Stent delivery device

Abstract

To provide a stent delivery device capable of easily achieving stent placing operation as intended.SOLUTION: A stent delivery device 100 comprises an outer tube part 10, an outer tube handle 20, an inner tube part 40, an inner shaft 50, a shaft handle 60, and one or a plurality of markers 55. A stent 200 can be placed in a body cavity by retreating the outer tube handle 20 to the shaft handle 60 side. The one or the plurality of markers 55 include at least any one of a first marker 56 indicating that it is at a position corresponding to a development start position of the stent 200, a second marker 57 indicating that it is at a position corresponding to a re-housing limit position of the stent 200, and a third marker 58 indicating that it is at a position corresponding to a full development position of the stent 200.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a stent delivery device.

Background Art

[0002] As a stent delivery device used for implanting a stent into a body cavity, for example, there is one described in Patent Document 1. The stent delivery device of Patent Document 1 (the same document is described as an implant carrier device) includes a tubular body that holds a stent (described as an implant in the same document) to be implanted into a body cavity, an operation part capable of bending the distal part of the tubular body, and a restricting member capable of restricting the movement of the stent toward the proximal side. With the distal part of the tubular body bent, the stent can be implanted into the body cavity by relatively moving the tubular body with respect to the restricting member.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] According to the study of the inventor of the present application, there is still room for improvement in the structure of the stent delivery device of Cited Document 1 for realizing the intended stent implantation operation.

[0005] The present invention has been made in view of the above problems, and provides a stent delivery device capable of more reliably and easily realizing the intended stent implantation operation.

Means for Solving the Problems

[0006] According to the present invention, an outer tube part, an outer tube handle to which the proximal end portion of the outer tube part is fixed, An inner tube portion that is inserted axially slidably with respect to the outer tube portion, An inner shaft that is integrated with the inner tube portion and extends from the base end side of the outer tube handle, A shaft handle to which the base end portion of the inner shaft is fixed, A stent held by the tip portion of the inner tube portion, A stent holding portion that is formed to have a larger diameter than the inner tube portion and is provided on the outer periphery of the inner tube portion, Comprising: By retracting the outer tube handle together with the outer tube portion toward the shaft handle side, the tip portion of the inner tube portion is exposed from the outer tube portion, and the stent can be placed in the body cavity, The inner shaft has an appearance and disappearance portion that is a section where the inner shaft is inserted into the outer tube handle or is exposed to the base end side of the outer tube handle according to the retraction amount of the outer tube handle, After the tip portion of the stent is deployed by slightly retracting the outer tube handle toward the shaft handle side, when the outer tube handle is advanced, the stent is re-stored in the outer tube portion, The appearance and disappearance portion has one or a plurality of markers, The one or more markers include at least any one of a first marker indicating that the outer tube handle is at a position corresponding to the start position of the deployment of the stent, a second marker indicating that the outer tube handle is at a position corresponding to the limit position of the re-storage of the stent, and a third marker indicating that the outer tube handle is at a position corresponding to the fully deployed position of the stent, The stent includes a main portion having a constant diameter and a proximal-side diameter-expanding portion that is connected to the proximal end side of the main portion and expands in diameter toward the proximal end side. A plurality of radiopaque markers are provided on the main portion. The plurality of radiopaque markers are arranged at intervals from each other in the circumferential direction. The The proximal-side diameter-expanding portion of the stent is externally inserted into the stent holding portion and is sandwiched by the inner peripheral surface of the outer tube portion and the outer peripheral surface of the stent holding portion and The position where the stent is held at the distal end portion of the inner tube portion is a position where the plurality of radiopaque markers are exposed from the outer tube portion when the outer tube handle is at a position corresponding to the limit position. When the outer tube handle is at a position corresponding to the limit position, the proximal-side diameter-expanding portion and the stent holding portion are housed in the outer tube portion, while the plurality of radiopaque markers are exposed from the outer tube portion. A stent delivery device is provided.

Advantages of the Invention

[0007] According to the present invention, it becomes possible to easily realize the intended stent placement operation.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

DETAILED DESCRIPTION OF THE INVENTION

[0009] Hereinafter, embodiments of the present invention will be described with reference to FIGS. 1 to 9(c). In all the drawings, the same reference numerals are given to the same components, and the description thereof will be omitted as appropriate. Also, in FIGS. 1, 2, 3, 4, and 8(a), the stent 200 is shown by a two-dot chain line. In the following, the distal side of the stent delivery device 100 is also referred to as the tip side, and the proximal side thereof is also referred to as the base end side. Also, the tip portion means a certain range including the distal end (the foremost end) and its periphery, and the base end portion means a certain range including the proximal end (the most proximal end) and its periphery.

[0010] As shown in FIG. 1, the stent delivery device 100 according to the present embodiment includes an outer tube portion 10, an outer tube handle 20 to which the base end portion 10a of the outer tube portion 10 is fixed, an inner tube portion 40 slidably inserted in the axial direction with respect to the outer tube portion 10, an inner shaft 50 integrated with the inner tube portion 40 and extending from the outer tube handle 20 toward the base end side, and a shaft handle 60 to which the base end portion of the inner shaft 50 is fixed. By retracting the outer tube handle 20 together with the outer tube portion 10 toward the shaft handle 60 side, the tip portion 40b of the inner tube portion 40 is exposed from the outer tube portion 10, and the stent 200 held by the inner tube portion 40 can be placed in the body cavity. The inner shaft 50 has an emerging and retracting portion 54 which is a section that can be in a state of being inserted into the outer tube handle 20 or a state of being exposed on the proximal side of the outer tube handle 20 according to the retraction amount of the outer tube handle 20. After the distal end portion of the stent 200 is deployed by slightly retracting the outer tube handle 20 toward the shaft handle 60 side, when the outer tube handle 20 is advanced, the stent 200 is re-stored in the outer tube portion 10. The emerging and retracting portion 54 has one or more markers 55, and among the one or more markers 55, there is at least any one of a first marker 56 indicating that the outer tube handle 20 is at a position corresponding to the deployment start position of the stent 200, a second marker 57 indicating that the outer tube handle 20 is at a position corresponding to the limit position of the re-storage of the stent 200, and a third marker 58 indicating that the outer tube handle 20 is at a position corresponding to the full deployment position of the stent 200.

