JP2018102353A - Balloon catheter and treatment method using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter that allows a blade part to come in contact with a calcified lesioned part while keeping good passing performance of the balloon, and a treatment method using the balloon catheter.SOLUTION: In a balloon catheter 1 having a balloon 11 at the tip of a long-sized shaft 10, the shaft 10 includes a lumen 24 for a long-sized body for inserting a long-sized body 13 having a blade part 41 at least at a part in the lengthwise direction. The lumen 24 for a long-sized body includes an opening 25 in the vicinity of the balloon 11. The balloon 11 includes a guide part 32 for guiding the long-sized body 13 exposed from the opening 25 in the lengthwise direction of the balloon 11.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a balloon catheter having a balloon at the tip of a long shaft and a treatment method using the same.

  Treatment of vascular lesions using a catheter is widely performed because of less surgical invasion. For example, in percutaneous transluminal coronary angioplasty, a balloon catheter is used to expand the coronary lesion and improve blood flow. A balloon catheter is also used to perform PTA (Percutaneous Transluminal Angioplasty) to treat arteriosclerosis that has occurred in the femoral artery, iliac artery, popliteal artery, inferior arteries, etc. of the lower limbs. Sometimes.

  As arteriosclerosis progresses, the lesion becomes calcified and a hard part is generated. In this case, the calcified lesion cannot be pushed and expanded only by the expansion force of the balloon catheter, and treatment with a normal balloon may be difficult. Further, in the calcified lesion, the balloon to be expanded may slip in the axial direction, which also contributes to the difficulty in treatment with a normal balloon.

  A scoring balloon catheter in which a balloon is provided with a blade is known as a device that can treat even a calcified lesion. The scoring balloon catheter has a blade-like or linear or spiral blade provided in the balloon, and when the calcified site is cracked by this blade and the lumen of the lesion is expanded, As the blade bites into the lesion, balloon slip can be suppressed. An example of a balloon catheter having such a blade is disclosed in Patent Document 1.

Japanese Patent No. 2591573

  Since the scoring balloon catheter has a blade on the surface of the balloon, the outer diameter becomes large. For this reason, the passability at the time of delivering a balloon to a lesioned part is inferior to a normal balloon. In addition, the blade is made of a hard material such as metal in order to crack the calcified lesion, and it is in a state where the blade is fixed to the front and rear of the balloon part or directly to the balloon. Reduce. This is also a factor that reduces the passage of the balloon.

  The present invention has been made to solve the above-described problems, and can improve the passage of the balloon while allowing the blade-like portion on the surface of the balloon to contact the calcified lesion. It aims at providing a catheter and a treatment method using the same.

A balloon catheter according to the present invention that achieves the above object is a balloon catheter having a balloon at the tip of a long shaft,
The shaft has a long body lumen through which a long body having a blade-like portion is inserted in at least a part of the length direction, and the long body lumen has an opening in the vicinity of the balloon. ,
The balloon has a guide portion that guides the elongated body exposed from the opening in the length direction of the balloon.

The treatment method according to the present invention that achieves the above object has a balloon at the tip of a long shaft, and the shaft allows a long body having a blade-like portion to be inserted in at least a part of the length direction. The long body lumen has an opening in the vicinity of the balloon, and the balloon guides the long body exposed from the opening in the length direction. A treatment method using a balloon catheter having a portion,
Delivering the balloon to the vicinity of the lesion in the living body lumen;
Inserting the elongate body through the elongate lumen, and exposing a distal end of the elongate body from the opening;
Causing the blade-like portion to be disposed at a lesion while guiding the elongated body exposed from the opening by a guide portion of the balloon; and
Inserting the balloon to the position of the lesioned part with the blade-like part disposed in the lesioned part; and
Expanding the balloon to expand the lesion,
Have

  The balloon catheter configured as described above can insert a long body having a blade-like portion along the long body lumen, and can be arranged along the balloon by the guide portion. Once delivered, the blade can be placed on the surface of the balloon. For this reason, the balloon can be inserted into the living body lumen without a blade-like portion on the surface of the balloon, the outer diameter of the balloon is reduced, the flexibility is increased, and the permeability in the living body lumen is increased. can do. By inserting the long body into the long body lumen and disposing the blade portion on the surface of the balloon, the blade portion can be brought into contact with the lesioned portion when the balloon is expanded.

