Medical treatment device

Abstract

To provide a medical treatment device suitably controlling movement in a lumen of a sealing member.SOLUTION: A linear member 20 has a tip end 26, an intermediate part 24 and a base end part 22. The intermediate part 24 is a part of a base end side with respect to the tip end 26 in the linear member 20, and the base end part 22 is a part of the base end side with respect to the intermediate part 24 in the linear member 20. The tip end 26, the intermediate part 24 and the base end part 22 each have a partial length region having a uniform external diameter. An external diameter of the partial length region having a uniform diameter in the intermediate part 24 is smaller than 85% of a width of a lumen 11 of a tubular member 10. In the partial length regions of the tip end 26, the intermediate part 24 and the base end part 22, the partial length region of the base end part 22 is the thickest and the partial length region of the tip end 26 is the thinnest.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to medical devices. [Background technology]

[0002] Some medical devices adjust the flow of liquids between a lumen and the outside by inserting and removing a linear member. For example, the following Patent Document 1 discloses a medical device in which a sealing member (30) is inserted into a tubular body (18) having an inflation port (22), and the sealing member (30) is advanced within or removed from the lumen (40) of the tubular body (18). When the sealing member (30) is partially withdrawn from the lumen (40) such that the sealer portion (36) is positioned proximal to the inflation port (22), liquid can be injected or withdrawn through the inflation port (22). On the other hand, when the sealing member (30) is fully inserted into the lumen (40) of the wire (32), the sealer portion (36) completely covers the secondary access inflation port (22), as shown in FIG. 3B of the '162 patent, and the outflow of liquid from the inflation port (22) is restricted. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2000-511082 Summary of the Invention [Problem to be solved by the invention]

[0004] However, there is room for improvement in controlling the movement of the sealer portion (36) in the lumen (40). For example, when an axial force is unexpectedly applied to the linear member provided with the sealing member (30) and the linear member is pushed into the tubular body (18), the sealer portion (36) may unexpectedly move in the lumen (40). More specifically, the sealer portion (36) may be disposed at a position proximal to the inflation port (22) and a predetermined amount of liquid may be injected into the lumen through the inflation port (22). At this time, if the linear member is unexpectedly pushed in and the sealer portion (36) is pushed distally, it may partially or completely block the inflation port (22), causing the liquid to be injected into the lumen (40) to overflow, making it impossible to accurately inject a predetermined amount into the lumen (40).

[0005] The present invention has been made in view of the above-mentioned problems, and provides a medical device in which the movement of a sealing member within a lumen can be well controlled. [Means for solving the problem]

[0006] The medical device of the present invention comprises 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 the tip end of the linear member which is in close contact with a portion of the inner wall defining the lumen of the tubular member, wherein the linear member has the tip end, an intermediate portion which is base end closer to the tip end, and a base end which is base end closer to the intermediate portion, wherein the tip end, the intermediate portion and the base end each have a partial length region having a uniform outer diameter, wherein 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, the intermediate portion and the 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.

[0007] As described above, the tip of the linear member is thin and flexible, so that the tip of the linear member can be deformed, such as bent, when the linear member is accidentally pushed into the inside of the tubular member. Therefore, the sealing member is prevented from moving immediately when the linear member is pushed into the inside of the tubular member. Effect of the Invention

[0008] According to the medical device of the present invention, the movement of the sealing member within the lumen can be well controlled. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic diagram showing an example of a medical device according to a first embodiment of the present invention. [Diagram 2] Figures 2(a) and 2(b) are schematic enlarged views of a portion of the area II indicated by the dashed line in Figure 1. Figure 2(a) shows an example of the sealing member in the open position, and Figure 2(b) shows an example of the sealing member in the closed position. [Diagram 3] FIG. 2 is a schematic diagram for explaining a structure of a linear member according to the first embodiment. [Figure 4] FIG. 2 is a schematic enlarged view of a portion within a frame IV indicated by a dashed dotted line in FIG. [Diagram 5] 3 is a schematic diagram showing an example of a balloon member and its vicinity according to the first embodiment. FIG. [Figure 6] 10 is a graph showing the relationship between the clearance and pull-out strength between the inner diameter of a tubular member and the amplitude of a linear member in a natural state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The various components of the medical device of the present invention do not need to be independent entities individually, and it is permitted that multiple components are formed as a single member, that one component is formed from multiple members, that one component is part of another component, that part of one component overlaps with part of another component, etc.

[0011] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the drawings, corresponding components are given the same reference numerals, and duplicated descriptions will be omitted as appropriate. Further, the term "flat surface" as used in the present invention means a shape that is physically formed with a flat surface as a target, and it is not necessarily required that the surface be a geometrically perfect flat surface.

[0012] First Embodiment (Medical Equipment) FIG. 1 is a schematic diagram showing an example of a medical device 1 according to a first embodiment of the present invention.

[0013] 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 a lumen 11 at a base 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 a tip 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, the intermediate portion 24, and the proximal end 22 each have a partial length region that has a uniform outer diameter. The outer diameter of the uniformly-diameter partial length region in intermediate portion 24 is smaller than 85% of the width of lumen 11 of tubular member 10. Of the partial length regions of distal portion 26, intermediate portion 24, and proximal portion 22, the partial length region of proximal portion 22 is the thickest, and the partial length region of distal portion 26 is the thinnest. In this way, since the tip 26 of the linear member 20 is thin and flexible, the movement of the sealing member 30 in the lumen 11 can be well controlled. For example, when the linear member 20 is accidentally pushed into the inside of the tubular member 10, the tip 26 of the linear member 20 bends. Therefore, when the linear member 20 is accidentally pushed into the inside of the tubular member 10, the sealing member 30 is prevented from moving immediately. As a specific example, even if the linear member 20 is accidentally inserted deep inside the lumen 11 (toward the tip side) when the sealing member 30 is disposed proximal to the injection port 18 (disposed in an open position described in detail later) and liquid or the like is injected into the lumen 11 from the injection port 18, the sealing member 30 is prevented from immediately moving and blocking a part or the whole of the injection port 18. Therefore, the injection of a predetermined amount of liquid is not hindered due to the injection port 18 being accidentally blocked, and it becomes easy to accurately inject a predetermined amount of liquid into the lumen 11. 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 . Since the tip portion arranged 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 well against the inner wall of the tubular member 10, thereby improving the sealing of the lumen 11 by the sealing member 30. 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 defining the lumen 11). There are cases where it is desired to form a thick sealing member 30 that exceeds the distance from the surface of the tip portion 26 to the inner wall of the tubular member 10, with the intention of pressing the sealing member 30 well against the inner wall of the tubular member 10 to increase the sliding resistance of the sealing member 30 on the inner wall and to seal the lumen 11 well. Generally, if a thick sealing member 30 is formed beyond the distance from the surface of the tip portion 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, and it may become difficult to insert the sealing member 30 into the lumen 11. However, if the tip portion 26 of the linear member 20 is thin and the distance from the surface of the tip portion 26 to the inner wall of the tubular member 10 is large, the sealing member 30 is sufficiently thick and can be deformed elastically. Therefore, the sealing member 30 can be easily inserted into the tubular member 10. Furthermore, since the wire diameter becomes thicker in the order of tip portion 26, intermediate portion 24, and base portion 22, force applied to base portion 22 in the axial direction (force applied to base portion 22 from the base end side to the tip side) is easily transmitted to tip portion 26, allowing the sealing member 30 formed at tip portion 26 to slide more smoothly within the lumen 11.

[0014] Next, the medical device 1 of this embodiment will be described in detail. The medical device 1 in this embodiment is a device for plugging an opening provided in a hollow part of a body cavity or a tubular organ in a living body. An example of the medical device 1 is a hemostatic device inserted into a blood vessel or the like. Furthermore, the medical device 1 in this embodiment is a member that is inserted into a particularly long body cavity and is a long member as a whole. An example of the medical device 1 is a guide wire or catheter that is inserted into a blood vessel or the like. The medical device 1 in this embodiment is a guide wire with a balloon. With regard to members such as the medical device 1, the tubular member 10, and the linear member 20, the end that is first inserted into the body cavity in the longitudinal direction (axial direction) of the medical device 1 may be called the tip, and the other end opposite to the tip (the end on the hand side that is operated) may be called the base. The base side may also be called the hand side or the proximal side, and the opposite side to the proximal side may also be called the distal side. The tubular member 10 is a long member extending with the longitudinal direction of the medical device 1 as the axial direction. The axial direction of the tubular member 10 may be simply referred to as the axial direction. In this embodiment, the tubular member 10 has superelasticity. For example, metal such as nickel titanium (nitinol) is exemplified as a material constituting the tubular member 10. Alternatively, the tubular member 10 may be made of other materials such as elastic resin. Alternatively, the tubular member 10 may be made of a material in which resin and metal are mixed, or may be configured by combining a resin portion and a metal portion. The tubular member 10 has a lumen 11 therein. The cross-sectional shape of the tubular member 10 is circular or polygonal, etc. The width of the lumen 11 (the inner diameter of the tubular member 10) is larger than the wire diameter of the linear member 20 described later. The lower limit of the outer diameter of the tubular member 10 is 250 μm, preferably 300 μm, and the upper limit of the outer diameter of the tubular member 10 is 400 μm, preferably 350 μm. The lower limit of the inner diameter of the tubular member 10 is 150 μm, preferably 200 μm, and the upper limit of the inner diameter of the tubular member 10 is 300 μm, preferably 250 μm. In addition, the lower limit of the thickness dimension of the tube wall of the tubular member 10 is 50 μm, preferably 80 μm, and the upper limit of the thickness dimension of the tube wall of the tubular member 10 is 150 μm, preferably 120 μm.

