adjacent annular units. 92b and 92a) are provided with a connecting portion 87 for connecting the connecting portion 86 to the forming portion thereof. In other words, the stent 9 is a tubular body formed by connecting a large number of annular units 84 by connecting portions 87. However, the shape of the stent 9 is not limited to this, and a known one such as a mesh shape can be used.

[0020] Examples of preferable materials for forming the stent 9 include stainless steel, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, and cobalt base alloy. It is done. In addition, precious metal plating (gold, platinum) may be performed after the stent shape is produced. The most corrosion resistant stainless steel SUS316L with is suitable.

Furthermore, it is preferable to anneal after creating the final shape of the stent. By annealing, the flexibility and plasticity of the entire stent is improved, and the indwellability in the bent blood vessel is improved. Compared to the case without annealing, the force that tries to restore the shape before expansion after expanding the stent, especially the force that tries to return to the linear shape when expanding at the bent blood vessel site, is reduced. Physical stimulation given to the bent inner wall of the blood vessel is reduced, and the factor of restenosis can be reduced. Annealing is preferably performed by heating to 900-1200 ° C in an inert gas atmosphere (for example, argon gas) and then cooling slowly so that no oxide film is formed on the stent surface! /. The diameter when the stent 9 is mounted is preferably about 0.8 to 1.5 mm, and more preferably 0.9 to 1.3 mm. The length of the stent is preferably about 5 to 50 mm, and particularly preferably 8 to 40 mm. The length of the stent is preferably about 1 to 0.95 times the length of the balloon tubular portion.

A proximal contrast marker 18 is fixed to the inner tube 5. In particular, in the force tape 1 of the present invention, the proximal end side marker 18 is fixed to the outer surface of the inner tube 5 so as to be positioned in the proximal end side tapered portion 6 c of the nolane 6.

Further, as shown in FIGS. 3 and 4, the proximal end 18a of the marker 18 has a position force on the proximal end side that is one fifth of the total length of the marker 18 from the distal end of the outer tube 8. It is located within the range up to the position lmm ahead. In the force tail 1 of the embodiment shown in FIGS. 2 to 4, the proximal end 18a of the marker 18 is located at the same position as the distal end of the outer tube 8 or slightly on the distal end side, and both overlap with each other in the axial direction. I don't have a part. In this embodiment, the distance L1 between the proximal end 18a of the marker 18 and the distal end 8a of the outer tube 8 is 1 mm or less. Preferably, L1 is 0.8 mm or less. In particular, it is preferable that the two have overlapping portions in the axial direction as described above, but it may be as shown in FIG. 5 and FIG. In the catheter 30 of the embodiment shown in FIGS. 5 to 7, the proximal end 18a of the marker 18 is located on the proximal end side from the distal end of the outer tube 8, and both have overlapping portions in the axial direction. ing. In this embodiment, the distance L2 (the length overlapping in the axial direction) between the proximal end 18a of the marker 18 and the distal end 8a of the outer tube 8 is 1Z5 or less of the total length of the marker 18. Yes. Preferably, L2 is 1/8 or less of the total length of the marker 18. Specifically, L2 is preferably 1.2 mm or less.

[0022] If the distal end of the outer tube is positioned on the distal end side at a distance less than one-fifth of the total length of the marker, the portion where the marker and the outer tube overlap is sufficiently short. Neither does it impede the responsiveness of balloon dilation, “inflow of deflation fluid into the balloon” or outflow.

Further, as shown in FIGS. 3 and 4, the distal end 18b of the marker 18 is located at a position corresponding to the proximal end of the stent 9 in the axial direction of the catheter 1 or slightly proximal from the position. The marker 18 and the stent 9 do not have an overlapping portion with respect to the axial direction. In this embodiment, the axial distance X between the distal end 18b of the marker 18 and the proximal end 9 of the stent 9 is preferably 1 mm or less. Particularly preferably, X is 0.5 mm or less.

As described above, when the catheter is positioned at the same position as the proximal end of the stent or the proximal end of the stent, when the catheter passes through a biological conduit such as a more peripheral tortuous blood vessel. The marker does not come into contact with the stent through the balloon wall, and there is no fear that the end of the stent or the balloon will be damaged by the marker. Therefore, it is possible to provide a stent delivery catheter that can reliably carry a stent to a peripheral target living organ site without damaging the stent or balloon.

