JP2021159393A - Stent for bypass between hollow organs - Google Patents

Abstract

To provide a stent for bypass between hollow organs that enables detention at an accurate position in an accurate state at the time of photography with an endoscope camera.SOLUTION: A stent for bypass between hollow organs 11 for bypass-connecting a hollow organ and another hollow organ includes a long and thin cylindrical main body 12, an end hooking part 14 and a main body hooking part 18 for preventing positional deviation in the axial direction of the main body 12, and a coloring region forming unit 20 that forms a coloring region 30 for allowing the positions of the end hooking part 14 and the main body hooking part 18 to be identified, on an outer peripheral surface 12d of the main body 12.SELECTED DRAWING: Figure 1

Description

The present invention relates to an interluminal bypass stent for bypass connecting a luminal organ to another luminal organ.

In recent years, endoscopic ultrasonography-guided biliary drainage (EUS-BD: endoscopic) is used in cases of unresectable malignant biliary stenosis or obstruction that require biliary drainage, such as when transduodenal papilla approach is not possible. There are reports of ultrasound-guided biliary drainage). EUS-BD inserts an endoscopic ultrasound into the stomach or duodenum, pierces the bile duct or gallbladder with a puncture needle from the stomach wall or duodenum wall while observing ultrasonic images in real time, and guides the wire to the bile duct or gallbladder. This is a procedure in which a bypass stent is inserted and placed so as to be inserted and to bridge the gastric wall or duodenal wall with the bile duct or gallbladder. This procedure enables bile duct drainage by implanting a stent in the body.

Examples of the stent used for EUS-BD include a covered stent in which the surface of a metal stent base material is coated with a covering material made of a polymer film. Further, as a covered stent particularly preferably used for EUS-BD, one having a hooking portion for preventing migration or the like has been proposed (see Patent Document 1).

In addition, the stent is often released from the stent delivery system and placed at the target site while checking the stent and the X-ray opaque marker provided near the distal end of the stent delivery system under fluoroscopy. However, in recent years, a method of releasing a stent from a stent delivery system while checking an image taken by an endoscopic camera on a monitor or the like has also been adopted.

International Publication No. WO 2019/019459

When a stent having a stent retaining part such as a hooking part for preventing migration is placed, the stent such as the hooking part is placed at the stent placement position so as to withstand the deformation of the luminal organ and maintain the bypass. It is necessary to determine and arrange the retaining part at an appropriate position. However, when performing stent placement while checking the image taken by the endoscopic camera, it may be difficult to confirm the stent removal part housed in the stent delivery system from the image taken by the endoscope camera, and the stent is removed. The problem may arise that the position of the portion cannot be properly controlled and the stent cannot be placed accurately. In particular, if the stent is placed while a part or all of the stent removal portion is outside the luminal organ, there arises a problem that the stent removal portion cannot sufficiently perform the function of preventing migration or the like.

The present invention has been made in view of the above problems, and provides a stent for bypass between luminal organs that enables indwelling in an accurate position and in an accurate state under an image taken by an endoscopic camera. With the goal.

In order to achieve the above object, the stent for bypassing between luminal organs according to the present invention is a stent for bypassing between luminal organs for bypass connecting a luminal organ and another luminal organ.
An elongated tubular body and
A stent retaining portion for preventing the axial displacement of the main body portion, and a stent retaining portion.
A colored region forming portion that forms a colored region that enables the position of the stent removal portion to be specified on the outer peripheral surface of the main body portion, and a colored region forming portion.
It is characterized by having.

According to this configuration, when the stent for bypass between luminal organs is placed in the body, the colored region formed on the outer peripheral surface of the stent for bypass between luminal organs can be confirmed from the image taken by the endoscopic camera. Therefore, the position of the stent withdrawal portion provided on the stent for bypassing between luminal organs can be specified. As a result, the position of the stent removal portion can be appropriately controlled so that the stent for bypassing between luminal organs can be placed in an accurate position and in an accurate state.

Further, in the stent for bypassing between luminal organs according to the present invention, the stent retaining portion that can be identified by the colored region may be provided on one end side in the axial direction of the main body portion.

According to this configuration, for example, the position of the stent withdrawal portion provided on the proximal side of the stent for bypassing between luminal organs can be specified by the colored region. When the stent for bypass between luminal organs is released from the stent delivery system, the inside of the luminal organ is photographed by the endoscopic camera, and it is confirmed whether or not the colored area is visible in this photographed image. As a result, it is possible to surely confirm that the stent withdrawal portion is inside the luminal organ, and the position of the stent withdrawal portion can be easily specified.

Further, in the stent for bypassing between luminal organs according to the present invention, on the outer peripheral surface of the main body portion, the peripheral portion of the colored region is formed along the circumferential direction so as to pass through the position of the stent extraction portion. You may.

According to this configuration, the position of the stent removal portion can be determined by confirming the edge portion of the colored region formed in a ring shape on the outer peripheral surface of the stent for bypassing between luminal organs from the image taken by the endoscopic camera. It will be easy to identify.

Further, the stent for bypassing between luminal organs according to the present invention has an end hooking portion provided at one end in the axial direction in the main body portion as the stent retaining portion.
The edge portion of the colored region may be formed along the circumferential direction so as to pass through the one end portion.

According to this configuration, by confirming the edge of the colored region formed in a ring shape on the outer peripheral surface of the stent for bypass between luminal organs from the image taken by the endoscopic camera, for example, bypass between luminal organs can be confirmed. The position of the end hooking portion provided at the proximal end of the stent can be specified. In addition, since the end hooking portion is provided at one end of the main body, the end hooking portion comes into contact with the inner wall of the luminal organ and functions as an anchor, effectively preventing migration. become able to.

Further, in the stent for bypassing between luminal organs according to the present invention, the end hooking portion is
Consists of elastic linear members
It has a base end that is integrally connected to one of the ends and a tip that has a free end.
The intermediate portion between the base end portion and the tip end portion is curved.
At least a part of the tip portion and the intermediate portion may be arranged radially outside the outer peripheral surface.

According to this configuration, the tip end portion or the intermediate portion of the elastic end hooking portion can come into contact with the inner wall of the luminal organ, and the migration of the stent for bypass between the luminal organs can be effectively prevented. Further, since the intermediate portion of the end hooking portion is curved, the risk that the inner wall surface of the luminal organ is damaged by the end hooking portion can be reduced.

Further, the stent for bypassing between luminal organs according to the present invention has a main body hooking portion provided on the outer peripheral surface of the main body portion other than both ends in the axial direction as the stent retaining portion.
The edge portion of the colored region may be formed along the circumferential direction so as to pass through the position of the main body hooking portion.

According to this configuration, by confirming the marginal portion of the colored region formed on the stent for bypass between luminal organs from the image taken by the endoscopic camera, other than both ends of the stent for bypass between luminal organs. The position of the main body hooking portion provided on the outer peripheral surface can be specified. Further, since the main body hooking portion is provided on the outer peripheral surface of the main body portion other than both ends in the axial direction, the main body hooking comes into contact with the inner wall or the like of the luminal organ and functions as an anchor between the luminal organs. Migration of bypass stents can be effectively prevented.

Further, in the stent for bypassing between luminal organs according to the present invention, the hooking portion of the main body is
Consists of elastic linear members
It has a base end portion integrally connected to the outer peripheral surface of the main body portion and a tip end portion having a free end.
The intermediate portion between the base end portion and the tip end portion is curved.
At least a part of the tip portion and the intermediate portion may be arranged radially outside the outer peripheral surface.

According to this configuration, the tip end portion or the intermediate portion of the elastic main body hooking portion can come into contact with the inner wall of the luminal organ, and the migration of the stent for bypass between the luminal organs can be effectively prevented. Further, since the intermediate portion of the main body hooking portion is curved, the risk that the inner wall surface of the luminal organ is damaged by the main body hooking portion can be reduced.

