JP7601933B2 - Extensions - Google Patents

Description

This disclosure relates to expanders, also known as dilators.

Patent Document 1 discloses a dilator that assists in the insertion of two guidewires into a blood vessel. This dilator has a first lumen into which a first guidewire that has been inserted into the blood vessel beforehand through a puncture needle is inserted, and a second lumen into which a second guidewire is inserted with the dilator inserted into the blood vessel through the first lumen and the first guidewire. After the dilator is removed, the two guidewires, the first guidewire and the second guidewire, remain in the blood vessel and assist in the insertion of other medical instruments, such as a catheter, into the blood vessel.

JP 2016-209319 A

If the lumens through which the guidewires pass are formed at positions offset from the central axis of the shaft, as in the dilator of Patent Document 1, the positioning accuracy of the lumens may deteriorate.

This disclosure was made in light of these circumstances, and aims to provide an expansion device etc. that can improve the placement accuracy of the lumen in the shaft.

In order to solve the above problems, an expansion device according to one embodiment of the present invention has a shaft with a tapered hole expansion section at its tip, and the shaft is provided with a through lumen with an opening at the tip through which a guidewire is inserted, and a non-through lumen with a closed tip.

In this embodiment, in addition to the through lumen through which the guidewire can pass, a non-through lumen with a closed tip is provided in the shaft. By providing a non-through lumen in a position where there is no through lumen, the positioning accuracy of the through lumen can be improved.

In addition, any combination of the above components, or expressions of these converted into methods, devices, systems, recording media, computer programs, etc., are also included in the present disclosure.

The expansion device disclosed herein can improve the accuracy of lumen placement in the shaft.

1 shows a schematic diagram of the overall appearance of a dilator. 2 is a schematic cross-sectional view including the central axis of the tip portion of the shaft. FIG. 1 shows a schematic cross section perpendicular to the axis of a shaft. 1 shows a schematic cross section perpendicular to the axis of a shaft. The flow of EUS-HGS is shown as an example of a procedure using a dilator. The flow of EUS-HGS is shown as an example of a procedure using a dilator. The flow of EUS-HGS is shown as an example of a procedure using a dilator. The flow of EUS-HGS is shown as an example of a procedure using a dilator. The flow of EUS-HGS is shown as an example of a procedure using a dilator. The flow of EUS-HGS is shown as an example of a procedure using a dilator. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft. 11A and 11B are schematic diagrams showing modified examples of a cross section perpendicular to the axis of the shaft.

Below, a detailed description of a form for carrying out the present invention (hereinafter also referred to as an embodiment) will be given with reference to the drawings. In the description and/or drawings, identical or equivalent components, members, processes, etc. will be given the same reference numerals, and duplicated descriptions will be omitted. The scale and shape of each part shown in the drawings are set for convenience in order to simplify the description, and should not be interpreted as being restrictive unless otherwise specified. The embodiment is an example, and does not limit the scope of the present invention in any way. All features and combinations thereof described in the embodiment are not necessarily essential to the present invention.

Figure 1 shows a schematic diagram of the overall appearance of a dilator 1 according to an embodiment of the present disclosure. The dilator 1 is, for example, an expander that assists in the insertion of one or more guidewires into the digestive system. As described below, the dilator 1 according to this embodiment assists in the insertion of one or more guidewires from the stomach, which is the digestive tract in the digestive system, into the intrahepatic bile duct, but the expander according to the present disclosure may also assist in the insertion of one or more guidewires into any other organ, including blood vessels.

In this embodiment, the name "dilator" is used for convenience and in a broad sense, and includes medical devices generally called "dilators" in the medical field, but is not limited to this. As described below, the dilator 1 according to this embodiment has the main functions of expanding the insertion site (hole) of the guidewire and passing one or more guidewires through it, but any medical device that can perform these main functions is included in the "dilator" of this embodiment, regardless of the name. For example, a tubular medical device called a cannula or a cannula is also included in the "dilator" of this embodiment when it is used in a manner that performs the above main functions.

The dilator 1 comprises a tubular shaft 2 and a port portion 3 provided at the base end of the shaft 2. When the dilator 1 is inserted into the body, the tip portion 2D of the shaft 2 is inside the body, and the port portion 3 (and the base end portion 2P of the shaft 2) is outside the body.

The shaft 2 is a tube that extends between the base end 2P and the tip end 2D. The flexible shaft 2 can move smoothly along the inner wall of an endoscope or a tubular organ (the bile duct in this embodiment) while being deformed (guided) according to the shape of the endoscope or tubular organ (the bile duct in this embodiment). The tip end 2D of the shaft 2 is provided with a tapered hole expansion section 21 (i.e., the hole expansion section 21 constitutes a part (at the tip side) of the tip end 2D). The hole expansion section 21 is provided at the tip of the tip end 2D (i.e., the tip of the entire shaft 2 or the entire dilator 1), and the diameter or size (cross-sectional area) gradually decreases from the base end side to the tip end side.

The hole expansion section 21, which has such a sharp tip, expands the insertion hole of the guidewire (for example, a hole opened by a puncture needle between the stomach and the intrahepatic bile duct, as described below). The tip 2D of the shaft 2 can enter the organ beyond the insertion hole expanded by the hole expansion section 21 (in the intrahepatic bile duct in this embodiment). In this way, the part of the shaft 2 that can enter the organ beyond the insertion hole expanded by the hole expansion section 21 may be defined as the tip 2D.