Furthermore, in the catheter 1 of these embodiments, the distal contrast marker 17 is fixed to the inner tube 5. In particular, in the catheter 1 of this embodiment, the distal side marker 17 is fixed to the outer surface of the inner tube 5 so as to be located in the distal side tapered portion 6b of the balloon 6. As shown in FIGS. 3 and 4, the proximal end of the marker 17 is located at a position corresponding to the distal end of the stent 9 in the axial direction of the catheter 1 or slightly on the distal side from the position. The marker 17 and the stent 9 do not have an overlapping portion with respect to the axial direction. In this embodiment, the axial distance between the proximal end of the marker 17 and the distal end of the stent 9 is preferably 1 mm or less. Particularly preferably, it is 0.5 mm or less.

As the contrast marker, a radiographic marker or an ultrasound contrast marker is used. Radiographic markers include gold, platinum, tungsten or Among these alloys, those formed of at least one metal or two or more alloy members from the group consisting of silver-palladium alloy force are preferable. As the ultrasonic contrast marker, stainless steel or the like can be used in addition to the metal described above.

[0024] The stent delivery catheter of the present invention includes a guide wire member constituted by the lumen of the inner tube 5. In particular, the stent delivery catheter of the illustrated embodiment has a guide wire lumen 51 constituted by the lumen of the inner tube 5 and a guide wire guide that communicates with the guide wire lumen 51 and opens at an intermediate portion of the stent delivery catheter. An entrance 52 is provided. More specifically, the catheter 1 of this embodiment includes a distal side shaft 3 that forms a distal end side portion, and a proximal side shaft 2 in which the distal end side portion is inserted and fixed in the distal end side shaft. The shaft 3 is formed at the proximal end portion of the distal end side shaft 3 and includes a guide wire introduction port 52 communicating with the inside of the inner tube 2, and the lumen 31 formed in the outer tube 8 is formed in the proximal side shaft 2. In communication with the formed proximal shaft lumen 20.

[0025] Therefore, the structure of the intermediate portion and the proximal end portion of the catheter 1 of this embodiment will be described.

As shown in FIGS. 9 and 10, the inner pipe 5 has a base end portion exposed from the outer pipe 8. The inner tube 5 is liquid-tightly fixed to the proximal end of the outer tube 8 at a portion slightly distal to the proximal end. In addition, a guide wire introduction port 52 is provided at the proximal end portion of the inner pipe 5, in this embodiment, the proximal end. As shown in FIGS. 9, 10, and 12, the guide wire introduction port 52 is formed obliquely so as to incline toward the base end side. This facilitates guide wire insertion.

As shown in FIG. 9 and FIG. 10, the connecting pipe part 4 has a tip formed obliquely. The distal end portion 41 of the connecting pipe portion 4 does not penetrate into the outer tube 8, is positioned outside the outer tube 8, and is a part of the inner surface of the distal end portion 41 of the connecting tube portion 4. Is in contact with a part of the outer surface of the base end portion of the outer tube 8. The outer tube 8 and the connecting tube 4 are fused in a liquid-tight manner at the contact surface described above. Furthermore, a part of the outer surface on the distal end side of the connecting pipe part 4 is in contact with a part of the outer surface of the proximal end part of the inner pipe 5. The inner tube 5 and the connecting tube 4 are fused in a liquid-tight manner at the contact portion 43. The contact portion 43 is melt-deformed into a shape corresponding to the curved shape of the proximal end portion of the inner tube 5, and forms an inclined surface continuous with the guide wire introduction port 52 of the inner tube 5. It is made.

[0026] In the catheter 1 of this embodiment, the connecting tube portion lumen 45 formed between the inner surface of the connecting tube portion 4 and the outer surface of the inner tube 5 and the base portion formed in the base side shaft 2 are used. In a state where the side shaft lumen 20 is in communication, the proximal end portion of the connecting pipe portion 4 and the distal end portion of the proximal side shaft 2 are fused.

