JP2019181291A - Guide tube - Google Patents

Abstract

An object of the present invention is to provide a guide tube capable of performing an accurate puncture operation while maintaining the strength of a region to be inserted into a body cavity. A guide tube has a lumen therein and is inserted into a body cavity, a puncture opening communicating with the lumen and the outside of the tube body, and a proximal end direction of the tube body. And a puncturing opening end surface 40 that defines the puncturing opening 30. The puncturing opening end surface 40 has a cross section cut perpendicular to the direction in which the axis X of the tube main body 10 extends. The opening angle θ formed by two line segments 14 connecting the end 16 on the side of the center X and the axis X is less than 180 degrees, and the opening direction II of the puncture opening 30 included in the perpendicular of the line segment 14 The direction component of the opening direction II included in the normal I of the puncture opening end face 40 is configured to be larger than the direction component of. [Selection diagram] FIG.

Description

  The present invention relates to a guide tube.

  Means have been proposed for guiding a puncture needle to a predetermined location inside a body cavity when puncturing a medical needle (hereinafter referred to as “puncture needle”) for puncturing a predetermined body surface of a subject.

  For example, Patent Document 1 discloses an opening portion for puncture formed in an introduction body of a tube material made of a flexible material to be inserted into the body in an axial direction and a circumferential direction (in Patent Document 1, “arc-shaped” A medical device (hereinafter also referred to as “prior art 1”) having a “cross-sectional portion” is disclosed.

  Prior art 1 has an arc-shaped cross-sectional portion that is largely opened by cutting out the wall surface of the introduction main body to a position deeper than a semicircle in the circumferential direction, and can be expanded and contracted along the lumen side surface of the introduction main body. (For example, refer to Patent Document 1 FIGS. 1 to 3). The expanded bumper expands from the lumen side of the introduction main body to the outside of the introduction main body through the arc-shaped cross-section and to a position where it can come into contact with the inner wall surface of the esophageal neck or the like. 6). This document describes that the expanded bumper contributes to the placement of the introduction body in the esophageal neck and the like, and serves as a mark for puncture. That is, the operator of the puncture needle (hereinafter simply referred to as “operator”) confirms the position of the bumper with an ultrasonic image obtained by ultrasonic examination, and punctures the puncture needle from the body surface toward the bumper using this as a mark. (Paragraph [0042], FIGS. 6 and 7).

JP 2012-239571 A

  In the prior art 1, the bumper that bulges out from the arc-shaped cross-section only roughly indicates the position of the arc-shaped cross-section provided in the introduction main body. However, since the arc-shaped cross-section portion is formed larger than the introduction main body, the bumper bulging from here is used as a mark, and the puncture needle is punctured to the lumen side of the introduction main body through the arc-shaped cross-section portion. Is possible.

  Such prior art 1 has the following problems. That is, the introduction main body provided with the arc-shaped cross-sectional portion that is largely opened by being cut out to a position deeper than the semicircle in the circumferential direction is not sufficient in terms of strength. That is, in the related art 1, when inserted into the body cavity or placed in the body cavity, the cross section in the insertion region may be deformed or bent.

  On the other hand, when the arc-shaped cross section is formed smaller than the semicircle in the circumferential direction, the strength of the introduction main body is improved, but the puncturable area is reduced. For this reason, when puncturing is performed using a bumper that merely indicates the opening position as a mark, the accuracy of the puncturing operation may be lacking. As a result, difficulty in puncturing work may occur.

  The present invention has been made in view of the above problems. That is, an object of the present invention is to provide a guide tube that enables an accurate puncturing operation while maintaining the strength of a region inserted into a body cavity.

  The guide tube of the present invention includes a tube main body having a lumen therein and inserted into a body cavity, a puncture opening communicating with the lumen and the outside of the tube main body, and extending in a distal end proximal direction of the tube main body. A puncture opening end face that divides the puncture opening, and an end portion on the axis side of the puncture opening end face in a cross section that is cut perpendicular to an extending direction of the axis of the tube main body. And an opening angle formed by two line segments connecting the axis and the axis is less than 180 degrees, and the direction component of the puncture opening direction of the puncture opening included in the perpendicular of the line segment is greater than the puncture opening end surface. The direction component in the opening direction included in the normal is large.

  The guide tube of the present invention having the above configuration enables an accurate puncturing operation while maintaining the strength of the region inserted into the body cavity. The configuration of the guide tube of the present invention and the excellent effect enjoyed thereby will be described in detail later.

(A) is a longitudinal cross-sectional view of the guide tube concerning 1st embodiment, (b) is the II sectional view taken on the line of the guide tube shown to (a). (A) is a disassembled perspective view of the tube main body and reinforcement member in 1st embodiment, (b) is a perspective view which shows the state which mounted | wore the reinforcement member with respect to the tube main body. FIG. 3 is a cross-sectional view taken along the line III-III in FIG. 1A, showing a state before the inner balloon and the outer balloon are inflated. FIG. 3 is a cross-sectional view taken along line III-III in FIG. 1 (a), showing a state where the inner balloon and the outer balloon are inflated. (A) is a schematic cross-sectional view of the guide tube concerning 1st embodiment, (b) And (c) is a schematic cross-sectional view of the guide tube concerning the modification of 1st embodiment. It is explanatory drawing which shows the state which inserted the guide tube concerning 1st embodiment orally into a test subject's esophageal neck, and punctured the puncture needle.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and redundant description will be appropriately omitted.
Regarding the tube body in the present invention, the tip means an insertion tip inserted into a body cavity, and the base end means an end opposite to the tip in the longitudinal direction of the tube body. Moreover, the distal end proximal direction means the longitudinal direction of the tube body. Further, in this specification, the distal ends of the guide wire and the puncture needle mean an insertion distal end inserted into a body cavity, and the proximal end means an end opposite to the distal end in the longitudinal direction.
In the present specification, the vertical cross section refers to a cross section cut in parallel to the longitudinal direction through the axis of the tube body. Moreover, a cross section means the cross section cut | disconnected perpendicularly | vertically with respect to the extension direction of the axial center of a tube main body.
The various components of the guide tube of the present invention do not have to be independent of each other, but a plurality of components are formed as a single member, and a single component is formed of a plurality of members. A certain constituent element is a part of another constituent element, a part of a certain constituent element and a part of another constituent element are allowed to overlap.