As described below, when the tip 2D of the shaft 2 is in the organ beyond the insertion hole, an additional guidewire (second guidewire) may be inserted into the organ through the tip 2D. Furthermore, through such one or more guidewires and the insertion hole expanded by the hole expansion section 21, other medical devices such as stents and catheters can be effectively guided to the target site.

The port section 3 connected to the base end 2P of the shaft 2 includes a first port 31 into which a first guide wire, which will be described later, is inserted, and a second port 32 into which various wire-like members and a second guide wire, which will be described later, are inserted. As will be described later, the first guide wire inserted into the first port 31 is guided to a first opening provided in the tip end 2D through a first through lumen that communicates with the first port 31 and that penetrates the shaft 2 from the base end 2P to the tip end 2D. In addition, various wire-like members inserted into the second port 32 can be inserted through a non-through lumen that communicates with the second port 32 and that extends from the base end 2P to the tip end 2D in the shaft 2, up to the occluded end of the non-through lumen in the tip end 2D. Alternatively, the second guide wire inserted into the second port 32 is guided to a second opening provided at the tip 2D through a second through lumen that communicates with the second port 32 and passes through the shaft 2 from the base end 2P to the tip 2D.

As described below, in addition to one or more through lumens, one or more non-through lumens with closed tips are provided in the shaft 2, and if various wire-like members or long rod-like members other than a guidewire, such as a shape-adjusting member, a stiffness-adjusting member, or a contrast member, are inserted into any of the non-through lumens, a port for inserting the various wire-like members into the non-through lumens may be provided in the port section 3 in addition to the first port 31 and the second port 32.

Figure 2 is a schematic cross-sectional view including the central axis of the distal end 2D of the shaft 2 (and the central axis of the through lumen 41, which will be described later). The distal end of the distal end 2D of the shaft 2 is the aforementioned tapered hole expansion section 21, and the proximal end is a straight tube section 22 of a substantially constant diameter or size (cross-sectional area).

Within the shaft 2, extending between the base end 2P and the tip end 2D are a first through lumen 41 into which a first guide wire 51 is inserted, and a non-through lumen 43C different from the first through lumen 41 into which various wire-shaped members may be inserted. As described above, the first through lumen 41 extends to the base end 2P of the shaft 2 and is connected to the first port 31, and the non-through lumen 43C extends to the base end 2P of the shaft 2 and is connected to the second port 32.

The first through lumen 41 has a first opening 411 at its tip. The tip of the non-through lumen 43C is closed. The first opening 411 of the first through lumen 41 and the closed end of the non-through lumen 43C are provided at the tip 2D of the shaft 2. In the illustrated example, the first opening 411 is located at the tip of the aforementioned hole expansion section 21 (i.e., the tip 2D or the tip of the entire shaft 2). In addition, the closed end of the non-through lumen 43C is located at the base end of the hole expansion section 21 (i.e., near the boundary with the straight tube section 22 in the hole expansion section 21) or preferably at the tip of the straight tube section 22 on the base end side thereof.

In the illustrated example, the first opening 411 located at the tip of the hole expansion section 21 opens in the extension direction of the shaft 2 (left-right direction in FIG. 2). In other words, the normal direction of the opening surface of the first opening 411 substantially coincides with the extension direction of the shaft 2. With this configuration, the first guide wire 51 passing through the first through lumen 41 exits the dilator 1 from the first opening 411 located at the tip of the hole expansion section 21 along the extension direction of the shaft 2.

The diameters of the first guidewire 51 and the second guidewire described later are arbitrary, but as described later, it is preferable to make the diameter of the first guidewire 51, which is inserted into the body first through the puncture needle, relatively small, and the diameter of the second guidewire, which is inserted into the body later through the dilator 1, relatively large. For example, a small-diameter guidewire of 0.018 inches, which is common for medical use, is used as the first guidewire 51, and a large-diameter guidewire of 0.025 inches, which is common for medical use, is used as the second guidewire. The diameters of the first guidewire 51 and the second guidewire may be equal, or the diameter of the first guidewire 51 may be larger than the diameter of the second guidewire.

Figure 3 is a cross-sectional view taken along line A-A in Figure 2, and shows a schematic cross section perpendicular to the axis of the shaft 2 (straight tube section 22). The shaft 2 is made of, for example, polyamide, polyamide elastomer, polyurethane elastomer, olefin resin, etc. In order to perform the main function of the dilator 1, which is to expand the insertion hole of a guidewire, stent, etc., it is preferable that the material constituting the shaft 2 has a relatively high hardness. For example, the preferred range of Shore D hardness, which is a parameter representing hardness, is between 50D and 95D, more preferably between 63D and 75D, and even more preferably between 69D and 72D.

The cross section perpendicular to the axis of the shaft 2 (straight tube section 22) is approximately circular, and the diameter is, for example, 2.45 mm. The first through lumen 41 through which the first guide wire 51 with a diameter of 0.018 inches (about 0.46 mm) passes and the non-through lumen 43C through which various wire-like members may pass may have any different diameters as long as the first guide wire 51 or various wire-like members can pass appropriately, but in the example shown in this figure, they have the same diameter (for example, 0.8 mm). The first through lumen 41 and the non-through lumen 43C are provided at a position shifted from the central axis (center O) of the shaft 2. As shown in FIG. 2 and FIG. 4 described later, in the hole expansion section 21 on the tip side from the closed end of the non-through lumen 43C, only the first through lumen 41 extends into the shaft 2, and its center is located closer to the central axis (center O) of the shaft 2 than in FIG. 3 (A-A cross section).

