JP2015167735A - balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter which excellently prevents a balloon from swelling beyond a maximum expansion diameter and is excellent in insertion property into a living body.SOLUTION: A balloon catheter 1 has: an inner tube shaft 10; an outer tube shaft 20; a balloon 30 which is expanded by pouring of fluid into an internal space; and regulation means 51, 52 which are extended between the inner tube shaft and the balloon, and are provided with four regulation members 51a to 51d whose one end sides are connected to an outside surface 10a of the inner tube shaft and whose other end sides are connected to an inner surface 30a of an extension valid part 31 of the balloon.

Description

  The present invention relates to a balloon catheter.

  As a technique for dilating a stenosis formed in a blood vessel of a living body, a so-called percutaneous arterial expansion (PTA) or percutaneous coronary artery dilatation (PTCA) performed using a balloon catheter is performed. Percutaneous Transluminal Coronary Angiology) is widely known.

  In a procedure using a balloon catheter, first, an operation of inserting a guide wire into a stenosis portion is performed. Next, the balloon catheter is placed over the guide wire, the entire balloon catheter is pushed in, and the balloon is inserted through the stenosis. Thereafter, the expansion fluid is filled in the balloon, the balloon is expanded by increasing the pressure in the balloon, and the blood flow is restored by pushing the stenosis portion apart.

  In such a balloon catheter, since the balloon diameter increases as the pressure in the balloon increases, the balloon may expand beyond the maximum expansion diameter. Therefore, the operator needs to carefully set the pressure in the balloon so that the balloon does not expand beyond the maximum expansion diameter, and the operation becomes complicated.

  In relation to this, for example, the following Patent Document 1 has a multilayer balloon composed of at least two layers, and expansion beyond a reference radius (maximum expansion diameter) is limited by appropriately setting the material of each layer. So-called non-compliant balloon catheters are described. According to this balloon catheter, the expansion in the radial direction can be limited in a range exceeding the reference radius.

Special table 2009-51981

  However, in the balloon catheter described in Patent Document 1, it is difficult to expand the balloon in the range exceeding the reference radius, but only the expansion in the radial direction is limited by appropriately setting the material of each layer. Therefore, in some cases, it is not possible to suppress the inflation of the balloon exceeding the reference radius. In addition, since the balloon catheter described in Patent Document 1 has a multilayer structure, the flexibility is relatively low and insertion into a living body is also reduced.

  The present invention has been invented in order to solve the above-described problems, and more preferably prevents a balloon from expanding beyond the maximum expansion diameter and provides a balloon catheter excellent in insertion into a living body. The purpose is to do.

  A balloon catheter according to the present invention that achieves the above object includes an inner tube shaft that includes an insertion lumen through which a guide wire is inserted and extends in an axial direction, an outer tube shaft that divides a flow lumen through which fluid can flow, A distal end side is joined to the inner tube shaft, and a proximal end side is joined to the outer tube shaft, and an internal space communicating with the flow lumen is defined between the inner tube shaft and the inner space. A balloon that is expanded by fluid injection, extends between the inner tube shaft and the balloon, one end is connected to the outer surface of the inner tube shaft, and the other end is the inner surface of the expansion effective portion of the balloon At least one for restricting the maximum expansion diameter of the balloon by applying a tensile force inwardly in the radial direction to the balloon as the balloon is expanded and deformed Having a regulating means comprising a control member.

  According to the above balloon catheter, as the balloon is expanded and deformed, the restricting member applies a tensile force directed radially inward to the balloon to restrict the maximum expanded diameter of the balloon. For this reason, it can prevent more suitably that a balloon expands exceeding a maximum expansion diameter. Moreover, even if the balloon is excellent in insertability, such as a single-layer balloon, it is possible to more suitably prevent the balloon from expanding beyond the maximum expansion diameter by applying this configuration. Therefore, it is possible to provide a balloon catheter that more suitably prevents the balloon from expanding beyond the maximum expansion diameter and is excellent in insertion into the living body.