A material having a certain degree of flexibility is preferable as a material for forming the inner tube 5, the connecting tube portion 4, and the outer tube 8. For example, polyamide, polyester, polyamide elastomer, polyester elastomer, polyolefin (for example, polyethylene) Polypropylene, ethylene propylene copolymer, ethylene vinyl acetate copolymer, and cross-linked or partially cross-linked products thereof, polyvinyl chloride, polyurethane and the like are suitable. The inner tube 5 may be formed of a single resin material. However, in order to improve the sliding property of the guide wire, the inner layer is made of a low friction material such as polyethylene, fluorine. It is preferable that the outer layer has a material force compatible with the material of the distal end side shaft (the outer tube 8 and the connecting tube portion 4). In this case, the inner layer forming material may not be compatible with the material of the base side shaft and the tip side shaft.

[0027] As shown in Figs. 9 to 12 and 15, the base side shaft 2 is a tube body penetrating from the distal end to the proximal end, and includes a node 7 fixed to the proximal end. The distal end portion of the base side shaft 2 is joined to the proximal end portion of the distal end side shaft 3.

The base side shaft 2 is fixed to the distal end portion of the hub 7 at the base end. A kink prevention tube 71 is attached to the outer surface of the boundary between the hub 7 and the base shaft 2 so as to cover both. Further, the base end portion of the hub 7 serves as a connection portion 72 of a balloon inflating fluid injection device (for example, a syringe).

As the basic rule shaft 2, the length force S800mm ~ 1500mm, more preferably 1000 ~ 13 OOmm, the outer diameter is 0.5 ~ 1.5mm, preferably 0.6 ~ 1.3mm, Is 0.3 to 1.4 mm, preferably 0.5 to 1.2 mm.

In the catheter 1 of this embodiment, as shown in FIG. 13, the base-side shaft 2 enters the body portion 21 and the lumen 45 of the connecting tube portion 4 which is narrower than the body portion 21. The base side shaft inclined portion 23 formed to connect the front end portion 22 and the main body portion 21 and the front end portion 22 to each other. I have. The length of the tip 22 is 3mn! About 15 mm is preferable. The length of the inclined portion 23 in the axial direction is preferably about 2 mm to 10 mm.

Specifically, in this base side shaft 2, as shown in FIGS. 10, 11, and 13, only a part of the main body portion 21 of the base side shaft 2 is axially moved. It is formed in the shape of a bowl extending to the top. The size of the arc formed by the cross section when cut in the direction perpendicular to the axial direction of the tip 22 is preferably about 1Z16 to LZ2 of the size of the circle formed by the cross section of the main body 21.

The distal end portion 22 is not limited to such a bowl-like shape curved in the direction of the central axis of the shaft 2, but is a bowl-like shape curved in the direction opposite to the direction of the central axis of the shaft 2. It may be a flat plate,

Further, in the base side shaft 2, the base side shaft inclined portion 23 is formed so as to be inclined with respect to the central axis of the base side shaft from the distal end of the main body portion 21 to the proximal end of the distal end portion 22. ing. In this base shaft 2, the base-side shaft inclined portion 23 has a form in which the base-side shaft is cut obliquely by a predetermined length, and the cut-out inclined portion forms the base-side shaft lumen 20 and the distal end side. A communication portion communicating with the shaft lumen 31 is formed. In other words, the distal end portion of the base side shaft 2 has a shape in which the base side shaft is cut out in a predetermined length and a predetermined width axis direction, and the base side shaft inclined portion 23 is formed by cutting the base side shaft. It has a shape that is obliquely cut out by a predetermined length, and the cut-out inclined portion forms a communication portion that communicates the base-side shaft lumen and the distal-end shaft lumen. Thus, by making the entire inclined portion an opening, the flow of the fluid injected into the base shaft lumen is improved. The inclined portion 23 may be opened only at the distal end portion and not at the proximal end portion.

As a material for forming the base side shaft 2, it is preferable to use a material having relatively high rigidity, for example, a metal such as Ni—Ti, brass, SUS, or aluminum. In addition, as long as the material is relatively high in rigidity, it is possible to use a resin such as polyimide, butyl chloride, and polycarbonate.

