Balloon-equipped guide wire, catheter set, and medical instrument

Abstract

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 is injected in a balloon member (40) through an injection port (18) and the volume thereof is increased, the balloon member (40) is expanded as a result of the dimensions of the balloon member (40) increasing in the radial direction and the axial direction of the tubular-shaped member (10).

Description

Balloon guidewires, catheter sets and medical devices

[0001] The present invention relates to a balloon guidewire, a catheter set including such a balloon guidewire, and a medical device.

[0002] There is a guidewire with a balloon at its distal end that is inserted into a body lumen such as a blood vessel and occludes the body lumen. Regarding this type of technology, Patent Document 1 listed below discloses a tubular member (14) that is a hypotube, and a balloon member (16) is provided at the distal end (tip) of the tubular member (14). As shown in Figure 2 of Patent Document 1, the balloon member (16) is coaxially attached to the distal end (14B) of the tubular member (14) at its proximal end (16A) and distal end (16B) by suitable adhesives (19) and (21).

[0003] Special Publication No. 2001-514544

[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 the proximal end (16A) and distal end (16B) of the balloon member (16) are fixed to the tubular member (14). As a result, the balloon member (16) expands radially along the tubular member (14) to become spherical. In this case, the largest diameter portion of the spherically expanded balloon member (16) presses against the inner wall of a body cavity, such as a blood vessel. However, because the area of ​​the balloon member (16) that presses against the inner wall is small in the axial direction of the tubular member (14), this may result in undesirable occlusion of the body cavity or unnecessary pressure being applied to the inner wall of the body cavity.

[0005] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a balloon-equipped guide wire that better occludes a body cavity or suppresses unnecessary pressure on the inner wall of a body cavity.

[0006] The balloon guidewire of the present invention is a balloon guidewire comprising: a tubular member having a lumen and having an opening at a proximal end provided in a tubular wall that communicates with the lumen; a balloon member provided on the outer diameter side of a distal end of the tubular member, the interior of which communicates 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 proximal end of the tubular member and movable in the axial direction of the tubular member, wherein a sealing member is provided at the distal end of the linear member that is in close contact with a part of the inner wall of the tubular member, and the sealing member closes the opening or is disposed distal to the opening and extends forward from the opening. The balloon member moves between a closed position, which blocks the flow of fluid toward the interior, and an open position, which is closer to the base end of the tubular member than the opening, in accordance with the movement of the linear member in the axial direction, and the tubular 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 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 through the opening to increase the volume of the balloon member, the dimensions of the balloon member in both the radial direction and the axial direction 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 thereof 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 communicates 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 of the tubular member and movable in the axial direction of the tubular member, the distal end of the linear member being provided with a sealing member that comes into close contact with a part of the inner wall of the tubular member, the sealing member being configured to close the opening or to prevent the opening from being obstructed. The balloon member moves in the axial direction between a closed position, which is positioned distal to the opening and blocks the flow of fluid from the opening toward the inside of the tubular member, and an open position, which is proximal to the opening of the tubular member, and the tubular 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 through the opening to increase the volume of the balloon member, the dimensions of the balloon member in both the radial direction and the axial direction 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 presses against the inner wall of the body lumen is increased in the axial direction of the tubular member. This results in better occlusion of the body lumen. Alternatively, by increasing the surface area of ​​the balloon member that presses against the inner wall of the body lumen, the pressure exerted by the balloon member on the inner wall of the body lumen is reduced, thereby preventing unnecessary pressure from being applied to the inner wall of the body lumen.

[0009] The balloon guidewire of the present invention can better occlude a body cavity, or can suppress unnecessary pressure from being applied to the inner wall of the body cavity.

[0010] The above-mentioned objects, as well as other objects, features and advantages, will become more apparent from the preferred embodiments described below and the accompanying drawings.

[0011] 1 is a schematic diagram showing an example of a balloon-equipped guidewire and catheter according to a first embodiment of the present invention. FIGS. 2(a) and 2(b) are partial enlarged schematic views of the area within frame II shown by the dashed-dotted line in FIG. 1. FIG. 2(a) shows an example of a case where the sealing member is in the open position, and FIG. 2(b) shows an example of a case where the sealing member is in the closed position.

[0034] FIG. 2 is a schematic diagram illustrating the structure of a linear member according to a first embodiment.

[0035] FIG. 2 is a partial enlarged schematic view of frame IV shown by the dashed-dotted line in FIG. 1.

[0036] FIG. 6 is a schematic diagram illustrating an example of a balloon member and its vicinity according to a first embodiment. FIGS. 6(a) to 6(c) are explanatory views illustrating the expansion process of a balloon member according to this embodiment.

[0037] FIG. 6(a) is a schematic diagram of a balloon member and its vicinity in a contracted diameter state, FIG. 6(b) is a schematic diagram of a small-diameter state, and FIG. 6(c) is a schematic diagram of a balloon member and its vicinity in a large-diameter state.

[0038] FIG. 7 is a graph showing the relationship between the amount of injected liquid and balloon size.

[0039] FIG. 7 is a graph showing the relationship between the clearance and pull-out strength between the inner diameter of a tubular member according to a second embodiment of the present invention and the amplitude of the linear member in its natural state.

[0012] The various components of the balloon guidewire, catheter set, and medical device 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.

[0013] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In each drawing, corresponding components are designated by common reference numerals, and duplicated descriptions will be omitted where appropriate. Furthermore, the term "plane" as used in this invention refers to a shape that is physically formed with a flat surface as the target, and of course, it does not necessarily have to be a geometrically perfect plane.

[0014] First Embodiment (Guidewire with Balloon) FIG. 1 is a schematic diagram showing an example of a guidewire with balloon 1 according to a first embodiment of the present invention.

[0015] First, an overview of the balloon-equipped guidewire 1 of this embodiment will be described. The balloon-equipped guidewire 1 includes 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 its tubular wall, which forms a portion of the base end of the tubular member 10 (the inlet-forming portion). The lumen 11 passes through the inlet 18. The balloon member 40 is provided on the outer diameter side of a portion of the tip end of the tubular member 10 (the attachment portion 13, described below). The interior (hollow portion 42) of the balloon member 40 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 the lumen 11 of the base end 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 defining the lumen 11). The sealing member 30 moves between a closed position and an open position in response to axial movement of the linear member 20. In the closed position, the sealing member 30 blocks the injection port 18 or is positioned distal to 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 refers to the fluid flow being sufficiently restricted (the fluid is dammed) to maintain the expanded state of the balloon member 40 for a predetermined period of time, but is not limited to complete blocking of the fluid flow. In the closed position, a portion of the lumen 11 (a portion distal to the sealing member 30) and the hollow portion 42 are liquid-tightly or air-tightly sealed. In the open position, the sealing member 30 is positioned proximal to the injection port 18 of the tubular member 10. A portion of the tube wall on the distal end side of the tubular member 10 is a spring (spring forming portion 15). Specifically, the spring is arranged in a spiral shape with a ribbon 15a around the central axis of the tubular member 10, with gaps (spiral slits 44) provided between turns. The width of the spiral slit 44 is less than one-fifth of the width of the ribbon 15a. A fluid (liquid or gas, referred to as liquid, etc.) is introduced from the inlet 18.When the volume of the balloon member 40 is increased by injecting a fluid such as saline, the dimensions of the balloon member 40 increase in both the radial and axial directions of the tubular member 10, thereby expanding the balloon member 40. A suitable example of the fluid is saline. A mixed solution containing a contrast agent and saline may also be used as the fluid. By expanding the balloon member 40 in the axial direction of the tubular member 10 as described above, the area of ​​the balloon member 40 that presses against the inner wall of the body cavity increases in the axial direction of the tubular member 10. This results in a better occlusion of the body cavity. Alternatively, by increasing the surface area of ​​the outer circumferential surface of the balloon member 40 that presses against the inner wall of the body cavity, the pressure exerted by the balloon member 40 on the inner wall of the body cavity is reduced, thereby preventing unnecessary pressure from being applied to the inner wall of the body cavity. Furthermore, the ability of the balloon member 40 to expand in the axial direction increases the amount of fluid that can be injected into the hollow portion 42 compared to when the balloon member 40 expands only radially. Therefore, even if an excessive amount of fluid is accidentally injected into the balloon member 40, for example, the balloon member 40 is prevented from expanding in the axial direction and damaging the balloon member 40. 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 relative to the axial direction of the tubular member 10 is made larger. This makes it easier for the portion where 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 where the spring is formed has ample room to expand in the axial direction of the tubular member 10.

[0016] Next, the balloon-equipped guidewire 1 (medical device 1) of this embodiment will be described in detail. The balloon-equipped guidewire 1 is an elongated component inserted into a body cavity of a living organism. Regarding components such as the balloon-equipped guidewire 1, the tubular member 10, and the linear member 20, the end of the balloon-equipped guidewire 1 that is first inserted into a body cavity in the longitudinal direction (axial direction) may be referred to as the distal end, and the other end opposite the distal end (the end closest to the operator) may be referred to as the proximal end. The proximal end may also be referred to as the proximal side, and the side opposite the proximal side may also be referred to as the distal side. The balloon-equipped guidewire 1 of this embodiment may be used together with other devices, such as the catheter 200 described in the second embodiment, or may be used alone. The tubular member 10 is an elongated component extending with the longitudinal direction of the balloon-equipped guidewire 1 as its axial direction. The axial direction of the tubular member 10 may also be referred to simply as the axial direction. In this embodiment, the tubular member 10 has superelasticity. For example, the tubular member 10 may be made of a metal such as nickel titanium (nitinol). Alternatively, the tubular member 10 may be made of another material, such as an elastic resin. Alternatively, the tubular member 10 may be made of a mixture of resin and metal, or may be made of a combination of resin and metal portions. The tubular member 10 has a lumen 11 therein. The cross-sectional shape of the tubular member 10 may be circular or polygonal. The width of the lumen 11 (the inner diameter of the tubular member 10) is greater than the wire diameter of the linear member 20 described below. 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. The lower limit of the thickness of the wall of the tubular member 10 is 50 μm, preferably 80 μm, and the upper limit of the thickness of the wall of the tubular member 10 is 150 μm, preferably 120 μm.

[0017] In the tubular member 10 of this embodiment, an injection port 18 (through-hole), which is an opening that communicates with the lumen 11, is provided in a portion of the tubular wall on the base end side (a portion through 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 through the injection port 18. The shape of the injection port 18 when viewed from the side of the balloon guidewire 1 may be circular or polygonal. In this embodiment, the dimension of the injection port 18 in a predetermined direction when viewed from above (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. Furthermore, the diameter of the injection port 18 is preferably larger than the thickness of the tubular wall of the tubular member 10.

[0018] As shown in Fig. 1, the lumen 11 in this embodiment is closed at the distal end (a portion closer to the proximal end than the coil portion described below). Furthermore, as shown in Fig. 5, in order to increase the flexibility of the tubular member 10, the distal-most portion of the tubular member 10 (the coil portion 14) is formed from a coil in which wire is tightly wound in a helical shape. Furthermore, in order to facilitate 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.

[0019] The balloon member 40 is a member that is placed in a portion of a body cavity of a living organism and expands in diameter to press against a wall defining the body cavity, thereby sealing the body cavity or closing an opening in the wall. The balloon member 40 does not need to completely seal the body cavity or completely close the opening in the wall; it only needs to dam the body cavity sufficiently to restrict the flow of liquid or the like through the body cavity or the opening in the wall, or cover the opening in the wall. For example, the balloon member 40 is placed in a blood vessel in an expanded state and presses against the vascular wall (the inner wall of the blood vessel) to suppress blood flow. As shown in FIG. 5 , the balloon member 40 has a hollow portion 42 covered by a membrane portion 41 inside. The hollow portion 42 of the balloon member 40 is in communication with the lumen 11 of the tubular member 10 (see FIG. 1 ). For example, a portion of the tubular member 10 disposed on the inner diameter side of the balloon member 40 has a through-hole such as a groove that connects the lumen 11 to the outside, and the hollow portion 42 and the lumen 11 communicate with each other through the through-hole. In this embodiment, as will be described later, a spiral slit 44 is formed in the tubular member 10 wall, and the hollow portion 42 and the lumen 11 communicate with each other through the spiral slit 44. By injecting a liquid or gas (referred to as a 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 expands. The expansion of the diameter of the balloon member 40 refers to an increase in the dimension of the balloon member 40 in the radial direction of the balloon guidewire 1 compared to before the injection of the liquid or the like. The radial direction of the balloon-equipped guide wire 1 is the radial direction toward the periphery of the balloon-equipped guide wire 1 (the periphery of the tubular member 10) when viewed axially from the axis of the balloon-equipped guide wire 1 (the axis of the tubular member 10).