[0011] According to the present embodiment, after the distal end portion of the stent 200 is deployed by slightly retracting the outer tube handle 20 toward the shaft handle 60 side, when the outer tube handle 20 is advanced, the stent 200 is re-stored in the outer tube portion 10. Therefore, for example, even if the deployment of the stent 200 is unintentionally started at a position other than the desired position in the body cavity, the position of the stent 200 in the body cavity can be adjusted again by re-storing the stent 200 in the outer tube portion 10. Furthermore, in the case of the present embodiment, among the plurality of markers 55, there is at least any one of a first marker 56 indicating that the outer tube handle 20 is at a position corresponding to the deployment start position of the stent 200, a second marker 57 indicating that the outer tube handle 20 is at a position corresponding to the limit position of the re-storage of the stent 200, and a third marker 58 indicating that the outer tube handle 20 is at a position corresponding to the full deployment position of the stent 200. Thus, when one or more markers 55 include the first marker 56, the user can easily recognize the start of the deployment of the stent 200 based on the position of the first marker 56, so that the deployment of the stent 200 can be started more reliably at a desired position. Also, when one or more markers 55 include the second marker 57, the user can easily recognize that the stent 200 is in the limit state of re - storage based on the position of the second marker 57, so that the outer tube handle 20 can be prevented from unintentionally retreating beyond the position corresponding to the limit position of the re - storage of the stent 200. Furthermore, when one or more markers 55 include the third marker 58, the user can recognize that the outer tube handle 20 is at the position corresponding to the fully deployed position of the stent 200 based on the position of the third marker 58, so that it becomes easy to complete the deployment of the stent 200 at the desired position. In this way, according to the present embodiment, it is possible to easily realize the indwelling operation of the stent 200 as intended.

[0012] In a state where the stent 200 is held by the inner tube portion 40, the stent 200 is accommodated in a reduced - diameter state between the inner peripheral surface of the outer tube portion 10 and the outer peripheral surface of the inner tube portion 40. Then, with the outer tube portion 10 and the inner tube portion 40 inserted along the guide wire 300 (see FIG. 8(a) etc.) into a desired part of the body cavity, the outer tube handle 20 is retracted together with the outer tube portion 10 toward the shaft handle 60 side, and the distal end portion 40b of the inner tube portion 40 is exposed from the outer tube portion 10, whereby the stent 200 can be deformed from the reduced - diameter state to the deployed state and indwelled at the desired part. More specifically, as the distal end portion 40b of the inner tube portion 40 is exposed from the outer tube portion 10, the stent 200 is also exposed from the outer tube portion 10, and the exposed portion of the stent 200 becomes the deployed state. That is, the deployment of the stent 200 progresses according to the retraction amount of the outer tube handle 20. Note that the reduced - diameter state of the stent 200 means a state where the stent 200 is compressed in the radial direction, and the deployed state of the stent 200 means a state where the stent 200 is expanded in the radial direction. Also, in the case of the present embodiment, as shown in FIG. 8(c), the stent 200 includes a main portion 211 having a constant diameter, a proximal-side diameter-expanded portion 212 that is connected to the proximal end side of the main portion 211 and expands in diameter toward the proximal end side, and a distal-side diameter-expanded portion 213 that is connected to the distal end side of the main portion 211 and expands in diameter toward the distal end side. The mesh size in each of the proximal-side diameter-expanded portion (proximal-side flare portion) 212 and the distal-side diameter-expanded portion (distal-side flare portion) 213 is larger than the mesh size in the main portion 211. In the deployed state of the stent 200, the outer diameter of the proximal end of the proximal-side diameter-expanded portion 212 is larger than the outer diameter of the main portion 211, and the outer diameter of the distal end of the distal-side diameter-expanded portion 213 is larger than the outer diameter of the main portion 211.

[0013] Here, in the case of the present embodiment, a radiopaque marker 215 (see FIG. 8(b) etc.) is provided in the intermediate portion in the axial direction of the stent 200 (in the case of the present embodiment, the main portion 211). Thereby, the user can accurately recognize the position of the stent 200 in the body cavity under X-ray (radiation) observation by using the position of the radiopaque marker 215 as an index. Also, since the radiopaque marker 215 is formed at a plurality of locations in the circumferential direction of the stent 200, for example, by using the positions (separation distances) between the radiopaque markers 215 as an index, it is possible to grasp whether the main portion 211 of the stent 200 is in a diameter-expanded state. The radiopaque marker 215 is composed of an X-ray impermeable material such as platinum or tungsten, for example.

[0014] The outer tube portion 10 is a long hollow tubular member. As shown in FIGS. 2 and 3, the inner tube portion 40 is inserted into the inner cavity of the outer tube portion 10, and the outer tube portion 10 is slidable in the axial direction with respect to the inner tube portion 40. In the case of the present embodiment, the inner diameter and the outer diameter of the outer tube portion 10 are constant regardless of the position in the axial direction. Therefore, the wall thickness of the outer tube portion 10 is constant regardless of the position in the axial direction. However, the outer diameter and the inner diameter of the outer tube portion 10 may be different depending on the position in the axial direction. As shown in FIGS. 2 and 4, the outer tube portion 10 has, for example, a two-layer structure including an inner layer 14 and an outer layer 15 provided around the inner layer 14, and is configured by being laminated in the order of the inner layer 14 and the outer layer 15 from the axial center side of the outer tube portion 10. Note that a hydrophilic layer (not shown) may be formed on the surface of the outer layer 15. The material of the hydrophilic layer is not particularly limited, and examples thereof include maleic anhydride-based polymers such as polyvinyl alcohol (PVA) and copolymers thereof, and hydrophilic resin materials such as polyvinylpyrrolidone. By doing so, the sliding resistance when the outer tube portion 10 is inserted into the body cavity of a living body can be reduced.

[0015] The inner layer 14 is the innermost layer of the outer tube portion 10 and is formed, for example, in a constant circular tubular shape regardless of the position in the axial direction of the wall thickness. The inner layer 14 is open at both ends, namely, the tip end and the base end of the outer tube portion 10. The inner layer 14 is composed of, for example, a fluorine-based thermoplastic polymer resin. The fluorine-based thermoplastic polymer material is not particularly limited, and examples thereof include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA). By configuring the inner layer 14 with such a fluorine-based polymer material, the sliding resistance when the inner tube portion 40 slides in the inner cavity of the outer tube portion 10 is reduced.

[0016] The outer layer 15 is the outermost layer of the outer tube portion 10. For example, most (more than half) of the wall thickness of the outer tube portion 10 is occupied by the wall thickness of the outer layer 15. The outer layer 15 is formed, for example, in a constant circular tubular shape regardless of the position in the axial direction of the wall thickness. For the outer layer 15, for example, a thermoplastic polymer material can be used. Examples of such thermoplastic polymer materials include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomers such as polyamide elastomer (PAE) and polyether block amide (PEBA), polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), or polypropylene (PP).

[0017] The inner diameter of the outer tube portion 10 is set to be larger than the outer diameter (maximum diameter) of the inner tube portion 40. Therefore, the inner tube portion 40 can be slidably inserted into the inner cavity of the outer tube portion 10. More specifically, the inner diameter of the outer tube portion 10 is not particularly limited, but is preferably 1 mm or more and 7 mm or less. The outer diameter of the outer tube portion 10 is not particularly limited, but is preferably 1.5 mm or more and 8 mm or less. Also, the total length of the outer tube portion 10 is not particularly limited, but is preferably 500 mm or more and 2500 mm or less.

