WO2021132141A1 - Balloon catheter - Google Patents

Abstract

In balloon catheters 20A, 20B, balloons 23A, 23B are provided with protrusion portions 41A, 41B protruding from the outer circumferential surfaces thereof. The protrusion portions 41A, 41B are formed on portions in the circumferential direction of the balloons 23A, 23B. The balloons 23A, 23B are each introduced into a body in a contracted state and are disposed adjacent to each other when introduced. At portions in the circumferential direction, the balloons 23A, 23B are respectively provided with suction members 45A, 45B that are sucked by each other by magnetic force. As the suction members 45A, 45B suck each other, the balloon 23A, 23B are rotated in the circumferential direction in the contracted state and each of the balloons 23A, 23B is positioned relative to the other in the direction of rotation.

Description

Balloon catheter Cross-reference of related applications

This application is based on Japanese Application No. 2019-325986 filed on December 26, 2019, and the contents of the description are incorporated herein by reference.

This disclosure relates to a balloon catheter.

Conventionally, balloon catheters have been used in treatments such as PTA (percutaneous angioplasty) and PTCA (percutaneous coronary angioplasty). The balloon catheter is provided with a balloon that can be expanded and contracted on the distal end side thereof. In a balloon catheter, a balloon is introduced in a contracted state into a site narrowed or occluded by a lesion generated in a vessel such as a blood vessel or lymphatic vessel, and then the balloon is inflated to expand the site. It has become.

Some balloon catheters are provided with a linear element extending in the axial direction on the outer surface of the balloon (see, for example, Patent Document 1). A plurality of elements are arranged at equal intervals in the circumferential direction of the balloon, for example. In such a balloon catheter, when the balloon is inflated at the lesion, an element can make a cut in the lesion. Therefore, it is possible to easily dilate the lesion.

Japanese Unexamined Patent Publication No. 2014-506140

By the way, in the bifurcated part where the vessel is branched in the body, it is assumed that the lesion is eccentrically generated (deposited) in the vessel due to the complicated flow of body fluid in the vessel. For example, it is assumed that a lesion occurs only in a part of the vessel in the circumferential direction.

Here, when such a lesion is treated using the balloon with the element described above, the lesion can be cut by the element, but the other element has a lesion in the vessel. It is conceivable that it hits a non-existent part, that is, a healthy part. In that case, there is a concern that the element may damage a healthy part.

In addition, it is assumed that the lesion part eccentrically occurs in the body not only in the bifurcation part of the vessel but also in the bifurcation part other than the bifurcation part. In that case, there is a concern that the above-mentioned inconvenience may occur in treating the lesion.

The present disclosure has been made in view of the above circumstances, and the main purpose of the present disclosure is to provide a balloon catheter capable of suitably treating a lesion.

In order to solve the above problems, the balloon catheter of the first disclosure includes a balloon that can be inflated and contracted and is introduced into the body in a contracted state, and the balloon is inflated on the outer peripheral surface of the balloon. A balloon catheter provided with a treatment unit for performing a predetermined treatment, the treatment unit is provided in a part of the circumferential direction of the balloon, and the balloon is introduced into the body when introduced into the body. It is arranged adjacent to an elongated introduction member introduced into the body together with the balloon, and the balloon is provided with a positioning portion for positioning the balloon with respect to the introduction member, and the positioning is performed. The unit positions the balloon in the rotational direction when the balloon rotates in the circumferential direction in the contracted state or the semi-contracted state.

According to the present disclosure, a treatment section for performing a predetermined treatment is provided on the outer peripheral surface of the balloon, and the treatment section is provided on a part of the circumferential direction of the balloon. The balloon is introduced into the body (intravascular) together with the elongated introduction member in the contracted state, and is arranged adjacent to the introduction member. The balloon is provided with a positioning portion for positioning the balloon with respect to the introduction member arranged adjacent to the balloon. The positioning unit positions the balloon in the rotational direction when the balloon rotates in the circumferential direction in the contracted state or the semi-contracted state. In this case, the treatment portion provided on the outer peripheral surface of the balloon can be positioned in the rotation direction by the positioning by the positioning portion. Therefore, by inflating the balloon in the positioned state, the treatment portion can be directed to a predetermined site in the circumferential direction in the vessel. As a result, when a lesion occurs in a part of the circumferential direction in the vessel, the treatment part is directed to the lesion side, and the treatment part is not directed to the healthy part where the lesion is not formed. Is possible. Therefore, the treatment of the lesion can be preferably performed.

The semi-contracted state of the balloon is an intermediate state between the contracted state and the inflated state.

In the first disclosure, the balloon catheter of the second disclosure is a protruding portion provided so as to project from the outer peripheral surface of the balloon.

According to the present disclosure, since a protruding portion protruding from the outer peripheral surface of the balloon is provided as a treatment portion, when the lesion portion is expanded by inflating the balloon, the lesion portion may be cut by the protruding portion. It will be possible. As a result, when the lesion is hardened due to calcification or the like, the lesion can be easily expanded by making a notch in the lesion.

Then, in the present disclosure, the above-mentioned first disclosure is applied to the configuration in which the protruding portion on the balloon is provided. As a result, when a hardened lesion is formed in a part of the vascular tube in the circumferential direction, the protruding portion is directed to the side of the lesion by using the positioning portion, and the healthy part where the lesion is not formed is directed. It is possible to prevent the treatment department from being turned. In this case, since it is possible to treat the lesion by applying it only to the lesion without applying the protrusion to the healthy part, it is possible to preferably treat the lesion using the protrusion. In particular, when the protruding portion hits a healthy portion, the portion may be damaged. Therefore, it is particularly effective to apply the first disclosure to a balloon having such a protruding portion.

As the treatment unit, in addition to the protrusion in the second disclosure, a drug unit formed by applying a drug to the outer peripheral surface of the balloon can be considered. In this case, the lesion can be treated with the drug of the drug part.

In the first or second disclosure, the balloon catheter of the third disclosure is such that the balloon is arranged adjacent to the introduction member on the outer peripheral side thereof, and the positioning portion is in the circumferential direction of the balloon. It is a suction member provided in a part of the above and attracted to the introduction member side by magnetic force or electrostatic force. When the suction member is attracted to the introduction member side, the balloon rotates in the circumferential direction, and the balloon is rotated. It is positioned at a predetermined position in the direction of rotation.

According to the present disclosure, a suction member that is attracted by magnetic force or electrostatic force is provided on the introduction member side in a part of the circumferential direction of the balloon. In this case, the balloon is rotated in the circumferential direction by being attracted to the introduction member side by magnetic force or electrostatic force, and is positioned at a predetermined position in the rotation direction. According to such a configuration, the positioning of the balloon and the positioning of the treatment portion are naturally performed by magnetic force or electrostatic force, so that the positioning can be easily performed.