[0030] In the catheter 1 of this embodiment, the lumen 45 of the connecting tube portion 4 forms the proximal end portion of the distal shaft lumen 31, and the lumen changing portion 46 is for connection. It is provided in the pipe 4. Then, the distal end portion 22 of the base side shaft 2 has entered the connecting tube lumen 45. . Specifically, the connecting pipe portion 4 has a form as shown in FIGS. The connecting pipe part 4 includes a fixing part (tip part) 41 to the outer pipe 8 at the tip part, and a part of the side wall on the proximal side from the fixing part 41 is a side wall of the base part of the inner pipe 5. A welded part (contact part) 43 that is liquid-tightly welded to a part of the tube, a lumen changing part 46 located on the proximal side of the welded part 43, and a lumen changing part 46, and a predetermined length. A cylindrical portion 44 that extends, and a fixing portion 42 to the base side shaft 2 formed at the base end are provided.

[0031] In this embodiment, the lumen 45 in the connecting pipe portion 4 is in a state of being parallel to the inner tube 5 at the distal end portion, and closer to the proximal end than the proximal end of the inner tube 5. The lumen 45 is present alone. Further, as shown in FIG. 10, the lumen 45 in a portion where the inner tube 5 does not exist is provided with a lumen changing portion 46 that is directed toward the distal end and becomes smaller in lumen cross section. In this embodiment, the lumen 45 in the connecting tube portion 4 has a smaller inner diameter on the distal end side than the proximal end side of the lumen changing portion (lumen inclined portion) 46. However, in the present invention, the lumen changing portion 46 is not limited to such a shape. For example, a wall portion formed in a direction perpendicular to the long axis of the connecting pipe portion is more than the wall portion. A shape in which the distal end side is narrower than the base end side than the wall portion may be used. That is, the lumen changing portion 46 may be either a lumen stepped portion or a lumen inclined portion. In this embodiment, the outer surface of the connecting tube portion 4 corresponding to the lumen changing portion 46 is also inclined according to the inclined surface of the lumen changing portion 46. In this way, by positioning the lumen changing portion 46 at the proximal end side from the portion where both the distal-side shaft lumen (connecting tube lumen) and the inner-tube lumen exist on the distal side from the guide wire introduction port, Since the inner diameter of the distal shaft shaft lumen in the portion where the two lumens coexist can be made small, the outer diameter of the portion where the two lumens coexist can be suppressed.

Further, the base side shaft inclined portion 23 of the base side shaft 2 and the lumen changing portion 46 of the connecting pipe portion 4 are in contact with each other. As a result, the pushing force applied to the main body portion 21 of the base side shaft 2 is transmitted to the distal end side shaft 3 through the contact portion between the two. Further, in this embodiment, as shown in FIG. 10, the base side shaft 2 is disposed at the base end portion of the connecting pipe portion 4 so that the tip end portion 22 is on the fused portion 43 and the inner tube 5 side. Has been placed. The distal end portion 22 of the base side shaft 2 may be in contact with the fused portion 43 (and the inner tube 5), or may be slightly separated. Preferably, it is in contact. further As shown in FIGS. 9 and 10, the distal end of the distal end portion 22 of the base side shaft 2 is preferably positioned closer to the distal end side of the catheter 1 than the guide wire introduction port 52 is. As a result, the guide wire introduction port 52 is reinforced, and the catheter can be prevented from being broken in the vicinity of the opening 52. Further, it is preferable that the distal end of the distal end portion 22 of the base side shaft 2 reaches the inside of the outer tube 8 as shown in FIGS. 9 and 10.

[0033] In this embodiment, the direction of the guide wire introduction port 52 of the inner tube 2 and the direction of the base-side shaft inclined portion 23 are opposite to the central axis of the outer tube. Being! In other words, in this embodiment, the opening 52 exists on the back side of the arc of the cross section of the base side shaft inclined portion 23 (outside of the curved portion of the inclined portion 23, on the outer surface side of the inclined portion 23). By doing so, it is possible to suppress the bending of the catheter when the guide wire is inserted into the guide wire lumen 51, and it is possible to suitably prevent the catheter from being kinked or bent in the vicinity of the guide wire introduction port. When the guide wire is inserted into the guide wire lumen, the catheter is easily bent in the direction in which the guide wire is outside the curve. When such bending occurs, the pushing force applied at hand tends to escape. However, in the portion where the base shaft tilt portion is formed, the catheter is unlikely to bend in the direction in which the side with the base shaft tilt portion is located inside the curve. Bending can be suppressed and prevented.