[0015] In the tubular member 10 of this embodiment, an injection port 18 (through hole) which is an opening communicating with the lumen 11 is provided in a part of the tubular wall on the base end side (a part into which the linear member 20 described later can be inserted). The injection port 18 is provided for injecting a fluid (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 from the outside via the injection port 18. The shape of the injection port 18 when viewed from the side of the medical device 1 may be circular or polygonal. The size of the injection port 18 in this embodiment (particularly the dimension of the injection port 18 in the axial direction) is smaller than the length of the sealing member 30 in the axial direction. In addition, the diameter of the injection port 18 is preferably larger than the thickness dimension of the tube wall of the tubular member 10.

[0016] As shown in FIG. 1, in this embodiment, a portion of the lumen 11 on the distal side (for example, a coil portion 14 described below or a portion on the proximal side of the coil portion 14) is closed. 5, in order to increase the flexibility of the tubular member 10, a portion of the most distal end of the tubular member 10 (coil portion 14) is formed of a coil in which wire is tightly wound in a helical shape. Furthermore, in order to facilitate the insertion of the tubular member 10 into a body cavity, a distal tip 16 is provided on the distal end of the coil portion 14. In this embodiment, the distal tip 16 is made of a metal such as an alloy of tin and gold.

[0017] As shown in FIG. 1, the medical device 1 of this embodiment is a balloon-attached guidewire having a balloon at a portion of the distal end. That is, the tubular member 10 has a balloon member 40 on the outer diameter side of a portion of the distal end. The balloon member 40 is a member that is arranged in a portion of the body cavity of a living body and expands in diameter to press against the inner wall that defines the body cavity to seal the body cavity or to block an opening provided in the wall. The balloon member 40 does not need to completely seal the body cavity or completely block the opening in the wall, but it is sufficient that it dams up the body cavity sufficiently to restrict the flow of liquid or the like through the body cavity or the opening in the wall, or that it covers the opening in the wall. For example, the balloon member 40 is arranged in a blood vessel in an expanded state and presses against the blood vessel wall to suppress the flow of blood. As shown in FIG. 5, the balloon member 40 has a hollow portion 42 therein covered with a membrane portion 41. The hollow portion 42 of the balloon member 40 communicates with the lumen 11 of the tubular member 10 (see FIG. 1). For example, a through-hole such as a groove that connects the lumen 11 to the outside is provided in the tubular wall of a part (attachment portion 13) of the tubular member 10 arranged on the inner diameter side of the balloon member 40, and the hollow portion 42 and the lumen 11 communicate with each other through the through-hole. In this embodiment, as described later, a spiral slit 44 is provided in the tubular wall of the tubular member 10, and the spiral slit 44 serves as a through-hole to connect the hollow portion 42 and the lumen 11. By injecting a liquid or gas (referred to as liquid or the like) into the hollow portion 42 of the balloon member 40 through the inlet 18, the lumen 11, and the spiral slit 44, the volume of the hollow portion 42 increases and the diameter of the balloon member 40 increases. The expansion of the balloon member 40 means that the dimension of the balloon member 40 in the radial direction of the medical device 1 becomes larger than before the injection of a liquid, etc. The radial direction of the medical device 1 is the radial direction from the axis of the medical device 1 (the axis of the tubular member 10) toward the periphery of the medical device 1 (the periphery of the tubular member 10) when viewed in the axial direction. A liquid such as physiological saline is preferably used as the liquid to be injected into the balloon member 40. A mixed liquid containing a contrast agent and physiological saline may also be used as the liquid.

[0018] 5, the spring forming portion 15, which is a part of the tip side of the tubular member 10, is a spring that can expand and contract in the axial direction by forming a spiral slit (spiral slit 44). Specifically, the tube wall that remains after the spiral slit 44 is formed is a narrow ribbon 15a, and the ribbon 15a is arranged spirally over multiple turns to form the spring. In this embodiment, ribbon 15a is a plate-like portion having a predetermined thickness. Ribbon 15a has a predetermined width. The width of ribbon 15a is the distance along the axial direction between one end of ribbon 15a on the tip side and one end of ribbon 15a on the base side in the axial direction. As described above, the width of the spiral slit 44 is less than one-fifth of the width of the ribbon 15a, and more preferably, the width of the spiral slit 44 is less than one-sixth of the width of the ribbon 15a. In order to stably inject a liquid or the like into the hollow portion 42, the width of the spiral slit 44 is preferably one-tenth or more of the width of the ribbon 15a, and more preferably one-twentieth of the width. The width of the spiral slit 44 is the distance along the axial direction between one end of the tip side of one turn of the ribbon 15a and one end of the base side of another turn adjacent to the tip side of the one turn. In this embodiment, the width of the spiral slit 44 is constant throughout the spring forming portion 15. Here, the ribbon 15a width being equal to or greater than the above-mentioned predetermined value or equal to or less than the above-mentioned predetermined value refers to the width of the narrowest ribbon 15a (ribbon 15a in a second region 15a2 described below) in the entire spring forming portion 15. In other words, the ribbon 15a in a length region other than the second region 15a2 does not have to be equal to or greater than the predetermined value or equal to or less than the predetermined value. Alternatively, the ribbon 15a width of the entire spring forming portion 15 may be equal to or greater than the above-mentioned predetermined value or equal to or less than the above-mentioned predetermined value. In this embodiment, the spiral direction of the ribbon 15a is opposite to the spiral direction of the coil portion 14. The spiral direction of the ribbon 15a is also opposite to the spiral direction of the radiopaque marker 19 described below. This prevents the radiopaque marker 19 from interfering with the spiral slit 44 of the spring forming portion 15. Alternatively, the spiral direction of the ribbon 15a may be the same as the spiral direction of the coil portion 14 or the radiopaque marker 19.

[0019] 5, the balloon member 40 (particularly the membrane portion 41 which is its main body portion) is disposed so as to go around the periphery of the tubular member 10 and has a cylindrical shape. A seal band 46 is disposed on the outer layer side of a part of the distal end side and a part of the proximal end side of the balloon member 40. The seal band 46 presses the balloon member 40 from the outer layer side to assist in fixing the balloon member 40 to the tubular member 10. In this embodiment, a resin layer (not shown) is provided on the outer layer side of the tubular member 10 as a base for arranging the balloon member 40. The resin layer may be formed of a resin such as polyethylene terephthalate (PET). The resin layer is arranged, for example, on the outer layer side of a part of the tubular member 10 where the seal band 46 is arranged and on the outer layer side of the base end side forming portion 15d described below. The resin layer is not arranged on the outer layer side of a part of the tubular member 10 (second region 15a2, etc.) arranged in the hollow portion 42. This allows the hollow portion 42 and the lumen 11 to communicate with each other. Moreover, the balloon member 40 (particularly the membrane portion 41) is fixed (bonded) to the tubular member 10 by an appropriate adhesive 50. More specifically, a first adhesive 51 is disposed on the outer layer side of the tubular member 10 on the base end side of the balloon member 40. The first adhesive 51 is formed to have a tapered shape. In this embodiment, a coil-shaped X-ray impermeable marker 19 is embedded inside the first adhesive 51. That is, the first adhesive 51 may be disposed on the inner diameter side and the outer diameter side of the X-ray impermeable marker 19, or the first adhesive 51 may be disposed between the turns of the X-ray impermeable marker 19. Moreover, a second adhesive 52 is provided on the distal end side of the balloon member 40 in a dome shape inflated toward the distal end. A third adhesive 53 is formed in a tapered shape to cover the second adhesive 52 and on the outer layer side of the tubular member 10. The third adhesive 53 is disposed on the outer layer side of the coil portion 14. In this embodiment, the thickness (width dimension) of the adhesive 50 is equivalent to the thickness of the balloon member 40 (particularly the thickness of the seal band 46). The length of the first adhesive 51 in the axial direction is smaller than the length of the third adhesive 53 in the axial direction. The angle that the tapered shape of the third adhesive 53 makes with respect to the axial direction is smaller than the angle that the tapered shape of the first adhesive 51 makes with respect to the axial direction. This makes it difficult for the flexibility of the coil portion 14 to be hindered by the third adhesive 53. In addition, when inserting the medical device 1 into a body cavity (particularly a narrowed portion), the third adhesive 53 is prevented from interfering with the insertion.