Further, the stent for bypassing between luminal organs according to the present invention has a diameter-expanded portion as the stent retaining portion, which is a part of the main body portion and has an outer diameter larger than that of the other portion of the main body portion.
The edge portion of the colored region may be formed along the circumferential direction so as to pass through the position of the enlarged diameter portion.

According to this configuration, it is provided for the purpose of preventing migration, etc. by confirming the edge portion of the colored region formed in a ring shape on the stent for bypassing between luminal organs from the image taken by the endoscopic camera. The position of the enlarged diameter portion can be specified.

It is a front view which shows an example of the stent for bypass between luminal organs in 1st Embodiment of this invention. FIG. 1 is a cross-sectional view taken along the line AA of FIG. 1 and is a diagram illustrating a first method of providing a colored region forming portion on a stent. FIG. 1 is a cross-sectional view taken along the line AA of FIG. 1 and is a diagram illustrating a second method of providing a colored region forming portion on the stent. It is an external view which shows an example of the stent delivery system which carries the stent for bypass between luminal organs in 1st Embodiment of this invention. 4 is a partially enlarged view of the stent delivery system near the distal end shown in FIG. 4, in which FIG. 4A shows a first state in which a reduced diameter stent is housed, and FIG. 4B shows a stent in which an outer sheath is moved. It is a figure which shows the 2nd state which released. It is a front view which shows the modification of the stent for bypass between luminal organs in 1st Embodiment of this invention. It is a front view which shows an example of the stent for bypass between luminal organs in 2nd Embodiment of this invention. It is a front view which shows an example of the stent for bypass between luminal organs in 3rd Embodiment of this invention. It is a front view which shows an example of the stent for bypass between luminal organs in 4th Embodiment of this invention, and is the figure which shows an example of the colored region on the outer peripheral surface of the stent for bypass between luminal organs.

Hereinafter, the first to fourth embodiments of the present invention will be described with reference to the drawings. In this specification, the inside of the patient's body is the distal side, and the operator's hand side is the proximal side, with the operator as the reference.

The stent for bypassing between luminal organs according to the present invention is a stent for bypassing between luminal organs for bypass connecting a luminal organ and another luminal organ, preferably between luminal organs used for EUS-BD. A bypass stent, that is, a bypass stent that bypass-connects the stomach or duodenum to the bile duct or gallbladder.

The stent for bypassing between luminal organs according to the present invention has an elongated tubular main body, and when placed in the body, one end of the main body is arranged in one luminal organ. Then, the other end of the main body is arranged in the other luminal organ, and the luminal of the main body can communicate between the luminal organs.

Further, the stent for bypassing between luminal organs according to the present invention has a stent retaining portion for preventing the axial displacement of the main body portion, and when placed in the body, the stent retaining portion Can abut on the wall of the luminal organ to regulate the axial movement of the body.

Further, the stent for bypassing between luminal organs according to the present invention has a colored region forming portion for forming a colored region on the outer peripheral surface of the main body portion so that the position of the stent removal portion can be specified, and the outer periphery of the main body portion. The position of the stent removal portion can be specified by the colored region formed on the surface.

Hereinafter, in the first to fourth embodiments of the present invention, a stent for bypassing between luminal organs having a specific configuration will be described as an example, but the configuration of the stent for bypassing between luminal organs according to the present invention will be described. , Not limited to those given as examples herein. In the present specification, the stent for bypass between luminal organs may be simply abbreviated as "stent".

[First Embodiment]
The stent for bypassing between luminal organs according to the first embodiment of the present invention will be described. FIG. 1 is a front view showing an example of a stent for bypassing between luminal organs according to the first embodiment of the present invention.

The stent 11 in the present embodiment is a self-expanding covered stent that contracts in the radial direction due to elasticity when a compressive force is applied in the radial direction and expands in the radial direction when the compressive force is released. FIG. 1 shows a state in which the stent 11 is expanded in the radial direction.

As shown in FIG. 1, the stent 11 includes an elongated substantially cylindrical main body portion 12, a main body hooking portion 18 protruding from the outer peripheral surface 12d of the main body portion 12 toward the upper side of the outer peripheral surface 12d, and a main body portion 12. It is possible to specify the positions of a plurality of end hooking portions 14 provided at the first end portion R (right end in FIG. 1), which is one of both end portions, and the main body hooking portion 18 and the end hooking portion 14. It has a colored region forming portion 20 that forms the colored region 30.

In the following, the direction in which the central axis C of the substantially cylindrical main body 12 extends will be described as the axial direction D2 in the description of the stent 11. Further, one end (right end in FIG. 1) of both ends of the main body 12 is set as the first end R, and the other end (left end in FIG. 1) of both ends of the main body 12 is the first end. It will be described as two ends L. When the stent 11 is housed in the stent delivery system, the first end R is located proximally and the second end L is located distal.

The main body portion 12 has a cylindrical frame portion 13 and a covering portion 12a that covers the frame portion 13. The frame portion 13 is formed of a strut 13a and a bridge 13b, which are linear members made of metal or resin. The frame portion 13 may be formed by knitting a wire rod, but is preferably a so-called laser cut type in which a strut 13a and a bridge 13b are formed by laser processing or the like on a tube-shaped or pipe-shaped base material. The cross-sectional shapes of the struts 13a and the bridges 13b constituting the frame portion 13 can be quadrangular or circular.

As shown in FIG. 1, the frame portion 13 has a plurality of struts 13a in a zigzag ring shape and a bridge 13b connecting between adjacent struts 13a. The struts 13a are continuous in a triangular wave shape along the circumferential direction of the frame portion 13 and are connected in an annular shape. However, in the state where the frame portion 13 is most contracted (the state after the laser cut), the struts 13a meander in an S shape and are connected in the circumferential direction.

As shown in FIG. 1, the bridge 13b connects the apex of the triangular wave or a part of the meandering curved portion of the adjacent strut 13a in the axial direction D2. By connecting the plurality of struts 13a in this way, the tubular frame portion 13 is configured. The bridges 13b connecting the two adjacent struts 13a are arranged at substantially equal intervals, but the positions of the bridges 13b connecting the two adjacent struts 13a are not formed side by side in the axial direction D2. , It is shifted in the circumferential direction.

The total length H of the main body 12 is determined according to the distance between the luminal organs to be bypassed, but can be 10 mm to 200 mm, preferably 40 mm to 120 mm. The outer diameter of the main body 12 when expanded (when no external force is applied) is determined according to the type and size of the luminal organ to be bypass-connected, but can be φ2 mm to φ40 mm. , Φ4 mm to φ15 mm, more preferably φ6 mm to φ10 mm. The outer diameter of the main body 12 when contracted (when the stent delivery system is housed) is about a fraction of the outer diameter when expanded.

The wire diameter of the struts 13a constituting the frame portion 13 is preferably 0.05 to 1 mm. When the cross section of the strut 13a is rectangular, the length in the long side direction of the cross section of the strut 13a is 0.06 to 1 mm, and the length in the short side direction is 0.05 to 0.9 mm. It is preferable to have. The outer diameter dimension of the frame portion 13 is substantially the same as the dimension of the main body portion 12 described above.

As the material of the frame portion 13, resin or metal is used. As the resin used for the frame portion 13, a resin having appropriate hardness and elasticity can be used, and a biocompatible resin is preferable. Examples of the resin used as the material of the frame portion 13 include polyolefin, polyester, fluororesin and the like. Examples of the metal used for the frame portion 13 include nickel-titanium (Ni-Ti) alloy, stainless steel, tantalum, titanium, cobalt-chromium alloy, magnesium alloy and the like, and superelasticity such as Ni-Ti alloy. Alloys are preferred. Specific examples of the superelastic alloy used for the frame portion 13 include a Ni—Ti alloy of 49 to 58% by weight Ni.

