Balloon-equipped guide wire and catheter set

Abstract

To provide a balloon-equipped guide wire which improves blocking of a body lumen and suppresses unnecessary pressure from being applied to the inner wall of the body lumen.SOLUTION: A portion of a tube wall located on the leading end side in a tubular-shaped member 10 is a spring. The spring has a ribbon 15a that is helically arranged with the central axis of the tubular-shaped member 10 serving as the axis thereof, such that a gap is provided between respective turns thereof. The width dimension of a helical slit 44 is less than one-fifth of the width dimension of the ribbon 15a. When a liquid or gas is injected in a balloon member 40 through an opening to increase the volume thereof, the balloon member 40 is expanded as the dimensions of the balloon member 40 increase in both the radial direction and the axial direction of the tubular-shaped member 10.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a balloon guidewire and a catheter set including such a balloon guidewire. [Background technology]

[0002] There is a guidewire that is inserted into a body lumen such as a blood vessel and has a balloon at its tip for blocking the body lumen. In relation to this type of technology, in the following Patent Document 1, a balloon member (16) is provided at the distal end (tip) of a tubular member (14) that is a hypotube. As shown in FIG. 2 of Patent Document 1, the balloon member (16) is coaxially attached to the distal end (14B) of the tubular member (14) at the proximal end (16A) and distal end (16B) of the balloon member (16) by suitable adhesives (19) and (21). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2001-514544 Summary of the Invention [Problem to be solved by the invention]

[0004] In Patent Document 1, a tubular member (14) which is a hypotube made of a Nitinol alloy is disposed inside a balloon member (16), and a proximal end (16A) and a distal end (16B) of the balloon member (16) are fixed to the tubular member (14). Therefore, the balloon member (16) expands in the radial direction of the tubular member (14) to become spherical. In this case, the largest diameter part of the spherically expanded balloon member (16) is pressed against the inner wall of the body cavity such as a blood vessel, but since the area of ​​the balloon member (16) that is pressed against the inner wall is small in the axial direction of the tubular member (14), it may be undesirable to block the body cavity or unnecessary pressure may be applied to the inner wall of the body cavity.

[0005] The present invention has been made in consideration of the above-mentioned problems, and provides a balloon-equipped guidewire that better occludes a body cavity or suppresses the application of unnecessary pressure to the inner wall of a body cavity. [Means for solving the problem]

[0006] The balloon-equipped guidewire of the present invention is a balloon-equipped guidewire comprising: a tubular member having a lumen and having an opening in a tubular wall at a base end that communicates with the lumen; a balloon member provided on the outer diameter side of a tip end of the tubular member, the interior of which is in communication with the lumen of the tubular member and is expandable by increasing the volume of the interior; and a linear member disposed in the lumen at the base end of the tubular member and movable in the axial direction of the tubular member, wherein a sealing member is provided at the tip end of the linear member in close contact with a part of the inner wall of the tubular member, the sealing member blocking the opening or being disposed distal to the opening and extending from the opening to the outside. The balloon member moves between a closed position, which blocks the flow of fluid toward the hollow portion, and an open position, which is closer to the base end of the tubular member than the opening, in association with movement of the linear member in the axial direction, and the tube wall at the tip of the tubular member is a spring in which a ribbon is arranged in a spiral shape with gaps between turns, with the central axis of the tubular member as an axis, and the width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, and when liquid or gas is injected through the opening to increase the volume of the balloon member, the dimensions of the balloon member in both the radial and axial directions of the tubular member increase, thereby expanding the balloon member.

[0007] The catheter set of the present invention comprises a balloon-equipped guidewire and a catheter into which the balloon-equipped guidewire is inserted, the balloon-equipped guidewire comprising: a tubular member having a lumen and having an opening in a tubular wall at a base end portion thereof communicating with the lumen; a balloon member provided on the outer diameter side of a tip end portion of the tubular member, the interior of which is in communication with the lumen of the tubular member and which is expandable by increasing the volume of the interior; and a linear member disposed in the lumen at the base end portion of the tubular member and movable in the axial direction of the tubular member, the linear member having a sealing member provided at the tip end portion of the linear member which is in close contact with a part of the inner wall of the tubular member, the sealing member being adapted to close the opening or to close the opening. The balloon member moves between a closed position, which is positioned distal to the opening and blocks the flow of fluid from the opening toward the inside, and an open position, which is proximal to the opening of the tubular member, in association with movement of the linear member in the axial direction, and the tube wall at the distal end of the tubular member is a spring in which a ribbon is arranged in a spiral shape with gaps between turns of the ribbon, with the central axis of the tubular member as the axis, and the width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, and when liquid or gas is injected from the opening to increase the volume of the balloon member, the dimensions of the balloon member in both the radial and axial directions of the tubular member increase, thereby expanding the balloon member.

[0008] As described above, by expanding the balloon member in the axial dimension of the tubular member, the area of ​​the balloon member that is in pressure contact with the inner wall of the body cavity is increased in the axial direction of the tubular member. This allows the body cavity to be more effectively blocked. Alternatively, by increasing the surface area of ​​the balloon member that is in pressure contact with the inner wall of the body cavity, the pressure applied from the balloon member to the inner wall of the body cavity is reduced, thereby preventing unnecessary pressure from being applied to the inner wall of the body cavity. Effect of the Invention

[0009] According to the balloon guidewire of the present invention, the occlusion of the body cavity is improved, and unnecessary pressure on the inner wall of the body cavity is suppressed. [Brief description of the drawings]

[0010] [Figure 1] 1 is a schematic diagram showing an example of a balloon-equipped guidewire and a catheter according to a first embodiment of the present invention. FIG. [Diagram 2] Figures 2(a) and 2(b) are schematic enlarged views of a portion of the area II indicated by the dashed line in Figure 1. Figure 2(a) shows the sealing member in the open position, and Figure 2(b) shows the sealing member in the closed position. [Diagram 3] FIG. 2 is a schematic diagram for explaining a structure of a linear member according to the first embodiment. [Figure 4] FIG. 2 is a schematic enlarged view of a portion within a frame IV indicated by a dashed dotted line in FIG. [Diagram 5] 3 is a schematic diagram showing an example of a balloon member and its vicinity according to the first embodiment. FIG. [Figure 6] Figures 6(a) to 6(c) are explanatory diagrams for explaining the process of expanding the balloon member of this embodiment. Figure 6(a) is a schematic diagram of the balloon member and its vicinity in a contracted diameter state, Figure 6(b) is a small diameter state, and Figure 6(c) is a schematic diagram of the balloon member and its vicinity in a large diameter state. [Figure 7] FIG. 7 is a graph showing the relationship between the amount of injected liquid and the balloon size. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The various components of the balloon guidewire of the present invention do not need to be independent entities, and it is acceptable for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be part of another component, or for part of one component to overlap with part of another component, etc.

[0012] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the drawings, corresponding components are designated by common reference numerals, and duplicated descriptions will be omitted as appropriate. Further, the term "flat surface" as used herein means a shape that is physically formed with a flat surface as a goal, and it is not necessarily required that the surface be a geometrically perfect flat surface.

[0013] First Embodiment (Balloon guidewire) FIG. 1 is a schematic plan view showing an example of a balloon-equipped guidewire 1 according to a first embodiment of the present invention.

[0014] First, an overview of a balloon guidewire 1 according to the present embodiment will be given. The balloon guidewire 1 has a tubular member 10 , a balloon member 40 , and a linear member 20 . The tubular member 10 has a lumen 11. The tubular member 10 has an opening (inlet 18) in a tubular wall that forms a part (inlet forming portion) on the base end side of the tubular member 10. At the inlet 18, the lumen 11 is open to the outside. The balloon member 40 is provided on the outer diameter side of a part (an attachment portion 13 described later) on the tip side of the tubular member 10. The inside of the balloon member 40 (hollow portion 42) communicates with the lumen 11 of the tubular member 10. The balloon member 40 can be expanded by increasing the volume of the hollow portion 42. The linear member 20 is disposed in a portion of the lumen 11 on the base end side of the tubular member 10. The linear member 20 is movable in the axial direction of the tubular member 10. A sealing member 30 is provided at a distal end 26 of the linear member 20. The sealing member 30 is in close contact with a portion of the inner wall of the tubular member 10 (the wall portion defining the lumen 11). The sealing member 30 moves between the closed position and the open position in accordance with the axial movement of the linear member 20. In the closed position, the sealing member 30 blocks the injection port 18 or is disposed on the tip side (distal side) of the injection port 18. In addition, in the closed position, the sealing member 30 blocks the flow of fluid from the injection port 18 toward the hollow portion 42. Blocking the flow of fluid means that the flow of fluid is sufficiently restricted (the fluid is dammed) to such an extent that the expanded state of the balloon member 40 can be maintained for a predetermined time, and is not limited to being completely blocked. In the closed position, a part of the lumen 11 (a part on the tip side of the sealing member 30) and the hollow portion 42 are sealed liquid-tight or air-tight. In the open position, the sealing member 30 is located on the base end side of the tubular member 10 from the injection port 18. A part of the tube wall on the tip side of the tubular member 10 is a spring (spring forming portion 15). Specifically, the spring is arranged in a spiral shape with the ribbon 15a around the central axis of the tubular member 10, with gaps (spiral slits 44) provided between the turns. The width dimension of spiral slit 44 is less than one-fifth the width dimension of ribbon 15a. When a fluid (liquid or gas, hereinafter referred to as a liquid or the like) is injected from the inlet 18 to increase the volume of the balloon member 40, the dimensions of the balloon member 40 in both the radial and axial directions of the tubular member 10 increase, thereby expanding the balloon member 40. As the liquid or the like, a liquid such as saline is preferably used. As the liquid or the like, a mixture containing a contrast agent and saline may also be used. As described above, the balloon member 40 is expanded in the axial dimension of the tubular member 10, so that the range of the balloon member 40 that is in pressure contact with the inner wall of the body cavity is increased in the axial direction of the tubular member. This allows the body cavity to be better blocked. Alternatively, the surface area of ​​the outer circumferential surface of the balloon member 40 that is in pressure contact with the inner wall of the body cavity is increased, so that the pressure applied from the balloon member 40 to the inner wall of the body cavity is reduced, and unnecessary pressure on the inner wall of the body cavity is suppressed. Furthermore, since the balloon member 40 can be expanded in the axial direction, the amount of fluid that can be injected into the hollow portion 42 is increased compared to when the balloon member 40 is expanded only in the radial direction. Therefore, even if an excessive amount of fluid is accidentally injected into the balloon member 40, the balloon member 40 is prevented from expanding in the axial direction and being damaged. Furthermore, because the width dimension of the spiral slit 44 is a small value less than one-fifth of the width dimension of the ribbon 15a, the spiral direction of the ribbon 15a becomes larger relative to the axial direction of the tubular member 10. This makes it easier for the portion in which the spring is formed to expand and contract in the axial direction of the tubular member 10. Furthermore, because the width dimension of the spiral slit 44 is a small value less than one-fifth of the width dimension of the ribbon and the spring is tightly wound, the portion in which the spring is formed has ample room to expand in the axial direction of the tubular member 10.