  In the treatment method configured as described above, when the balloon is inserted to the vicinity of the lesioned part, there is no blade-like part on the surface of the balloon. Insertion into the cavity can be facilitated. In the lesioned part, the elongated body is inserted and the blade-like part is arranged on the surface of the balloon, so that the balloon can be expanded while the blade-like part is in contact with the lesioned part.

  The balloon in the contracted state is folded such that a plurality of blade portions are along the circumferential direction of the shaft, and the guide portion is formed in a gap shape at a portion where the blade portions are folded and the balloon films overlap each other. By doing so, it is easy to hold the long body at a predetermined position on the surface of the balloon, and when the long body and the balloon are relatively moved in the axial direction, the long body is not easily displaced in the circumferential direction of the balloon. Can be.

  If the guide portion is formed in a groove shape on the surface of the balloon, the elongated body to be guided can be made difficult to shift in the circumferential direction of the balloon.

  The balloon has a base end fixing portion fixed to the shaft and an intermediate portion that is expandable and formed with the guide portion, and the base end fixing portion is substantially continuous with the guide portion and has the long length. A proximal guide portion for guiding the scale is formed. Thereby, the elongate body exposed from the opening part can be easily guide | induced to a guide part.

  The opening is open in the axial direction of the shaft. Thereby, the elongate body exposed from the opening part can be easily guided toward the guide part of the balloon.

  The blade-like portion is formed in a part in the circumferential direction of the long body, and a portion other than the blade-like portion of the long body is in contact with the surface of the balloon. Thereby, the blade-like portion can be reliably brought into contact with the inner wall surface of the living body lumen so that the blade-like portion faces the outer peripheral side of the balloon.

  The long body is covered with a long tubular protective member, and the protective member moves in the length direction with respect to the long body so that the long body protrudes and appears from the protective member. By doing so, the blade-like portion can be prevented from being exposed in the long-body lumen or the guide portion when the long body is inserted, and the inner wall can be prevented from being damaged by the blade-like portion.

  The shaft has a plurality of openings at different positions in the circumferential direction, and a plurality of the elongated bodies that can be exposed from the openings are provided. Thereby, the blade-like portion can be selectively provided in the circumferential direction of the balloon, and the blade-like portion can be arranged on the surface of the balloon according to the state of the lesioned portion.

  The method further comprises the step of selecting whether or not to use the elongated body. If the elongated body is not used, the balloon is delivered to the vicinity of the lesioned part in the living body lumen, and then the elongated body is used. If the balloon is inserted to the position of the lesioned part without being inserted into the long body lumen, and the balloon is expanded to expand the lesioned part, the length may be increased according to the state of the lesioned part. A treatment that does not use a scale can be selected, and in this case, the lesion can be expanded with a normal balloon.

It is the whole balloon catheter front view of this embodiment. FIG. 3 is an enlarged cross-sectional view of the vicinity of the tip of the balloon catheter. It is a front view of a long body. They are AA sectional drawing (FIG. 4 (a)) of FIG. 3, and BB sectional drawing (FIG.4 (b)). It is an enlarged front view near the tip of the balloon catheter. It is sectional drawing of the site | part of the balloon of the contracted state of the state which penetrated the elongate body to the guide part. It is sectional drawing of the site | part of the balloon of an expanded state. It is sectional drawing of the biological lumen of the state which inserted the balloon to the lesioned part vicinity. FIG. 9 is a cross-sectional view of a living body lumen in a state in which a long body is inserted to a position beyond a lesion after the state of FIG. 8. FIG. 10 is a cross-sectional view of a living body lumen in a state where a balloon is disposed at the position of a lesion after the state of FIG. 9. It is sectional drawing of the biological lumen of the state which expanded the balloon after the state of FIG. It is sectional drawing of the site | part of the balloon of the contracted state which has a guide part of another form. It is sectional drawing of the site | part of the balloon of the expanded state which has a guide part of another form. It is sectional drawing of the site | part of the balloon of the expanded state by which the elongate body of another form was arrange | positioned on the surface. It is an expanded sectional view near the balloon when a protective member is provided on a long body. It is an expanded sectional view of the state where the protection member was pulled from the state of FIG. 15 to the vicinity of the opening.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. Further, in this specification, the side of the balloon catheter 1 that is inserted into the living body lumen is referred to as “tip” or “tip side”, and the proximal side that is operated is referred to as “base end” or “base end side”.