The frame portion 13 is covered with a covering portion 12a. The covering portion 12a has a function of protecting the frame portion 13 and smoothing the surface of the stent 11 to prevent waste products and the like from adhering and accumulating on the surface of the stent 11. The specific configuration of the covering portion 12a will be described later with reference to FIGS. 2 and 3.

Further, as shown in FIG. 1, the stent 11 has a plurality of main body hooking portions 18 and a plurality of end hooking portions 14. The main body hooking portion 18 and the end hooking portion 14 have a function of preventing the stent 11 from being displaced in the axial direction D2, and correspond to the stent retaining portion in the present invention.

A plurality of main body hooking portions 18 are provided on the outer peripheral surfaces 12d of the main body portion 12 other than both end portions R and L in the axial direction D2. The main body hooking portion 18 has an elongated shape extending from a base end portion 18b connected to an outer peripheral surface 12d through an intermediate portion 18c to a tip portion 18a which is a free end. The main body hooking portion 18 protrudes upward from the outer peripheral surface 12d other than both ends R and L in the axial direction D2 in the main body portion 12. That is, the main body hooking portion 18 is composed of a base end portion 18b, a tip end portion 18a, and an intermediate portion 18c between the base end portion 18b and the tip end portion 18a, and at least the tip end portion 18a and the intermediate portion 18c. A part of the tubular main body 12 is arranged radially outside the outer peripheral surface 12d. As a result, the stent 11 placed in the body is restricted from moving in the axial direction D2 by the hooking portion 18 of the main body being caught (prevented) from the wall of the luminal organ.

The main body hooking portion 18 may be formed from, for example, a pipe-shaped base material common to the frame portion 13. As an example, the base end portion 18b of the main body hooking portion 18 is connected to the strut 13a of the frame portion 13 adjacent to the second end portion L side with respect to the base end portion 18b, and the strut 13a to the first end portion R It protrudes to the side. Further, the main body hooking portion 18 may be formed independently of the main body portion 12 and integrally fixed to the frame portion 13 by laser welding or the like.

The main body hooking portion 18 has a curved shape that bulges and curves so as to be convex toward the first end portion R along the longitudinal direction from the base end portion 18b through the intermediate portion 18c toward the tip end portion 18a. However, when the stent 11 is housed in the stent delivery system, the body hooking portion 18 is in a state of being stretched in the axial direction D2 (see FIG. 5A). The main body hooking portion 18 is habituated so as to protrude radially outward of the outer peripheral surface 12d by its own elastic force when the stent 11 is released from the stent delivery system.

The stent 11 shown in FIG. 1 is provided with three main body hooking portions 18 at uniform angular intervals (that is, 120 degree intervals) in the circumferential direction. However, the number of the main body hooking portions 18 may be two or four or more, and is not particularly limited.

In the stent 11 shown in FIG. 1, the base end portions 18b of the plurality of main body hooking portions 18 are arranged at the same distance from the first end portion R. However, the present invention is not limited to this, and two or more or all of the plurality of main body hooking portions 18 may be arranged at different distances from the first end portion R. The distance W from the first end portion R to the base end portion 18b of the main body hooking portion 18 is not particularly limited, but is preferably 1/2 or less, and preferably 1/4 or less of the total length H in the axial direction of the main body portion 12. Is more preferable.

A plurality of end hooking portions 14 are provided on the first end portion R. The end hooking portion 14 has an elongated shape extending from a base end portion 14b connected to the first end portion R through an intermediate portion 14c to a tip portion 14a which is a free end. The end hooking portion 14 extends in a direction away from the first end portion R starting from the base end portion 14b, and then the intermediate portion 14c is curved outward in the radial direction of the main body portion 12. That is, the end hooking portion 14 is composed of a base end portion 14b connected to the first end portion R, a tip end portion 14a, and an intermediate portion 14c between the base end portion 14b and the tip end portion 14a. At least a part of the tip portion 14a and the intermediate portion 14c is arranged radially outside the outer peripheral surface 12d of the substantially cylindrical main body portion 12. As a result, the stent 11 placed in the body is restricted from moving in the axial direction D2 by the end hooking portion 14 being caught (prevented) from the wall of the luminal organ.

The end hooking portion 14 may be formed from, for example, a pipe-shaped base material common to the frame portion 13, is formed independently of the main body portion 12, and is located at the first end portion R by laser welding or the like. It may be integrally fixed to the frame portion 13.

The end hooking portion 14 bulges so as to be convex from the first end portion R toward the outside (right side in FIG. 1) in the axial direction D2 along the longitudinal direction from the base end portion 14b toward the tip end portion 14a. It has a curved shape that curves with. However, when the stent 11 is housed in the stent delivery system, the end hooking portion 14 is in a state of being stretched in the axial direction D2 (see FIG. 5A). The end hooking portion 14 is habituated so that when the stent 11 is released from the stent delivery system, it protrudes radially outward of the outer peripheral surface 12d by its own elastic force.

The stent 11 shown in FIG. 1 is provided with three end hooking portions 14 at uniform angular intervals (that is, 120 degree intervals) in the circumferential direction. However, the number of the end hooking portions 14 may be two or four or more, and is not particularly limited.

The tip portion 14a of the end hooking portion 14 and the tip portion 18a of the main body hooking portion 18 are provided with a substantially elliptical plate-shaped tip protection portion having a smooth outer surface. This tip protection portion has a function of preventing damage to the inner wall of the luminal organ when it comes into contact with the inner wall or the like.

Further, the stent 11 shown in FIG. 1 is provided with a plurality of first end markers 16 and a plurality of second end markers 17 made of an X-ray opaque material. The first end marker 16 has a disk shape and is attached in the vicinity of the base end 14b of the end hooking portion 14 connected to the first end R. Further, the plurality of second end markers 17 are also disk-shaped and are attached to the second end L of the main body 12. When the stent 11 is placed in the body, by confirming the positions of the first end marker 16 and the second end marker 17 under X-ray angiography, the positions of both ends R and L of the main body 12, that is, the stent The detention position of 11 can be grasped.

In the stent 11 shown in FIG. 1, the main body hooking portion 18 and the end hooking portion 14 are curved in the same direction. In such a stent 11, for example, the main body hooking portion 18 and the end hooking portion 14 are both placed so as to be located on the proximal side of the luminal organ wall, so that the stent 11 is placed in the body cavity from the luminal organ. The problem of falling off to the side can be effectively prevented in two stages of the main body hooking portion 18 and the end hooking portion 14. In other words, when the stent 11 is placed, the main body hooking portion 18 can be arranged at a position where it comes into contact with the inner wall of the luminal organ from the luminal organ side, and the main body hooking portion is formed due to deformation of the luminal organ or the like. Even when the retaining part 18 is released and the main body hooking part 18 moves so as to enter the body cavity from the tract organ side, the end hooking part 14 comes into contact with the inner wall of the tract organ to cause a stent. It is possible to prevent the eleven from falling off.

Further, a colored region forming portion 20 is provided on the outer peripheral surface 12d of the main body portion 12 on the first end R side from the center of the main body portion 12. Specifically, the colored region forming portion 20 is a position where the base end portion 18b of the main body hooking portion 18 is connected to the outer peripheral surface 12d and a position where the base end portion 14b of the end hooking portion 14 is connected to the outer peripheral surface 12d ( That is, the colored region 30 is formed on the entire outer peripheral surface 12d existing between the first end portion R). By providing the colored region forming portion 20, the stent 11 shown in FIG. 1 is colored between the main body hooking portion 18 and the end hooking portion 14 (first end portion R), and the main body hooking portion 18 and the first end portion R are colored. The space between the two ends L will be uncolored.