[0015] Next, the balloon guidewire 1 of the present embodiment will be described in detail. The balloon guidewire 1 is a member that is inserted into a body cavity in a living body and is an entirely long member. With regard to members such as the balloon guidewire 1, the tubular member 10, and the linear member 20, the end that is first inserted into the body cavity in the longitudinal direction (axial direction) of the balloon guidewire 1 may be called the tip, and the other end opposite the tip (the end closest to the operator) may be called the base. The base side may also be called the hand side or proximal side, and the side opposite the proximal side may also be called the distal side. The tubular member 10 is a long member extending with the longitudinal direction of the balloon-equipped guidewire 1 as its axial direction. The axial direction of the tubular member 10 may be simply referred to as the axial direction. In this embodiment, the tubular member 10 has superelasticity. For example, metal such as nickel titanium (nitinol) is exemplified as a material constituting the tubular member 10. Alternatively, the tubular member 10 may be made of other materials such as elastic resin. Alternatively, the tubular member 10 may be made of a material in which resin and metal are mixed, or may be configured by combining a resin portion and a metal portion. The tubular member 10 has a lumen 11 therein. The cross-sectional shape of the tubular member 10 is circular or polygonal, etc. The width of the lumen 11 (the inner diameter of the tubular member 10) is larger than the wire diameter of the linear member 20 described later. The lower limit of the outer diameter of the tubular member 10 is 250 μm, preferably 300 μm, and the upper limit of the outer diameter of the tubular member 10 is 400 μm, preferably 350 μm. The lower limit of the inner diameter of the tubular member 10 is 150 μm, preferably 200 μm, and the upper limit of the inner diameter of the tubular member 10 is 300 μm, preferably 250 μm. In addition, the lower limit of the thickness dimension of the tube wall of the tubular member 10 is 50 μm, preferably 80 μm, and the upper limit of the thickness dimension of the tube wall of the tubular member 10 is 150 μm, preferably 120 μm.

[0016] In the tubular member 10 of this embodiment, an injection port 18 (through hole) which is an opening communicating with the lumen 11 is provided in a tubular wall of a part on the base end side (a part into which the linear member 20 described below can be inserted). The injection port 18 is provided for injecting a solution or gas for expanding the balloon member 40, or for injecting a drug. A solution or the like can be injected into the lumen 11 via the injection port 18. The shape of the injection port 18 when viewed from the side of the balloon guide wire 1 may be circular or polygonal. The size of the injection port 18 in this embodiment (particularly the dimension of the injection port 18 in the axial direction) is smaller than the length of the sealing member 30 in the axial direction. In addition, the diameter of the injection port 18 is preferably larger than the thickness dimension of the tube wall of the tubular member 10.

[0017] As shown in FIG. 1, the lumen 11 in this embodiment is closed at the distal end (a portion on the proximal side relative to a coil portion described later). 5, in order to increase the flexibility of the tubular member 10, a portion of the most distal end of the tubular member 10 (coil portion 14) is formed of a coil in which wire is tightly wound in a helical shape. Furthermore, in order to facilitate the insertion of the tubular member 10 into a body cavity, a distal tip 16 is provided on the distal end of the coil portion 14. In this embodiment, the distal tip 16 is made of a metal such as an alloy of tin and gold.

[0018] The balloon member 40 is a member that is placed in a part of a body cavity of a living body and expands in diameter to press against a wall portion that defines the body cavity, thereby sealing the body cavity or blocking an opening provided in the wall portion. The balloon member 40 does not need to completely seal the body cavity or completely block the opening in the wall portion, but it is sufficient that it dams up the body cavity sufficiently to restrict the flow of liquid or the like through the body cavity or opening, or that it covers the opening. For example, the balloon member 40 is placed in a blood vessel in an expanded state and presses against the blood vessel wall to suppress the flow of blood. As shown in FIG. 5, the balloon member 40 has a hollow portion 42 therein covered with a membrane portion 41. The hollow portion 42 of the balloon member 40 communicates with the lumen 11 (see FIG. 1) of the tubular member 10. For example, a through-hole such as a groove that connects the lumen 11 to the outside is provided in a part of the tubular wall of the tubular member 10 arranged on the inner diameter side of the balloon member 40, and the hollow portion 42 and the lumen 11 communicate with each other through the through-hole. In this embodiment, as described later, a spiral slit 44 is provided in the tubular wall of the tubular member 10, and the hollow portion 42 and the lumen 11 communicate with each other through the spiral slit 44 that is the through-hole. By injecting a liquid or gas (referred to as liquid or the like) into the hollow portion 42 of the balloon member 40 through the inlet 18, the lumen 11, and the spiral slit 44, the volume of the hollow portion 42 increases and the diameter of the balloon member 40 increases. The expansion of the balloon member 40 means that the dimension of the balloon member 40 in the radial direction of the balloon guidewire 1 becomes larger than before the injection of a liquid or the like. The radial direction of the balloon guidewire 1 is the radial direction toward the periphery of the balloon guidewire 1 (the periphery of the tubular member 10) when viewed in the axial direction from the axis of the balloon guidewire 1 (the axis of the tubular member 10).

[0019] 5, the spring forming portion 15, which is a part of the tip side of the tubular member 10, is a spring that can expand and contract in the axial direction by forming a spiral slit (spiral slit 44). Specifically, the tube wall that remains after the spiral slit 44 is formed is a narrow ribbon 15a, and the ribbon 15a is arranged spirally over multiple turns to form the spring. In this embodiment, ribbon 15a is a plate-like portion having a predetermined thickness. Ribbon 15a has a predetermined width. The width of ribbon 15a is the distance along the axial direction between one end of ribbon 15a on the tip side and one end of ribbon 15a on the base side. As described above, the width of the spiral slit 44 is less than one-fifth of the width of the ribbon 15a, and more preferably less than one-sixth of the width of the ribbon 15a. In order to stably inject a liquid or the like into the hollow portion 42, the width of the spiral slit 44 is preferably one-tenth or more of the width of the ribbon 15a, and more preferably one-twentieth. The width of the spiral slit 44 is the distance along the axial direction between one end of the tip side of one turn of the ribbon 15a and one end of the base side of another turn adjacent to the tip side of the one turn. In this embodiment, the width of the spiral slit 44 is constant throughout the spring forming portion 15. Here, the ribbon 15a width being equal to or greater than the above-mentioned predetermined value or equal to or less than the above-mentioned predetermined value refers to the width of the narrowest ribbon 15a (ribbon 15a in a second region 15a2 described below) in the entire spring forming portion 15. In other words, the ribbon 15a in a length region other than the second region 15a2 does not have to be equal to or greater than the predetermined value or equal to or less than the predetermined value. Alternatively, the ribbon 15a width of the entire spring forming portion 15 may be equal to or greater than the above-mentioned predetermined value or equal to or less than the above-mentioned predetermined value. In this embodiment, the spiral direction of the ribbon 15a is opposite to the spiral direction of the coil portion 14. The spiral direction of the ribbon 15a is also opposite to the spiral direction of the radiopaque marker 19 described below. This prevents the radiopaque marker 19 from interfering with the spiral slit 44 of the spring forming portion 15. Alternatively, the spiral direction of the ribbon 15a may be the same as the spiral direction of the coil portion 14 or the radiopaque marker 19.

[0020] 5, the balloon member 40 (particularly the membrane portion 41 which is its main body portion) is disposed so as to go around the tubular member 10 (particularly the attachment portion 13) and has a cylindrical shape. A seal band 46 is disposed on the outer layer side of a part of the distal end side and a part of the proximal end side of the balloon member 40. The seal band 46 presses the balloon member 40 from the outer layer side to assist in fixing the balloon member 40 to the tubular member 10. In this embodiment, a resin layer (not shown) is provided on the outer layer side of the tubular member 10 as a base for arranging the balloon member 40. The resin layer may be formed of a resin such as polyethylene terephthalate (PET). The resin layer is arranged, for example, on the outer layer side of a part of the tubular member 10 where the seal band 46 is arranged and on the outer layer side of the base end side forming portion 15d described below. The resin layer is not arranged on the outer layer side of a part of the tubular member 10 (second region 15a2, etc.) arranged in the hollow portion 42. This allows the hollow portion 42 and the lumen 11 to communicate with each other. The balloon member 40 (particularly the membrane portion 41) is fixed (bonded) to the tubular member 10 by an appropriate adhesive 50. More specifically, a first adhesive 51 is disposed on the outer layer side of the tubular member 10 on the base end side of the balloon member 40. The first adhesive 51 is formed to have a tapered shape. In this embodiment, a coil-shaped X-ray impermeable marker 19 is embedded inside the first adhesive 51. That is, the first adhesive 51 may be disposed on the inner diameter side and the outer diameter side of the X-ray impermeable marker 19, and the first adhesive 51 may be disposed between the turns of the X-ray impermeable marker 19. A second adhesive 52 is provided on the distal end side of the balloon member 40 in a dome shape inflated toward the distal end. A third adhesive 53 is formed in a tapered shape to cover the second adhesive 52 and on the outer layer side of the tubular member 10. The third adhesive 53 is disposed on the outer layer side of the coil portion 14. In this embodiment, the thickness (width dimension) of the adhesive 50 is equivalent to the thickness of the balloon member 40 (particularly the thickness of the seal band 46). The length of the first adhesive 51 in the axial direction is smaller than the length of the third adhesive 53 in the axial direction. The angle that the tapered shape of the third adhesive 53 makes with respect to the axial direction is smaller than the angle that the tapered shape of the first adhesive 51 makes with respect to the axial direction. This makes it difficult for the flexibility of the coil portion 14 to be hindered by the third adhesive 53. In addition, when the balloon guidewire 1 is inserted into a body cavity (particularly a narrowed portion), the third adhesive 53 is prevented from interfering with the insertion.