The first through lumen 41 and the non-through lumen 43C are arranged in line symmetry with respect to the X-axis, which is the axis of symmetry in a cross section perpendicular to the axis of the shaft 2. Specifically, the first through lumen 41 and the non-through lumen 43C are arranged in positions that are line symmetric with respect to the X-axis. Here, in the illustrated example in which the first through lumen 41 and the non-through lumen 43C are both approximately circular, their respective centers are arranged in positions that are line symmetric with respect to the X-axis. Note that, if the first through lumen 41 and the non-through lumen 43C have different shapes, their respective centers, centers of gravity, or other corresponding representative points are arranged in positions that are line symmetric with respect to the X-axis (the same applies to other examples of line symmetric arrangements described later).

The first through lumen 41 and the non-through lumen 43C are arranged to be line-symmetrical with respect to the Y-axis, which is the axis of symmetry in a cross section perpendicular to the axis of the shaft 2. Specifically, the first through lumen 41 has a shape that is line-symmetrical with respect to the Y-axis, and the non-through lumen 43C has a shape that is line-symmetrical with respect to the Y-axis. In the illustrated example in which the first through lumen 41 and the non-through lumen 43C are both substantially circular, the Y-axis passes through their centers.

Here, the Y axis is a straight line connecting the center O (central axis) of the shaft 2, the center (central axis) of the substantially circular first through lumen 41, and the center (central axis) of the substantially circular non-through lumen 43C. In other words, the center O of the shaft 2, the center of the first through lumen 41, and the center of the non-through lumen 43C are aligned on a straight line on the Y axis. The X axis is a straight line perpendicular to the Y axis in a cross section perpendicular to the axis of the shaft 2. In addition, the first through lumen 41 and the non-through lumen 43C are provided point-symmetrically with respect to the center O of the shaft 2. For example, if the position of the first through lumen 41 is the "0 o'clock (12 o'clock)" position on a clock, the non-through lumen 43C is at the "6 o'clock" position.

In this embodiment, the terms line symmetry and point symmetry are used for convenience, but in an actual dilator 1, each lumen, such as the first penetrating lumen 41 and the non-penetrating lumen 43C, is not required to be provided in a strictly line symmetrical position (or line symmetrical shape) and/or point symmetrical position. For example, each lumen may be located within a predetermined distance from the intended line symmetrical position and/or point symmetrical position. Specifically, the distance of each lumen from the intended line symmetrical position and/or point symmetrical position may be within 30% of the diameter of each lumen, preferably within 20%, and more preferably within 10%.

In addition to the first through lumen 41 and non-through lumen 43C arranged symmetrically as described above, a pair of non-through lumens 43L, 43R of the same diameter are provided at the "3 o'clock" and "9 o'clock" positions, offset from the central axis (center O) of the shaft 2. The pair of non-through lumens 43L, 43R of the same diameter are arranged symmetrically with respect to the X-axis and Y-axis, which are the common axes of symmetry with the first through lumen 41 and non-through lumen 43C.

That is, the non-through lumen 43L has a shape that is line-symmetrical with respect to the X-axis, and the non-through lumen 43R has a shape that is line-symmetrical with respect to the X-axis. Furthermore, the non-through lumens 43L, 43R are provided at positions that are line-symmetrical with respect to the Y-axis. The center O (central axis) of the shaft 2 and the centers (central axes) of the approximately circular non-through lumens 43L, 43R are aligned in a straight line on the X-axis. Furthermore, the non-through lumens 43L, 43R are provided point-symmetrical with respect to the center O of the shaft 2.

As described above, the pair of non-penetrating lumens 43L, 43R that are provided to fill the gap between the first penetrating lumen 41 and the non-penetrating lumen 43C improves the positioning accuracy of the first penetrating lumen 41. In other words, the non-penetrating lumens 43C, 43L, 43R effectively suppress misalignment of the first penetrating lumen 41. In addition, by adjusting the shape and size of the non-penetrating lumens 43C, 43L, 43R, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

In this way, the non-through lumens 43C, 43L, and 43R have a favorable effect simply by being formed, so nothing needs to be inserted inside them. Therefore, the tip of each non-through lumen 43C, 43L, and 43R is closed and does not have an opening such as the first opening 411 (first through lumen 41). In this case, each non-through lumen 43C, 43L, and 43R extending within the straight tube section 22 of the shaft 2 loses diameter to zero midway through the hole expansion section 21 of the shaft 2 and disappears. Note that each non-through lumen 43C, 43L, and 43R may disappear, preferably at the tip of the straight tube section 22.

3, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumen 41 and the non-through lumens 43C, 43L, and 43R exist or coexist in thirds in the X-axis direction as a first direction and in thirds in the Y-axis direction as a second direction perpendicular to the X-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each include at least a portion of at least one of the through lumen 41 and the non-through lumens 43C, 43L, and 43R. In the illustrated example, rectangular area A1 includes a portion of the through lumen 41, rectangular area A2 includes a portion of the non-through lumen 43C, rectangular area A3 includes a portion of the non-through lumen 43R, and rectangular area A4 includes a portion of the non-through lumen 43L. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, which have a relatively large effect on the placement accuracy of each lumen, placement accuracy can be effectively improved.

Figure 4 is a cross-sectional view taken along line B-B in Figure 2, and shows a schematic cross section perpendicular to the axis of the shaft 2 (hole expansion section 21) distal to the point where each non-penetrating lumens 43C, 43L, and 43R have disappeared. The only lumen present in this cross section is the first penetrating lumen 41, and each non-penetrating lumens 43C, 43L, and 43R that have disappeared due to their diameter or cross-sectional area becoming zero do not exist.