It is a schematic structure figure showing a balloon catheter concerning an embodiment of the present invention. It is a top view which shows the front end side of a balloon catheter. FIG. 3 is a side sectional view of FIG. 2. FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. FIG. 5 is a view corresponding to FIG. 4 in a state where the balloon is deflated. It is a graph which shows the stress-strain diagram of a control member. FIG. 7A is a diagram illustrating a state before the balloon is expanded, and FIG. 7B is a diagram illustrating a state after the balloon is expanded. It is a graph which shows the relationship between the pressure in the internal space of a balloon, and a balloon diameter. It is side surface sectional drawing which shows a mode that the balloon of the balloon catheter which concerns on a comparative example was bent and expanded. 10 is a side cross-sectional view showing the distal end side of a balloon catheter according to Modification Example 1. FIG. It is a figure corresponding to FIG. 4 of the balloon catheter which concerns on the modification 2. It is a figure corresponding to FIG. 4 of the balloon catheter which concerns on the modification 3.

  Hereinafter, embodiments of the present invention will be described 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. In the following description, the proximal operation side of the balloon catheter 1 according to the present embodiment is referred to as “proximal end side”, and the side inserted into the living body lumen is referred to as “distal end side”.

  FIG. 1 is a schematic configuration diagram showing a balloon catheter 1 according to an embodiment of the present invention. FIG. 2 is a top view showing the prior application side of the balloon catheter 1. 3 is a side sectional view of FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. FIG. 5 is a view corresponding to FIG. 4 in a state where the balloon 30 is deflated. FIG. 6 is a graph showing a stress strain diagram of the regulating member.

  As shown in FIGS. 1 to 5, the balloon catheter 1 according to the embodiment of the present invention includes an inner tube shaft 10, an outer tube shaft 20, a balloon 30, a hub 40, a first restricting means 51 and a second member. And restricting means 52.

  As shown in FIG. 3, the inner tube shaft 10 includes an insertion lumen 11 through which the guide wire 90 is inserted, and extends inside the balloon 30 and the outer tube shaft 20 in the left-right direction (axial direction) in FIG. 3. The distal end side of the inner tube shaft 10 is joined to the distal end side of the balloon 30. The joining method is not particularly limited, but for example, adhesion or heat fusion. The proximal end side of the inner tube shaft 10 is joined to the inner periphery of a guide wire port 22 of the outer tube shaft 20 described later.

  In the procedure, the guide wire 90 is inserted with the opening 10b on the distal end side of the inner tube shaft 10 as an inlet, and is inserted through the insertion lumen 11 of the inner tube shaft 10 from the distal end side to the proximal end side, so that a guide wire port 22 to the outside.

  As shown in FIG. 3, the outer tube shaft 20 includes a flow lumen 21 through which a fluid for expanding the balloon 30 can flow, and extends in the left-right direction in FIG. 3. The distal end side of the outer tube shaft 20 is joined to the proximal end side of the balloon 30. The proximal end side of the outer tube shaft 20 extends to the hub 40, and the flow lumen 21 communicates with an opening 40a of the hub 40 described later. The outer tube shaft 20 is provided with a guide wire port 22 through which the guide wire 90 is inserted.

  Since the inner tube shaft 10 and the outer tube shaft 20 can be smoothly inserted into living organs such as blood vessels, it is preferable to have appropriate flexibility and appropriate rigidity. Therefore, the inner tube shaft 10 and the outer tube shaft 20 are made of, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these) ), A polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.

  As the guide wire 90 used together with the balloon catheter 10, a guide wire 90 known in the medical field is used. For example, long elastic wires such as superelastic alloys such as nickel-titanium alloys and copper-zinc alloys, metal materials such as stainless steel, and resin materials with relatively high rigidity, such as polyvinyl chloride, polyethylene, polypropylene, ethylene- A guide wire 90 is formed by coating a resin material such as a propylene copolymer.

  The balloon 30 divides an internal space 30V communicating with the flow lumen 21 between the inner tube shaft 10 and is expanded by injecting fluid into the internal space 30V. Examples of the fluid that expands the balloon 30 include, but are not limited to, an X-ray contrast medium, physiological saline, and an electrolyte solution.

  The material constituting the balloon 30 is preferably flexible, for example, polyolefin, cross-linked polyolefin, polyester, polyester elastomer, polyvinyl chloride, polyurethane, polyurethane elastomer, polyphenylene sulfide, polyamide, polyamide elastomer, fluororesin Polymer materials such as silicone rubber and latex rubber. The polyester is, for example, polyethylene terephthalate. The constituent material of the balloon 30 is not limited to the form in which the polymer material is used alone, and for example, a film in which the polymer material is appropriately laminated can be applied.

