WO2019111847A1 - Gastrostomy catheter, insertion jig set, insertion jig, and gastrostomy catheter set - Google Patents

Abstract

This gastrostomy catheter is provided with: a shaft having a lumen; a flexible bumper disposed at a distal end of the shaft; and a wire having elasticity and configured to urge the bumper in a diameter-increasing direction or to limit deformation of the bumper in a diameter-decreasing direction. At least a part of the distal end side of the wire, when in a state of being arranged within the bumper, uses the elasticity of the wire to urge the bumper in the diameter-increasing direction or to limit deformation of the bumper in the diameter-decreasing direction.

Description

Gastrostomy catheter, insertion jig set, insertion jig and gastrostomy catheter set

The present invention relates to a gastrostomy catheter, an insertion jig set used for attaching a gastrostomy catheter into a stomach, an insertion jig, and a gastrostomy catheter set.
The present application is related to Japanese Patent Application No. 2017-232868 filed on Dec. 4, 2017, Japanese Patent Application No. 2018-145805 filed on Aug. 2, 2018, and August 21, 2018. The priority is claimed based on Japanese Patent Application No. 2018-154832 filed in Japan, the contents of which are incorporated herein by reference.

Conventionally, as a gastrostomy catheter, it enables administration of nutrients into the stomach, and in order to maintain the state, it is tipped in the stomach by an intragastric fixed part (intragastric indwelling device) such as an expandable bumper or balloon. It is known to have a configuration in which the part can be indwelled.
Specifically, as disclosed in Patent Document 1, a balloon provided with a bumper reduced in diameter by a rod, and as disclosed in Patent Document 2, a balloon expanded and contracted by a fluid such as a salt solution There is something that is provided.

When attaching the gastrostomy catheter to the body, it is important to prevent or suppress the intragastric fixation part from pressing or damaging the wall of the fistula to reduce the burden on the subject.

For example, in Patent Document 3, a cap (in the same document, a capsule and the like) which can be held in a state in which the intragastric fixed part is folded so as to cover the intragastric fixed part (described in the same document as an internal bolster). DESCRIPTION OF THE PREFERRED EMBODIMENTS An insertion jig set for a gastrostomy catheter (described as an instrument for gastrostomy) is disclosed.
In the insertion jig set described in the same document, the intragastric fixed part is folded by the cap, and the intragastric fixed part can be inserted into the stomach through the fistula, thereby reducing the burden on the subject. The cap is formed with a hole for passing a lip cord (tearing cord). The cap is torn by pulling the rip cord passed through the hole, and from the state of restraining the intragastric fixation portion to a state in which the intragastric fixation portion becomes expandable, the intragastric fixation portion is intragastrically It is described that it is detained.

Japanese Patent Application Publication No. 2003-180841 Japanese Patent Application Publication No. 2002-534168 Japanese Patent Application Publication No. 2005-511206

In the gastrostomy catheter of Patent Document 1, it is necessary to stably place a bumper in the stomach, so it has been difficult to use a highly flexible bumper. Therefore, when inserting or removing the gastrostomy catheter from the fistula, a large resistance may be applied to the wall surface portion of the fistula from the bumper. In order to reduce the burden on the body, one with less resistance is desired.
In the balloon catheter of Patent Document 2, replacement of the fluid filling the inside of the balloon is required, which requires a lot of administrative effort, and long-term indwelling is difficult.

In the insertion jig set described in Patent Document 3, when the cap is torn by the lip cord, a state in which the torn cap is stuck to the intragastric fixation part because there is no mechanism for separating the cap from the intragastric fixation part There was a risk of being left behind. In this case, there is a possibility that the transition from the folded state of the intragastric fixed part to the expanded state may be inhibited.
In addition, the cap needs to be provided with a hole for passing the lip cord, and the cap needs to have a thickness and material which can be torn by the lip cord, and for keeping the intragastric fixed part in a folded state Holding power may be limited. Therefore, when this cap is used for the intragastric fixed part with high elasticity, the cap can be removed unexpectedly from the intragastric fixed part without being able to suppress the elastic restoration of the intragastric fixed part. Is considered.
Furthermore, it was difficult for the operator to obtain confirmation that the cap had been removed from the intragastric fixed part only by pulling the rip cord.

The present invention has been made in view of the above problems, and has an object to provide a gastrostomy catheter which can be relatively indwelled for a relatively long time while reducing the administrative burden while suppressing the resistance applied to the body low.

Another object of the present invention is to provide an insertion jig set, an insertion jig, and a gastrostomy catheter set capable of preferably removing the cap while preventing the cap from being accidentally detached from the gastrostomy catheter. Do.

The gastrostomy catheter according to the present invention has a shaft provided with a lumen, a flexible bumper provided at the tip of the shaft, and elasticity to be able to bias the bumper in the radial direction or the bumper And a linear member capable of restricting the deformation in the diameter reduction direction.

The insertion jig set of the present invention is an insertion jig set for inserting a gastrostomy catheter having a foldable intragastric fixation portion at its tip into the body, and is advanced into the tubular mantle and the mantle An insertion jig configured to include a retractable insertion portion, the gastrostomy catheter attached around the outer collar, and the distal end side of the outer collar and folded A cap covering at least a part of the intragastric fixation part in a fixed state, and one of the gastrostomy catheter or the mantle and the cap has a locking part for locking to the other, The said insertion part is characterized by releasing the latching by the said latching part, when it passes through in the said outer collar part, and is advanced.

The insertion jig of the present invention is for inserting a gastrostomy catheter having a collapsible intragastric fixation part at its tip and a cap covering at least a part of the intragastric fixation part in a folded state into the body. The insertion jig, comprising: a tubular mantle through which the gastrostomy catheter can be attached; and an insertion section which is inserted into the mantle. The mantle is the insertion jig. A locking portion for locking to a cap is provided, and the insertion portion is characterized in that the locking by the locking portion is released when the insertion portion is advanced into the outer collar portion.

The gastrostomy catheter set of the present invention comprises a gastrostomy catheter having a collapsible intragastric fixation section at its tip, and a cap covering at least a part of the intragastric fixation section in a folded state; The gastrostomy catheter is formed so as to be able to insert a part of an insertion jig for insertion into the stomach, and the cap has a locked portion which is locked to the insertion jig. I assume.

According to the gastrostomy catheter of the present invention, by providing a linear member capable of biasing the bumper in the radial direction or restricting the deformation of the bumper in the radial direction, flexibility can be achieved compared to the conventional gastrostomy catheter It becomes possible to use the bumper of the material which it has. Therefore, the resistance applied to the body during insertion and removal of the catheter can be suppressed low. Furthermore, unlike a gastrostomy catheter with a balloon, it does not use fluid, so there is no need to replace fluid. For this reason, compared with what is provided with a balloon, administrative effort is reduced and relatively long-term indwelling becomes possible.

According to the insertion jig set, the insertion jig, and the gastrostomy catheter set of the present invention, it is possible to preferably remove the cap while preventing the cap from being accidentally detached from the gastrostomy catheter.

It is a front view of the gastrostomy catheter which concerns on this embodiment. It is a front sectional view of a gastrostomy catheter. It is a 1 III direction arrow line view of FIG. 1, and is a bottom view of a bumper. It is explanatory drawing explaining the angle with respect to the internal peripheral surface of the bumper in each site | part of a wire. It is a typical explanatory view showing the state of the gastrostomy catheter in which the bumper was detained in the stomach. It is a schematic explanatory drawing which shows the state which has inserted the gastrostomy catheter into the stomach via the fistula. It is a typical explanatory view showing the state where the bumper was expanded by removing the cover from the gastrostomy catheter by the insertion jig. It is typical explanatory drawing which shows the state of the gastrostomy catheter of the state which removed the proximal end holding | maintenance part from the external fixation device. It is a schematic explanatory drawing which shows the state which has removed the gastrostomy catheter from the inside of the stomach. It is front sectional drawing which shows the extracorporeal fixing tool which concerns on a 1st-1 modification. It is a bottom view showing the communicating hole of the bumper concerning the 1-2nd modification. It is front sectional drawing which shows the front-end | tip part of the sublumen which concerns on the 1-3rd modification. It is a perspective view showing a bumper concerning a 1-4th modification, and a shaft with which a bumper was attached. FIG. 14 is a perspective view corresponding to FIG. 13 with the bumper outer layer removed to show the bumper inner layer. FIG. 14 is a cross-sectional view showing a 1XV-1XV cross section of the bumper and shaft of FIG. 13; It is a perspective view which shows the extracorporeal fixing tool provided with the proximal end holding | maintenance part and the support part which supports a proximal end holding | maintenance part based on a 1st-5 modification. It is a top view which shows the extracorporeal fixing tool in an initial state. It is a top view which shows the state which removed the restriction | limiting part from the external fixation device. It is a top view which shows the state which pushed in the support part from both sides, and pushed out the proximal end holding | maintenance part from the extracorporeal fixing tool. It is a perspective view which shows the insertion jig set which concerns on embodiment of this invention, and is a figure which shows the state which has restrained the cap so that a bumper may be in a folding state. FIG. 19 is a partial cross-sectional view showing a part of the insertion jig set, and is a view showing a 2II-2II cross section of FIG. 18; FIG. 19 is a partial cross-sectional perspective view showing a cross section of the distal end of the mantle and is a view showing a 2III-2III cross section of FIG. 18; It is a perspective view which shows an insertion jig set, and is a figure which shows the state which the cap released and expanded the bumper. It is a fragmentary sectional view which shows a part of insertion jig set, and is a figure which shows the 2V-2V cross section of FIG. It is sectional drawing which shows the latching structure of the outer collar part and cap which concerns on a 2nd-1 modification, and is a figure which shows the bending end part of a closed arm state. It is sectional drawing which shows the latching structure of the outer collar part and cap which concerns on a 2nd-1 modification, and is a figure which shows the bending end part of an open arm state. It is sectional drawing which shows the latching structure of the gastrostomy catheter and cap which concern on a 2nd-2 modification. FIG. 21 is a cross-sectional view showing a locking structure of a gastrostomy catheter and a cap according to a second to third modified example, showing a locked state. FIG. 21 is a cross-sectional view showing a locking structure of a gastrostomy catheter and a cap according to a second to third modified example, showing a locking released state.

Hereinafter, embodiments of the present invention will be described using the drawings.
The embodiments described below are merely examples for facilitating the understanding of the present invention, and do not limit the present invention. That is, the shape, size, arrangement, and the like of members described below can be changed and improved without departing from the spirit of the present invention, and the present invention includes the equivalents thereof.
Further, in all the drawings, similar components are denoted by the same reference numerals, and overlapping descriptions will be appropriately omitted.

<< Overview >>
First, an overview of a gastrostomy catheter 11 according to the present embodiment will be described with reference mainly to FIGS. 1 and 2. FIG. 1 is a front view of a gastrostomy catheter 11 according to this embodiment, and FIG. 2 is a front cross-sectional view of the gastrostomy catheter 11.
In the present specification, “distal side” means the side far from the operator of the gastrostomy catheter 11 in the gastrostomy catheter 11 unless specifically stated otherwise, specifically, the side provided with the bumper 13 Say Also, the distal side may be referred to as the distal side.
Also, “proximal side” refers to the side closer to the operator of the gastrostomy catheter 11, unless otherwise noted. Also, the proximal side may be referred to as the proximal side.
The gastrostomy catheter 11 has a shaft 12 provided with a lumen, a flexible bumper 13 provided at the distal end of the shaft 12, and elasticity so that the bumper 13 can be biased in the radial direction or the bumper 13 And a linear member (wire 14) capable of restricting the deformation in the diameter reduction direction.
Here, "capable of biasing the bumper 13 in the diameter expansion direction" means that the wire 14 is elastically deformed to apply a restoring force in the diameter expansion direction of the bumper 13 by contacting in the radial direction of the bumper 13 We say that it is possible.
In addition, “the deformation of the bumper 13 in the diameter reduction direction can be limited” means that the wire 14 abuts the bumper 13 when the bumper 13 tries to reduce the diameter by contacting the edge surface of the stomach wall, etc. It means that the deformation in the radial direction of the bumper 13 can be limited. That is, the wire 14 is not limited to one constantly urged in the radial direction with respect to the bumper 13, and may be biased in the radial direction only when an external force is applied to the bumper 13.
Further, in the present embodiment, although the restoring force of the wire 14 is applied to the bumper 13 in the diameter expansion direction from the inner side, for example, the diameter expansion from a linear member (not shown) disposed outside the bumper 13 The configuration may be such that a directional restoring force is applied.