When the colored region 30 is formed on the outer peripheral surface 12d by the colored region forming portion 20, at the same time, the outer peripheral surface 12d of the stent 11 is described as a region 40 having a color different from the colored region 30 (hereinafter, referred to as a non-colored region 40). ) Will occur. The color of the colored region 30 is not particularly limited as long as it is not the same color as the non-colored region 40, but it is preferable that the color is a color that can be easily visually identified as a region different from the non-colored region 40. When the stent 11 carried into the body is photographed by an endoscopic camera when the stent 11 is placed, the non-colored region 40 reflected in the photographed image is often reflected as a high-brightness color (whitish color). For this reason, the color of the colored region 30 is preferably a color having a high contrast with the non-colored region 40 and a low lightness that suppresses halation, and is preferably black, for example.

When the adjacent colored region 30 and the non-colored region 40 have different colors, the contour (edge) exists in the colored region 30 or the non-colored region 40, or the colored region 30 and the non-colored region 40 It is recognized that there is a boundary between them. In the present specification, the outline portion of the colored region 30 or the non-colored region 40, or the boundary portion between the colored region 30 and the non-colored region 40 is referred to as an edge portion of the colored region 30.

In the stent 11 shown in FIG. 1, the colored region 30 is formed in a ring shape. The edge portion 30d of the colored region 30 is formed along the circumferential direction so as to pass through the position of the base end portion 18b of the main body hooking portion 18. The edge portion 30p of the colored region 30 is formed along the circumferential direction so as to pass through the position of the base end portion 14b of the end hooking portion 14, that is, the first end portion R.

The edge portion 30d of the colored region 30 represents the position of the base end portion 18b of the main body hooking portion 18 in the axial direction D2. Visually, in the edge portion 30d of the colored region 30, different colors appear between the colored region 30 and the non-colored region 40 outside the colored region 30, so that the margin portion 30d of the colored region 30 can be easily confirmed. As a result, the position of the main body hooking portion 18 in the axial direction D2 can be easily specified.

In the stent 11 shown in FIG. 1, the base end portions 18b of the plurality of main body hooking portions 18 are arranged at the same distance from the first end portion R, but two or more of the plurality of main body hooking portions 18 or All may be located at different distances from the first end R. In such a case, for example, one or several main body hooking portions 18 may be selected to form a colored region 30 that can specify the position of the selected main body hooking portion 18.

The edge portion 30p of the colored region 30 represents the position of the base end portion 14b of the end hooking portion 14 in the axial direction D2. Visually, in the marginal portion 30p of the colored region 30, different colors appear between the colored region 30 and the space outside the colored region 30 where the main body portion 12 does not exist, so that the marginal portion 30p of the colored region 30 can be easily used. As a result, the position of the end hooking portion 14 in the axial direction D2 (the position of the first end portion R) can be easily specified.

The method of providing the colored region forming portion 20 on the outer peripheral surface 12d of the main body portion 12 is not particularly limited, but for example, the first and second methods described below can be adopted.

FIG. 2 is a cross-sectional view taken along the line AA of FIG. 1 (cross-sectional view in the colored region 30), and is a diagram illustrating a first method of providing the colored region forming portion 20 on the stent 11. As described above, the frame portion 13 is covered with the covering portion 12a. According to the first method, as shown in FIG. 2, the covering portion 12a in the colored region 30 is composed of the coating film 12ac and the colored resin 20x colored in a desired color. The coating portion 12a in the non-colored region 40 is composed of a coating film 12ac and a colorless and transparent non-colored resin.

As shown in FIG. 2, the frame portion 13 is covered with the coating film 12ac. The coating film 12ac extends so as to fill the space between the adjacent struts 13a and covers the outer peripheral surface of the frame portion 13.

In the colored region 30, the colored resin 20x constituting the colored region forming portion 20 further covers the outer peripheral side of the frame portion 13 covered with the coating film 12ac. The colored resin 20x is a resin colored with a pigment of a desired color (for example, black). For example, the colored resin 20x can be formed on the outer peripheral side of the frame portion 13 covered with the coating film 12ac by a method of spray coating the colored resin 20x, a method of immersing in a resin solution colored with a pigment and drying, or the like. can. According to the first method, in the colored region 30, the colored resin 20x forms the outer peripheral surface 12d.

On the other hand, in the non-colored region 40, for example, a colorless and transparent non-colored resin covers the outer peripheral side of the frame portion 13 covered with the coating film 12ac. That is, in the non-colored region 40, a colorless and transparent non-colored resin is used instead of the colored resin 20x shown in FIG. 2, and the colorless and transparent non-colored resin forms the outer peripheral surface 12d.

In the present embodiment, the colored region 30 is formed on the first end R side of the position of the base end portion 18b of the main body hooking portion 18 with the position of the base end portion 18b of the main body hooking portion 18 as a boundary, and the main body hooking portion 18 is formed. A non-colored region 40 is formed on the second end L side from the position of the base end portion 18b. According to the first method, for example, the colored region 30 is covered with a colored resin 40 colored in a desired color on the first end R side from the position of the base end 18b of the main body hooking portion 18. The non-colored region 40 can be formed by coating the second end L side from the position of the base end 18b of the main body hooking portion 18 with a colorless and transparent non-colored resin.

Further, FIG. 3 is a cross-sectional view taken along the line AA of FIG. 1 (cross-sectional view in the colored region 30), and is a diagram illustrating a second method of providing the colored region forming portion 20 on the stent 11. According to the second method, the coating portion 12a in the colored region 30 is composed of a coating film 12ac, a colored polymer film 20y colored in a desired color, and a protective layer 20z, as shown in FIG. The coating portion 12a in the non-colored region 40 is composed of a coating film 12ac, a colorless and transparent non-colored polymer film, and a protective layer 20z.

In the colored region 30, a colored polymer film 20y that has been colored to a desired color (for example, black) is prepared, and the colored polymer film 20y is wound around the outer peripheral side of the frame portion 13 covered with the coating film 12ac, for example, once. Wrap around. Further, the protective layer 20z is formed by spray-coating a resin on the outside of the colored polymer film 20y or wrapping the film around the colored polymer film 20y. According to the second method, the protective layer 20z forms the outer peripheral surface 12d.

On the other hand, in the non-colored region 40, for example, a colorless and transparent colored polymer film is prepared, and the non-colored polymer film is wound around the outer peripheral side of the frame portion 13 covered with the coating film 12ac so as to make one turn, for example. Further, the protective layer 20z is formed by spray-coating a resin on the outside of the non-colored polymer film or wrapping the film around the film. That is, in the non-colored region 40, a colorless and transparent non-colored polymer film is wound around the outer peripheral side of the frame portion 13 instead of the colored polymer film 20y shown in FIG.

In the present embodiment, the colored region 30 is formed on the first end R side of the position of the base end portion 18b of the main body hooking portion 18 with the position of the base end portion 18b of the main body hooking portion 18 as a boundary, and the main body hooking portion 18 is formed. A non-colored region 40 is formed on the second end L side from the position of the base end portion 18b. According to the second method, for example, the colored region 30 is covered with the colored polymer film 20y colored in a desired color on the first end R side from the position of the base end 18b of the main body hooking portion 18. The non-colored region 40 can be formed by coating a colorless and transparent non-colored polymer film on the second end L side from the position of the base end portion 18b of the main body hooking portion 18.

In either of the first and second methods described above, the thickness of the layer formed on the outer peripheral side of the frame portion 13 covered with the coating film 12ac is not particularly limited, but the flexibility and self-expansion of the stent 11 are limited. It is preferable to make it thin so that it is not lost. Further, in the first and second methods described above, the non-colored region 40 is formed by using the colorless and transparent non-colored resin and the non-colored polymer film. For example, the colorless and transparent non-colored resin and the non-colored polymer are used. Instead of the film, the non-colored region 40 may be positively colored by using a resin or a polymer film colored so as to have a color different from the colored region 30 (for example, white).

Next, a stent delivery system for transporting the stent 11 will be described. FIG. 4 is an external view showing an example of the stent delivery system 50 that transports the stent 11. FIG. 5 is a partially enlarged view of the vicinity of the distal end of the stent delivery system 50 shown in FIG. 4, and FIG. 5 (a) shows the first state in which the reduced diameter stent 11 is housed. FIG. 5B shows a second state in which the outer sheath is moved and the stent 11 is released. In addition, in FIG. 5A and FIG. 5B, the outer sheath 66 is drawn by a dotted line.