[0020] As shown in FIG. 5 , the spring-forming portion 15, which is a distal portion of the tubular member 10, has a helical slit (helical slit 44) formed therein, forming a spring that can expand and contract in the axial direction. Specifically, the tube wall remaining after the helical slit 44 is formed is a narrow ribbon 15a, and the ribbon 15a is arranged helically over multiple turns to form the spring. In this embodiment, the ribbon 15a is a plate-like portion having a predetermined thickness. The ribbon 15a has a predetermined width. The width of the ribbon 15a is the axial distance between one end of the ribbon 15a on the distal side and one end of the ribbon 15a on the proximal side. As described above, the width of the helical slit 44 is less than one-fifth of the width of the ribbon 15a, and more preferably, the width of the helical slit 44 is less than one-sixth of the width of the ribbon 15a. Furthermore, to stably inject a liquid or the like into the hollow portion 42, the width of the helical slit 44 is preferably at least one-tenth of the width of the ribbon 15a, and more preferably, one-twentieth of the width of the ribbon 15a. The width dimension of the spiral slit 44 is the axial distance between one end of one turn of the ribbon 15a on the tip side and one end of the base end of another turn adjacent to the tip side of the one turn. In this embodiment, the width dimension 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 in the entire spring forming portion 15 (the ribbon 15a in the second region 15a2 described below). In other words, the ribbon 15a in a length region other than the second region 15a2 does not necessarily have to be equal to or greater than the above-mentioned predetermined value or less than the above-mentioned predetermined value. Alternatively, the width of the ribbon 15a throughout the entire spring forming portion 15 may be equal to or greater than the above-mentioned predetermined value or less than the above-mentioned predetermined value. Note that 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 opposite to the spiral direction of the radiopaque marker 19, which will be described later. This prevents the radiopaque marker 19 from interfering with the helical slit 44 of the spring forming portion 15.Alternatively, the spiral direction of the ribbon 15 a may be the same as the spiral direction of the coil portion 14 or the radiopaque marker 19 .

[0021] As shown in FIG. 5 , the balloon member 40 (particularly the membrane portion 41, which is its main body portion) is disposed around the tubular member 10 (particularly the attachment portion 13) and has a cylindrical shape. Seal bands 46 are disposed on the outer layer side of a portion of the distal end and a portion of the proximal end of the balloon member 40. The seal bands 46 press the balloon member 40 from the outer layer side to help secure the balloon member 40 to the tubular member 10. In this embodiment, a resin layer (not shown) is disposed on the outer layer side of the tubular member 10, serving as a base for disposing the balloon member 40. The resin layer may be formed of a resin such as polyethylene terephthalate (PET). For example, the resin layer is disposed on the portion of the tubular member 10 where the seal band 46 is disposed and on the outer layer side of the proximal end forming portion 15d, which will be described later. The resin layer is not disposed on the outer layer side of the portion of the tubular member 10 (e.g., the second region 15a2) disposed in the hollow portion 42. This allows communication between the hollow portion 42 and the lumen 11. Furthermore, the balloon member 40 (particularly the membrane portion 41) is fixed (bonded) to the tubular member 10 with an appropriate adhesive 50. More specifically, a first adhesive 51 is disposed on the outer layer side of the tubular member 10, closer to the base end than the balloon member 40. The first adhesive 51 is formed to have a tapered shape. In this embodiment, a coil-shaped radiopaque marker 19 is embedded inside the first adhesive 51. That is, the first adhesive 51 may be disposed on both the inner and outer diameter sides of the radiopaque marker 19, or the first adhesive 51 may be disposed between turns of the radiopaque marker 19. Furthermore, a second adhesive 52 is disposed on the distal end side of the balloon member 40 in a dome shape that bulges toward the distal end. A third adhesive 53 is formed in a tapered shape on the outer layer side of the tubular member 10, covering the second adhesive 52. 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 formed by the tapered shape of the third adhesive 53 with respect to the axial direction is smaller than the angle formed by the tapered shape of the first adhesive 51 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. Furthermore, when the balloon guide wire 1 is inserted into a body cavity (particularly a narrowed portion), the third adhesive 53 is prevented from interfering with the insertion.

[0022] As shown in FIG. 1 , the linear member 20 is disposed in the lumen 11 of the tubular member 10. Specifically, an opening (proximal end opening 12) that penetrates the tubular member 10 in the axial direction and communicates the outside of the tubular member 10 with the lumen is provided at the proximal end of the tubular member 10. 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 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. Furthermore, in this embodiment, a portion of the proximal end of the linear member 20 (a proximal end portion 22 and a portion of a second transitional portion 23 described later) protrudes proximally from the proximal end opening 12 at the proximal end of the tubular member 10 and is disposed outside the tubular member 10. Therefore, by grasping a portion (particularly the base end 22) of the linear member 20 arranged outside the tubular member 10 with an instrument or by hand 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 distal 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 will be described later.

[0023] The sealing member 30 is a member for regulating the flow of liquid or gas in the lumen 11. The sealing member 30 is fixed (anchored) around the distal end 26 of the linear member 20. In this embodiment, the sealing member 30 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 another material (such as high-density cotton) that allows a small amount of liquid or gas to pass through. The sealing member 30 seals the lumen 11 by pressing or tightly contacting a portion 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 tightly contacts at least a portion of the inner wall of the tubular member 10 in the radial direction. More preferably, the sealing member 30 tightly contacts the inner wall of the tubular member 10 over the entire radial direction of the tubular member 10. In other words, the sealing member 30 seals substantially the entire cross section of the lumen 11. As a result, the movement of liquid or gas within the lumen 11 in the axial direction is restricted by sandwiching the sealing member 30. When the linear member 20 is removed from the tubular member 10, the width dimension of the sealing member 30 (the dimension in a direction perpendicular to the axial direction of the linear member 20) is preferably larger than the width of the lumen 11. As a result, the sealing member 30 is in pressure contact with a portion of the inner wall of the tubular member 10 within the lumen 11.

[0024] As shown in FIGS. 2( a) and 2(b) and described above, the sealing member 30 is movable between an open position and a closed position in response to axial movement of the linear member 20. The closed position of the sealing member 30 is a position in which the sealing member 30 blocks the injection port 18 or is positioned distal to the injection port 18 to liquid-tightly or air-tightly seal a portion of the lumen 11 (a portion distal to the sealing member 30) and the hollow portion 42. That is, in the closed position, the sealing member 30 blocks the flow of fluid (e.g., liquid) from the injection port 18 through the lumen 11 to the hollow portion 42. Blocking the flow of fluid refers to the flow of fluid being sufficiently restricted (i.e., the fluid is dammed) to the extent that the expanded state of the balloon member 40 can be maintained for a predetermined period of time, but is not limited to complete blocking of the flow of fluid. The open position of the sealing member 30 is a position closer to the proximal end of the tubular member 10 than the injection port 18. 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. The positions of other components when the sealing member 30 is in the closed or open position are sometimes referred to as the closed or open position. As shown in FIG. 2( a ), in the open position, the sealing member 30 is located proximal to the injection port 18. Therefore, a portion of the lumen 11 distal to 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. In the open state, the sealing member 30 prevents a liquid or the like from flowing from the injection port 18 into the proximal portion of the lumen 11. As shown in FIG. 2( b ), in the closed position, the sealing member 30 is located approximately at the same position as the injection port 18 or distal to the injection port 18 in the axial direction of the tubular member 10. Specifically, when the sealing member 30 is 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 (press-welded) with at least a portion 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 contacts (presses) substantially the entire edge of the injection port 18 (a portion of the tubular wall that defines the injection port 18 and surrounds the injection port 18). This blocks at least a portion (preferably the entirety) of the injection port 18 with the sealing member 30. This prevents leakage of liquid or the like from the injection port 18. When the balloon member 40 is expanded in diameter by injecting liquid or the like into the lumen 11 and the hollow portion 42, leakage of liquid or the like from the hollow portion 42 to the outside through the lumen 11 and the injection port 18 is prevented, thereby maintaining the expanded diameter of the balloon member 40. As shown in FIG. 2( b ), the sealing member 30 of this embodiment has a large-diameter portion at the center in the axial direction, and the diameters decrease 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 greater than the width of the lumen 11 in its natural state (when disposed outside the tubular member 10). Furthermore, 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. 2, when the sealing member 30 is disposed in the closed position to close the injection port 18, a portion of the sealing member 30 on both ends of the large diameter portion is in pressure contact with a portion of the pipe wall that defines the injection port 18. Alternatively, the length of the large diameter portion in the axial direction may be the same as or greater 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 close the injection port 18, it is preferable that the large diameter portion is in pressure contact with a portion of the pipe wall that defines the injection port 18.

[0025] The linear member 20 has a distal end portion 26, an intermediate portion 24, and a proximal end portion 22. The intermediate portion 24 is a portion of the linear member 20 closer to the proximal end than the distal end portion 26. The proximal end portion 22 is a portion of the linear member 20 closer to the proximal end than the intermediate portion 24. The distal end portion 26, the intermediate portion 24, and the proximal end portion 22 each have a partial length region with a uniform outer diameter. Of the partial length regions of the distal end portion 26, the intermediate portion 24, and the proximal end portion 22, the partial length region of the proximal end portion 22 is the thickest, and the partial length region of the distal end portion 26 is the thinnest. As shown in FIG. 1 , the proximal end portion 22 of the linear member 20 is a portion of the linear member 20 on the proximal side. Specifically, the proximal end portion 22 is a portion of the linear member 20 that protrudes proximally from the proximal opening 12 and is disposed outside the tubular member 10. The distal end portion 26 of the linear member 20 is a portion of the linear member 20 to which the sealing member 30 is fixed and a length region in the vicinity thereof. In this embodiment, the distal end portion 26 is a length region of the linear member 20 extending from the distal end to a position slightly toward the proximal end of the position where the sealing member 30 is fixed. The intermediate portion 24 of the linear member 20 is a partial length region of the linear member 20 located between the proximal end portion 22 and the distal end portion 26. It is preferable that substantially the entire intermediate portion 24 is located in the lumen 11 in the closed position. Furthermore, a partial length region of the intermediate portion 24 on the proximal side may protrude from the proximal opening 12 to the outside of the lumen 11 in the open position.

[0026] The proximal end portion 22, the intermediate portion 24, and the distal end portion 26 each have a uniform outer diameter over a partial length region or the entire length region in the axial direction. In this embodiment, the proximal end portion 22, the intermediate portion 24, and the distal end portion 26 each have a uniform outer diameter over the entire length region in the axial direction. Here, a uniform outer diameter refers to a substantially uniform outer diameter; it does not necessarily have to be a completely uniform outer diameter due to slight irregularities, etc. In FIG. 1, the outer diameter and inner diameter (width of the lumen 11) of the tubular member 10, the outer diameter of the linear member 20 (particularly the outer diameters of the proximal end portion 22, the intermediate portion 24, the distal portion 26, and the transition portion described below), and the size of the sealing member 30 are partially exaggerated for convenience. The same applies to FIGS. 2(a) to 5. The outer diameter of the proximal end portion 22 is preferably substantially equal to the outer diameter of the tubular member 10. Specifically, the outer diameter of the proximal end portion 22 is preferably at least two-thirds but less than 1.5 times the outer diameter of the tubular member 10. The lower limit of the outer diameter of the proximal end portion 22 is, for example, 0.250 mm, preferably 0.300 mm. The upper limit of the outer diameter of the proximal end portion 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. Furthermore, the outer diameter of the intermediate portion 24 is larger than the outer diameter of the distal end portion 26 and smaller than the outer diameter of the proximal end portion 22. Preferably, the outer diameter of the intermediate portion 24 is smaller than the difference between the outer diameters of the distal end portion 26 and the proximal end portion 22. This provides the intermediate portion 24 with sufficient flexibility, allowing the linear member 20 to be pulled out of the tubular member 10 with a predetermined pull-out strength even when the difference between the amplitude of the waveform in the intermediate portion 24 (described later) and the width of the lumen 11 (the clearance (described later)) is large. This will be described in detail later. Furthermore, by having the outer diameter of the base end 22 be equal to or greater than the combined outer diameter of the tip end 26 and the outer diameter of the intermediate portion 24, it becomes easy to grasp and pull out the base end 22. Furthermore, by having the outer diameter of the tip end 26 be a small value less than the difference between the outer diameter of the base end 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 to seal the lumen 11. The lower limit of the outer diameter of the intermediate portion 24 is, for example, 0.15 mm, and 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 at least 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 at least 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.

[0027] Next, using Figures 6(a) to 6(c), we will explain the change in shape of the balloon member 40 when a liquid or the like is injected through the injection port 18 and the balloon member 40 is expanded. As described above, the injection of a liquid or the like into the hollow portion 42 causes the balloon member 40 to expand in both the axial and radial directions. Figures 6(a) to 6(c) schematically illustrate the spiral shape of the spring-forming portion 15. Specifically, the ribbon 15a within the hollow portion 42 is formed in a spiral shape, but in Figures 6(a) to 6(c), the individual turns are illustrated as separated and spaced apart in the axial direction for convenience. Figure 6(a) shows the reduced-diameter state of the balloon member 40 before a liquid or the like is injected. The reduced-diameter state refers to the state of the balloon member 40 before a liquid or the like is injected to expand the diameter of the balloon member 40. In the reduced-diameter state, the hollow portion 42 and the lumen 11 may be filled with a fluid (e.g., physiological saline). The fluid filling the hollow portion 42 and the lumen 11 may be the same or different from the liquid or the like used to expand the diameter of the balloon member 40. In the contracted-diameter state, the volume of the hollow portion 42 is small or substantially zero. The inner surface of the membrane portion 41 may be substantially entirely in contact with the tubular member 10 (the outer surface of the ribbon 15a in the spring-forming portion 15), 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 (especially by pressure) through the injection port 18, the fluid or the like passes through the lumen 11, seeps out through the spiral slit 44, and is injected into the hollow portion 42. As a result, the balloon member 40 transitions from the small-diameter state shown in FIG. 6( b) to the large-diameter state shown in FIG. 6( c). The large-diameter state here refers to a state in which the width of the balloon member 40 has increased to approximately the same as the maximum inner diameter of a generally expected wide-width body lumen for which the balloon guidewire 1 is to be used. For example, in the balloon guidewire 1 of this embodiment, the balloon member 40 is placed inside a blood vessel (e.g., a carotid artery), and the typical inner diameter of the blood vessel is 5 mm, and the typical inner diameter of a large carotid artery is approximately 6 to 7 mm. That is, the large-diameter state of the balloon member 40 in the balloon guidewire 1 of this embodiment refers to a state in which the balloon member 40 has expanded to a width dimension of approximately 6.5 mm.The amount of fluid required to expand from the reduced-diameter state to the large-diameter state is referred to as the total pressure injection amount. The balloon member 40 may be expandable in the width direction even more than the large-diameter state. In this embodiment, the total pressure injection amount is approximately 0.175 ml. The total pressure injection amount may be 0.160 ml or more and 0.190 ml or less, including 0.175 ml. Alternatively, the total pressure injection amount may be 0.160 ml or less or 0.190 ml or more, depending on the inner diameter of the body cavity. The total pressure injection amount is approximately 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 will not damage the membrane portion 41 or the vicinity of the seal band 46). The small-diameter state refers to the state of the balloon member 40 when approximately one-quarter of the total pressure injection amount is injected. In this embodiment, 0.0425 ml of fluid is injected through the injection port 18 to expand from the reduced-diameter state to the small-diameter state. The injection amount is, for example, about one-tenth of the maximum amount of fluid that can be injected into the hollow portion 42 or the like.