<First embodiment>
Below, regarding the guide tube of this invention, the structure of the guide tube 100 which is 1st embodiment of this invention is demonstrated using FIGS. 1-6.
FIG. 1A is a longitudinal sectional view of the guide tube 100 and shows a state where the inner balloon 60 and the outer balloon 70 are inflated. A broken line in FIG. 1A indicates the inner balloon 60 before being inflated. FIG. 1B is a cross-sectional view taken along line II of the guide tube 100 shown in FIG. 1A, and the sub-lumen 22 and the contrast unit 24 are visually recognized in the cross-section of the tube body 10. 2A is an exploded perspective view of the tube main body 10 and the reinforcing member 50, and FIG. 2B is a perspective view showing a state in which the reinforcing member 50 is attached to the tube main body 10. As shown in FIG. FIG. 3 is a cross-sectional view taken along line III-III in FIG. 1A and shows a state before the inner balloon 60 and the outer balloon 70 are inflated. FIG. 4 is a cross-sectional view taken along line III-III in FIG. 1A and shows a state where the inner balloon 60 and the outer balloon 70 are inflated. Fig.5 (a) is a schematic cross-sectional view of the guide tube 100, FIG.5 (b) and FIG.5 (c) are schematic cross-sectional views of the guide tube 100 concerning the modification of 1st embodiment. . FIG. 6 is an explanatory diagram showing a state in which the guide tube 100 is orally inserted into the esophageal neck 172 of the subject 170 and the puncture needle 200 is punctured.

As shown to Fig.1 (a), the guide tube 100 concerning this embodiment has the tube main body 10 which has the lumen | rumen 20 inside and is inserted in a body cavity. The guide tube 100 has a puncture opening 30 that communicates with the lumen 20 and the outside of the tube main body 10, and a puncture opening end face 40 that extends in the proximal direction toward the distal end of the tube main body 10 and defines the puncture opening 30 (FIGS. 3 and 4). Reference).
The guide tube 100 according to the present embodiment has the following two features.
That is, as shown in FIG. 3, the guide tube 100 has an end portion on the axis center X side of the puncture opening end surface 40 in a cross section obtained by cutting perpendicularly to the extending direction of the axis X of the tube body 10. The opening angle θ formed by the two line segments 14 connecting 16 and the axis X is less than 180 degrees. Hereinafter, this feature may be referred to as a first feature.
In addition, the guide tube 100 has a larger direction component in the opening direction II included in the normal I of the puncture opening end surface 40 than in the direction component in the opening direction II of the puncture opening 30 included in the perpendicular IV of the line segment 14. Hereinafter, this feature may be referred to as a second feature.
The end 16 on the side of the axis X is the end of the puncture opening end face 40 located on the lumen (lumen 20) side of the tube body 10.

The guide tube 100 includes the first feature and the second feature described above, thereby enabling an accurate puncturing operation while maintaining the strength of the tube body 10.
That is, by having the first feature, the opening area of the guide tube 100 is limited so that the opening is not formed by being cut out by a semicircle or more in the circumferential direction as in the prior art 1. Therefore, it is possible to prevent the tube body 10 from being deformed or bent at a location where the puncture opening 30 is provided or in the vicinity thereof.
In general, by limiting the opening area of the puncture opening 30 in this manner, the puncture range is narrowed and puncture work becomes severe. However, the guide tube 100 has the second feature, so that the puncture range is narrowed. The puncturing operation can be accurately performed on the puncture opening 30.

That is, according to the guide tube 100 having the second feature, the puncture opening end face 40 lies in the opening direction II as compared to a virtual plane (not shown) including the line segment 14. Therefore, during the puncturing operation, when the ultrasonic probe (not shown) is pressed against the body surface of the subject and ultrasonic waves are generated in the opening direction of the puncture opening 30, the guide tube 100 has the puncture opening end face. The accuracy with which the ultrasonic wave reflected by 40 is received by the receiving unit of the ultrasonic tester is high. By an ultrasonic image formed by receiving the ultrasonic waves reflected at the puncture opening end face 40, the operator (not shown) reliably sees the two puncture opening end faces 40 and punctures between them. It is possible to grasp the area and perform the puncture work with certainty.
Note that the term “ultrasonic wave” used without particular mention in the following description means an ultrasonic wave irradiated from the body surface side of the subject to the puncture opening 30 side in the opening direction II in order to confirm the puncture opening 30. .

  As described above, the guide tube 100 can securely insert the puncture needle 200 into the puncture opening 30 while maintaining the strength of the tube body 10, so that a percutaneous route for various purposes can be safely Can be created reliably.