The gastrostomy catheter 11 is more flexible than the gastrostomy catheter 11 configured not to include the wire 14 capable of biasing the bumper 13 in the radial direction or limiting the deformation of the bumper 13 in the radial direction. It is possible to adopt a material having elasticity to the bumper 13.
Therefore, the resistance applied to the body at the time of insertion and removal of the gastrostomy catheter 11 can be suppressed low. Furthermore, the gastrostomy catheter 11 with the bumper 13 and the wire 14 does not use fluid unlike the gastrostomy catheter with the balloon, so there is no need to replace fluid. For this reason, compared with the case where a balloon is used, administrative effort is reduced, and relatively long-term indwelling becomes possible.

<< About the structure of the gastrostomy catheter >>
Next, the structure of the gastrostomy catheter 11 will be described in detail with reference to FIGS. 3 to 5 in addition to FIGS. 1 and 2. 3 is a bottom view of the bumper 13 and FIG. 4 is an explanatory view for explaining an angle with respect to the inner peripheral surface of the bumper 13 at each portion of the wire 14. As shown in FIG. FIG. 5 is a schematic explanatory view showing the state of the gastrostomy catheter 11 in which the bumper 13 is placed in the stomach 152. As shown in FIG.

The gastrostomy catheter 11 includes a shaft 12, a fixed portion (extracorporeal fixture 15) provided at the proximal end of the shaft 12, a bumper 13 provided at the distal end, the extracorporeal fixture 15, the shaft 12 and the bumper 13 And the wire 14 disposed over the inside of each of the
The gastrostomy catheter 11 according to the present embodiment is integrally molded of silicone rubber or urethane rubber except for the wire 14. However, the present invention is not limited to such a configuration, and separate components may be joined and configured. In particular, it is preferable in terms of quality that the same kind of material is used even if another component is joined.

The extracorporeal fixture 15 and the shaft 12 are provided with a lumen. The lumen includes a main lumen 18 for injecting a nutrient, and a sub-lumen 19 that accommodates at least a portion (proximal side) of the wire 14.
The main lumen 18 communicates with the hollow space of the bumper 13 and a communication hole 13a formed in the bumper 13 to be described later, and forms a flow path penetrating from the proximal end to the distal end in the gastrostomy catheter 11, Nutrients can be infused into the stomach 152 from outside the body. The main lumen 18 is formed to have a D-shaped cross section in the present embodiment, and extends linearly along the axial direction of the shaft 12 on the center side of the shaft 12 and the extracorporeal fixture 15.
In the hollow bumper 13, a communication hole 13 a which is a circular hole is formed at the end of the main lumen 18. The communication hole 13 a is formed to have a large diameter so as to expose the main lumen 18 and the sub lumen 19 and to include the main lumen 18 and the sub lumen 19 in a bottom view of the bumper 13.

Nutrients supplied to the stomach 152 (see FIG. 5) through the gastrostomy catheter 11 pass through the external fixation device 15 and the main lumen 18 of the shaft 12 and through the communication holes 13a of the bumper 13 to the stomach 152. It will be supplied. In the main lumen 18, a check valve is provided to prevent backflow of contents such as gastric juice from the inside of the stomach 152 to the outside of the body, but this is omitted and FIG. 2 etc. are illustrated.

The sub lumen 19 is formed on the outer peripheral side of the main lumen 18. The main lumen 18 is formed to have a D-shaped cross section at a portion passing through the shaft 12, so that the sub lumen 19 is formed through a portion formed thicker than the other portions. The sub-lumen 19 is formed in a circular shape in cross section, and is formed by being bent along the shaft 12 and the extracorporeal fixture 15 in an L shape. Specifically, the sub-lumen 19 linearly extends along the axial direction in the shaft 12, and is bent at a right angle at the part reaching the extracorporeal fixture 15, and the extension direction of the extracorporeal fixture 15 Extends linearly along the As a part of the wire 14 is accommodated in the sub-lumen 19, the injection of the nutrient through the main lumen 18 is not inhibited. Also, the wire 14 can be protected within the sublumen 19.

A distal end 19 b which is a distal end having a certain length in the sub-lumen 19 linearly extends from the proximal side to the distal side and continues in the bumper 13. Here, that the tip end open portion 19b of the sub-lumen 19 is continued in the bumper 13 means that the tip end open portion 19b of the sub-lumen 19 is provided in a space that is continuous with the space in the bumper 13. Thus, the sub lumen 19 is formed, and the proximal end side of the wire 14 is disposed in the sub lumen 19 so that the distal end side of the wire 14 can be guided in the bumper 13.

The extracorporeal fixture 15 fixes outside (limits movement to a predetermined position) outside the stomach so that the gastrostomy catheter 11 will not be buried in the fistula 153 by abutting on the abdominal wall 150. The extracorporeal fixture 15 is larger than the shaft 12 in at least one direction perpendicular to the axial direction of the shaft 12 passed through the fistula 153. The extracorporeal fixture 15 in this embodiment is in the form of a small piece linearly extending perpendicularly to the axial center of the shaft 12. The fistula 153 is formed penetrating the abdominal wall 150 and the stomach wall 151, as shown in FIG.
The extracorporeal fixture 15 according to the present embodiment is integrally formed with the shaft 12 and the bumper 13. The extracorporeal fixture 15 is formed with an opening 18 a which is a radially central portion of the shaft 12 and is an opening on the proximal side of the main lumen 18 formed in the axial direction. Further, a strap 17 integrally extends from the side surface of the extracorporeal fixture 15, and a cap 16 capable of sealing the opening 18a is formed at the tip of the strap 17.

The extracorporeal fixture 15 is provided with a proximal end holding portion 15 c that holds a proximal end portion 14 a of a wire 14 described later.
The proximal end holding portion 15 c holds the proximal end portion 14 a by being embedded in the proximal end portion 14 a of the wire 14. In order to facilitate extraction of the wire 14 from the other part of the gastrostomy catheter 11, the proximal end holding portion 15 c is provided on the extracorporeal fixture 15 so as to be cut away. The configuration of the proximal end holding portion 15 c that holds the proximal end portion 14 a of the wire 14 is not limited to one that is held by embedding the proximal end portion 14 a. For example, a stopper or the like may be provided at the proximal end of the wire 14, and a part of the extracorporeal fixture 15 may be locked to the stopper, or the proximal end 14a of the wire 14 may be fixed by a part of the extracorporeal fixture 15. May be held to hold the wire 14.

In particular, on the side surface of the extracorporeal fixture 15 according to the present embodiment, a linear marker 15b is attached which serves as a reference for the cutout portion. The marker 15b is attached to a position within a virtual plane (vertical plane in the present embodiment) intersecting with the proximal end 19a of the sub-lumen 19 which is a position where the proximal end holding portion 15c can be reliably cut out. ing. Here, the proximal end 19a does not mean the proximal end, but means a portion having a certain length at the proximal end.
The position where the marker 15 b is attached may be the upper surface (proximal end surface) of the extracorporeal fixture 15. Moreover, the marker 15b may be formed of a paint, and may be a groove-like cut. Also, if the positions of the wire 14 and the sub-lumen 19 can be visually recognized, the marker 15 b is not necessarily an essential configuration.
Thus, by providing the proximal end holding portion 15 c, the wire 14 can be held at a predetermined position where the distal end portion of the wire 14 is positioned in the bumper 13.

For example, in the gastrostomy catheter 11 according to the present embodiment, the site disposed outside the body may be a so-called button type or a tube type. If there is another site to be placed outside the body, such as in the case of a tube type, the present invention is not limited to the case where the proximal end holding portion 15c is provided to the extracorporeal fixture 15; On the proximal side, there may be a site for holding the proximal end 14 a of the wire 14.
As in the proximal end holding unit 15c according to the above-described configuration, if the proximal end holding unit 15c is not cut off, the patient inadvertently removes the wire 14 by preventing the wire 14 from being detached from the extracorporeal fixture 15 or the like. You can prevent it from

The bumper 13 is integrally formed with the shaft 12 and has a hollow disk shape. The shape of the bumper 13 in the present embodiment is a disk shape having the same appearance (including substantially the same) in a natural state and in a state where the distal end side of the wire 14 is accommodated. However, the bumper 13 is not limited to such a shape, and may have flexibility to expand radially outward only when the distal end side of the wire 14 is accommodated.

In addition, the thickness of the shaft 12 (strictly speaking, the distance between the wall surface of the main lumen 18 and the outer surface of the shaft 12 at a portion where the sub-lumen 19 is not formed is set so that the bumper 13 has predetermined flexibility. It is formed thinner than). As described above, since the bumper 13 is thinner than the shaft 12, the bumper 13 can be easily expanded and contracted.
As described above, on the distal side of the bumper 13 and on the extension of the main lumen 18, the communication hole 13a is formed to communicate the inside and the outside of the bumper 13.

The bumper 13 is biased radially outward by being disposed so that the tip end side of the super elastic alloy wire 14 winds in the bumper 13, and its disk shape (a diameter is slightly reduced in the radial direction). The shape is also maintained in the stomach 152). The wire 14 is not limited to the one that always biases the bumper 13 radially outward, but when the external force is applied to the bumper 13 and the wire 14 is deformed in the radial direction to abut the wire 14, the wire 14 is biased radially outward. It may be configured to limit its deformation.
Furthermore, the bumper 13 is not limited to one formed in a disk shape in the natural state, and may be formed in a disk shape only by arranging the tip end of the wire 14.

The linear member (wire 14) is at least partially disposed on the front end side in the bumper 13 so that the bumper 13 can be urged radially outward or deformation in the radial direction of the bumper 13 can be limited. In the first state and the first state, the bumper 13 is biased or not urged radially outward lower than in the first state, or the deformation in the radial direction of the bumper 13 is allowed to be smaller than in the first state It is configured to be variable in two states. In the second state, the wire 14 is disposed on the proximal side of the bumper 13 or pulled out more proximal than the bumper 13 than when the wire 14 is in the first state.
Specifically, as the wire 14 is completely pulled out of the bumper 13 (pulled more proximally than the bumper 13), the wire 14 is naturally not urged at all against the bumper 13. On the other hand, when the wire 14 is partially pulled out of the bumper 13, the bumper 13 is biased with a lower force than before pulling out the bumper 13, or allows the deformation of the bumper 13 in the contraction direction of the bumper 13 which has been restricted. It will be done. The state of the bumper 13 pertaining to both of these is referred to as a "second state".
Thus, depending on the position of the wire 14 with respect to the bumper 13, the state in which the wire 14 restricts the deformation of the bumper 13 can be made variable.
The "radially outward" means an orientation having a component of radially outward, and means all directions except inward in the radial direction (in other words, the orientation in the center of the bumper 13). The same is true for

The proximal end portion 14a of the wire 14 is embedded in the proximal end holding portion 15c as described above. At least the front end portion 14b of the wire 14 is movably disposed in the bumper 13 without being supported by other members, and the inside and the outside of the bumper 13 (more specifically, the inside of the bumper 13 , Can be inserted into and removed from the distal side of the bumper 13).
According to such a configuration, it is possible to easily manufacture the gastrostomy catheter 11 disposed so as to wind the tip end portion 14b of the wire 14 in the bumper 13. Specifically, the manufacturer first causes the distal end portion 14 b of the wire 14 passing through the sub-lumen 19 to be temporarily pulled out of the communication hole 13 a to the outside of the bumper 13. Thereafter, the proximal end side of the distal end portion 14b of the wire 14 coming out of the bumper 13 is housed in the bumper 13 so as to gradually roll the coil in the bumper 13, and the wire 14 is disposed in the bumper 13 to the distal end. Set up. In this way, it is possible to easily manufacture the gastrostomy catheter 11 having the wire 14 housed so as to wind the tip end side.