[0028] A predetermined amount of fluid is injected from the contracted diameter state to the small diameter state. When fluid is injected, the membrane portion 41 is pushed radially by the liquid or the like in the hollow portion 42 and expands, causing the width dimension (vertical dimension in the figure) of the balloon member 40 to become larger than its width dimension in the contracted diameter state. Furthermore, because both axial ends of the membrane portion 41 are fixed to the tubular member 10 by the sealing bands 46, the central portion of the membrane portion 41 expands axially. Furthermore, when fluid or the like is injected into the hollow portion 42, the spring formed in the attachment portion 13 expands axially, and the membrane portion 41 is biased by the liquid or the like and stretched axially. As the balloon member 40 expands axially, the position of the proximal sealing band 46 may be approximately fixed, and the distal sealing band 46 may move distally, thereby expanding the balloon member 40 axially. When fluid is further injected into the hollow portion 42 from the small diameter state, the balloon member 40 further expands to a large diameter state, as shown in FIG. 6( c). The membrane portion 41 is forced radially and axially outward by the liquid or the like within the hollow portion 42, causing the balloon member 40 to expand radially and axially. In the large-diameter state or during the transition 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 (maximum diameter portion) of the membrane portion 41 in the axial direction (tension in the axial direction). Furthermore, in the large-diameter state, a sealing band 46 may be wedged axially inward into one end of the membrane portion 41 in the axial direction. Specifically, a portion of the sealing band 46 may be positioned within the envelope volume of the spherically inflated balloon member 40 (membrane portion 41). The balloon member 40 may restrict blood flow in the body lumen in the small-diameter state, the large-diameter state, or an intermediate state between them. 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 lumen. For example, the membrane portion 41 may be pressed radially inward by the inner wall forming the body cavity, so that the width dimension of the balloon member 40 is smaller than that in its natural state (when not placed in the body cavity). Also, the axial dimension of the balloon member 40 may be larger than that in its natural state.

[0029] FIG. 7 shows an example of the relationship between the amount of fluid injected through the inlet 18 (amount of fluid injected based on the reduced-diameter state) and the axial or width dimensions (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 mid-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 approximately one-quarter of the total injected volume of fluid. The mid-expansion stage is the process from the small-diameter state to the expanded-diameter state (medium-diameter state) by further injecting approximately one-half of the total injected volume of fluid. The late expansion stage is the process from the medium-diameter state to the large-diameter state by further injecting approximately one-quarter of the total injected volume of fluid. As shown in FIG. 7, in the reduced-diameter state, the axial dimension is sufficiently larger than the width dimension. However, when fluid is injected (approximately 0.1 ml of fluid is injected), the width and axial dimensions become approximately equal. In other words, in the middle stage of expansion, the widthwise and axial dimensions are approximately equal. When fluid is further injected to reach the late stage of expansion, the axial dimension becomes larger than the widthwise dimension, and the shape of the balloon member 40 viewed from the side becomes an ellipse elongated in the axial direction.

[0030]

[0031] Table 1 shows the expansion rates of the widthwise or axial dimensions of the balloon-equipped guidewire 1, an example of this embodiment, at the early, mid, and late diastolic stages, as well as the ratio of the axial expansion rate to the widthwise expansion rate. The expansion rate at each stage is calculated by dividing the change in dimension throughout that stage by the amount of fluid injected during that stage. That is, the expansion rates of the widthwise or axial dimensions at each of the early, mid, and late diastolic stages are the slopes of the linear function graphs in the ranges a1-3 and b1-3 in FIG. 7 . The widthwise expansion rates at the early, mid, and late diastolic stages are 75.6 mm / ml, 20.5 mm / ml, and 10.7 mm / ml, respectively. The axial expansion rates at the early, mid, and late diastolic stages are 10.8 mm / ml, 15.7 mm / ml, and 18.0 mm / ml. In this embodiment, the widthwise expansion rate decreases as the expansion stage progresses. Meanwhile, the axial expansion rate increases as the expansion stage progresses. That is, the balloon member 40 does not expand much axially in the early stage after fluid is injected, but expands significantly in the axial direction once the fluid is injected and the balloon member 40 has sufficiently expanded in diameter. This is because the axial elasticity of the spring is smaller than that of the membrane portion 41. Elasticity refers to the amount by which a member stretches when pulled in a given direction. Furthermore, in this embodiment, the axial expansion rate is smaller than the widthwise expansion rate in the early expansion stage, but is greater than the widthwise expansion rate in the late expansion stage. Thus, the balloon member 40 expands significantly in the axial direction in the late expansion stage, positioning it more closely in the direction of extension of the body lumen, resulting in better contact between the inner wall of the body lumen and the balloon member 40, thereby providing a better seal for the body lumen. Furthermore, by expanding the diameter of the balloon member 40 not only in the width direction but also in the axial direction during the late expansion stage, the maximum amount of fluid that can be injected into the hollow portion 42, etc. (the maximum injection amount that will damage the balloon member 40) can be increased. As a result, deformation or damage to the balloon member 40 can be suppressed even if an excessive amount of fluid is accidentally injected.7 and Table 1 show the balloon size when a predetermined amount of fluid is injected into the balloon member 40 when the balloon member 40 is not particularly constrained from the outer diameter side of the balloon member 40. When the balloon member 40 is placed in a body lumen, the outer surface of the balloon member 40 may be pressed against the inner wall of the body lumen during inflation when a predetermined amount of fluid is injected into the balloon member 40. In this case, after the outer surface of the balloon member 40 is pressed against the inner wall of the body lumen, the expansion rate in the width direction may become smaller and the expansion rate in the axial direction may become larger.

[0032] As shown in Table 1, during the initial stage of expansion of the balloon member 40, the axial expansion rate of the balloon member 40 (also referred to as the axial expansion rate) is 5.0% or more, preferably 7.5% or more, and more preferably 10.0% or more, of the radial expansion rate of the balloon member 40. By preliminarily increasing the axial dimension of the balloon member 40 during the initial stage of expansion, when the balloon member 40 is placed in a body lumen, the axial dimension of the balloon member 40 is large even before the outer circumferential surface of the balloon member 40 presses against the inner wall of the body lumen. This prevents unnecessary pressure from being applied to the inner wall of the body lumen when the balloon member 40 presses against the inner wall of the body lumen. Furthermore, during the initial stage of expansion, the axial expansion rate is preferably less than 30.0%, more preferably less than 20.0%, and even more preferably less than 15.0%. By keeping this rate below the above value, the balloon member 40 expands sufficiently in the width direction during the initial stage of expansion. This allows the objective of sealing the body lumen to be achieved more quickly. On the other hand, the axial expansion rate in the late 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. By configuring the balloon member 40 so that the axial dimension increases more as the diameter of the balloon member 40 expands upon fluid injection, the expanded balloon member 40 expands axially, making it less likely to press against the inner wall of the body lumen, thereby alleviating pressure on the inner wall of the body lumen. In particular, as shown in Table 1, the axial expansion rate in the late expansion stage is 80.0% or greater, preferably 100.0% or greater, and more preferably 150.0% or greater. By achieving this ratio or greater and being greater in the late expansion stage than in the early expansion stage, the balloon member 40 can be sufficiently expanded 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 expansion in the axial direction, interference with treatment instruments and the like arranged near the balloon member 40 in the body cavity is suppressed.

[0033] As shown in FIG. 5 , the attachment portion 13 is a portion of the tubular member 10 located 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 proximal end side and a non-spring-forming portion 17 on the distal end side. The spring-forming portion 15 is a portion formed with a spring that can expand and contract in the axial direction, such as by forming a spiral slit 44. The non-spring-forming portion 17 is a portion without a spiral slit 44 and without a spring that does not substantially expand and contract in the axial direction. Because the distal portion of the attachment portion 13 does not have a spring, this portion is less flexible than 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 along the extension direction of the non-spring-forming portion 17, which is the distal portion of the attachment portion 13. In other words, if the entire mounting portion 13 were a spring, the entire mounting portion 13 would be flexible and the balloon member 40 would be unexpectedly bent or twisted during expansion when the balloon member 40 was expanded in the axial direction. However, since the distal end portion of the mounting portion 13 does not have significant flexibility, the balloon member 40 can be expanded approximately in the axial direction.

[0034] 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 non-spring-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. Alternatively, 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 non-spring-forming portion 17.

[0035] 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 axial distance from one end of the tip of one turn to one end of the tip of another turn adjacent to the tip of the one turn. In other words, the winding pitch can be considered the sum of the width of the spiral slit 44 and the width 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. 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 of the spring. 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 the spring that is distal to the first region 15a1. The third region 15a3 is a region of the spring that is distal to the second region 15a2. In this embodiment, the winding pitch in the second region 15a2 is the smallest among the winding pitches of the attachment portion 13. The small winding pitch in the second region 15a2 increases the amount of liquid flowing into the hollow portion 42, allowing the liquid to be efficiently delivered into the hollow portion 42. Furthermore, the large winding pitch in the third region 15a3, which is distal to the second region 15a2, prevents the tubular member 10 from accidentally bending between the spring-forming portion 15 and the non-spring-forming portion 17.

[0036] In this embodiment, the first region 15a1 to the third region 15a3 are all disposed in the attachment 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 attachment portion 13, thereby preventing the attachment portion 13 from becoming excessively flexible. Furthermore, 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. The large width of the spiral slit 44 in the second region 15a2 allows sufficient communication between the hollow portion 42 and the lumen 11. Furthermore, the small width of the spiral slit 44 in the first region 15a1 or the third region 15a3 maintains the rigidity of the first region 15a1 or the third region 15a3, preventing the attachment portion 13 from becoming excessively flexible. That is, with the above configuration, the hollow portion 42 and the lumen 11 can be sufficiently communicated with each other in the second region 15a2, while the rigidity of the attachment portion 13 can be maintained within a desired range.

[0037] In this embodiment, the spring is also formed in a portion of the pipe wall proximal to the attachment portion 13 (proximal forming portion 15d). That is, the proximal forming portion 15d is also 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 within the hollow portion 42, but also in the pipe wall disposed on the inner diameter side of the seal band 46 and the first adhesive 51 and the pipe wall proximal to the first adhesive 51 (the pipe wall in the proximal forming portion 15d). That is, the spring is integrally formed in the pipe wall within the hollow portion 42, the pipe wall disposed on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall in the proximal forming portion 15d. Because the spring is also formed in the proximal forming portion 15d, the proximal forming portion 15d is flexible. 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, preventing unnecessary loads from being applied to the balloon member 40 and nearby components (e.g., adhesive 50, etc.). This prevents deformation of the balloon member 40 and nearby components, preventing damage to the balloon member 40 or leakage of liquid from the balloon member 40, for example. The winding pitch of the spring formed in the proximal forming portion 15d is greater than the winding pitch in the third region 15a3. In other words, the width of the ribbon 15a in the proximal forming portion 15d is greater 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 proximal side of the spring-forming portion 15.

[0038] In this embodiment, the angle of the spiral direction of a portion of the ribbon 15a relative to the axial direction in the contracted diameter 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 relative to the axial direction may be 60 degrees or more. Alternatively, the angle of the spiral direction of substantially the entire ribbon 15a at the attachment portion 13 relative to the axial direction may be 60 degrees or more. More preferably, this angle is 75 degrees or more. This allows the spring-forming portion 15 to expand and contract in the axial direction more effectively. As a result, the balloon member 40 can be sufficiently expanded in the axial direction in the small-diameter state or the large-diameter state (expanded state). Similarly, the angle of the spiral direction of a portion of the ribbon 15a relative to the axial direction may be 60 degrees or more in the small-diameter state or the large-diameter state.