[0021] 1, the linear member 20 is disposed in the lumen 11 of the tubular member 10. Specifically, an opening (proximal end opening 12) is provided at the proximal end of the tubular member 10, which penetrates the tubular member 10 in the axial direction and connects the outside of the tubular member 10 to the lumen. The linear member 20 is inserted into the lumen 11 from the proximal end opening 12. The linear member 20 is disposed in a portion of the proximal end side of the tubular member 10. More specifically, the linear member 20 is inserted from the proximal end of the tubular member 10 to the vicinity of the injection port 18. In this embodiment, a part of the base end side of the linear member 20 (the base end 22 and a part of the second transition portion 23 described later) protrudes from the base end opening 12 at the base end of the tubular member 10 toward the base end side and is disposed outside the tubular member 10. Therefore, by holding a part of the linear member 20 disposed outside the tubular member 10 (particularly the base end 22) with an instrument or a hand, etc. and then pulling out or inserting it, the linear member 20 can be moved in the axial direction of the tubular member 10 inside the tubular member 10. By moving the linear member 20 in the axial direction of the tubular member 10, the position of the sealing member 30 attached to the tip end 26 of the linear member 20 can be changed in the axial direction of the tubular member 10. This makes it possible to adjust the inflow and outflow of liquid, etc. in the lumen 11 as described later.

[0022] The sealing member 30 is a member for adjusting the flow of liquid or gas in the lumen 11. The sealing member 30 is fixed (bonded) around the distal end 26 of the linear member 20. The sealing member 30 in this embodiment is made of a resin such as a thermoplastic resin. Alternatively, the sealing member 30 may be made of a resin other than a thermoplastic resin, or may be made of other materials (such as high-density cotton) that allow a small amount of liquid or gas to pass through. The sealing member 30 seals the lumen 11 by pressing or adhering to a part of the inner wall of the tubular member 10 in the axial direction and substantially the entire circumferential direction of the inner wall. Specifically, the sealing member 30 presses and preferably adheres to at least a part of the inner wall of the tubular member 10 in the radial direction, preferably in close contact. More preferably, the sealing member 30 adheres to the inner wall of the tubular member 10 over the entire radial direction of the tubular member 10. That is, the sealing member 30 seals substantially the entire cross section of the lumen 11. As a result, the movement of liquid or gas in the axial direction within the lumen 11 is restricted by sandwiching the sealing member 30. It is preferable that the width dimension of the sealing member 30 (the dimension in a direction perpendicular to the axial direction of the linear member 20) when the linear member 20 is taken out of the tubular member 10 is larger than the width of the lumen 11. As a result, the sealing member 30 is in pressure contact with a part of the inner wall of the tubular member 10 within the lumen 11.

[0023] 2(a) and 2(b) and described above, the sealing member 30 can move between an open position and a closed position in accordance with the axial movement of the linear member 20. Fig. 2(a) shows the sealing member 30 in the open position, and Fig. 2(b) shows the sealing member 30 in the closed position. Note that the positions of other members when the sealing member 30 is in the closed position or the open position may be referred to as the closed position or the open position. As shown in FIG. 2(a), in the open position, the sealing member 30 is disposed at a position closer to the base end than the injection port 18. Therefore, a part of the lumen 11 on the tip side than the injection port 18 and the hollow portion 42 (see FIG. 5) are in communication with the outside of the tubular member 10 via the injection port 18. Therefore, a liquid or the like can be injected into the hollow portion 42 via the injection port 18, or a liquid or the like within the hollow portion 42 can be withdrawn via the injection port 18. Note that in the open state, the sealing member 30 prevents the inflow of a liquid or the like from the injection port 18 into a part of the lumen 11 on the base end side. As shown in FIG. 2(b), in the closed position, the sealing member 30 is disposed at approximately the same position as the injection port 18 in the axial direction of the tubular member 10 or at a position on the tip side of the position. Specifically, when the sealing member 30 is disposed at approximately the same position as the injection port 18, the sealing member 30 and the injection port 18 at least partially overlap when the tubular member 10 is viewed from the side. At this time, the sealing member 30 is in contact (pressed against) at least a part of the edge of the injection port 18. Preferably, when the tubular member 10 is viewed from the side (from a direction perpendicular to the axial direction), the entire injection port 18 overlaps with the sealing member 30. At this time, it is preferable that the sealing member 30 is in contact (pressed against) approximately the entire edge of the injection port 18 (a part of the tube wall that defines the injection port 18 and is disposed so as to go around the injection port 18). As a result, at least a part (preferably the entirety) of the injection port 18 is blocked by the sealing member 30. This prevents liquid or the like from leaking out of the injection port 18. When a liquid or the like is injected into the lumen 11 and the hollow portion 42 and the balloon member 40 is expanded in diameter, the liquid or the like in the hollow portion 42 is prevented from leaking to the outside through the lumen 11 and the injection port 18, thereby maintaining the expanded state of the balloon member 40. As shown in FIG. 2(b), in the sealing member 30 of this embodiment, the center in the axial direction is a large diameter portion, and the diameter decreases from the large diameter portion toward both ends in the axial direction. The width of the large diameter portion of the sealing member 30 is larger than the width of the lumen 11 in the natural state (a state in which the sealing member 30 is disposed outside the tubular member 10). The length of the large diameter portion in the axial direction is smaller than the dimension of the injection port 18 in the axial direction. Therefore, as shown in FIG. 2, when the sealing member 30 is disposed in the closed position to block the injection port 18, a part of both ends of the large diameter portion is in pressure contact with a part of the pipe wall that defines the injection port 18. Instead of this embodiment, the length of the large diameter portion in the axial direction may be the same as or larger than the dimension of the injection port 18 in the axial direction. In this case, as shown in FIG. 2(b), when the sealing member 30 is disposed in the closed position to block the injection port 18, it is preferable that the large diameter portion is in pressure contact with a part of the pipe wall that defines the injection port 18.

[0024] The linear member 20 has a distal end 26, an intermediate portion 24, and a proximal end 22. The intermediate portion 24 is a portion of the linear member 20 that is closer to the proximal end than the distal end 26. The proximal end 22 is a portion of the linear member 20 that is closer to the proximal end than the intermediate portion 24. The distal end 26, the intermediate portion 24, and the proximal end 22 each have a partial length region having a uniform outer diameter. Of the partial length regions of the distal end 26, the intermediate portion 24, and the proximal end 22, the partial length region of the proximal end 22 is the thickest, and the partial length region of the distal end 26 is the thinnest. As illustrated in FIG. 1, the base end 22 of the linear member 20 is a part of the linear member 20 on the base end side. Specifically, the base end 22 is a part of the linear member 20 that protrudes from the base end opening 12 to the base end side and is disposed outside the tubular member 10. The tip end 26 of the linear member 20 is a part of the linear member 20 to which the sealing member 30 is fixed and a length region in the vicinity of the part. In this embodiment, the tip end 26 is a length region from the tip of the linear member 20 to a position slightly toward the base end side from the position where the sealing member 30 is fixed. The intermediate portion 24 of the linear member 20 is a partial length region disposed at a position sandwiched between the base end 22 and the tip end 26 of the linear member 20. It is preferable that the intermediate portion 24 is disposed in the lumen 11 almost entirely in the closed position. In addition, a partial length region on the base end side of the intermediate portion 24 may protrude from the base end opening 12 to the outside of the lumen 11 in the open position.

[0025] Each of the base end 22, the intermediate portion 24, and the tip portion 26 has a uniform outer diameter in a partial length region or the entire length region in the axial direction. In this embodiment, each of the base end 22, the intermediate portion 24, and the tip portion 26 has a uniform outer diameter in the entire length region in the axial direction. Here, the uniform outer diameter means a substantially uniform outer diameter, and may not have a completely uniform outer diameter due to slight unevenness, etc. In FIG. 1, the outer diameter, inner diameter (width of the lumen 11) of the tubular member 10, the outer diameter of the linear member 20 (particularly the outer diameter of the base end 22, the intermediate portion 24, the tip portion 26, and the transition portion described later), and the size of the sealing member 30 are partially exaggerated for convenience. The same applies to FIG. 2(a) to FIG. 5. The outside diameter of the base end 22 is preferably approximately equal to the outside diameter of the tubular member 10. Specifically, the outside diameter of the base end 22 is preferably at least two-thirds and less than 1.5 times the outside diameter of the tubular member 10. The lower limit of the outside diameter of the base end 22 is, for example, 0.250 mm, preferably 0.300 mm. The upper limit of the outside diameter of the base end 22 is, for example, 0.400 mm, preferably 0.350 mm. The outer diameter of the intermediate portion 24 is smaller than the width of the lumen 11 (the dimension of the lumen 11 in a direction perpendicular to the axial direction. The diameter of the lumen 11), and is preferably less than 85% of the width of the lumen 11. Moreover, the outer diameter of the intermediate portion 24 is larger than the outer diameter of the tip portion 26 and smaller than the outer diameter of the base portion 22. Preferably, the outer diameter of the intermediate portion 24 is smaller than the difference between the outer diameter of the tip portion 26 and the outer diameter of the base portion 22. As a result, the intermediate portion 24 has sufficient flexibility, so that even if the difference between the amplitude of the wave shape in the intermediate portion 24 described later and the width of the lumen 11 (clearance described later) is large, the linear member 20 can be pulled out from the tubular member 10 with a predetermined pull-out strength. This will be described in detail later. Moreover, the outer diameter of the base portion 22 has a large value equal to or larger than the combined value of the outer diameter of the tip portion 26 and the outer diameter of the intermediate portion 24, so that the base portion 22 can be easily grasped and pulled out. Furthermore, since the outer diameter of the tip portion 26 is a small value less than the difference between the outer diameter of the base portion 22 and the outer diameter of the intermediate portion 24, the sealing member 30 can be formed sufficiently thick to be pressed well against the inner wall of the tubular member 10, thereby improving the sealing ability of the sealing member 30 against the lumen 11. The lower limit of the outer diameter of the intermediate portion 24 is, for example, 0.15 mm, preferably 0.17 mm. The upper limit of the outer diameter of the intermediate portion 24 is, for example, 0.23 mm, preferably 0.20 mm. The outer diameter of the tip portion 26 is preferably equal to or greater than half the width of the lumen 11. In this embodiment, the outer diameter of the tip portion 26 is approximately equal to the diameter of the injection port 18. Specifically, the outer diameter of the tip portion 26 is equal to or greater than two-thirds and less than 1.5 times the diameter of the injection port 18. The lower limit of the outer diameter of the tip portion 26 is, for example, 0.10 mm, preferably 0.12 mm. The upper limit of the outer diameter of the tip portion 26 is, for example, 0.20 mm, preferably 0.16 mm.