[0020] 1, the linear member 20 is disposed in the lumen 11 of the tubular member 10. Specifically, an opening (proximal end opening 12) is provided at the proximal end of the tubular member 10, which penetrates the tubular member 10 in the axial direction and connects the outside of the tubular member 10 to the lumen. The linear member 20 is inserted into the lumen 11 from the proximal end opening 12. The linear member 20 is disposed in a portion of the proximal end side of the tubular member 10. More specifically, the linear member 20 is inserted from the proximal end of the tubular member 10 to the vicinity of the injection port 18. In this embodiment, a part of the base end side of the linear member 20 (the base end 22 and a part of the second transition portion 23 described later) protrudes from the base end opening 12 at the base end of the tubular member 10 toward the base end side and is disposed outside the tubular member 10. Therefore, by holding a part of the linear member 20 disposed outside the tubular member 10 (particularly the base end 22) with an instrument or a hand, etc. and then pulling out or inserting it, the linear member 20 can be moved in the axial direction of the tubular member 10 inside the tubular member 10. By moving the linear member 20 in the axial direction of the tubular member 10, the position of the sealing member 30 attached to the tip end 26 of the linear member 20 can be changed in the axial direction of the tubular member 10. This makes it possible to adjust the inflow and outflow of liquid, etc. in the lumen 11 as described later.

[0021] 1 is a member for adjusting the flow of liquid or gas in the lumen 11. The sealing member 30 is fixed (anchored) around the tip 26 of the linear member 20. The sealing member 30 in this embodiment is made of a resin such as a thermoplastic resin. Alternatively, the sealing member 30 may be made of a resin other than a thermoplastic resin, or may be made of other materials (such as high-density cotton) that allow a small amount of liquid or gas to pass through. The sealing member 30 seals the lumen 11 by pressing or adhering to a part of the inner wall of the tubular member 10 in the axial direction and substantially the entire circumferential direction of the inner wall. Specifically, the sealing member 30 presses and preferably adheres to at least a part of the inner wall of the tubular member 10 in the radial direction, preferably in close contact. More preferably, the sealing member 30 adheres to the inner wall of the tubular member 10 in the entire radial direction of the tubular member 10. That is, the sealing member 30 seals substantially the entire cross section of the lumen 11. This restricts the movement of liquids and the like in the lumen 11 in the axial direction by sandwiching the sealing member 30. The width dimension of the sealing member 30 (the dimension in the direction perpendicular to the axial direction of the linear member 20; the diameter of the sealing member 30) when the linear member 20 is taken out of the tubular member 10 is preferably larger than the width of the lumen 11. As a result, the sealing member 30 is pressed against a part of the inner wall of the tubular member 10 in the lumen 11. As illustrated in FIG. 2(a) and FIG. 2(b), the sealing member 30 can move between a closed position and an open position in accordance with the axial movement of the linear member 20. The closed position of the sealing member 30 is a position where the sealing member 30 blocks the injection port 18 or is disposed distal to the injection port 18 to liquid-tightly or air-tightly seal a part of the lumen 11 (a part 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 a fluid (such as a liquid) from the injection port 18 through the lumen 11 to the hollow portion 42. Blocking the flow of a fluid refers to the flow of a fluid being sufficiently restricted (the fluid is dammed up) to the extent that the expanded diameter state of the balloon member 40 can be maintained for a predetermined time, and is not limited to the flow of a fluid being completely blocked. The open position of the sealing member 30 is a position closer to the base 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. Note that the positions of other members when the sealing member 30 is in the closed position or open position may be referred to as the closed position or open position. As shown in FIG. 2(a), in the open position, the sealing member 30 is disposed at a position closer to the base end than the injection port 18. Therefore, a part of the lumen 11 on the tip side than the injection port 18 and the hollow portion 42 (see FIG. 5) are in communication with the outside of the tubular member 10 via the injection port 18. Therefore, a liquid or the like can be injected into the hollow portion 42 via the injection port 18, or a liquid or the like within the hollow portion 42 can be withdrawn via the injection port 18. Note that in the open state, the sealing member 30 prevents the inflow of a liquid or the like from the injection port 18 into a part of the lumen 11 on the base end side. As shown in FIG. 2(b), in the closed position, the sealing member 30 is disposed at approximately the same position as the injection port 18 in the axial direction of the tubular member 10 or at a position on the tip side of the position. Specifically, when the sealing member 30 is disposed at approximately the same position as the injection port 18, the sealing member 30 and the injection port 18 at least partially overlap when the tubular member 10 is viewed from the side. At this time, the sealing member 30 is in contact (pressed against) at least a part of the edge of the injection port 18. Preferably, when the tubular member 10 is viewed from the side (from a direction perpendicular to the axial direction), the entire injection port 18 overlaps with the sealing member 30. At this time, it is preferable that the sealing member 30 is in contact (pressed against) approximately the entire edge of the injection port 18 (a part of the tube wall that defines the injection port 18 and is disposed so as to go around the injection port 18). As a result, at least a part (preferably the entirety) of the injection port 18 is blocked by the sealing member 30. This prevents liquid or the like from leaking out of the injection port 18. When a liquid or the like is injected into the lumen 11 and the hollow portion 42 and the balloon member 40 is expanded in diameter, the liquid or the like in the hollow portion 42 is prevented from leaking to the outside through the lumen 11 and the injection port 18, thereby maintaining the expanded state of the balloon member 40. As shown in FIG. 2(b), in the sealing member 30 of this embodiment, the center in the axial direction is a large diameter portion, and the diameter decreases from the large diameter portion toward both ends in the axial direction. The width of the large diameter portion of the sealing member 30 is larger than the width of the lumen 11 in the natural state (a state in which the sealing member 30 is disposed outside the tubular member 10). The length of the large diameter portion in the axial direction is smaller than the dimension of the injection port 18 in the axial direction. Therefore, as shown in FIG. 2(b), when the sealing member 30 is disposed in the closed position to block the injection port 18, a part of both ends of the large diameter portion is in pressure contact with a part of the pipe wall that defines the injection port 18. Instead of this embodiment, the length of the large diameter portion in the axial direction may be the same as or larger than the dimension of the injection port 18 in the axial direction. In this case, as shown in FIG. 2(b), when the sealing member 30 is disposed in the closed position to block the injection port 18, it is preferable that the large diameter portion is in pressure contact with a part of the pipe wall that defines the injection port 18.

[0022] As illustrated in FIG. 1, the base end 22 of the linear member 20 is a part of the linear member 20 on the base end side. Specifically, the base end 22 is a part of the linear member 20 that protrudes from the base end opening 12 to the base end side and is disposed outside the tubular member 10. The tip end 26 of the linear member 20 is a part of the linear member 20 to which the sealing member 30 is fixed and a length region in the vicinity of the part. In this embodiment, the tip end 26 is a length region from the tip of the linear member 20 to a position slightly toward the base end side from the position where the sealing member 30 is fixed. The intermediate portion 24 of the linear member 20 is a partial length region disposed at a position sandwiched between the base end 22 and the tip end 26 of the linear member 20. It is preferable that the intermediate portion 24 is disposed in the lumen 11 almost entirely in the closed position. In addition, a partial length region on the base end side of the intermediate portion 24 may protrude from the base end opening 12 to the outside of the lumen 11 in the open position.