The wire 14 described above is disposed on the proximal side in the direction of being pulled out from the bumper 13 from the first state to be in the second state, thereby weakening the biasing force to the bumper 13 or deforming the bumper 13 in the radial direction. Can be tolerated. By setting the wire 14 in the second state in this manner, the resistance applied to the body when the gastrostomy catheter 11 is removed can be suppressed to a low level.
Further, in the present embodiment, as described later, in a state in which the distal end side of the wire 14 is accommodated in the bumper 13, the gastrostomy catheter 11 is inserted in a state where the bumper 13 is folded by the capsule cover 110. For example, when inserting the gastrostomy catheter 11 without using the capsule cover 110, after the wire 14 is pulled out from the bumper 13 and the bumper 13 is put into the second state, the gastrostomy catheter 11 is inserted. It is also good. Also in this case, the resistance applied to the body can be suppressed low.
The tip end side of the coiled wire 14 is not limited to the one formed with a curvature which always makes the inner surface of the bumper 13 non-biased. That is, the tip end side of the coiled wire 14 has a radius of curvature larger than the outer diameter of the shaft 12, and the bumper 13 can be locked to the edge of the fistula 153 in the stomach 152. It may be disposed apart from the inner surface of the bumper 13 as long as deformation can be suppressed.

In the above embodiment, the configuration in which the wire 14 is completely withdrawn from the gastrostomy catheter 11 has been described, but the present invention is not limited to such a configuration. For example, only a portion of the wire 14 may be pulled out of the bumper 13 to reduce the amount of the portion of the wire 14 in the bumper 13. Even if the amount of the wire 14 is reduced, the biasing force of the bumper 13 outward in the radial direction is weakened or the force for limiting the deformation in the diameter decreasing direction is weakened. On the other hand, the resistance at the time of inserting and removing can be suppressed. According to these configurations, the load of the wire 14 acting on the bumper 13 can be easily adjusted, which is preferable.
However, the present invention is not limited to such a configuration, and is not limited to the configuration in which the wire 14 is drawn to the proximal side of the gastrostomy catheter 11 as long as the load of the wire 14 on the bumper 13 can be adjusted. For example, the rod that hooks the wire 14 may be inserted from the main lumen 18 and the radially outward load on the bumper 13 may be reduced by winding the wire 14 in the bumper 13 to reduce its diameter.

In addition, at least the tip portion 14b of the wire 14 is covered with a coating portion 14c whose hardness is lower than that of the wire 14, or is formed into a blunt (substantially spherical) shape by electric discharge machining.
At least the tip portion 14b of the wire 14 is covered with the coating portion 14c, or is blunted (substantially spherical) by electric discharge machining. With such a configuration, when the distal end portion 14 b of the wire 14 is accommodated in the bumper 13, damage to the bumper 13 by the distal end portion 14 b can be suppressed.

In the state where the wire 14 is disposed across the sublumen 19 and the bumper 13, the first portion 14x disposed in the sublumen 19 of the wire 14 and the second portion 14y disposed in the bumper 13 are shown in FIG. As shown in 2, it is bent at a bending point 14j and continuously formed. In other words, the wire 14 is bent outward at the bending point 14 j in the bumper 13 in the radial direction of the bumper 13.
As described above, since the wire 14 is bent, the bumper 13 can be smoothly urged in the diameter expansion direction or the deformation in the diameter reduction direction of the bumper 13 can be uniformly restricted at the end where the sub-lumen 19 is inserted. Become. For this reason, it is possible to preferably maintain the biased state in the radial direction with respect to the bumper 13 and the state in which the deformation in the radial direction of the bumper 13 is limited. Unexpected withdrawal from 153 can be prevented.

Furthermore, in a state where the wire 14 is disposed across the sub-lumen 19 and the bumper 13, at least a part of the portion of the wire 14 disposed in the bumper 13 extends in the direction along the inner circumferential surface of the bumper 13 As a result, it is bent at the bending point 14k.
Here, as shown in FIG. 4, an angle between an arbitrary extension of the wire 14 and the normal to the inner peripheral surface of the bumper 13 is taken as an incident angle 1α, from the bending point 14 j to the inner peripheral surface of the bumper 13 The incident angle 1α1 for the extending line, and the incident angle 1α2 for the extending line from the bending point 14k to the inner circumferential surface of the bumper 13 are set. In this case, bending so as to extend in a direction along the inner peripheral surface of the bumper 13 means bending so that the incident angle 1α2 is larger than the incident angle 1α1.
The wire 14 is bent in a direction along the inner peripheral surface of the bumper 13 so that the wire 14 can be made to follow the inner peripheral surface of the bumper 13, and the bumper 14 is provided at each position in the circumferential direction of the bumper 13. It becomes easy to apply uniformly the load which biases 13 in the diameter-expanding direction, or the load which limits a deformation | transformation of the bumper 13. FIG.

<< How to attach the gastrostomy catheter >>
Next, a method of attaching the gastrostomy catheter 11 will be described with reference to FIGS. 6 and 7 in addition to FIG. 6 is a schematic explanatory view showing a state in which the gastrostomy catheter 11 is inserted into the stomach 152 through the fistula 153. FIG. 7 is a diagram showing the capsule cover 110 from the gastrostomy catheter 11 by the insertion jig 111. It is a typical explanatory view showing the state where the bumper 13 was expanded by removing.

The gastrostomy catheter 11 includes a cover (capsule cover 110) that holds and accommodates the bumper 13 in a folded state in which the distal end side of the wire 14 is disposed in the bumper 13. Here, the capsule cover 110 can be attached directly or indirectly to the shaft 12, and the bumper 13 may be accommodated while maintaining the folded state of the bumper 13. That is, the term "to contain" includes those that entirely accommodate the bumper 13 and those that accommodate at least a part of the bumper 13.
The capsule cover 110 suppresses the resistance applied to the wall surface of the fistula hole 153 while maintaining the bumper 13 in a folded state when the bumper 13 is disposed in the stomach 152 via the fistula hole 153, and enters the body of the bumper 13. To facilitate the insertion of

The capsule cover 110 is a hard capsule cover used for food made of cellulose-based or gelatin-based material, or a material which is decomposed in the body such as polylactic acid, and has a bottom on one side and the other end is an open end. It is formed in the shape of a blunt head cap. The shape of the capsule cover 110 is not particularly limited, and may be hemispherical or the like.

The operator can expand the diameter of the bumper 13 by urging the wire 14 in the radial direction by removing the capsule cover 110 in the body. An insertion jig 111 is used for attaching the gastrostomy catheter 11 to the fistula 153 and removing the capsule cover 110.
The insertion jig 111 is connected to the main body cylinder 111a, the pair of claws 111b attached to the main body cylinder 111a, the operation portion 111c, the piston 111d capable of reciprocating with respect to the main body cylinder 111a, and the piston 111d And pushing rod 111e.

When inserting the gastrostomy catheter 11 into the fistula 153, the operator folds the bumper 13 and covers the bumper 13 in the folded state with the capsule cover 110, thereby keeping the bumper 13 in a folded state.
Further, the operator holds the insertion jig 111 and holds the shaft 12 with the pair of claws 111b to support the lower surface (distal side surface) of the extracorporeal fixture 15 of the gastrostomy catheter 11, as shown in FIG. Hold as shown.
Next, the operator inserts the bumper 13 covered by the capsule cover 110 into the fistula hole 153 together with the capsule cover 110, and inserts the bumper 13 to a position where the bumper 13 reaches the stomach 152 (a position where the nail 111b abuts the surface of the abdominal wall 150) The gastrostomy catheter 11 is pushed in by the jig 111.

Thereafter, as shown in FIG. 7, the operator operates the operation portion 111 c so as to push the operation portion 111 c to the distal side, pushes the piston 111 d into the main body cylinder 111 a, and causes the push rod 111 e to protrude. At this time, the push rod 111 e pushes out only the capsule cover 110 through the communication hole 13 a of the bumper 13, and as shown in FIG. 7, the capsule cover 110 drops out of the bumper 13.
The bumper 13 released from the holding from the capsule cover 110 is expanded in diameter larger than the hole diameter of the fistula 153 by the biasing force of the wire 14, and is placed in the stomach 152.
Since the capsule cover 110 dropped into the stomach 152 is a material which is edible or degraded in the body as described above, it is excreted or dissolved together with the stomach contents and there is no impact on the body.

<< About the removal method of the gastrostomy catheter >>
The operator needs to replace the gastrostomy catheter 11 at predetermined intervals in order to suitably maintain the hygienic condition when using the gastrostomy catheter 11. A method of removing the existing gastrostomy catheter 11 necessary for replacing the gastrostomy catheter 11 will be described with reference to FIGS. 8 and 9. FIG. 8 is a schematic explanatory view showing the state of the gastrostomy catheter 11 in a state in which the proximal end holding portion 15 c is removed from the extracorporeal fixture 15. FIG. 9 is a schematic explanatory view showing a state in which the gastrostomy catheter 11 is removed from the stomach 152.

The operator first removes the proximal end holding portion 15c of the extracorporeal fixture 15 from the other part of the extracorporeal fixture 15 with scissors or the like so that a cut is made along the marker 15b. At this time, the operator separates the proximal end holding portion 15 c from the other part of the extracorporeal fixture 15 so as not to cut the wire 14. Since the marker 15b is attached to the position included in the virtual plane intersecting the proximal end 19a of the sub-lumen 19 as described above, by separating the proximal end holding portion 15c along the marker 15b, The embedded portion of the proximal end portion 14 a of the wire 14 in the extracorporeal fixture 15 is eliminated.
The operator grasps the proximal end 14 a and withdraws the wire 14 from the bumper 13, the shaft 12 and the extracorporeal fixture 15.
Finally, the operator grasps the extracorporeal fixture 15 and pulls the gastrostomy catheter 11 out of the fistula 153. At this time, as shown in FIG. 9, the bumper 13 is in the second state due to the wire 14 being pulled out, and when the wall surface of the fistula hole 153 is touched, the bumper 13 is contracted to the body. Resistance will be suppressed low.

[1-1st modified example]
In the above embodiment, the proximal end holding portion 15c holding the proximal end portion 14a of the wire 14 is integrally formed with the extracorporeal fixture 15 as shown in FIG. Then, the holding of the wire 14 is released by being cut off. However, the present invention is not limited to such a configuration.
Next, an extracorporeal fixture 115 according to a first modification will be described with reference to FIG. FIG. 10 is a front cross-sectional view showing an extracorporeal fixture 115 according to a first modification.

The proximal end holding portion 115a for holding the proximal end portion 14a of the wire 14 is separate from the fixing portion (extracorporeal fixture 115), and is detachably attached to the fixing portion (extracorporeal fixture 115).
Specifically, the proximal end holding portion 115a is disposed on the extension of the proximal end 19a of the sub-lumen 19, and has a neck with a small diameter and a head with a large diameter and is located downward (distally) It has a locking projection 115b that protrudes at the bottom. A concave groove 115c is formed in a portion of the extracorporeal fixture 115 opposite to the locking protrusion 115b in a shape relative to the locking protrusion 115b.
The locking projection 115b is accommodated in the recessed groove 115c and locked by being expanded so as to elastically deform the opening forming the recessed groove 115c.

According to such a configuration, by attaching the proximal end holding portion 115a to the extracorporeal fixture 115, the state in which the distal end portion of the wire 14 is disposed in the bumper 13 can be maintained. Further, by releasing the locking of the locking protrusion 115b to the recessed groove 115c and removing the proximal end holding portion 115a from the extracorporeal fixture 115, the wire 14 together with the proximal end holding portion 115a is the shaft 12, bumper 13 and The extracorporeal fixture 115 can be removed.