  The hub 40 has an opening 40 a on the proximal end side to which an indeflator (pressure applying device) for supplying a fluid for expanding the balloon 30 is connected. The fluid supplied from the indeflator is supplied to the internal space 30V of the balloon 30 via the flow lumen 21, and the balloon 30 is expanded.

  The material constituting the hub 40 is, for example, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, or methacrylate-butylene-styrene copolymer.

  As shown in FIG. 3, the first restricting means 51 and the second restricting means 52 are respectively located at the same distance in the left-right direction from the center position of the effective expansion portion 31 of the balloon 30 in the left-right direction in FIG. Be placed.

  The 1st control means 51 is provided in the left side in FIG. 3, and has four control members 51a-51d as shown in FIG. In general, the four regulating members 51a to 51d each extend between the inner tube shaft 10 and the balloon 30, one end side is connected to the outer surface 10a of the inner tube shaft 10, and the other end side is an expansion of the balloon 30. The effective portion 31 is connected to the inner surface 30a. The four regulating members 51 a to 51 d regulate the maximum expanded diameter of the balloon 30 by applying a tensile force toward the radially inward direction to the balloon 30 as the balloon 30 is expanded and deformed.

  As shown in FIGS. 3 and 4, the four regulating members 51 a to 51 d are arranged on the same axis orthogonal cross section of the inner tube shaft 10. Further, the four restricting members 51 a to 51 d are arranged at intervals of 90 degrees in the circumferential direction of the inner tube shaft 10.

  The second restricting means 52 is provided on the right side in FIG. 3, and has four restricting members like the first restricting means 51.

  If the first restricting means 51 and the second restricting means 52 arranged in this way, as shown in FIG. 4, since the entire cross section is not covered, injection of fluid into the internal space 30V is hindered. Absent.

  Next, of the four regulating members 51a to 51d, the configuration of the regulating member 51a will be described using the regulating member 51a as an example. Since the other restricting members 51b to 51d have the same configuration as the restricting member 51a, the description thereof is omitted.

  The regulating member 51a is configured by a linear member that bends when the balloon 30 is in a contracted state (see FIG. 5) and expands when the balloon 30 is in an expanded state (see FIG. 4). Moreover, it is preferable that the regulating member 51a has contrast properties. Since the regulating member 51a has a contrast property, the position and the expanded state of the regulating member 51a can be confirmed by irradiating the living body with X-rays during the procedure, and the position and the expanded state of the balloon 30 can be confirmed. Becomes easy.

  The restricting member 51 a is compatible with the first fixing portion 30 b where the restricting member 51 a is fixed in the balloon 30 and the second fixing portion 10 c where the restricting member 51 a is fixed on the inner tube shaft 10. In other words, the first connecting portion P1 to which the balloon 30 and the regulating member 51a are connected and the second connecting portion P2 to which the inner tube shaft 10 and the regulating member 51a are connected have compatibility. According to this configuration, by applying heat, the first connection portion P1 and the second connection portion P2 are dissolved, and the balloon 30 and the restriction member 51a, the inner tube shaft 10 and the restriction member 51a are connected, respectively. Connection becomes easy.

  The material constituting the regulating member 51a is, for example, polyolefin, a crosslinked polyolefin, polyester, polyester elastomer, polyvinyl chloride, polyurethane, polyurethane elastomer, polyphenylene sulfide, polyamide, or polyamide elastomer.

  FIG. 6 is a graph showing a stress strain diagram of the regulating member 51a. The yield point strength of the regulating member 51a is preferably higher than the average burst pressure of the balloon 30, as shown in FIG. The average burst pressure of the balloon 30 is an average value of the pressure in the internal space 30V when the balloon 30 bursts when a fluid is injected into the internal space 30V of the balloon 30, for example, 2026 kPa. According to this configuration, the restriction member 51a is not damaged until the balloon 30 is ruptured, and the maximum expansion diameter of the balloon 30 can be more suitably restricted.

  Next, the effect | action of the balloon catheter 1 which concerns on embodiment of this invention is demonstrated with reference to FIG.