[0018] Furthermore, the outer tube portion 10 includes, for example, a reinforcing layer 16 (see FIGS. 1 and 2, etc.) configured in a mesh shape by braided metal wires. In FIGS. 1 and 7 to 9(c), the illustration of the reinforcing layer 16 is omitted. The reinforcing layer 16 is, for example, embedded in the outer layer 15 and disposed around the inner layer 14. The reinforcing layer 16 is, for example, disposed from the tip end to the base end of the outer tube portion 10. The entire outer tube portion 10 is reinforced by the reinforcing layer 16. Note that the reinforcing layer 16 may be constituted by, for example, a metal wire wound in a coil shape. Also, the reinforcing layer 16 may be disposed, for example, in a part of the outer tube portion 10 in the axial direction.

[0019] Also, in the case of this embodiment, an annular marker member 11 is embedded, for example, in the vicinity of the tip end of the outer tube portion 10. The marker member 11 is made of a radiopaque material such as platinum or tungsten, for example. By using the position of the marker member 11 as an index, the position of the distal end portion 10b of the outer tube portion 10 within the body cavity can be accurately recognized under X-ray (radiation) observation. However, when the marker member 11 is not embedded in the outer tube portion 10, an inorganic filler may be mixed into the outer layer 15 of the outer tube portion 10. Examples of the inorganic filler include contrast agents such as barium sulfate and bismuth subcarbonate. By mixing the contrast agent into the outer layer 15, the X-ray contrast of the outer tube portion 10 within the body cavity can be improved.

[0020] As shown in FIG. 5, the outer tube handle 20 is, for example, a hollow member and is formed in a substantially rectangular parallelepiped shape that is long in one direction. The inner shaft 50 is inserted slidably into the outer tube handle 20, and by moving the outer tube handle 20 along the inner shaft 50 toward the shaft handle 60 side, the proximal end portion 10a of the outer tube portion 10 can also be retracted along the inner shaft 50 toward the shaft handle 60 side. Regarding the description of the outer tube handle 20, the left side in FIG. 5 is referred to as the distal end side, and the right side in FIG. 5 is referred to as the proximal end side. Also, the direction toward the distal end side and the proximal end side is referred to as the distoproximal direction. As shown in FIGS. 1 and 5, the outer tube handle 20 has, for example, a first member 22a and a second member 22b, and the outer tube handle 20 is constituted by the first member 22a and the second member 22b being assembled to each other. In FIG. 5, the illustration of the second member 22b is omitted, and these figures are side views in a state where the internal structure of the outer tube handle 20 can be seen. The first member 22a and the second member 22b are formed to have the same dimensions and the same outer shape as each other. The proximal end of the outer tube portion 10 is introduced into the inside of the outer tube handle 20, and the proximal end portion 10a of the outer tube portion 10 is arranged along the longitudinal direction of the outer tube handle 20.

[0021] More specifically, as shown in FIG. 5, in the case of this embodiment, a fixing ring member 19 is provided on the outer periphery of the base end portion 10a of the outer tube portion 10. The outer tube handle 20 has a housing recess 23, and the fixing ring member 19 is housed in the housing recess 23, whereby the outer tube portion 10 is fixed to the outer tube handle 20. The fixing ring member 19 is, for example, an annular member and is made of an elastic material such as silicone rubber or elastomer. The fixing ring member 19 is fixed to the outer tube portion 10, for example, by being externally fitted to the outer tube portion 10. Also, as shown in FIG. 5, a housing recess 23 having a rectangular shape in side view is formed by four wall portions erected from the inner side surface of the first member 22a. The fixing ring member 19 is housed inside the housing recess 23, and the movement of the fixing ring member 19 in the proximal-distal direction is restricted by the housing recess 23. Here, two notch-shaped portions 24c are formed in the housing recess 23. The shape of each notch-shaped portion 24c viewed in the proximal-distal direction is a semi-circular shape, and its diameter is set to a dimension slightly larger than that of the outer tube portion 10. In the outer tube portion 10, the portions on the proximal side and the distal side of the fixing ring member 19 protrude outside the housing recess 23 through the respective notch-shaped portions 24c. Note that, for example, a housing recess 23 may be similarly formed on the inner side surface of the second member 22b. In this case, a part of the fixing ring member 19 is disposed inside the housing recess 23 of the first member 22a, and the remaining part of the fixing ring member 19 is disposed inside the housing recess 23 of the second member 22b.

[0022] The outer tube handle 20 is made of, for example, a hard resin material. The hard resin material is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, and polystyrene.

[0023] As shown in FIGS. 1, 2, and 3, the inner tube portion 40 includes, for example, a relatively small-diameter small-diameter portion 41 and a relatively large-diameter large-diameter portion 42. Each of the small-diameter portion 41 and the large-diameter portion 42 is a long hollow tubular member. The outer diameter of the small-diameter portion 41 is set to be smaller than the inner diameter of the large-diameter portion 42. As shown in FIG. 3, a part of the small-diameter portion 41 in the axial direction is inserted into the inner cavity of the large-diameter portion 42. Also, the total length of the small-diameter portion 41 is set to be longer than the total length of the large-diameter portion 42. And, with reference to the large-diameter portion 42, the small-diameter portion 41 protrudes toward the distal end side from the opening on the distal end side of the large-diameter portion 42 and protrudes toward the proximal end side from the opening on the proximal end side of the large-diameter portion 42. Here, in the small-diameter portion 41, the portion on the distal end side of the distal end of the large-diameter portion 42 constitutes an arrangement section 41a where the stent 200 is arranged. The stent 200 is held by the small-diameter portion 41 of the inner tube portion 40 while being externally inserted into the arrangement section 41a in the small-diameter portion 41. Also, in the small-diameter portion 41, the portion on the proximal end side of the proximal end of the large-diameter portion 42 is inserted into the inner cavity of the inner shaft 50. More specifically, the distal end portion of the inner shaft 50 is inserted into the opening on the proximal end side of the large-diameter portion 42, and the inner cavity of the large-diameter portion 42 and the inner cavity of the inner shaft 50 communicate with each other. And the small-diameter portion 41 is inserted across the inner cavity of the large-diameter portion 42 and the inner cavity of the inner shaft 50, and further reaches inside the shaft handle 60.