The detailed configuration of the guide tube 100 will be described below.
The tube body 10 is a thin-walled tube and has one or more lumens. Specifically, the guide tube 100 according to the present embodiment includes a lumen 20 and a sub-lumen 22 as the lumen.
For example, the lumen 20 penetrates from the proximal end to the distal end of the tube body 10 and is a large-diameter lumen through which medical instruments such as an endoscope 160 (see FIG. 6) can be taken in and out from the proximal end and a medical solution or the like can be injected. is there. The diameter of the lumen 20 is not particularly limited, but from the viewpoint of reducing the diameter of the tube main body 10, the lumen 20 can have a size substantially equal to the outer diameter of the endoscope 160 to be inserted.
The sub-lumen 22 is a lumen that continues from the proximal end of the tube body 10 to the front of the distal end. A side hole 12 is provided on the distal end side of the tube body 10 so that the sub-lumen 22 communicates with the outside. The sub-lumen 22 terminates in the vicinity of the side hole 12, and the distal end side thereof is sealed. Yes.
As shown in FIG. 1A, the guide tube 100 according to the present embodiment covers the inner balloon 60 and the puncture opening 30 that seal the puncture opening 30 and circulates around the outer periphery of the tube body 10 to expand outward in the radial direction. It has a possible outer balloon 70. Inside the outer balloon 70, an airtight chamber 90 capable of airtightly filling a liquid or gas is formed. The airtight chamber 90 is an internal space inside the outer balloon 70. Details of the inner balloon 60, the outer balloon 70, and the airtight chamber 90 will be described later.

  Although the material which comprises the tube main body 10 is not specifically limited, For example, synthetic resins, such as a soft vinyl chloride resin, a polyurethane resin, and silicone rubber, can be used as said material. This is because these synthetic resins have good flexibility and elasticity in a temperature range of about room temperature or body temperature. More preferably, the material is transparent. Further, as the tube main body 10, a composite tube in which a metal mesh, a metal wire, or the like is embedded in at least a partial region inside the tube mainly composed of synthetic resin may be used. The length of the tube body 10 is appropriately designed in accordance with the target site of the subject for which the guide tube 100 is used. For example, when the guide tube 100 is applied to the esophageal neck 172, the length of the tube body 10 is generally in the range of 15 cm to 50 cm.

  The tube main body 10 in the present embodiment is provided with a contrast unit 24 (see FIGS. 1A and 1B) on a straight line including the puncture opening 30. The contrast unit 24 includes a material that does not transmit radiation such as X-rays, such as platinum. The contrast unit 24 may be embedded in the tube body 10 or may be provided on the peripheral surface of the tube body 10. Thereby, the position of the puncture opening 30 in the circumferential direction of the tube body 10 can be easily confirmed by radiation irradiation observation such as X-rays. The contrast section 24 in the present embodiment is configured in a straight line extending across the puncture opening 30 and continuously extending from the distal end to the proximal end of the tube body 10 as shown in FIG. However, the contrast unit 24 is not limited to this, and the X-ray opaque material may be discontinuously arranged in the linear direction, or may be provided only in the vicinity of the puncture opening 30. In particular, the contrast portion 24 is provided in contact with or close to both ends of the puncture opening 30 in the proximal direction of the distal end, so that the opening position of the puncture opening 30 in the proximal direction of the distal end of the puncture opening 30 can be accurately confirmed. can do.

  The guide tube 100 according to the present embodiment has two puncture opening end faces 40 extending in the proximal direction of the distal end of the tube body 10 and defining the puncture opening 30, and both ends of the puncture opening 30 in the distal proximal direction. A contrast unit 24 that abuts or is close to is provided. That is, the puncture opening 30 is surrounded on all sides by the puncture opening end face 40 and the contrast unit 24. Therefore, the operator can grasp the formation position of the puncture opening end face 40 using four inspection points such as X-rays and ultrasonic echoes from the body surface side of the subject as marks.

  The guide tube 100 in the present embodiment has a reinforcing member 50 provided along the inner peripheral surface or outer peripheral surface of the tube main body 10. Here, the reinforcing member 50 being along the inner peripheral surface or outer peripheral surface of the tube body 10 means that the reinforcing member 50 extends in the same direction as the extending direction of the inner peripheral surface or the outer peripheral surface. One surface of the member 50 and the inner peripheral surface or the outer peripheral surface face each other directly or indirectly.

  The reinforcing member 50 is provided in the vicinity of the puncture opening 30 in the proximal direction of the distal end of the tube main body 10 and reinforces the tube main body 10 so as not to be deformed or bent. The reinforcing member 50 may be provided only in the vicinity of the puncture opening 30, but may be a hollow pipe and may extend to a position facing the puncture opening 30 across the axis. Accordingly, it is possible to prevent the distal end portion of the puncture needle 200 that has passed through the puncture opening 30 from penetrating the tube body 10 and projecting toward the body cavity side, which is desirable from the viewpoint of safety. More specifically, as shown in FIGS. 2 (a) and 2 (b), the reinforcing member 50 can be mounted by penetrating the tube body 10 into the lumen of the hollow pipe-shaped reinforcing member 50. As described above, the guide tube 100 according to the present embodiment is provided with the reinforcing member 50 along the outer peripheral surface of the tube main body 10, but the present invention is not limited thereto, and is along the inner peripheral surface of the tube main body 10. A reinforcing member 50 may be provided.

  The reinforcing member 50 in the present embodiment has a hole 52 that penetrates in the thickness direction, as shown in FIG. The hole 52 is aligned with the position overlapping the side hole 12 and allows the sub-lumen 22 and the airtight chamber 90 to communicate with each other.

  From the viewpoint of reinforcement and safety, the reinforcing member 50 is preferably formed from a material harder than the main material constituting the tube body 10. For example, the reinforcing member 50 is preferably configured to include a rigid resin that is harder than the sheet-shaped or pipe-shaped metal material or the synthetic resin that forms the tube body 10. Further, the reinforcing member 50 may be formed of a mesh-like member that does not penetrate the distal end portion of the puncture needle 200.

As described above, the guide tube 100 has the reinforcing member 50 provided along the inner peripheral surface or the outer peripheral surface of the tube main body 10.
The puncture opening 30 in this embodiment is provided in the tube opening 32 which is an opening provided in the wall surface of the tube main body 10 and the wall surface of the reinforcing member 50 as shown in FIGS. 2 (a) and 2 (b). The pipe opening 34 which is an opening is formed by overlapping. By providing the reinforcing member 50 in which the pipe opening 34 for puncturing is secured, the strength of the tube body 10 in the vicinity of the puncturing opening 30 is reinforced.