The locking protrusion 115b may be made of resin rubber harder than the recessed groove 115c. According to such a configuration, the locking projection 115b can be easily fitted into the relatively soft concave groove 115c. The configuration may be such that a recessed groove is provided on the proximal end holding portion 115 a side, and a locking protrusion is provided on the extracorporeal fixation member 115 side.
In order to prevent the patient from erroneously removing the proximal end holding portion 115a from the extracorporeal fixture 115, a clip (not shown) may be further provided which holds the proximal end holding portion 115a and the extracorporeal fixture 115. .

[The 1-2nd modified example]
In the above embodiment, as shown in FIG. 3, the communication hole 13 a is described as being formed in the bumper 13 with a large diameter so as to expose the main lumen 18 and the sub lumen 19. However, the present invention is not limited to such a configuration.
Next, a bumper 113 according to a 1-2nd modified example will be described with reference to FIG. FIG. 11 is a bottom view showing the communication hole 113a of the bumper 113 according to the 1-2nd modified example.

A part of the inner wall of the bumper 113 according to the first to second modifications is located on the extension of the sub-lumen 19. Specifically, the communication hole 113a in the present example is formed in a D-shaped cross section so as not to expose the sub-lumen 19 while exposing the main lumen 18 and exposing it in a bottom view.
According to such a configuration, when the wire 14 is inserted into the sub-lumen 19 and the distal end portion 14 b is disposed in the bumper 113, the distal end portion 14 b abuts a part of the inner wall of the bumper 113. Therefore, the tip end side of the wire 14 is naturally disposed in the radial direction of the bumper 113.
In particular, with the second state in which the distal end side of the wire 14 is not disposed in the bumper 113, the bumper 113 can be inserted into the stomach hole 152 through the fistula 153 while suppressing resistance applied to the body.
Thereafter, the distal end side of the wire 14 in which the proximal end portion 14a is embedded in the proximal end holding portion 115a shown in FIG. 10 is fed so as to wind a coil in the bumper 113 via the sublumen 19 to expand the bumper 113. It is possible to facilitate the state in which the radial direction can be biased or the state in which the radial deformation of the bumper 113 can be limited. Therefore, instead of expanding the diameter of the bumper 13 by removing the capsule cover 110 with the insertion jig 111, the bumper 113 can be put in the first state by a simple method of inserting the wire 14 into the sub-lumen 19 .

Although the main lumen 18 in the above embodiment and this example is described as being formed in a D-shaped cross section, if the thickness for forming the sub-lumen 19 can be secured in the shaft 12, the cross-sectional circular shape or It may be rectangular and is not limited to such a shape. Along with this, the shape of the communication hole 113a may also be circular or rectangular in cross section as long as a part of the inner wall of the bumper 113 can be positioned on the extension of the sub-lumen 19, and it is not limited to such a shape .

[First to third modified example]
In the above embodiment, as shown in FIG. 2, the tip end open portion 19 b of the sub-lumen 19 linearly extends from the proximal side to the distal side and continues in the bumper 13. However, the present invention is not limited to such a configuration.
Next, a sub-lumen 129 according to the first to third modifications will be described with reference to FIG. FIG. 12 is a front cross-sectional view showing a tip end opening portion 129b of the sub-lumen 129 according to the first to third modifications.

The tip end portion (tip end opening portion 129 b) of the sub-lumen 129 passing through the shaft 122 according to the first to third modifications is formed by being bent outward in the radial direction of the bumper 13. Specifically, the tip end opening portion 129 b extends into the bumper 13, and the wall portion defining the tip end opening portion 129 b is bent and extended radially outward of the bumper 13 in the bumper 13. .
According to such a configuration, when inserting the wire 14 into the sub-lumen 129 and disposing the tip portion 14 b in the bumper 13, the tip portion 14 b is the tip of the sub-lumen 129 outward in the radial direction of the bumper 13. It is guided by the opening part 129b. Therefore, the tip end side of the wire 14 is naturally disposed radially outward of the bumper 13.
In particular, as in the first-second modification, the distal end side of the wire 14 is in the second state in which the distal end side of the wire 14 is not disposed in the bumper 13, and the bumper 13 is inserted into the stomach hole 153 while suppressing resistance applied to the body. Can be placed on
Thereafter, the distal end side of the wire 14 in which the proximal end portion 14a is embedded in the proximal end holding portion 115a shown in FIG. 10 is fed so as to wind a coil in the bumper 13 via the sublumen 129, That is, the bumper 13 can be easily biased into a state in which the bumper 13 can be biased in the radial direction, or in a state in which deformation in the radial direction can be suppressed. Therefore, instead of expanding the diameter of the bumper 13 by removing the capsule cover 110 with the insertion jig 111, the bumper 13 can be brought into the first state by the simple method of inserting the wire 14 into the sub-lumen 19 .

[First to fourth modified examples]
About bumpers 13 and 113 concerning the above-mentioned embodiment, it explained as what was formed in a hollow disk shape. However, the present invention is not limited to such a configuration.
Next, a bumper 133 and a shaft 132 to which the bumper 133 is attached according to the first to fourth modifications will be described mainly with reference to FIGS. 13 to 15. 13 is a perspective view showing a bumper 133 according to a first to fourth modification and a shaft 132 to which the bumper 133 is attached. FIG. 14 is a view showing an inner layer 134 of the bumper 133 with the outer layer 135 of the bumper 133 removed. Is a perspective view corresponding to FIG. FIG. 15 is a cross-sectional view showing the 1 × V-1 × V cross section of the bumper 133 and the shaft 132 of FIG.

The bumper 133 according to the present embodiment is formed in a star shape as viewed from the axial direction of the bumper 133 and is connected to the tip of the shaft 132.
The shaft 132 has a shaft body 132a and a tip (a first tip 132b and a second tip 132c shown in FIG. 15) formed to have a smaller diameter than the other portion (shaft body 132a). A bumper 133, which will be described in detail later, extends from the tip of the shaft 132.
The first tip end portion 132b is formed continuously from the shaft main body 132a to the tip end side, and has a smaller diameter than the shaft main body 132a. The second distal end portion 132c is formed continuously from the first distal end portion 132b to the distal end side, and has a smaller diameter than the first distal end portion 132b.
A connection cylindrical portion 134 a of an inner layer 134 of the bumper 133 described later is connected to a tip portion (second tip portion 132 c) of the shaft 132, and the inner layer 134 extends. In addition, a connection cylindrical portion 135a of an outer layer 135 of the bumper 133 described later is connected to a tip portion (first tip portion 132b) of the shaft 132, and the outer layer 135 extends.

According to the above configuration, the bumper 133 connected to the first end 132b of the shaft 132 is expanded compared to the case where the end (first end 132b) of the shaft 132 is formed to have the same diameter as the shaft body 132a. The maximum amount of radial deformation can be increased. That is, as described later, the inclination of the bumper 133 (the inclined portion 135c thereof) after deformation with respect to the axial direction can be increased by the wire 14 (see FIG. 15) partially provided in the bumper 133. Therefore, the contact area between the bumper 133 after deformation and the inner surface of the stomach wall 151 (see FIG. 5) can be increased, and the bumper 133 can be easily placed in the stomach 152.

As shown in FIG. 15, the bumper 133 includes an inner layer 134 and an outer layer 135, and there is a space 133s between the inner layer 134 and the outer layer 135, and one space on the tip side of the linear member (wire 14) in the space 133s. Department is arranged.
Further, as shown in FIG. 15, the shaft 132 is provided with a single sub-lumen 132d, through which a wire 14 described later is passed, extending in parallel in the axial direction. The sub-lumen 132 d is in communication with the space 133 s between the inner layer 134 and the outer layer 135 of the bumper 133 attached to the tip of the shaft 132 through the tip surface of the first tip 132 b.
According to such a configuration, a space 133 s that accommodates part of the wire 14 can be formed between the inner layer 134 and the outer layer 135. In addition, since the space 133s is formed and the rigidity is lowered, when the wire 14 is pulled out from the bumper 133, the bumper 133 can be smoothly deformed into a folded state.

On the surface of the outer layer 135 of the bumper 133, a plurality of recessed portions 135f which are depressed in the radial direction of the bumper 133 and extends along the axial direction of the bumper 133 are formed in the circumferential direction of the bumper 133.
As described above, the concave portion 135f is formed on the surface of (the outer layer 135 of) the bumper 133, so that the bumper 133 can be smoothly deformed into the folded state. Specifically, when the bumper 133 is folded, a load applied from the wall of the hole 153 (see FIG. 5) is locally applied to a portion of the bumper 133 other than the recess 135f, and a folding starting point is generated in the recess 135f. The bumper 133 can be smoothly deformed into the folded state by the recess 135 f being a space for folding.

The outer layer 135 of the bumper 133 is provided on the distal end side of the connection cylindrical portion 135a connected to the shaft 132 from the base end side to the distal end side, the large diameter portion 135b having the largest diameter portion 135e, And a small diameter portion 135g.
The inner layer 134 of the bumper 133 extends from the proximal end side to the distal end side in a radial direction from the distal end of the connecting cylindrical portion 134a connected to the shaft 132 and the distal end of the distal end portion 134d. And a tip portion 134d provided on the tip side of the slope portion 134b.

The connecting cylindrical portion 135a is connected to the first end portion 132b of the shaft 132, and the inner diameter of the connecting cylindrical portion 135a is formed to be substantially equal to the outer diameter of the first front end portion 132b.
The large diameter portion 135b is provided with an inclined portion 135c which is inclined so as to expand in diameter toward the tip in a direction parallel to the axial direction of the shaft 132 including the largest diameter portion 135e, the maximum diameter portion 135e, and And an inclined portion 135d inclined so as to decrease in diameter toward the end.
As shown in FIG. 15, the tip portion 14b of the wire 14 is accommodated in a plane space perpendicular to the axial direction of the bumper 133 including the largest diameter portion 135e. As described above, the inclined portion 135c and the inclined portion 135d are formed on both sides of the largest diameter portion 135e, so that the distal end portion 14b of the wire 14 inserted in the space 133s is elastically restored in the radial direction. In doing so, it is suitably guided in the above-mentioned plane space containing the largest diameter portion 135e.

The largest diameter portion 135 e of the outer layer 135 of the bumper 133 is formed at a position spaced apart from the tip of the shaft 132 toward the tip.
As described above, the largest diameter portion 135e is formed at a position spaced apart from the tip end of the shaft 132 toward the tip end side, whereby the bumper 133 covers and overlaps the shaft 132 when the maximum diameter portion 135e is contracted. The folding shape of the bumper 133 can be made compact by restraining.

A plurality of recesses 135f are formed in the large diameter portion 135b of the outer layer 135, and a plurality of recesses 135h are formed in the small diameter portion 135g in the circumferential direction. Recesses 135 f and 135 h in the large diameter portion 135 b and the small diameter portion 135 g are formed at corresponding positions in the circumferential direction of the bumper 133.
A plurality of concave portions 135f and 135h formed in the large diameter portion 135b and the small diameter portion 135g are formed at corresponding positions in the circumferential direction, so that the portion serving as the starting point of folding of the large diameter portion 135b and the small diameter portion 135g is large. It becomes linear over the diameter part 135b and the small diameter part 135g. For this reason, the outer layer 135 of the bumper 133 can be smoothly deformed in the folded state.
The “corresponding position in the circumferential direction” specifically means that the bumper 133 is at the same angle with the axis of the bumper 133 as a center when viewed from the axial direction.