[0024] More specifically, for example, an endoscope visual recognition marker 46 is provided at the distal end portion of the large-diameter portion 42. Therefore, in the small-diameter portion 41, the portion on the distal end side of the endoscope visual recognition marker 46 is the arrangement section 41a, and the entire stent 200 is externally inserted into the arrangement section 41a. That is, the endoscope visual recognition marker 46 is arranged on the proximal end side of the stent 200. Therefore, the user can easily grasp the position of the stent 200 by using the position of the endoscope visual recognition marker 46 as an index based on the captured image by the endoscope. More specifically, when using the stent delivery device 100, as shown in FIG. 7, in the inner tube portion 40, at least the portion on the distal end side of the endoscope visual recognition marker 46 is in a state of being exposed from the distal end of the insertion portion of the endoscope 400. Also, the tip of the endoscope visual marker 46 is fixed to the small-diameter portion 41. More specifically, an adhesive 42a is applied in a circumferential shape at the tip of the endoscope visual marker 46 and at a location corresponding to the tip on the outer peripheral surface of the small-diameter portion 41. Thereby, the small-diameter portion 41 is fixed to the endoscope visual marker 46 and thus to the large-diameter portion 42. The proximal end of the endoscope visual marker 46 is connected to the tip side of the large-diameter portion 42, and the lumen of the endoscope visual marker 46 and the lumen of the large-diameter portion 42 communicate with each other. Therefore, the small-diameter portion 41 is inserted through the lumen of the endoscope visual marker 46 and the lumen of the large-diameter portion 42. The outer diameter of the endoscope visual marker 46 is set to be approximately the same as the outer diameter of the large-diameter portion 42. The endoscope visual marker 46 is constituted by, for example, a resin tube that is a separate member from the large-diameter portion 42 and is colored in a color different from that of the large-diameter portion 42. Also, the outer tube portion 10 is constituted by, for example, a transparent (transparent to visible light) resin material. For this reason, the user can visually recognize the endoscope visual marker 46 through the outer tube portion 10. Note that the endoscope visual marker 46 may be formed, for example, by applying ink to the tip portion of the large-diameter portion 42, or may be constituted by an X-ray impermeable material such as platinum or tungsten.

[0025] Also, a tip chip 43 (see FIGS. 1 and 4) is provided at the tip portion of the small-diameter portion 41. The tip chip 43 is formed, for example, in a conical shape that gradually decreases in diameter toward the tip side. The proximal end portion of the tip chip 43 is connected to the tip portion of the small-diameter portion 41, and the lumen of the tip chip 43 and the lumen of the small-diameter portion 41 communicate with each other. When inserting the stent delivery device 100 into the body cavity, a guide wire 300 (see FIGS. 8(a), etc.) that has been previously inserted into the body cavity is inserted into the lumen of the inner tube portion 40 through the opening on the tip side of the tip chip 43. Thereby, the outer tube portion 10 and the inner tube portion 40 can be inserted into the body cavity along the guide wire 300. In FIGS. 8(a) to 9(c), the guide wire 300 is indicated by a dashed line. Also, in the case of the present embodiment, the base end of the tip chip 43 and the tip of the outer tube portion 10 face each other. And, as shown in FIG. 4, the outer diameter of the tip chip 43 is set to be substantially equal to or slightly larger than the outer diameter of the outer tube portion 10, and the inner diameter of the tip chip 43 is set to be smaller than the inner diameter of the outer tube portion 10. For this reason, for example, when the outer tube handle 20 is advanced toward the tip chip 43 together with the outer tube portion 10, the front end surface of the outer tube portion 10 abuts against the base end surface of the tip chip 43, thereby restricting further advancement of the outer tube portion 10. Therefore, further advancement of the outer tube handle 20 integrated with the outer tube portion 10 is also restricted. In the following description, the state where the front end surface of the outer tube portion 10 abuts against the base end surface of the tip chip 43 (see FIG. 1 etc.) is taken as the initial state of the stent delivery device 100.

[0026] Here, in the case of the present embodiment, the stent delivery device 100 is formed to have a larger diameter than the inner tube portion 40 and further includes a stent holding portion 48 (see FIG. 1 etc.) provided on the outer periphery of the inner tube portion 40. More specifically, the stent holding portion 48 is formed to have a larger diameter than the small diameter portion 41 and is provided on the outer periphery of the small diameter portion 41. The stent holding portion 48 holds the stent 200 in the arrangement section 41a, and the stent holding portion 48 restricts the stent 200 from being displaced with respect to the arrangement section 41a as the outer tube portion 10 retreats or advances. More specifically, the stent holding portion 48 is, for example, a resin tube and is externally fitted to the small diameter portion 41. Also, an adhesive (not shown) is applied, for example, to the outer peripheral surface of the stent holding portion 48 and the vicinity of the arrangement region of the stent holding portion 48 in the arrangement section 41a, and the stent holding portion 48 is fixed to the arrangement section 41a by the adhesive. The inner diameter of the stent holding portion 48 is set to be substantially equal to the outer diameter of the small-diameter portion 41. The outer diameter of the stent holding portion 48 is set to be smaller than the inner diameter of the outer tube portion 10 and larger than the inner diameter of the stent 200 in the reduced-diameter state. The stent 200 is held between the inner peripheral surface of the outer tube portion 10 and the outer peripheral surface of the small-diameter portion 41 with a part of the stent 200 in the longitudinal direction thereof being externally inserted into the stent holding portion 48. More specifically, in the stent 200, the portion externally inserted into the stent holding portion 48 is in a state of being sandwiched between the inner peripheral surface of the outer tube portion 10 and the outer peripheral surface of the stent holding portion 48, whereby the stent 200 is restricted from being displaced axially relative to the arrangement section 41a as the outer tube portion 10 moves backward or forward. The length dimension (dimension in the axial direction) of the stent holding portion 48 is not particularly limited, but is preferably set appropriately according to the length dimension of the stent 200.

[0027] The small-diameter portion 41 is made of, for example, a fluorine-based thermoplastic polymer resin. The fluorine-based thermoplastic polymer material is not particularly limited, and can be, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), etc. By forming the small-diameter portion 41 with such a fluorine-based polymer material, the sliding resistance when the guide wire 300 slides in the lumen of the small-diameter portion 41 is reduced. Also, the large-diameter portion 42 is integrally formed entirely of, for example, a thermoplastic polymer material. Examples of this thermoplastic polymer material include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), polyether block amide (PEBA) and other nylon elastomers, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), or polypropylene (PP). Note that the large-diameter portion 42 may be, for example, a single tubular body formed by connecting tubular members formed separately from each other.

[0028] The outer diameter of the small-diameter portion 41 is not particularly limited, but is preferably 0.1 mm or more and 2 mm or less. The inner diameter of the small-diameter portion 41 is not particularly limited, but is preferably 0.05 mm or more and 1 mm or less. Further, the total length of the small-diameter portion 41 is not particularly limited, but is preferably 500 mm or more and 3000 mm or less. The outer diameter of the large-diameter portion 42 is not particularly limited, but is preferably 1 mm or more and 6 mm or less. The inner diameter of the large-diameter portion 42 is not particularly limited, but is preferably 0.5 mm or more and 4 mm or less. Further, the total length of the large-diameter portion 42 is not particularly limited, but is preferably 500 mm or more and 2500 mm or less.