Further, in this embodiment, as shown in FIG. 10, the distal end portion 22 of the base side shaft 2 is formed in a bowl shape in which only a part of the main body portion 21 of the base side shaft 2 extends in the axial direction. At the same time, the distal end portion 22 is disposed so as to be on the fused portion 43 side and the inner tube 5 side. For this reason, the bowl-shaped distal end portion 22 is in a state of being turned to the back with respect to the fused portion 43 and the inner tube 5, thereby suppressing or preventing the bending of the catheter when the guide wire is inserted.

Further, as shown in FIGS. 10 and 13, a slit 25 or a large number of openings may be formed in the distal end portion of the main body portion of the base side shaft 2. As a formation region of the slit or the opening, it is preferable that a distal end is provided slightly on the proximal end side with respect to the base shaft inclined portion 46 and extends to the proximal end side for a predetermined length. A slit or an opening may also be formed in the base shaft inclined portion. The length of the slit or aperture formation area is lOOmn! About 300mm is suitable. By providing such slits or openings, the tip of the main body of the shaft 2 The abrupt change in physical properties at the end side portion is eliminated, catheter kinking is prevented, and deformation (curvature) is facilitated.

The slit 25 is preferably a spiral slit as shown in the figure, but may be a slit extending in parallel with the central axis of the shaft 2. Further, when the spiral slit is used, the flexibility may be changed by appropriately changing the slit pitch in the longitudinal direction of the base side shaft. In addition, it is preferable that the pitch of the spiral slit is short on the tip end side of the slit and is long on the base end side of the slit. By doing so, it becomes flexible toward the tip, so that the curve with a sudden change in physical properties becomes natural. Further, it is preferable that the intermediate portion between the front end portion and the base end portion has an intermediate pitch between them or the pitch gradually changes. In particular, it is preferable that the spiral slit has a pitch that gradually decreases toward the tip! / Or that the width gradually increases toward the tip.

[0035] When an opening is provided instead of a slit, the hole diameter is 0.1 nm! About 0.4mm is more preferable, 0.2mn! ~ 0.3mm. The hole diameter is preferably about 1Z10 to 1Z3, which is the outer diameter of the base side shaft. The distance between the openings is preferably about 0.1 to 0.5 mm. Further, the shape of the opening does not need to be a perfect circle, but may be an ellipse, for example, an ellipse elongated in the circumferential direction or the axial direction of the base side shaft, or a polygon (for example, a quadrangle, a pentagon). In addition, it is preferable that the number of apertures in the aperture formation region is larger at the tip than at the base end. Furthermore, it is preferable that the number of apertures gradually increases as the force is directed toward the distal end side from the proximal end side.

In this embodiment, a slit or a large number of apertures are formed in the distal end side portion of the main body portion 21 of the base side shaft 2, and the base end portion of the distal end side shaft 3 is slit or multi-opened. It encloses the main body 21 of the base side shaft 2 in which a number of apertures are formed, and is fixed to the base side shaft on the base end side with respect to the slits or the portions where the plurality of apertures are formed. Specifically, the connecting pipe portion 4 includes a cylindrical portion 44 that encloses the slit or hole forming region of the base side shaft 2. Further, the fixing portion 42 of the connecting pipe portion 4 is fixed to the base side shaft 2 in a liquid-tight manner on the base side from the slit or opening formation region. Furthermore, a gap 47 is formed between the base side shaft 2 and the cylindrical portion 44 of the connecting pipe portion 4 as shown in FIGS. That is, the cylindrical part 44 of the connecting pipe part 4 is The part side shaft 2 is not in close contact. For this reason, it is possible to make a good curve with little deformation inhibition of the slit or the opening forming region of the base side shaft 2 by the cylindrical portion.

[0037] The connecting pipe portion 4 preferably has a total length of about 100 mm to 400 mm. In addition, the length from the distal end of the connecting tube portion 4 to the proximal end of the lumen changing portion is preferably about 3 to 15 mm, more preferably 5 to 7 mm. The length of the cylindrical portion 44 of the connecting pipe portion 4 is preferably about 50 mm to 300 mm.

In this embodiment, the connecting pipe part covers the slit part of the base side shaft, so that the connecting pipe part is rather long at the distal end side of the connecting pipe part. ) Is to be positioned. However, the present invention is not limited to this, and the lumen changing portion may be located on the proximal end side of the connecting pipe portion.