As described above, in the process in which each of the non-through lumens 43C, 43L, and 43R, which extend straight within the straight tube section 22 of the shaft 2, disappears midway through the tapered hole expansion section 21 of the shaft 2, the cross-sectional area of each of the non-through lumens 43C, 43L, and 43R gradually decreases toward the tip, which is blocked midway through the hole expansion section 21. For example, if the cross-sectional area of each of the non-through lumens 43C, 43L, and 43R in Figure 3 (straight tube section 22) is "100", it gradually becomes smaller until it reaches "0" in Figure 4 (hole expansion section 21).

In this way, the process of blocking the tips of each non-penetrating lumen 43C, 43L, 43R within the hole expansion section 21 can be performed all at once during the process of forming the hole expansion section 21 into a tapered shape by heat. That is, when the straight-tube-shaped hole expansion section 21 (not shown) is heated to form a tapered shape, each non-penetrating lumen 43C, 43L, 43R inside it is naturally filled in while being affected by heat (the cross-sectional area gradually decreases toward the tip, and finally becomes "0" and is blocked). Note that, when the shaft 2 is formed by three-dimensional printing (3D printing) that can directly form the final shape without thermal shaping, the cross-sectional area of each non-penetrating lumen 43C, 43L, 43R may be approximately constant up to the blocked tip (i.e., the cross-sectional area does not gradually decrease toward the tip).

At least one of the non-penetrating lumens 43C, 43L, and 43R may be inserted with various wire-like members other than a guide wire. For example, at least one of the non-penetrating lumens 43C, 43L, and 43R may be inserted with a shape-adjusting member having a predetermined extension shape. Specifically, by inserting a shape-adjusting member having a curved extension shape into at least one of the non-penetrating lumens 43C, 43L, and 43R, a desired curved shape can be imparted to the entire shaft 2 or dilator 1 to facilitate insertion into an endoscope, a tubular organ, or the like. A plurality of shape-adjusting members having different extension shapes may be prepared in advance, and a shape-adjusting member having an optimal extension shape may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R according to the insertion target of the dilator 1. A plurality of shape-adjusting members may be replaced while the dilator 1 is inserted in the body. Since it is not necessary to remove the dilator 1 from the body to replace a plurality of shape-adjusting members, this leads to a reduction in the burden on the patient and a reduction in the procedure time.

In addition, a stiffness adjusting member for adjusting the stiffness of the shaft 2 or the dilator 1 may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R. For example, the effective stiffness of the shaft 2 or the dilator 1 can be increased by inserting a stiffness adjusting member, preferably made of a material harder than the material of the shaft 2, into at least one of the non-penetrating lumens 43C, 43L, and 43R. On the other hand, the flexibility of the shaft 2 or the dilator 1 can be increased by not inserting a stiffness adjusting member into any of the non-penetrating lumens 43C, 43L, and 43R. In this way, the effective stiffness of the shaft 2 or the dilator 1 can be adjusted by the presence or absence of a stiffness adjusting member into at least one of the non-penetrating lumens 43C, 43L, and 43R, or by designing the diameter or size of the non-penetrating lumens 43C, 43L, and 43R themselves, without changing the material of the shaft 2.

For example, when the guidewire insertion hole is expanded by the hole expansion section 21, a stiffness adjustment member may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R to increase the stiffness of the shaft 2 or the dilator 1. After the guidewire insertion hole is expanded by the hole expansion section 21, the stiffness adjustment member inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R may be removed to increase the deliverability of the shaft 2 or the dilator 1. A plurality of stiffness adjustment members having different stiffness may be prepared in advance, and a stiffness adjustment member having an optimal stiffness according to the insertion target of the dilator 1 may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R. The plurality of stiffness adjustment members may be replaced while the dilator 1 is inserted in the body. Since it is not necessary to remove the dilator 1 from the body to replace the plurality of stiffness adjustment members, this leads to a reduction in the burden on the patient and a reduction in the procedure time.

Furthermore, a contrast member having contrast properties may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R. For example, by inserting a contrast member having contrast properties at least at the tip into at least one of the non-penetrating lumens 43C, 43L, and 43R, contrast properties can be imparted to the tip 2D of the shaft 2 (particularly the hole expansion portion 21). A plurality of contrast members having different contrast properties may be prepared in advance, and a contrast member having optimal contrast properties according to the insertion target or imaging target of the dilator 1 may be inserted into at least one of the non-penetrating lumens 43C, 43L, and 43R. For example, by preparing a plurality of contrast members having different lengths of the contrast portion, the desired insertion amount of the dilator 1 can be accurately grasped. A plurality of contrast members may be replaced while the dilator 1 is inserted into the body. Since it is not necessary to remove the dilator 1 from the body to replace a plurality of contrast members, this leads to a reduction in the burden on the patient and a reduction in the procedure time.

Here, contrast properties refer to the property of being visualized in a manner that can be distinguished from other objects in images constructed by any medical image construction technology, such as X-ray photography, magnetic resonance imaging (MRI), and computed tomography (CT). For example, in order to impart contrast properties in X-ray photography to the contrast member, iodine compounds, barium compounds, bismuth compounds, gadolinium compounds, gold, platinum-iridium alloys, tungsten, and the like that block X-rays may be mixed into the constituent material of the contrast member. Such contrast properties are particularly useful when guiding the hole expansion portion 21 located at the tip of the entire shaft 2 to a desired location (for example, the aforementioned insertion hole).