[0039] Next, the structure of the proximal end of the tubular member 10 will be described in detail. As shown in FIGS. 1 and 2(a), the first transitional section 25 is disposed between the distal end 26 and the intermediate section 24. The second transitional section 23 is disposed between the intermediate section 24 and the proximal end 22. The first transitional section 25 and the second transitional section 23 each have a tapered shape. The first transitional section 25 and the second transitional section 23 are transitional sections in the linear member 20, each of which has a larger rate of change in outer diameter than the proximal end 22, the intermediate section 24, or the distal end 26 adjacent to the transitional section. The rate of change in outer diameter refers to the amount of change in outer diameter per predetermined length. In this embodiment, the outer diameters of the proximal end 22, the intermediate section 24, and the distal end 26 are substantially uniform and do not change. Furthermore, the outer diameter of the linear member 20 gradually decreases at the second transitional section 23 or the first transitional section 25 from the proximal end 22 to the intermediate section 24 or from the intermediate section 24 to the distal end 26. Alternatively, in the case where the outer diameter of the base end portion 22, the intermediate portion 24, and the tip end portion 26 gradually increases or decreases toward the tip at a small rate of change, the portion where the outer diameter increases or decreases at a rate greater than the rate of change at the base end portion 22, etc. may be defined as the transition portion. The angle of the tapered shape of the second transitional portion 23 relative to the axial direction is greater than the angle of the tapered shape of the first transitional portion 25 relative to the axial direction. The rate of change of the outer diameter of the second transitional portion 23, which decreases toward the tip, is greater than the rate of change of the outer diameter of the first transitional portion 25, which decreases toward the tip. The angle of the tapered shape of the second transitional portion 23 or the first transitional portion 25 relative to the axial direction is the angle between the extending direction of the surface of the tapered second transitional portion 23 or the first transitional portion 25 and the axial direction. Note that due to the wave-shaped forming portion 24c described below, the extending direction of the first transitional portion 25 or the second transitional portion 23 (the axial direction of the central axis of the first transitional portion 25 or the second transitional portion 23) may not be parallel to the axial direction of the tubular member 10, but may intersect or be twisted relative to the axial direction. In this case, the angle between the tapered shape of the first transitional portion 25 or the second transitional portion 23 and the axial direction in a state in which the extending direction of the first transitional portion 25 or the second transitional portion 23 and the axial direction of the tubular member 10 are not parallel may be the angle that the tapered shape of the transitional portion makes with the axial direction.Alternatively, the angle between the tapered shape of the first transitional section 25 or the second transitional section 23 and the axial direction of the tubular member 10 when the extending direction of the first transitional section 25 or the second transitional section 23 is corrected to be parallel to the axial direction may be the angle that the tapered shape of the transitional section makes with the axial direction. The outer diameter (wire diameter) of the proximal end 22 is greater than the width of the lumen 11. As shown in FIG. 1 , when the linear member 20 is fully inserted into the tubular member 10, a portion of the distal side of the second transitional section 23 is inserted into the lumen 11, and a portion of the proximal side of the second transitional section 23 is disposed outside the lumen 11. At this time, the surface of the second transitional section 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 threaded through the tubular member 10, the second transitional portion 23 between the base end portion 22 and the intermediate portion 24 acts as a flange, preventing the linear member 20 from being inserted excessively into the tubular member 10. Furthermore, because the first transitional portion 25 has a gentle taper, the linear member 20 is less likely to break at the first transitional portion 25, where the wire diameter changes, when the linear member 20 is pushed into the tubular member 10. It is preferable that the length of the second transitional portion 23 in the axial direction be shorter than the length of the first transitional portion 25 in the axial direction. This is because the second transitional portion 23 can be inclined more greatly with respect to the axial direction, and the first transitional portion 25 can be inclined less with respect to the axial direction.

[0040] As shown in FIG. 3 , the intermediate portion 24 of the linear member 20 has a wave-like shape. Specifically, the intermediate portion 24 is bent at multiple bends 29. In this embodiment, the intermediate portion 24 is bent at eight bends 29. The bends 29, which are multiple first bends 29a and multiple second bends 29b, are alternately arranged in the intermediate portion 24. In this embodiment, the intermediate portion 24 has four first bends 29a and four second bends 29b. The wave-like shape is formed by mountain folds or valley folds at the multiple first bends 29a and multiple second bends 29b, respectively. The bends 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, which will be described later. Here, a mountain fold refers to a fold in one direction intersecting the axial direction, and a valley fold refers to a fold in a direction different (particularly the opposite direction) from the predetermined mountain fold 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 multiple second bent portions 29b.

[0041] The right side of Fig. 4 is the distal end side, and the left side of Fig. 4 is the proximal end side. As will be described in detail later, Fig. 4 illustrates the linear member 20 in a shape when disposed outside the tubular member 10 (in a 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 from 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 regions 24a and the second length regions 24b are alternately arranged in the intermediate portion 24, sandwiching the bent portion 29 therebetween. 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 at the distal end 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 at the distal end. The lengths of the first length region 24a and the second length region 24b refer to the lengths of the first length region 24a and 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 at least one-quarter but less than one-half the length of the second length region 24b adjacent to the first length region at the distal end. The lengths of the multiple first length regions 24a may be substantially the same as each other. The lengths of the multiple second length regions 24b may also be substantially the same as each other. The lengths of the plurality of length regions being substantially the same means that each length is 90% to 110% of the average length of the plurality of length regions. Alternatively, the length of one first length region 24a may be greater than the lengths of other first length regions 24a located distally of the one first length region 24a. Similarly, the length of one second length region 24b may be greater than the lengths of other second length regions located distally of the one second length region 24b.As a result, when the linear member 20 is pulled out, the linear member 20 catches on the inner wall of the tubular member 10 at the bent portion 29 on the proximal side of the intermediate portion 24, and when the linear member 20 is inserted, the bent portion 29 on the distal side allows the linear member 20 to slide smoothly against the tubular wall. This is because the amplitude, described below, in the intermediate portion 24 becomes smaller toward the distal end and becomes larger toward the proximal end. Specifically, if 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 due to the short length of the first length region 24a or the second length region 24b. When the amplitude is small, the force that the linear member 20 applies to the inner wall of the tubular member 10 becomes smaller. In other words, when the amplitude is small, the sliding resistance of the linear member 20 against the tubular member 10 becomes smaller. Alternatively, the length of one first length region 24 a may be smaller than the length of another first length region 24 a located distally of the one first length region 24 a. Similarly, the length of one second length region 24 b may be smaller than the length of another second length region located distally of the one second length region 24 b. This increases the sliding resistance of a portion of the distal end of the linear member 20 (intermediate portion 24), thereby suppressing unexpected movement of the sealing member 30.

[0042] 4, the angle that the first length region 24a forms with respect to the axial direction is larger than the angle that the second length region 24b forms with respect to the axial direction. With the above configuration, the first length region 24a is arranged so as to stand upright with respect to 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 an attempt is made to pull out the linear member 20 from the tubular member 10, the linear member 20 gets caught at the first bent portion 29a and is therefore less likely to come out of the tubular member 10.

[0043] In the intermediate portion 24, the amplitude of the waveform in a distal portion is smaller than the amplitude of the waveform in another portion closer to the base end than the distal portion. As described above, the smaller amplitude in the distal portion 26 prevents the linear member 20 from getting stuck on the wall of the tubular member at the distal end of the waveform-forming portion 24c when inserted. This allows the linear member 20 to be smoothly inserted into the tubular member 10. The amplitude of the waveform in a partial length region in 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 the waveform is the extension direction ignoring the waveform. For example, the extension direction of the waveform-forming portion 24c is the direction indicated by the dashed line III in FIG. 3 . Furthermore, the maximum dimension of the partial length region in a direction perpendicular to the extension direction of the entire partial length region is the maximum 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 the first bent portion 29 a and the second bent portion 29 b that are adjacent to each other (e.g., amplitude L1a in FIG. 3 ) is smaller than the amplitude of other partial length regions including other first bent portions 29 a and other second bent portions 29 b that are adjacent to each other on the proximal end side of the partial length region (e.g., amplitude L1b, amplitude L1c, or amplitude L1d in FIG. 3 ). The amplitudes L1a, L1b, L1c, and L1d may increase in this order. In this embodiment, the amplitude L1a of the partial length region including the first bent portion 29 a and the second bent portion 29 b that are located most distally in the intermediate portion 24 (the partial length region that does not include the first bent portion 29 a and the second bent portion 29 b that are located second from the distal end) is smaller than the amplitude of the entire intermediate portion 24 (particularly the wave-shaped portion 24 c). Furthermore, the amplitude L1a is smaller than the average amplitude (average of amplitudes L1a to L1d) of the length region near the first bent portion 29a and the second bent portion 29b that are adjacent to each other. Furthermore, in this embodiment, the amplitude L1a is smaller than any of amplitudes L1b to L1d.More specifically, in this embodiment, the amplitude of the waveform in a distal portion of the intermediate portion 24 may be substantially the same as the amplitude of another portion of the waveform closer to the base end than the distal portion. That is, the amplitude of the waveform may be constant from the distal end to the base end of the intermediate portion 24. Note that the amplitudes of multiple waveform portions may be substantially the same, and the magnitude relationship between the amplitudes may be established as described above. The phrase "the amplitude of one portion is substantially the same as the amplitude of another portion" means that the amplitude of the one portion is 90% to 110% of the amplitude of the other portion adjacent to the one portion, and the maximum amplitude of the comparison is 1.5 times or less than the minimum amplitude of the comparison. For example, when comparing the amplitudes of two adjacent length regions, the phrase "the amplitude of one portion is substantially the same as the amplitude of the other portion" means that the amplitude of one portion is 90% to 110% of the amplitude of the other portion. As in this embodiment, when adjacent first bent portions 29a and second bent portions 29b are grouped together, there may be three or more groups, and three or more amplitudes (amplitudes L1a to L1d) may be present. When determining whether multiple amplitudes are substantially the same in this manner, the amplitude of one portion and the amplitude of another portion are considered to be substantially the same if the amplitude of the one portion is within a range of 90% to 110% of the amplitude of the other portion adjacent to the one portion, and the maximum value of the target amplitude is 1.5 times or less than the minimum value of the target amplitude. Alternatively, the amplitude of one portion and the amplitude of another portion do not have to be substantially the same. That is, the amplitude of one portion may be less than 90% or more than 110% of the amplitude of the other portion. Furthermore, when comparing the amplitudes of multiple length regions, the maximum amplitude may be more than 1.5 times the minimum amplitude.

[0044] As will be described later, the amplitude of the wavy portion 24c when disposed outside the tubular member 10 (in its natural state) 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 portions 29. That is, when disposed in the lumen 11, the wavy portion 24c has a shape that is more flattened than its shape in its natural state. Specifically, when disposed in the lumen 11, the amplitude of the wavy portion 24c is approximately equal to the width of the lumen 11, and the radius of curvature at the bent portions 29 is greater than the radius of curvature of the bent portions 29 in its natural state. The radius of curvature of the bent portions 29 described in the upper part or in the latter part may be the radius of curvature of the bent portions 29 in the wave-shaped portion 24c disposed in the lumen 11, or may be the radius of curvature of the bent portions 29 in the wave-shaped portion 24c in its natural state. Furthermore, the amplitude of the wave-shaped portion 24c described in the upper part or in the latter part may be the amplitude of the wave-shaped portion 24c disposed in the lumen 11, or may be the amplitude of the wave-shaped portion 24c in its natural state. For convenience of explanation, Figure 4 illustrates the shape of the wave-shaped portion 24c in its natural state. Therefore, although Figure 4 appears to show the bent portions 29 biting into the inner wall of the tubular member 10, in reality, the bent portions 29 deform so as to be widened and press against the inner wall of the tubular member 10, as described above.

[0045] In this embodiment, the radius of curvature of the bent portion 29 is smaller than the length of the second length region 24b. This makes 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 thus gives the bent portion 29 a pointed shape, which makes it easier for the linear member 20 to catch 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 a perfect circular arc, and the radius of curvature may be constant throughout the entire length of the bent portion 29. Alternatively, the radius of curvature may not be constant throughout 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 portion of the bent portion 29 on the distal end side or the portion of the proximal end side. The radius of curvature at the bent portion 29 is preferably larger than the length of the first length region 24a. This prevents the intermediate portion 24 from bending at the first bent portion 29a, causing the first length region 24a to get stuck and prevent the linear member 20 from being pulled out, 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 pulling the linear member 20 out of the tubular member 10.

[0046] In this embodiment, the radius of curvature of the first bent portion 29a and the radius of curvature of the second bent portion 29b adjacent to the first bent portion 29a across the first length region 24a are substantially the same. The "radius of curvature of the first bent portion 29a and the radius of curvature of the second bent portion 29b being substantially the same" refers to the radius of curvature of the first bent portion 29a being 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 and the radius of curvature of the second bent portion 29b being substantially the same" refers to the radius of curvature of the first bent portion 29a being between 90% and 110% of the radius of curvature of the second bent portion 29b. Furthermore, in this embodiment, the radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same. The expression "the radii of curvature of the first bent portions 29a" or "the radii of curvature of the second bent portions 29b are substantially the same" means that the radius of curvature of one first bent portion 29a (or second bent portion 29b) is 90% to 110% of the radius of curvature of another first bent portion 29a (or second bent portion 29b) adjacent to the first bent portion 29a (or second bent portion 29b), and the maximum radius of curvature of the target first bent portion 29a (or second bent portion 29b) is 1.5 times the minimum radius of curvature of the target first bent portion 29a (or second bent portion 29b). Furthermore, 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. By reducing the radius of curvature of the first bent portion 29a as described above, the linear member 20 is caught by the first bent portion 29a when the linear member 20 is removed, making it easier for the first length region to stand upright in the axial direction. As a result, accidental removal of the linear member 20 is suppressed. On the other hand, because 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 that is closer to a straight line, making it harder for the first length region 24a to stand upright in the axial direction when the linear member 20 is inserted.As a result, when inserting the linear member 20 into the tubular member 10, the first length region 24a is prevented from standing upright in the axial direction, making it difficult to insert the linear member 20 into the tubular member 10.