[0023] Each of the base end 22, the intermediate portion 24, and the tip portion 26 has a uniform outer diameter in a partial length region or the entire length region in the axial direction. In this embodiment, each of the base end 22, the intermediate portion 24, and the tip portion 26 has a uniform outer diameter in the entire length region in the axial direction. Here, the uniform outer diameter means a substantially uniform outer diameter, and may not have a completely uniform outer diameter due to slight unevenness, etc. In FIG. 1, the outer diameter, inner diameter (width of the lumen 11) of the tubular member 10, the outer diameter of the linear member 20 (particularly the outer diameter of the base end 22, the intermediate portion 24, the tip portion 26, and the transition portion described later), and the size of the sealing member 30 are partially exaggerated for convenience. The same applies to FIG. 2(a) to FIG. 5. The outside diameter of the base end 22 is preferably approximately equal to the outside diameter of the tubular member 10. Specifically, the outside diameter of the base end 22 is preferably at least two-thirds and less than 1.5 times the outside diameter of the tubular member 10. The lower limit of the outside diameter of the base end 22 is, for example, 0.250 mm, preferably 0.300 mm. The upper limit of the outside diameter of the base end 22 is, for example, 0.400 mm, preferably 0.350 mm. The outer diameter of the intermediate portion 24 is smaller than the width of the lumen 11 (the dimension of the lumen 11 in a direction perpendicular to the axial direction. The diameter of the lumen 11), and is preferably less than 85% of the width of the lumen 11 as described above. In addition, the outer diameter of the intermediate portion 24 is larger than the outer diameter of the tip portion 26 and smaller than the outer diameter of the base portion 22. Preferably, the outer diameter of the intermediate portion 24 is smaller than the difference between the outer diameter of the tip portion 26 and the outer diameter of the base portion 22. As a result, the intermediate portion 24 has sufficient flexibility, so that even if the difference between the amplitude of the wave shape in the intermediate portion 24 described later and the width of the lumen 11 (clearance described later) is large, the linear member 20 can be pulled out from the tubular member 10 with a predetermined pull-out strength. This will be described in detail later. In addition, the outer diameter of the base portion 22 has a large value equal to or larger than the combined value of the outer diameter of the tip portion 26 and the outer diameter of the intermediate portion 24, so that the base portion 22 can be easily grasped and pulled out. Furthermore, since the outer diameter of the tip portion 26 is a small value less than the difference between the outer diameter of the base portion 22 and the outer diameter of the intermediate portion 24, the sealing member 30 can be formed sufficiently thick to be pressed well against the inner wall of the tubular member 10, thereby improving the sealing ability of the sealing member 30 against the lumen 11. The lower limit of the outer diameter of the intermediate portion 24 is, for example, 0.15 mm, preferably 0.17 mm. The upper limit of the outer diameter of the intermediate portion 24 is, for example, 0.23 mm, preferably 0.20 mm. The outer diameter of the tip portion 26 is preferably equal to or greater than half the width of the lumen 11. In this embodiment, the outer diameter of the tip portion 26 is approximately equal to the diameter of the injection port 18. Specifically, the outer diameter of the tip portion 26 is equal to or greater than two-thirds and less than 1.5 times the diameter of the injection port 18. The lower limit of the outer diameter of the tip portion 26 is, for example, 0.10 mm, preferably 0.12 mm. The upper limit of the outer diameter of the tip portion 26 is, for example, 0.20 mm, preferably 0.16 mm.

[0024] As shown in FIG. 1 and FIG. 2(a), the first transitional portion 25 is disposed between the tip portion 26 and the intermediate portion 24. The second transitional portion 23 is disposed between the intermediate portion 24 and the base end portion 22. The first transitional portion 25 and the second transitional portion 23 each have a tapered shape. The first transitional portion 25 and the second transitional portion 23 are partial length regions in which the rate of change in the outer diameter is greater than that of the base end portion 22, the intermediate portion 24, or the tip portion 26 adjacent to the transitional portion in the linear member 20. The rate of change in the outer diameter is the amount of change in the outer diameter per a predetermined length. In this embodiment, the outer diameters of the base end portion 22, the intermediate portion 24, and the tip portion 26 are almost uniform and do not change. In addition, the outer diameter of the linear member 20 gradually decreases in the second transitional portion 23 or the first transitional portion 25 from the base end portion 22 to the intermediate portion 24, or from the intermediate portion 24 to the tip portion 26. Alternatively, in the case where the outer diameter of the base end 22, the intermediate portion 24, and the tip end 26 gradually increases or decreases at a small rate of change toward the tip, the portion where the outer diameter increases or decreases at a rate of change greater than the rate of change at the base end 22, etc. may be defined as the transition portion. The angle of the tapered shape of the second transition section 23 with respect to the axial direction is larger than the angle of the tapered shape of the first transition section 25 with respect to the axial direction. The rate of change of the outer diameter of the second transition section 23, which narrows toward the tip, is larger than the rate of change of the outer diameter of the first transition section 25, which narrows toward the tip. The angle of the tapered shape of the first transition section 25 or the second transition section 23 with respect to the axial direction is the angle between the extension direction of the surface of the first transition section 25 or the second transition section 23 having the tapered shape and the axial direction. Note that, due to the wave-shaped forming section 24c described later, the extension direction of the first transition section 25 or the second transition section 23 (the axial direction of the central axis of the first transition section 25 or the second transition section 23) may not be parallel to the axial direction of the tubular member 10, but may cross or be twisted with each other. In this case, the angle between the tapered shape of the first transition section 25 or the second transition section 23 and the axial direction in a state in which the extending direction of the first transition section 25 or the second transition section 23 is not parallel to the axial direction of the tubular member 10 may be the angle that the tapered shape of the transition section makes with respect to the axial direction. Alternatively, the angle between the tapered shape of the first transition section 25 or the second transition section 23 and the axial direction in a state in which the extending direction of the first transition section 25 or the second transition section 23 is corrected to be parallel to the axial direction of the tubular member 10 may be the angle that the tapered shape of the transition section makes with respect to the axial direction. The outer diameter (wire diameter) of the base end 22 is larger than the width of the lumen 11. As shown in Fig. 1, when the linear member 20 is completely inserted into the tubular member 10, a part of the distal side of the second transition portion 23 is fitted into the lumen 11, and a part of the proximal side of the second transition portion 23 is disposed outside the lumen 11. At this time, the surface of the second transition portion 23 abuts against the proximal end of the inner wall that defines the lumen 11. With the above configuration, when the linear member 20 is passed through the tubular member 10, the second transition portion 23 between the base end portion 22 and the intermediate portion 24 serves as a flange, and the second transition portion 23 prevents the linear member 20 from being excessively inserted into the inside of the tubular member 10. In addition, because the first transition portion 25 has a gentle taper, when the linear member 20 is pushed into the tubular member 10, the linear member 20 is less likely to break at the first transition portion 25 where the wire diameter changes. It is preferable that the length of the second transition portion 23 in the axial direction is smaller than the length of the first transition portion 25 in the axial direction, because the second transition portion 23 can be inclined more to the axial direction and the first transition portion 25 can be inclined less to the axial direction.

[0025] As shown in FIG. 3, the intermediate portion 24 of the linear member 20 has a wave shape. Specifically, the intermediate portion 24 is folded at a plurality of folding portions 29. In this embodiment, the intermediate portion 24 is folded at eight folding portions 29. The folding portions 29 are a plurality of first folding portions 29a and a plurality of second folding portions 29b, which are alternately arranged in the intermediate portion 24. The intermediate portion 24 of this embodiment has four first folding portions 29a and four second folding portions 29b. The wave shape is formed by folding the first folding portions 29a and the second folding portions 29b into mountain or valley shapes, respectively. The folding portions 29 are length regions (curved or bent length regions) in the intermediate portion 24 that have a smaller radius of curvature than the first length region 24a or the second length region 24b described later. Here, the mountain folding refers to folding in one direction among the directions intersecting with the axial direction, and the valley folding refers to folding in a direction different from the predetermined direction of the mountain folding (particularly the opposite direction). In this embodiment, the linear member 20 is bent in a predetermined direction at the first bent portions 29a, and in a direction opposite to the predetermined direction at the second bent portions 29b. That is, the linear member 20 is bent in the same direction at the multiple first bent portions 29a, and the linear member 20 is bent in the same direction at the multiple second bent portions 29b. Alternatively, the linear member 20 may be bent in different directions at each of the multiple first bent portions 29a or each of the second bent portions 29b.

[0026] The right side in FIG. 4 is the distal end side, and the left side in FIG. 4 is the proximal end side. As will be described in detail later, in FIG. 4, the linear member 20 is shown in a shape when it is disposed outside the tubular member 10 (natural state). As shown in FIG. 4, the first length region 24a is a length region from one first bent portion 29a1 to a second bent portion 29b1 adjacent to the first bent portion 29a1 on the distal side of the first bent portion 29a1. The second length region 24b is a length region to another first bent portion 29a2 adjacent to the second bent portion 29b1 on the distal side of the second bent portion 29b1. In this embodiment, as shown in FIG. 3, the first length region 24a and the second length region 24b are alternately arranged in the intermediate portion 24 with the bent portion 29 in between. The length of the first length region 24a from one first bent portion 29a1 to the second bent portion 29b1 is shorter than the length of the second length region 24b from the second bent portion 29b1 to another first bent portion 29a2 adjacent to the second bent portion 29b1 on the tip side of the second bent portion 29b1. That is, the length of the first length region 24a is shorter than the length of the adjacent second length region on the tip side. The lengths of the first length region 24a and the second length region 24b are the lengths of the first length region 24a or the second length region 24b in the extension direction of the first length region 24a or the second length region 24b. In this embodiment, the length of the first length region 24a is equal to or greater than one-quarter and less than one-half the length of the second length region 24b adjacent to the first length region on the tip side. The lengths of the first length regions 24a may be substantially the same as each other. The lengths of the second length regions 24b may be substantially the same as each other. The lengths of the length regions being substantially the same as each other means that each length is 90% to 110% of the average value of the length regions. Alternatively, the length of one first length region 24a may be greater than the length of another first length region 24a located distally of the one first length region 24a. Similarly, the length of one second length region 24b may be greater than the length of another second length region located distally of the one second length region 24b. As a result, when the linear member 20 is pulled out, the linear member 20 is caught on the inner wall of the tubular member 10 at the bent portion 29 on the base end side of the intermediate portion 24, and when the linear member 20 is inserted, the linear member 20 slides smoothly against the tube wall at the bent portion 29 on the tip end side. This is because the amplitude of the linear member 20 in the intermediate portion 24, which will be described later, becomes smaller toward the tip end and becomes larger toward the base end. Specifically, when the bending angle in the bent portion 29 is constant, the amplitude of the linear member 20 in the vicinity of the first length region 24a or the second length region 24b becomes smaller because the length of the first length region 24a or the length of the second length region 24b is small. When the amplitude is small, the force applied by the linear member 20 to the inner wall of the tubular member 10 is small. That is, when the amplitude is small, the sliding resistance of the linear member 20 to the tubular member 10 is small. Alternatively, the length of one first length region 24a may be smaller than the length of another first length region 24a located on the distal side of the one first length region 24a. Similarly, the length of one second length region 24b may be smaller than the length of another second length region located on the distal side of the one second length region 24b. This increases the sliding resistance of a portion on the distal side of the linear member 20 (middle portion 24), thereby suppressing unexpected movement of the sealing member 30.