[0026] Next, the change in shape of the balloon member 40 when a liquid or the like is injected from the injection port 18 and the balloon member 40 is expanded will be described with reference to Figures 6(a) to 6(c). As described above, the balloon member 40 becomes larger in both the axial and radial directions by injecting a liquid or the like into the hollow portion 42. Figures 6(a) to 6(c) show a schematic representation of the spiral shape of the spring forming portion 15. Specifically, the ribbon 15a in the hollow portion 42 is formed in a spiral shape, but in Figures 6(a) to 6(c), each turn is conveniently divided and illustrated spaced apart in the axial direction. FIG. 6(a) shows a reduced diameter state before liquid or the like is injected. The reduced diameter state is the state of the balloon member 40 before liquid or the like for expanding the diameter of the balloon member 40 is injected. In the reduced diameter state, the hollow portion 42 and the lumen 11 may be filled with a fluid (such as physiological saline). The fluid filling the hollow portion 42 and the lumen 11 may be the same type as or a different type from the liquid or the like for expanding the diameter of the balloon member 40. In the reduced diameter state, the volume of the hollow portion 42 is small or substantially zero. The inner surface of the membrane portion 41 may be in contact with the tubular member 10 (the outer surface of the ribbon 15a in the spring forming portion 15) substantially entirely, or may be at least partially separated from the tubular member 10. When a fluid for expanding the diameter of the balloon member 40 is injected (particularly by pressure) from the injection port 18, the liquid passes through the lumen 11, seeps out from the spiral slit 44, and is injected into the hollow portion 42. As a result, the balloon member 40 passes through the small diameter state shown in Figure 6(b) and then reaches the large diameter state shown in Figure 6(c). Here, the large diameter state is a state in which the dimension in the width direction of the balloon member 40 is increased to the same extent as the maximum inner diameter of a general wide width that can be assumed for the body cavity in which the balloon guidewire 1 is used. For example, in the balloon guidewire 1 in this embodiment, the balloon member 40 is placed in a blood vessel (particularly the carotid artery is exemplified), and the general inner diameter of the blood vessel is exemplified as 5 mm, and the inner diameter of a general wide carotid artery that can be assumed is exemplified as about 6 mm to 7 mm. That is, the large diameter state of the balloon member 40 in the balloon guidewire 1 in this embodiment is a state in which the balloon member 40 is expanded to a dimension in the width direction of the balloon member 40 of about 6.5 mm. Here, the amount of fluid that needs to be pressed in from the reduced diameter state to the large diameter state is called the total pressurized amount. Note that the balloon member 40 may be expandable in the width direction even more than in the large diameter state. In this embodiment, the total pressurized amount is about 0.175 ml. The total pressurized amount may be 0.160 ml or more and 0.190 ml or less, including 0.175 ml. Alternatively, the total amount of fluid to be injected may be 0.160 ml or less or 0.190 ml or more depending on the inner diameter of the body cavity. The total amount of fluid to be injected is about 40% to 50% of the maximum amount of fluid that can be injected into the hollow portion 42, etc. (the maximum amount of fluid that can be injected without damaging the membrane portion 41 or the vicinity of the seal band 46). The small diameter state here refers to the state of the balloon member 40 when about one-fourth of the total amount of fluid injected is injected. In this embodiment, 0.0425 ml of fluid is injected from the injection port 18 to change from the contracted diameter state to the small diameter state. This injection amount is, for example, about one-tenth of the maximum amount of fluid that can be injected into the hollow portion 42, etc.

[0027] A predetermined amount of fluid is injected from the contracted state to the small diameter state. When the fluid is injected, the membrane portion 41 is pushed radially by the liquid in the hollow portion 42 and inflates, and the width dimension (the vertical dimension in the figure) of the balloon member 40 becomes larger than the width dimension in the contracted state. In addition, since both ends of the membrane portion 41 in the axial direction are fixed to the tubular member 10 by the seal bands 46, the central portion of the membrane portion 41 in the axial direction is expanded. Furthermore, by injecting the liquid into the hollow portion 42, the spring formed in the attachment portion 13 expands in the axial direction, while the membrane portion 41 is biased by the liquid and stretched in the axial direction. When the balloon member 40 expands in the axial direction, the position of the seal band 46 on the base end side may be approximately fixed, and the seal band 46 on the tip end side may move toward the tip end, thereby expanding the balloon member 40 in the axial direction. When fluid is further injected into the hollow portion 42 from the small diameter state, the balloon member 40 is further expanded to a large diameter state, as shown in FIG. 6(c). The membrane portion 41 is urged radially and axially outward by the liquid or the like in the hollow portion 42, and the balloon member 40 is expanded radially and axially. In the large diameter state or in the process of changing from the small diameter state to the large diameter state, the tension applied to one end of the membrane portion 41 in the axial direction (tension in the axial direction) may be greater than the tension applied to the center (part with the maximum diameter) of the membrane portion 41 in the axial direction (tension in the axial direction). In addition, in the large diameter state, the seal band 46 may be embedded axially inward into one end of the membrane portion 41 in the axial direction. In particular, a part of the seal band 46 may be disposed within the envelope volume of the balloon member 40 (membrane portion 41) inflated into a spherical shape. The balloon member 40 may restrict blood flow in the body cavity in a small diameter state, a large diameter state, or an intermediate state. The size of the balloon member 40 in the small diameter state or the large diameter state after expansion may vary depending on the width of the body cavity. For example, the membrane portion 41 may be pressed radially inward by the inner wall forming the body cavity, so that the dimension of the balloon member 40 in the width direction may be smaller than that in the natural state (when not placed in the body cavity). The dimension of the balloon member 40 in the axial direction may be larger than that in the natural state.

[0028] FIG. 7 shows an example of the relationship between the amount of fluid injected from the inlet 18 (amount of fluid injected based on the reduced diameter state) and the dimension in the axial direction or width direction (balloon size). As shown in FIG. 7, the expansion process from the reduced diameter state to the large diameter state is divided into an early expansion stage, a middle expansion stage, and a late expansion stage. The early expansion stage is the process from the reduced diameter state to the small diameter state by injecting about one-quarter of the total pressurized amount of fluid. The middle expansion stage is the process from the small diameter state to the expanded diameter state (medium diameter state) when about one-half of the total pressurized amount of fluid is further injected. The late expansion stage is the process from the medium diameter state to the large diameter state by injecting about one-quarter of the total pressurized amount of fluid. As shown in Fig. 7, in the contracted state, the axial dimension is sufficiently larger than the width dimension, but when fluid is injected (when about 0.1 ml of fluid is injected), the width and axial dimensions become approximately equal to each other. That is, in the middle stage of expansion, the width and axial dimensions become approximately equal. When fluid is further injected to reach the late stage of expansion, the axial dimension becomes larger than the width dimension, and the shape of the balloon member 40 viewed from the side becomes an ellipse elongated in the axial direction.

[0029] [Table 1]

[0030] Table 1 shows the expansion ratio of the width direction or axial direction dimension in each of the early expansion stage, the middle expansion stage, and the late expansion stage, and the ratio of the axial direction expansion ratio to the width direction expansion ratio, for the balloon guidewire 1, which is an example of this embodiment. The expansion ratio of each stage is a value obtained by dividing the amount of change in dimension through the stage by the amount of fluid injected during the stage. In other words, the expansion ratio of the width direction or axial direction dimension in each of the early expansion stage, the middle expansion stage, and the late expansion stage is the slope of a linear function graph in the ranges indicated by a1 to 3 and b1 to 3 in FIG. 7. The widthwise expansion rates in the early, mid, and late diastole were 75.6, 20.5, and 10.7 mm / ml, respectively. The axial expansion rates in the early, mid, and late diastole were 10.8, 15.7, and 18.0 mm / ml, respectively. In this embodiment, the expansion rate in the width direction decreases as the expansion stage progresses. On the other hand, the expansion rate in the axial direction increases as the expansion stage progresses. That is, the balloon member 40 does not expand much in the axial direction in the early stage after the fluid is injected, but when the fluid is injected and the balloon member 40 expands sufficiently in diameter, it expands greatly in the axial direction. This is because the elasticity of the spring in the axial direction is smaller than that of the membrane portion 41. Elasticity is the amount by which the member stretches when pulled in a predetermined direction. Furthermore, in this embodiment, the expansion rate in the axial direction is smaller than the expansion rate in the width direction in the early expansion stage, but the expansion rate in the axial direction is larger than the expansion rate in the width direction in the late expansion stage. In this way, by the balloon member 40 expanding greatly in the axial direction in the late expansion stage, the balloon member 40 is arranged to be closer to the extension direction of the body cavity, and the inner wall of the body cavity and the balloon member 40 come into closer contact with each other, thereby sealing the body cavity well. Furthermore, by expanding the balloon member 40 in the axial direction as well as the width direction in the later expansion stage, the maximum amount of fluid that can be injected into the hollow portion 42, etc. (the maximum injection amount at which the balloon member 40 is damaged) can be increased. As a result, even if an excessive amount of fluid is accidentally injected, deformation or damage to the balloon member 40 can be suppressed. 7 and Table 1 show the balloon size when a predetermined amount of fluid is injected into the balloon member 40 in a state in which the balloon member 40 is not particularly restrained from the outer diameter side of the balloon member 40. When the balloon member 40 is placed in a body cavity, the outer peripheral surface of the balloon member 40 may be pressed against the inner wall of the body cavity midway through the expansion when a predetermined amount of fluid is injected into the balloon member 40. In this case, after the outer peripheral surface of the balloon member 40 is pressed against the inner wall of the body cavity, the expansion rate in the width direction may become smaller and the expansion rate in the axial direction may become larger.

[0031] As shown in Table 1, in the initial stage of expansion of the balloon member 40, the ratio of the expansion rate in the axial direction of the balloon member 40 (also referred to as the axial expansion rate) is 5.0% or more of the expansion rate in the radial direction of the balloon member 40, preferably 7.5% or more, and more preferably 10.0% or more. Since the dimension of the balloon member 40 in the axial direction is already large in the initial stage of expansion, when the balloon member 40 is placed in a body cavity, the dimension of the balloon member 40 in the axial direction is large before the outer peripheral surface of the balloon member 40 is pressed against the inner wall of the body cavity. This prevents unnecessary pressure from being applied to the inner wall of the body cavity when the balloon member 40 is pressed against the inner wall of the body cavity. In addition, in the initial stage of expansion, the axial expansion ratio is preferably less than 30.0%, more preferably less than 20.0%, and even more preferably less than 15.0%. By keeping the ratio below the above value, the balloon member 40 expands sufficiently in the width direction in the initial stage of expansion. This allows the objective of sealing the body cavity to be achieved earlier. On the other hand, the axial expansion rate in the later expansion stage is greater than the axial expansion rate in the early expansion stage. More specifically, the axial expansion rate increases with each expansion stage. In this way, by configuring the balloon member 40 so that the increase in the axial dimension increases as the balloon member 40 expands in diameter by injecting fluid, the expanded balloon member 40 expands in the axial direction, making it less likely to press against the inner wall of the body cavity, and thereby alleviating the pressure on the inner wall of the body cavity. In particular, in the late expansion stage, the axial expansion ratio is 80.0% or more, preferably 100.0% or more, and more preferably 150.0% or more, as shown in Table 1. When the ratio is equal to or greater than the above value and is greater in the late expansion stage than in the early expansion stage, the balloon member 40 can be expanded sufficiently large in the axial direction. The upper limit of the ratio of the axial expansion rate to the widthwise expansion rate in the late expansion stage is 250.0%, preferably 200.0%, and more preferably 175.0%. By limiting the axial expansion, interference with treatment instruments and the like disposed near the balloon member 40 in the body cavity is suppressed.