[0047] The radius of curvature of one second bent portion 29b located on the distal side may be larger than the radius of curvature of another second bent portion 29b located closer to the base end than the one second bent portion 29b. This allows the intermediate portion 24 to slide more easily on the inner wall of the tubular member 10 toward the distal end, and the sliding resistance against the inner wall of the tubular member 10 increases toward the proximal end. This makes it difficult for the linear member 20 to be accidentally pulled out of the tubular member 10, but makes it easier to insert the linear member 20 into the tubular member 10. Alternatively, the radius of curvature of one second bent portion 29b located on the distal side may be smaller than the radius of curvature of another second bent portion 29b located closer to the base end than the one second bent portion 29b. This increases the sliding resistance on the distal side of the intermediate portion 24. As a result, unexpected axial movement of the sealing member 30 is suppressed when an unexpected force is applied to the linear member 20. Alternatively, the radii of curvature of the plurality of second bent portions 29b may be substantially the same from the distal end to the proximal end. Similarly, the radius of curvature of one first bent portion 29a disposed distally may be greater than the radius of curvature of another first bent portion 29a disposed proximally relative to the first bent portion 29a. Alternatively, the radius of curvature of one first bent portion 29a disposed distally may be smaller than the radius of curvature of another first bent portion 29a disposed proximally relative to the 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 disposed in the closed position that maintains the balloon member 40 in an expanded diameter state, the sealing member 30 is prevented from shifting proximally due to internal pressure in the lumen 11, etc. Alternatively, the radii of curvature of the plurality of first bent portions 29a may be substantially the same from the distal end to the proximal end.

[0048] As shown in FIG. 1 or 3 , the intermediate section 24 has a wave-shaped portion 24c, a first wave-unshaped portion (first wave-unshaped portion 24d), and a second wave-unshaped portion (second wave-unshaped portion 24e). The wave-shaped portion 24c is a portion of the intermediate section 24 where a wave is formed. The first wave-unshaped portion 24d and the second wave-unshaped portion 24e are wave-unshaped portions where no wave is formed. The first wave-unshaped portion 24d is a partial length region located closer to the base end than the wave-shaped portion 24c. The second wave-unshaped portion 24e is a partial length region located closer to the tip end than the wave-shaped portion 24c. As shown in FIG. 1 , the length of the first wave-unshaped portion 24d in the axial direction is shorter than the length of the second wave-unshaped portion 24e in the axial direction. As described above, by arranging the wavy portion 24c on the proximal end side of the linear member 20 (particularly the intermediate portion 24), force is easily applied to the wavy portion 24c when force is applied to the proximal end portion 22 in the axial direction for insertion or removal. As a result, unexpected bending of the linear member 20 at the wavy non-forming portion (particularly the first non-forming portion 24d) is suppressed, and the wavy portion 24c can slide more smoothly along the inner wall of the tubular member 10. Furthermore, the length of the first non-forming portion 24d in the axial direction is preferably shorter than the length of the wavy portion 24c in the axial direction. This makes it easier for force to be transmitted to the wavy portion 24c when applied to the proximal end portion 22 to insert the linear member 20 into the tubular member 10. Furthermore, the length of the second non-forming portion 24e in the axial direction is preferably longer than the length of the first length region 24a. This allows the second non-forming portion 24e to be positioned 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 allows the sealing member 30 to slide straight in the approximately axial direction.

[0049] In this embodiment, the difference (hereinafter also referred to as clearance; the sum of differences L2a and 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 the wave-shaped portion of the intermediate portion 24 (wave-shaped 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 proximal end 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, the sufficient clearance allows the intermediate portion 24 to be pressed against the inner wall of the tubular member 10 at the bent portion 29, increasing the sliding resistance of the intermediate portion 24 against the inner wall of the tubular member 10. As a result, the linear member 20 is prevented from accidentally coming out of the tubular member 10. Furthermore, since the pullout strength is 2.6 N or more but less than 6.5 N, it is relatively easy to pull the linear member 20 out of the tubular member 10 using an instrument or the like, while it is difficult to pull the linear member 20 out of the tubular member 10 by grasping the proximal end 22 with a hand or the like, thereby preventing the linear member 20 from accidentally pulling 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 its natural state. In other words, the clearance is the value obtained by subtracting the inner diameter of the tubular member 10 from the amplitude of the corrugated portion 24c in its natural state. The pullout strength is the force required to pull out the linear member 20, which has been 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 proximal end relative to the tubular member 10.

[0050] (Catheter Set) As shown in FIG. 1 , the balloon guidewire 1 may be provided as a component of a catheter set 100. Specifically, the catheter set 100 includes the balloon guidewire 1 and a catheter 200. The balloon guidewire 1 is inserted into the catheter 200. Specifically, the catheter 200 has 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 proximal to the balloon member 40). Specifically, after the balloon guidewire 1 is inserted into a body cavity, the proximal end of the balloon guidewire 1 can be passed through the wire lumen 210, and the catheter 200 can be advanced distally along the outer layer side of the balloon guidewire 1. Furthermore, in this embodiment, the width of the wire lumen 210 may be smaller or larger than the width of the balloon member 40 in a contracted or expanded state. As a result, the catheter 200, which advances distally along the balloon guidewire 1 through a body lumen, can stop at a position proximal to the balloon member 40. In this embodiment, the wire lumen 210 is provided only in a portion of the distal end of the catheter 200. The catheter 200 has a main lumen 220 that extends longitudinally of the catheter 200 and is distinct from the wire lumen 210. The catheter 200 supplies a drug to a body lumen or aspirates and removes substances from the body lumen via the main lumen 220. In the catheter 200, the open end (distal end) of the wire lumen 210 is preferably positioned to protrude distally (distal to) the opening of the main lumen 220. In other words, the portion of the catheter 200 that forms the opening of the wire lumen 210 protrudes distally beyond the portion of the catheter 200 that forms the opening of the main lumen 220. In this embodiment, the distal end of the catheter 200 (particularly the portion where the main lumen 220 may be formed) has a shape that is notched into a smoothly curved surface. As a result, the tip of the wire lumen 210 is positioned closer to the tip of the catheter 200 than the tip of the main lumen 220 .Alternatively, the wire lumen 210 may be formed distal to the opening of the catheter 200 so that the open end of the wire lumen 210 is positioned distal to the opening of the main lumen 220, thereby positioning the tip of the wire lumen 210 at the very tip of the catheter 200.

[0051] Second Embodiment FIG. 1 is a schematic plan view showing an example of a medical device 1 (a guidewire with a balloon 1) according to this embodiment.

[0052] The medical device of the second embodiment comprises a tubular member and a linear member that is disposed in a lumen at the base end of the tubular member and is movable in the axial direction of the tubular member, wherein the distal end of the linear member is provided with a sealing member that adheres to a portion of the inner wall that defines the lumen of the tubular member, the linear member having the distal end, an intermediate portion that is proximal to the distal end, and a proximal end that is proximal to the intermediate portion, the distal end, the intermediate portion and the proximal end each having a partial length region with a uniform outer diameter, the outer diameter of the partial length region in the intermediate portion being smaller than 85% of the width of the lumen of the tubular member, and of the partial length regions of the distal end, the intermediate portion and the proximal end, the partial length region of the proximal end is the thickest and the partial length region of the distal end is the thinnest.

[0053] (Medical Device) First, an overview of the medical device 1 of this embodiment will be described. The medical device 1 has a tubular member 10 and a linear member 20. The linear member 20 is disposed in the lumen 11 at the proximal end 22 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 around the 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 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, intermediate portion 24, and proximal end 22 each have a partial length region with a uniform outer diameter. The outer diameter of the partial length region having a uniform diameter in the intermediate portion 24 is smaller than 85% of the width of the lumen 11 of the tubular member 10. Among 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. With the above-described configuration, the distal end of the linear member is thin and flexible, allowing the distal end of the linear member to bend or deform when the linear member is accidentally pushed into the tubular member. This prevents the sealing member from immediately moving when the linear member is pushed into the tubular member. As a result, a medical device can be provided that provides good control over the movement of the sealing member within the lumen. Specifically, the thin and flexible distal end 26 of the linear member 20 allows good control over the movement of the sealing member 30 within the lumen 11. For example, the distal end 26 of the linear member 20 can bend or deform when the linear member 20 is accidentally pushed into the tubular member 10. This prevents the sealing member 30 from moving immediately when the linear member 20 is pushed into the tubular member 10. To give a specific example, even if the linear member 20 is accidentally inserted deeper into the lumen 11 (toward the tip side) while the sealing member 30 is positioned proximal to the injection port 18 (positioned in the open position, which will be described in detail later) and a liquid or the like is being injected into the lumen 11 through the injection port 18, the sealing member 30 is prevented from immediately moving and blocking part or all of the injection port 18.Therefore, the injection port 18 is not accidentally blocked, preventing the injection of the predetermined amount of liquid, and it is easy to accurately inject a predetermined amount of liquid into the lumen 11. Furthermore, as will be described later, the sealing member 30 in this embodiment is disposed on the outer diameter side of the tip portion 26 of the linear member 20. Because the tip portion disposed on the inner diameter side of the sealing member 30 has a small diameter, the sealing member 30 can be formed sufficiently thick (wide) to be pressed against the inner wall of the tubular member 10, thereby improving the sealing ability of the sealing member 30 to the lumen 11. Specifically, by thinning the tip portion 26 of the linear member 20, it is possible to increase the distance from the surface of the tip portion 26 to the inner wall of the tubular member 10 (the inner wall that defines the lumen 11). In some cases, it may be desirable to form a thick sealing member 30 that exceeds the distance from the surface of the distal end 26 to the inner wall of the tubular member 10, with the intention of sufficiently pressing the sealing member 30 against the inner wall of the tubular member 10 to increase the sliding resistance of the sealing member 30 on the inner wall and thereby effectively sealing the lumen 11. Generally, if a thick sealing member 30 is formed that exceeds the distance from the surface of the distal end 26 to the inner wall of the tubular member 10, a greater force is required to insert the sealing member 30 into the tubular member 10, which may make it difficult to insert the sealing member 30 into the lumen 11. However, if the distal end 26 of the linear member 20 is thin and the distance from the surface of the distal end 26 to the inner wall of the tubular member 10 is large, the sealing member 30 will be sufficiently thick and will be able to deform elastically. This allows the sealing member 30 to be easily inserted into the tubular member 10. Furthermore, since the wire diameter becomes thicker in the order of the tip portion 26, the intermediate portion 24, and the base portion 22, force applied to the base portion 22 in the axial direction (force applied to the base portion 22 from the base end side to the tip side) is easily transmitted to the tip portion 26, allowing the sealing member 30 formed at the tip portion 26 to slide more smoothly within the lumen 11.

[0054] The medical device 1 of this embodiment is characterized in that the diameters of multiple partial length regions in the linear member 20 have a predetermined size relationship, regardless of the manner of expansion of the balloon member 40 in the balloon-equipped guide wire 1 (medical device 1) described in the first embodiment.

[0055] Next, the medical device 1 of this embodiment will be described in detail. Descriptions that overlap with those of the medical device 1 of the first embodiment will be omitted as appropriate. The medical device 1 (balloon-equipped guidewire 1) of this embodiment is an instrument for embolizing an opening in a hollow portion, such as a body cavity, or a tubular organ in a living organism. An example of the medical device 1 is a hemostatic instrument inserted into a blood vessel or the like. Furthermore, the medical device 1 of this embodiment is a particularly long member inserted into a body cavity, and is an entirely long member. An example of the medical device 1 is a guidewire or catheter inserted into a blood vessel or the like. The medical device 1 of this embodiment is a balloon-equipped guidewire 1. More specifically, as shown in FIG. 1 , the medical device 1 of this embodiment is a balloon-equipped guidewire 1 having a balloon on a portion of the distal end. That is, a tubular member 10 has a balloon member 40 on the outer diameter side of a portion of the distal end.