Similarly, a plurality of recesses 134c are formed in the inclined portion 134b of the inner layer 134, and a plurality of recesses 134e are formed in the tip portion 134d in the circumferential direction. Recesses 134 c and 134 e in each of the inclined portion 134 b and the tip end portion 134 d are formed at corresponding positions in the circumferential direction of the bumper 133.
A plurality of concave portions 134c and 134e formed in the inclined portion 134b and the distal end portion 134d are formed at corresponding positions in the circumferential direction, so that a portion serving as a starting point of folding of the inclined portion 134b and the distal end portion 134d is the inclined portion 134b. And the tip portion 134d. For this reason, the inner layer 134 of the bumper 133 can be smoothly deformed in the folded state.

Furthermore, in the present embodiment, the recess 135 f of the outer layer 135 and the recess 134 c of the inner layer 134, and the recess 135 h of the outer layer 135 and the recess 134 e of the inner layer 134 are provided at overlapping positions in the radial direction of the bumper 133. In other words, a straight line extending in the radial direction of the bumper 133 by connecting the concaved portions of the concave portion 135f and the concave portion 134c, and the concave portion 135h and the concave portion 134e is in a positional relationship intersecting the axis of the bumper 133.
According to such a configuration, interference between the inner layer 134 and the outer layer 135 can be suppressed, and the bumper 133 can be smoothly deformed into a folded state.

In the large diameter portion 135b, the inner layer 134 and the outer layer 135 are separated, and in the small diameter portion 135g, the inner layer 134 (strictly, the tip portion 134d) is in contact with the outer layer 135.
According to the above configuration, the rigidity is reduced and the structure is easily shrunk because the inner layer 134 and the outer layer 135 are separated in the large diameter portion 135 b. Further, by the inner layer 134 and the outer layer 135 being in contact with each other in the small diameter portion 135g, the rigidity can be enhanced and the configuration can be excellent in the shape retention.

[First to fifth modified examples]
In the embodiment shown in FIG. 8, when removing the wire 14 from the bumper 13 when removing the bumper 13 of the gastrostomy catheter 11 from the inside of the stomach, the proximal end holding portion 15 c is cut out from the extracorporeal fixture 15. did. Further, in the embodiment shown in FIG. 10, the locking on the concave groove 115c by the locking projection 115b is released, and the proximal end holding portion 115a is removed from the extracorporeal fixture 15. However, the present invention is not limited to such a configuration.

Next, an extracorporeal fixture 145 according to a first to fifth modifications will be described mainly with reference to FIGS. 16 and 17. FIG. FIG. 16 is a perspective view showing an extracorporeal fixture 145 including a proximal end holding portion 148 and a support portion 146 for supporting the proximal end holding portion 148 according to the first to fifth modifications. FIG. 17A is a plan view showing the extracorporeal fixture 145 in the initial state, FIG. 17B is a plan view showing a state in which the limiting piece 147 is removed from the extracorporeal fixture 145, and FIG. 17C shows the support 146 on both sides. And the proximal end holding portion 148 is pushed out of the extracorporeal fixture 145. FIG. In FIGS. 16 and 17, the illustration of the cap 16 and the strap 17 shown in FIG. 1 is omitted.

The fixing portion (extracorporeal fixing tool 145) according to the first to fifth modifications limits the movement of the proximal end holding portion 148 and the detachment from the supporting portion 146, which supports the proximal end holding portion 148 movably. And a restriction unit (restriction unit 147).
The proximal end holding portion 148 according to the present embodiment is a plate piece having a trapezoidal thickness in a plan view, and the proximal end portion of the wire 14 is embedded inside. The proximal end holding portion 148 has a reverse tapered portion 148 a formed so as to spread outward of the fixing portion (extracorporeal fixture 145).

The support portion 146 has a bottom wall 146 c supporting the proximal end holding portion 148 from below and a connecting wall 146 b provided on both sides of the bottom wall 146 c and standing. The bottom wall 146 c and the connection wall 146 b protrude outward in the extension direction of the extracorporeal fixture 145 more than other portions of the support portion 146.
A planar-view trapezoidal opening 146 d for exposing at least a part of the proximal end holding portion 148 is formed on the proximal side of the support portion 146. Since the opening 146 d is formed in this manner, the operator touches the proximal end holding portion 148 with a finger to grasp the proximal end holding portion 148 as an extracorporeal fixing tool, in addition to pinching the support portion 146 from both sides as described later. It is also possible to separate it from 145.

The limiting piece 147 is connected to the connection wall 146b and the bottom wall 146c of the support portion 146, and is in the direction in which the proximal end holding portion 148 separates from the support portion 146, and its thickness direction with respect to the proximal end holding portion 148. Provided in a size and position overlapping the
The proximal end holding portion 148 is configured to be separable from the support portion 146 by the restriction piece 147 being separated from the support portion 146 as shown in FIG. 17B.

Since the extracorporeal fixture 145 includes the support 146 and the limiting piece 147, the limitation piece 147 can be supported as compared to the case where the entire proximal end holding part 148 is connected to the extracorporeal fixture 145. It is possible to easily separate the proximal end holding portion 148 from the support portion 146 only by separating it from the 146.
As a configuration in which the proximal end holding portion 148 is separable, in the present embodiment, the support portion 146 is not provided on the path obtained by projecting the proximal end holding portion 148 onto the limiting piece 147, as shown in FIGS. 17A and 17B. A through hole 146e shown is formed. With such a configuration, the movement of the proximal end holding portion 148 in the direction toward the limiting piece 147 is not limited by the support portion 146, and the movement is limited only by the limiting piece 147.

The support portion 146 has an opposing portion 146 a extending along the reverse tapered portion 148 a of the proximal end holding portion 148 in a state of being attached to the extracorporeal fixture 145. In the support portion 146, after the limiting piece 147 is separated from the support portion 146, the opposing portion 146a abuts against the reverse taper portion 148a, and the proximal end holding portion 148 is the outer side of the fixing portion (extracorporeal fixture 145) It is configured to be deformable so that it can be pushed into the

According to such a configuration, as shown in FIG. 17C, the operator pinches the support portion 146 from both sides in the direction (in the direction of the thick arrow) sandwiching the proximal end holding portion 148, and the opposing portion 146a of the support portion 146 is Transform it. Then, a force component (in the direction of the thin arrow) of the load applied from the facing portion 146a to the reverse tapered portion 148a toward the outer side in the extension direction of the extracorporeal fixation device 145 is generated. It will be easily removed to the outside of the tool 145.
The “outside of the extracorporeal fixture 145” is not limited to the direction in which the extracorporeal fixture 145 extends away from the shaft 12 (see FIG. 16), but in the direction intersecting the extension direction of the extracorporeal fixture 145. Alternatively, it may be directed outward from the center of the thickness of the extracorporeal fixture 145. The above "deformable" is a concept including elastic deformation and plastic deformation.

The shape of the proximal end holding portion 148 is not limited to a trapezoidal shape including the reverse taper portion 148a in a plan view, and for example, is formed in a pair of arcs instead of the linear reverse taper portion 148a. It may be That is, the shape of the proximal end holding portion 148 may be a shape that is enlarged as it goes outward (in the removal direction of the proximal end holding portion 148) of the extracorporeal fixture 145.

<< Overview >>
First, an outline of the insertion jig set 2S and the insertion jig (obturator 21) according to the present embodiment will be described with reference to FIGS. FIG. 18 is a perspective view showing the insertion jig set 2S according to the embodiment of the present invention, showing a state in which the cap 25 restrains the bumper 24a to be in the folded state, and FIG. FIG. 19 is a partial cross-sectional view showing a part of a tool set 2S, and is a view showing a 2II-2II cross section of FIG. 18; FIG. 20 is a partial cross-sectional perspective view showing a cross section of the distal end of the mantle 22 and is a view showing a 2III-2III cross section of FIG. 18; FIG. 21 is a perspective view showing the insertion jig set 2S, showing the cap 25 releasing and expanding the bumper 24a. FIG. 22 is a partial cross-sectional view showing a part of the insertion jig set 2S, and is a view showing a 2V-2V cross section of FIG.

In the present specification, the “distal side” refers to the side of the insertion jig set 2S and the obturator 21 far from the operator of the insertion jig set 2S and the obturator 21 unless specifically stated otherwise, specifically It refers to the side attached or covered by the cap 25. Also, the distal side may be referred to as the distal side.
Further, “proximal side” means the side closer to the operator of the insertion jig set 2S and the obturator 21 unless otherwise noted. Also, the proximal side may be referred to as the proximal side.
Also, movement of the components of the insertion jig set 2S in the distal direction may be referred to as advancing, and conversely, movement in the proximal direction may be referred to as retraction.

An insertion jig set 2S according to an embodiment of the present invention is an insertion jig set 2S for inserting a gastrostomy catheter 24 having a foldable intragastric fixation portion (bumper 24a) at its tip into the body (inside the stomach). is there.
The insertion jig set 2S includes an insertion jig (obturator 21) configured to include a cylindrical outer collar 22 and an inserter 23 that can be advanced and retracted inside the outer collar 22; A gastrostomy catheter 24 attached around the circumference 22 and a cap 25 disposed on the distal end side of the mantle 22 and covering at least a part of the intragastric fixation part (bumper 24a) in a folded state.
One of the gastrostomy catheter 24 or the mantle 22 and the cap 25 has a locking portion (locking claw 22b) for locking to the other, and the insertion portion 23 is passed through the mantle 22 It is characterized in that when it advances, the locking by the locking claw 22b is released.

According to the above configuration, the gastrostomy catheter 24 or the mantle 22 and the cap 25 are engaged, and the insertion is configured to be capable of releasing the anchor by the intercalated portion 23. It is possible to prevent the cap 25 from being accidentally detached from the mantle 22.
In the present invention, "locking" refers to a state in which movement is temporarily held and fixed to limit movement, and in addition to the state of structural locking described below, physical properties may be obtained by using an adhesive or the like. It adheres to and includes the removable state.

As a configuration for releasing the locking by the locking portion when the inserting portion 23 is advanced into the outer collar portion 22, the insertion portion 23 advanced to the member provided with the locking portion is directly connected In the structure, the locking force of the locking portion is weakened to release the locking by deforming the member by abutting on or indirectly.
In addition, the advanced insertion portion 23 directly or indirectly presses against the member provided with the locking portion or the locking target member and presses the member provided with the locking portion or the locking There is a configuration in which there is a configuration in which the locking by the locking portion is released by applying a load stronger than the locking force by the locking portion to the target member. Details of these will be described later.

An insertion jig (obturator 21) according to an embodiment of the present invention includes a gastrostomy catheter 24 having a foldable intragastric fixation part (bumper 24a) at its tip, and at least a part of the intragastric fixation part in a folded state. And a cap 25 covering the inside of the body.
The insertion jig (obturator 21) is configured to include a tubular mantle 22 around which the gastrostomy catheter 24 can be attached, and an insertion section 23 which is inserted into the mantle 22. . The outer collar 22 has a locking portion (locking claw 22 b) that locks to the cap 25.
The insertion portion 23 releases the locking by the locking claw 22 b when the insertion portion 23 is advanced into the outer collar portion 22.
According to the above-described configuration, the outer collar portion 22 and the cap 25 are engaged, and the insertion portion 23 is configured to be able to release the engagement so that the cap 25 is unexpectedly detached from the outer collar portion 22. Can be prevented.

In a gastrostomy catheter set 2S1 according to an embodiment of the present invention, a gastrostomy catheter 24 having a foldable intragastric fixation portion (bumper 24a) at its tip and a cap covering at least a part of the bumper 24a in a folded state. And 25 are configured.
The gastrostomy catheter 24 is formed so as to be able to insert a part of an insertion jig (obturator 21) for insertion into the stomach, and the cap 25 is engaged with the engagement claw 22b of the obturator 21. It has a stop (locking block 25c).
The cap 25 having the locked portion locked to the obturator 21 can prevent the cap 25 from being unintentionally detached from the gastrostomy catheter 24.

<< Configuration >>
Next, the configurations of the insertion jig set 2S and the insertion jig (obturator 21) will be described with reference to FIGS. As described above, the insertion jig set 2S is disposed on the distal end side of the gastrostomy catheter 24 for inserting the gastrostomy catheter 24 into the body, the gastrostomy catheter 24 attached around the mantle 22 and And a cap 25 covering at least a part of the intragastric fixed part in the folded state.