  As shown in FIG. 1, the balloon catheter 1 has a long shaft 10, a balloon 11 provided at the distal end portion of the shaft 10, and a hub 12 provided at the proximal end portion of the shaft 10. . Further, a long body 13 can be inserted into the shaft 10, and the long body 13 can be exposed to the outside of the shaft 10 from the vicinity of the balloon 11.

  As shown in FIG. 2, the shaft 10 includes an outer tube 20 and an inner tube 21 that are each formed in a long hollow shape and are arranged concentrically. The inner diameter of the outer tube 20 is larger than the outer diameter of the inner tube 21, and the inner tube 21 is accommodated in the hollow interior of the outer tube 20. The hollow interior of the inner tube 21 forms a guide wire lumen 23 through which the guide wire 15 is inserted. Further, an expansion lumen 22 through which the expansion fluid of the balloon 11 is circulated is formed inside the hollow of the outer tube 20 and outside the inner tube 21.

  A long body lumen 24 for inserting the long body 13 is formed in the outer tube 20 of the shaft 10. The long body lumen 24 has an opening 25 in the vicinity of the distal end of the shaft 10 and in the vicinity of the proximal end of the balloon 11, and exposes the long body 13 from the opening 25 toward the distal end side. be able to. The elongated body 13 is in contact with the inner wall surface of the living body lumen along the outer surface of the balloon 11 in the expanded state. The opening 25 of the long body lumen 24 is formed so as to face the axial direction of the shaft 10.

  The shaft 10 has long body lumens 24 at three locations in the circumferential direction, and the long body 13 can be inserted through each of the long body lumens 24. That is, three long bodies 13 can be inserted through the shaft 10.

The inner tube 21 protrudes further to the distal end side than the distal end of the outer tube 20. The balloon 11 has a proximal end portion fixed to the distal end portion of the outer tube 20, and a distal end portion fixed to the distal end portion of the inner tube 21. Thereby, the inside of the balloon 12 communicates with the expansion lumen 22. The balloon 11 can be expanded by injecting the expansion fluid into the balloon 11 via the expansion lumen 22. The expansion fluid may be a gas or a liquid. For example, a gas such as helium gas, CO ₂ gas, or O ₂ gas, or a liquid such as physiological saline or contrast medium can be used.

  The outer tube 20 and the inner tube 21 are preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, Examples thereof include fluororesins such as polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polytetrafluoroethylene, silicone rubber, and latex rubber.

  The hub 12 includes a first opening 12 a that communicates with the guide wire lumen 23, a second opening 12 b that functions as a port that communicates with the expansion lumen 22 of the outer tube 20 and allows the expansion fluid to flow in, and the outer tube 20. It has the 3rd opening part 12c which functions as a port which inserts the long body 13 in communication with the lumen | bore 24 for long bodies. Three third openings 12c are provided corresponding to the three long body lumens 24, but only one is shown in FIG. 1 for convenience. The material of the hub 12 is not particularly limited. For example, a hard resin such as polycarbonate, polyethylene, or polypropylene can be used.

  The long body 13 will be described. In FIG. 3, the long body 13 has a proximal side on the left side in the drawing and a distal side on the right side in the drawing. The long body 13 has a long wire portion 40 extending from the proximal end to the distal end, and has a blade-like portion 41 having a predetermined length in the vicinity of the distal end. The wire portion 40 is formed of a flexible material similar to that of the shaft 10. The blade-like part 41 is formed of a metal material having a sharp part. However, the blade-like portion 41 may be formed of other materials such as hard resin or ceramics. At least the distal end portion and the proximal end portion of the blade-like portion 41 have X-ray contrast properties, and the position of the blade-like portion 41 can be visually recognized when the elongated body 13 is inserted into the living body lumen. it can. Note that the entire blade-like portion 41 may have X-ray contrast properties. Further, the distal end portion of the long body 13 also has X-ray contrast properties, and the distal end position of the long body 13 can also be visually recognized in the living body lumen.