[0056] As shown in FIGS. 1 and 2(a), the first transitional section 25 is disposed between the distal end section 26 and the intermediate section 24. The second transitional section 23 is disposed between the intermediate section 24 and the proximal end section 22. The first transitional section 25 and the second transitional section 23 each have a tapered shape. The first transitional section 25 and the second transitional section 23 are transitional sections in the linear member 20, each of which has a larger rate of change in outer diameter than the proximal end section 22, the intermediate section 24, or the distal end section 26 adjacent to the transitional section. The rate of change in outer diameter refers to the amount of change in outer diameter per predetermined length. In this embodiment, the outer diameters of the proximal end section 22, the intermediate section 24, and the distal end section 26 are substantially uniform and do not change. Furthermore, the outer diameter of the linear member 20 gradually decreases in the second transitional section 23 or the first transitional section 25 from the proximal end section 22 to the intermediate section 24 or from the intermediate section 24 to the distal end section 26. Alternatively, in the case where the outer diameter of the base end portion 22, the intermediate portion 24, and the tip end portion 26 gradually increases or decreases toward the tip at a small rate of change, the transitional portion may be the portion where the outer diameter increases or decreases at a rate greater than that of the base end portion 22, etc. The angle of the tapered shape of the second transitional portion 23 with respect to the axial direction is greater than the angle of the tapered shape of the first transitional portion 25 with respect to the axial direction. The rate of change of the outer diameter of the second transitional portion 23, which decreases toward the tip, is greater than the rate of change of the outer diameter of the first transitional portion 25, which decreases toward the tip. The angle of the tapered shape of the first transitional portion 25 or the second transitional portion 23 with respect to the axial direction is the angle between the extending direction of the surface of the tapered first transitional portion 25 or the second transitional portion 23 and the axial direction. Note that due to the wave-shaped forming portion 24c described below, the extending direction of the first transitional portion 25 or the second transitional portion 23 (the axial direction of the central axis of the first transitional portion 25 or the second transitional portion 23) may not be parallel to the axial direction of the tubular member 10, but may intersect or be twisted relative to the axial direction. In this case, the angle between the tapered shape of the first transitional portion 25 or the second transitional portion 23 and the axial direction in a state in which the extending direction of the first transitional portion 25 or the second transitional portion 23 and the axial direction of the tubular member 10 are not parallel may be the angle that the tapered shape of the transitional portion makes with the axial direction.Alternatively, the angle between the tapered shape of the first transitional section 25 or the second transitional section 23 and the axial direction of the tubular member 10 when the extending direction of the first transitional section 25 or the second transitional section 23 is corrected to be parallel to the axial direction may be the angle that the tapered shape of the transitional section makes with the axial direction. The outer diameter (wire diameter) of the proximal end 22 is greater than the width of the lumen 11. As shown in FIG. 1 , when the linear member 20 is fully inserted into the tubular member 10, a portion of the distal side of the second transitional section 23 is inserted into the lumen 11, and a portion of the proximal side of the second transitional section 23 is disposed outside the lumen 11. At this time, the surface of the second transitional section 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 threaded through the tubular member 10, the second transitional portion 23 between the base end portion 22 and the intermediate portion 24 acts as a flange, preventing the linear member 20 from being inserted excessively into the tubular member 10. Furthermore, because the first transitional portion 25 has a gentle taper, the linear member 20 is less likely to break at the first transitional portion 25, where the wire diameter changes, when the linear member 20 is pushed into the tubular member 10. It is preferable that the length of the second transitional portion 23 in the axial direction be shorter than the length of the first transitional portion 25 in the axial direction. This is because the second transitional portion 23 can be inclined more greatly with respect to the axial direction, and the first transitional portion 25 can be inclined less with respect to the axial direction.

[0057] As shown in FIG. 3 , the intermediate portion 24 of the linear member 20 has a wave-like shape. Specifically, the intermediate portion 24 is bent at multiple bends 29. In this embodiment, the intermediate portion 24 is bent at eight bends 29. The bends 29, which are multiple first bends 29a and multiple second bends 29b, are alternately arranged in the intermediate portion 24. In this embodiment, the intermediate portion 24 has four first bends 29a and four second bends 29b. The wave-like shape is formed by mountain folds or valley folds at the multiple first bends 29a and multiple second bends 29b, respectively. The bends 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, which will be described later. Here, a mountain fold refers to a fold in one direction intersecting the axial direction, and a valley fold refers to a fold in a direction different (particularly the opposite direction) from the predetermined mountain fold 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 multiple second bent portions 29b.

[0058] The right side of Fig. 4 is the distal end side, and the left side of Fig. 4 is the proximal end side. As will be described in detail later, Fig. 4 illustrates the linear member 20 in a shape when disposed outside the tubular member 10 (in a 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 from 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 regions 24a and the second length regions 24b are alternately arranged in the intermediate portion 24, sandwiching the bent portion 29 therebetween. 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 at the distal end 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 at the distal end. The lengths of the first length region 24a and the second length region 24b refer to the lengths of the first length region 24a and 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 at least one-quarter but less than one-half the length of the second length region 24b adjacent to the first length region at the distal end. The lengths of the multiple first length regions 24a may be substantially the same as each other. The lengths of the multiple second length regions 24b may also be substantially the same as each other. The lengths of the plurality of length regions being substantially the same means that each length is 90% to 110% of the average length of the plurality of length regions. Alternatively, the length of one first length region 24a may be greater than the lengths of other first length regions 24a located distally of the one first length region 24a. Similarly, the length of one second length region 24b may be greater than the lengths of other second length regions located distally of the one second length region 24b.As a result, when the linear member 20 is pulled out, the linear member 20 catches on the inner wall of the tubular member 10 at the bent portion 29 on the proximal side of the intermediate portion 24, and when the linear member 20 is inserted, the bent portion 29 on the distal side allows the linear member 20 to slide smoothly against the tubular wall. This is because the amplitude, described below, in the intermediate portion 24 becomes smaller toward the distal end and becomes larger toward the proximal end. Specifically, if 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 due to the short length of the first length region 24a or the second length region 24b. When the amplitude is small, the force that the linear member 20 applies to the inner wall of the tubular member 10 becomes smaller. In other words, when the amplitude is small, the sliding resistance of the linear member 20 against the tubular member 10 becomes smaller. Alternatively, the length of one first length region 24 a may be smaller than the length of another first length region 24 a located distally of the one first length region 24 a. Similarly, the length of one second length region 24 b may be smaller than the length of another second length region located distally of the one second length region 24 b. This increases the sliding resistance of a portion of the distal end of the linear member 20 (intermediate portion 24), thereby suppressing unexpected movement of the sealing member 30.

[0059] 4, the angle that the first length region 24a forms with respect to the axial direction is larger than the angle that the second length region 24b forms with respect to the axial direction. With the above configuration, the first length region 24a is arranged so as to stand upright with respect to 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 an attempt is made to pull out the linear member 20 from the tubular member 10, the linear member 20 gets caught at the first bent portion 29a and is therefore less likely to come out of the tubular member 10.

[0060] In the intermediate portion 24, the amplitude of the waveform in a distal portion is smaller than the amplitude of the waveform in another portion closer to the base end than the distal portion. As described above, the smaller amplitude in the distal portion 26 prevents the linear member 20 from getting stuck on the tubular wall of the tubular member 10 at the distal end of the waveform-forming portion 24c when inserted. This allows the linear member 20 to be smoothly inserted into the tubular member 10. The amplitude of the waveform in a partial length region in 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 the waveform is the extension direction ignoring the waveform. For example, the extension direction of the waveform-forming portion 24c is the direction indicated by the dashed line III in FIG. 3 . Furthermore, the maximum dimension of the partial length region in a direction perpendicular to the extension direction of the entire partial length region is the maximum 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 the first bent portion 29 a and the second bent portion 29 b that are adjacent to each other (e.g., amplitude L1a in FIG. 3 ) is smaller than the amplitude of other partial length regions including other first bent portions 29 a and other second bent portions 29 b that are adjacent to each other on the proximal end side of the partial length region (e.g., amplitude L1b, amplitude L1c, or amplitude L1d in FIG. 3 ). The amplitudes L1a, L1b, L1c, and L1d may increase in this order. In this embodiment, the amplitude L1a of the partial length region including the first bent portion 29 a and the second bent portion 29 b that are located most distally in the intermediate portion 24 (the partial length region that does not include the first bent portion 29 a and the second bent portion 29 b that are located second from the distal end) is smaller than the amplitude of the entire intermediate portion 24 (particularly the wave-shaped portion 24 c). Furthermore, the amplitude L1a is smaller than the average amplitude (average of amplitudes L1a to L1d) of the length region near the first bent portion 29a and the second bent portion 29b that are adjacent to each other. Furthermore, in this embodiment, the amplitude L1a is smaller than any of amplitudes L1b to L1d.More specifically, in this embodiment, the amplitude of the waveform in a distal portion of the intermediate portion 24 may be substantially the same as the amplitude of another portion of the waveform closer to the base end than the distal portion. That is, the amplitude of the waveform may be constant from the distal end to the base end of the intermediate portion 24. Note that the amplitudes of multiple waveform portions may be substantially the same, and the magnitude relationship between the amplitudes may be established as described above. The phrase "the amplitude of one portion is substantially the same as the amplitude of another portion" means that the amplitude of the one portion is 90% to 110% of the amplitude of the other portion adjacent to the one portion, and the maximum amplitude of the comparison is 1.5 times or less than the minimum amplitude of the comparison. For example, when comparing the amplitudes of two adjacent length regions, the phrase "the amplitude of one portion is substantially the same as the amplitude of the other portion" means that the amplitude of one portion is 90% to 110% of the amplitude of the other portion. As in this embodiment, when adjacent first bent portions 29a and second bent portions 29b are grouped together, there may be three or more groups, and three or more amplitudes (amplitudes L1a to L1d) may be present. When determining whether multiple amplitudes are substantially the same in this manner, the amplitude of one portion and the amplitude of another portion are considered to be substantially the same if the amplitude of the one portion is within a range of 90% to 110% of the amplitude of the other portion adjacent to the one portion, and the maximum value of the target amplitude is 1.5 times or less than the minimum value of the target amplitude. Alternatively, the amplitude of one portion and the amplitude of another portion do not have to be substantially the same. That is, the amplitude of one portion may be less than 90% or more than 110% of the amplitude of the other portion. Furthermore, when comparing the amplitudes of multiple length regions, the maximum amplitude may be more than 1.5 times the minimum amplitude.

[0061] As will be described later, the amplitude of the wavy portion 24c when disposed outside the tubular member 10 (in its natural state) 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 portions 29. That is, when disposed in the lumen 11, the wavy portion 24c has a shape that is more flattened than its shape in its natural state. Specifically, when disposed in the lumen 11, the amplitude of the wavy portion 24c is approximately equal to the width of the lumen 11, and the radius of curvature at the bent portions 29 is greater than the radius of curvature of the bent portions 29 in its natural state. The radius of curvature of the bent portions 29 described in the upper part or in the latter part may be the radius of curvature of the bent portions 29 in the wave-shaped portion 24c disposed in the lumen 11, or may be the radius of curvature of the bent portions 29 in the wave-shaped portion 24c in its natural state. Furthermore, the amplitude of the wave-shaped portion 24c described in the upper part or in the latter part may be the amplitude of the wave-shaped portion 24c disposed in the lumen 11, or may be the amplitude of the wave-shaped portion 24c in its natural state. For convenience of explanation, Figure 4 illustrates the shape of the wave-shaped portion 24c in its natural state. Therefore, although Figure 4 appears to show the bent portions 29 biting into the inner wall of the tubular member 10, in reality, the bent portions 29 deform so as to be widened and press against the inner wall of the tubular member 10, as described above.

[0062] In this embodiment, the radius of curvature of the bent portion 29 is smaller than the length of the second length region 24b. This makes 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 thus gives the bent portion 29 a pointed shape, which makes it easier for the linear member 20 to catch 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 a perfect circular arc, and the radius of curvature may be constant throughout the entire length of the bent portion 29. Alternatively, the radius of curvature may not be constant throughout 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 portion of the bent portion 29 on the distal end side or the portion of the proximal end side. The radius of curvature at the bent portion 29 is preferably larger than the length of the first length region 24a. This prevents the intermediate portion 24 from bending at the first bent portion 29a, causing the first length region 24a to get stuck and prevent the linear member 20 from being pulled out, 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 pulling the linear member 20 out of the tubular member 10.

[0063] In this embodiment, the radius of curvature of the first bent portion 29a and the radius of curvature of the second bent portion 29b adjacent to the first bent portion 29a across the first length region 24a are substantially the same. The "radius of curvature of the first bent portion 29a and the radius of curvature of the second bent portion 29b being substantially the same" refers to the radius of curvature of the first bent portion 29a being 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 and the radius of curvature of the second bent portion 29b being substantially the same" refers to the radius of curvature of the first bent portion 29a being between 90% and 110% of the radius of curvature of the second bent portion 29b. Furthermore, in this embodiment, the radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same. The expression "the radii of curvature of the first bent portions 29a" or "the radii of curvature of the second bent portions 29b are substantially the same" means that the radius of curvature of one first bent portion 29a (or second bent portion 29b) is 90% to 110% of the radius of curvature of another first bent portion 29a (or second bent portion 29b) adjacent to the first bent portion 29a (or second bent portion 29b), and the maximum radius of curvature of the target first bent portion 29a (or second bent portion 29b) is 1.5 times the minimum radius of curvature of the target first bent portion 29a (or second bent portion 29b). Furthermore, 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. By reducing the radius of curvature of the first bent portion 29a as described above, the linear member 20 is caught by the first bent portion 29a when the linear member 20 is removed, making it easier for the first length region to stand upright in the axial direction. As a result, accidental removal of the linear member 20 is suppressed. On the other hand, because 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 that is closer to a straight line, making it harder for the first length region 24a to stand upright in the axial direction when the linear member 20 is inserted.As a result, when inserting the linear member 20 into the tubular member 10, the first length region 24a is prevented from standing upright in the axial direction, making it difficult to insert the linear member 20 into the tubular member 10.

[0064] The radius of curvature of one second bent portion 29b located on the distal side may be larger than the radius of curvature of another second bent portion 29b located closer to the base end than the one second bent portion 29b. This allows the intermediate portion 24 to slide more easily on the inner wall of the tubular member 10 toward the distal end, and the sliding resistance against the inner wall of the tubular member 10 increases toward the proximal end. This makes it difficult for the linear member 20 to be accidentally pulled out of the tubular member 10, but makes it easier to insert the linear member 20 into the tubular member 10. Alternatively, the radius of curvature of one second bent portion 29b located on the distal side may be smaller than the radius of curvature of another second bent portion 29b located closer to the base end than the one second bent portion 29b. This increases the sliding resistance on the distal side of the intermediate portion 24. As a result, unexpected axial movement of the sealing member 30 is suppressed when an unexpected force is applied to the linear member 20. Alternatively, the radii of curvature of the plurality of second bent portions 29b may be substantially the same from the distal end to the proximal end. Similarly, the radius of curvature of one first bent portion 29a disposed distally may be greater than the radius of curvature of another first bent portion 29a disposed proximally relative to the first bent portion 29a. Alternatively, the radius of curvature of one first bent portion 29a disposed distally may be smaller than the radius of curvature of another first bent portion 29a disposed proximally relative to the 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 disposed in the closed position that maintains the balloon member 40 in an expanded diameter state, the sealing member 30 is prevented from shifting proximally due to internal pressure in the lumen 11, etc. Alternatively, the radii of curvature of the plurality of first bent portions 29a may be substantially the same from the distal end to the proximal end.