  The puncture opening end face 40 formed by overlapping the tube opening 32 and the pipe opening 34 includes both the case where the opening shapes of the tube opening 32 and the pipe opening 34 match and the case where they do not match. When they do not match, both the case where the pipe opening 34 is larger than the tube opening 32 and the case where the tube opening 32 is larger than the pipe opening 34 are included.

  In FIG. 2A, an example in which the tube opening 32 is provided in the tube main body 10 and the pipe opening 34 is provided in the reinforcing member 50 and then the reinforcing member 50 is attached to the tube main body 10 is shown. In such an example, the puncture opening end face 40 is configured by aligning the tube opening 32 and the pipe opening 34 so as to overlap when mounted. However, the method of forming the puncture opening end face 40 is not limited to this. For example, a puncture opening end face 40 that penetrates the tube body 10 and the reinforcing member 50 in the thickness direction at a predetermined location after attaching the reinforcing member 50 without the pipe opening 34 to the tube body 10 with the tube opening 32 not formed. May be formed. Alternatively, the reinforcing member 50 in which the pipe opening 34 is formed is attached to the tube body 10 in which the tube opening 32 is not formed, and then the tube opening 32 that penetrates the thickness direction of the tube body 10 at a position overlapping the pipe opening 34. And the puncture opening end face 40 may be formed.

The pipe opening 34 provided in the reinforcing member 50 is an opening provided in the wall surface of the reinforcing member 50 and penetrating in the thickness direction of the pipe-shaped reinforcing member 50 so that the puncture needle 200 can pass therethrough. Examples of the pipe opening 34 include an opening that is not continuous with the distal end or the base end of the pipe-shaped reinforcing member 50, and a part of the wall surface that penetrates, or a wall surface that continues to the distal end or the proximal end of the pipe-shaped reinforcing member 50 And a slit formed by cutting out a part of the pipe-shaped reinforcing member 50 and a slit continuous with the tip.
The tube opening 32 provided in the tube main body 10 is an opening provided in the wall surface of the tube main body 10 and penetrating in the thickness direction of the tube-shaped tube main body 10 so that the puncture needle 200 can pass therethrough. As an example of the tube opening 32, there can be mentioned an opening which is not continuous with the distal end or the base end of the tube main body 10 and a part of the wall surface penetrates.

The guide tube 100 according to the present embodiment includes a pipe opening end surface 44 and a tube opening end surface 42 which are continuous as shown in FIGS. 3, 4, and 5 (a). A puncture opening end face 40 is constituted by the opening end face 42.
Here, the pipe opening end surface 44 is a surface that extends in the proximal end direction of the tube main body 10 and divides the pipe opening 34 (see FIGS. 2A and 2B). The tube opening end surface 42 is a surface that extends in the proximal direction of the distal end of the tube body 10 and divides the tube opening 32 (see FIGS. 2A and 2B). Note that the pipe opening end face 44 and the tube opening end face 42 being continuous means that both end faces are adjacent to each other without a step.

  According to such a configuration, the area of the puncture opening end surface 40 is the sum of the pipe opening end surface 44 and the tube opening end surface 42, and increases as compared with the case of either one. Therefore, in the guide tube 100, the visibility of the puncture opening end surface 40 in the ultrasonic examination is particularly excellent.

As a modification of the present embodiment, as shown in FIGS. 5B and 5C, the pipe opening 34 extends in the proximal direction of the distal end of the tube body 10 (see FIGS. 2A and 2B). The pipe opening end face 44 that divides the puncture opening end face 40 may be formed. The modification shown in FIG. 5B is different from FIG. 5A in that the reinforcing member 50 is provided along the inner peripheral surface of the tube main body 10.
More specifically, in the modified example, the pipe opening end surface 44 of the reinforcing member 50 provided along the inner peripheral surface of the tube main body 10 is more than the tube opening end surface 42 in FIG. Are also located above (that is, on the puncture opening 30 side). According to this aspect, the pipe opening end surface 44 forms the puncture opening end surface 40.
As another modification, in FIG. 5C illustrated in the upward opening, the pipe opening end surface 44 of the reinforcing member 50 provided along the outer peripheral surface of the tube body 10 is above the tube opening end surface 42 (that is, puncture). The mode located in the opening 30 side may be sufficient. According to this aspect, the pipe opening end surface 44 forms the puncture opening end surface 40.

  The reinforcing member 50 is generally formed of a material harder than the tube body 10. Therefore, even if the puncture opening 30 is partitioned by the pipe opening end face 44 without depending on the tube opening end face 42, the shape retaining property of the puncture opening 30 can be maintained well. Here, it is generally known that the reflection of ultrasonic waves varies depending on the material of the object. Since the puncture opening end face 40 is configured only by the pipe opening end face 44, reflection of ultrasonic waves at the puncture opening end face 40 is difficult to scatter, and visibility in the ultrasonic image can be made clearer.

  As a different modification of the present embodiment (not shown), a tube opening end surface 42 that extends in the proximal direction of the distal end of the tube body 10 and defines the tube opening 32 may form a puncture opening end surface 40.

  As shown in FIGS. 3 and 4, the guide tube 100 according to the present embodiment has two puncture openings in a cross section with a line segment (not shown) extending in the opening direction II passing through the axis X as a symmetry axis. The end face 40 is line symmetric. With this configuration, the accuracy with which the ultrasonic waves reflected by the respective puncture opening end faces 40 are received by the receiving unit of the ultrasonic tester can be made comparable. As a result, the two puncture opening end faces 40 are shown with the same clarity in the ultrasonic image, and the operator can clearly grasp the opening position of the puncture opening 30 from the ultrasonic image.