In the third disclosure, the balloon catheter of the fourth disclosure is made of a magnetic material that generates a magnetic force when a magnetic field is applied from the outside.

According to the present disclosure, the attractive member is made of a magnetic material that generates a magnetic force when an external magnetic field is applied, and is attracted to the introduction member side by the generated magnetic force. In this case, when the balloon is introduced into the body, a magnetic force is not generated in the suction member without applying an external magnetic field, and after the balloon is introduced into the body, when the balloon is positioned with respect to the introduction member, it is external. A magnetic field can be applied to generate a magnetic force in the suction member. As a result, it is possible to prevent the suction member from being attracted to the introduction member side by the magnetic force when the balloon is introduced into the body, so that it is possible to prevent the balloon introduction work from becoming difficult due to the magnetic force.

In the third or fourth disclosure of the balloon catheter of the fifth disclosure, the suction member is arranged inside the balloon.

According to the present disclosure, since the suction member is arranged inside the balloon, it is possible to suppress inconveniences such as damage to the tube wall in the body by the suction member when the balloon is introduced into the body.

In any of the first to fifth disclosures, the balloon catheter of the sixth disclosure is such that the balloon is arranged adjacent to the introduction member on the outer peripheral side thereof, and the positioning portion is the balloon. The treatment unit is provided at least on the tip side of the positioning unit so that the treatment unit faces the introduction member side when the balloon is inflated. , The balloon is positioned in the direction of rotation.

In the bifurcated part where the vessel is branched in the body, the lesion part tends to be biased in the circumferential direction in the tube because the flow of body fluid in the tube becomes complicated. Further, in the bifurcated portion, it is considered that the lesion portion is likely to occur on the crotch side of the bifurcation. Therefore, in the present disclosure, in view of this point, the positioning unit positions the balloon in the rotation direction so that the treatment unit faces the introduction member side when the balloon is inflated. According to such a configuration, when treating a lesion formed in a bifurcated portion, it can be treated as follows. First, the introduction member is introduced into one of the main pipe and the branch pipe branched at the branch portion, and the balloon is introduced into the other. At this time, with respect to the balloon, a part of the base end side thereof is positioned on the base end side of the branch portion and is adjacent to the introduction member. Then, the balloon is positioned with respect to the introduction member in the rotational direction by the positioning portion arranged on the base end side of the balloon in the adjacent state. In this case, when the balloon is inflated in this positioning state, the treatment unit is directed toward the introduction member side. That is, in this case, the treated portion can be directed to the crotch side where the lesion is generated at the bifurcation portion, and cannot be directed to the anti-crotch side where the lesion is not generated. Thereby, the lesion portion generated in the bifurcated portion can be suitably treated.

In the sixth disclosure, the balloon catheter of the seventh disclosure is a protrusion in which the treatment portion protrudes from the outer peripheral surface of the balloon, and the protrusion is a tip of the positioning portion in the axial direction of the balloon. It is located on the side.

According to the present disclosure, since the treatment portion is a protruding portion protruding from the outer peripheral surface of the balloon, the lesion portion generated in the bifurcated portion can be more preferably treated by the protruding portion. Further, since the protruding portion is arranged on the tip side of the positioning portion, it is possible to prevent the protruding portion from interfering with the introduction member and interfering with the positioning when the positioning portion positions the balloon in the rotational direction. Can be done.

In any of the first to seventh disclosures, the balloon catheter of the eighth disclosure is configured by the balloon having a first positioning portion as the positioning portion, or is separate from the first positioning portion. A second positioning portion formed of is provided, and the second positioning portion performs axial positioning of the balloon with respect to the introduction member in the contracted state or the semi-contracted state.

According to the present disclosure, since the balloon can be positioned in the axial direction with respect to the introduction member in the contracted state or the semi-contracted state of the balloon, the treatment portion is positioned in the axial direction with respect to the lesion portion by the positioning. Is possible. This makes it possible to more preferably treat the lesion.

The above objectives and other objectives, features and advantages of the present disclosure will be clarified by the following detailed description with reference to the accompanying drawings.
Schematic overall side view showing the configuration of a balloon catheter set. A side view of the balloon and its surroundings in the inflated state. (A) is a cross-sectional view taken along the line AA of FIG. 2, and (b) is a cross-sectional view taken along the line BB of FIG. The figure for demonstrating the procedure at the time of treating a lesion formed in the bifurcation part of a blood vessel using a balloon catheter set. The figure which shows another example of the protrusion. The figure which shows another example of the protrusion. The figure which shows another example of the protrusion. The figure which shows another example about the positioning of a balloon by a suction member. The figure which shows another example about the positioning of a balloon by a suction member. The figure which shows another example about how to use a suction member. The figure which shows another example of the suction member.

Hereinafter, an embodiment of the balloon catheter set will be described with reference to the drawings. FIG. 1 is a schematic overall side view showing the configuration of a balloon catheter set.

As shown in FIG. 1, the balloon catheter set 10 includes two balloon catheters 20A and 20B. In the present embodiment, both of these two balloon catheters 20A and 20B have the same configuration. Therefore, the configurations of these balloon catheters 20A and 20B will be collectively described below. In the following description, A is attached to the code of each part constituting the balloon catheter 20A, and B is attached to the code of each part constituting the balloon catheter 20B.

The balloon catheters 20A and 20B are the catheter bodies 21A and 21B, the hubs 22A and 22B attached to the proximal end (proximal end) of the catheter bodies 21A and 21B, and the distal end side (distal) of the catheter bodies 21A and 21B. It is provided with balloons 23A and 23B attached to the end side).

The catheter bodies 21A and 21B include outer tubes 25A and 25B and inner tubes 26A and 26B inserted inside the outer tubes 25A and 25B. The outer tubes 25A and 25B are made of, for example, a resin material. The base ends of the outer tubes 25A and 25B are joined to the hubs 22A and 22B, and the tip ends thereof are joined to the balloons 23A and 23B. Further, the outer tubes 25A and 25B have lumens 27A and 27B (see FIG. 2) extending in the entire axial direction inside the outer tubes 25A and 25B. The lumens 27A and 27B communicate with the hubs 22A and 22B and also with the balloons 23A and 23B.

The outer tubes 25A and 25B may be formed by joining a plurality of tubes arranged in the axial direction to each other. In this case, for example, among the tubes, the tube on the proximal end side may be formed of a metal material such as Ni—Ti alloy or stainless steel, and the tube on the distal end side may be formed of a resin material such as a polyamide elastomer.