[0065] As shown in FIG. 1 or 3 , the intermediate section 24 has a wave-shaped portion 24c, a first wave-unshaped portion (first wave-unshaped portion 24d), and a second wave-unshaped portion (second wave-unshaped portion 24e). The wave-shaped portion 24c is a portion of the intermediate section 24 where a wave is formed. The first wave-unshaped portion 24d and the second wave-unshaped portion 24e are wave-unshaped portions where no wave is formed. The first wave-unshaped portion 24d is a partial length region located closer to the base end than the wave-shaped portion 24c. The second wave-unshaped portion 24e is a partial length region located closer to the tip end than the wave-shaped portion 24c. As shown in FIG. 1 , the length of the first wave-unshaped portion 24d in the axial direction is shorter than the length of the second wave-unshaped portion 24e in the axial direction. As described above, by arranging the wavy portion 24c on the proximal end side of the linear member 20 (particularly the intermediate portion 24), force is easily applied to the wavy portion 24c when force is applied to the proximal end portion 22 in the axial direction for insertion or removal. As a result, unexpected bending of the linear member 20 at the wavy non-forming portion (particularly the first non-forming portion 24d) is suppressed, and the wavy portion 24c can slide more smoothly along the inner wall of the tubular member 10. Furthermore, the length of the first non-forming portion 24d in the axial direction is preferably shorter than the length of the wavy portion 24c in the axial direction. This makes it easier for force to be transmitted to the wavy portion 24c when applied to the proximal end portion 22 to insert the linear member 20 into the tubular member 10. Furthermore, the length of the second non-forming portion 24e in the axial direction is preferably longer than the length of the first length region 24a. This allows the second non-forming portion 24e to be positioned 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 allows the sealing member 30 to slide straight in the approximately axial direction.

[0066] In this embodiment, the difference (hereinafter also referred to as clearance; the sum of differences L2a and 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 the wave-shaped portion of the intermediate portion 24 (wave-shaped 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 proximal end 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, the sufficient clearance allows the intermediate portion 24 to be pressed against the inner wall of the tubular member 10 at the bent portion 29, increasing the sliding resistance of the intermediate portion 24 against the inner wall of the tubular member 10. As a result, the linear member 20 is prevented from accidentally coming out of the tubular member 10. Furthermore, since the pullout strength is 2.6 N or more but less than 6.5 N, it is relatively easy to pull the linear member 20 out of the tubular member 10 using an instrument or the like, while it is difficult to pull the linear member 20 out of the tubular member 10 by grasping the proximal end 22 with a hand or the like, thereby preventing the linear member 20 from accidentally pulling 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 its natural state. In other words, the clearance is the value obtained by subtracting the inner diameter of the tubular member 10 from the amplitude of the corrugated portion 24c in its natural state. The pullout strength is the force required to pull out the linear member 20, which has been 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 proximal end relative to the tubular member 10.

[0067] As described above, the outer diameter of the intermediate portion 24 is preferably smaller than the difference between the outer diameter of the distal end portion 26 and the outer diameter of the proximal end portion 22. This allows the linear member 20 to be pulled out of the tubular member 10 with a predetermined pullout strength even when the clearance is large. In this regard, the relationship between clearance and pullout strength for multiple medical devices 1 will be explained using FIG. 8 . As shown in FIG. 8 , there is a positive correlation between clearance and pullout strength. FIG. 8 shows a graph in which the clearance of each medical device 1 in a group of medical devices 1 having different outer diameters of the intermediate portion 24 is plotted on the x-axis and the pullout strength on the y-axis, approximating the relationship for the group of medical devices 1 to a linear function. Figure 8 was created by designating groups A, B, and C as medical devices 1 having (average) outer diameters of the intermediate portion 24 of 0.215 mm, 0.210 mm, and 0.185 mm, respectively. In all of Groups A, B, and C, the difference between the outer diameter of the distal portion 26 and the outer diameter of the proximal portion 22 is 0.190 mm. That is, in Groups A and B, the outer diameter of the intermediate portion 24 is greater than the difference between the outer diameter of the distal portion 26 and the outer diameter of the proximal portion 22, while in Group C, the outer diameter of the intermediate portion 24 is smaller than the difference between the outer diameter of the distal portion 26 and the outer diameter of the proximal portion 22. As shown in Figure 8, when the clearance is in the range of 0.090 mm or more and less than 0.15 mm, which fully includes the range of 0.095 mm or more and less than 0.135 mm, the actual measured pull-out strength of the medical devices 1 in Group A is between 3.5 N and 10.5 N, and the actual measured pull-out strength of the medical devices 1 in Group B is between 4.5 N and 7.0 N. On the other hand, the actual measured pull-out strength of the medical devices 1 in Group C is between 3.5 N and 5.0 N. That is, of groups A to C, only the medical device 1 in group C has a pull-out strength value that is equal to or greater than 2.6 N and less than 6.5 N. When the clearance is in the range of 0.095 mm or greater and less than 0.135 mm, the actual measured pull-out strength values ​​for the medical device 1 in groups B and C are equal to or greater than 2.6 N and less than 6.5 N. When the clearance is in the range of 0.090 mm or greater and less than 0.15 mm, the pull-out strength calculated based on the approximation formula in the graph above is as follows: The pull-out strength for group A is equal to or greater than 2.5 N and less than 13.3 N, and the pull-out strength for group B is equal to or greater than 4.0 N and less than 6.6 N.On the other hand, the pullout strength in Group C is 3.8 N or more and 5.4 N or less, and falls within the above-mentioned range of 2.6 N or more and less than 6.5 N. When the clearance is in the range of 0.095 mm or more and less than 0.135 mm, the pullout strength values ​​for the medical devices 1 in Groups B and C fall within the above-mentioned range of 2.6 N or more and less than 6.5 N. The slopes of the approximation equations of the graphs for Groups A, B, and C are 178.37 [N / mm], 41.01 [N / mm], and 23.37 [N / mm], respectively, and the intercepts are -13.54 N, 0.39 N, and 1.79 N. In a medical device 1 group consisting of a plurality of medical devices 1, when the relationship between the increase in pullout strength and the increase in clearance is approximated to a linear function with clearance [mm] on the X-axis and pullout strength [N] on the Y-axis, the slope is 10 or more, preferably 20 or more. Furthermore, the inclination is less than 100, preferably less than 50, and more preferably less than 30. When the inclination is smaller than a predetermined value, the range of pull-out strength of the medical device 1 can be narrowed even when the range of clearance is large. On the other hand, when the inclination is larger than a predetermined value, the linear member 20 has sufficient rigidity to be less likely to come out of the tubular member 10 (to have sufficient pull-out strength).

[0068] Next, the distal end of the tubular member 10 (the portion where the balloon member 40 is disposed and its vicinity) will be described in detail. In this embodiment, when a liquid or gas (e.g., liquid) is injected through the injection port 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 shown in FIG. 5 , the attachment portion 13 is a portion of the tubular member 10 disposed 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 member wall. The attachment portion 13 has a spring-forming portion 15 on the proximal end side and a non-spring-forming portion 17 on the distal end side. The spring-forming portion 15 is a portion formed with a spring that can expand and contract in the axial direction, such as by forming a spiral slit 44. The non-spring-forming portion 17 is a portion without a spiral slit 44 and without a spring that does not substantially expand and contract in the axial direction. Because the distal end portion of the attachment portion 13 does not have a spring, this portion is less flexible than the spring-formed portion 15 and is more rigid than the spring-formed 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 relative to the extension direction of the non-spring-formed portion 17, which is the distal end portion of the attachment portion 13. In other words, if the entire attachment portion 13 were a spring, the entire attachment portion 13 would be flexible, and the balloon member 40 would be expanded while unexpectedly bending or twisting. However, because the distal end portion of the attachment portion 13 does not have significant flexibility, the balloon member 40 can be expanded approximately in the axial direction.

[0069] 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 non-spring-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. Alternatively, 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 non-spring-forming portion 17.

[0070] 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 axial distance from one end of the tip of one turn to one end of the tip of another turn adjacent to the tip of the one turn. In other words, the winding pitch can be considered the sum of the width of the spiral slit 44 and the width 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. 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 of the spring. 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 the spring that is distal to the first region 15a1. The third region 15a3 is a region of the spring that is distal to the second region 15a2. In this embodiment, the winding pitch in the second region 15a2 is the smallest among the winding pitches of the attachment portion 13. The small winding pitch in the second region 15a2 increases the amount of liquid flowing into the hollow portion 42, allowing the liquid to be efficiently delivered into the hollow portion 42. Furthermore, the large winding pitch in the third region 15a3, which is distal to the second region 15a2, prevents the tubular member 10 from accidentally bending between the spring-forming portion 15 and the non-spring-forming portion 17.

[0071] In this embodiment, the first region 15a1 to the third region 15a3 are all disposed in the attachment 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 attachment portion 13, thereby preventing the attachment portion 13 from becoming excessively flexible. Furthermore, 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. The large width of the spiral slit 44 in the second region 15a2 allows sufficient communication between the hollow portion 42 and the lumen 11. Furthermore, the small width of the spiral slit 44 in the first region 15a1 or the third region 15a3 maintains the rigidity of the first region 15a1 or the third region 15a3, preventing the attachment portion 13 from becoming excessively flexible. That is, the above configuration allows the hollow portion 42 and the lumen 11 to be sufficiently connected in the second region 15a2 while maintaining the rigidity of the attachment portion 13 within a desired range. The large-diameter state and small-diameter state refer to the expanded diameter states of the balloon member 40. Expanding the diameter of the balloon member 40 from the reduced-diameter state leads to the small-diameter state and then to the large-diameter state. The large-diameter state refers to a state in which the width of the balloon member 40 has increased to approximately the maximum inner diameter of a typical wide-width lumen in the body in which the medical device 1 is to be used. For example, in the medical device 1 of this embodiment, the balloon member 40 is placed in a blood vessel (e.g., a carotid artery), and the typical inner diameter of the blood vessel is 5 mm, while the typical wide-width inner diameter of a carotid artery is approximately 6 mm to 7 mm. That is, the large-diameter state of the balloon member 40 in the medical device 1 of this embodiment refers to a state in which the width of the balloon member 40 has expanded to approximately 6.5 mm. The amount of fluid that must be injected to change from the reduced diameter state to the increased diameter state is referred to as the total injection amount. The reduced diameter state is the state of the balloon member 40 when approximately one-fourth of the total injection amount of fluid is injected.

[0072] In this embodiment, the spring is also formed in a portion of the pipe wall proximal to the attachment portion 13 (proximal forming portion 15d). That is, the proximal forming portion 15d is also 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 within the hollow portion 42, but also in the pipe wall disposed on the inner diameter side of the seal band 46 and the first adhesive 51 and the pipe wall proximal to the first adhesive 51 (the pipe wall in the proximal forming portion 15d). That is, the spring is integrally formed in the pipe wall within the hollow portion 42, the pipe wall disposed on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall in the proximal forming portion 15d. Because the spring is also formed in the proximal forming portion 15d, the proximal forming portion 15d is flexible. 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, preventing unnecessary loads from being applied to the balloon member 40 and nearby components (e.g., adhesive 50, etc.). This prevents deformation of the balloon member 40 and nearby components, preventing damage to the balloon member 40 or leakage of liquid from the balloon member 40, for example. The winding pitch of the spring formed in the proximal forming portion 15d is greater than the winding pitch in the third region 15a3. In other words, the width of the ribbon 15a in the proximal forming portion 15d is greater 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 proximal side of the spring-forming portion 15.

[0073] In this embodiment, the angle of the spiral direction of a portion of the ribbon 15a relative to the axial direction in the contracted diameter 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 relative to the axial direction may be 60 degrees or more. Alternatively, the angle of the spiral direction of substantially the entire ribbon 15a at the attachment portion 13 relative to the axial direction may be 60 degrees or more. More preferably, this angle is 75 degrees or more. This allows the spring-forming portion 15 to expand and contract in the axial direction more effectively. As a result, the balloon member 40 can be sufficiently expanded in the axial direction in the small-diameter state or the large-diameter state (expanded state). Similarly, the angle of the spiral direction of a portion of the ribbon 15a relative to the axial direction may be 60 degrees or more in the small-diameter state or the large-diameter state.

[0074] The present invention is not limited to the above-described embodiment and includes various modifications, improvements, and the like, as long as the object of the present invention is achieved. For example, in the above embodiment, the carotid artery is illustrated as an example of a blood vessel in which the balloon guidewire 1 is placed. However, this is merely an example and is not limiting. Other blood vessels, such as the aorta, may also 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. Furthermore, the balloon guidewire 1 may also be used for post-dilation of a stent graft (not shown) placed in another blood vessel (e.g., the aorta). 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 approximately 20 mm to 40 mm.