  In particular, it is preferable that the normal I of the two puncture opening end faces 40 that are line symmetric is parallel to the opening direction II (see FIGS. 3 and 4). Thereby, the precision with which the ultrasonic wave irradiated to the inner direction of the opening direction II from the body surface side is received by the receiving part of an ultrasonic tester can be made very high. As a result, the two puncture opening end faces 40 are clearly shown in the ultrasonic image, and the opening position of the puncture opening 30 can be confirmed easily and accurately.

Next, the inner balloon 60 will be described.
As shown in FIGS. 3 and 4, the guide tube 100 according to the present embodiment includes an inner balloon 60 that seals the puncture opening 30 and can be inflated on the side of the axis X from the puncture opening 30. FIG. 3 shows the inner balloon 60 before inflating, and FIG. 4 shows the inflated inner balloon 60. For the inflated inner balloon 60 observed in the longitudinal section, see FIG.

  By having the inner balloon 60, the puncture needle 200 that passes through the puncture opening 30 also penetrates the inner balloon 60. Due to the resistance when the puncture needle 200 penetrates the inner balloon 60, the operator can know that the tip of the puncture needle 200 has reached the lumen of the tube main body 10 by the touch of the puncture hand (hereinafter, “ Also referred to as the effect of puncture confirmation).

  In the embodiment in which the inner balloon 60 is provided that covers the puncture opening 30 and is hermetically sealed, it is advantageous that the guide tube 100 has the first feature described above. In other words, the guide tube 100 having the first feature can substantially exhibit the effect of puncture confirmation by providing the inner balloon 60.

  That is, in order to obtain the puncture confirmation effect, an appropriate distance is required between the inner balloon 60 that is inflated toward the lumen of the tube main body 10 and the inner peripheral surface of the tube main body 10 that faces the inner balloon 60. . However, as in the prior art 1, the arc-shaped cross-section portion that is largely opened by being cut out to a semicircular or deeper position in the circumferential direction extends to the inner peripheral surface of the tube main body (introduction main body) facing this. The distance is small. Therefore, when the inner balloon 60 is provided in the arc-shaped cross section, it is difficult to ensure an appropriate distance between the inflated inner balloon 60 and the inner peripheral surface of the tube main body (introduction main body) facing the inner balloon 60. . Therefore, according to the aspect in which the inner balloon 60 is provided in the related art 1, there is a possibility that the inflated inner balloon 60 and the inner peripheral surface of the tube main body 10 come into contact with each other. Further, the distance between the inflated inner balloon 60 and the inner peripheral surface of the tube body 10 is small, and the puncture needle 200 that has passed through the puncture opening 30 is pushed by the puncture needle 200 before passing through the inner balloon 60. The balloon 60 may come into contact with the inner peripheral surface of the tube body 10.

  On the other hand, the guide tube 100 having the first feature can secure a larger distance between the puncture opening 30 and the inner peripheral surface of the tube body 10 facing the puncture opening 30 than the related art 1. Therefore, the guide tube 100 can ensure an appropriate distance between the inflated inner balloon 60 and the inner peripheral surface of the tube main body 10, and can substantially exhibit the effect of the puncture confirmation.

  As described above, the guide tube 100 having the inner balloon 60 that seals the puncture opening 30 and can be inflated on the side of the axis X from the puncture opening 30 preferably has the following configuration. That is, as shown in FIG. 4, the inflated inner balloon 60 has a circle having a diameter of a line segment B (see FIG. 4) connecting the two end portions 16 on the axis center X side of the puncture opening end surface 40 (see FIG. 4). It is preferable to expand with a curvature smaller than the curvature of (omitted) or expand flat. 1A and 4 show the inner balloon 60 inflated flat.

  According to such a configuration, in the cross section of the inner balloon 60 observed in the cross section, an area where the crossing angle with the opening direction II is 90 degrees or an angle close to 90 degrees increases. Thereby, the precision which receives the ultrasonic wave reflected on the cross section of the inner balloon 60 in the receiving part of an ultrasonic tester becomes high. As a result, the inner balloon 60 is clearly visually recognized between the two puncture opening end faces 40 visually recognized in the ultrasonic image, and the operator performs puncture work more accurately by puncturing the inner balloon 60 as a mark. be able to.

In order to inflate flat like the inner balloon 60 shown in FIG. 4, for example, a region facing the puncture opening 30 of the inner balloon 60 (hereinafter referred to as an inflated region) may be configured as follows. That is, the outer edge region 61 (see FIG. 4), which is near the outer edge in the expansion region, is formed more flexibly than the central region 62 (see FIG. 4) located in the center of the expansion region from the outer edge region 61. Note that the inflated region of the inner balloon 60 is a region inflated radially inward from the puncture opening 30 in FIG.
Here, the phrase “inflating the inner balloon 60 in a flat state” refers to the extent to which the central region 62 of the inflated inner balloon 60 is confirmed to be flat. This includes the case where the top of the expansion is flat enough not to be confirmed.

Specifically, for example, the central region 62 may be cured by heat treatment while leaving the outer edge region 61 of the inner balloon 60 formed of synthetic resin, and the flexibility of the central region 62 may be relatively reduced.
Alternatively, the thickness of the central region 62 may be made larger than the thickness of the outer edge region 61 of the inner balloon 60 formed of synthetic resin, and the flexibility of the central region 62 may be relatively reduced.
Alternatively, the central region 62 may be formed in a flat shape, the outer edge region 61 may be formed in a bellows shape, and the flexibility of the outer edge region 61 may be relatively enhanced by the extension of the bellows.