  As shown in FIG. 4A, the wire portion 40 has a substantially circular cross section. Moreover, as shown in FIG.4 (b), the blade-shaped part 41 has a sharp part in the circumferential direction 1 place, and the opposite side to the sharp part in the circumferential direction is formed in cross-sectional arc shape. In the cross section shown in FIG. 4 (b) of the blade-like portion 41, the position of the center of gravity is biased toward the side formed in the cross-section arc shape, so that when the blade-like portion 41 is arranged on the surface of the balloon 11, This part tends to face the outside of the balloon 11. For this reason, when the balloon 11 is expanded, it is possible to easily bring the sharp portion of the blade-like portion 41 into contact with the inner wall surface of the living body lumen.

  As shown in FIG. 5, the balloon 11 has a proximal end fixing portion 30 fixed to the shaft 10 and an intermediate portion 31 that is radially expandable. The intermediate portion 31 has a plurality of blade portions in the contracted state. 34 is wound in the circumferential direction and folded. Thereby, the outer diameter at the time of insertion in a living body lumen can be made small. A guide portion 32 is formed in the intermediate portion 31 of the balloon 11 so as to face the opening portion 25 of the shaft 10. The guide part 32 guides the long body 13 in the length direction of the balloon 11. The proximal end fixing portion 30 of the balloon 11 is formed with a proximal end guide portion 33 that guides the long body 13 to the guide portion 32. The proximal-side guide portion 33 is formed in a groove shape along the length direction of the balloon 11 on the surface of the balloon 11.

  As shown in FIG. 6, in the middle portion 31 of the balloon 11 in the deflated state, the plurality of blade portions 34 are folded along the circumferential direction of the shaft 10. In the present embodiment, three blade portions 34 are formed in the circumferential direction, and each blade portion 34 is laid so as to overlap a portion of the balloon membrane along the shaft 10. A gap is formed along the length direction in a part of a region where the blade portion 34 and the portion along the shaft 10 overlap in the balloon membrane, and the guide portion 32 is formed by this gap-shaped portion. That is, the long body 13 is inserted through the guide portion 32 that is a gap-shaped portion.

  As shown in FIG. 7, when the balloon 11 is expanded at the lesioned part, the outer diameter of the balloon 11 is increased, and the long body 13 arranged along the balloon 11 from the guide part 32 is outside the balloon 11. It arrange | positions on the surface and contact | abuts to the inner wall surface of a biological lumen. As described above, the blade-like portion 41 of the elongated body 13 has a shape in which a sharp portion that is also visible in X-ray contrast or the like tends to face the outer peripheral side, and this sharp portion is a living body lumen. By making contact with the inner wall surface, it is possible to make the portion hardened by calcification easily cracked and spread.

  Next, a treatment method using the balloon catheter 1 of the present embodiment will be described. First, a catheter introducer (not shown) is punctured percutaneously into a blood vessel that is a living body lumen by the Seldinger method or the like. Next, a guiding catheter (not shown) into which the guide wire 15 is inserted is inserted into the catheter introducer, the guide wire 15 is protruded from the distal end, and the distal end of the guiding catheter is then inserted into the blood vessel from the distal opening of the catheter introducer. Insert inside. Thereafter, the guiding catheter is gradually advanced to the target site while the guide wire 15 is advanced.

  Next, the end of the guide wire 15 is inserted into the distal end opening of the guide wire lumen 23 of the balloon catheter 1 in a state where the balloon 11 is deflated, and the guide wire 15 is taken out from the first opening 12 a of the hub 12. Next, the balloon catheter 1 is inserted into the guiding catheter inserted into the blood vessel from the tip, and the balloon catheter 1 is pushed along the guide wire 15.

  As shown in FIG. 8, in the state where the balloon 11 is inserted to the vicinity of the lesioned part in the blood vessel, the guide wire 15 is inserted beyond the lesioned part. Further, when the balloon 11 is inserted to this position, the long body 13 is not inserted through the shaft 10. For this reason, the outer diameter of the balloon 11 can be prevented from being increased by the blade-like portion 41. Moreover, since the balloon 11 does not have the blade-like part 41 at the time of insertion into the blood vessel, the flexibility of the balloon 11 can be ensured and the passability can be improved.