Next, the flow of EUS-HGS (EUS-hepaticogastrostomy: ultrasonic endoscopic gastrobiliary anastomosis) will be shown as an example of a procedure using the dilator 1 having the above-mentioned configuration. EUS-HGS is a procedure in which an ultrasonic endoscope (endoscopic ultrasound) is used to form a fistula connecting the stomach and the intrahepatic bile duct and then a stent is placed. In this embodiment, a dilator 1 having two through lumens 41, 42 as shown in FIG. 12 described later is used. A first guide wire 51 is inserted into the first through lumen 41, and a second guide wire 52 is inserted into the second through lumen 42.

In FIG. 5, a puncture needle 71 is advanced from the tip of an ultrasonic endoscope 7 inserted into the stomach G, which serves as the digestive tract. The puncture needle 71 opens a fistula connecting the stomach G and the intrahepatic bile duct H. Then, a first guide wire 51 having a diameter of 0.018 inches is inserted into the intrahepatic bile duct H through the puncture needle 71. Thereafter, the puncture needle 71 is removed as shown in FIG. 6. In this state, the first guide wire 51 advanced from the tip of the ultrasonic endoscope 7 extends into the intrahepatic bile duct H through the fistula opened in the stomach G.

In FIG. 7, the shaft 2 of the dilator 1 is inserted into the stomach G (inside the body) via the ultrasonic endoscope 7. The shaft 2 is inserted from the base end (not shown) of the existing first guide wire 51 outside the body so that the existing first guide wire 51 passes through the first through lumen 41. In other words, the shaft 2 is guided by the existing first guide wire 51 (and the ultrasonic endoscope 7) into the stomach G, and is further guided to the fistula opened in the stomach G, which is the target of dilation by the dilator 1. Then, the tapered hole expansion part 21 provided at the tip of the dilator 1 enters the fistula, thereby expanding the fistula. When contrast is imparted to at least the hole expansion part 21 (tip part 2D) of the shaft 2 by a contrast material inserted into at least one of the non-penetrating lumens 43L and 43R, the hole expansion part 21 can be effectively inserted into the fistula as the dilated part while being contrasted or visually recognized by X-ray photography or the like.

In FIG. 8, the tip 2D of the shaft 2 enters the intrahepatic bile duct H through the fistula expanded by the hole expansion section 21. In this state, the second guide wire 52 is inserted from the base end (not shown) outside the body of the second through lumen 42 of the shaft 2. The second guide wire 52 is guided by the second through lumen 42 and led into the intrahepatic bile duct H from the second opening 421 at the tip. When contrast is imparted to at least the second opening 421 of the shaft 2 by a contrast member inserted into at least one of the non-through lumens 43L and 43R, the second guide wire 52 can be introduced at an appropriate position in the intrahepatic bile duct H while imaging or visually confirming the position where the second guide wire 52 exits from the second opening 421 by X-ray photography or the like.

Then, as shown in Figure 9, the shaft 2 is removed. In this state, the first guide wire 51 and the second guide wire 52 sent out from the tip of the ultrasonic endoscope 7 extend into the intrahepatic bile duct H through the fistula opened in the stomach G. In the next Figure 10, the stent 8 is guided through the ultrasonic endoscope 7 and the two existing guide wires 51 and 52 to the fistula connecting the target site, the stomach G, and the intrahepatic bile duct H.

Since the fistula has been expanded by the dilator 1 (hole expansion section 21), the contracted stent 8 (not shown) can be smoothly inserted into the fistula. With the tip of the stent 8 inserted into the fistula in the intrahepatic bile duct H and the base in the stomach G, the stomach G and the intrahepatic bile duct H are connected by the stent 8 by expanding the stent 8 as shown. After that, the two guidewires 51, 52 and the ultrasonic endoscope 7 are removed from the body, leaving only the stent 8 in the body (not shown).

In FIG. 9, even if one of the two guide wires 51, 52 becomes dislodged from the stent 8, the procedure can be continued using the other guide wire, which functions as a safety wire. This makes it possible to avoid redoing the procedure, which involves re-puncturing the stomach. Re-puncturing the stomach can lead to an increase in the amount of gastric acid that falls from the stomach into the abdominal cavity, which can cause complications such as peritonitis. Therefore, according to this embodiment, in which the stability of the procedure is increased by using multiple guide wires 51, 52, the risk of complications can be minimized.

The present disclosure has been described above based on the embodiments. Various modifications are possible to the combinations of the components and processes in the exemplary embodiments, and it will be obvious to those skilled in the art that such modifications are included within the scope of the present disclosure.

In FIG. 3, an example of the arrangement of one through lumen 41 and three non-through lumens 43C, 43L, 43R in a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) is shown, but in the present disclosure, it is sufficient that at least one through lumen and at least one non-through lumen are provided in the shaft, and shapes and/or arrangements as shown in FIG. 11 to FIG. 17 as modified examples of FIG. 3 may be adopted. In FIG. 11 to FIG. 17, the same components as in FIG. 3 are given the same reference numerals and redundant explanations are omitted. Note that, although FIG. 11 to FIG. 13 show various symmetrical arrangements of the through lumen and/or non-through lumens, the arrangement of the through lumen and non-through lumens in the present disclosure is arbitrary, and the through lumen and/or non-through lumens may be arranged asymmetrically (i.e., neither line symmetric nor point symmetric).

In FIG. 11, one through lumen 41 into which one guide wire 51 is inserted and five non-through lumens 43 with closed tips are provided in the shaft 2 (straight tube section 22). These through lumens 41 and non-through lumens 43 are provided at positions offset from the central axis of the shaft 2.