[0075] The above embodiments include the following technical ideas: (1) A balloon-equipped guidewire comprising: a tubular member having a lumen and a tubular wall at a proximal end provided with an opening communicating with the lumen; a balloon member provided on the outer diameter side of a distal 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 proximal end of the tubular member and movable in the axial direction of the tubular member, wherein a sealing member is provided at the distal end of the linear member so as to come into close contact with a part of the inner wall of the tubular member, and the sealing member moves in the axial direction of the linear member between a closed position where the sealing member closes the opening or is disposed distal to the opening and blocks the flow of fluid from the opening to the interior, and an open position proximal to the opening of the tubular member, and the tubular wall at the distal end of the tubular member is a spring in which a ribbon is spirally arranged with a central axis of the tubular member as an axis with gaps between turns, a balloon-equipped guidewire according to claim 1, wherein the width of the gap is less than one-fifth the width of the ribbon, and when the volume of the balloon member is increased by injecting a 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-equipped guidewire as described in (1), wherein an attachment portion, which is a portion of the tubular wall arranged on the inner diameter side of the balloon member, has a spring-formed portion on the proximal end side where the spring is formed, and a spring-free portion on the distal 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 of the attachment portion is greater than the length of the spring-free portion in the axial direction of the attachment portion. (3) The balloon guide wire described in (2), wherein the interior of the balloon member and the lumen are connected via the gap, the winding pitch in a second region of the spring that is distal to the first region on the base end side is smaller than the winding pitch in the first region, and the winding pitch in a third region of the spring that is distal to the second region is larger than the winding pitch in the second region.(3-2) A balloon-equipped guidewire, in which 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 larger than the width of the spiral slit 44 in the first region or the third region. (4) A balloon-equipped guidewire as described in (3), in which the spring is also formed in a portion of the tube wall that is closer to the base end than the attachment portion. (4-1) A balloon-equipped guidewire, in which the winding pitch of the spring formed in the proximal-end forming portion is larger than the winding pitch in the third region. (5) A balloon-equipped guidewire as described in any one of (1) to (4), in which, 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) A balloon-equipped guidewire as described in (5), in which 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 guidewire comprising: a catheter into which the balloon guidewire is inserted; and the balloon guidewire comprising: a tubular member having a lumen and having an opening in a tubular wall at a base end portion thereof that communicates 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 communicates 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; wherein a sealing member is provided at the tip end portion of the linear member so as to come into close contact with a part of the inner wall of the tubular member; and the sealing member moves in the axial direction of the linear member between a closed position where the sealing member closes the opening or is disposed distal to the opening and blocks the flow of fluid from the opening toward the interior, and an open position proximal to the opening of the tubular member, as the linear member moves in the axial direction. a catheter set in which the tubular wall at the distal end of the tubular member is a spring in which a ribbon is spirally arranged with gaps between turns of the ribbon around the central axis of the tubular member, the width of the gaps being less than 1 / 5 of the width of the ribbon, and when the volume of the balloon member is increased by injecting a 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-equipped guidewire is inserted is smaller than the width of the balloon member in a contracted or expanded state.(8) A medical device comprising: a tubular member; and a linear member disposed in a lumen at a proximal end of the tubular member and movable in the axial direction of the tubular member, wherein a sealing member is provided at the distal end of the linear member to fit tightly against a portion of an inner wall defining the lumen of the tubular member, wherein the linear member has the distal end, an intermediate portion proximal to the distal end, and a proximal end proximal to the intermediate portion, wherein the distal end, the intermediate portion, and the proximal end each have a partial length region having a uniform outer diameter, wherein the outer diameter of the partial length region in the intermediate portion is smaller than 85% of the width of the lumen of the tubular member, and wherein, of the partial length regions of the distal end, the intermediate portion, and the proximal end, the partial length region of the proximal end is the thickest and the partial length region of the distal end is the thinnest. (8-1) A medical device wherein the outer diameter of the intermediate portion is smaller than the difference between the outer diameter of the distal end and the outer diameter of the proximal end. (9) The medical device according to (8), wherein a first transitional section between the distal end and the intermediate section and a second transitional section between the intermediate section and the proximal end each have a tapered shape, an angle of the tapered shape of the second transitional section with respect to the axial direction is larger than an angle of the tapered shape of the first transitional section with respect to the axial direction, and a wire diameter of the proximal end is larger than a width of the lumen. (9-1) A medical device, wherein a length of the first transitional section in the axial direction is shorter than a length of the second transitional section in the axial direction. (10) The medical device described in (9), wherein the intermediate portion of the linear member is bent at a plurality of bending portions to have a wave shape, the wave shape being formed by mountain folds or valley folds at a plurality of alternatingly arranged first bending portions and a plurality of second bending portions, respectively, the length of a first length region from a first bending portion to a second bending portion adjacent to the first bending portion on the tip side of the first bending portion is smaller than the length of a second length region to another first bending portion adjacent to the second bending portion on the further tip side of the second bending portion, and the angle formed by the first length region with respect to the axial direction is larger than the angle formed by the second length region with respect to the axial direction.(10-1) A medical device in which the length of one first length region is greater than the length of another first length region located distally of the one first length region, and the length of one second length region is greater than the length of another second length region located distally of the one second length region. (11) A medical device according to (10), in which the amplitude of the waveform in a distal portion of the intermediate section is smaller than the amplitude of the waveform in another portion proximal to the distal portion. (11-1) A medical device in which the amplitude in a partial length region including the first bent portion located most distally and the second bent portion located most distally in the intermediate section is smaller than the average amplitude of a length region near the group of adjacent first bent portions and second bent portions. (12) A medical device according to (11), in which the radius of curvature of the bent portion is smaller than the length of the second length region. (12-1) A medical device in which the radius of curvature of the bent portion is greater than the length of the first length region. (13) The medical device according to (12), wherein the intermediate section has a wave-formed section in which the wave shape is formed, a first wave-non-formed section in which the wave shape is not formed and which is located proximal to the wave-formed section, and a second wave-non-formed section which is located distal to the wave-formed section, and wherein the length of the first wave-non-formed section in the axial direction is shorter than the length of the second wave-non-formed section in the axial direction. (13-1) A medical device wherein the length of the first non-formed section in the axial direction is shorter than the length of the wave-formed section in the axial direction. (13-2) A medical device wherein the length of the second non-formed section in the axial direction is longer than the length of the first length region. (14) The medical device according to any one of (10) to (13), wherein a difference between an inner diameter of the tubular member when the linear member is disposed outside the tubular member and an amplitude of a part of the linear member having the wave shape in the intermediate portion is 0.095 mm or more and less than 0.135 mm, and a force required to move the linear member toward the proximal end side of the tubular member relative to the tubular member is 2.6 N or more and less than 6.5 N. (15) The medical device according to (14), wherein a radius of curvature of a first bent portion is smaller than a radius of curvature of a second bent portion adjacent to the first bent portion across the first length region.(15-1) A medical device in which the radius of curvature of one first bent portion located on the distal side is larger than the radius of curvature of another first bent portion located proximal to the one first bent portion, and the radius of curvature of one second bent portion located distally is larger than the radius of curvature of another second bent portion located proximal to the one second bent portion. (16) A group of medical devices in which the relationship between the increase in the pull-out strength and the increase in the difference between the inner diameter of the tubular member and the amplitude is approximated to a linear function with the difference [mm] on the X-axis and the pull-out strength [N] on the Y-axis, and the slope is 10 or more, preferably 20 or more, and the slope is less than 100, preferably less than 50, and more preferably less than 30. (17) A balloon-equipped guidewire in which the expansion rate in the width direction decreases as the expansion stage progresses, and the expansion rate in the axial direction increases as the expansion stage progresses.

[0076] This application claims priority based on Japanese Patent Application No. 2023-165927 filed on September 27, 2023, and Japanese Patent Application No. 2023-165928 filed on September 27, 2023, the disclosures of which are incorporated herein in their entireties.

[0077] 1 Medical device, balloon-equipped guide wire 10 Tubular member 11 Lumen 12 Proximal end opening 13 Attachment portion 14 Coil portion 15 Spring-forming portion 15a Ribbon 15a1 First region 15a2 Second region 15a3 Third region 15d Proximal end formed portion 16 Distal tip 17 Spring-non-forming portion 18 Inlet 19 Radiopaque marker 20 Linear member 22 Proximal end portion 23 Second transition portion 24 Intermediate portion 24a First length region 24b Second length region 24c Wave-shaped formed portion 24d First non-forming portion 24e Second non-forming portion 25 First transition portion 26 Distal portion 29 Bent portion 29a, 29a1, 29a2 First bent portion 29b, 29b1 Second bent portion 30 Sealing member 40: Balloon member 41: Membrane portion 42: Hollow portion 44: Spiral slit 46: Seal band 50: Adhesive 51: First adhesive 52: Second adhesive 53: Third adhesive 100: Catheter set 200: Catheter 210: Wire lumen 220: Main lumen

Claims

1. A balloon guidewire comprising: a tubular member having a lumen and a tubular wall at a base end provided with an opening communicating 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, and the sealing member moves in the axial direction of the linear member between a closed position where the sealing member blocks the opening or is disposed distal to the opening and blocks the flow of fluid from the opening to the inside, and an open position proximal to the opening of the tubular member, and the tubular wall at the tip end of the tubular member is a spring in which a ribbon is spirally arranged with a central axis of the tubular member as an axis with gaps between turns, A balloon-equipped guidewire, wherein the width dimension of the gap is less than 1 / 5 of the width dimension of the ribbon, and when the volume of the balloon member is increased by injecting liquid or gas through the opening, the dimensions of the balloon member in each of the radial and axial directions of the tubular member increase, thereby expanding the balloon member.

2. A balloon guidewire as described in claim 1, wherein the attachment portion, which is a portion of the tubular member's wall 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. A balloon guidewire as described in claim 2, wherein the interior of the balloon member and the lumen are in communication via the gap, the winding pitch in a second region of the spring that is distal to a first region on the base end side is smaller than the winding pitch of the first region, and the winding pitch in a third region of the spring that is distal to the second region is larger than the winding pitch of 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 base end side relative to the mounting portion.

5. A balloon-equipped guidewire as described in any one of claims 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-equipped guidewire according to claim 5, wherein an angle of the helical direction of a portion of said ribbon with respect to said axial direction is 60 degrees or more.

7. A balloon guidewire comprising: a catheter into which the balloon guidewire is inserted; the balloon 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 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; a sealing member 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 moving in the axial direction of the tubular member between a closed position where the opening is blocked or where the sealing member is disposed distal to the opening and blocks the flow of fluid from the opening toward the inside, and an open position proximal to the opening of the tubular member in accordance with the movement of the linear member in the axial direction; a catheter set in which the tubular 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, the width dimension of the gap being less than 1 / 5 of the width dimension of the ribbon, and 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.

8. A medical device comprising: a tubular member; and a linear member disposed in a lumen at a base end of the tubular member and movable in the axial direction of the tubular member, wherein a sealing member is provided at a tip end of the linear member which is in close contact with a portion of an inner wall defining the lumen of the tubular member, wherein the linear member has the tip end, an intermediate portion proximal to the tip end, and a base end proximal to the intermediate portion, wherein the tip end, intermediate portion and base end each have a partial length region having a uniform outer diameter, and the outer diameter of the partial length region at the intermediate portion is smaller than 85% of the width of the lumen of the tubular member, and among the partial length regions of the tip end, intermediate portion and base end, the partial length region of the base end is the thickest and the partial length region of the tip end is the thinnest.

9. The medical device of claim 8, wherein a first transition section between the distal end and the intermediate section, and a second transition section between the intermediate section and the proximal end, each have a tapered shape, an angle of the tapered shape of the second transition section relative to the axial direction is greater than an angle of the tapered shape of the first transition section relative to the axial direction, and a wire diameter of the proximal end is greater than a width of the lumen.

10. The medical device according to claim 9, wherein the intermediate portion of the linear member has a wavy shape formed by being folded at a plurality of bending portions, the wavy shape being formed by mountain folds or valley folds at a plurality of first bending portions and a plurality of second bending portions that are alternately arranged, the length of a first length region from a first bending portion to a second bending portion adjacent to the first bending portion on the tip side of the first bending portion being smaller than the length of a second length region to another first bending portion adjacent to the second bending portion on the further tip side of the second bending portion, and the angle that the first length region makes with respect to the axial direction being larger than the angle that the second length region makes with respect to the axial direction.

11. The medical device according to claim 10, wherein in the intermediate section, the amplitude of the waveform in one part on the tip side is smaller than the amplitude of the waveform in another part on the base end side of the one part.

12. The medical device of claim 11, wherein the radius of curvature at the bend is less than the length of the second length region.

13. The medical device of claim 12, wherein the intermediate portion has a wave-shaped forming portion in which the wave shape is formed, a first wave-shaped non-forming portion in which the wave shape is not formed and which is located on the base end side of the wave-shaped forming portion, and a second wave-shaped non-forming portion which is located on the tip end side of the wave-shaped forming portion, and the length of the first wave-shaped non-forming portion in the axial direction is smaller than the length of the second wave-shaped non-forming portion in the axial direction.

14. A medical device according to any one of claims 10 to 13, wherein the difference between the inner diameter of the tubular member when the linear member is disposed outside the tubular member and the amplitude of a portion of the linear member having the wave shape in the middle portion is 0.095 mm or more and less than 0.135 mm, and the force required to move the linear member relative to the tubular member toward the base end of the tubular member is 2.6 N or more and less than 6.5 N.

15. The medical device of claim 14, wherein the radius of curvature of a first bent portion is smaller than the radius of curvature of a second bent portion adjacent to the first bent portion across the first length region.

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