The inner tubes 26A and 26B are formed of a resin material, for example, a polyamide elastomer. The inner tubes 26A and 26B have lumens 28A and 28B (see FIG. 2) extending in the entire axial direction inside the inner tubes 26A and 26B. The base ends of the inner tubes 26A and 26B are joined to the outer tubes 25A and 25B at intermediate positions in the axial direction, and a part of the tip side thereof extends toward the tip side of the outer tubes 25A and 25B. The balloons 23A and 23B are provided so as to cover the extended region of the inner tubes 26A and 26B from the outside.

The lumens 27A and 27B of the outer tubes 25A and 25B function as fluid lumens through which the compressed fluid flows when the balloons 23A and 23B are expanded or contracted. Further, the lumens 28A and 28B of the inner tubes 26A and 26B function as lumens for the guide wire through which the guide wire G is inserted. The proximal openings 29A and 29B of the lumens 28A and 28B are located in the middle of the balloon catheters 20A and 20B in the axial direction. Therefore, the balloon catheters 20A and 20B are so-called RX type catheters. The proximal openings 29A and 29B of the lumens 28A and 28B may be located at the proximal ends of the balloon catheters 20A and 20B, in which case the balloon catheters 20A and 20B are so-called over-the-wire catheters. To.

Next, the configurations of the balloons 23A and 23B and their surroundings will be described with reference to FIGS. 2 and 3. FIG. 2 is a side view of the balloons 23A and 23B in the inflated state and their surroundings. 3A is a cross-sectional view taken along the line AA of FIG. 2, and FIG. 3B is a cross-sectional view taken along the line BB of FIG.

As described above, the balloons 23A and 23B are provided so as to cover the extension area of the inner tubes 26A and 26B extending toward the tip side of the outer tubes 25A and 25B from the outside. As shown in FIG. 2, the balloons 23A and 23B have their base ends joined to the tips of the outer tubes 25A and 25B, and the tips thereof joined to the tips of the inner tubes 26A and 26B.

Balloons 23A and 23B are formed of a thermoplastic polyamide elastomer. However, if the balloons 23A and 23B can be expanded and contracted satisfactorily with the supply and discharge of the fluid, the balloons 23A and 23B may be formed of a thermoplastic resin other than the polyamide elastomer. For example, it may be formed of polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyamide, polyimide, polyimide elastomer, silicon rubber, or the like.

The balloons 23A and 23B are formed by a film portion having a predetermined thickness. The balloons 23A and 23B have joints at both ends that are joined to the catheter bodies 21A and 21B, and expansion and contraction portions that are provided between the joints and perform expansion and contraction. Specifically, the balloons 23A and 23B have the proximal end side leg regions 31A and 31B joined to the tip portions of the outer tubes 25A and 25B, and the inner and outer diameters of the balloons 23A and 23B are continuous toward the distal end side. A straight pipe having the same inner and outer diameters over the entire length direction and forming the maximum outer diameter region of the balloons 23A and 23B with the base end side cone regions 32A and 32B which are tapered so as to be expanded in diameter. Regions 33A and 33B, tip side cone regions 34A and 34B tapered so that the inner and outer diameters of balloons 23A and 23B are continuously reduced toward the tip side, and tips of inner tubes 26A and 26B. The tip side leg regions 35A and 35B to be joined to the side are provided in this order from the base end side. In this case, the proximal end side cone regions 32A and 32B, the straight pipe regions 33A and 33B, and the distal end side cone regions 34A and 34B form an expansion / contraction portion, and the proximal end side leg regions 31A and 31B and the distal end side leg regions 35A and 35B. And are the joints, respectively.

The balloons 23A and 23B are in an expanded state when the compressed fluid is supplied into the balloons 23A and 23B through the lumens 27A and 27B of the outer tubes 25A and 25B, and negative pressure is applied to the lumens 27A and 27B. When the compressed fluid is discharged from the balloons 23A and 23B, it is in a contracted state.

In the inner tubes 26A and 26B, the contrast rings 36A and 36B are attached to the inside of the balloons 23A and 23B. The contrast rings 36A and 36B improve the visibility of the balloons 23A and 23B under X-ray projection. This facilitates the introduction of balloons 23A and 23B to the target treatment site.

As shown in FIGS. 2 and 3A, the outer peripheral surfaces of the balloons 23A and 23B are provided with protruding portions 41A and 41B protruding from the outer peripheral surface. The protrusions 41A and 41B are for making a notch in the lesion when the lesion is expanded by inflating the balloons 23A and 23B. As a result, in the balloon catheters 20A and 20B, even if the lesion is hardened due to calcification or the like, the lesion is destroyed by making a cut in the lesion by the protrusions 41A and 41B. It is possible to make it easier to expand. Therefore, each of the balloon catheters 20A and 20B is configured as a so-called cutting balloon catheter (also referred to as a scoring balloon catheter). The protruding portion 41A corresponds to the treatment portion.

The protrusions 41A and 41B are formed of a metal material, specifically a superelastic alloy such as nickel titanium (Ni—Ti). The protruding portions 41A and 41B are fixed to the outer peripheral surfaces of the balloons 23A and 23B by adhesion or the like. The projecting portions 41A and 41B extend linearly along the axial direction of the balloons 23A and 23B, and a plurality of the projecting portions 41A and 41B are arranged at predetermined intervals (specifically, at equal intervals) in the circumferential direction of the balloons 23A and 23B. In this embodiment, three protrusions 41A and 41B are arranged.

These protrusions 41A and 41B are arranged in a part of the balloons 23A and 23B in the circumferential direction. Specifically, these projecting portions 41A and 41B are arranged unevenly in the circumferential direction of the balloons 23A and 23B, in other words, are locally arranged in the circumferential direction of the balloons 23A and 23B. More specifically, the protrusions 41A and 41B are arranged only in a part of the circumferential direction in the balloons 23A and 23B, and are not arranged in the other areas. Further, in the present embodiment, a part of the above range is defined as a region of half or less in the circumferential direction in the balloons 23A and 23B, and more specifically, a region of 1/4 or less.

The protruding portions 41A and 41B are arranged in the straight pipe regions 33A and 33B of the balloons 23A and 23B. The lengths of the protrusions 41A and 41B are all the same, and are about half the length of the straight pipe regions 33A and 33B in the axial direction. The protrusions 41A and 41B are arranged on the distal end side in the straight tube regions 33A and 33B of the balloons 23A and 23B. The tips of the protrusions 41A and 41B are located at the same positions as the tips of the straight tube regions 33A and 33B in the axial direction of the balloons 23A and 23B.