[0029] The inner shaft 50 is formed, for example, in a tubular shape that is long in one direction. The distal end portion of the inner shaft 50 is press-fitted and fixed to the proximal end portion of the large-diameter portion 42, whereby the large-diameter portion 42 and the inner shaft 50 are fixed to each other. Note that the large-diameter portion 42 and the inner shaft 50 may be fixed to each other by, for example, adhesion or fusion. In the case of this embodiment, a section of the inner shaft 50 that is exposed on the proximal end side of the outer tube handle 20 in the initial state constitutes the protruding and retracting portion 54. The shaft handle 60 is formed, for example, in a cylindrical shape, and the shaft handle 60 is connected to the proximal end side of the large-diameter portion 42 and has a lumen that is continuous with the lumen of the large-diameter portion 42. When using the stent delivery device 100, for example, physiological saline, a contrast agent, or the like can be injected into the lumen of the small-diameter portion 41 through the opening on the proximal end side of the shaft handle 60.

[0030] The inner shaft 50 is made of, for example, a metal material such as stainless steel (SUS). Further, the shaft handle 60 is made of, for example, a resin material such as polyurethane or polyamide.

[0031] The outer diameter (maximum diameter) of the inner shaft 50 is not particularly limited, but is preferably 1 mm or more and 6 mm or less. The inner diameter of the inner shaft 50 is not particularly limited, but is preferably 0.5 mm or more and 3 mm or less. Further, the overall length of the inner shaft 50 is not particularly limited, but is preferably 30 mm or more and 500 mm or less.

[0032] Here, as described above, the protruding / retracting portion 54 has one or more markers 55. In the case of the present embodiment, as shown in FIG. 1, one or more markers 55 include a first marker 56, a second marker 57, and a third marker 58. In FIGS. 1 and 9(a) to 9(c), the formation locations of the first marker 56 to the third marker 58 are shaded with dots. As described above, the first marker 56 indicates that the outer tube handle 20 is at a position corresponding to the start position of the deployment of the stent 200. As shown in FIG. 8(a), in this state, at least the tip of the stent 200 is exposed from the outer tube portion 10, and the deployment of the exposed portion has started. As described above, the second marker 57 indicates that the outer tube handle 20 is at a position corresponding to the limit position of the re-storage of the stent 200. As shown in FIG. 8(b), in this state, at least the portion of the stent 200 on the tip side of at least the stent holding portion 48 is exposed from the outer tube portion 10, and the deployment of the exposed portion has started. As described above, the third marker 58 indicates that the outer tube handle 20 is at a position corresponding to the fully deployed position of the stent 200. As shown in FIG. 8(c), in this state, the entire stent 200 is exposed from the outer tube portion 10, and the deployment of the stent 200 is completed. The user can grasp the stepwise deployment state of the stent 200 by using the positions of the outer tube handle 20 with respect to these three markers 55 as an index. The first marker 56 to the third marker 58 are respectively formed at a plurality of positions different from each other in the axial direction of the protruding / retracting portion 54. More specifically, the second marker 57 is formed on the proximal side of the first marker 56, and the third marker 58 is formed on the proximal side of the second marker 57. In the case of the present embodiment, the first marker 56 to the third marker 58 are formed, for example, by applying ink. Note that the formation range of the first marker 56 to the third marker 58 in the circumferential direction may be the entire circumference or a part thereof in the circumferential direction of the outer peripheral surface of the inner shaft 50.

[0033] More specifically, as shown in FIG. 1, in the initial state of the stent delivery device 100, the entire protruding / retracting portion 54 of the inner shaft 50 is exposed from the proximal side of the outer tube handle 20. Therefore, the first marker 56 to the third marker 58 are also exposed from the proximal side of the outer tube handle 20. Then, from the initial state, as shown in FIGS. 8(a) and 9(b), until the proximal end portion of the outer tube handle 20 approaches the tip of the first marker 56, by retracting the outer tube handle 20 toward the shaft handle 60 side, the tip portion 10b of the outer tube portion 10 can be slightly retracted with respect to the inner tube portion 40, and the tip-side portion in the arrangement section 41a of the reduced-diameter portion 41 can be exposed from the outer tube portion 10. Thereby, the tip portion of the stent 200 can be slightly exposed from the outer tube portion 10, and the deployment of the stent 200 can be started. Next, from the state shown in FIGS. 8(a) and 9(b), as shown in FIGS. 8(b) and 9(c), until the proximal end portion of the outer tube handle 20 approaches the tip of the second marker 57, by retracting the outer tube handle 20 toward the shaft handle 60 side, the tip portion 10b of the outer tube portion 10 can be further retracted with respect to the inner tube portion 40, and a longer range of the arrangement section 41a in the reduced-diameter portion 41 can be exposed from the outer tube portion 10. Thereby, a longer range of the tip portion of the stent 200 can be exposed from the outer tube portion 10, and the portion of the stent 200 exposed from the outer tube portion 10 can be locally set in a deployed state. Here, in the case of this embodiment, the stent holding portion 48 holds the proximal end side diameter-expanded portion 212. More specifically, the stent holding portion 48 holds, for example, the tip portion of the proximal end side diameter-expanded portion 212. And when the outer tube handle 20 is at the limit position (in the case of this embodiment, near the tip of the second marker 57), the stent holding portion 48 is housed in the outer tube portion 10. That is, in the stent 200, the proximal end side diameter-expanded portion 212 is in a state of being sandwiched between the outer peripheral surface of the stent holding portion 48 and the inner peripheral surface of the outer tube portion 10. Thereby, it is possible to regulate the relative axial displacement of the proximal end side diameter-expanded portion 212 of the stent 200 with respect to the arrangement section 41a as the outer tube portion 10 moves backward or forward. Therefore, for example, even if the distal end side diameter-expanded portion 213 of the stent 200 and the distal end side portion of the main portion 211 are exposed from the outer tube portion 10 and are in a diameter-expanded state, the entire stent 200 can be re-housed in the outer tube portion 10. Also, when the outer tube handle 20 is at the limit position, since the stent holding portion 48 is housed in the outer tube portion 10, when an attempt is made to further retract the outer tube handle 20 from the limit position, frictional resistance will occur between the stent 200 and the inner peripheral surface of the outer tube portion 10. And the user can recognize that the outer tube handle 20 is attempting to retract toward the proximal end side from the limit position by the frictional feeling generated between the stent 200 and the inner peripheral surface of the outer tube portion 10, so it is possible to suppress inadvertently retracting the outer tube handle 20 beyond the limit position. Subsequently, from the states shown in FIGS. 8(b) and 9(b), as shown in FIGS. 8(c) and 9(c), by retracting the outer tube handle 20 toward the shaft handle 60 side until the proximal end portion of the outer tube handle 20 approaches the tip of the third marker 58, the tip portion 10b of the outer tube portion 10 can be retracted to the proximal end side of the endoscope visual recognition marker 46, and the entire arrangement section 41a of the stent 200 and the stent holding portion 48 in the reduced diameter portion 41 can be exposed from the outer tube portion 10. Thereby, the entire stent 200 can be exposed from the outer tube portion 10, the stent 200 can be released from the state of being sandwiched between the outer peripheral surface of the stent holding portion 48 and the inner peripheral surface of the outer tube portion 10, and the deformation of the stent 200 from the reduced diameter state to the deployed state can be completed.