<Obturator>
As described above, the obturator 21 is configured to include the mantle 22 and the interpolator 23.
A holding portion 22 d for holding the extracorporeal fixation portion 24 b on the proximal side of the gastrostomy catheter 24 is provided at the central portion of the mantle 22. The holding portion 22 d has a bifurcated portion extending in a direction intersecting the axial direction of the obturator 21 and holds the extracorporeal fixation portion 24 b of the gastrostomy catheter 24 at the bifurcated portion.
Attached to the outer periphery of the distal end of the mantle 22 is a gastrostomy catheter 24 passed from the distal end of the mantle 22.
The proximal end of the obturator 21 is provided with a control unit 23 b continuous with the insertion unit 23, and the operator reciprocates the control unit 23 b in the axial direction with respect to the mantle 22 to obtain an insertion unit. It is possible to make 23 reciprocate.

As shown in FIG. 20, four slits 22 c are formed at the tip of the outer collar 22, and the slits 22 c extend in the axial direction of the outer ridge 22 up to the tip of the outer ridge 22. The front end of the outer collar 22 is divided into four pieces by four slits 22c. The term "axially extending" means extending including an axial component, and includes not only a direction parallel to the axial direction but also one extending obliquely with respect to the axial direction.
The slit 22 c is formed at the tip of the outer collar 22, so that the tip of the outer ridge 22 can be easily expanded. Therefore, when the operator advances the insertion portion 23 and releases the locking by the locking claw 22b as described later, the cap 25 can be smoothly detached from the mantle 22.

When the number of slits 22c is four, the distal end of the mantle 22 can be divided into four pieces, and the two opposing pieces can be bent and deformed in a balanced manner. Therefore, the locking and releasing of the cap 25 with respect to the locked block 25c by the locking claws 22b described later can be stably performed, which is preferable. However, the present invention is not limited to such a configuration, and the number of slits 22c is arbitrary as long as it is possible to expand the diameter of the distal end of the mantle 22 and release the lock of the cap 25. is there. Furthermore, for example, in the case where the mantle 22 is formed of an elastically deformable material, the slit 22c may not be provided.

The outer collar portion 22 is provided with a locking portion (locking claw 22 b) for locking a part of the cap 25.
The locking claws 22 b are provided on the inner wall surface of the outer collar portion 22 and configured to be able to be locked to a constricted portion of a locked block 25 c of a cap 25 described later. More specifically, of the four pieces divided at the front end of the outer collar portion 22, two opposing pieces are provided.
The locking claws 22 b are not limited to those provided on the two opposing pieces divided at the tip of the outer collar 22, the number of the locking claws 22 b is arbitrary, and the division at the tip of the outer collar 22 is It may be provided on all of the four pieces. If the locking claws 22 b are provided on all the four pieces, each of the locking claws 22 b arranged at four positions at every 90 degrees in the circumferential direction of the outer collar portion 22 is a locked block 25 c of the cap 25. It will be locked in the neck part. For this reason, it becomes possible to maintain the locking state with respect to the cap 25 more suitably.
Further, as described above, when the distal end portion of the outer collar portion 22 is further configured with a plurality of pieces by forming the plurality of slits 22c, the locking claws may be formed on any plurality of pieces. 22b may be provided.

The cross section of the locking claw 22b according to the present embodiment in the radial direction with respect to the axial center of the outer collar portion 22 is formed in a trapezoidal shape whose upper side is the axial center side. In this trapezoidal shape, the acute angle between the distal side and the other nearby inner wall is smaller than the acute angle between the proximal side and the other nearby inner wall It is formed as. That is, the surface formed including the distal side of the trapezoid is an inclined surface that is more inclined than the surface formed including the proximal side of the trapezoid.
In the present embodiment, the proximal side is formed at right angles to the other nearby inner wall surface. That is, the surface on the proximal side of the locking claw 22 b is a surface orthogonal to the axial direction of the mantle 22. The distal surface of the locked block 25 c provided on the cap 25, which is the target of locking of the locking claw 22 b, is also inserted into the distal end of the outer collar 22. It is formed in the direction orthogonal to the axial direction.

When the locked block 25c of the cap 25 is inserted from the distal side into the locking claw 22b formed in this manner, the diameter is naturally expanded by the abutment of the proximal end face 25a with the inclined surface. A force is applied in the direction, and the distal end of the mantle 22 can be easily expanded.
On the other hand, as described above, the proximal surface of the locking claw 22b and the distal surface of the locked block 25c are surfaces orthogonal to the axial direction of the mantle 22. Therefore, when the locked block 25c of the cap 25 is inserted to the proximal side beyond the locking claw 22b, even if the cap 25 moves in the axial direction of the mantle 22, the distance of the mantle 22 is increased. A force is less likely to be applied in the direction of expanding the lateral end, and the locking by the locking claw 22 b is less likely to be released.

On each of the inner wall surfaces of the two pieces provided with the locking claws 22b in the outer collar portion 22, protruding portions 22a protruding inward in the radial direction are formed. As will be described later, when the insertion portion 23 is inserted into the mantle 22 and advanced (when inserted from the proximal side to the distal side of the mantle 22), the outer circumferential surface of the insertion portion 23 is By abutting on the protrusion 22 a, it has a function of expanding (bending and deforming radially outward) the distal side of the two pieces of the mantle 22. The projecting portion 22a is formed in a circular arc shape in cross section, extends in the circumferential direction, and is disposed on the proximal side of the locking portion (locking claw 22b). The engagement between the cap 25 and the outer collar portion 22 can be suitably released by causing the insertion portion 23 to abut on the projecting portion 22 a and expand the outer collar portion 22.

In addition, the protruding portions 22 a are formed in a circular arc shape in cross section, so that the distal side of the two pieces of the outer collar 22 is not in the outer direction, without obstructing the axial movement of the outer collar 22 with respect to the insertion portion 23. Can be deformed smoothly to the outside of the However, the shape of the protrusion according to the present invention is not limited to the one formed in a circular arc shape in cross section, and the surface on the proximal side that abuts the outer surface of the insertion portion 23 inclines gently with respect to the axial direction. As long as it is an inclined surface, it may be triangular in cross section or trapezoidal in cross section.

<Stomach fistula catheter>
The gastrostomy catheter 24 communicates the outside with the inside of the stomach through the fistula, is attached to the outer periphery of the mantle 22 and is held by the holding portion 22d of the obturator 21 so as to hold and fix the extracorporeal fixation portion 24b. It is done. The gastrostomy catheter 24 includes a radially expandable and contractible bumper 24a which is placed in the stomach, an extracorporeal fixation portion 24b disposed outside the body surface, and a shaft 24c which communicates these. It is done.
The bumper 24a according to the present embodiment is formed in an umbrella shape, extends in a radial direction perpendicular to the axial direction in a natural state, and is housed in a space 25s of a cap 25 described later in a state of being folded and elastically deformed. It is configured to be possible. The bumper 24a is not limited to the umbrella shape as long as the bumper 24a can be expanded and contracted in the radial direction, and may be formed of only a plurality of bendable rod-like members.

<Cap>
The cap 25 suppresses the resistance applied to the wall surface of the fistula while holding the folded state of the bumper 24a when the bumper 24a is disposed in the stomach via the fistula (not shown), thereby the bumper 24a being introduced into the body. Make insertion easy. The cap 25 is formed of a hard capsule cover used for food made of cellulose-based or gelatin-based material, or a material that is degraded in the body such as polylactic acid, and has a cap on the distal end side with a blunt head. It is formed.
In detail, the cap 25 includes a locked block 25c, an axial center 25b continuously extending from the locked block 25c in the radial center, and a distal end of the axial center 25b. It is integrally formed of a peripheral wall 25d provided radially outward continuously with the lateral side. A circular deep moat-shaped space 25s capable of accommodating the folded bumper 24a is formed by the outer peripheral portion of the axial center portion 25b and the inner peripheral portion of the peripheral wall 25d.

At least a portion of the intragastric fixation portion (bumper 24a) is a locking portion (locking claw 22b) of the cap 25 in a state shown in FIG. ) Is accommodated in a part of the space 25s except for the portion (locked block 25c) to be locked to the.
According to such a configuration, it is possible to accommodate at least a part of the bumper 24a in a state where the cap 25 is locked to the mantle 22.
The space 25s is formed in a size that can accommodate the bumper 24a. Specifically, the outer diameter of the axial center portion 25b is smaller than the inner diameter of the shaft 24c of the gastrostomy catheter 24, and the inner diameter of the proximal end face of the peripheral wall 25d is formed larger than the outer diameter of the shaft 24c.
A through hole 25 e is formed to extend in the axial direction from the axial center portion 25 b to the locked block 25 c. The through hole 25 e allows a guide wire (not shown) to pass therethrough.

<< Operation >>
Next, the insertion operation of the gastrostomy catheter 24 into the body by the insertion jig set 2S will be described with reference to FIG. 18 to FIG.
The operator passes the gastrostomy catheter 24 oriented with the extracorporeal fixation part 24b on the proximal side to the distal end of the mantle 22 and places the holding part 22d on the extracorporeal fixation part 24b. The catheter 24 is attached to the mantle 22. The operator inserts the cap 25 into the mantle 22 while attaching the cap 25 to the gastrostomy catheter 24 so that the bumper 24a of the gastrostomy catheter 24 fits within the space 25s of the cap 25, and the locking claw 22b Lock it. Here, the locking position of the cap 25 by the locking claw 22 b is a position where the locked block 25 c exceeds the locking claw 22 b of the outer collar portion 22.

Next, the operator passes the bumper 24a covered by the cap 25 through the stoma together with the cap 25, and the stomach of the obturator 21 until the position where the bumper 24a reaches the inside of the stomach (the position where the holding portion 22d abuts the surface of the abdominal wall) Push in the fistula catheter 24.
As shown in FIG. 21, the operator operates the operation portion 23 b so as to push the insertion portion 23 to the distal side, and pushes the insertion portion 23 to the distal side of the mantle 22. The insertion portion 23 abuts on the projection 22a when it is advanced into the mantle 22 by passing it, and a bending load is applied to the two pieces provided with the projection 22a at the distal end of the mantle 22. The two pieces at the distal end of the mantle 22 are expanded.

As a result, the locking with respect to the locked block 25c by the locking claws 22b provided at the distal ends of the two sides of the mantle 22 is released, and the cap 25 can be dropped into the stomach by its own weight. Since the cap 25 which has fallen into the stomach is a material which is edible or degraded in the body as described above, there is no influence on the body by being excreted or dissolved together with the stomach contents.
In this manner, the bumper 24a released from restraint by the cap 25 can be expanded in the radial direction to place the bumper 24a of the gastrostomy catheter 24 in the stomach.

In the above, the configuration has been described in which the outer collar portion 22 is expanded to release the locking of the locking claw 22 b and the cap 25 is detached from the outer collar portion 22 by its own weight. Furthermore, as shown in FIGS. 21 and 22, the insertion portion 23 abuts on the proximal end (proximal end face 25a) of the cap 25 to separate the cap 25 from the gastrostomy catheter 24 and the mantle 22. Preferably, it is configured to be able to be advanced to a position where it can be

According to the above configuration, even if the cap 25 is not detached from the gastrostomy catheter 24 and the mantle portion 22 only by releasing the locking between the locking claw 22 b and the cap 25, the insertion portion 23 is in the vicinity of the cap 25. The cap 25 can be reliably released by coming into contact with the end face 25a.
When the insertion portion 23 is abutted against the proximal end face 25 a of the cap 25 and pushed in to remove the cap 25, the extracorporeal fixation portion 24 b is held by the holding portion 22 d of the obturator 21. Since it does not move, it is possible to easily move the cap 25 relative to one another.