The cross section of one through lumen 41 is approximately circular, and is arranged line-symmetrically with respect to the Y axis, which is the axis of symmetry in a cross section perpendicular to the axis of the shaft 2. That is, the through lumen 41 has a shape that is line-symmetric with respect to the Y axis. The cross sections of the five non-through lumens 43 are approximately circular with approximately the same diameter, and are arranged line-symmetrically with respect to the Y axis, which is the axis of symmetry common to the through lumen 41. That is, of the five non-through lumens 43, the central non-through lumen 43 has a shape that is line-symmetric with respect to the Y axis, and the remaining four non-through lumens 43 are arranged in positions that are line-symmetric with respect to the Y axis. The five non-through lumens 43 are arranged to surround the outer periphery of the through lumen 41 on one side in the Y axis direction (upper side in FIG. 11).

In this way, the five non-through lumens 43 are symmetrically arranged to fill the area of the shaft 2 where no through lumen 41 is provided (the upper area in FIG. 11), thereby improving the placement accuracy of the through lumen 41. In other words, the non-through lumens 43 effectively suppress misalignment of the through lumen 41. In addition, by adjusting the shape and size of each non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

11, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumen 41 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each contain at least a portion of at least one of the through lumen 41 and the non-through lumen 43. In the illustrated example, the rectangular region A1 contains a portion of the non-through lumen 43, the rectangular region A2 contains a portion of the through lumen 41, the rectangular region A3 contains a portion of the non-through lumen 43, and the rectangular region A4 contains a portion of the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

In FIG. 12, two through lumens 41, 42 into which two guide wires 51, 52 are inserted, and two non-through lumens 43L, 43R whose tips are closed, are provided in the shaft 2 (straight tube section 22). These through lumens 41, 42 and non-through lumens 43L, 43R are provided at positions offset from the central axis (center O) of the shaft 2.

The cross section of the two through lumens 41, 42 is a substantially ellipse long in the X-axis direction, and is provided line-symmetrically with respect to the X-axis and Y-axis, which are axes of symmetry in a cross section perpendicular to the axis of the shaft 2. That is, the through lumens 41, 42 are provided at positions line-symmetrical with respect to the X-axis. Also, the through lumens 41, 42 each have a shape line-symmetrical with respect to the Y-axis. The two through lumens 41, 42 are provided point-symmetrical with respect to the center O of the shaft 2. The cross section of the two non-through lumens 43L, 43R is a substantially circular shape with substantially the same diameter, and is provided line-symmetrical with respect to the X-axis and Y-axis, which are axes of symmetry common to the through lumens 41, 42. That is, the non-through lumens 43L, 43R each have a shape line-symmetrical with respect to the X-axis. Also, the non-through lumens 43L, 43R are provided at positions line-symmetrical with respect to the Y-axis. The non-through lumens 43L, 43R are provided point-symmetrical with respect to the center O of the shaft 2.

The two non-through lumens 43L, 43R are symmetrically arranged on both sides in the X-axis direction (left and right sides in FIG. 12) so as to fill the area of the shaft 2 where the two through lumens 41, 42 are not provided. Such non-through lumens 43L, 43R improve the positioning accuracy of the through lumens 41, 42. In other words, the non-through lumens 43L, 43R effectively suppress misalignment of the through lumens 41, 42. In addition, by adjusting the shape and size of each non-through lumen 43L, 43R, the thickness of each part of the shaft 2 can be adjusted, so that the shaft 2 can be given the desired flexibility.

12, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumens 41, 42 and the non-through lumens 43L, 43R exist or coexist into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely two rectangular regions A1, A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3, A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each include at least a portion of at least one of the through lumens 41, 42 and the non-through lumens 43L, 43R. In the illustrated example, rectangular area A1 includes a portion of through lumen 41, rectangular area A2 includes a portion of through lumen 42, rectangular area A3 includes the through lumens 41, 42 and a portion of the non-through lumen 43R, and rectangular area A4 includes the through lumens 41, 42 and a portion of the non-through lumen 43L. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, which have a relatively large effect on the placement accuracy of each lumen, placement accuracy can be effectively improved.

In FIG. 13, one through lumen 41 into which one guide wire 51 is inserted and one non-through lumen 43 with a closed tip are provided in the shaft 2 (straight tube section 22). These through lumen 41 and non-through lumen 43 are provided at positions offset from the central axis of the shaft 2.

The cross section of each through lumen 41 is approximately circular, and is arranged line-symmetrically with respect to the Y axis, which is the axis of symmetry in a cross section perpendicular to the axis of the shaft 2. That is, the through lumen 41 has a shape that is line-symmetric with respect to the Y axis. The cross section of each non-through lumen 43 is approximately arc-shaped, and is arranged line-symmetrically with respect to the Y axis, which is the axis of symmetry shared with the through lumen 41. That is, the non-through lumen 43 has a shape that is line-symmetric with respect to the Y axis. Each non-through lumen 43 is arranged to surround the outer periphery of the through lumen 41 on one side in the Y axis direction (the upper side in FIG. 13).