In the present embodiment, an example using a hollow cylindrical inner balloon 60 is shown. The hollow cylindrical inner balloon 60 is mounted so as to directly or indirectly cover the entire outer peripheral surface of the tube main body 10. Specifically, the inner balloon 60 covers the puncture opening 30 and is attached to the outer periphery of the tube main body 10. The member 50 is in close contact with the outer periphery.
As another example not shown in the drawings, the inner balloon 60 covers the puncture opening 30 and is provided on the inner peripheral surface side of the tube body 10, or covers the puncture opening 30 so that the tube body 10 and the reinforcing member 50 The aspect provided between can be mentioned.
As an alternative to the hollow cylindrical inner balloon 60, a non-continuous sheet-like inner balloon 60 in the circumferential direction of the tube body 10 can be used.

  The inner balloon 60 in this embodiment has a hole 63 that penetrates in the thickness direction, as shown in FIG. The hole 63 is aligned with the position overlapping the side hole 12 and the hole 52, and allows the sub-lumen 22 and the airtight chamber 90 to communicate with each other.

  The material of the inner balloon 60 is not particularly limited as long as it does not depart from the spirit of the present invention. For example, it is preferable to select a material that has appropriate elasticity and tensile properties, can be expanded by a predetermined pressure, and does not immediately burst when the puncture needle 200 penetrates in the expanded state. Such a material is preferably selected from, for example, soft vinyl chloride resin, polyurethane resin, polyethylene, polyester, or synthetic resin such as silicone rubber, and natural rubber such as natural rubber latex. When a material that does not easily obtain good elasticity, such as silicone rubber or natural rubber, is selected as the material of the inner balloon 60, the inner balloon 60 may be appropriately treated. Examples of the treatment include a method of laminating or embedding nylon mesh or the like in the inner balloon 60 formed from these materials. Further, as a different process, another synthetic resin may be coated on the peripheral surface of the inner balloon 60 formed from these materials to form a multilayer. With this process, it is possible to prevent the inner balloon 60 from rupturing at the moment when the puncture needle 200 penetrates the inner balloon 60.

Next, the outer balloon 70 will be described.
The guide tube 100 according to the present embodiment includes an outer balloon 70 that covers the puncture opening 30 and circulates around the outer periphery of the tube main body 10 to expand radially outward.
Inside the outer balloon 70, an airtight chamber 90 capable of airtightly filling a liquid or gas is formed. The outer balloon 70 inflated radially outward abuts on the inner wall surface of the body cavity into which the tube body 10 is inserted (for example, the esophageal neck 172 shown in FIG. 6), stabilizes the indwelling state of the tube body 10, and The state where the body cavity is expanded can be maintained.

The material of the outer balloon 70 is not particularly limited as long as it does not depart from the spirit of the present invention. Specifically, the material of the outer balloon 70 can be appropriately selected from materials that can be used as the material of the inner balloon 60, for example. As with the inner balloon 60, the outer balloon 70 is preferably not immediately ruptured by the penetration of the puncture needle 200. From this viewpoint, the synthetic resin selected as the material of the outer balloon 70 has a hardness of JISA 20 degrees to 80 degrees, a tensile strength of 8 MPa to 25 MPa, a tear strength of 20 kg / cm to 60 kg / cm, and a 100% modulus of 3 MPa to 6 MPa. It is preferable to have any one or more of physical properties in the range of elongation rate of 300% to 460%, or balloon internal pressure of 2.8 psi to 75 psi.
The inner balloon 60 also preferably has any one or more of the above-described physical property ranges, and these physical properties can be comparable to those of the outer balloon 70. The inner balloon 60 and the outer balloon 70 may be made of the same material, or may be made of different materials.

  The dimensions of the outer balloon 70 are not particularly limited, and can be appropriately designed according to the location of the body cavity to which the guide tube 100 is applied, the outer diameter of the tube body 10, and the like. For example, the outer balloon 70 can be determined so that the dimension in the proximal direction of the distal end is in a range of 1 cm to 20 cm, an expanded diameter of 5 mm to 250 mm, and a wall thickness of 0.01 mm to 1 mm. More specifically, for example, in the guide tube 100 for the esophagus, it is preferable that the outer balloon 70 has a dimension in the distal proximal direction of 2 cm to 10 cm and an expanded diameter of 20 mm to 35 mm. In the gastric guide tube 100, the outer balloon 70 preferably has a dimension in the distal proximal direction of 5 to 20 cm and an inflated diameter of 150 to 250 mm. However, all the numerical ranges described above are preferred examples and do not limit the present invention.

The outer balloon 70 is expanded outward by the internal pressure of the hermetic chamber 90 filled with a fluid such as gas or liquid. Similarly, the inner balloon 60 is also inflated toward the axis X side by the internal pressure of the airtight chamber 90 described above.
As shown in FIG. 1A, a fluid is injected into the inside from the proximal end side of the sub-lumen 22 by a syringe 150 or the like, and the fluid flows through the side hole 12, the hole 52, and the hole 63 from the sub-lumen 22. The closed chamber 90 is filled.

  Next, referring to FIG. 6, as an example of a method of using the guide tube 100 applied to the esophageal neck 172, a method of securing an insertion route for inserting a medical device such as a catheter percutaneously into the esophagus. explain. The puncture needle 200 used in the example of the usage method includes, for example, a needle body and a grip part 210. The needle body 220 has a hole (not shown) penetrating in the longitudinal direction, and a guide wire (not shown) can be inserted into and removed from the hole.