[0027] As shown in FIG. 4, the angle that the first length section 24a makes with respect to the axial direction is greater than the angle that the second length section 24b makes with respect to the axial direction. With the above-mentioned configuration, the first length region 24a is arranged to stand in the axial direction. This prevents the linear member 20 from being pulled out of the tubular member 10 even if the linear member 20 is accidentally pulled out of the tubular member 10. This is because even if the linear member 20 is about to be pulled out of the tubular member 10, the linear member 20 gets stuck at the first bent portion 29a and is therefore difficult to pull out of the tubular member 10.

[0028] In the intermediate portion 24, the amplitude of the waveform in one portion on the distal end side is smaller than the amplitude of the waveform in another portion on the proximal end side of the distal portion. As described above, the amplitude of the tip portion 26 is reduced, so that the tip side of the corrugated portion 24c of the linear member 20 is prevented from getting stuck on the tube wall of the tubular member 10 when the linear member 20 is inserted. This allows the linear member 20 to be inserted into the tubular member 10 in a good condition. The amplitude of the wave shape in the partial length region of the intermediate portion 24 is the maximum dimension of the partial length region in a direction perpendicular to the extension direction of the entire partial length region. The extension direction of the entire length region having a wave shape is the extension direction ignoring the wave shape. For example, the extension direction of the wave shape forming portion 24c is the direction shown by the dashed line III in FIG. 3. Moreover, the maximum dimension of the partial length region in the direction perpendicular to the extension direction of the entire partial length region is the maximum value of the distance between the first bent portion 29a and the second bent portion 29b along the direction perpendicular to the extension direction of the entire partial length region. In this embodiment, as shown in Fig. 3, the amplitude of a partial length region including a first bent portion 29a and a second bent portion 29b adjacent to each other (for example, amplitude L1a in Fig. 3) is smaller than the amplitude of another partial length region including another first bent portion 29a and another second bent portion 29b adjacent to each other on the base end side of the partial length region (for example, amplitude L1b, amplitude L1c, or amplitude L1d in Fig. 3). The values ​​may be larger in the order of amplitude L1a, amplitude L1b, amplitude L1c, and amplitude L1d. In this embodiment, the amplitude L1a in a partial length region including the first bent portion 29a and the second bent portion 29b arranged at the most distal end in the intermediate portion 24 (a partial length region not including the first bent portion 29a and the second bent portion 29b arranged second from the distal end) is smaller than the amplitude of the entire intermediate portion 24 (particularly the wave-shaped portion 24c). Moreover, the amplitude L1a is smaller than the average amplitude (average of the amplitudes L1a to L1d) of the partial length region near the group of the first bent portion 29a and the second bent portion 29b adjacent to each other. Furthermore, in this embodiment, the amplitude L1a is smaller than any of the amplitudes L1b to L1d. More specifically, in this embodiment, the amplitude of the waveform in a part on the tip side of the intermediate portion 24 may be substantially the same as the amplitude of the waveform in another part on the base end side of the part. That is, the amplitude of the waveform may be constant from the tip to the base end of the intermediate portion 24. In addition, the amplitudes of the multiple waveforms may be substantially the same, and the magnitude relationship between the amplitudes may be established as described above. The amplitude of one part and the amplitude of the other part may be substantially the same as the amplitude of the other part, and the amplitude of the other part may be 90% or more and 110% or less of the amplitude of the other part adjacent to the amplitude of the one part, and the maximum amplitude of the comparison object may be 1.5 times or less of the minimum amplitude of the comparison object. For example, when comparing the amplitudes of two adjacent length regions, the amplitude of one part and the amplitude of the other part may be substantially the same as the amplitude of the other part. When the first bent portion 29a and the second bent portion 29b that are close to each other are grouped together as in this embodiment, there may be three or more groups, and there may be three or more amplitudes (amplitudes L1a to L1d). When determining whether multiple amplitudes are approximately identical in this manner, the amplitude of one part is said to be approximately identical to the amplitude of another part if the amplitude of the one part is within the range of 90% to 110% of the amplitude of the other part adjacent to the one part, and the maximum value of the amplitude of the target is 1.5 times or less than the minimum value of the amplitude of the target. Alternatively, the amplitude of one portion and the amplitude of the other portion may not be substantially the same as each other. That is, the amplitude of one portion may be less than 90% of the amplitude of the other portion or more than 110%. Furthermore, when comparing the amplitudes of a plurality of length regions, the maximum amplitude may be more than 1.5 times the minimum amplitude.

[0029] As described later, the amplitude of the wavy portion 24c (in its natural state) when disposed outside the tubular member 10 is greater than the width of the lumen 11 in the tubular member 10 (the inner diameter of the tubular member 10). That is, the amplitude L4 shown in FIG. 4 is greater than the inner diameter L3 of the tubular member 10. Therefore, the wavy portion 24c is pressed against the inner wall of the tubular member 10 at the bent portion 29. That is, the wavy portion 24c when disposed in the lumen 11 has a shape that is more flattened than the shape in its natural state. Specifically, the amplitude of the wavy portion 24c when disposed in the lumen 11 is approximately equal to the width of the lumen 11, and the radius of curvature at the bent portion 29 is greater than the radius of curvature of the bent portion 29 in its natural state. The radius of curvature of the bent portion 29 described in the upper part or later may be the radius of curvature of the bent portion 29 in the corrugated portion 24c disposed in the lumen 11, or may be the radius of curvature of the bent portion 29 in the corrugated portion 24c in its natural state. Moreover, the amplitude of the corrugated portion 24c described in the upper part or later may be the amplitude of the corrugated portion 24c disposed in the lumen 11, or may be the amplitude of the corrugated portion 24c in its natural state. For convenience of explanation, the shape of the wave-shaped portion 24c in its natural state is shown in Fig. 4. Therefore, in Fig. 4, the bent portion 29 looks as if it is biting into the inner wall of the tubular member 10, but in reality, the bent portion 29 is deformed so as to be spread and is pressed against the inner wall of the tubular member 10 as described above.

[0030] In this embodiment, the radius of curvature at the bend 29 is smaller than the length of the second length region 24b. As a result, by making the radius of curvature of the bent portion 29 smaller than the length of the second length region 24b, which is the longest straight portion in the wave-shaped portion 24c, and forming a pointed shape, the linear member 20 is more likely to be caught on the inner wall of the tubular member 10 at the bent portion 29. As a result, the linear member 20 is less likely to come off the tubular member 10. The bent portion 29 is bent into an arc of a perfect circle, and the radius of curvature may be constant over the entire length of the bent portion 29. Alternatively, the radius of curvature may not be constant over the entire length of the bent portion 29. In this case, the radius of curvature of the bent portion 29 may be the average, maximum, or minimum value of the radius of curvature of the bent portion 29. Alternatively, the radius of curvature of the bent portion 29 may be the radius of curvature of a part of the bent portion 29 on the distal end side or a part of the bent portion 29 on the proximal end side. It is preferable that the radius of curvature at the bent portion 29 is larger than the length of the first length region 24a. As a result, even if the resistance between the linear member 20 and the inner wall of the tubular member 10 at the bent portion 29 (particularly the first bent portion 29a) is large when, for example, the linear member 20 is pulled out from the tubular member 10, the middle portion 24 is bent at the first bent portion 29a, and the first length region 24a is prevented from getting stuck, making it impossible for the linear member 20 to be pulled out.