<<< The 2-1st modification >>
In the obturator 21 according to the above-described embodiment, the configuration has been described in which the distal end of the mantle 22 is expanded by bringing the insertion section 23 into contact with the projection 22a of the mantle 22. It is not limited to such a configuration.
Next, the locking structure according to the 2-1st modification will be described mainly with reference to FIGS. 23 and 24. FIG. FIG. 23 is a cross-sectional view showing the locking structure between the outer collar portion 212 and the cap 25 according to the 2-1st modification, showing the bending end 212 a in the closed arm state, and FIG. It is a sectional view showing a locking structure with cap 25, and is a figure showing bent end 212a in the open arm state.

A gastrostomy catheter set 2S2 according to the present modification includes a gastrostomy catheter 24 having a foldable intragastric fixation portion (bumper 24a) at its tip, and a cap 25 covering at least a part of the bumper 24a in a folded state. Is composed including.
The gastrostomy catheter 24 is formed so as to be able to insert a part (outer cap 212) of an insertion jig (obturator 21) for insertion into the stomach, and the cap 25 is engaged with the locking claw 212b of the obturator 21. It is characterized by having a locked portion (locked block 25c) to be stopped.
The cap 25 having the locked block 25 c locked to the locking claw 212 b of the obturator 21 can prevent the cap 25 from being unintentionally detached from the gastrostomy catheter 24.

In particular, the two opposing pieces of the distal end of the mantle 212 form a bent end 212a which is bent toward the axial center toward the distal end in the natural state. The distal end of the bending end 212 a is formed to be located on the axial center side of the size between the outer surfaces of the insertion portion 23, and the distal end of the bending end 212 a extends in the axial direction from the distal end of the bending end 212 a. A locking claw 212b is formed protrudingly for locking at the distal end of the locking block 25c.

Thus, as shown in FIG. 24, the insertion portion 23 pushed to the distal side with respect to the mantle portion 212 abuts on the bending end portion 212 a which is a part of the inner wall surface of the mantle portion 212 and By expanding the bent end 212a of the portion 212, the locking by the locking portion (locking claw 212b) can be released.
In particular, unlike the mantle 22 according to the above-described embodiment, the two opposing distal end portions of the mantle 212 do not protrude radially outward from the other portions of the mantle 212, and therefore the stomach The inner wall of the hemorrhoid catheter 24 does not inhibit the deformation. Therefore, the locked state between the outer collar portion 212 and the cap 25 can be released more smoothly than the outer collar portion 22.

The bent ends 212 a are not limited to those provided on the two opposing pieces of the distal end of the mantle 212, and the number of the bent ends 212 a is arbitrary, and at the distal end of the mantle 212. It may be provided on all four divided pieces. If the bent end 212 a is provided in all the four pieces, each of the bent ends 212 a arranged at four places at every 90 degrees in the circumferential direction of the outer collar 212 is the locked block 25 c of the cap 25. It will be locked in the neck part. For this reason, it becomes possible to maintain the locking state with respect to the cap 25 more suitably.
Further, as described above, when the plurality of bending end portions 212a are further formed, when the tip end portion of the outer collar portion 212 is further configured with a plurality of pieces, the bending is performed to any plurality of pieces. An end 212a may be provided.

<< 2nd modification >>
In the above embodiment, an example in which the locking claws 22b and 212b of the outer hooks 22 and 212 are locked to the locked block 25c of the cap 25 has been described, but the present invention is not limited to such a configuration.
Next, a locking structure according to the 2-2nd modification will be described mainly with reference to FIG. FIG. 25 is a cross-sectional view showing a locking structure of the gastrostomy catheter 24 and the cap 225 according to the second-2 modification.

A gastrostomy catheter set 2S3 according to the present modification includes a gastrostomy catheter 24 having a foldable intragastric fixation portion (bumper 24a) at its tip, and a cap 225 covering at least a part of the bumper 24a in a folded state. Is composed including. The gastrostomy catheter 24 is formed so as to be able to insert a part (capsule 222) of an insertion jig (obturator 21) for insertion into the stomach.
The cap 225 according to the present modification has a locking portion (locking protrusion 225 b) that locks to the bumper 24 a of the gastrostomy catheter 24.

For example, the locking projection 225b is made of an elastic material, and the bumper 24a is accommodated in the space 225s of the cap 225 so as to be compressed and deformed radially outward from the outer peripheral surface of the bumper 24a. The cap 225 is locked to the bumper 24a by the frictional force due to the elastic restoring force of the locking projection 225b.
With such a locking structure, the cap 225 being locked to the gastrostomy catheter 24 can prevent the cap 225 from being accidentally detached from the gastrostomy catheter 24.

When releasing the locking by the locking projection 225b, the distal end surface 23a of the insertion portion 23 is brought into contact with the proximal end surface 225a of the cap 225 as in the embodiment described above, and the locking projection 225b is a bumper. The insertion portion 23 may be pushed distally to a position where it is separated from 24a.
Further, on the inner surface of the peripheral wall 225d of the cap 225, a locking portion (not shown) for locking on the inner surface of the peripheral wall 225d of the cap 225 is provided on the bumper 24a of the gastrostomy catheter 24 without providing the locking projection 225b. You may

<< 2nd modification >>
Although the cap 225 having the locking projection 225b locked to the umbrella-shaped bumper 24a has been described in the above-described second to third modifications, the present invention is not limited to such a configuration.
Next, a locking structure according to a second to third modifications will be described mainly with reference to FIGS. 26 and 27. FIG. 26 is a cross-sectional view showing the locking structure of the gastrostomy catheter 234 and the cap 235 according to the second to third modifications, and FIG. 26 and FIG. FIG. 10 is a cross-sectional view showing a locking structure of the embodiment of the present invention, showing a locking released state.

A gastrostomy catheter set 2S4 according to the present modification includes a gastrostomy catheter 234 having a foldable intragastric fixation portion (bumper 234a) at its tip, and a cap 235 covering at least a part of the bumper 234a in a folded state. Is composed including.
The gastrostomy catheter 234 is formed so as to be able to insert a part (outer cap 222) of an insertion jig for insertion into the stomach, and the cap 235 is a locking portion (engaging part) It has a locking projection 235b).
In particular, the bumper 234a comprises a wire 234b wound so as to wind a coil inside. The bumper 234 a is accommodated in the space 235 s of the cap 235 in a state where the wire 234 b is contracted toward the axial center side of the bumper 234 a than in the natural state.
When the locking protrusion 235b of the cap 235 abuts against the wire 234b inside the bumper 234a via the bumper 234a, the cap 235 locks to the gastrostomy catheter 234.

The insertion portion 23 is passed through the mantle 222 to a position where it can abut the proximal end (proximal end face 235a) of the cap 235 to release the cap 235 from the gastrostomy catheter 234 and the mantle 222. Is configured to be able to move forward. Specifically, the distal end of the cap 235 is inserted by the insertion portion 23 until the distal end surface 23a of the insertion portion 23 abuts on the proximal end surface 235a of the cap 235 and the locking projection 235b passes over the wire 234b. Pushed into. By pushing the cap 235 in this manner, the cap 235 can be detached from the gastrostomy catheter 234 as shown in FIG.

By removing the cap 235 in the body, the operator can expand the diameter of the bumper 234a by urging when restoring the wire 234b in the diameter expansion direction. By enlarging the diameter larger than the hole diameter of the stoma (not shown) of the bumper 234a, the distal end of the gastrostomy catheter 234 is indwelled in the stomach.

Although the locking projections 225b and 235b of the caps 225 and 235 according to the above modification have been described as locking to the bumpers 24a and 234a of the gastrostomy catheters 24 and 234, the present invention is limited to such a configuration It may be configured to be locked to the shaft portion.
Further, in the above embodiment, the insertion portion 23 is described as releasing the locking by the locking portion by directly contacting and pressing the member provided with the locking portion or the locking target member. However, the above-described member may be indirectly pressed via the third member to release the lock.

The present embodiment includes the following technical ideas.
(1) a shaft provided with a lumen,
A flexible bumper provided at the tip of the shaft;
A linear member having elasticity and capable of biasing the bumper in a radial direction or restricting deformation of the bumper in a radial direction;
(2) The linear member is
A first state, at least a part of which is disposed in the bumper to be capable of biasing the bumper radially outward or restricting the deformation of the bumper in the radial direction;
It is disposed proximal to the bumper or pulled out more proximal than the bumper in the first state to lower the bumper radially outward than in the first state. The stomach according to (1), wherein the stomach described in (1) is configured to be variable or not be biased or biased, or a second state that allows the bumper to be deformed in a diameter reduction direction than in the first state. Acupuncture catheter.
(3) The proximal end of the shaft is provided with a fixing portion for holding the gastrostomy catheter at a predetermined position,
The stomach according to (1) or (2), wherein a proximal end holding portion for holding the proximal end portion of the linear member is provided on the fixation portion or on the more proximal side than the distal end of the fixation portion. Acupuncture catheter.
(4) The proximal end holding portion holds the proximal end portion by the proximal end portion of the linear member being embedded in the proximal end holding portion, and the proximal end holding portion is provided so as to be cut away at the fixing portion The gastric fistula catheter according to (3).
(5) The gastrostomy catheter according to (3), wherein the proximal end holding portion is detachably attached to the fixing portion.
(6) The lumen includes a main lumen for injecting a nutrient and a sub-lumen accommodating at least a part of the linear member,
The gastrostomy catheter according to any one of (1) to (5), wherein the distal end open portion of the sub-lumen is connected in the bumper.
(7) The gastrostomy catheter according to (6), wherein a part of the inner wall of the bumper is located on the extension of the sub-lumen.
(8) The gastrostomy catheter according to (6) or (7), wherein the tip end portion of the sub-lumen is formed by being bent outward in the radial direction of the bumper.
(9) In the state where the linear member is disposed across the sub-lumen and the bumper, a portion of the linear member disposed in the sub-lumen and a portion disposed in the bumper include: The gastrostomy catheter according to any one of (6) to (8), which is bent and continuously formed.
(10) In the state where the linear member is disposed across the sub-lumen and the bumper, at least a part of the portion of the linear member disposed in the bumper is along the inner circumferential surface of the bumper. The gastrostomy catheter according to (9), which is bent to extend in a direction.
(11) A communication hole is formed in the bumper to communicate the inside and the outside of the bumper,
The tip end portion of the linear member is movably disposed in the bumper, and can be taken in and out of the bumper via the communication hole. (1) to (10) The gastrostomy catheter as described in.
(12) Any one of (1) to (11), wherein at least a tip end portion of the linear member is covered with a coating portion having a hardness lower than that of the linear member, or formed blunt. The gastrostomy catheter as described in.
(13) The vehicle further comprises a cover for holding and accommodating the bumper in the folded state,
The gastrostomy catheter according to any one of (1) to (12), wherein the cover holds and accommodates the bumper in a state where at least a part of the linear member is disposed in the bumper.
(14) The gastrostomy catheter according to any one of (1) to (13), wherein the largest diameter portion of the bumper is formed at a position spaced farther to the tip side than the tip of the shaft.
(15) The surface of the bumper is recessed in the radial direction of the bumper, and a recess extending along the axial direction of the bumper is formed in any one of (1) to (14). Gastrostomy catheter.
(16) The bumper includes a large diameter portion having a maximum diameter portion, and a small diameter portion provided on the tip side of the large diameter portion,
A plurality of the concave portions are formed in each of the large diameter portion and the small diameter portion,
The gastrostomy catheter according to (15), wherein the recess in each of the large diameter portion and the small diameter portion is formed at a corresponding position in the circumferential direction of the bumper.
(17) The bumper includes an inner layer and an outer layer, and there is a space between the inner layer and the outer layer, and a part of the linear member is disposed in the space (1) to (16) The gastric fistula catheter according to any one of the preceding claims.
(18) The bumper includes a large diameter portion having a largest diameter portion, and a small diameter portion provided on the tip end side of the large diameter portion,
In the large diameter portion, the inner layer and the outer layer are separated,
The gastrostomy catheter according to (17), wherein in the small diameter portion, the inner layer and the outer layer are in contact with each other.
(19) The shaft has a tip portion formed smaller in diameter than other portions,
The gastrostomy catheter according to (1) or (2), wherein the bumper extends from the tip of the shaft.
(20) The fixing portion is provided on a supporting portion for movably supporting the proximal end holding portion, and on the direction in which the proximal end holding portion is connected to the supporting portion and the proximal end holding portion is separated from the supporting portion. And a restriction portion for restricting the movement of the holding portion and the detachment from the support portion,
The proximal end holding unit is
The gastrostomy catheter according to (3), wherein the restriction portion is configured to be separable from the support portion by being separated from the support portion.
(21) The proximal end holding portion has a reverse taper portion formed so as to spread as it goes outward of the fixing portion,
The support portion is
An opposite portion extending along the reverse tapered portion;
After the limiting portion is separated from the supporting portion, the opposing portion abuts against the reverse tapered portion so that the proximal end holding portion can be deformed so as to be pushed outward of the fixing portion. The gastric fistula catheter according to (20), which is configured.
(22) An insertion jig set for inserting a gastrostomy catheter having a foldable intragastric fixed portion at its tip into the body,
An insertion jig including a cylindrical outer collar portion and an insertion portion which can be advanced and retracted through the outer collar portion;
The gastrostomy catheter attached around the mantle;
A cap disposed on the distal end side of the mantle and covering at least a part of the intragastric fixation part in a folded state;
One of the gastrostomy catheter or the mantle and the cap has a locking portion for locking to the other,
The insertion jig set which the said insertion part cancels | releases the latching by the said latching | locking part, when it passes and advances to the inside of the said mantle part.
(23) The locking portion is provided on the inner wall surface of the outer collar portion and configured to be lockable to the cap,
The insertion jig set according to (22), wherein the insertion portion releases the locking by the locking portion by coming into contact with a part of the inner wall surface of the outer collar portion to expand the outer collar portion.
(24) A protruding portion that protrudes radially inward is formed on the inner wall surface of the outer collar portion,
The protrusion is disposed proximal to the locking portion,
The insertion jig set according to (23), wherein when the insertion portion is passed through the inside of the outer collar portion and advances, the insertion portion abuts on the projecting portion to expand the outer collar portion.
(25) A slit is formed at the tip of the outer collar,
The insertion jig set according to (23) or (24), wherein the slit extends in the axial direction of the outer collar portion to the tip of the outer collar portion.
(26) The insertion portion is configured to be able to advance to a position where it can be separated from the gastrostomy catheter and the mantle by contacting the proximal end of the cap (22) (25) The insertion jig set according to any one of (25).
(27) At least a portion of the intragastric fixed portion is accommodated in a part of the space excluding the locking portion in the cap or a portion locked to the locking portion (22) to (26) The insertion jig set according to any one of the above.
(28) An insertion jig for inserting a gastrostomy catheter having a foldable intragastric fixation part at its tip, and a cap covering at least a part of the intragastric fixation part in a folded state into the body. ,
A tubular mantle through which the gastrostomy catheter can be attached and an insertion section which is inserted into the mantle;
The outer collar portion has a locking portion for locking to the cap,
The insertion part releases the locking by the locking part when the insertion part is advanced through the inside of the outer collar part.
(29) A gastrostomy catheter having a foldable intragastric fixation at its tip,
A cap covering at least a part of the intragastric fixation part in a folded state;
The gastrostomy catheter is configured to be insertable with a part of an insertion jig for insertion into the stomach,
The said cap is a gastrostomy catheter set which has a to-be-locked part latched by the said insertion jig.
(30) A gastrostomy catheter having a foldable intragastric fixed portion at its tip,
A cap covering at least a part of the intragastric fixation part in a folded state;
The gastrostomy catheter is configured to be insertable with a part of an insertion jig for insertion into the stomach,
A gastrostomy catheter set having a locking portion for locking one of the gastrostomy catheter and the cap to the other.