In this usage method, an example in which the guide tube 100 is used as a so-called overtube for inserting an endoscope into the lumen 20 is shown.
As shown in FIG. 6, the tube body 10 is orally inserted to the esophageal neck 172 with the endoscope 160 inserted into the lumen 20. For example, alignment may be performed while confirming the contrast unit 24 by X-ray observation so that the position of the puncture opening 30 faces the left side of the subject 170. The guide tube 100 is provided with a mouthpiece 140 that is externally arranged at a predetermined position of the tube body 10 as an arbitrary configuration. The mouthpiece 140 has an oral cavity insertion portion 142 that the subject 170 can hold with the mouth. FIG. 6 shows a state in which the subject 170 holds the middle position of the oral cavity insertion portion 142 of the mouthpiece 140 with the tube body 10 inserted to an appropriate depth. Thereby, the insertion position of the tube main body 10 inserted in the oral cavity is stabilized. At this time, in order to facilitate confirmation of the insertion path, the distal end of the endoscope 160 may be appropriately projected from the distal end of the tube body 10.
Next, the endoscope 160 is pulled toward the proximal end side relative to the tube main body 10 and aligned so that the outer balloon 70 comes to a predetermined position (near the esophageal neck 172). The distal end (not shown) of the endoscope 160 is positioned closer to the proximal end side than the puncture opening 30 and secures an expansion space for the inner balloon 60 that is inflated to the axis X (see FIG. 4) side from the puncture opening 30. Good. Then, a fluid (for example, physiological saline) containing a contrast agent is injected into the sublumen 22 from the syringe 150 connected to the proximal end side of the sublumen 22, and the airtight chamber 90 is filled with the fluid. To inflate the outer balloon 70 and the inner balloon 60.

Next, an ultrasonic probe is pressed against the body surface of the subject 170 to confirm the position of the puncture opening 30. It is preferable that the direction in which the ultrasonic probe is pressed and the opening direction of the puncture opening 30 are substantially parallel so that the puncture opening 30 can be satisfactorily observed by ultrasonic inspection. Further, the ultrasonic probe is strongly pressed so that the thyroid gland, trachea, artery, vein and the like are shifted from side to side with respect to the outer balloon 70, and the needle body 220 is inserted with the aim of the puncture opening 30. At this time, the puncture position can be clearly confirmed by confirming the two puncture opening end faces 40 with an ultrasonic image. More specifically, the opening position of the puncture opening 30 in the circumferential direction of the tube body 10 can be accurately confirmed. Note that the opening position of the puncture opening 30 in the proximal direction of the distal end of the tube body 10 may be confirmed by the contrast unit 24 as described above. As described above, the guide tube 100 can surely visually recognize and confirm the position of the puncture opening 30 that is a local opening provided in the guide tube 100 placed in the body cavity by the inspection apparatus, so there is no possibility of erroneous puncturing.
The fact that the needle body 220 punctured from the body surface side passes through the outer balloon 70 and the inner balloon 60 and reaches the lumen side of the tube body 10 rather than the inner balloon 60 is an endoscope inserted into the lumen 20. 160 can be observed and confirmed.

  Next, a required amount of guide wire (not shown) is inserted into the lumen of the tube body 10 from the tip of the needle body 220. Then, the needle body 220 is removed from the subject 170 leaving the guide wire. A guide wire (not shown) exposed from the needle main body 220 is fixed so that it cannot be moved in the longitudinal direction by, for example, being taped to an appropriate portion of the body surface. In this state, the tube body 10 is pushed to the stomach side, the guide wire is directed to the stomach side, and the tube body 10 is pushed to the stomach side, whereby the guide wire is detached from the puncture opening 30. In order to push the tube body 10 toward the stomach, for example, as shown in FIG. 6, the distal end side of the oral cavity insertion portion 142 is held in advance, and the base of the oral cavity insertion portion 142 is moved along with the movement of the tube body 10 toward the stomach. The region on the end side may be moved in the direction of pushing into the oral cavity. Thereafter, the guide tube 100 is removed from the esophageal neck 172, and a dilator with a sheath (not shown) is attached from the proximal end side of the guide wire and inserted from the body surface to the esophageal neck 172 to expand the puncture site. Subsequently, the route into the esophagus is secured by the sheath by removing only the dilator. As a result, a medical device such as a catheter can be subsequently inserted into the esophagus or further into the body cavity through the sheath. The outer balloon 70 may be deflated by sucking the fluid filled in the hermetic chamber 90 with the syringe 150 before performing the operation of inserting the dilator with the sheath.

  The embodiment of the present invention and the usage example thereof have been described above. The present invention is not limited to the above description, and includes various modifications and improvements as long as the object of the present invention is achieved. Moreover, the usage method of this invention can also be changed suitably.

The above embodiment includes the following technical idea.
(1) a tube body having a lumen therein and inserted into a body cavity;
A puncture opening leading to the lumen and the outside of the tube body;
A puncture opening end face extending in the proximal direction toward the distal end of the tube main body and defining the puncture opening;
In a cross section cut perpendicularly to the extending direction of the axial center of the tube main body, it is formed by two line segments connecting the axial center end of the puncture opening end face and the axial center. The opening angle is less than 180 degrees, and the direction component in the opening direction included in the normal line of the puncture opening end surface is larger than the direction component in the opening direction of the puncture opening included in the perpendicular of the line segment. Guide tube characterized by.
(2) The guide tube according to (1), wherein the guide tube includes an inner balloon that seals the puncture opening and is inflatable closer to the axial center than the puncture opening.
(3) an outer balloon that covers the puncture opening and circulates around the outer circumference of the tube body and is inflatable radially outward;
The guide tube according to (1) or (2), wherein an airtight chamber capable of airtightly filling a liquid or a gas is formed inside the outer balloon.
(4) Any one of (1) to (3) above, wherein two puncture opening end faces are line-symmetric with respect to a line segment extending in the opening direction through the axis in the transverse section. Guide tube as described in.
(5) The guide tube according to (4), wherein the normal lines of the two puncture opening end faces are parallel to the opening direction.
(6) having a reinforcing member provided along an inner peripheral surface or an outer peripheral surface of the tube main body,
A tube opening which is an opening provided on the wall surface of the tube body;
A pipe opening which is an opening provided in the wall surface of the reinforcing member,
The guide tube according to any one of (1) to (5), wherein the puncture opening is formed by overlapping.
(7) The guide tube according to (6), wherein a pipe opening end surface that extends in a distal end proximal direction of the tube main body and defines the pipe opening forms the puncture opening end surface.
(8) The guide tube according to (6), wherein a tube opening end surface that extends in a distal end proximal direction of the tube main body and defines the tube opening forms the puncture opening end surface.
(9) a pipe opening end surface extending in a distal end proximal direction of the tube body and defining the pipe opening;
The tube opening end surface extending in the distal end proximal direction of the tube body and defining the tube opening is continuous,
The guide tube according to (6), wherein the puncture opening end surface is configured by the pipe opening end surface and the tube opening end surface.
(10) having an inner balloon that seals the puncture opening and is inflatable on the side of the axial center from the puncture opening;
The inner balloon is inflated with a curvature smaller than the curvature of a circle whose diameter is a line segment connecting two end portions on the axial center side of the puncture opening end face, or inflated flatly ( The guide tube according to any one of 1) to 9).