Each of the protruding portions 41A and 41B has a triangular cross section (specifically, a cross section orthogonal to the length direction of the protruding portions 41A and 41B). The protrusions 41A and 41B are arranged so that one of the top portions 42A and 42B protrudes toward the outer periphery (diameterally outside) of the balloons 23A and 23B. Specifically, the cross-sectional shape of the protrusions 41A and 41B is an isosceles triangle with two adjacent sides having the same length across the tops 42A and 42B, and more specifically, the angle between the two sides is obtuse. ing. The protrusions 41A and 41B do not necessarily have to have a triangular shape in the cross section, and may have other shapes such as a semicircular shape or a quadrangular shape in the cross section.

As shown in FIGS. 2 and 3B, the balloons 23A and 23B are provided with suction members 45A and 45B that are attracted to each other by a magnetic force. The attractive members 45A and 45B are made of a magnetic material, and when a magnetic field is applied from the outside, they are magnetized to generate a magnetic force. Specifically, the suction members 45A and 45B are magnetized and generate a magnetic force only when a magnetic field is applied from the outside, and are not magnetized and do not generate a magnetic force when an external magnetic field is not applied. The suction members 45A and 45B correspond to the positioning unit and the first positioning unit.

The suction members 45A and 45B are provided inside the balloons 23A and 23B, and are fixed to the inner peripheral surfaces of the balloons 23A and 23B by adhesion or the like. Only one suction member 45A, 45B is provided on the balloons 23A, 23B, and is arranged so as to be located in a part of the balloons 23A, 23B in the circumferential direction. Further, in the suction members 45A and 45B, the circumferential length of the balloons 23A and 23B is sufficiently smaller than the outer peripheral length of the balloons 23A and 23B, and the suction members 45A and 45B are substantially the same as the protruding portions 41A and 41B in the circumferential direction of the balloons 23A and 23B. It is placed in a position. Specifically, the suction members 45A and 45B are arranged at the same positions as the protrusions 41A and 41B arranged in the center of the plurality (three) protrusions 41A and 41B arranged in the circumferential direction of the balloons 23A and 23B. There is.

The suction members 45A and 45B are arranged on the proximal end side in the straight pipe regions 33A and 33B of the balloons 23A and 23B, and more specifically, they are arranged on the proximal end portion of the straight pipe regions 33A and 33B. In this case, the suction members 45A and 45B are arranged closer to the base end side than the protrusions 41A and 41B in the axial direction, and the suction members 45A and 45B and the protrusions 41A and 41B are separated from each other in the axial direction. ..

Next, how to use the balloon catheter set 10 described above will be described. Here, it is assumed that the lesion portion formed at the bifurcation portion of the blood vessel in the body is treated with the balloon catheter set 10, and the usage method in that case will be described below with reference to FIG. Note that FIG. 4 is a diagram for explaining a procedure for treating a lesion formed at a bifurcation of a blood vessel using the balloon catheter set 10.

As shown in FIG. 4A, at the branch portion 51 of the blood vessel, the blood vessel is branched into a main pipe 52 and a branch pipe 53. At the bifurcated portion 51, the lesion portion tends to be biased in the circumferential direction in the blood vessel because the blood flow in the blood vessel becomes complicated. In particular, in the bifurcated portion 51, the lesion portion tends to occur on the crotch portion 54 side of the branch, and in the example of FIG. 4A, the lesion portion 55 occurs only on the crotch portion 54 side.

In treating the lesion 55, first, a guiding catheter is inserted into the sheath introducer inserted into the blood vessel, and the guiding catheter is pushed and pulled to introduce it to just before the branch portion 51 of the blood vessel. After the introduction, two guide wires G are inserted into the guiding catheter, and the guide wires G are introduced to a position beyond the branch portion 51.

Next, the balloon catheters 20A and 20B are introduced into the guiding catheter along each guide wire G. At the time of this introduction, the balloons 23A and 23B are kept in a contracted state. After the introduction, as shown in FIG. 4A, the balloons 23A and 23B of the balloon catheters 20A and 20B are introduced to the branch portion 51 in a contracted state while applying a push-pull operation. At this time, the balloon 23A is introduced into the main pipe 52, and the balloon 23B is introduced into the branch pipe 53.

At the time of this introduction, the balloons 23A and 23B are arranged so as to be arranged in the radial direction at the branch portion 51. In this case, the base end sides of the balloons 23A and 23B are arranged adjacent to each other on the base end side of the branch portion 51. Further, the protruding portions 41A and 41B of the balloons 23A and 23B are arranged so as to be at the same position as the lesion portion 55 in the axial direction.

Note that FIG. 4A shows the balloons 23A and 23B separated from each other for convenience of explanation. Further, when introducing the balloons 23A and 23B into the branch portion 51, the balloons 23A and 23B may be introduced at the same time or may be introduced one by one.

Next, a magnetic field is generated by a magnetic field generator (not shown) prepared in advance, and a magnetic field is applied to the suction members 45A and 45B of the balloons 23A and 23B. As a result, the suction members 45A and 45B are magnetized, and a magnetic force is generated from the suction members 45A and 45B. Then, the suction members 45A and 45B are attracted to each other by the generated magnetic force, and the balloons 23A and 23B rotate in the circumferential direction (in other words, around the axes of the balloons 23A and 23B) in a state of being adjacent to each other by the attraction.

Specifically, in this case, as shown in FIG. 4B, with respect to the balloon 23A side, the suction member 45A is attracted to the balloon 23B side (specifically, the suction member 45B) by a magnetic force, whereby the balloon 23A is attracted. It naturally rotates in the circumferential direction. Then, when the suction member 45A reaches the position closest to the balloon 23B side, specifically, the balloon 23B by the rotation, the rotation of the balloon 23A ends at that position, and the balloon 23A is positioned in the rotation direction at that position. That is, the balloon 23A is positioned in the rotation direction with respect to the balloon 23B. Then, due to the positioning, the protruding portion 41A of the balloon 23A is directed toward the balloon 23B side, and by extension, is directed toward the crotch portion 54 where the lesion portion 55 is generated at the bifurcation portion 51.

Similarly, on the balloon 23B side, the suction member 45B is attracted to the balloon 23A side (specifically, the suction member 45A) by a magnetic force, whereby the balloon 23B rotates in the circumferential direction. Then, when the suction member 45B reaches the position closest to the balloon 23A side, specifically, the balloon 23A by the rotation, the rotation of the balloon 23B ends at that position, and the balloon 23B is positioned in the rotation direction at that position. That is, the balloon 23B is positioned in the rotation direction with respect to the balloon 23A. Then, due to the positioning, the protruding portion 41B of the balloon 23B is directed toward the balloon 23A side, and by extension, is directed toward the crotch portion 54 where the lesion portion 55 is generated at the branch portion 51.