[0038] Further, as shown in Figs. 9 to 12 and 15, a rigidity imparting member 11 may be inserted into the base side shaft 2. The rigidity imparting body 11 is fixed to the hub 7 of the base side shaft 2 at the base end, and the tip protrudes from the tip of the base side shaft 2 and extends into the tip side shaft 3. In this embodiment, the distal end of the rigidity imparting body 11 reaches the distal end shaft lumen 31 (in other words, the balloon expansion lumen) formed by the inner tube 5 and the outer tube 8 of the distal shaft 3. is doing.

The rigidity imparting body 11 extends from the proximal end of the base side shaft 2 to the distal end side. Further, the rigidity imparting body 11 is fixed to the base side shaft 2 or the hub 7 only at the base end so as not to obstruct the bending of the catheter 1, and other parts, specifically, the base side shaft 2 is fixed. It is not fixed to any of the inside, the inner tube 5 and the distal end side shaft 3 except for the base end portion. The rigidity imparting body 11 prevents the base-side shaft 2 from being meandered in the blood vessel by extreme bending of the base-side shaft 2 at the bent portion without significantly reducing the flexibility of the base-side shaft 2. The rigidity imparting body 11 is preferably formed of a linear body. The linear body is preferably a metal wire, preferably a wire diameter of 0.05 to L: 5 mm, preferably 0.1 to 1. Omm, such as an elastic metal such as stainless steel, a superelastic alloy, etc. High-strength stainless steel and superelastic alloy wire are preferable.

[0039] Here, the superelastic alloy is generally a shape memory alloy, and is superelastic at least at a living body temperature (around 37 ° C). Particularly preferred is a Ti-Ni compound of 49-53 atomic% Ni. Gold, 38. 5-41. 5 wt% Zn Cu—Zn alloy, 1 10 wt% 01—211—alloy (X = Be, Si, Sn, Al, Ga), 36—38 atomic% Ni Ni — Superelastic alloys such as Al alloys are preferably used. In particular, the above Ti-Ni alloy is desirable. Further, Ti- part of Ni alloy 0. 01~:. L0 0 atoms ⁰ / was replaced by oX Ti- Ni- X alloy (X = Co, Fe, Mn , Cr, V, Al, Nb, W, B, etc.) to force or Ti- Ni part of alloys 0.01 to 30.0 atom ^_0/0 and substitution with chi Ti- Ni- X alloy (X = Cu, Pb, Zr ) to be, In addition, the mechanical characteristics can be appropriately changed by selecting the cold working rate and / or the final heat treatment conditions. In addition, the mechanical properties can be changed as appropriate by selecting the cold work rate and Z or final heat treatment conditions using the Ti-Ni-X alloy described above.

[0040] In all the embodiments described above, the balloon may have a shape like the stent delivery catheter 40 shown in FIG. The difference between the balloon 6 described above and the catheter 16 of this embodiment is only the distal-end-side outer diameter changing portion 16b and the proximal-end-side outer diameter changing portion 16c.

The proximal-side outer diameter changing portion 16c is continuous with the proximal-side joining portion 16e, and has an outer diameter that increases toward the distal direction, and an inclination angle with respect to the longitudinal axis of the balloon 16 is 3 to 10 °. The proximal low slope part is located on the distal side of the proximal low slope part, and the outer diameter increases at a rate of change larger than the change rate of the outer diameter in the proximal low slope part toward the distal direction. And a base-side high slope portion.

Similarly, the distal end side outer diameter changing portion 16b is continuous with the distal end side joint portion 16d, the outer diameter increases toward the proximal direction, and the inclination angle with respect to the longitudinal axis of the balloon 16 is 3 to 10 °. It is located at the base end side of the tip side low slope part and the tip side low slope part, and the outer diameter is directed toward the base end and increases at a change rate larger than the change rate of the outer diameter in the tip side low slope part. And a tip side high inclined portion.