  FIG. 7A is a diagram illustrating a state before the balloon 30 is expanded, and FIG. 7B is a diagram illustrating a state after the balloon 30 is expanded. Note that the description of the guide wire 90 is omitted in FIG. 7A for easy understanding. FIG. 8 is a graph showing the relationship between the pressure in the internal space 30V of the balloon 30 and the balloon diameter. In FIG. 8, the solid line indicates the relationship between the pressure and the balloon diameter in the internal space 30V of the balloon 30 according to the present embodiment, and the dotted line indicates the pressure and the balloon diameter in the internal space of the balloon that is not provided with the regulating means according to the comparative example. Show the relationship.

  In the procedure of expanding the stenosis N by the balloon catheter 1, the guide wire 90 and the contracted balloon catheter 1 are introduced into the living organ. At this time, the balloon catheter 1 is moved over the guide wire 90 introduced prior to the balloon catheter 1 until the dilation effective portion 31 of the balloon 30 reaches the stenosis N (FIG. 7A). )reference). At this time, the guide wire 90 is inserted through the insertion lumen 11 of the inner tube shaft 10.

  After the effective expansion portion 31 of the balloon 30 reaches the constricted portion N, the fluid is introduced from the opening 40a of the hub 40, and the balloon 30 passes through the flow lumen 21 partitioned on the inner periphery of the outer tube shaft 20. The balloon 30 is expanded by introducing a fluid into the internal space 30V. As a result, a pressure is applied to the stenosis N via the effective expansion portion 31 of the balloon 30, and the stenosis N is pushed and expanded (see FIG. 7B).

  At this time, the four restricting members 51 a to 51 d of the restricting means 51 and the four restricting members of the restricting means 52 respectively apply a tensile force toward the radially inward direction to the balloon 30 to increase the maximum expanded diameter of the balloon 30. regulate. For this reason, as shown by the solid line in FIG. 8, until the balloon diameter reaches the maximum expansion diameter, the balloon diameter expands as the pressure in the internal space 30V of the balloon 30 increases, but when the balloon diameter reaches the maximum expansion diameter, The balloon diameter does not expand even when the pressure is increased. On the other hand, as shown by the dotted line in FIG. 8, in the balloon catheter in which the regulating member according to the comparative example is not provided, the balloon diameter is undesirably expanded by applying pressure even when the maximum expansion diameter is exceeded.

  Here, FIG. 9 shows a state in which a balloon 930 of a general balloon catheter 900 not provided with a regulating member according to a comparative example is bent and expanded. As one of the reasons for the uneven expansion of the balloon 930, the ease of expansion of the balloon differs in the circumferential direction. In the case of the balloon catheter 1 according to the present embodiment, as described above, the two restricting means 51 and 52 are arranged at the same distance in the left-right direction from the center position of the effective expansion portion 31 in the left-right direction. Since a tensile force directed radially inward is applied to the balloon at a symmetrical position in the left-right direction, it is possible to suitably prevent the balloon 30 as shown in FIG.

  As described above, the balloon catheter 1 according to the present embodiment partitions the inner tube shaft 10 that includes the insertion lumen 11 through which the guide wire 90 is inserted and extends in the left-right direction, and the distribution lumen 21 through which fluid can flow. The outer tube shaft 20 and the inner tube shaft 10 are joined at the distal end side, and the proximal end side is joined to the outer tube shaft 20, and the inner space 30V communicating with the flow lumen 11 is interposed between the inner tube shaft 10 and the inner tube shaft 10. A balloon 30 that is partitioned and expanded by injecting fluid into the internal space 30V, and extends between the inner tube shaft 10 and the balloon 30, and has one end connected to the outer surface 10a of the inner tube shaft 10 and the other end. The side is connected to the inner surface 30 a of the expansion effective portion 31 of the balloon 30, and a tensile force directed radially inward is applied to the balloon 30 as the balloon 30 expands and deforms. Having a regulating means 51 comprising four regulating members 51a~51d for restricting the maximum expanded diameter of the balloon 30, the Te. According to this configuration, as the balloon 30 is expanded and deformed, the four restricting members 51 a to 51 d apply a tensile force inward in the radial direction to the balloon 30 to restrict the maximum expanded diameter of the balloon 30. . For this reason, it is possible to more suitably prevent the balloon 30 from expanding beyond the maximum expansion diameter. Moreover, even if it is the balloon 30 excellent in the insertability, it can prevent more suitably that the balloon 30 expand | swells exceeding a maximum expansion diameter by applying this structure. Therefore, it is possible to provide a balloon catheter 1 that more suitably prevents the balloon 30 from expanding beyond the maximum expansion diameter and is excellent in insertion into a living body.