[0032] As shown in FIG. 5, the attachment portion 13 is a portion of the tubular member 10 arranged on the inner diameter side of the balloon member 40 (particularly within the hollow portion 42). Specifically, the attachment portion 13 is a partial length region of the tubular wall of the tubular member. The attachment portion 13 has a spring-forming portion 15 on the base end side and a non-spring-forming portion 17 on the tip end side. The spring-forming portion 15 is a portion in which a spring capable of expanding and contracting in the axial direction is formed by forming a spiral slit 44, etc. The non-spring-forming portion 17 is a portion in which the spiral slit 44 is not formed and in which a spring that does not substantially expand and contract in the axial direction is not formed. Since a part of the tip side of the attachment portion 13 does not form a spring, the part does not have the same flexibility as the spring forming portion 15 and is more rigid than the spring forming portion 15. Therefore, when the balloon member 40 is inflated and expanded in the axial direction, the balloon member 40 can be expanded in a straight line with respect to the extension direction of the non-spring forming portion 17, which is a part of the tip side of the attachment portion 13. In other words, if the entire attachment portion 13 is a spring, when the balloon member 40 is expanded in the axial direction, the entire attachment portion 13 may have flexibility and the balloon member 40 may be expanded while unexpectedly bending or twisting. However, since the part of the tip side of the attachment portion 13 does not have a large flexibility, the balloon member 40 can be expanded approximately in the axial direction.

[0033] In this embodiment, the central portion of the mounting portion 13 in the axial direction is the spring forming portion 15. In other words, the length (axial length) of the spring forming portion 15 in the mounting portion 13 is greater than the length (axial length) of the spring non-forming portion 17 in the mounting portion 13. Instead of this embodiment, substantially the entire mounting portion 13 in the axial direction may be the spring forming portion 15. Also, only the central portion of the mounting portion 13 in the axial direction may be the spring forming portion 15, and both ends of the mounting portion 13 in the axial direction may be the spring non-forming portion 17.

[0034] The winding pitch of the second region 15a2 of the spring is smaller than the winding pitch of the first region 15a1 of the spring. The winding pitch of the third region 15a3 of the spring is larger than the winding pitch of the second region 15a2. Here, the winding pitch is the distance along the axial direction from one end of the tip side of one turn to one end of the tip side of another turn adjacent to the tip side of the one turn. That is, the winding pitch can be said to be the sum of the width dimension of the spiral slit 44 and the width dimension of the ribbon 15a. In this embodiment, the width of the spiral slit 44 in the contracted state is approximately constant from the first region 15a1 to the third region 15a3. That is, the width of the ribbon 15a in the second region 15a2 of the spring is smaller than the width of the ribbon 15a in the first region 15a1 of the spring. Also, the width of the ribbon 15a in the third region 15a3 of the spring is larger than the width of the ribbon 15a in the second region 15a2. The first region 15a1 is a region of a predetermined length on the base end side of the spring. The second region 15a2 is a region of a length on the tip side of the spring from the first region 15a1. The third region 15a3 is a region of a length on the tip side of the spring from the second region 15a2. In this embodiment, the winding pitch in the second region 15a2 is the smallest value among the winding pitches of the attachment portion 13. The smaller winding pitch in the second region 15a2 increases the amount of liquid flowing into the hollow portion 42, and allows the liquid to be smoothly sent into the hollow portion 42. In addition, the larger winding pitch in the third region 15a3, which is closer to the tip than the second region 15a2, prevents the tubular member 10 from bending unexpectedly between the spring forming portion 15 and the non-spring forming portion 17.

[0035] In this embodiment, the first region 15a1 to the third region 15a3 are all disposed in the mounting portion 13. The first region 15a1 to the third region 15a3 are particularly disposed inside the hollow portion 42. In this manner, the first region 15a1 and the third region 15a3, which do not have the smallest winding pitch, are disposed at both ends of the mounting portion 13, thereby preventing the mounting portion 13 from having excessive flexibility. In addition, in the large diameter state or the small diameter state, the width of the spiral slit 44 in the second region 15a2 is preferably larger than the width of the spiral slit 44 in the first region 15a1 or the third region 15a3. In this manner, the large width of the spiral slit 44 in the second region 15a2 allows the hollow portion 42 and the lumen 11 to communicate sufficiently. In addition, the small width of the spiral slit 44 in the first region 15a1 or the third region 15a3 keeps the first region 15a1 or the third region 15a3 rigid, and prevents the attachment portion 13 from having excessive flexibility. In other words, the above configuration allows the rigidity of the attachment portion 13 to be kept within a desired range while allowing the hollow portion 42 and the lumen 11 to communicate sufficiently in the second region 15a2.

[0036] In this embodiment, the spring is also formed in a part of the pipe wall on the base end side of the attachment portion 13 (the base end forming portion 15d). That is, the base end forming portion 15d is also a part of the spring forming portion 15. More specifically, the spring is formed by a common spiral slit 44 not only in the pipe wall in the hollow portion 42, but also in the pipe wall arranged on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall on the base end side of the first adhesive 51 (the pipe wall in the base end forming portion 15d). That is, the spring is integrally formed in the pipe wall in the hollow portion 42, the pipe wall arranged on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall in the base end forming portion 15d. Since a spring is also formed in the base end forming portion 15d, the base end forming portion 15d has flexibility. This allows the tubular member 10 near the balloon member 40 to conform to the shape of the body cavity when the balloon member 40 is placed in the body cavity, and prevents unnecessary load from being applied to the balloon member 40 and members in its vicinity (e.g., adhesive 50, etc.). This prevents deformation of the balloon member 40 and members in its vicinity, and prevents, for example, damage to the balloon member 40 or leakage of liquid from the balloon member 40. The winding pitch of the spring formed in the base end side forming portion 15d is larger than the winding pitch in the third region 15a3. In other words, the width of the ribbon 15a in the base end side forming portion 15d is larger than the width of the ribbon 15a in the third region 15a3. This prevents the tubular member 10 from easily bending between the spring forming portion 15 and the non-spring forming portion 17 on the base end side of the spring forming portion 15.

[0037] In this embodiment, the angle of the spiral direction of a portion of the ribbon 15a with respect to the axial direction in the contracted state is 60 degrees or more. More specifically, in the second region 15a2, the angle of the spiral direction of a portion of the ribbon 15a with respect to the axial direction may be 60 degrees or more. Alternatively, the angle of the spiral direction of substantially the entire ribbon 15a in the attachment portion 13 with respect to the axial direction may be 60 degrees or more. Or, more preferably, the angle is 75 degrees or more. This allows the spring forming portion 15 to expand and contract in the axial direction more satisfactorily. As a result, the balloon member 40 can be sufficiently expanded in the axial direction in the small diameter state or large diameter state (expanded state). Similarly, in either the small diameter state or the large diameter state, the angle of the spiral direction of a portion of ribbon 15a with respect to the axial direction may be 60 degrees or more.

[0038] Next, the structure of the proximal end portion of the tubular member 10 will be described in detail. As shown in FIG. 1 and FIG. 2(a), the first transitional portion 25 is disposed between the tip portion 26 and the intermediate portion 24. The second transitional portion 23 is disposed between the intermediate portion 24 and the base end portion 22. The first transitional portion 25 and the second transitional portion 23 each have a tapered shape. The first transitional portion 25 and the second transitional portion 23 are partial length regions in which the rate of change in the outer diameter is greater than that of the base end portion 22, the intermediate portion 24, or the tip portion 26 adjacent to the transitional portion in the linear member 20. The rate of change in the outer diameter is the amount of change in the outer diameter per a predetermined length. In this embodiment, the outer diameters of the base end portion 22, the intermediate portion 24, and the tip portion 26 are almost uniform and do not change. In addition, the outer diameter of the linear member 20 gradually decreases in the second transitional portion 23 or the first transitional portion 25 from the base end portion 22 to the intermediate portion 24, or from the intermediate portion 24 to the tip portion 26. Alternatively, in the case where the outer diameter of the base end 22, the intermediate portion 24, and the tip end 26 gradually increases or decreases at a small rate of change toward the tip, the portion where the outer diameter increases or decreases at a rate of change greater than the rate of change at the base end 22, etc. may be defined as the transition portion. The angle of the tapered shape of the second transition section 23 with respect to the axial direction is larger than the angle of the tapered shape of the first transition section 25 with respect to the axial direction. The rate of change of the outer diameter of the second transition section 23, which narrows toward the tip, is larger than the rate of change of the outer diameter of the first transition section 25, which narrows toward the tip. The angle of the tapered shape of the second transition section 23 or the first transition section 25 with respect to the axial direction is the angle between the extending direction of the surface of the second transition section 23 or the first transition section 25 having the tapered shape and the axial direction. Note that, due to the wave-shaped forming section 24c described later, the extending direction of the first transition section 25 or the second transition section 23 (the axial direction of the central axis of the first transition section 25 or the second transition section 23) may not be parallel to the axial direction of the tubular member 10, but may cross or be twisted with each other. In this case, the angle between the tapered shape of the first transition section 25 or the second transition section 23 and the axial direction in a state in which the extending direction of the first transition section 25 or the second transition section 23 is not parallel to the axial direction of the tubular member 10 may be the angle that the tapered shape of the transition section makes with respect to the axial direction. Alternatively, the angle between the tapered shape of the first transition section 25 or the second transition section 23 and the axial direction in a state in which the extending direction of the first transition section 25 or the second transition section 23 is corrected to be parallel to the axial direction of the tubular member 10 may be the angle that the tapered shape of the transition section makes with respect to the axial direction. The outer diameter (wire diameter) of the base end 22 is larger than the width of the lumen 11. As shown in Fig. 1, when the linear member 20 is completely inserted into the tubular member 10, a part of the distal side of the second transition portion 23 is fitted into the lumen 11, and a part of the proximal side of the second transition portion 23 is disposed outside the lumen 11. At this time, the surface of the second transition portion 23 abuts against the proximal end of the inner wall that defines the lumen 11. With the above configuration, when the linear member 20 is passed through the tubular member 10, the second transition portion 23 between the base end portion 22 and the intermediate portion 24 serves as a flange, and the second transition portion 23 prevents the linear member 20 from being excessively inserted into the inside of the tubular member 10. In addition, because the first transition portion 25 has a gentle taper, when the linear member 20 is pushed into the tubular member 10, the linear member 20 is less likely to break at the first transition portion 25 where the wire diameter changes. It is preferable that the length of the second transition portion 23 in the axial direction is smaller than the length of the first transition portion 25 in the axial direction, because the second transition portion 23 can be inclined more to the axial direction and the first transition portion 25 can be inclined less to the axial direction.