[0041] The catheter of the present invention is not limited to the rabbit status change type having the guide wire introduction port 52 in the intermediate portion. For example, a stent delivery catheter 100 of the type shown in FIG. 17 may be used. The catheter 100 of this embodiment has the structure shown in FIGS. 2 to 4 or FIGS. 5 to 7 similar to the catheter 1 or catheter 30 of the embodiment described above. In this catheter 100, the inner tube 5 is It penetrates the entire length of the tube. Therefore, the overall force of the catheter is a double tube structure consisting of an inner tube and an outer tube force. The hub 110 that fixes the proximal end of the inner tube 5 and the proximal end of the outer tube 8 includes a guide wire inlet 109 that communicates with the inner tube 5 and an expansion fluid inlet 111 that communicates with the inner tube 5. .

Industrial applicability

According to the stent delivery catheter of the present invention, since there is no overlapping marker portion in the axial direction in the balloon and on the outer surface of the inner tube, there is no overlap between the marker and the stent. In addition, there is no formation of a hard part due to this, and since the distance between the marker and the outer tube is within a predetermined range, kinking between the marker and the outer tube is prevented, and pushability to the peripheral target living organ part is improved. Excellent. In addition, it is possible to reliably expand a stent that does not impede the flow of expansion liquid into the balloon.

Claims

The scope of the claims

[1] An outer tube, an inner tube having a tip portion that is inserted through the outer tube and protrudes from the tip of the outer tube for a predetermined length, and a cylindrical portion that has a substantially uniform outer diameter when expanded, A distal catheter joining portion, a distal outer diameter changing portion located between a distal end of the tubular portion and a proximal end of the distal catheter joining portion, a proximal catheter joining portion, and the proximal end A proximal-side outer diameter changing portion located between the distal end of the side catheter joint and the proximal end of the tubular portion, and the distal catheter joint is fixed to the distal end of the inner tube, A balloon in which the proximal catheter connection portion is fixed to the outer tube; a stent that is attached to the outer surface of the balloon and is expanded by expansion of the balloon; and a proximal end of the balloon in the balloon A contrast marker provided on the outer surface of the inner tube at a certain position and having a contrast material force. A stent delivery catheter having a distal end portion,

The proximal end of the stent is located at the proximal end of the tubular portion of the nolane, and the distal end of the marker is at a position corresponding to the stent proximal end in the axial direction of the catheter or slightly from the position. Located at the base end side, the base end of the marker is one-fifth of the total length of the marker from the tip of the outer tube, and is lmm from the tip of the outer tube from the position of the base end side. A stent delivery catheter characterized by being located within the range up to the position.

[2] The stent according to claim 1, wherein the distal end of the marker is located within a range of positional force corresponding to the proximal end of the stent in the axial direction of the catheter up to lmm on the proximal end side of the catheter. Delivery catheter.

[3] The stent delivery catheter according to [1] or [2], wherein the contrast marker is a radiographic marker or an ultrasound contrast marker.

[4] The radiographic contrast marker is formed of at least one metal or two or more alloying forces of a group including gold, platinum, tungsten or alloys thereof, or silver-noradium alloy force. 3. The stent delivery catheter according to 3.

[5] The stent delivery catheter is a guide wire constituted by a lumen of the inner tube. The stent delivery catheter according to any one of claims 1 to 4, comprising a lumen.

[6] The stent delivery catheter has a guide wire lumen constituted by the lumen of the inner tube, and a guide wire introduction that communicates with the guide wire lumen and opens at an intermediate portion of the stent delivery force tail. The stent delivery catheter according to claim 1, further comprising a mouth.

[7] The stent delivery catheter includes a distal-side shaft that forms the distal-side portion, and a base-side shaft in which the distal-side portion is inserted and fixed in the distal-side shaft, A proximal-side shaft lumen formed in the base-side shaft is formed in a base-end portion of the distal-side shaft, and includes a guide wire introduction port communicating with the inside of the inner tube. The stent delivery catheter according to any one of claims 1 to 6, wherein the stent delivery catheter is in communication with the stent delivery catheter.

8. The catheter according to claim 1, further comprising a guide wire lumen having one end opened at a distal end of the catheter and the other end opened at a rear end of the catheter. The stent delivery catheter according to 1.

[9] The base-end-side outer diameter changing portion of the balloon extends to the tip side from the tip of the outer tube, and all or most of the marker is located in the base-end-side outer diameter changing portion of the balloon. The stent delivery catheter according to any one of claims 1 and 8, wherein