In this way, in the positioning state of the balloons 23A and 23B, the balloons 23A and 23B are positioned in the rotational direction so that the suction members 45A and 45B are closest to each other. In this case, the suction members 45A and 45B are arranged so as to face each other in the line-up (adjacent) direction of the balloons 23A and 23B.

Next, as shown in FIG. 4C, the balloons 23A and 23B are inflated with the balloons 23A and 23B positioned. In this case, due to the expansion, the protruding portion 41A of the balloon 23A is directed to the balloon 23B side (specifically, the balloon 23B side in the alignment direction of the balloons 23A and 23B), and the crotch where the lesion portion 55 is generated at the branch portion 51. It is directed to the portion 54 side. Further, the protruding portion 41B of the balloon 23B is directed toward the balloon 23A side, and by extension, is directed toward the crotch portion 54 where the lesion portion 55 is generated at the bifurcation portion 51. In this case, the protrusions 41A and 41B are pressed against the lesion 55, whereby a notch (crack) is made in the lesion 55. Therefore, the lesion portion 55 can be suitably expanded by using the notch as a trigger.

Further, in this case, due to the expansion of the balloons 23A and 23B, the protruding portions 41A and 41B of the balloons 23A and 23B can be directed only to the crotch portion 54 side where the lesion portion 55 is generated. That is, it is possible to prevent the protruding portions 41A and 41B from being directed to a portion (healthy region) other than the crotch portion 54 in which the lesion portion 55 does not occur. Therefore, the lesion portion 55 can be preferably treated at the bifurcation portion 51.

After the treatment of the lesion 55 is completed, the generation of the magnetic field by the magnetic field generator is terminated. As a result, each of the suction members 45A and 45B is in a state of not generating a magnetic force. Then, as shown in FIG. 4D, the balloons 23A and 23B are brought into a contracted state, and the balloon catheters 20A and 20B are withdrawn from the body in that state. This completes a series of operations.

As described above, in the above embodiment, when the balloon 23A of the balloon catheter 20A is positioned in the rotation direction, the balloon 23A is positioned with respect to the balloon catheter 20B (specifically, the balloon 23B). The balloon 23B of the balloon catheter 20B is positioned with respect to the balloon catheter 20A (specifically, the balloon 23A) when it is positioned in the direction of its rotation. Therefore, for the balloon catheter 20A, the balloon catheter 20B corresponds to the introduction member to be the positioning partner, and for the balloon catheter 20B, the balloon catheter 20A corresponds to the introduction member to be the positioning partner.

According to the configuration of the present embodiment described in detail above, the following excellent effects can be obtained.

Suction members 45A and 45B are provided in a part of the balloons 23A and 23B in the circumferential direction, and the suction members 45A and 45B are attracted by magnetic force to the side of the other balloons 23A and 23B so that the balloons 23A and 23B are rotated in the circumferential direction. It was rotated so that it could be positioned at a predetermined position in the direction of rotation. In this case, since the balloons 23A and 23B and the protrusions 41A and 41B are naturally positioned by the magnetic force, the positioning can be easily performed.

Since the suction members 45A and 45B are made of a magnetic material, when the balloons 23A and 23B are introduced into the body, the suction members 45A and 45B are prevented from generating a magnetic force by not applying an external magnetic field, and the balloons 23A and 23B are prevented from being generated. When positioning the balloons 23A and 23B to the other balloons 23A and 23B after introducing the balloon 23A and 23B into the body, an external magnetic field can be applied to generate a magnetic force in the suction members 45A and 45B. As a result, when the balloons 23A and 23B are introduced into the body, it is possible to prevent the suction members 45A and 45B from being attracted to the other party's balloons 23A and 23B by magnetic force. Can be avoided from becoming difficult due to magnetic force.

Since the suction members 45A and 45B are arranged inside the balloons 23A and 23B, it is possible to suppress inconveniences such as damage to the tube wall in the body by the suction members 45A and 45B when the balloons 23A and 23B are introduced into the body. Can be done.

Since the protrusions 41A and 41B are arranged closer to the tip side than the suction members 45A and 45B, when the suction members 45A and 45B position the balloons 23A and 23B in the rotational direction, the protrusions 41A and 41B are located on the other side of the balloon 23A, It is possible to prevent the 23B and the protrusions 41A and 41B from interfering with each other and obstructing the positioning.

Further, since the protruding portions 41A and 41B and the suction members 45A and 45B are separated from each other in the axial direction, the protruding portions 41A and 41B are attached to the other balloons 23A and 23B and the protruding portions 41A and 41B when positioning the balloons 23A and 23B. It is possible to preferably suppress interference and obstruction of positioning.

According to the suction members 45A and 45B, when the balloons 23A and 23B are introduced into the body, even if the balloons 23A and 23B are arranged so as to be offset from each other in the axial direction, the balloons 23A and 23B by the suction members 45A and 45B The balloons 23A and 23B can be positioned at the same position in the axial direction. That is, in this case, when the suction members 45A and 45B are sucked, the balloons 23A and 23B are displaced in the axial direction and are positioned at the same position in the axial direction. Specifically, the balloons 23A and 23B are positioned at positions where the suction members 45A and 45B are at the same position in the axial direction. In this case, such positioning makes it possible to position the protruding portions 41A and 41B in the axial direction with respect to the lesion portion 55, so that the treatment of the lesion portion 55 can be performed more preferably. In this case, the suction members 45A and 45B correspond to the first positioning portion and the second positioning portion.

The two balloons 23A and 23B were introduced into the main pipe 52 and the branch pipe 53 of the branch portion 51, respectively, and the balloons 23A and 23B were inflated in the introduced state, so that the lesion portion 55 generated in the branch portion 51 was treated. At this time, it is possible to suppress the occurrence of so-called plaque shift.

The present disclosure is not limited to the above embodiment, and may be implemented as follows, for example.

(1) In the above embodiment, the suction members 45A and 45B are made of a magnetic material, but the suction member may be made of a magnet. Also in this case, the magnetic force of the suction member makes it possible to position the balloons 23A and 23B in the rotational direction. However, when the suction member is a magnet, a magnetic force is constantly generated in the suction member, so when the balloons 23A and 23B are introduced into the body, there is a concern that the suction members will be attracted to each other by the magnetic force and it will be difficult to introduce the balloons 23A and 23B. The magnet. Therefore, in view of this point, it is desirable that the suction member is made of a magnetic material.