[0039] As shown in FIG. 3, the intermediate portion 24 of the linear member 20 has a wave shape. Specifically, the intermediate portion 24 is folded at a plurality of folding portions 29. In this embodiment, the intermediate portion 24 is folded at eight folding portions 29. The folding portions 29 are a plurality of first folding portions 29a and a plurality of second folding portions 29b, which are alternately arranged in the intermediate portion 24. The intermediate portion 24 of this embodiment has four first folding portions 29a and four second folding portions 29b. The wave shape is formed by folding the first folding portions 29a and the second folding portions 29b into mountain or valley shapes, respectively. The folding portions 29 are length regions (curved or bent length regions) in the intermediate portion 24 that have a smaller radius of curvature than the first length region 24a or the second length region 24b described later. Here, the mountain folding refers to folding in one direction among the directions intersecting with the axial direction, and the valley folding refers to folding in a direction different from the predetermined direction of the mountain folding (particularly the opposite direction). In this embodiment, the linear member 20 is bent in a predetermined direction at the first bent portions 29a, and in a direction opposite to the predetermined direction at the second bent portions 29b. That is, the linear member 20 is bent in the same direction at the multiple first bent portions 29a, and the linear member 20 is bent in the same direction at the multiple second bent portions 29b. Alternatively, the linear member 20 may be bent in different directions at each of the multiple first bent portions 29a or each of the second bent portions 29b.

[0040] The right side in FIG. 4 is the distal end side, and the left side in FIG. 4 is the proximal end side. As will be described in detail later, in FIG. 4, the linear member 20 is shown in a shape when it is disposed outside the tubular member 10 (natural state). As shown in FIG. 4, the first length region 24a is a length region from one first bent portion 29a1 to a second bent portion 29b1 adjacent to the first bent portion 29a1 on the distal side of the first bent portion 29a1. The second length region 24b is a length region to another first bent portion 29a2 adjacent to the second bent portion 29b1 on the distal side of the second bent portion 29b1. In this embodiment, as shown in FIG. 3, the first length region 24a and the second length region 24b are alternately arranged in the intermediate portion 24 with the bent portion 29 in between. The length of the first length region 24a from one first bent portion 29a1 to the second bent portion 29b1 is shorter than the length of the second length region 24b from the second bent portion 29b1 to another first bent portion 29a2 adjacent to the second bent portion 29b1 on the tip side of the second bent portion 29b1. That is, the length of the first length region 24a is shorter than the length of the adjacent second length region on the tip side. The lengths of the first length region 24a and the second length region 24b are the lengths of the first length region 24a or the second length region 24b in the extension direction of the first length region 24a or the second length region 24b. In this embodiment, the length of the first length region 24a is equal to or greater than one-quarter and less than one-half the length of the second length region 24b adjacent to the first length region on the tip side. The lengths of the first length regions 24a may be substantially the same as each other. The lengths of the second length regions 24b may be substantially the same as each other. The lengths of the length regions being substantially the same as each other means that each length is 90% to 110% of the average value of the length regions. Alternatively, the length of one first length region 24a may be greater than the length of another first length region 24a located distally of the one first length region 24a. Similarly, the length of one second length region 24b may be greater than the length of another second length region located distally of the one second length region 24b. As a result, when the linear member 20 is pulled out, the linear member 20 is caught on the inner wall of the tubular member 10 at the bent portion 29 on the base end side of the intermediate portion 24, and when the linear member 20 is inserted, the linear member 20 slides smoothly against the tube wall at the bent portion 29 on the tip end side. This is because the amplitude of the linear member 20 in the intermediate portion 24, which will be described later, becomes smaller toward the tip end and becomes larger toward the base end. Specifically, when the bending angle in the bent portion 29 is constant, the amplitude of the linear member 20 in the vicinity of the first length region 24a or the second length region 24b becomes smaller because the length of the first length region 24a or the length of the second length region 24b is small. When the amplitude is small, the force applied by the linear member 20 to the inner wall of the tubular member 10 is small. That is, when the amplitude is small, the sliding resistance of the linear member 20 to the tubular member 10 is small. Alternatively, the length of one first length region 24a may be smaller than the length of another first length region 24a located on the distal side of the one first length region 24a. Similarly, the length of one second length region 24b may be smaller than the length of another second length region located on the distal side of the one second length region 24b. This increases the sliding resistance of a portion on the distal side of the linear member 20 (middle portion 24), thereby suppressing unexpected movement of the sealing member 30.

[0041] As shown in FIG. 4, the angle that the first length section 24a makes with respect to the axial direction is greater than the angle that the second length section 24b makes with respect to the axial direction. With the above-mentioned configuration, the first length region 24a is arranged to stand in the axial direction. This prevents the linear member 20 from being pulled out of the tubular member 10 even if the linear member 20 is accidentally pulled out of the tubular member 10. This is because even if the linear member 20 is about to be pulled out of the tubular member 10, the linear member 20 gets stuck at the first bent portion 29a and is therefore difficult to pull out of the tubular member 10.

[0042] In the intermediate portion 24, the amplitude of the waveform in one portion on the distal end side is smaller than the amplitude of the waveform in another portion on the proximal end side of the distal portion. As described above, the amplitude of the tip portion 26 is reduced, so that the tip side of the corrugated portion 24c of the linear member 20 is prevented from getting stuck on the tube wall of the tubular member when the linear member 20 is inserted. This allows the linear member 20 to be inserted into the tubular member 10 in a good condition. The amplitude of the wave shape in the partial length region of the intermediate portion 24 is the maximum dimension of the partial length region in a direction perpendicular to the extension direction of the entire partial length region. The extension direction of the entire length region having a wave shape is the extension direction ignoring the wave shape. For example, the extension direction of the wave shape forming portion 24c is the direction shown by the dashed line III in FIG. 3. Moreover, the maximum dimension of the partial length region in the direction perpendicular to the extension direction of the entire partial length region is the maximum value of the distance between the first bent portion 29a and the second bent portion 29b along the direction perpendicular to the extension direction of the entire partial length region. In this embodiment, as shown in Fig. 3, the amplitude of a partial length region including a first bent portion 29a and a second bent portion 29b adjacent to each other (for example, amplitude L1a in Fig. 3) is smaller than the amplitude of another partial length region including another first bent portion 29a and another second bent portion 29b adjacent to each other on the base end side of the partial length region (for example, amplitude L1b, amplitude L1c, or amplitude L1d in Fig. 3). The values ​​may be larger in the order of amplitude L1a, amplitude L1b, amplitude L1c, and amplitude L1d. In this embodiment, the amplitude L1a in a partial length region including the first bent portion 29a and the second bent portion 29b arranged at the most distal end in the intermediate portion 24 (a partial length region not including the first bent portion 29a and the second bent portion 29b arranged second from the distal end) is smaller than the amplitude of the entire intermediate portion 24 (particularly the wave-shaped portion 24c). Moreover, the amplitude L1a is smaller than the average amplitude (average of the amplitudes L1a to L1d) of the partial length region near the group of the first bent portion 29a and the second bent portion 29b adjacent to each other. Furthermore, in this embodiment, the amplitude L1a is smaller than any of the amplitudes L1b to L1d. More specifically, in this embodiment, the amplitude of the waveform in a part on the tip side of the intermediate portion 24 may be substantially the same as the amplitude of the waveform in another part on the base end side of the part. That is, the amplitude of the waveform may be constant from the tip to the base end of the intermediate portion 24. In addition, the amplitudes of the multiple waveforms may be substantially the same, and the magnitude relationship between the amplitudes may be established as described above. The amplitude of one part and the amplitude of the other part may be substantially the same as the amplitude of the other part, and the amplitude of the other part may be 90% or more and 110% or less of the amplitude of the other part adjacent to the amplitude of the one part, and the maximum amplitude of the comparison object may be 1.5 times or less of the minimum amplitude of the comparison object. For example, when comparing the amplitudes of two adjacent length regions, the amplitude of one part and the amplitude of the other part may be substantially the same as the amplitude of the other part. When the first bent portion 29a and the second bent portion 29b that are close to each other are grouped together as in this embodiment, there may be three or more groups, and there may be three or more amplitudes (amplitudes L1a to L1d). When determining whether multiple amplitudes are approximately identical in this manner, the amplitude of one part is said to be approximately identical to the amplitude of another part if the amplitude of the one part is within the range of 90% to 110% of the amplitude of the other part adjacent to the one part, and the maximum value of the amplitude of the target is 1.5 times or less than the minimum value of the amplitude of the target. Alternatively, the amplitude of one portion and the amplitude of the other portion may not be substantially the same as each other. That is, the amplitude of one portion may be less than 90% of the amplitude of the other portion or more than 110%. Furthermore, when comparing the amplitudes of a plurality of length regions, the maximum amplitude may be more than 1.5 times the minimum amplitude.

[0043] As described later, the amplitude of the wavy portion 24c (in its natural state) when disposed outside the tubular member 10 is greater than the width of the lumen 11 in the tubular member 10 (the inner diameter of the tubular member 10). That is, the amplitude L4 shown in FIG. 4 is greater than the inner diameter L3 of the tubular member 10. Therefore, the wavy portion 24c is pressed against the inner wall of the tubular member 10 at the bent portion 29. That is, the wavy portion 24c when disposed in the lumen 11 has a shape that is more flattened than the shape in its natural state. Specifically, the amplitude of the wavy portion 24c when disposed in the lumen 11 is approximately equal to the width of the lumen 11, and the radius of curvature at the bent portion 29 is greater than the radius of curvature of the bent portion 29 in its natural state. The radius of curvature of the bent portion 29 described in the upper part or later may be the radius of curvature of the bent portion 29 in the corrugated portion 24c disposed in the lumen 11, or may be the radius of curvature of the bent portion 29 in the corrugated portion 24c in its natural state. Moreover, the amplitude of the corrugated portion 24c described in the upper part or later may be the amplitude of the corrugated portion 24c disposed in the lumen 11, or may be the amplitude of the corrugated portion 24c in its natural state. For convenience of explanation, the shape of the wave-shaped portion 24c in its natural state is shown in Fig. 4. Therefore, in Fig. 4, the bent portion 29 looks as if it is biting into the inner wall of the tubular member 10, but in reality, the bent portion 29 is deformed so as to be spread and is pressed against the inner wall of the tubular member 10 as described above.