In this way, the placement precision of the through lumen 41 is improved by one non-through lumen 43 that is arranged to fill the area of the shaft 2 where the through lumen 41 is not provided (the upper area in FIG. 13). In other words, the non-through lumen 43 effectively prevents the through lumen 41 from shifting out of position. In addition, by adjusting the shape and size of the non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

13, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumen 41 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each contain at least a portion of at least one of the through lumen 41 and the non-through lumen 43. In the illustrated example, the rectangular region A1 contains a portion of the non-through lumen 43, the rectangular region A2 contains a portion of the through lumen 41, the rectangular region A3 contains a portion of the through lumen 41 and the non-through lumen 43, and the rectangular region A4 contains a portion of the through lumen 41 and the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

Figures 14 to 17 show further modified examples of Figure 3. In these figures, 41 and 42 are through lumens into which a guidewire (not shown) is inserted, and 43 is a non-through lumen whose tip is blocked. As shown in these figures, the number of through lumens 41, 42 and non-through lumens 43 may be any number (but must be one or more). Furthermore, the shape and arrangement of each of the through lumens 41, 42 and non-through lumen 43 in a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) may also be any number. In particular, as shown diagrammatically in some of these figures, the through lumens 41, 42 and/or non-through lumen 43 may be arranged asymmetrically (i.e., neither line-symmetric nor point-symmetric).

In FIG. 14, one through lumen 41 into which one guide wire 51 is inserted and three non-through lumens 43 with closed tips are provided in the shaft 2 (straight tube section 22). These through lumens 41 and non-through lumens 43 are provided at positions offset from the central axis of the shaft 2.

The cross section of one through lumen 41 is approximately circular, and is arranged asymmetrically with respect to the X-axis and Y-axis (neither shown) in a cross section perpendicular to the axis of the shaft 2. The cross sections of the three non-through lumens 43 are approximately circular with approximately the same diameter, and are arranged asymmetrically with respect to the X-axis and Y-axis in a cross section perpendicular to the axis of the shaft 2. The three non-through lumens 43 are arranged to surround the outer periphery of the through lumen 41 on one side in the Y-axis direction (upper side in FIG. 14).

In this way, the three non-through lumens 43 arranged to fill the area of the shaft 2 where no through lumen 41 is provided (the upper area in FIG. 14) improve the placement accuracy of the through lumen 41. In other words, the non-through lumens 43 effectively suppress misalignment of the through lumen 41. In addition, by adjusting the shape and size of each non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

14, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumen 41 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each contain at least a portion of at least one of the through lumen 41 and the non-through lumen 43. In the illustrated example, the rectangular region A1 contains a portion of the non-through lumen 43, the rectangular region A2 contains a portion of the through lumen 41, the rectangular region A3 contains a portion of the non-through lumen 43, and the rectangular region A4 contains a portion of the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

In FIG. 15, one through lumen 41 into which one guide wire 51 is inserted and two non-through lumens 43 with closed tips are provided in the shaft 2 (straight tube section 22). These through lumen 41 and non-through lumen 43 are provided at positions offset from the central axis of the shaft 2.

The cross section of one through lumen 41 is approximately circular, and is provided asymmetrically with respect to the X-axis and Y-axis (neither shown) in a cross section perpendicular to the axis of the shaft 2. The cross section of one (right) non-through lumen 43 is approximately elliptical, and the cross section of the other (left) non-through lumen 43 is approximately circular. The two non-through lumens 43 are provided asymmetrically with respect to the X-axis and Y-axis in a cross section perpendicular to the axis of the shaft 2. The two non-through lumens 43 are arranged to surround the outer periphery of the through lumen 41 on one side in the Y-axis direction (upper side in FIG. 15).

In this way, the two non-through lumens 43 arranged to fill the area of the shaft 2 where the through lumen 41 is not provided (the upper area in FIG. 15) improve the placement accuracy of the through lumen 41. In other words, the non-through lumen 43 effectively suppresses misalignment of the through lumen 41. In addition, by adjusting the shape and size of each non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

15, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumen 41 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each include at least a portion of at least one of the through lumen 41 and the non-through lumen 43. In the illustrated example, rectangular region A1 includes a portion of the two non-through lumens 43, rectangular region A2 includes a portion of the through lumen 41, rectangular region A3 includes a portion of the through lumen 41 and the non-through lumen 43, and rectangular region A4 includes a portion of the through lumen 41 and the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

In FIG. 16, two through lumens 41, 42 into which two guide wires 51, 52 are inserted, and two non-through lumens 43 with closed tips are provided in the shaft 2 (straight tube section 22). These through lumens 41, 42 and non-through lumens 43 are provided at positions offset from the central axis of the shaft 2.

The two through lumens 41, 42 have a substantially circular cross section, and in a cross section perpendicular to the axis of the shaft 2, they are provided asymmetrically with respect to the X axis and are provided line-symmetrically with respect to the Y axis. That is, the two through lumens 41, 42 are provided at positions asymmetrical with respect to the X axis. Also, the two through lumens 41, 42 each have a shape that is line-symmetrical with respect to the Y axis. The two non-through lumens 43 have a substantially circular cross section, and in a cross section perpendicular to the axis of the shaft 2, they are provided asymmetrically with respect to the X axis and are provided line-symmetrical with respect to the Y axis. That is, the two non-through lumens 43 each have a shape that is line-symmetrical with respect to the X axis. Also, the two non-through lumens 43 are provided at positions that are line-symmetrical with respect to the Y axis. The two non-through lumens 43 are disposed on the outer periphery of the through lumens 41, 42 on both sides in the X axis direction (left and right sides in FIG. 16).