As shown in FIG. 4, the stent delivery system 50 includes a stent 11 and a transport mechanism 52 that transports the stent 11 to a predetermined position in the body. The transport mechanism 52 includes an operation unit 60, an outermost pipe 64, an outer sheath 66, an inner shaft 68, a tip tip 62, and the like. The total length of the stent delivery system 50 varies depending on the placement position of the stent 11, the transport path, and the like, but is, for example, about 300 to 2500 mm.

As shown in FIG. 4, the stent 11 is housed near the distal end of the stent delivery system 50. The operator of the stent delivery system 50 transports the stent 11 to the position to be placed in the body in the first state shown in FIG. 5 (a), and then sets the stent delivery system 50 as the second state shown in FIG. 5 (b). By releasing 11, the stent 11 is placed in place in the body.

As shown in FIG. 4, the inner shaft 68 is provided in the axial direction D1 from the operation unit 60 provided at the proximal end of the stent delivery system 50 to the tip tip 62 provided at the distal end of the stent delivery system 50. It is extending. In the first state shown in FIG. 5A, the inner shaft 68 is housed inside the outer sheath 66, the housing 61 of the operation unit 60, and the like.

The inner shaft 68 has a small diameter portion 68a in the vicinity of the distal end, which is smaller in outer diameter than the other portions. The small diameter portion 68a is a portion where the stent 11 is housed in a reduced diameter state. When the stent 11 is placed, the outer sheath 66 moves to the proximal side to expose the small diameter portion 68a at the distal end, and the stent 11 has its own elastic force accordingly. To increase the diameter. After the diameter of the stent 11 is expanded, the inner shaft 68 is moved to the proximal side to achieve the second state shown in FIG. 5 (b). Further, a guide wire lumen for passing the guide wire is formed inside the inner shaft 68.

A tip tip 62 is provided at the distal end of the inner shaft 68, and the tip tip 62 is formed with a through hole communicating with the guide wire lumen of the inner shaft 68. The tip tip 62 is made of resin or the like, and has a rounded outer shape so as to prevent damage to the inner wall of the luminal organ when it comes into contact with the tip 62.

The outer sheath 66 is movable relative to the inner shaft 68 in the axial direction D1 from the first state shown in FIG. 5 (a) to the second state shown in FIG. 5 (b). The proximal end of the outer sheath 66 is housed inside the housing 61 of the operating unit 60. The operation unit 60 moves the outer sheath 66 relative to the inner shaft 68 toward the proximal side, which is one of the axial directions D1, in conjunction with the operation of the operation lever 63 attached to the housing 61. As a result, in the stent delivery system 50, from the first state (see FIG. 5A) in which the outer sheath 66 covers the small diameter portion 68a of the inner shaft 68 and the accommodated stent 11, the small diameter portion 68a and the accommodation of the inner shaft 68 are accommodated. It changes to a second state (see FIG. 5B) that exposes the stent 11. An outermost pipe 64 that further covers the outer circumference of the outer sheath 66 is provided in the vicinity of the operation unit 60. If the operator directly grasps the outer sheath 66, the movement of the outer sheath 66 by the operating unit 60 may be hindered, but such a problem can be prevented by covering the outer sheath 66 with the outermost pipe 64.

The outermost pipe 64 and the inner shaft 68 of the transport mechanism 52 are made of, for example, a flexible resin tube or the like. Similarly, the outer sheath 66 is also composed of a flexible resin tube or the like, but in order to allow the colored region 30 of the stent 11 housed inside the outer sheath 66 to be visible through the outer sheath 66. A transparent polymer material is used. Further, a metal wire may be embedded in the resin tube used for the outer sheath 66.

A push ring 69 that pushes the stent 11 in the axial direction D1 when the stent 11 is released may be provided on the proximal side of the small diameter portion 68a of the inner shaft 68, and the push ring 69 is made of an X-ray opaque material. It may have been. The material of the tip tip 62 and the operation unit 60 in the transport mechanism 52 is not particularly limited, but for example, a resin molded or processed material can be used.

Hereinafter, an example of a procedure for placing the stent 11 in the body according to the present embodiment will be described using the stent delivery system 50.

For the placement of the stent 11 in the present embodiment, for example, an ultrasonic endoscopy system with a camera is used. This endoscope is provided with a camera configured by a CCD or the like at the distal end of an ultrasonic endoscope (EUS). The captured image signal acquired by photographing with the camera is sent to a monitor or the like that can be visually recognized by the operator of the stent delivery system 50 through the internal wiring of the endoscope. The operator can determine the placement position of the stent 11 while checking the captured image displayed on the monitor and release the stent 11.

When the stent 11 in the present embodiment is placed in the body, a guide wire is inserted into the bile duct or gallbladder and the distal end portion of the stent delivery system 50 is moved along the guide wire, as in the conventional procedure. Then, in the first state (see FIG. 5A) covering the stent 11 in which the outer sheath 66 is housed, the stent 11 is carried to the indwelling position. At this time, the area around the distal end of the stent delivery system 50 is photographed by an endoscopic camera, and the operator adjusts the position where the stent 11 is released while checking the photographed image on the monitor.

As shown in FIG. 1, the stent 11 in the present embodiment has a main body hooking portion 18 and an end hooking portion 14, and a colored region 30 is formed between the main body hooking portion 18 and the end hooking portion 14. Has been done. While checking the captured image displayed on the monitor, the operator arranges, for example, the edge portion 30d of the colored region 30 representing the position of the main body hooking portion 18 on the proximal side of the inner wall of the luminal organ, and at that position. The diameter of the stent 11 is expanded by moving the outer sheath 66 to the proximal side with respect to the inner shaft 68 in a fixed state. By releasing the stent 11 in this aligned state, the main body hooking portion 18 is arranged on the proximal side of the inner wall of the luminal organ, and the stent 11 is placed at the exact position desired by the operator. You will be able to make it. When it is desired to arrange the end hooking portion 14 on the proximal side of the inner wall of the luminal organ, the operator confirms the captured image displayed on the monitor and positions the end hooking portion 14. The marginal portion 30p of the colored region 30 representing the above may be arranged on the proximal side of the inner wall of the luminal organ to release the stent 11.

FIG. 6 is a front view showing a modified example of the stent for bypassing between luminal organs according to the first embodiment of the present invention. In the description of the stent 11a shown in FIG. 6, components having the same function as the stent 11 shown in FIG. 1 are designated by the same reference numerals to simplify or omit the description.

The stent 11a shown in FIG. 6 is different from the stent 11 shown in FIG. 1 in the positions of the colored regions 30a and 30b formed by the colored region forming portions 20a and 20b. In the stent 11a shown in FIG. 6, the colored region forming portion 20a is the position where the base end portion 14b of the end hooking portion 14 is connected to the outer peripheral surface 12d of the main body portion 12 (that is, the first end portion R) and the first. A colored region 30a is formed on the entire outer peripheral surface 12d existing between the end portion R and a position separated by a predetermined distance d1 (range of width d1).

Further, in the stent 11a shown in FIG. 6, the colored region forming portion 20b is located at a position where the base end portion 18b of the main body hooking portion 18 is connected to the outer peripheral surface 12d of the main body portion 12, and from this position to the second end portion L side. A colored region 30b is formed on the entire outer peripheral surface 12d existing between positions separated by a predetermined distance d2 (range of width d2). By providing the colored region forming portions 20a and 20b, the stent 11 shown in FIG. 1 is colored in the vicinity of the end hooking portion 14 (first end portion R) and in the vicinity of the main body hooking portion 18. Areas other than the above will have an uncolored appearance. In the stent 11a shown in FIG. 6, the two colored regions 30a and 30b are formed in a ring shape, respectively, and a contrast is generated between the two colored regions 40a and 40b.