[0031] In this embodiment, the radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b adjacent to the first bent portion 29a across the first length region 24a. The radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b, which is between two-thirds and 1.5 times the radius of curvature of the second bent portion 29b. Preferably, the radius of curvature of the first bent portion 29a is substantially the same as the radius of curvature of the second bent portion 29b, which is between 90% and 110% of the radius of curvature of the second bent portion 29b. In this embodiment, the radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same as each other. The radii of curvature of the first bent portions 29a or the second bent portions 29b are substantially the same as each other means that the radius of curvature of one first bent portion 29a (or the second bent portion 29b) is 90% to 110% of the radius of curvature of another first bent portion 29a (or the second bent portion 29b) adjacent to the one first bent portion 29a (or the second bent portion 29b), and the maximum radius of curvature of the target first bent portion 29a (or the second bent portion 29b) is 1.5 times the minimum radius of curvature of the target first bent portion 29a (or the second bent portion 29b). In this embodiment, the radius of curvature of the first bent portion 29a (first bent portion 29a1) may be smaller than the radius of curvature of the second bent portion 29b (second bent portion 29b1) adjacent to the first bent portion 29a1 across the first length region 24a. In other words, the radius of curvature of the first bent portion 29a1 is smaller than the radius of curvature of the second bent portion 29b1 adjacent to the first bent portion 29a1 on the tip side of the first bent portion 29a1. As described above, by making the radius of curvature of the first bent portion 29a small, when the linear member 20 is removed, the linear member 20 is caught by the first bent portion 29a, and the first length region is likely to stand up in the axial direction. As a result, the linear member 20 is prevented from being accidentally removed. On the other hand, since the radius of curvature of the second bent portion 29b is large, the first length region 24a and the second length region 24b sandwiching the second bent portion 29b1 are bent in a curved shape closer to a straight line, when the linear member 20 is inserted, the first length region 24a is unlikely to stand up in the axial direction. As a result, when the linear member 20 is inserted into the tubular member 10, the first length region 24a is unlikely to stand up in the axial direction, which makes it difficult to insert the linear member 20 into the tubular member 10.

[0032] The radius of curvature of one second bent portion 29b arranged on the distal side may be larger than the radius of curvature of another second bent portion 29b arranged on the proximal side of the one second bent portion 29b. This allows the intermediate portion 24 to slide on the inner wall of the tubular member 10 more easily toward the distal side, and the sliding resistance against the inner wall of the tubular member 10 is larger toward the proximal side. Therefore, the linear member 20 is less likely to be accidentally pulled out of the tubular member 10, but is easily inserted into the tubular member 10. Alternatively, the radius of curvature of one second bent portion 29b arranged on the distal side may be smaller than the radius of curvature of another second bent portion 29b arranged on the proximal side of the one second bent portion 29b. This allows the sliding resistance on the distal side of the intermediate portion 24 to be larger. As a result, the sealing member 30 is prevented from moving unexpectedly in the axial direction when an unexpected force is applied to the linear member 20. Alternatively, instead of this embodiment, the radii of curvature of the second bent portions 29b may be substantially the same from the tip end to the base end. Similarly, the radius of curvature of one first bent portion 29a arranged on the distal side may be larger than the radius of curvature of another first bent portion 29a arranged on the proximal side of the one first bent portion 29a. Alternatively, the radius of curvature of one first bent portion 29a arranged on the distal side may be smaller than the radius of curvature of another first bent portion 29a arranged on the proximal side of the one first bent portion 29a. This sufficiently increases the sliding resistance of the distal side of the intermediate portion 24 against the inner wall of the tubular member 10. As a result, for example, when the sealing member 30 is arranged in a closed position that maintains the balloon member 40 in an expanded diameter state, the sealing member 30 is prevented from shifting to the proximal side due to the internal pressure of the lumen 11, etc. Alternatively, instead of this embodiment, the radii of curvature of the multiple first bent portions 29a from the distal end to the proximal end may be approximately the same.

[0033] As shown in FIG. 1 or FIG. 3, the intermediate portion 24 has a wavy shape forming portion 24c, a first wavy shape non-forming portion (first non-forming portion 24d), and a second wavy shape non-forming portion (second non-forming portion 24e). The wavy shape forming portion 24c is a portion in which a wavy shape is formed in the intermediate portion 24. The first non-forming portion 24d and the second non-forming portion 24e are wavy shape non-forming portions in which a wavy shape is not formed. The first non-forming portion 24d is a partial length region located on the base end side of the wavy shape forming portion 24c. The second non-forming portion 24e is a partial length region located on the tip end side of the wavy shape forming portion 24c. As shown in FIG. 1, the length of the first non-forming portion 24d in the axial direction is smaller than the length of the second non-forming portion 24e in the axial direction. As described above, by arranging the wavy-shaped portion 24c on the base end side of the linear member 20 (particularly the intermediate portion 24), a force is easily applied to the wavy-shaped portion 24c when a force for insertion or removal is applied in the axial direction to the base end portion 22. As a result, unexpected bending of the linear member 20 at the wavy-shaped non-forming portion (particularly the first non-forming portion 24d) is suppressed, and the wavy-shaped portion 24c can slide on the inner wall of the tubular member 10 more smoothly. In addition, the length of the first non-forming portion 24d in the axial direction is preferably smaller than the length of the corrugated portion 24c in the axial direction. As a result, when a force is applied to the base end portion 22 to insert the linear member 20 into the tubular member 10, the force is easily transmitted to the corrugated portion 24c. Furthermore, the length of the second non-forming portion 24e in the axial direction is preferably larger than the length of the first length region 24a. As a result, the second non-forming portion 24e is disposed sufficiently along the axial direction. As a result, when the linear member 20 is inserted into the tubular member 10, the second non-forming portion 24e can slide the sealing member 30 straight in the approximately axial direction.

[0034] In this embodiment, the difference (hereinafter also referred to as clearance; the sum of difference L2a and difference L2b in FIG. 4) between the inner diameter (inner diameter L3 in FIG. 4) of the tubular member 10 when the linear member 20 is disposed outside the tubular member 10 (referred to as a natural state) and the amplitude (amplitude L4 in FIG. 4) of a portion having a wave shape in the intermediate portion 24 (wave shape forming portion 24c) is 0.095 mm or more and less than 0.135 mm. The force required to move the linear member 20 toward the base end side of the tubular member 10 relative to the tubular member 10 (hereinafter referred to as pull-out strength) is 2.6 N or more and less than 6.5 N. As described above, since the clearance is a sufficient value, the intermediate portion 24 is pressed against the inner wall of the tubular member 10 at the bent portion 29, and the sliding resistance of the intermediate portion 24 against the inner wall of the tubular member 10 is large. As a result, the linear member 20 is prevented from accidentally coming out of the tubular member 10. Furthermore, since the pull-out strength is equal to or greater than 2.6 N and less than 6.5 N, it is relatively easy to pull the linear member 20 out of the tubular member 10 using a tool or the like, but it is difficult to pull the linear member 20 out of the tubular member 10 by grasping the base end portion 22 with a hand or the like, and the linear member 20 is prevented from accidentally coming out of the tubular member 10. As described above, the inner diameter of the tubular member 10 is smaller than the amplitude of the corrugated portion 24c in the natural state. In other words, the clearance is a value obtained by subtracting the inner diameter of the tubular member 10 from the amplitude of the corrugated portion 24c in the natural state. The pull-out strength is the force required to pull out the linear member 20, which is inserted into the tubular member 10 while the tubular member 10 is fixed, from the tubular member 10. Pulling out the linear member 20 from the tubular member 10 means moving the linear member 20 a predetermined distance toward the base end relative to the tubular member 10.