(2) In the above embodiment, only one suction member 45A, 45B is provided, but a plurality of suction members 45A, 45B may be provided. In this case, a plurality of suction members 45A and 45B may be arranged side by side in the axial direction of the balloons 23A and 23B. In short, the number of suction members is arbitrary as long as they are arranged only in a part of the balloons 23A and 23B in the circumferential direction.

(3) In the above embodiment, the suction members 45A and 45B are used to position the balloons 23A and 23B in the rotational direction, but the positioning portion for such positioning does not necessarily have to be the suction members 45A and 45B. .. For example, as the positioning portion, it is conceivable to provide an engaging portion that engages with each other on the outer peripheral surfaces of the balloons 23A and 23B. Specifically, it is conceivable to provide a convex portion protruding from the outer peripheral surface of the balloons 23A and 23B as an engaging portion. In this case, when positioning the balloons 23A and 23B, the balloon catheters 20A and 20B are operated to rotate the balloons 23A and 23B in the circumferential direction in opposite directions. Then, the balloons 23A and 23B are positioned at positions where the convex portions of the balloons 23A and 23B are engaged with each other. With such a configuration, it is possible to position the balloons 23A and 23B in the rotation direction.

(4) In the above embodiment, the lengths of the protruding portions 41A and 41B are set to about half the lengths of the straight pipe regions 33A and 33B, but the lengths of the protruding portions 41A and 41B do not necessarily have to be such a length. .. For example, the lengths of the protruding portions 41A and 41B may be set to be the same as the lengths of the straight pipe regions 33A and 33B, and may be arranged so as to cover the entire axial direction of the straight pipe regions 33A and 33B. However, in this case, since the protruding portions 41A and 41B are located at the same positions as the suction members 45A and 45B in the axial direction, the protruding portions 41A and 41B are positioned when the suction members 45A and 45B position the balloons 23A and 23B in the rotational direction. May interfere with the other party's balloons 23A and 23B and the protrusions 41A and 41B, which hinders positioning. Therefore, in view of this point, the length of the protruding portions 41A and 41B is set to about half the length of the straight pipe regions 33A and 33B as in the above embodiment, and the positions are the same as those of the suction members 45A and 45B in the axial direction. It is desirable to make the length so that it does not become.

(5) In the above embodiment, the protruding portions 41A and 41B are formed of a metal material, but the protruding portions may be formed of a material other than metal such as a resin material (for example, hard resin). Also in this case, the protruding portion may be fixed to the balloons 23A and 23B by adhesion or the like. Further, the protruding portion may be integrally formed with the balloons 23A and 23B.

Further, the protruding portion may be formed separately from the balloons 23A and 23B by a linear member, and the linear member may be provided on the outer peripheral side of the balloons 23A and 23B so as to straddle the balloons 23A and 23B in the axial direction. In this case, it is conceivable that the base end side of the linear member is joined to the outer tubes 25A and 25B, and the tip end side of the linear member is joined to the inner tubes 26A and 26B. Even in such a configuration, since the linear member can be provided so as to project from the outer peripheral surface of the balloons 23A and 23B, it can be a protruding portion.

(6) In the above embodiment, the protruding portions 41A and 41B are arranged only in the straight pipe regions 33A and 33B of the balloons 23A and 23B, but in addition to this, the protruding portions are arranged on the proximal end side cone regions 32A and 32B and the distal end side. It may be arranged in the cone regions 34A and 34B. In this case, the protruding portion arranged in the cone region may be provided continuously or discontinuously in the protruding portions 41A and 41B of the straight pipe regions 33A and 33B.

(7) In the above embodiment, the suction members 45A and 45B rotate the balloons 23A and 23B so that the protrusions 41A and 41B face the other balloons 23A and 23B when the balloons 23A and 23B are inflated. Although positioning has been performed, it is not always necessary for the protrusions 41A and 41B to face the other side of the balloons 23A and 23B, and the protrusions 41A and 41B may face the other side. For example, it is assumed that the lesion 55 occurs on a side different from the crotch 54 side at the bifurcation 51, and in that case, when the balloons 23A and 23B are inflated, the protrusions 41A and 41B are formed on that side. The balloons 23A and 23B may be positioned so as to face each other. That is, the arrangement positions of the suction members 45A and 45B may be determined so that the balloons 23A and 23B are positioned in this way.

(8) In the above embodiment, the protrusions 41A and 41B are formed in a linear shape extending in the axial direction of the balloons 23A and 23B, but the shape of the protrusions is not necessarily limited to this. For example, as shown in FIGS. 5A and 5B, the protruding portion 62 may be formed in a linear shape extending in the circumferential direction of the balloon 61. In this example, a plurality (specifically, three) of the protrusions 62 are arranged at predetermined intervals in the axial direction of the balloon 61. Each of these protrusions 62 extends over approximately half of the balloon 61 in the circumferential direction. Therefore, also in this example, each protruding portion 62 is provided unevenly in the circumferential direction of the balloon 61. In this example, the protrusion height of the balloon 61 from the outer peripheral surface of each protrusion 62 is set to the maximum at the central portion in the length direction.

Further, in the examples of FIGS. 6A and 6B, the shape of the protruding portion is different from that of the examples of FIGS. 5A and 5B. In this example, the width of the protrusion 63 (the length in the direction of the balloon axis) is reduced toward the protrusion tip side of the protrusion 63, and the tip of the protrusion 63 is sharpened. Further, in this example, the protruding height of the protruding portion 63 is increased on both end sides in the length direction of the protruding portion 63 and decreased in the intermediate portion.

Further, the protruding portion does not necessarily have to be formed in a linear shape, and may be formed in a dotted shape as shown in FIGS. 7 (a) to 7 (c), for example. 7 (b) is a cross-sectional view taken along the line CC of FIG. 7 (a), and FIG. 7 (c) is a cross-sectional view taken along the line DD of FIG. 7 (a). In the examples of FIGS. 7A to 7C, a plurality of point-shaped protrusions 64 are formed on the outer peripheral surface of the balloon 61. These projecting portions 64 project hemispherically from the outer peripheral surface of the balloon 61, and are arranged side by side in the axial direction and the circumferential direction of the balloon 61, respectively. Further, each protrusion 64 is arranged only in a part of the circumferential direction of the balloon 61, and more specifically, is arranged only in a quarter of the circumferential direction of the balloon 61. Therefore, also in this example, the protruding portions 64 are unevenly arranged in the circumferential direction of the balloon 61.