[0034] Here, in the case of this embodiment, when the outer tube handle 20 is at a position corresponding to the limit position, the radiation-opaque marker 215 of the stent 200 is exposed from the outer tube portion 10. Accordingly, in a state where the outer tube handle 20 is at a position corresponding to the limit position, it is possible to easily grasp whether at least the arrangement region of the radiation-opaque marker 215 in the stent 200 has switched to the expanded diameter state.

[0035] Further, in the case of this embodiment, the stent delivery device 100 further includes a switching operation unit 30 capable of switching between a state in which the advancement and retraction of the outer tube handle 20 with respect to the inner shaft 50 is restricted and a state in which the advancement and retraction of the outer tube handle 20 with respect to the inner shaft 50 is possible (hereinafter, simply referred to as a switching operation). Thereby, since the advancement and retraction of the outer tube handle 20 with respect to the inner shaft 50 can be appropriately restricted, it is possible to suppress the outer tube handle 20 from being moved unintentionally, and it becomes easy to retract the outer tube handle 20 toward the shaft handle 60 at a desired timing and retraction amount. Therefore, it is possible to more reliably and easily realize the intended placement operation of the stent 200.

[0036] As shown in FIGS. 6(a) and 6(b), the switching operation unit 30 includes, for example, a ring member 33 formed of an elastic body and through which the inner shaft 50 is inserted, a housing member 35 through which the inner shaft 50 is inserted and which houses the ring member 33, and a screwing member 37 through which the inner shaft 50 is inserted and which is screwed to the housing member 35. In the case of this embodiment, by screwing the screwing member 37 into the housing member 35 and compressing the ring member 33 between the housing member 35 and the screwing member 37, the inner shaft 50 is held by the ring member 33, and the advancement and retraction of the switching operation unit 30 with respect to the inner shaft 50 is restricted.

[0037] The ring member 33 is formed, for example, in a cylindrical shape with the proximal end direction as the axial direction, and the inner shaft 50 is inserted into the inner cavity of the ring member 33. The inner diameter of the ring member 33 in the natural state is set to a dimension substantially equal to the outer diameter of the inner shaft 50, for example. The elastic body constituting the ring member 33 is not particularly limited, and examples thereof include elastic materials such as silicone rubber and elastomer.

[0038] The housing member 35 is formed in a cylindrical shape with the proximal end direction as the axial direction. The inner shaft 50 is inserted into the inner cavity of the housing member 35 and is slidable in the axial direction of the housing member 35 with respect to the housing member 35. More specifically, as shown in FIG. 6(a), the housing member 35 includes, for example, a main body portion 35a into which the screwing member 37 is screwed and an operation receiving portion 35b that receives a switching operation. Each of the main body portion 35a and the operation receiving portion 35b is formed in a cylindrical shape with the proximal end direction as the axial direction. Further, the main body portion 35a and the operation receiving portion 35b are coaxially arranged with each other. The inner diameter of the main body portion 35a is smaller than the inner diameter (maximum diameter) of the operation receiving portion 35b, and the outer diameter of the main body portion 35a is smaller than the outer diameter of the operation receiving portion 35b. Also, the inner cavity of the proximal end portion of the operation receiving portion 35b is formed to have a smaller diameter than the inner cavities of other portions, and the inner cavity of the operation receiving portion 35b includes a large-diameter portion and a small-diameter portion. The ring member 33 is accommodated in the large-diameter portion of the inner cavity of the operation receiving portion 35b. A part of the inner peripheral surface of the operation receiving portion 35b constitutes a stepped surface facing the tip side at the boundary between the large-diameter portion and the small-diameter portion of the inner cavity of the operation receiving portion 35b. The shape of the stepped surface viewed in the axial direction of the operation receiving portion 35b is annular, and the stepped surface faces the front end surface of the ring member 33. Also, as shown in FIG. 5, on the outer peripheral surface of the operation receiving portion 35b, for example, a plurality of grooves extending in its axial direction are intermittently arranged in the circumferential direction of the operation receiving portion 35b, and portions between adjacent grooves among the plurality of grooves constitute a plurality of irregularities arranged alternately in the circumferential direction.

[0039] The threaded member 37 is formed in a cylindrical shape with the tip proximal direction as the axial direction. The inner shaft 50 is inserted into the inner cavity of the threaded member 37 and is slidable in the axial direction of the threaded member 37 with respect to the threaded member 37. More specifically, as shown in FIGS. 6(a) and 6(b), the threaded member 37 includes, for example, a threaded portion 37a that is threaded to the housing member 35, a flange portion 37c formed on the tip side of the threaded portion 37a, and an insertion portion 37b that is inserted into the inner cavity of the main body portion 35a of the housing member 35. Each of the threaded portion 37a and the insertion portion 37b is formed, for example, in a cylindrical shape with the tip proximal direction as the axial direction. The proximal end of the threaded portion 37a is connected to the tip of the insertion portion 37b. Also, the inner cavity of the threaded portion 37a and the inner cavity of the insertion portion 37b communicate with each other. The outer diameter of the threaded portion 37a is set to a dimension larger than the outer diameter of the insertion portion 37b, for example, and the inner diameter of the threaded portion 37a is set to a dimension substantially equivalent to the inner diameter of the insertion portion 37b, for example. As shown in FIG. 6(a), the outer shape of the flange portion 37c viewed in the axial direction of the flange portion 37c is, for example, a regular hexagonal shape, and the outer peripheral surface of the flange portion 37c is composed of six surfaces, and the six surfaces are formed on surfaces orthogonal to the axial direction. The dimension of the flange portion 37c in the radial direction is larger than the outer diameter of the threaded portion 37a.

[0040] In the case of this embodiment, the threaded member 37 is screwed into the inside of the housing member 35 from the tip side More specifically, a thread is formed on the outer peripheral surface of the threaded portion 37a, and the threaded portion 37a serves as a male thread portion. Also, a thread is formed on the inner peripheral surface of the main body portion 35a, and the main body portion 35a serves as a female thread portion. By screwing the female thread portion and the male thread portion together, the threaded member 37 and the housing member 35 are interconnected. And the ring member 33 is disposed between the end surface on the proximal end side of the threaded portion 37a and the stepped surface of the operation receiving portion 35b. Further, the inner shaft 50 is inserted across the inner cavity of the screwing member 37 and the inner cavity of the housing member 35. The inner shaft 50 protrudes toward the distal end from the opening on the distal end side of the screwing member 37 and protrudes toward the proximal end from the opening on the proximal end side of the housing member 35.

[0041] Each of the housing member 35 and the screwing member 37 is made of, for example, a hard resin material. This resin material is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like. The housing member 35 and the screwing member 37 may be made of the same type of resin material as each other, or may be made of different resin materials from each other.