DESCRIPTION OF SYMBOLS 10 ... Tube main body 12 ... Side hole 14 ... Line segment 16 ... End part 20 ... Lumen 22 ... Sub-lumen 24 ... Contrast part 30 ... Puncture opening 32 ... Tube opening 34 ... Pipe opening 40 ... Puncture opening end surface 42 ... Tube opening end surface 44 ... Pipe opening end surface 50 ... Reinforcement member 52 ... Hole 60 ... Inner balloon 61 ... Outer edge region 62 ... central region 63 ... hole 70 ... outer balloon 90 ... airtight chamber 100 ... guide tube 140 ... mouthpiece 142 ... oral cavity insertion part 150 ... syringe 160 ... endoscope 170 ... subject 172 ... esophageal neck 200 ... puncture needle 210 ... grasping part 220 ... needle body θ ... opening angle B ... line segment I ... Normal II ... Opening direction IV ... Vertical X ... Axis

The guide tube of the present invention includes a tube main body having a lumen therein and inserted into a body cavity, a puncture opening communicating with the lumen and the outside of the tube main body, and extending in a distal end proximal direction of the tube main body. A tube opening that is an opening provided on the wall surface of the tube body , and has a puncture opening end face that divides the puncture opening and a reinforcing member provided along the inner peripheral surface or the outer peripheral surface of the tube main body, The puncture opening is formed by overlapping a pipe opening which is an opening provided in the wall surface of the reinforcing member, and the pipe extends in the distal end proximal direction of the tube body and divides the pipe opening The opening end surface extends in the proximal direction of the distal end of the tube body and is positioned closer to the puncture opening than the tube opening end surface defining the tube opening, and forms the puncture opening end surface. Ri, the puncturing opening end surface, at cross-section obtained by cutting perpendicularly to the extending direction of the axis of the tube body and an end portion of the side and the axis of the axis of the puncture opening end face The opening angle formed by the two connecting line segments is less than 180 degrees, and the direction component in the opening direction of the puncture opening included in the perpendicular of the line segment includes the normal line of the puncture opening end surface. It has a function of reflecting ultrasonic waves due to a large directional component in the opening direction.

Claims (10)

A tube body having a lumen therein and inserted into a body cavity;
A puncture opening leading to the lumen and the outside of the tube body;
A puncture opening end face extending in the proximal direction toward the distal end of the tube main body and defining the puncture opening;
In a cross section cut perpendicularly to the extending direction of the axial center of the tube main body, it is formed by two line segments connecting the axial center end of the puncture opening end face and the axial center. The opening angle is less than 180 degrees, and the direction component in the opening direction included in the normal line of the puncture opening end surface is larger than the direction component in the opening direction of the puncture opening included in the perpendicular of the line segment. Guide tube characterized by.   The guide tube according to claim 1, further comprising an inner balloon that seals the puncture opening and is inflatable closer to the axial center than the puncture opening. An outer balloon that covers the puncture opening and circulates around the outer periphery of the tube body and is inflatable radially outward;
The guide tube according to claim 1 or 2, wherein an airtight chamber capable of airtightly filling a liquid or a gas is formed inside the outer balloon.   4. The guide tube according to claim 1, wherein two puncture opening end faces are axisymmetric with respect to a line segment extending in the opening direction passing through the axis in the transverse section. 5.   The guide tube according to claim 4, wherein the normal lines of the two puncture opening end faces are parallel to the opening direction. A reinforcing member provided along an inner peripheral surface or an outer peripheral surface of the tube main body;
A tube opening which is an opening provided on the wall surface of the tube body;
A pipe opening which is an opening provided in the wall surface of the reinforcing member,
The guide tube according to any one of claims 1 to 5, wherein the puncture opening is formed by overlapping. A pipe opening end surface extending in the proximal direction toward the distal end of the tube body and defining the pipe opening,
The guide tube according to claim 6 which makes the puncture opening end face.   The guide tube according to claim 6, wherein a tube opening end surface that extends in a distal end proximal direction of the tube main body and defines the tube opening forms the puncture opening end surface. A pipe opening end face extending in the distal proximal direction of the tube body and defining the pipe opening;
The tube opening end surface extending in the distal end proximal direction of the tube body and defining the tube opening is continuous,
The guide tube according to claim 6, wherein the puncture opening end face is constituted by the pipe opening end face and the tube opening end face. An inner balloon that seals the puncture opening and is inflatable on the axial center side relative to the puncture opening;
The inner balloon is inflated with a curvature smaller than a curvature of a circle whose diameter is a line segment connecting two end portions on the axial center side of the puncture opening end face, or inflated. The guide tube according to any one of 1 to 9.

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