(9) In the above embodiment, the balloons 23A and 23B of the balloon catheters 20A and 20B are provided with protrusions 41A and 41B, respectively, but only one of the balloons 23A and 23B is provided with a protrusion and the other. May not be provided with a protrusion. For example, it is conceivable that the balloon 23A of the balloon catheter 20A is provided with the protruding portion 41A, while the balloon 23B of the balloon catheter 20B is not provided with the protruding portion. With such a configuration, the lesion 55 will be treated by the protrusion 41A (only) of the balloon 23A. Therefore, in this case, the balloon 23B of the balloon catheter 20B is used only as a positioning partner when the balloon 23A is positioned on the balloon 23B by using the suction members 45A and 45B. In this case, the balloon catheter 20B corresponds to the introduction member.

Further, as the introduction member used only as the positioning partner in this way, it is not always necessary to use a balloon catheter, and a catheter other than the balloon catheter, a medical wire, or the like may be used. Even in that case, if the suction member 45B is provided on the tip end side of the introduction member, the balloon 23A can be positioned by suction between the suction members 45A and 45B.

(10) The configuration relating to the positioning of the balloon in the rotational direction by suction of the suction member is not necessarily limited to that of the above embodiment. Therefore, in the following, another example of the configuration relating to the positioning of the balloon will be described with reference to FIG. In the example of FIG. 8, the main pipe 72 and the branch pipe 73 are branched in a T shape at the branch portion 71 of the blood vessel. The balloon 76A of the balloon catheter 75A is introduced into the main pipe 72, and the balloon 76B of the balloon catheter 75B is introduced into the branch pipe 73. The balloon 76A is provided with a suction member 77A at the center in the axial direction, and a protrusion 79A is provided on the tip side of the suction member 77A. Further, the balloon 76B is provided with a suction member 77B at the tip end portion in the axial direction.

The balloon 76A is adjacent to the tip of the balloon 76B on the outer peripheral side thereof. In this case, the suction member 77A of the balloon 76A is sucked by the suction member 77B of the balloon 76B, and the suction is used to position the balloon 76A in the rotational direction. Also in this case, by inflating the balloon 76A in the positioned state, the protruding portion 79A can be directed to a predetermined portion in the circumferential direction in the blood vessel. Therefore, it is possible to direct the protruding portion 79A toward the lesioned portion in the blood vessel, but not toward the healthy portion where the lesioned portion does not occur. In this example, the balloon catheter 75B is used only as a positioning partner for positioning the balloon 76A, as in the case of (9) described above. Therefore, in this example, the balloon catheter 75B corresponds to the introduction member.

(11) Another example of the configuration related to the positioning of the balloon is further shown in FIG. In the example of FIG. 9, at the intersection 81 where the two blood vessels 82, 83 intersect in a cross shape, the balloon 86A of the balloon catheter 85A is introduced into one of the intersecting blood vessels 82, 83, and the other. The balloon 86B of the balloon catheter 85B is introduced into the blood vessel 83. Each of these balloons 86A and 86B is provided with suction members 87A and 87B at the center in the axial direction. In this example, the balloons 86A and 86B of the balloon catheters 85A and 85B are arranged so as to intersect each other at the intersection 81 of the blood vessel 82. Then, in that arrangement state, the suction members 87A and 87B are positioned to position the balloons 86A and 86B in the rotational direction. Also in this case, the protruding portions 89A and 89B of the balloons 86A and 86B can be directed to a predetermined side in the blood vessel.

(12) Another example of how to use the suction member will be described with reference to FIG. In the example shown in FIG. 10A, the balloon 93 of the balloon catheter 92 is introduced into the bent blood vessel 91, and the balloon 93 is inflated. In such a case, since the balloon 93 bends following the bent blood vessel 91, the stress of the balloon 93 is biased.

On the other hand, in the example of FIG. 10B, the balloons 94A and 94B of the two balloon catheters 93A and 93B are introduced into the flexion blood vessel 91, respectively. The length of these balloons 94A and 94B in the axial direction is shorter than that of the balloon 93 of FIG. 10 (a), and in detail, it is about half the length of the balloon 93. Further, the balloons 94A and 94B are provided with suction members 95A and 95B at their respective tips, and the balloons 94A and 94B are joined to each other by sucking the suction members 95A and 95B to each other. According to the example of FIG. 10B, since the lengths of the balloons 94A and 94B introduced into the flexion blood vessel 91 are shortened, the bias of stress generated in the balloons 94A and 94B in the flexion blood vessel 91 is suppressed. be able to.

(13) In the above embodiment, as the suction members 45A and 45B, suction members (specifically, magnetic materials) that are attracted by magnetic force are used, but even if suction members that are attracted by electrostatic force are used as the suction members. Good. A specific example thereof is shown in FIG. In the example shown in FIG. 11, the suction members 71A and 71B provided on the balloons 23A and 23B are made of a chargeable material. The suction members 71A and 71B are connected to the power supply unit 75 via the conducting wires 72A and 72B. The power supply unit 75 is a charge generator that generates electric charges in the suction members 71A and 71B, and is provided outside the body. The conducting wires 72A and 72B extend from the power supply unit 75 through the inside of the outer tubes 25A and 25B to the inside of the balloons 23A and 23B, and are connected to the suction members 71A and 71B provided inside the balloons 23A and 23B.

In the above configuration, when the power supply unit 75 is turned on (power supply ON state), one of the suction members 71A and 71B is positively charged and the other is negatively charged. As a result, an electrostatic force is generated between the suction members 71A and 71B, and the suction members 71A and 71B are attracted to each other by the generated electrostatic force. Therefore, even in this case, the balloons 23A and 23B can be positioned in the rotational direction by suction by the suction members 71A and 71B.

Further, in the above configuration, when the power supply unit 75 is in the OFF state (power supply OFF state), the electric charge disappears in each of the suction members 71A and 71B, and the electrostatic force is not generated. Therefore, when the balloons 23A and 23B are introduced into the body, the power supply unit 75 is turned off so that the suction members 71A and 71B do not generate an electrostatic force, so that the introduction work of the balloons 23A and 23B is an electrostatic force. It can be avoided that it becomes more difficult.

(14) In the above embodiment, the suction members 45A and 45B are provided inside the balloons 23A and 23B, but the suction members may be provided on the outer peripheral side of the balloons 23A and 23B. In this case, for example, it is conceivable to form the suction member in a thin film shape and fix the suction member to the outer peripheral surfaces of the balloons 23A and 23B by adhesion or the like. In such a configuration, when the suction members of the balloons 23A and 23B are attracted by magnetic force, they are attracted without passing through the film portion of the balloons 23A and 23B, so that the suction force can be suitably secured.