The colored regions 30a and 30b and the non-colored regions 40a and 40b can be formed by using the first and second methods described above with reference to FIGS. 2 and 3. Further, for example, after wrapping a colorless and transparent non-colored polymer film around each of the first end portion R side and the second end portion L side from this position with the position of the base end portion 18b of the main body hooking portion 18 as a boundary. Further, the colored regions 30a and 30b and the non-colored regions 40a and 40b may be formed by winding the colored polymer film 20y colored in a desired color around the positions where the colored regions 30a and 30b should be formed.

The edge portion 30ap of the colored region 30a is formed along the circumferential direction so as to pass through the position of the proximal end portion 14b of the end hooking portion 14 in the axial direction D2, whereby the axial direction of the proximal end portion 14b is formed. It represents the position of D2. Visually, in the marginal portion 30ap of the colored region 30a, different colors appear between the colored region 30a and the space outside the colored region 30a where the main body portion 12 does not exist, so that the marginal portion 30ap of the colored region 30a can be easily specified. As a result, the position of the end hooking portion 14 in the axial direction D2 (the position of the first end portion R) can be easily specified. If the predetermined distance d1 is small, the width d1 of the colored region 30a in the axial direction D2 becomes small, and the colored region 30a cannot be visually recognized. From this, the predetermined distance d1 is preferably a size that makes the colored region 30a visible, and varies depending on the size of the stent 11a, the observable range of the endoscope camera, etc., but for example, the predetermined distance d1 is 1 mm or more. Can be.

Further, the edge portion 30bp of the colored region 30b is formed along the circumferential direction so as to pass through the position of the base end portion 18b of the main body hooking portion 18 in the axial direction D2, whereby the axis of the base end portion 18b is formed. It represents the position in direction D2. Visually, in the marginal portion 30bp of the colored region 30b, the colored region 30b and the non-colored region 40a appear to have different colors, so that the marginal portion 30bp of the colored region 30b can be easily confirmed. As a result, the position of the main body hooking portion 18 in the axial direction D2 can be easily specified. If the predetermined distance d2 is small, the width d2 of the colored region 30b in the axial direction D2 becomes small, and the colored region 30b cannot be visually recognized. For this reason, the predetermined distance d2 is preferably a size that makes the colored region 30b visible, and varies depending on the size of the stent 11a, the observable range of the endoscopic camera, and the like, but for example, the predetermined distance d2 is 1 mm or more. Can be.

According to the first embodiment described above, the main body hooking is performed by forming colored regions 30, 30a, and 30b on the outer peripheral surface 12d of the main body portion 12 so that the positions of the main body hooking portion 18 and the end hooking portion 14 can be specified. The positions of the portion 18 and the end hooking portion 14 in the axial direction D2 can be easily identified, and the stents 11 and 11a can be placed at accurate positions. In particular, the peripheral portions 30p, 30d, 30ap, 30bp of the colored regions 30, 30a, 30b make it possible to easily identify the position of the axial direction D2 in which the main body hooking portion 18 and the end hooking portion 14 are connected to the outer peripheral surface 12d. become.

[Second Embodiment]
The stent for bypassing between luminal organs in the second embodiment of the present invention will be described. FIG. 7 is a front view showing an example of a stent for bypassing between luminal organs according to the second embodiment of the present invention. In the description of the stent 111 shown in FIG. 7, the components having the same function as the stent 11 shown in FIG. 1 are designated by the same reference numerals to simplify or omit the description.

The stent 111 shown in FIG. 7 has a different shape of the main body hooking portion 118 as compared with the stent 11 shown in FIG. In the stent 111 shown in FIG. 7, the main body hooking portion 118 bulges toward the second end portion L along the longitudinal direction from the base end portion 118b through the intermediate portion 118c to the tip end portion 118a. There is. Similar to the main body hooking portion 18 of the stent 11 shown in FIG. 1, the main body hooking portion 118 has a function of preventing the stent 111 from being displaced in the axial direction D2, and is a stent retaining portion in the present invention. Is equivalent to.

In the stent 111 shown in FIG. 7, the colored region forming portion 20c is the position where the base end portion 14b of the end hooking portion 14 is connected to the outer peripheral surface 12d of the main body portion 12 (that is, the first end portion R) and the stent delivery. A colored region 30c is formed on the entire outer peripheral surface 12d existing between the position of the tip portion 118a of the main body hooking portion 18 when the stent 111 is housed in the system 50 (range of width d2).

The colored region 30c and the non-colored region 40c can be formed by using the first and second methods described above with reference to FIGS. 2 and 3. However, since there is a possibility that the main body hooking portion 18 may be suppressed from protruding outward in the radial direction when released from the stent delivery system, the polymer film is wrapped around the base end portion 18b of the main body hooking portion 18. That is not desirable. From this point of view, for example, with the position of the base end portion 18b of the main body hooking portion 18 as a boundary, a colored polymer film 20y colored in a desired color is wound around the first end portion R side from this position, and from this position. After wrapping a colorless and transparent non-colored polymer film around the second end L side, it is further colored between this position and the position of the tip 118a of the main body hooking portion 18 when housed in the stent delivery system. A colored region 30c and a non-colored region 40c may be formed by winding the polymer film 20y.

The edge portion 30cp of the colored region 30c is formed along the circumferential direction so as to pass through the position of the proximal end portion 14b of the end hooking portion 14 in the axial direction D2, whereby the axial direction of the proximal end portion 14b is formed. It represents the position of D2. Visually, the edge portion 30 cp of the colored region 30c looks different between the colored region 30c and the space outside the colored region 30c where the main body portion 12 does not exist, so that the margin portion 30 cp of the colored region 30c can be easily set. As a result, the position of the end hooking portion 14 in the axial direction D2 (the position of the first end portion R) can be easily specified.

Further, the marginal portion 30cd of the colored region 30c is formed along the circumferential direction so as to pass through the position of the tip portion 118a of the main body hooking portion 18 in the axial direction D2 when housed in the stent delivery system. Represents the position of the tip 118a in the axial direction D2 when housed in the stent delivery system. Visually, in the edge portion 30cd of the colored region 30c, the colored region 30c and the non-colored region 40c appear to have different colors, so that the margin portion 30cd of the colored region 30c can be easily confirmed. As a result, the position of the tip portion 118a of the main body hooking portion 18 in the axial direction D2 can be easily specified.

The stent 111 shown in FIG. 7 may be used by being placed in the body so that, for example, the wall of the luminal organ is sandwiched between the main body hooking portion 118 and the end hooking portion 14 from both the outer and inner sides. .. In such a stent 111, the main body hooking portion 118 and the end hooking portion 14 work together to perform both migration in which the stent 111 moves to the body cavity side and migration in which the stent 111 moves to the luminal organ side. Can be effectively prevented. When the stent 111 is used in this way, the operator places the marginal portion 30 cp of the colored region 30 c representing the position of the end hooking portion 14 on the proximal side of the inner wall of the luminal organ to place the stent 111. Should be released.

Further, in the stent 111 shown in FIG. 7, similarly to the stent 11a shown in FIG. 6, both the main body hooking portion 118 and the end hooking portion 14 are arranged on the proximal side of the inner wall of the luminal organ. It can also be used by indwelling in the body. In this case, the operator confirms the position of the tip portion 118a of the main body hooking portion 118 by confirming the position of the marginal portion 30cd of the colored region 30c, and the tip portion 118a is close to the inner wall of the luminal organ. It may be placed on the lumen side to release the stent 111.