[0035] As described above, it is preferable that the outer diameter of the intermediate portion 24 is smaller than the difference between the outer diameter of the tip portion 26 and the outer diameter of the base portion 22. This makes it possible to pull out the linear member 20 from the tubular member 10 with a predetermined pull-out strength even when there is a large clearance. In this regard, the relationship between the clearance and the pull-out strength in a plurality of medical devices 1 will be described with reference to FIG. 6. As shown in FIG. 6, there is a positive correlation between the clearance and the pull-out strength. FIG. 6 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 pull-out strength on the y-axis, and the relationship of the group of medical devices 1 is approximated to a linear function. FIG. 6 is created by plotting the groups of medical devices 1 having the outer diameters (average) of the intermediate portion 24 of 0.215 mm, 0.210 mm, and 0.185 mm as groups A, B, and C, respectively. In each of groups A, B, and C, the difference between the outer diameter of the tip portion 26 and the outer diameter of the base end portion 22 is 0.190 mm. That is, in groups A and B, the outer diameter of intermediate portion 24 is larger than the difference between the outer diameter of tip portion 26 and the outer diameter of base end portion 22, and in group C, the outer diameter of intermediate portion 24 is smaller than the difference between the outer diameter of tip portion 26 and the outer diameter of base end portion 22. As shown in FIG. 6, 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 values ​​of the pull-out strength of the medical device 1 in group A are 3.5 N to 10.5 N, and the actual measured values ​​of the pull-out strength of the medical device 1 in group B are 4.5 N to 7.0 N. On the other hand, the actual measured values ​​of the pull-out strength of the medical device 1 in group C are 3.5 N to 5.0 N. That is, among groups A to C, only the medical device 1 in group C has a pull-out strength value that is 2.6 N or more and less than 6.5 N. Note that when the clearance is in the range of 0.095 mm or more and less than 0.135 mm, the actual measured values ​​of the pull-out strength of the medical device 1 in groups B and C are 2.6 N or more and less than 6.5 N. When the clearance is in the range of 0.090 mm or more 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 in group A is 2.5 N or more and 13.3 N or less, and the pull-out strength in group B is 4.0 N or more and 6.6 N or less. On the other hand, the pull-out strength in group C is 3.8 N or more and 5.4 N or less, and falls within the above 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 pull-out strength values ​​for medical devices 1 in groups B and C fall within the above range of 2.6 N or more and less than 6.5 N. The slopes of the approximation equations of the above graphs for group A, group B, and group C are 178.37 [N / mm], 41.01 [N / mm], and 23.37 [N / mm], respectively, and the intercepts are -13.54N, 0.39N, and 1.79N. In a medical device 1 group consisting of a plurality of medical devices 1, the slope of the linear function approximating the relationship between the increase in clearance and the increase in pull-out strength when the clearance [mm] is on the X-axis and the pull-out strength [N] is on the Y-axis is 10 or more, preferably 20 or more. In addition, the slope is less than 100, preferably less than 50, and more preferably less than 30. When the slope is smaller than a predetermined value, the range of the pull-out strength in the medical device 1 can be made small even when the clearance range is large. On the other hand, when the slope is larger than a predetermined value, the linear member 20 has sufficient rigidity to be difficult to pull out of the tubular member 10 (to have sufficient pull-out strength).

[0036] Next, the distal end portion 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 the volume of the balloon member 40 is increased by injecting a liquid or gas (referred to as a liquid, etc.) through the injection port 18, 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 arranged on the inner diameter side of the balloon member 40 (particularly within the hollow portion 42). Specifically, the attachment portion 13 is a partial length region of the tubular wall of the tubular member. The attachment portion 13 has a spring-forming portion 15 on the base end side and a non-spring-forming portion 17 on the tip end side. The spring-forming portion 15 is a portion in which a spring capable of expanding and contracting in the axial direction is formed by forming a spiral slit 44, etc. The non-spring-forming portion 17 is a portion in which the spiral slit 44 is not formed and in which a spring that does not substantially expand and contract in the axial direction is not formed. Since a part of the tip side of the attachment portion 13 does not form a spring, the part does not have the same flexibility as the spring forming portion 15 and is more rigid than the spring forming portion 15. Therefore, when the balloon member 40 is inflated and expanded in the axial direction, the balloon member 40 can be expanded in a straight line with respect to the extension direction of the non-spring forming portion 17, which is a part of the tip side of the attachment portion 13. In other words, if the entire attachment portion 13 is a spring, when the balloon member 40 is expanded in the axial direction, the entire attachment portion 13 may have flexibility and the balloon member 40 may be expanded while unexpectedly bending or twisting. However, since the part of the tip side of the attachment portion 13 does not have a large flexibility, the balloon member 40 can be expanded approximately in the axial direction.

[0037] In this embodiment, the central portion of the mounting portion 13 in the axial direction is the spring forming portion 15. In other words, the length (axial length) of the spring forming portion 15 in the mounting portion 13 is greater than the length (axial length) of the spring non-forming portion 17 in the mounting portion 13. Instead of this embodiment, substantially the entire mounting portion 13 in the axial direction may be the spring forming portion 15. Also, only the central portion of the mounting portion 13 in the axial direction may be the spring forming portion 15, and both ends of the mounting portion 13 in the axial direction may be the spring non-forming portion 17.

[0038] The winding pitch of the second region 15a2 of the spring is smaller than the winding pitch of the first region 15a1 of the spring. The winding pitch of the third region 15a3 of the spring is larger than the winding pitch of the second region 15a2. Here, the winding pitch is the distance along the axial direction from one end of the tip side of one turn to one end of the tip side of another turn adjacent to the tip side of the one turn. That is, the winding pitch can be said to be the sum of the width dimension of the spiral slit 44 and the width dimension of the ribbon 15a. In this embodiment, the width of the spiral slit 44 in the contracted state is approximately constant from the first region 15a1 to the third region 15a3. That is, the width of the ribbon 15a in the second region 15a2 of the spring is smaller than the width of the ribbon 15a in the first region 15a1 of the spring. Also, the width of the ribbon 15a in the third region 15a3 of the spring is larger than the width of the ribbon 15a in the second region 15a2. The first region 15a1 is a region of a predetermined length on the base end side of the spring. The second region 15a2 is a region of a length on the tip side of the spring from the first region 15a1. The third region 15a3 is a region of a length on the tip side of the spring from the second region 15a2. In this embodiment, the winding pitch in the second region 15a2 is the smallest value among the winding pitches of the attachment portion 13. The smaller winding pitch in the second region 15a2 increases the amount of liquid flowing into the hollow portion 42, and allows the liquid to be smoothly sent into the hollow portion 42. In addition, the larger winding pitch in the third region 15a3, which is closer to the tip than the second region 15a2, prevents the tubular member 10 from bending unexpectedly between the spring forming portion 15 and the non-spring forming portion 17.

[0039] In this embodiment, the first region 15a1 to the third region 15a3 are all disposed in the mounting portion 13. The first region 15a1 to the third region 15a3 are particularly disposed inside the hollow portion 42. In this manner, the first region 15a1 and the third region 15a3, which do not have the smallest winding pitch, are disposed at both ends of the mounting portion 13, thereby preventing the mounting portion 13 from having excessive flexibility. In addition, in the large diameter state or the small diameter state, the width of the spiral slit 44 in the second region 15a2 is preferably larger than the width of the spiral slit 44 in the first region 15a1 or the third region 15a3. In this manner, the large width of the spiral slit 44 in the second region 15a2 allows the hollow portion 42 and the lumen 11 to communicate sufficiently. In addition, the small width of the spiral slit 44 in the first region 15a1 or the third region 15a3 keeps the first region 15a1 or the third region 15a3 rigid, and prevents the attachment portion 13 from having excessive flexibility. In other words, the above configuration allows the rigidity of the attachment portion 13 to be kept within a desired range while allowing the hollow portion 42 and the lumen 11 to communicate sufficiently in the second region 15a2. The large diameter state and the small diameter state refer to the state in which the balloon member 40 is expanded. When the balloon member 40 is expanded from the reduced diameter state, it reaches the small diameter state and then reaches the large diameter state. The large diameter state is a state in which the dimension in the width direction of the balloon member 40 is increased to the same extent as the maximum inner diameter of a general wide width that can be assumed for the body cavity in which the medical device 1 is used. For example, in the medical device 1 in this embodiment, the balloon member 40 is placed in a blood vessel (especially the carotid artery is exemplified), and the general inner diameter of the blood vessel is exemplified as 5 mm, and the inner diameter of a general wide carotid artery that can be assumed is exemplified as about 6 mm to 7 mm. That is, the large diameter state of the balloon member 40 in the medical device 1 in this embodiment is a state in which the balloon member 40 is expanded to the extent that the dimension in the width direction of the balloon member 40 is about 6.5 mm. Here, the amount of fluid that needs to be pressed in from the reduced diameter state to the large diameter state is called the total pressurized amount. The small diameter state is the state of the balloon member 40 when approximately one-fourth of the total pressure is injected with fluid.

[0040] In this embodiment, the spring is also formed in a part of the pipe wall on the base end side of the attachment portion 13 (the base end forming portion 15d). That is, the base end forming portion 15d is also a part of the spring forming portion 15. More specifically, the spring is formed by a common spiral slit 44 not only in the pipe wall in the hollow portion 42, but also in the pipe wall arranged on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall on the base end side of the first adhesive 51 (the pipe wall in the base end forming portion 15d). That is, the spring is integrally formed in the pipe wall in the hollow portion 42, the pipe wall arranged on the inner diameter side of the seal band 46 and the first adhesive 51, and the pipe wall in the base end forming portion 15d. Since a spring is also formed in the base end forming portion 15d, the base end forming portion 15d has flexibility. This allows the tubular member 10 near the balloon member 40 to conform to the shape of the body cavity when the balloon member 40 is placed in the body cavity, and prevents unnecessary load from being applied to the balloon member 40 and members in its vicinity (e.g., adhesive 50, etc.). This prevents deformation of the balloon member 40 and members in its vicinity, and prevents, for example, damage to the balloon member 40 or leakage of liquid from the balloon member 40. The winding pitch of the spring formed in the base end side forming portion 15d is larger than the winding pitch in the third region 15a3. In other words, the width of the ribbon 15a in the base end side forming portion 15d is larger than the width of the ribbon 15a in the third region 15a3. This prevents the tubular member 10 from easily bending between the spring forming portion 15 and the non-spring forming portion 17 on the base end side of the spring forming portion 15.