In this way, the two non-through lumens 43 arranged to fill the areas of the shaft 2 where the through lumens 41, 42 are not provided (the left and right areas in FIG. 16 ) improve the positioning accuracy of the through lumens 41, 42. In other words, the non-through lumens 43 effectively suppress misalignment of the through lumens 41, 42. In addition, by adjusting the shape and size of each non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

16, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumens 41, 42 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each include at least a portion of at least one of the through lumens 41, 42 and the non-through lumen 43. In the illustrated example, rectangular region A1 includes a portion of the two through lumens 41, rectangular region A2 includes a portion of the through lumen 42, rectangular region A3 includes a portion of the through lumen 41 and the non-through lumen 43, and rectangular region A4 includes a portion of the through lumen 41 and the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

In FIG. 17, two through lumens 41, 42 into which two guide wires 51, 52 are inserted, and one non-through lumen 43 whose tip is closed, are provided in the shaft 2 (straight tube section 22). These through lumens 41, 42 and non-through lumen 43 are provided at positions offset from the central axis of the shaft 2.

The two through lumens 41, 42 have a substantially circular cross section, and are arranged asymmetrically with respect to the X-axis and Y-axis (neither shown) in a cross section perpendicular to the axis of the shaft 2. The single non-through lumen 43 has a substantially circular cross section, and is arranged asymmetrically with respect to the X-axis and Y-axis in a cross section perpendicular to the axis of the shaft 2. The single non-through lumen 43 is disposed on the outer periphery of the through lumens 41, 42 (upper left side in FIG. 17).

In this way, the positioning accuracy of the through lumens 41, 42 is improved by the single non-through lumen 43 that is arranged to fill the area of the shaft 2 where the through lumens 41, 42 are not provided (the area in the upper left of FIG. 17). In other words, the non-through lumen 43 effectively suppresses misalignment of the through lumens 41, 42. In addition, by adjusting the shape and size of the non-through lumen 43, the thickness of each part of the shaft 2 can be adjusted, thereby imparting the desired flexibility to the shaft 2.

17, nine rectangular regions are formed by dividing a cross section perpendicular to the axis of the shaft 2 (straight tube section 22) in which the through lumens 41, 42 and the non-through lumen 43 exist or coexist, into thirds in the X-axis direction and thirds in the Y-axis direction. Of these nine rectangular regions, four rectangular regions A1 to A4, namely, two rectangular regions A1 and A2 at both ends (upper and lower ends) in the Y-axis direction at the center in the X-axis direction and two rectangular regions A3 and A4 at both ends (right and left ends) in the X-axis direction at the center in the Y-axis direction, each include at least a portion of at least one of the through lumens 41, 42 and the non-through lumen 43. In the illustrated example, the rectangular region A1 includes a portion of the through lumen 41 and the non-through lumen 43, the rectangular region A2 includes a portion of the through lumen 42, the rectangular region A3 includes a portion of the through lumen 41, and the rectangular region A4 includes a portion of the non-through lumen 43. In this way, by arranging each lumen in a well-balanced manner in the four rectangular areas A1 to A4, where the influence on the placement accuracy of each lumen is relatively large, placement accuracy can be effectively improved.

The configuration, action, and function of each device and method described in the embodiments can be realized by hardware resources or software resources, or by the cooperation of hardware resources and software resources. For example, a processor, ROM, RAM, and various integrated circuits can be used as hardware resources. For example, an operating system, an application, and other programs can be used as software resources.

1 Dilator, 2 Shaft, 2D Tip, 2P Base, 21 Hole expansion section, 22 Straight tube section, 41 First through lumen, 42 Second through lumen, 43, 43L, 43R Non-through lumen, 51 First guide wire, 52 Second guide wire, 411 First opening, 421 Second opening.

Claims (6)

A shaft having a tapered hole expansion portion at a tip portion thereof,
The shaft is provided with a plurality of through lumens having openings at the distal ends into which guide wires are inserted, and a plurality of non-through lumens having closed distal ends.
The plurality of through lumens are arranged in positions and shapes that are linearly symmetrical with respect to a first axis of symmetry in a cross section perpendicular to the axis of the shaft,
The plurality of non-penetrating lumens are arranged in positions and shapes that are line-symmetrical with respect to a second axis of symmetry perpendicular to the first axis of symmetry in the cross section,
The tapered shape is formed to a tip of the shaft,
A cross section perpendicular to the axis of the shaft is substantially circular over the entire length of the shaft from the base end to the tip end.
Expansion tool. The expander of claim 1 , wherein the plurality of through lumens and the plurality of non-through lumens are disposed at positions offset from a central axis of the shaft. The expander of claim 1 or 2 , wherein the cross-sectional area of the non-through lumen gradually decreases toward the distal end, which is occluded. The expansion tool according to claim 1 or 2 , wherein a contrast member having contrast properties is inserted into the non-penetrating lumen. The expansion device described in claim 1 or 2, wherein at least a portion of at least either the through lumen or the non-through lumen is included in four regions out of nine regions formed by dividing a cross section perpendicular to the axis of the shaft in which the through lumen and the non-through lumen exist into thirds in a first direction and thirds in a second direction perpendicular to the first direction: two regions on both ends of the second direction in the center of the first direction and two regions on both ends of the first direction in the center of the second direction. A shaft having a tapered hole expansion portion at a tip portion thereof,
The shaft is provided with a plurality of through lumens having an opening at a tip end into which a guide wire is inserted, and a plurality of non-through lumens extending from a base end to a tip end of the shaft and closed at least at the portions other than the base end,
The plurality of through lumens are arranged in positions and shapes that are linearly symmetrical with respect to a first axis of symmetry in a cross section perpendicular to the axis of the shaft,
The plurality of non-penetrating lumens are arranged in positions and shapes that are line-symmetrical with respect to a second axis of symmetry perpendicular to the first axis of symmetry in the cross section,
The tapered shape is formed to a tip of the shaft,
A cross section perpendicular to the axis of the shaft is substantially circular over the entire length of the shaft from the base end to the tip end.
Expansion tool.

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