(15) In the above embodiment, when positioning the balloons 23A and 23B in the rotational direction by the suction members 45A and 45B, the balloons 23A and 23B are positioned in the contracted state, but this is changed to the balloon 23A. , 23B may be in a semi-contracted state for positioning. In this case, the semi-contracted state means an intermediate state between the contracted state and the expanded state of the balloons 23A and 23B. Since the balloons 23A and 23B are allowed to rotate in the circumferential direction even in the semi-contracted state, the balloons 23A and 23B can be positioned in the rotational direction.

(16) In the above embodiment, a plurality of (specifically, three) projecting portions 41A and 41B are arranged so as to be biased in the circumferential direction of the balloons 23A and 23B, but the plurality of projecting portions 41A and 41B are arranged in the balloon 23A, It may be arranged at equal intervals (120 ° intervals) in the circumferential direction of 23B. It is assumed that lesions occur over a wide area (for example, over 300 °) in the circumferential direction in the blood vessel. In such a case, according to the above configuration, by positioning the balloons 23A and 23B (that is, the protruding portions 41A and 41B) in the rotational direction, when the balloons 23A and 23B are inflated, a wide range of lesions is formed. It is possible to direct the protrusions 41A and 41B to each of the protrusions 41A and 41B, and not to direct the protrusions 41A and 41B to the healthy part where the lesion does not occur. Therefore, such a lesion can be suitably treated.

(17) A drug layer may be formed on the surface of the protrusions 41A and 41B by applying a drug to the protrusions 41A and 41B of the balloons 23A and 23B. In that case, the drug in the drug layer can enhance the therapeutic effect on the lesion.

Further, the balloons 23A and 23B may not be provided with the protruding portions 41A and 41B, and the drug layer may be formed by applying a drug to the outer peripheral surfaces of the balloons 23A and 23B. For example, on the outer peripheral surface of the balloons 23A and 23B, it is conceivable that the region between the portions where the protrusions 41A and 41B at both ends are provided among the protrusions 41A and 41B is used as the drug layer. In this case, the drug layer is formed in a part of the balloons 23A and 23B in the circumferential direction, in other words, is formed only in a predetermined range in the circumferential direction of the balloons 23A and 23B. In such a configuration, when the balloons 23A and 23B are inflated while the balloons 23A and 23B are positioned by the suction members 45A and 45B, the drug layer can be directed only to the lesion side. Therefore, it is possible to preferably treat the lesion portion with a drug. In this case, the drug layer corresponds to the treatment unit.

(18) In the above embodiment, the suction members 45A and 45B are used to position the balloons 23A and 23B in the rotational direction as well as the balloons 23A and 23B in the axial direction. That is, in the above embodiment, the suction members 45A and 45B are configured to correspond to both the first positioning portion and the second positioning portion, in other words, the suction members 45A and 45B as the first positioning portion form the second positioning portion. I tried to configure it, but you can change it. For example, the balloons 23A and 23B are provided with a second positioning unit (separately) from the first positioning unit, the first positioning unit positions the balloons 23A and 23B in the rotational direction, and the second positioning unit positions the balloon. Positioning of 23A and 23B in the axial direction may be performed.

(19) In the above embodiment, the case where the lesion portion is treated using two balloon catheters 20A and 20B has been described, but the case where the treatment is performed using three or more balloon catheters is also assumed. Even in that case, if the balloons of those balloon catheters are provided with a protrusion and a suction member, it is possible to perform positioning in the rotational direction between adjacent balloons in the body by the suction member. It is possible to direct the protrusion only to the side of the lesion.

(20) In the above embodiment, the case where the balloon catheter of the present disclosure is used for treatment in blood vessels has been described, but the balloon catheter of the present disclosure is used for treatment of vessels other than blood vessels such as ureters, sperm ducts, and lymph vessels. It can also be used for.

Although this disclosure has been described in accordance with an embodiment, it is understood that this disclosure is not limited to that embodiment or structure. The present disclosure also includes various modifications and modifications within an equal range. In addition, various combinations and forms, as well as other combinations and forms that include only one element, more, or less, are also within the scope of the present disclosure.

10 ... Balloon catheter set, 20A, 20B ... Balloon catheter, 23A, 23B ... Balloon, 41A, 41B ... Protruding part, 45A, 45B ... Suction member.

Claims (8)

1. It has a balloon that can be inflated and contracted and is introduced into the body in a contracted state.
   A balloon catheter provided with a treatment portion on the outer peripheral surface of the balloon for performing a predetermined treatment by inflating the balloon.
   The treatment unit is provided in a part of the balloon in the circumferential direction.
   The balloon is arranged adjacent to an elongated introduction member introduced into the body together with the balloon when it is introduced into the body.
   The balloon is provided with a positioning portion for positioning the balloon with respect to the introduction member.
   The positioning portion is a balloon catheter that positions the balloon in the rotational direction when the balloon rotates in the circumferential direction in the contracted state or the semi-contracted state.
2. The balloon catheter according to claim 1, wherein the treatment unit is a protrusion provided so as to project from the outer peripheral surface of the balloon.
3. The balloon is arranged adjacent to the introduction member on the outer peripheral side thereof.
   The positioning portion is a suction member provided in a part of the balloon in the circumferential direction and attracted to the introduction member side by a magnetic force or an electrostatic force.
   The balloon catheter according to claim 1 or 2, wherein when the suction member is sucked toward the introduction member, the balloon rotates in the circumferential direction and is positioned at a predetermined position in the rotation direction.
4. The balloon catheter according to claim 3, wherein the suction member is made of a magnetic material that generates a magnetic force when a magnetic field is applied from the outside.
5. The balloon catheter according to claim 3 or 4, wherein the suction member is arranged inside the balloon.
6. The balloon is arranged adjacent to the introduction member on the outer peripheral side thereof.
   The positioning portion is arranged on the proximal end side of the balloon.
   The treatment unit is provided at least on the distal end side of the positioning unit.
   The balloon according to any one of claims 1 to 5, wherein the positioning unit positions the balloon in the rotational direction so that the treatment unit faces the introduction member side when the balloon is inflated. catheter.
7. The treatment portion is a protrusion protruding from the outer peripheral surface of the balloon.
   The balloon catheter according to claim 6, wherein the protruding portion is arranged on the distal end side of the positioning portion in the axial direction of the balloon.
8. The balloon is provided with a second positioning portion that is composed of a first positioning portion as the positioning portion or is formed separately from the first positioning portion.
   The balloon catheter according to any one of claims 1 to 7, wherein the second positioning portion positions the balloon in the axial direction with respect to the introduction member in the contracted state or the semi-contracted state.

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