[0041] In this embodiment, the angle of the spiral direction of a portion of the ribbon 15a with respect to the axial direction in the contracted state is 60 degrees or more. More specifically, in the second region 15a2, the angle of the spiral direction of a portion of the ribbon 15a with respect to the axial direction may be 60 degrees or more. Alternatively, the angle of the spiral direction of substantially the entire ribbon 15a in the attachment portion 13 with respect to the axial direction may be 60 degrees or more. Or, more preferably, the angle is 75 degrees or more. This allows the spring forming portion 15 to expand and contract in the axial direction more satisfactorily. As a result, the balloon member 40 can be sufficiently expanded in the axial direction in the small diameter state or large diameter state (expanded state). Similarly, in either the small diameter state or the large diameter state, the angle of the spiral direction of a portion of ribbon 15a with respect to the axial direction may be 60 degrees or more.

[0042] The present invention is not limited to the above-described embodiment, but includes various modifications and improvements as long as the object of the present invention is achieved.

[0043] The above embodiment encompasses the following technical ideas. (1) a tubular member; a linear member disposed in a lumen at a proximal end of the tubular member and movable in an axial direction of the tubular member; a sealing member is provided at a distal end of the linear member and adapted to be in close contact with a portion of an inner wall defining the lumen of the tubular member; the linear member has the tip portion, an intermediate portion located on the base end side of the tip portion, and a base portion located on the base end side of the intermediate portion, the distal end portion, the intermediate portion, and the proximal end portion each have a partial length region having a uniform outer diameter; an outer diameter of the partial length region at the intermediate portion is less than 85% of a width of the lumen of the tubular member; A medical device, wherein among the partial length regions of the tip portion, the intermediate portion and the base portion, the partial length region of the base portion is the thickest and the partial length region of the tip portion is the thinnest. (1-1) A medical device, wherein the outer diameter of the intermediate portion is smaller than the difference between the outer diameter of the tip portion and the outer diameter of the base portion. (2) 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 having a tapered shape; an angle that the tapered shape of the second transition portion makes with respect to the axial direction is larger than an angle that the tapered shape of the first transition portion makes with respect to the axial direction; The medical device described in (1), wherein the wire diameter of the base end is larger than the width of the lumen. (2-1) A medical device, wherein the length of a first transition portion in the axial direction is smaller than the length of a second transition portion in the axial direction. (3) The intermediate portion of the linear member is bent at a plurality of bending portions to have a wavy shape, The wave shape is formed by mountain folding or valley folding at a plurality of first bent portions and a plurality of second bent portions that are alternately arranged, a length of a first length region from a first bent portion to a second bent portion adjacent to the first bent portion on the tip side of the first bent portion is shorter than a length of a second length region from the second bent portion to another first bent portion adjacent to the second bent portion on the tip side of the second bent portion; The medical device described in (2), wherein an angle of the first length region relative to the axial direction is greater than an angle of the second length region relative to the axial direction. (3-1) A medical device, wherein the length of one first length region is greater than the length of another first length region located more distal than the one first length region, and the length of one second length region is greater than the length of another second length region located more distal than the one second length region. (4) The medical device according to (3), wherein in the intermediate portion, the amplitude of the waveform in a portion on the tip side is smaller than the amplitude of the waveform in another portion on the base side of the portion on the tip side. (4-1) A medical device, in which the amplitude in a partial length region including the first fold portion located at the most distal end in the intermediate portion and the second fold portion located at the most distal end is smaller than the average amplitude of the length region near the group of the first fold portion and the second fold portion that are adjacent to each other. (5) The medical device described in (4), wherein the radius of curvature at the bent portion is smaller than the length of the second length region. (5-1) A medical device, wherein the radius of curvature at the bent portion is greater than the length of the first length region. (6) 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 disposed on the base end side of the wave-shaped forming portion, and a second wave-shaped non-forming portion disposed on the tip end side of the wave-shaped forming portion, The medical device according to (5), wherein the length of the first non-wave-shaped portion in the axial direction is smaller than the length of the second non-wave-shaped portion in the axial direction. (6-1) A medical device, wherein the length of the first non-formed portion in the axial direction is smaller than the length of the wave-shaped formed portion in the axial direction. (6-2) A medical device, wherein the length of the second non-forming portion in the axial direction is greater than the length of the first length region. (7) 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, The medical device according to any one of (3) to (6), wherein 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. (8) The medical device described in (7), 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. (8-1) A medical device in which the radius of curvature of a first bend located at the tip side is larger than the radius of curvature of another first bend located at the base side of the one first bend, and the radius of curvature of a second bend located at the tip side is larger than the radius of curvature of another second bend located at the base side of the one second bend. (9) A group of medical devices in which a relationship between an increase in the difference between the inner diameter of the tubular member and the amplitude and an increase in the pull-out strength 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 is less than 100, preferably less than 50, and more preferably less than 30. [Explanation of symbols]

[0044] 1 Medical Equipment 10 Tubular member 11 Lumen 12 Proximal opening 13 Mounting part 14 Coil section 15 Spring forming section 15a Ribbon 15a1 First area 15a2 Second area 15a3 Third area 15d Proximal forming part 16 Tip 17 Non-spring forming part 18 Inlet 19 Radiopaque markers 20 Linear members 22 Proximal end 23 Second transition part 24 Middle section 24a First Length Area 24b Second Length Area 24c Wave shape forming part 24d First non-formed part 24e Second non-forming part 25 First transition part 26 Tip 29 Bending section 29a, 29a1, 29a2 First bend 29b, 29b1 Second bent portion 30 Sealing member 40 Balloon member 41 Membrane part 42 Hollow part 44 Spiral Slit 46 Seal Band 50 Adhesive 51 First Adhesive 52 Second Adhesive 53 Third Adhesive

Claims

1. A tubular member; a linear member disposed in a lumen at a proximal end of the tubular member and movable in an axial direction of the tubular member; a sealing member is provided at a distal end of the linear member and adapted to be in close contact with a portion of an inner wall that defines the lumen of the tubular member; the linear member has the tip portion, an intermediate portion located on the base end side of the tip portion, and a base portion located on the base end side of the intermediate portion, the distal end portion, the intermediate portion, and the proximal end portion each have a partial length region having a uniform outer diameter; an outer diameter of the partial length region at the intermediate portion is less than 85% of a width of the lumen of the tubular member; A medical device, wherein among the partial length regions of the tip portion, the intermediate portion and the base portion, the partial length region of the base portion is the thickest and the partial length region of the tip portion is the thinnest.

2. 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 that the tapered shape of the second transition portion makes with respect to the axial direction is larger than an angle that the tapered shape of the first transition portion makes with respect to the axial direction; The medical device of claim 1 , wherein the wire diameter of the proximal end is greater than the width of the lumen.

3. The intermediate portion of the linear member is bent at a plurality of bending portions to have a wavy shape, The wave shape is formed by mountain folding or valley folding at a plurality of first bent portions and a plurality of second bent portions that are alternately arranged, a length of a first length region from a first bent portion to a second bent portion adjacent to the first bent portion on the tip side of the first bent portion is shorter than a length of a second length region from the second bent portion to another first bent portion adjacent to the second bent portion on the tip side of the second bent portion; The medical device of claim 2 , wherein an angle of the first length region relative to the axial direction is greater than an angle of the second length region relative to the axial direction.

4. The medical device according to claim 3 , wherein in the intermediate portion, an amplitude of the waveform in a portion on the distal end side is smaller than an amplitude of the waveform in another portion on the proximal end side of the portion on the distal end side.

5. The medical device of claim 4 , wherein the radius of curvature at the bend is less than the length of the second length region.

6. The intermediate portion has a wave-shaped forming portion in which the wave shape is formed, a first wave-shaped non-formed portion in which the wave shape is not formed and which is disposed on the base end side of the wave-shaped forming portion, and a second wave-shaped non-formed portion disposed on the tip end side of the wave-shaped forming portion, The medical device according to claim 5 , wherein a length of the first non-wave-shaped portion in the axial direction is smaller than a length of the second non-wave-shaped portion in the axial direction.

7. 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; The medical device according to claim 3 , wherein a force required to move the linear member relative to the tubular member toward the base end side of the tubular member is equal to or greater than 2.6 N and less than 6.5 N.

8. The medical device according to claim 7 , 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.

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