[0042] Here, inside the outer tube handle 20, a pair of holding portions 25 for holding the screwing member 37 and a housing portion 26 for housing the housing member 35 are respectively formed. The pair of holding portions 25 restricts the rotation of the screwing member 37 with respect to the outer tube handle 20, while the housing portion 26 allows the rotation of the housing member 35 with respect to the outer tube handle 20. As shown in FIG. 5, the pair of holding portions 25 are arranged, for example, on the distal end side of the housing portion 26. And in the case of the present embodiment, by rotating the housing member 35 out of the screwing member 37 and the housing member 35, the screwing member 37 moves in the proximal-distal direction.

[0043] More specifically, each of the pair of holding portions 25 is constituted by a pair of flat wall portions standing on the inner surface of the first member 22a. Each of the pair of wall portions is arranged with the flange portion 37c of the screwing member 37 interposed therebetween. More specifically, among the six surfaces constituting the outer peripheral surface of the flange portion 37c, any one surface is in surface contact with one of the pair of wall portions, and the surface parallel to the said surface is in surface contact with the other of the pair of wall portions. Therefore, while the movement of the threaded member 37 in the proximal direction is permitted, the threaded member 37 is held by the pair of holding portions 25 in a state where its rotation is restricted. However, in the case of this embodiment, on the inner surface of the first member 22a, a regulating plate 27 is formed between the pair of holding portions 25 to regulate the movement of the threaded member 37 to the tip side of the holding portion 25. As a result, the movement of the threaded member 37 to the base end side of the regulating plate 27 is restricted. Note that the shape of the flange portion 37c viewed in the proximal - distal direction is not particularly limited, and it may have a shape having a pair of surfaces whose outer peripheral surfaces face each other.

[0044] In the case of this embodiment, four wall portions are erected on the inner surface of the first member 22a. A frame - shaped accommodating portion 26 having a substantially rectangular shape in side view is formed by the aggregate of these four wall portions. Further, two notch - shaped portions 26a are formed in the accommodating portion 26. One of the two notch - shaped portions 26a allows the passage of the tip side of the main body portion 35a, and the other allows the passage of the base end side of the inner shaft 50. As a result, the accommodating member 35 can rotate around the axis with respect to the outer tube handle 20 while being accommodated inside the accommodating portion 26. Then, the user can perform a switching operation, for example, by rotating the operation receiving portion 35b around the axis. Note that such an accommodating portion 26 may be formed, for example, at a portion corresponding to the accommodating portion 26 of the first member 22a on the inner surface of the second member. Here, in each of the first member 22a and the second member 22b, an opening 22c (see FIG. 1) that allows the internal space of the outer tube handle 20 and the outside of the outer tube handle 20 to communicate with each other is formed at a portion corresponding to the operation receiving portion 35b. And at least a part of the operation receiving portion 35b in the circumferential direction is accessible to the user's finger from the outside of the outer tube handle 20 through the opening 22c. Note that a part of the operation receiving portion 35b may or may not protrude to the outside of the outer tube handle 20 through the opening 22c. The opening 22c is formed, for example, in a substantially rectangular shape in side view.

[0045] More specifically, by an operation of rotating the operation receiving portion 35b of the accommodating member 35 relative to the outer tube handle 20 in one direction in the circumferential direction (hereinafter, a closing operation), the advance and retreat of the outer tube handle 20 with respect to the inner shaft 50 can be switched to a restricted state. Along with the closing operation, the screwing member 37 screws into the accommodating member 35 and screws in from the tip side toward the base end side. At this time, as the screwing member 37 screws in, in the tip-to-base end direction, the stepped surface of the main body portion 35a of the accommodating member 35 and the end surface on the base end side of the screwed portion 37a of the screwing member 37 approach each other. As a result, the ring member 33 disposed between the stepped surface of the main body portion 35a and the end surface on the base end side of the screwed portion 37a is pressed by these surfaces and elastically deformed, and is in a state of being compressed in the axial direction, and the inner diameter of the ring member 33 is reduced. Then, by further performing the closing operation, the inner shaft 50 can be brought into a state of being circumferentially tightened by the ring member 33 compressed in the tip-to-base end direction. Also, by an operation of rotating the operation receiving portion 35b of the accommodating member 35 relative to the screwing member 37 in the other direction in the circumferential direction (the direction opposite to the rotation direction in the closing operation) (hereinafter, an opening operation), the advance and retreat of the outer tube handle 20 with respect to the inner shaft 50 can be switched to a state where it is possible. Along with the opening operation, the screwing member 37 moves toward the tip side, the ring member 33 is released from the compressed state, and the switching operation portion 30 can advance and retreat with respect to the inner shaft 50. Here, as described above, a restricting plate 27 is disposed between the pair of holding portions 25 that hold the screwing member 37. By the screwing member 37 coming into contact with the restricting plate 27, it is restricted that the screwing between the accommodating member 35 and the screwing member 37 is completely released. Note that the screwing direction of the screwing member 37 is not limited to the tip side to the base end side, and the screwing member 37 may be configured to screw in from the base end side toward the tip side. In this case, in the tip-to-base end direction, the positional relationship between the accommodating member 35 and the screwing member 37 is reversed.

[0046] Hereinafter, an example of the usage method of the stent delivery device 100 of the present embodiment will be described. Hereinafter, as an example, an example will be described in which the stent delivery device 100 is used in a procedure for placing the stent 200 inside the bile duct (not shown). Note that the tip of the insertion portion of the endoscope 400 (see FIG. 7) is previously placed near the duodenal papilla (Farter papilla) inside the duodenum (not shown), and a needle hole is formed in the bile duct (not shown), and the tip of the guide wire 300 is anchored (locked) to the needle hole. The description will be made from this state. First, the stent delivery device 100 is introduced along the guide wire 300. More specifically, the thin-diameter portion 41 of the inner tube portion 40 is externally inserted into the guide wire 300, and while sliding the inner tube portion 40 along the axial direction of the guide wire from the proximal end side to the distal end side, the inner tube portion 40 and the outer tube portion 10 are fed to the above-described needle hole. At this time, the advance and retreat of the outer tube handle 20 with respect to the inner shaft 50 is restricted by the switching operation portion 30. Next, when the arrangement section 41a of the stent 200 in the inner tube portion 40 is inserted into the bile duct, the stent 200 is placed. More specifically, first, the switching operation portion 30 is switched to a state in which the outer tube handle 20 can advance and retreat with respect to the inner shaft 50. Then, while gripping the shaft handle 60 with one hand, the outer tube handle 20 is retracted toward the shaft handle 60 together with the outer tube portion 10 with the other hand, so that the tip portion 40b of the inner tube portion 40 is exposed from the outer tube portion 10. Then, until the proximal end portion of the outer tube handle 20 is positioned in front of the third marker 58, that is, until the entire arrangement section 41a of the stent 200 in the inner tube portion 40 is exposed from the outer tube portion 10, the outer tube handle 20 is retracted, so that the entire stent 200 changes from the reduced diameter state to the deployed state. As a result, the stent 200 is placed inside the bile duct. Here, even if the deployment of the stent 200 is unintentionally started at a position other than the desired position in the body cavity, as described above, when the proximal end portion of the outer tube handle 20 is on the distal end side of the distal end of the second marker 57, the stent 200 can be rehoused in the outer tube portion 10 by advancing the outer tube handle 20. Then, until the tip of the outer tube portion 10 comes into contact with the tip chip, while advancing the outer tube handle 20 together with the outer tube portion 10, the switching operation unit 30 switches again to a state in which the forward and backward movement of the outer tube handle 20 with respect to the inner shaft 50 is restricted. In this state, the inner tube portion 40 and the outer tube portion 10 are removed from the body cavity, and the guide wire 300 is also removed from the body cavity.