[0044] In this embodiment, the radius of curvature at the bend 29 is smaller than the length of the second length region 24b. As a result, by making the radius of curvature of the bent portion 29 smaller than the length of the second length region 24b, which is the longest straight portion in the wave-shaped portion 24c, and forming a pointed shape, the linear member 20 is more likely to be caught on the inner wall of the tubular member 10 at the bent portion 29. As a result, the linear member 20 is less likely to come off the tubular member 10. The bent portion 29 is bent into an arc of a perfect circle, and the radius of curvature may be constant over the entire length of the bent portion 29. Alternatively, the radius of curvature may not be constant over the entire length of the bent portion 29. In this case, the radius of curvature of the bent portion 29 may be the average, maximum, or minimum value of the radius of curvature of the bent portion 29. Alternatively, the radius of curvature of the bent portion 29 may be the radius of curvature of a part of the bent portion 29 on the distal end side or a part of the bent portion 29 on the proximal end side. It is preferable that the radius of curvature at the bent portion 29 is larger than the length of the first length region 24a. As a result, even if the resistance between the linear member 20 and the inner wall of the tubular member 10 at the bent portion 29 (particularly the first bent portion 29a) is large when, for example, the linear member 20 is pulled out from the tubular member 10, the middle portion 24 is bent at the first bent portion 29a, and the first length region 24a is prevented from getting stuck, making it impossible for the linear member 20 to be pulled out.

[0045] In this embodiment, the radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b adjacent to the first bent portion 29a across the first length region 24a. The radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b, which is between two-thirds and 1.5 times the radius of curvature of the second bent portion 29b. Preferably, the radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b, which is between 90% and 110% of the radius of curvature of the second bent portion 29b. In this embodiment, the radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same as each other. The radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same as each other means that the radius of curvature of one first bent portion 29a (or the second bent portion 29b) is 90% to 110% of the radius of curvature of another first bent portion 29a (or the second bent portion 29b) adjacent to the one first bent portion 29a (or the second bent portion 29b), and the maximum radius of curvature of the target first bent portion 29a (or the second bent portion 29b) is 1.5 times the minimum radius of curvature of the target first bent portion 29a (or the second bent portion 29b). In this embodiment, the radius of curvature of the first bent portion 29a (first bent portion 29a1) may be smaller than the radius of curvature of the second bent portion 29b (second bent portion 29b1) adjacent to the first bent portion 29a1 across the first length region 24a. In other words, the radius of curvature of the first bent portion 29a1 is smaller than the radius of curvature of the second bent portion 29b1 adjacent to the first bent portion 29a1 on the tip side of the first bent portion 29a1. As described above, by making the radius of curvature of the first bent portion 29a small, when the linear member 20 is removed, the linear member 20 is caught by the first bent portion 29a, and the first length region is likely to stand up in the axial direction. As a result, the linear member 20 is prevented from being accidentally removed. On the other hand, since the radius of curvature of the second bent portion 29b is large, the first length region 24a and the second length region 24b sandwiching the second bent portion 29b1 are bent in a curved shape closer to a straight line, when the linear member 20 is inserted, the first length region 24a is unlikely to stand up in the axial direction. As a result, when the linear member 20 is inserted into the tubular member 10, the first length region 24a is unlikely to stand up in the axial direction, which makes it difficult to insert the linear member 20 into the tubular member 10.

[0046] The radius of curvature of one second bent portion 29b arranged on the distal side may be larger than the radius of curvature of another second bent portion 29b arranged on the proximal side of the one second bent portion 29b. This allows the intermediate portion 24 to slide on the inner wall of the tubular member 10 more easily toward the distal side, and the sliding resistance against the inner wall of the tubular member 10 is larger toward the proximal side. Therefore, the linear member 20 is less likely to be accidentally pulled out of the tubular member 10, but is easily inserted into the tubular member 10. Alternatively, the radius of curvature of one second bent portion 29b arranged on the distal side may be smaller than the radius of curvature of another second bent portion 29b arranged on the proximal side of the one second bent portion 29b. This allows the sliding resistance on the distal side of the intermediate portion 24 to be larger. As a result, the sealing member 30 is prevented from moving unexpectedly in the axial direction when an unexpected force is applied to the linear member 20. Alternatively, instead of this embodiment, the radii of curvature of the second bent portions 29b may be substantially the same from the tip end to the base end. Similarly, the radius of curvature of one first bent portion 29a arranged on the distal side may be larger than the radius of curvature of another first bent portion 29a arranged on the proximal side of the one first bent portion 29a. Alternatively, the radius of curvature of one first bent portion 29a arranged on the distal side may be smaller than the radius of curvature of another first bent portion 29a arranged on the proximal side of the one first bent portion 29a. This sufficiently increases the sliding resistance of the distal side of the intermediate portion 24 against the inner wall of the tubular member 10. As a result, for example, when the sealing member 30 is arranged in a closed position that maintains the balloon member 40 in an expanded diameter state, the sealing member 30 is prevented from shifting to the proximal side due to the internal pressure of the lumen 11, etc. Alternatively, instead of this embodiment, the radii of curvature of the multiple first bent portions 29a from the distal end to the proximal end may be approximately the same.

[0047] As shown in FIG. 1 or FIG. 3, the intermediate portion 24 has a wavy shape forming portion 24c, a first wavy shape non-forming portion (first non-forming portion 24d), and a second wavy shape non-forming portion (second non-forming portion 24e). The wavy shape forming portion 24c is a portion in which a wavy shape is formed in the intermediate portion 24. The first non-forming portion 24d and the second non-forming portion 24e are wavy shape non-forming portions in which a wavy shape is not formed. The first non-forming portion 24d is a partial length region located on the base end side of the wavy shape forming portion 24c. The second non-forming portion 24e is a partial length region located on the tip end side of the wavy shape forming portion 24c. As shown in FIG. 1, the length of the first non-forming portion 24d in the axial direction is smaller than the length of the second non-forming portion 24e in the axial direction. As described above, by arranging the wavy-shaped portion 24c on the base end side of the linear member 20 (particularly the intermediate portion 24), a force is easily applied to the wavy-shaped portion 24c when a force for insertion or removal is applied in the axial direction to the base end portion 22. As a result, unexpected bending of the linear member 20 at the wavy-shaped non-forming portion (particularly the first non-forming portion 24d) is suppressed, and the wavy-shaped portion 24c can slide on the inner wall of the tubular member 10 more smoothly. In addition, the length of the first non-forming portion 24d in the axial direction is preferably smaller than the length of the corrugated portion 24c in the axial direction. As a result, when a force is applied to the base end portion 22 to insert the linear member 20 into the tubular member 10, the force is easily transmitted to the corrugated portion 24c. Furthermore, the length of the second non-forming portion 24e in the axial direction is preferably larger than the length of the first length region 24a. As a result, the second non-forming portion 24e is disposed sufficiently along the axial direction. As a result, when the linear member 20 is inserted into the tubular member 10, the second non-forming portion 24e can slide the sealing member 30 straight in the approximately axial direction.

[0048] In this embodiment, the difference (hereinafter also referred to as clearance; the sum of difference L2a and difference L2b in FIG. 4) between the inner diameter (inner diameter L3 in FIG. 4) of the tubular member 10 when the linear member 20 is disposed outside the tubular member 10 (referred to as a natural state) and the amplitude (amplitude L4 in FIG. 4) of a portion having a wave shape in the intermediate portion 24 (wave shape forming portion 24c) is 0.095 mm or more and less than 0.135 mm. The force required to move the linear member 20 toward the base end side of the tubular member 10 relative to the tubular member 10 (hereinafter referred to as pull-out strength) is 2.6 N or more and less than 6.5 N. As described above, since the clearance is a sufficient value, the intermediate portion 24 is pressed against the inner wall of the tubular member 10 at the bent portion 29, and the sliding resistance of the intermediate portion 24 against the inner wall of the tubular member 10 is large. As a result, the linear member 20 is prevented from accidentally coming out of the tubular member 10. Furthermore, since the pull-out strength is equal to or greater than 2.6 N and less than 6.5 N, it is relatively easy to pull the linear member 20 out of the tubular member 10 using a tool or the like, but it is difficult to pull the linear member 20 out of the tubular member 10 by grasping the base end portion 22 with a hand or the like, and the linear member 20 is prevented from accidentally coming out of the tubular member 10. As described above, the inner diameter of the tubular member 10 is smaller than the amplitude of the corrugated portion 24c in the natural state. In other words, the clearance is a value obtained by subtracting the inner diameter of the tubular member 10 from the amplitude of the corrugated portion 24c in the natural state. The pull-out strength is the force required to pull out the linear member 20, which is inserted into the tubular member 10 while the tubular member 10 is fixed, from the tubular member 10. Pulling out the linear member 20 from the tubular member 10 means moving the linear member 20 a predetermined distance toward the base end relative to the tubular member 10.

[0049] (catheter set) As shown in FIG. 1, the above-described balloon guidewire 1 may be provided as a component of a catheter set 100. Specifically, the catheter set 100 includes a balloon guidewire 1 and a catheter 200. The balloon guidewire 1 is inserted into the catheter 200. Specifically, the catheter 200 includes a wire lumen 210 extending along the longitudinal direction of the catheter 200, and the balloon guidewire 1 is inserted into the wire lumen 210. The width of the wire lumen 210 is larger than the outer diameter of the tubular member 10 (particularly the portion on the proximal side of the balloon member 40). Specifically, after the balloon guidewire 1 is inserted into a body cavity, the proximal end of the balloon guidewire 1 is passed through the wire lumen 210, and the catheter 200 can proceed toward the distal end on the outer layer side of the balloon guidewire 1. In this embodiment, the width of the wire lumen 210 may be smaller or larger than the width of the balloon member 40 in the contracted or expanded state. As a result, the catheter 200 that has advanced into the body cavity toward the distal end along the balloon guidewire 1 can stop at a position on the proximal side of the balloon member 40. In this embodiment, the wire lumen 210 is provided only in a portion of the catheter 200 on the distal end side. The catheter 200 has a main lumen 220 that extends in the longitudinal direction of the catheter 200 and is different from the wire lumen 210. The catheter 200 supplies a drug to a body cavity via the main lumen 220, or aspirates and removes a substance or the like from the body cavity. In the catheter 200, the open end (tip) of the wire lumen 210 is preferably disposed so as to protrude toward the tip side (distal side) from the opening of the main lumen 220. In other words, a part of the catheter 200 forming the opening of the wire lumen 210 protrudes toward the tip side from a part of the catheter 200 forming the opening of the main lumen 220. The tip of the catheter 200 in this embodiment (particularly the part where the main lumen 220 may be formed) has a shape cut into a smooth curved surface. As a result, the tip of the wire lumen 210 is disposed closer to the tip side of the catheter 200 than the tip of the main lumen 220. Alternatively, the tip of the wire lumen 210 may be disposed at the forefront of the catheter 200 by forming the wire lumen 210 on the tip side of the opening of the catheter 200 so that the open end of the wire lumen 210 is disposed closer to the tip side than the opening of the main lumen 220.