  When the balloon 11 is inserted to the vicinity of the lesioned part, the elongated body 13 is inserted from the third opening 12c of the hub 12. As described above, since three long body lumens 24 and three openings 25 are provided in the circumferential direction of the shaft 10, a maximum of three long bodies 13 can be inserted into the shaft 10. it can. The number of the long bodies 13 inserted through the shaft 10 can be changed according to the state of the lesioned part. For example, when the calcified lesion part extends over the entire circumference of the blood vessel, three elongated bodies 13 are inserted so that the blade-like parts 41 are arranged at three locations in the circumferential direction of the balloon 11. Can be. On the other hand, when a calcified lesion is formed in a part of the blood vessel, one or two elongated bodies are arranged so that the blade-like portion 41 is arranged at a position facing the calcified lesion. 13 can be inserted.

  If there is no calcified site in the lesion, the balloon 11 can be expanded as it is without inserting the elongated body 13. That is, the balloon catheter 1 of this embodiment can also be used as a normal balloon catheter. When selection is made not to use the long body 13, the balloon 11 is inserted as it is to the lesioned part and expanded to expand the lesioned part. For example, when both the expansion of a blood vessel using a normal balloon and the expansion of a blood vessel using a balloon having a blade-like portion are required, a normal balloon catheter and a balloon catheter having a blade-like portion are attached. Although it is necessary to exchange in the procedure, the balloon catheter 1 of this embodiment can perform both expansions in the blood vessel without exchanging the device. For this reason, the time for the procedure can be shortened and the number of devices to be used can be reduced.

  The long body 13 is inserted into the long body lumen 24, proceeds toward the distal end side, and is exposed to the outside of the shaft 10 through the opening 25. The elongated body 13 exposed to the outside of the shaft 10 is guided to the entrance of the guide portion 32 formed in the intermediate portion 31 of the balloon 11 by the proximal end side guide portion 33 formed in the proximal end fixing portion 30 of the balloon 11. Is done. The elongated body 13 guided into the guide portion 32 advances along the length direction of the balloon 11 and is exposed to the outside again from the tip portion of the guide portion 32. As shown in FIG. 9, the tip of the long body 13 is inserted to the end of the lesion. At this time, the long body 13 is arranged so that the portion of the blade-like portion 41 is located in the lesioned portion in the length direction.

  Next, as shown in FIG. 10, the balloon 11 is inserted to the lesioned part while the position of the elongated body 13 in the blood vessel is fixed. When the balloon 11 is located at the lesioned part, the blade-like part 41 of the long body 13 is located at the guide part 32. By the guide portion 32, the blade-like portion 41 is reliably located at a predetermined position in the circumferential direction of the balloon 11.

  Next, as shown in FIG. 11, the expansion fluid is supplied into the balloon 11 from the second opening 12 b of the hub 12 through the expansion lumen 22 to expand the balloon 11. At this time, the blade-like portion 41 located on the guide portion 32 of the balloon 11 faces the outer peripheral side of the balloon 11 and is pressed against the lesioned portion. Thereby, the blade-like part 41 can cause a crack in the lesioned part, and the lesioned part can be expanded by the expansion force of the balloon 11. Further, the blade-like portion 41 allows the balloon 11 to be expanded without sliding in the length direction at the lesioned portion.

  Thereafter, the expansion fluid is discharged from the balloon 11 to deflate the balloon 11. When the balloon 11 is deflated, the long body 13 is removed from the shaft 10. Since the long body 13 is not fixed to the balloon 11, it is not affected by the balloon 11 when the long body 13 is removed, and does not fall off or tear. When the elongated body 13 is removed, the balloon catheter 1 is removed from the living body. When the balloon catheter 1 is removed, the guide wire 15 is also removed. Note that the guide wire 15 may be left when another treatment is performed subsequently. When the balloon catheter 1 is removed, the guiding catheter is removed from the catheter introducer, and the catheter introducer is also removed from the living body to complete the procedure.

  Another form of the guide portion will be described. As shown in FIG. 12, the deflated balloon 11 has three blade portions 34 in the circumferential direction around the shaft 10, and is folded so that they are laid down in the circumferential direction of the shaft 10. A groove-shaped guide portion 35 is formed along the length direction at the tip of each blade portion 34, and the long body 13 is accommodated in the guide portion 35. Thus, the guide part 35 may be formed in a groove shape on the surface of the balloon 11.