  Moreover, the 1st control means 51 and the 2nd control means 52 do not prevent the injection | pouring of the fluid to the internal space 30V. For this reason, the balloon 30 can be expanded reliably.

  Further, the restricting means 51 includes four restricting members 51 a to 51 d that are connected to each other on the same axis orthogonal cross section of the inner tube shaft 10. According to this configuration, in the cross section where the regulating members 51a to 51d are provided, it is possible to uniformly apply a tensile force inward in the radial direction to the balloon 30, so that the maximum expansion diameter of the balloon 30 can be more suitably increased. Can be regulated.

  Further, the restricting means 51 includes four restricting members 51 a to 51 d arranged at equal intervals in the circumferential direction of the inner tube shaft 10. According to this configuration, since the four regulating members 51a to 51d uniformly apply the tensile force directed radially inward, the inner tube shaft 10 and the balloon 30 maintain a concentric positional relationship, and the balloon 30 is more preferably used. The maximum expansion diameter can be regulated.

  Further, the two restricting means 51 and 52 are arranged at the same distance in the left-right direction from the central position of the expansion effective part 31 in the left-right direction. According to this configuration, as described above, the balloon 30 can be suitably prevented from expanding unevenly.

  The restricting member 51 a is compatible with the first fixing portion 30 b where the restricting member 51 a is fixed in the balloon 30 and the second fixing portion 10 c where the restricting member 51 a is fixed on the inner tube shaft 10. According to this configuration, since the balloon 30 and the regulating member 51a, the inner tube shaft 10 and the regulating member 51a are connected by applying heat, the connection is facilitated.

  Further, the regulating member 51a has a contrast property. For this reason, by irradiating the living body with X-rays during the procedure, the position and the expanded state of the regulating member 51a can be confirmed, and the position and the expanded state of the balloon 30 can be easily confirmed.

  Further, the yield point strength of the regulating member 51 a is higher than the average burst pressure of the balloon 30. For this reason, the restriction member 51a is not damaged until the balloon 30 is ruptured, and the maximum expansion diameter of the balloon 30 can be restricted more suitably.

  The restricting member 51 is configured by a linear member that bends when the balloon 30 is in a contracted state and expands when the balloon 30 is in an expanded state. For this reason, the maximum expansion diameter of the balloon 30 can be regulated with a simple and lightweight configuration.

  Hereinafter, modifications of the above-described embodiment will be exemplified.

<Modification 1>
FIG. 10 is a side sectional view showing the distal end portion of the balloon catheter 2 according to Modification 1. In the embodiment described above, the balloon catheter 1 has the two restricting means 51 and 52 arranged at the same distance in the left-right direction from the center position of the effective expansion portion 31 in the left-right direction. However, as shown in FIG. 10, the balloon catheter 2 may have one restricting means 151 disposed at the center position of the expansion effective portion 31 in the left-right direction. According to this configuration, the maximum expanded diameter of the balloon 30 can be regulated while reducing the weight. Furthermore, the configuration is not limited to this, and it is only necessary to provide at least one regulating member having one end connected to the outer surface 10 a of the inner tube shaft 10 and the other end connected to the inner surface 30 a of the expansion effective portion 31 of the balloon 30.

<Modification 2>
FIG. 11 is a view corresponding to FIG. 4 of the balloon catheter 3 according to the second modification. In the embodiment described above, the restricting means 51 has four restricting members 51a to 51d. However, as shown in FIG. 11, the restricting means 251 of the balloon catheter 3 may have three restricting members 251a to 251c. Furthermore, it is not limited to this, and it is not particularly limited as long as it is two or more, but it is preferable to have three or four regulating members from the viewpoint of weight and stability.