[0050] The present invention is not limited to the above-described embodiment, but includes various modifications and improvements as long as the object of the present invention is achieved. For example, in the above embodiment, the carotid artery is exemplified as the blood vessel in which the balloon guidewire 1 is placed, but this is merely an example and is not limiting, and other blood vessels such as the aorta may be used. In this case, since the inner diameter varies depending on the blood vessel, the dimensions of the balloon member 40 can be appropriately changed. In addition, the balloon guidewire 1 may be used for post-dilation of a stent graft (not shown) placed in another blood vessel (for example, the aorta), and similarly, the dimensions of the balloon member 40 can be appropriately changed depending on the inner diameter of the stent graft. Specifically, when the balloon guidewire 1 is placed in the aorta or used for post-dilation of a stent graft, the widthwise dimension of the balloon member 40 in the large diameter state is about 20 mm to 40 mm.

[0051] The above embodiment encompasses the following technical ideas. (1) a tubular member having a lumen and an opening in a tubular wall at a proximal end that communicates with the lumen; a balloon member provided on an outer diameter side of a distal end portion of the tubular member, the inside of the balloon member being in communication with the lumen of the tubular member, and the balloon member being expandable by increasing the volume of the inside of the balloon member; a linear member disposed in the lumen at the proximal end of the tubular member and movable in an axial direction of the tubular member, a sealing member is provided at a tip end of the linear member and is in close contact with a part of an inner wall of the tubular member; the sealing member moves between a closed position in which the sealing member blocks the opening or is disposed distal to the opening to block the flow of fluid from the opening toward the hollow portion, and an open position in which the sealing member is disposed proximal to the opening of the tubular member, in association with movement of the linear member in the axial direction; the tube wall at the tip end of the tubular member is a spring in which a ribbon is spirally arranged with gaps between turns about a central axis of the tubular member, The width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, A balloon-equipped guidewire in which, when the volume of the balloon member is increased by injecting liquid or gas through the opening, the dimensions of the balloon member increase in both the radial and axial directions of the tubular member, thereby expanding the balloon member. (2) A balloon guidewire as described in (1), wherein the attachment portion, which is a portion of the tubular wall of the tubular member arranged on the inner diameter side of the balloon member, has a spring-forming portion on the base end side where the spring is formed, and a spring-non-forming portion on the tip end side where the spring is not formed. (2-1) A balloon-equipped guidewire, wherein the length of the spring-formed portion in the axial direction at the attachment portion is greater than the length of the non-spring-formed portion in the axial direction at the attachment portion. (3) the interior of the balloon member and the lumen are in communication with each other through the gap; a winding pitch in a second region of the spring that is closer to a tip end than a first region of the spring that is closer to a base end than a winding pitch in the first region; The balloon-equipped guidewire according to (2), wherein the winding pitch in a third region of the spring, which is located distal to the second region, is greater than the winding pitch in the second region. (3-2) A balloon-equipped guidewire, wherein the first region, the second region and the third region are disposed at an attachment portion inside the hollow portion. (3-3) A balloon-equipped guidewire, in which, in the large diameter state or the small diameter state, the width of the spiral slit in the second region is greater than the width of the spiral slit 44 in the first region or the third region. (4) The balloon guidewire according to (3), wherein the spring is also formed on a portion of the tube wall on the base end side relative to the mounting portion. (4-1) A balloon-equipped guidewire, wherein the winding pitch of the spring formed in the base end side forming portion is larger than the winding pitch in the third region. (5) A guidewire with a balloon as described in any one of (1) to (4), wherein, in an initial stage of expansion of the balloon member, the expansion rate of the balloon member in the axial direction is 5.0% or more of the expansion rate of the balloon member in the radial direction. (6) The balloon guidewire described in (5), wherein the angle of the spiral direction of a portion of the ribbon with respect to the axial direction is 60 degrees or more. (6-1) A balloon-equipped guidewire, in which the angle of the spiral direction of a portion of the ribbon relative to the axial direction is 75 degrees or more. (7) a balloon-equipped guidewire; a catheter into which the balloon guidewire is inserted; The balloon-equipped guidewire includes: a tubular member having a lumen and an opening in a wall at a proximal end thereof communicating with the lumen; a balloon member provided on an outer diameter side of a distal end portion of the tubular member, the inside of the balloon member being in communication with the lumen of the tubular member, and the balloon member being expandable by increasing the volume of the inside of the balloon member; a linear member disposed in the lumen at the proximal end of the tubular member and movable in an axial direction of the tubular member; a sealing member is provided at a tip end of the linear member and is in close contact with a part of an inner wall of the tubular member; the sealing member moves between a closed position where the sealing member blocks the opening or is disposed distal to the opening to block the flow of fluid from the opening toward the inside, and an open position where the sealing member is disposed proximal to the opening of the tubular member, in association with movement of the linear member in the axial direction; the tube wall at the tip end of the tubular member is a spring in which a ribbon is spirally arranged with gaps between turns about a central axis of the tubular member, The width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, A catheter set in which, when the volume of the balloon member is increased by injecting liquid or gas through the opening, the dimensions of the balloon member in both the radial and axial directions of the tubular member increase, thereby expanding the balloon member. (7-1) A catheter set, in which the width of a wire lumen into which a balloon guidewire is inserted is smaller than the width of a balloon member in a contracted or expanded state. (8) A balloon guidewire in which the widthwise expansion rate decreases as the expansion stages progress, and the axial expansion rate increases as the expansion stages progress. [Explanation of symbols]

[0052] 1. Balloon guidewire 10 Tubular member 11 Lumen 12 Proximal opening 13 Mounting part 14 Coil section 15 Spring forming section 15a Ribbon 15a1 First area 15a2 Second area 15a3 Third area 15d Proximal forming part 16 Tip 17 Non-spring forming part 18 Inlet 19 Radiopaque markers 20 Linear members 22 Proximal end 23 Second transition part 24 Middle section 24a First Length Area 24b Second Length Area 24c Wave shape forming part 24d First non-formed part 24e Second non-forming part 25 First transition part 26 Tip 29 Bending section 29a, 29a1, 29a2 First bent portion 29b, 29b1 Second bent portion 30 Sealing member 40 Balloon member 41 Membrane part 42 Hollow part 44 Spiral Slit 46 Seal Band 50 Adhesive 51 First Adhesive 52 Second Adhesive 53 Third Adhesive 100 Catheter Set 200 Catheters 210 Wire Lumens 220 main lumens

Claims

1. a tubular member having a lumen and an opening in a wall at a proximal end thereof communicating with the lumen; a balloon member provided on an outer diameter side of a distal end portion of the tubular member, the inside of the balloon member being in communication with the lumen of the tubular member, and the balloon member being expandable by increasing the volume of the inside of the balloon member; a linear member disposed in the lumen at the proximal end of the tubular member and movable in an axial direction of the tubular member, a sealing member is provided at a tip end of the linear member and is in close contact with a part of an inner wall of the tubular member; the sealing member moves between a closed position where the sealing member blocks the opening or is disposed distal to the opening to block the flow of fluid from the opening toward the inside, and an open position where the sealing member is disposed proximal to the opening of the tubular member, in association with movement of the linear member in the axial direction; the tube wall at the tip end of the tubular member is a spring in which a ribbon is spirally arranged with gaps between turns about a central axis of the tubular member, The width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, A balloon-equipped guidewire in which, when the volume of the balloon member is increased by injecting liquid or gas through the opening, the dimensions of the balloon member increase in both the radial and axial directions of the tubular member, thereby expanding the balloon member.

2. 2. The balloon guidewire according to claim 1, wherein the attachment portion, which is a portion of the tubular wall of the tubular member arranged on the inner diameter side of the balloon member, has a spring-formed portion on the base end side in which the spring is formed, and a spring-non-formed portion on the tip end side in which the spring is not formed.

3. The interior of the balloon member and the lumen are in communication with each other through the gap, a winding pitch in a second region of the spring that is closer to a tip end than a first region of the spring that is closer to a base end than a winding pitch in the first region; The balloon-equipped guidewire according to claim 2 , wherein a winding pitch in a third region of the spring that is distal to the second region is greater than a winding pitch in the second region.

4. The balloon guidewire according to claim 3 , wherein the spring is also formed on a portion of the tube wall on the proximal side of the attachment portion.

5. 5. The balloon guidewire according to claim 1, wherein in an initial stage of expansion of the balloon member, an expansion rate of the balloon member in the axial direction is 5.0% or more of an expansion rate of the balloon member in the radial direction.

6. The balloon-equipped guidewire according to claim 5 , wherein an angle of the helical direction of a portion of the ribbon with respect to the axial direction is 60 degrees or more.

7. A balloon guidewire; a catheter into which the balloon guidewire is inserted; The balloon-equipped guidewire includes: a tubular member having a lumen and an opening in a wall at a proximal end thereof communicating with the lumen; a balloon member provided on an outer diameter side of a distal end portion of the tubular member, the inside of the balloon member being in communication with the lumen of the tubular member, and the balloon member being expandable by increasing the volume of the inside of the balloon member; a linear member disposed in the lumen at the proximal end of the tubular member and movable in an axial direction of the tubular member; a sealing member is provided at a tip end of the linear member and is in close contact with a part of an inner wall of the tubular member; the sealing member moves between a closed position where the sealing member blocks the opening or is disposed distal to the opening to block the flow of fluid from the opening toward the inside, and an open position where the sealing member is disposed proximal to the opening of the tubular member, in association with movement of the linear member in the axial direction; the tube wall at the tip end of the tubular member is a spring in which a ribbon is spirally arranged with gaps between turns about a central axis of the tubular member, The width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, A catheter set in which, when the volume of the balloon member is increased by injecting liquid or gas through the opening, the dimensions of the balloon member in both the radial and axial directions of the tubular member increase, thereby expanding the balloon member.

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