According to the second embodiment described above, the main body hooking portion 118 and the end are formed by forming a colored region 30c on the outer peripheral surface 12d of the main body portion 12 so that the positions of the main body hooking portion 118 and the end hooking portion 14 can be specified. The position of the partial hooking portion 14 can be easily specified, and the stent 111 can be placed at an accurate position. In particular, the edge portion 30cp of the colored region 30c makes it possible to easily identify the position of the axial D2 where the end hooking portion 14 connects to the outer peripheral surface 12d, and the edge portion 30cd of the coloring region 30c makes it possible to easily identify the stent delivery. When the stent 111 is housed in the system 50, the position of the tip portion 118a of the main body hooking portion 118 in the axial direction D2 can be easily specified.

[Third Embodiment]
The stent for bypassing between luminal organs according to the third embodiment of the present invention will be described. FIG. 8 is a front view showing an example of a stent for bypassing between luminal organs according to the third embodiment of the present invention. In the description of the stent 211 shown in FIG. 8, the components having the same function as the stent 11a shown in FIG. 6 are designated by the same reference numerals to simplify or omit the description.

The stent 211 shown in FIG. 8 is different from the stent 11a shown in FIG. 6 in that it does not have the main body hooking portion 18 and does not have the colored region forming portion 20b that forms the colored region 30b.

The stent 211 shown in FIG. 8 has only an end hooking portion 14 as a stent retaining portion for preventing the stent 211 from being displaced in the axial direction D2, and the outer peripheral surface 212d of the main body portion 212 has. , Only one colored region 30a is formed in a ring shape.

According to the third embodiment described above, the position of the end hooking portion 14 can be easily specified by forming the colored region 30a on the outer peripheral surface 212d of the main body 212 so that the position of the end hooking portion 14 can be specified. This will allow the stent 211 to be placed in the correct location. In particular, the edge portion 30ap of the colored region 30a makes it possible to easily identify the position of the end hooking portion 14 in the axial direction D2.

[Fourth Embodiment]
The stent for bypassing between luminal organs according to the fourth embodiment of the present invention will be described. FIG. 9 is a front view showing an example of a stent according to a fourth embodiment of the present invention. FIG. 9 schematically shows the outer shape of the stent 311 in a state of being expanded in the radial direction.

The stent 311 shown in FIG. 9 has an elongated substantially tubular body portion 312. The main body portion 312 is located at the axially central portion of the main body portion 312 and the two diameter-expanded portions 314 and 316 arranged in the vicinity of both ends of the main body portion 312, and the two diameter-expanded portions 314 and 316. It is composed of a saddle portion 318 that connects the two.

The stent 311 shown in FIG. 9 is a self-expanding covered stent. The main body 312 of the stent 311 expands to a non-uniform size according to the axial position when the diameter is expanded, and the diameter expansion dimension in which the two diameter expansion portions 314 and 316 expand outward in the radial direction is the saddle portion. The 318 is formed so as to be larger than the enlarged diameter dimension extending outward in the radial direction.

When the stent 311 shown in FIG. 9 is placed, the enlarged diameter portions 314 and 316 are arranged so as to sandwich the wall of the luminal organ. The enlarged diameter portions 314 and 316 are a part of the main body portion 312 deformed so as to project radially outward from the outer peripheral surface of the saddle portion 318. The stent 311 placed in the body is restricted from moving in the axial direction by the enlarged diameter portions 314 and 316 being caught (prevented) from the wall of the luminal organ. The enlarged diameter portions 314 and 316 have a function of preventing the displacement of the stent 311 in the axial direction, and correspond to the stent retaining portion in the present invention.

In the stent 311 shown in FIG. 9, a colored region forming portion 320 is provided on the entire outer peripheral surface of the enlarged diameter portion 314. The colored region forming portion 320 forms the colored region 330 on the entire outer peripheral surface of the enlarged diameter portion 314.

The edge portions 330p and 330d of the colored region 330 are formed along the circumferential direction so as to pass through the positions of the axial directions D2 of both end portions of the enlarged diameter portion 314, whereby both end portions of the enlarged diameter portion 314 are formed. It represents the position of each axial direction D2. Visually, in the marginal portion 330p of the colored region 330, the colored region 330 and the non-colored region 340a appear to have different colors, so that the marginal portion 330p of the colored region 330 can be easily confirmed. Further, since the peripheral portion 330d of the colored region 330 looks different in color between the colored region 330 and the non-colored region 340b, the peripheral portion 330d of the colored region 330 can be easily confirmed. As a result, the position of the enlarged diameter portion 314 in the axial direction D2 can be easily specified.

According to the fourth embodiment described above, the position of the enlarged diameter portion 314 can be easily specified by forming the colored region 330 on the outer peripheral surface of the main body portion 312 so that the position of the enlarged diameter portion 314 can be specified. This allows the stent 311 to be placed in the correct position. In particular, the peripheral portions 330d and 330p of the colored region 330 make it possible to easily identify the position of the enlarged diameter portion 314 in the axial direction D2.

Hereinafter, the operation according to the present invention will be described.

The stent for bypassing between luminal organs according to the present invention is a stent for bypassing between luminal organs for bypass-connecting a luminal organ and another luminal organ, and has an elongated tubular main body and a main body. It has a stent retaining portion for preventing the displacement of the stent in the axial direction, and a colored region forming portion for forming a colored region on the outer peripheral surface of the main body portion so that the position of the stent retaining portion can be specified.

According to this configuration, when the stent for bypass between luminal organs is placed in the body, the colored region formed on the outer peripheral surface of the stent for bypass between luminal organs can be confirmed from the image taken by the endoscopic camera. Therefore, the position of the stent withdrawal portion provided on the stent for bypassing between luminal organs can be specified. As a result, the position of the stent withdrawal portion can be appropriately controlled so that the stent for bypassing between luminal organs can be placed in an accurate position and in an accurate state.

In addition, the stent removal part is a stent for bypass between luminal organs in order to prevent migration (movement) in which the stent for bypass between luminal organs placed at a predetermined position in the body is displaced from an appropriate position. It means a member or structure provided. The main body hooking portions 18 and 118 and the end hooking portions 14 in the first to third embodiments described above, and the diameter-expanded portions 314 and 316 in the fourth embodiment described above correspond to the stent retaining portions according to the present invention.

Further, the position of the stent removal portion means the relative position of the stent removal portion with respect to the main body portion, for example, when the stent removal portion is connected to the main body portion or is housed in the stent delivery system. The position of the stent removal portion in the above. In the first embodiment described above, the position where the base end portion 18b of the main body hooking portion 18 is connected to the main body portion 12 and the position where the base end portion 14b of the end hooking portion 14 is connected to the main body portion 12 are the positions where the stent is removed. Corresponds to the position of the part. In the second embodiment described above, the position of the tip portion 118a of the main body hooking portion 118 when housed in the stent delivery system 50 and the position where the base end portion 14b of the end hooking portion 14 is connected to the main body portion 12 are located. , Corresponds to the position of the stent removal part. In the third embodiment described above, the position where the base end portion 14b of the end hooking portion 14 connects to the main body portion 212 corresponds to the position of the stent removal portion. Further, in the fourth embodiment described above, the diameter-expanded portions 314 and 316 are composed of a part of the main body portion 312 that greatly protrudes outward in the radial direction, and the position of the main body portion 312 that constitutes the diameter-expanded portion 314 is located. , Corresponds to the position of the stent removal part.

Further, the stent for bypassing between luminal organs according to the present invention may be provided with a stent retaining portion that can be identified by a colored region on one end side in the axial direction of the main body portion.

According to this configuration, for example, the position of the stent withdrawal portion provided on the proximal side of the stent for bypassing between luminal organs can be specified by the colored region. When the stent for bypass between luminal organs is released from the stent delivery system, the inside of the luminal organ is photographed by the endoscopic camera, and it is confirmed whether or not the colored area is visible in this photographed image. As a result, it is possible to surely confirm that the stent withdrawal portion is inside the luminal organ, and the position of the stent withdrawal portion can be easily specified.

Further, in the stent for bypassing between luminal organs according to the present invention, on the outer peripheral surface of the main body portion, the peripheral portion of the colored region may be formed along the circumferential direction so as to pass through the position of the stent extraction portion. ..