[0047] The present invention is not limited to the above-described embodiments, and includes various modifications, improvements, and the like as long as the object of the present invention is achieved.

[0048] This embodiment includes the following technical ideas. (1) An outer tube portion, an outer tube handle to which the base end portion of the outer tube portion is fixed, an inner tube portion slidably inserted in the axial direction with respect to the outer tube portion, an inner shaft integrated with the inner tube portion and extending from the outer tube handle toward the base end side, a shaft handle to which the base end portion of the inner shaft is fixed, and by retracting the outer tube handle together with the outer tube portion toward the shaft handle side, the tip portion of the inner tube portion is exposed from the outer tube portion, and a stent held by the inner tube portion can be placed in the body cavity, the inner shaft has a projecting and retracting portion which is a section in which the inner shaft is inserted into the outer tube handle or is exposed on the base end side of the outer tube handle according to the retraction amount of the outer tube handle, after the tip portion of the stent is deployed by slightly retracting the outer tube handle toward the shaft handle side, when the outer tube handle is advanced, the stent is re-stored in the outer tube portion, the projecting and retracting portion has one or a plurality of markers, The stent delivery device includes at least one of the following among the one or more markers: a first marker indicating that the outer tube handle is at a position corresponding to the start position of stent deployment; a second marker indicating that the outer tube handle is at a position corresponding to the limit position of the stent re - accommodation; and a third marker indicating that the outer tube handle is at a position corresponding to the fully deployed position of the stent. (2) The stent delivery device according to (1), wherein the one or more markers include the first marker. (3) The stent delivery device according to (1) or (2), wherein the one or more markers include the second marker. (4) A radiation - opaque marker is provided at an intermediate portion in the axial direction of the stent. (5) The stent delivery device according to (3), wherein when the outer tube handle is at a position corresponding to the limit position, the radiation - opaque marker is exposed from the outer tube portion. (6) The stent delivery device according to any one of (1) to (4), wherein the one or more markers include the third marker. (7) The stent delivery device further includes a stent holding portion that is formed to have a larger diameter than the inner tube portion and is provided on the outer periphery of the inner tube portion. The stent includes a main portion having a constant diameter and a proximal - end - side enlarged - diameter portion that is connected to the proximal - end side of the main portion and has an enlarged diameter toward the proximal - end side. (8) The stent delivery device according to any one of (1) to (5), wherein the stent holding portion holds the proximal - end - side enlarged - diameter portion. (9) The stent delivery device according to (6), wherein when the outer tube handle is at the limit position, the stent holding portion is housed in the outer tube portion.

Description of Reference Numerals

[0049] 10 Outer tube portion 10a Base end portion 10b Tip portion 11 Marker member 14 Inner layer 15 Outer layer 16 Reinforcing layer 19 Fixing ring member 20 Outer tube handle 22a First member 22b Second member 22c Opening 23 Receiving recess 24c Notch-shaped part 25 Holding part 26 Receiving part 26a Notch-shaped part 27 Regulation plate 30 Switching operation part 33 Ring member 35 Receiving member 35a Body part 35b Operation receiving part 37 Screwing member 37a Screwing part 37b Insertion part 37c Flange part 40 Inner tube part 40a Base end part 40b Tip part 41 Reduced diameter part 42 Enlarged diameter part 43 Tip chip 46 Endoscope visual marker 46a Adhesive 48 Stent holding part 50 Inner shaft 54 Appearing and disappearing part 55 Marker 56 First marker 57 Second marker 58 Third marker 60 Shaft handle 100 Stent delivery device 200 Stent 211 Main part 212 Base end side enlarged diameter part 213 Tip side enlarged diameter part 215 Radiopaque marker 300 Guide wire 400 Endoscope

Claims

1. an outer tube portion, an outer tube handle to which a proximal end portion of the outer tube portion is fixed, an inner tube portion slidably inserted axially with respect to the outer tube portion, an inner shaft integrated with the inner tube portion and extending from the outer tube handle toward the proximal end side, a shaft handle to which a proximal end portion of the inner shaft is fixed, a stent held by a distal end portion of the inner tube portion, a stent holding portion formed to have a larger diameter than the inner tube portion and provided on an outer periphery of the inner tube portion, comprising By retracting the outer tube handle together with the outer tube portion toward the shaft handle side, a distal end portion of the inner tube portion is exposed from the outer tube portion, and the stent can be placed in a body cavity. The inner shaft has an emerging and disappearing portion which is a section in which the inner shaft is inserted into the outer tube handle or is exposed to the proximal end side of the outer tube handle according to the retraction amount of the outer tube handle. After the distal end portion of the stent is deployed by slightly retracting the outer tube handle toward the shaft handle side, when the outer tube handle is advanced, the stent is re-stored in the outer tube portion. The emerging and disappearing portion has one or more markers. The one or more markers include at least any one of a first marker indicating that the outer tube handle is at a position corresponding to a deployment start position of the stent, a second marker indicating that the outer tube handle is at a position corresponding to a limit position of the re-storage of the stent, and a third marker indicating that the outer tube handle is at a position corresponding to a fully deployed position of the stent. The stent includes a main portion having a constant diameter and a proximal end side diameter-expanded portion connected to the proximal end side of the main portion and expanding in diameter toward the proximal end side. A plurality of radiopaque markers are provided on the main portion. The plurality of radiopaque markers are arranged at intervals in the circumferential direction. The proximal-side diameter-expanding portion of the stent is inserted externally into the stent holding portion and is sandwiched between the inner circumferential surface of the outer tube portion and the outer circumferential surface of the stent holding portion. The position where the stent is held at the distal end portion of the inner tube portion is a position where the plurality of radiopaque markers are exposed from the outer tube portion when the outer tube handle is at a position corresponding to the limit position. A stent delivery device in which, when the outer tube handle is at a position corresponding to the limit position, the proximal-side diameter-expanding portion and the stent holding portion are housed in the outer tube portion while the plurality of radiopaque markers are exposed from the outer tube portion.

2. The stent delivery device according to claim 1, wherein the one or more markers include the first marker.

3. The stent delivery device according to claim 1 or 2, wherein the one or more markers include the second marker.

4. The stent delivery device according to any one of claims 1 to 3, wherein the one or more markers include the third marker.

Images