  As shown in FIG. 13, even when the balloon 11 of FIG. 12 is expanded, the surface of the balloon 11 has a groove-shaped guide portion 35, and the long body 13 is placed at a predetermined position in the circumferential direction of the balloon 11. Can be held in.

  Another elongate body will be described. As shown in FIG. 14, the long body 16 of the present embodiment has a substantially pentagonal cross section at the blade-like portion 42. Moreover, parts other than the blade-shaped part 42 of the elongate body 16 have cross-sectional substantially square shape. Thus, the cross-sectional shape of the long body 16 is not limited to a circular shape or an arc shape, and may have other shapes. Since the blade-like portion 42 of the long body 16 has a substantially pentagonal cross section, the surface that comes into contact with the surface of the balloon 11 becomes large, and the position of the long body 16 with respect to the balloon 11 can be stabilized. it can.

  The elongate body 13 may be provided with a tubular protective member 45. As shown in FIG. 15, by providing the protective member 45 that covers the long body 13, it is possible to prevent the blade-like portion 42 from damaging the shaft 10 or the like when the long body 13 is inserted. When the long body 13 and the balloon 11 are arranged in the lesioned part, the long body 13 is exposed by pulling the protective member 45 as shown in FIG. Thereby, the balloon 11 can be expanded in a state where the blade-like portion 42 of the long body 13 is disposed on the surface of the balloon 11.

  As described above, the balloon catheter 1 according to the present embodiment is the balloon catheter 1 having the balloon 11 at the distal end portion of the long shaft 10, and the shaft 10 has a blade shape at least partially in the length direction. The long body lumen 24 through which the long body 13 having the portion 41 is inserted has an opening 25 in the vicinity of the balloon 11, and the balloon 11 is exposed from the opening 25. A guide portion 32 for guiding the elongated body 13 in the length direction of the balloon 11 is provided. Accordingly, the long body 13 having the blade-like portion 41 can be inserted along the long body lumen 24 and arranged along the balloon 11 by the guide portion 32, so that the balloon 11 is delivered to the lesioned part or the vicinity thereof. Then, the blade portion 41 can be disposed on the surface of the balloon 11. Therefore, the balloon 11 can be inserted into the living body lumen without the blade-like portion 41 on the surface of the balloon 11, and the outer diameter of the balloon 11 is reduced, the flexibility is increased, and the passability is increased. be able to. By inserting the long body 13 through the long body lumen 24 and disposing the blade-like portion 41 on the surface of the balloon 11, the blade-like portion 41 can be brought into contact with the lesion when the balloon 11 is expanded. .

  Further, the balloon 11 in the contracted state is folded so that the plurality of blade portions 34 are along the circumferential direction of the shaft 10, and the guide portion 32 is a gap in the portion where the blade portions 34 are folded and the balloon membranes overlap each other. If the long body 13 is formed in the shape, it is easy to hold the long body 13 at a predetermined position on the surface of the balloon 11, and when the long body 13 and the balloon 11 are relatively moved in the axial direction, the long body 13 It can be made difficult to shift in the circumferential direction of the balloon 11.

  Further, if the guide portion 35 is formed in a groove shape on the surface of the balloon 11, the elongated body 13 to be guided can be prevented from being displaced in the circumferential direction of the balloon 11.

  The balloon 11 has a proximal end fixing portion 30 fixed to the shaft 10 and an intermediate portion 31 that is expandable and formed with a guide portion 32. The proximal end fixing portion 30 is substantially the same as the guide portion 32. A proximal end side guide portion 33 that continuously guides the long body 13 is formed. Thereby, the long body 13 exposed from the opening 25 can be easily guided to the guide portion 32.

  The opening 25 opens toward the axial direction of the shaft 10. Thereby, the elongate body 13 exposed from the opening part 25 can be easily guided toward the guide part 32 of the balloon 11.

  Further, the blade-like portion 41 is formed in part in the circumferential direction of the long body 13, and portions other than the blade-like portion 41 of the long body 13 abut against the surface of the balloon 11. Thereby, the blade-like portion 41 can be reliably brought into contact with the inner wall surface of the living body lumen so that the blade-like portion 41 faces the outer peripheral side of the balloon 11.