According to this configuration, the position of the stent removal portion can be determined by visually recognizing the edge portion of the colored region formed in a ring shape on the outer peripheral surface of the stent for bypassing between luminal organs from the image taken by the endoscopic camera. It will be easy to identify.

Further, the stent for bypassing between luminal organs according to the present invention has an end hooking portion provided at one end in the axial direction in the main body portion as a stent retaining portion, and an edge portion of a colored region is formed. It may be formed along the circumferential direction so as to pass through one end.

According to this configuration, by confirming the edge of the colored region formed in a ring shape on the outer peripheral surface of the stent for bypass between luminal organs from the image taken by the endoscopic camera, for example, bypass between luminal organs can be confirmed. The position of the end hooking portion provided at the proximal end of the stent can be specified. In addition, since the end hooking portion is provided at one end of the main body, the end hooking portion comes into contact with the inner wall of the luminal organ and functions as an anchor, effectively preventing migration. become able to.

Further, in the stent for bypassing between luminal organs according to the present invention, the end hooking portion is composed of an elastic linear member, and the proximal end portion and the free end portion are integrally connected to one end portion. The intermediate portion between the proximal end portion and the distal end portion is curved, and at least a part of the distal end portion and the intermediate portion is arranged radially outside the outer peripheral surface. It may be like this.

According to this configuration, the tip end portion or the intermediate portion of the elastic end hooking portion can come into contact with the inner wall of the luminal organ, and the migration of the stent for bypass between the luminal organs can be effectively prevented. Further, since the intermediate portion of the end hooking portion is curved, the risk that the inner wall surface of the luminal organ is damaged by the end hooking portion can be reduced.

Further, the stent for bypassing between luminal organs according to the present invention has a main body hooking portion provided on the outer peripheral surface of the main body portion other than both ends in the axial direction as a stent removal portion, and the peripheral portion of the colored region is provided. , It may be formed along the circumferential direction so as to pass through the position of the main body hooking portion.

According to this configuration, by confirming the marginal portion of the colored region formed on the stent for bypass between luminal organs from the image taken by the endoscopic camera, other than both ends of the stent for bypass between luminal organs. The position of the main body hooking portion provided on the outer peripheral surface can be specified. Further, since the main body hooking portion is provided on the outer peripheral surface of the main body portion other than both ends in the axial direction, the main body hooking comes into contact with the inner wall or the like of the luminal organ and functions as an anchor between the luminal organs. Migration of bypass stents can be effectively prevented.

Further, in the stent for bypassing between luminal organs according to the present invention, the main body hooking portion is composed of an elastic linear member, and the base end portion and the free end portion integrally connected to the outer peripheral surface of the main body portion. The middle part between the base end part and the tip part is curved so that at least a part of the tip part and the middle part is arranged radially outward from the outer peripheral surface. It may be.

According to this configuration, the tip end portion or the intermediate portion of the elastic main body hooking portion can come into contact with the inner wall of the luminal organ, and the migration of the stent for bypass between the luminal organs can be effectively prevented. Further, since the intermediate portion of the main body hooking portion is curved, the risk that the inner wall surface of the luminal organ is damaged by the main body hooking portion can be reduced.

Further, the stent for bypassing between luminal organs according to the present invention has a diameter-expanded portion which is a part of the main body portion and has an outer diameter larger than that of the other portion of the main body portion as a stent removal portion, and has a colored region. The edge portion may be formed along the circumferential direction so as to pass through the position of the enlarged diameter portion.

According to this configuration, it is provided for the purpose of preventing migration, etc. by confirming the edge portion of the colored region formed in a ring shape on the stent for bypassing between luminal organs from the image taken by the endoscopic camera. The position of the enlarged diameter portion can be specified.

The embodiments described above are described for facilitating the understanding of the present invention, and are not described for limiting the present invention. Therefore, each element disclosed in the above-described embodiment is intended to include all design changes and equivalents belonging to the technical scope of the present invention.

For example, in the first to third embodiments described above, for example, the main body hooking portion may be provided on the second end L side, and the end hooking portion connected to the second end L may be provided. May be good. In this case, a colored region may be formed on the outer peripheral surface of the main body portion so that the positions of the main body hooking portion and the end hooking portion on the second end L side can be specified. Similarly, a colored region that makes it possible to specify the position of the enlarged diameter portion 316 on the distal side in the fourth embodiment described above may be formed on the outer peripheral surface of the main body portion.

11, 11a, 111, 211, 311 Stent for bypass between luminal organs (stent)
12, 212, 312 Main body part 12a Coating part 12ac Coating film 12d, 212d Outer peripheral surface 13 Frame part 13a Strut 13b Bridge 14 End hooking part (stent removal part)
14a, 18a, 118a Tip 14b, 18b, 118b Base end 14c, 18c, 118c Intermediate part 16 1st end marker 17 2nd end marker 18, 118 Main body hooking part (stent removal part)
20, 20a, 20b, 320 Colored region forming part 20x Colored resin 20y Colored polymer film 20z Protective layer 30p, 30d, 30ap, 30ad, 30bp, 30bd, 30cp, 30cd, 330d, 330p Peripheral part 30, 30a, 30b, 30c , 330 Colored area 40, 40a, 40b, 40c, 340a, 340b Non-colored area 50 Stent delivery system 52 Transport mechanism 60 Operation part 61 Housing 62 Tip tip 63 Operation lever 64 Outer tube 66 Outer sheath 68 Inner shaft 68a Small diameter part 69 Push ring 314, 316 Enlarged diameter part (stent removal part)
318 saddle section

Claims (8)

A stent for bypassing between tract organs for bypass connection between a tract organ and another luminal organ.
An elongated tubular body and
A stent retaining portion for preventing the axial displacement of the main body portion, and a stent retaining portion.
A colored region forming portion that forms a colored region that enables the position of the stent removal portion to be specified on the outer peripheral surface of the main body portion, and a colored region forming portion.
A stent for bypass between luminal organs, characterized by having. The stent for luminal inter-organ bypass according to claim 1, wherein the stent retaining portion that can be identified by the colored region is provided on one end side in the axial direction of the main body portion. The tube according to claim 1 or 2, wherein an edge portion of the colored region is formed along the circumferential direction on the outer peripheral surface of the main body portion so as to pass through the position of the stent retaining portion. Stent for bypass between luminal organs. The stent retaining portion has an end hooking portion provided at one end in the axial direction of the main body.
The luminal inter-organ bypass according to any one of claims 1 to 3, wherein the peripheral portion of the colored region is formed along the circumferential direction so as to pass through the one end portion. Stent for. The end hooking part
Consists of elastic linear members
It has a base end that is integrally connected to one of the ends and a tip that has a free end.
The intermediate portion between the base end portion and the tip end portion is curved.
The stent for bypassing between luminal organs according to claim 4, wherein at least a part of the tip portion and the intermediate portion is arranged radially outside the outer peripheral surface. As the stent retaining portion, a main body hooking portion provided on an outer peripheral surface of the main body portion other than both ends in the axial direction is provided.
The luminal organ according to any one of claims 1 to 5, wherein the peripheral portion of the colored region is formed along the circumferential direction so as to pass through the position of the main body hooking portion. Bypass stent. The main body hooking part
Consists of elastic linear members
It has a base end portion integrally connected to the outer peripheral surface of the main body portion and a tip end portion having a free end.
The intermediate portion between the base end portion and the tip end portion is curved.
The stent for bypassing between luminal organs according to claim 6, wherein at least a part of the tip portion and the intermediate portion is arranged radially outside the outer peripheral surface. The stent retaining portion has a diameter-expanded portion that is a part of the main body portion and has an outer diameter larger than that of the other portion of the main body portion.
The space between luminal organs according to any one of claims 1 to 3, wherein the peripheral portion of the colored region is formed along the circumferential direction so as to pass through the position of the enlarged diameter portion. Bypass stent.

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