<Modification 3>
FIG. 12 is a view corresponding to FIG. 4 of the balloon catheter 4 according to Modification 3. In the embodiment described above, the regulating members 51a to 51d of the regulating means 51 are each constituted by a linear member. However, as shown in FIG. 12, the restriction means 351 of the balloon catheter 4 according to the modified example 3 is a film having a plurality of holes 352 through which fluid can flow when the balloon 30 is expanded. The entire inner peripheral surface may be connected to the entire outer surface 10a of the inner tube shaft 10 in the axial orthogonal cross section, and the entire outer peripheral surface may be connected to the entire inner surface 30a of the balloon 30. In this configuration, in order to make the balloon 30 easy to fold, it is preferable that the regulating means 351 is provided with a broken line 353. According to this configuration, since the restricting means 351 is connected to the entire outer surface 10a of the inner tube shaft 10 and the entire inner surface 30a of the balloon 30 in the cross section orthogonal to the inner tube shaft 10, the balloon is more preferably used. 30 maximum expansion diameters can be regulated. Further, in the case of the restricting means 351 configured as described above, since a plurality of holes 352 that can be circulated are provided, the injection of fluid into the internal space 30V is not hindered.

<Modification 4>
In the embodiment described above, the regulating members 51a to 51d are linear members. However, the configuration of the restricting member is not particularly limited as long as it applies a tensile force directed radially inward, and may be, for example, a belt-like member.

<Modification 5>
In the embodiment described above, the four regulating members 51 a to 51 d are arranged at equal intervals in the circumferential direction of the inner tube shaft 10. However, the present invention is not limited to this, and they may be arranged at unequal intervals.

<Modification 6>
In the embodiment described above, the four restricting members 51 a to 51 d are disposed on the same axis orthogonal cross section of the inner tube shaft 10. However, the present invention is not limited to this, and they may be arranged on different axis orthogonal cross sections.

<Modification 7>
In the embodiment described above, the balloon catheter 1 was a rapid exchange (RX) type. However, the present invention is not limited to this, and application to an over-the-wire (OTW) type is also possible.

1, 2, 3, 4 balloon catheter,
10 Inner tube shaft,
10a The outer surface of the inner tube shaft,
10c 2nd fixing | fixed part,
11 Inserting lumen,
20 outer pipe shaft,
21 Distribution lumen,
30 balloon,
30a The inner surface of the balloon,
30b first fixing part,
30V internal space,
31 Effective extension part,
51, 52, 151, 251 and 351 regulating means,
51a-51d, 251a-251c Restriction member.

Claims (9)

An inner tube shaft having an insertion lumen through which a guide wire is inserted and extending in the axial direction;
An outer tube shaft that defines a flow lumen through which fluid can flow;
A distal end side is joined to the inner tube shaft, and a proximal end side is joined to the outer tube shaft, and an internal space communicating with the flow lumen is defined between the inner tube shaft and the inner space. A balloon that is expanded by injection of the fluid;
Extending between the inner tube shaft and the balloon, one end side is connected to the outer surface of the inner tube shaft, and the other end side is connected to the inner surface of the expansion effective portion of the balloon, for expansion deformation of the balloon And a restricting means including at least one restricting member that restricts the maximum expansion diameter of the balloon by applying a tensile force inward in the radial direction to the balloon.   The balloon catheter according to claim 1, wherein the regulating means does not prevent the fluid from being injected into the internal space.   The balloon catheter according to claim 1 or 2, wherein the restricting means includes a plurality of the restricting members respectively connected on the same axis orthogonal cross section of the inner tube shaft.   The balloon catheter according to any one of claims 1 to 3, wherein the restricting means includes a plurality of the restricting members arranged at equal intervals in a circumferential direction of the inner tube shaft.   The balloon catheter according to any one of claims 1 to 4, wherein at least two of the restricting means are disposed at a position spaced apart from the central position of the expansion effective portion in the axial direction by the same distance in the axial direction.   The said regulating member has compatibility with respect to the 1st fixing | fixed part to which the said regulating member is fixed in the said balloon, and the 2nd fixing | fixed part to which the said regulating member is fixed to the said inner tube shaft, respectively. 6. The balloon catheter according to any one of 5 above.   The balloon catheter according to claim 1, wherein the regulating member has a contrast property.   The balloon catheter according to any one of claims 1 to 7, wherein a yield point strength of the regulating member is higher than an average burst pressure of the balloon.   The balloon catheter according to any one of claims 1 to 8, wherein the regulating member is constituted by a linear member that bends in a contracted state of the balloon and extends in an expanded state of the balloon.