  Further, the long body 13 is covered with a long tubular protection member 45, and the protection member 45 moves in the length direction with respect to the long body 13, so that the long body 13 appears and disappears from the protection member 45. By doing so, the blade-like portion 41 can be prevented from being exposed at the long-body lumen 24 and the guide portion 32 when the elongated body 13 is inserted, and the inner wall can be prevented from being damaged by the blade-like portion 41.

  The shaft 10 has a plurality of openings 25 at different positions in the circumferential direction, and a plurality of long bodies 13 that can be exposed from the openings 25 are provided. Thereby, the blade-like portion 41 can be selectively provided in the circumferential direction of the balloon 11, and the blade-like portion 41 can be arranged on the surface of the balloon 11 according to the state of the lesioned portion.

  Moreover, the treatment method according to the present embodiment has the balloon 11 at the distal end portion of the long shaft 10, and the shaft 10 has the long body 13 having the blade-like portion 41 at least at a part in the length direction. The long body lumen 24 is inserted into the long body lumen 24. The long body lumen 24 has an opening 25 in the vicinity of the balloon 11. The balloon 11 exposes the long body 13 exposed from the opening 25 in the length direction. A method of using the balloon catheter 1 having the guide portion 32 for guiding the balloon 11 to the vicinity of the lesioned portion in the living body lumen, and the elongated body 13 to the lumen 24 for the elongated body. , The step of exposing the distal end portion of the long body 13 from the opening portion 25, and the long body 13 exposed from the opening portion 25 are guided by the guide portion 32 of the balloon 11 while the blade-like portion 41 is affected by the lesion. Placed in A step of inserting the balloon 11 to the position of the lesioned part in a state where the blade-like part 41 is disposed in the lesioned part, and a step of expanding the balloon 11 and pushing the lesioned part. . As a result, when the balloon 11 is inserted to the vicinity of the lesioned portion, the blade-like portion 41 does not exist on the surface of the balloon 11, so that the outer diameter is small and the balloon 11 having high flexibility enters the living body lumen. Can be easily inserted. In the lesioned part, the elongated body 13 is inserted and the blade-like part 41 is arranged on the surface of the balloon 11, so that the balloon 11 can be expanded while the blade-like part 41 is in contact with the lesioned part.

  In addition, the method further includes a step of selecting whether or not the long body 13 is used. When the long body 13 is not used, the balloon 11 is delivered to the vicinity of the lesioned part in the living body lumen, and then the long body 13 is used. If the balloon 11 is inserted to the position of the lesioned part without inserting the body 13 into the long body lumen 24 and the balloon 11 is expanded to expand the lesioned part, the state of the lesioned part will be increased. Thus, a treatment that does not use the long body 13 can be selected. In this case, the lesion can be expanded by the normal balloon 11.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the above-described embodiment, the guide portion 32 is formed in a linear shape along the axial direction of the balloon 11, but the blade portion 34 of the balloon 11 is spirally wound around the shaft 10, and the guide portion 32 is the balloon. 11 may be formed in a spiral shape. In this case, since the elongate body 13 is spirally arranged with respect to the balloon 11, when the balloon 11 is expanded, the blade-like portion 41 is distributed in the circumferential direction with respect to the inner wall surface of the living body lumen. Thereby, a crack can be effectively made in the circumferential direction with respect to the lesioned part.

  Moreover, when the guide part 32 is linearly formed along the axial direction of the balloon 11 as in the above-described embodiment, the elongate body 13 is inserted into the guide part 32 and the tip part of the balloon 11 is fixed. Then, by rotating the proximal end portion of the balloon 11, the balloon 11 may be twisted and the guide portion 32 may be spiral. Further, when the balloon 11 is twisted, the proximal end portion of the balloon 11 may be fixed and the distal end portion of the balloon 11 may be rotated, or the distal end portion and the proximal end portion of the balloon 11 may be rotated in opposite directions. . Thereafter, the elongated body 13 is once removed from the guide portion 32, the balloon 11 is inserted to the vicinity of the lesioned portion, and the elongated body is inserted into the spiral guide portion 32 through the elongated body lumen 24 and the opening 25. By inserting 13, the blade-like portion 32 can be arranged spirally with respect to the balloon 11.

  Moreover, although the long lumen | rumen 24 formed in the shaft 10 is three in the circumferential direction in the above-mentioned embodiment, other numbers may be sufficient.

  Further, the long body lumen 24 and the opening 25 are not limited to the above-described embodiments. For example, a tubular long shaft may be provided around the shaft 10 and the long shaft may have a long lumen and an opening. The long body shaft is rotatable in the circumferential direction with respect to the shaft 10, and the opening can be disposed at any position in the circumferential direction of the balloon 11. In this aspect, guide portions are formed at a plurality of positions in the circumferential direction of the balloon 11, and the elongated body 13 is rotated by rotating the elongated body shaft so that the opening portion is arbitrarily opposed to the guide portion and the desired length of the elongated body 13 is guided. Can be inserted through the part.

  Further, the opening is formed in a slit shape that is long in the circumferential direction of the shaft, and the long body 13 may be exposed from an arbitrary position in the circumferential direction of the slit.

DESCRIPTION OF SYMBOLS 1 Balloon catheter 10 Shaft 11 Balloon 12 Hub 12a 1st opening part 12b 2nd opening part 12c 3rd opening part 13 Long body 15 Guide wire 20 Outer tube 21 Inner pipe 22 Expansion lumen 23 Guide wire lumen 24 Long body lumen 25 Opening portion 30 Base end fixing portion 31 Intermediate portion 32 Guide portion 33 Base end side guide portion 34 Blade portion 40 Wire portion 41 Blade portion 45 Protection member

Claims (10)

A balloon catheter having a balloon at the tip of a long shaft,
The shaft has a long body lumen through which a long body having a blade-like portion is inserted in at least a part of the length direction, and the long body lumen has an opening in the vicinity of the balloon. ,
The balloon is a balloon catheter having a guide portion that guides the elongated body exposed from the opening in the length direction of the balloon.   The balloon in the contracted state is folded such that a plurality of blade portions are along the circumferential direction of the shaft, and the guide portion is formed in a gap shape at a portion where the blade portions are folded and the balloon films overlap each other. The balloon catheter according to claim 1.   The balloon catheter according to claim 1, wherein the guide portion is formed in a groove shape on a surface of the balloon.   The balloon has a base end fixing portion fixed to the shaft and an intermediate portion that is expandable and formed with the guide portion, and the base end fixing portion is substantially continuous with the guide portion and has the long length. The balloon catheter according to claim 3, wherein a proximal end guide portion for guiding the scale is formed.   The balloon catheter according to any one of claims 1 to 4, wherein the opening is open toward an axial direction of the shaft.   The said blade-shaped part is formed in a part in the circumferential direction of the said elongate body, and parts other than the said blade-shaped part of the said elongate body contact | abut with respect to the surface of the said balloon. The balloon catheter according to claim 1.   The long body is covered with a long tubular protective member, and the protective member moves in a length direction with respect to the long body, so that the long body appears and disappears from the protective member. The balloon catheter according to any one of 1 to 6.   The balloon catheter according to claim 1, wherein the shaft has a plurality of the openings at different positions in the circumferential direction, and a plurality of the elongated bodies that can be exposed from the openings are provided. . A long shaft has a balloon at the tip thereof, and the shaft has a long body lumen through which a long body having a blade-like portion is inserted in at least a part of the length direction. The lumen for treatment has an opening in the vicinity of the balloon, and the balloon is a treatment method using a balloon catheter having a guide portion for guiding the elongated body exposed from the opening in the length direction. ,
Delivering the balloon to the vicinity of the lesion in the living body lumen;
Inserting the elongate body through the elongate lumen, and exposing a distal end of the elongate body from the opening;
Causing the blade-like portion to be disposed at a lesion while guiding the elongated body exposed from the opening by a guide portion of the balloon; and
Inserting the balloon to the position of the lesioned part with the blade-like part disposed in the lesioned part; and
Expanding the balloon to expand the lesion,
A treatment method comprising: Further comprising the step of selecting whether to use the elongated body;
When the elongated body is not used, the balloon is delivered to the vicinity of the lesioned part in the living body lumen, and then the balloon is inserted into the lesioned part without inserting the elongated body into the elongated body lumen. The treatment method according to claim 9, further comprising a step of inserting the balloon to a position and expanding the balloon to expand the lesion.

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