It is possible to provide a gastrostomy catheter that can be relatively indwelled with less administrative effort while keeping resistance applied to the body low. In addition, it is possible to provide an insertion jig set, an insertion jig, and a gastrostomy catheter set capable of preferably removing the cap while preventing the cap from being accidentally detached from the gastrostomy catheter.

11 gastrostomy catheter 12 shaft 13 bumper 13a communicating hole 14 wire (linear member)
14a proximal end 14b distal end 14c coating 14j, 14k bending point 14x first portion 14y second portion 15 extracorporeal fixture (fixing portion)
15a distal end 15b marker 15c proximal end holding portion 16 cap 17 strap 18 main lumen
18a opening 19 sub-lumens
19a base end 19b tip open part 110 capsule cover 111 insertion jig 111a main body cylinder 111b claw 111c operation part 111d piston 111e push rod 113 bumper 113a communicating hole 115 extracorporeal fixing member (fixed part)
115a proximal end holding portion 115b locking projection 115c recessed groove 122 shaft 129 sub-lumens
129b tip open part 132 shaft 132a shaft main body 132b first tip (tip)
132c second tip (tip)
132d sub-lumens 133 bumpers 133s space 134 inner tube 134a connecting tube 134b slope 134c recess 134d tip 134e recess 135 outer layer 135a connecting tube 135b large diameter 135c, 135d slope 135e maximum diameter 135f recess 135g recess 135g recess 135h Extracorporeal fixture (fixed part)
146 support portion 146a opposite portion 146b connection wall 146c bottom wall 146d opening 146e through hole 147 restriction piece (restriction portion)
148 proximal end holding portion 148a reverse tapered portion 150 abdominal wall 151 stomach wall 153 fistula 153 fistula 1α, 1α1, 1α2 incidence angle 2S insertion jig set 2S1, 2S2, 2S3, 2S4 gastrostomy catheter set 21 obturator (insertion jig)
22 Outer collar 22a Protrusion 22b Locking claw (locking portion)
22c slit 22d holding part 23 intercalation part 23a distal end face 23b operation part 24 gastrostomy catheter 24a bumper (fixed part in stomach)
24b extracorporeal fixing portion 24c shaft 25 cap 25a proximal end face 25b axial center portion 25c locked block (locked portion)
25 d Peripheral wall 25 e Through hole 25 s Space 212 Outer collar portion 212 a Bending end 212 b Locking claw (locking portion)
222 Outer sleeve portion 225 cap 225a proximal end face 225b locking projection (locking portion)
225d peripheral wall 225s space 234 gastrostomy catheter 234a bumper (fixed part in stomach)
234b wire 235 cap 235a proximal end face 235b locking projection (locking portion)
235s space

Claims (30)

1. A shaft with a lumen,
   A flexible bumper provided at the tip of the shaft;
   A linear member having elasticity and capable of biasing the bumper in a radial direction or restricting deformation of the bumper in a radial direction;
2. The linear member is
   A first state, at least a part of which is disposed in the bumper to be capable of biasing the bumper radially outward or restricting the deformation of the bumper in the radial direction;
   It is disposed proximal to the bumper or pulled out more proximal than the bumper in the first state to lower the bumper radially outward than in the first state. The stomach according to claim 1, wherein the stomach is configured to be variable in a second state in which the bumper is allowed to deform in the radial direction rather than being biased or biased or in the first state. Acupuncture catheter.
3. The proximal end of the shaft is provided with a fixing part for holding the gastrostomy catheter in place;
   The gastric fistula catheter according to claim 1 or 2, further comprising: a proximal end holding portion for holding the proximal end portion of the linear member on the proximal side of the fixing portion or the distal end of the fixing portion. .
4. The proximal end holding portion holds the proximal end portion by being embedded in the proximal end holding portion by the proximal end portion of the linear member, and is provided so as to be cut away at the fixing portion. The gastric fistula catheter according to 3.
5. The gastrostomy catheter according to claim 3, wherein the proximal end holding portion is detachably attached to the fixed portion.
6. The lumen includes a main lumen for injecting a nutrient, and a sub-lumen accommodating at least a portion of the linear member,
   The gastrostomy catheter according to any one of claims 1 to 5, wherein the distal end open portion of the sub-lumen is continuous in the bumper.
7. The gastrostomy catheter according to claim 6, wherein a part of the inner wall of the bumper is located on the extension of the sub-lumen.
8. The gastrostomy catheter according to claim 6 or 7, wherein the distal end portion of the sub-lumen is formed by being bent radially outward of the bumper.
9. In the state where the linear member is disposed across the sub-lumen and the bumper, a portion of the linear member disposed in the sub-lumen and a portion disposed in the bumper are bent. 9. The gastrostomy catheter according to any one of claims 6 to 8, which is formed continuously.
10. In the state where the linear member is disposed across the sub-lumen and the bumper, at least a portion of the portion of the linear member disposed in the bumper extends in the direction along the inner circumferential surface of the bumper. The gastrostomy catheter according to claim 9, which is bent to be present.
11. The bumper is formed with a communication hole for communicating the inside and the outside of the bumper,
    The tip end portion of the linear member is movably disposed in the bumper, and can be inserted in and out of the bumper through the communication hole. Gastrostomy catheter.
12. The gastrostomy according to any one of claims 1 to 11, wherein at least a tip end portion of the linear member is covered with a coating portion having a hardness lower than that of the linear member or formed in a blunt shape. catheter.
13. And a cover for holding and housing the bumper in a folded state.
    The gastrostomy catheter according to any one of claims 1 to 12, wherein the cover holds and accommodates the bumper in a state where at least a part of the linear member is disposed in the bumper.
14. The gastrostomy catheter according to any one of claims 1 to 13, wherein the largest diameter portion of the bumper is formed at a position spaced apart from the tip of the shaft to the tip.
15. The gastrostomy catheter according to any one of claims 1 to 14, wherein the surface of the bumper is recessed in the radial direction of the bumper to extend in the axial direction of the bumper.
16. The bumper includes a large diameter portion having a maximum diameter portion, and a small diameter portion provided on the tip side of the large diameter portion.
    A plurality of the concave portions are formed in each of the large diameter portion and the small diameter portion,
    The gastrostomy catheter according to claim 15, wherein the recess in each of the large diameter portion and the small diameter portion is formed at a corresponding position in the circumferential direction of the bumper.
17. 17. The bumper according to any one of claims 1 to 16, wherein the bumper includes an inner layer and an outer layer, a space is provided between the inner layer and the outer layer, and a part of the linear member is disposed in the space. The gastrostomy catheter as described in.
18. The bumper includes a large diameter portion having a maximum diameter portion, and a small diameter portion provided on the tip side of the large diameter portion.
    In the large diameter portion, the inner layer and the outer layer are separated,
    18. The gastrostomy catheter according to claim 17, wherein the inner layer and the outer layer are in contact with each other at the small diameter portion.
19. The shaft has a tip portion formed smaller in diameter than other portions,
    The gastrostomy catheter according to claim 1 or 2, wherein the bumper extends from the tip of the shaft.
20. The fixing portion is provided on a support portion for movably supporting the proximal end holding portion, and on a direction in which the proximal end holding portion is separated from the support portion and connected to the support portion. And a restriction unit for restricting movement and detachment from the support unit,
    The proximal end holding unit is
    The gastrostomy catheter according to claim 3, wherein the restriction portion is configured to be separable from the support portion by being separated from the support portion.
21. The proximal end holding portion has a reverse tapered portion formed so as to spread as it goes outward of the fixed portion,
    The support portion is
    An opposite portion extending along the reverse tapered portion;
    After the limiting portion is separated from the supporting portion, the opposing portion abuts against the reverse tapered portion so that the proximal end holding portion can be deformed so as to be pushed outward of the fixing portion. 21. The gastrostomy catheter of claim 20 configured.
22. An insertion jig set for inserting into a body a gastrostomy catheter having a foldable intragastric fixed part at its tip,
    An insertion jig including a cylindrical outer collar portion and an insertion portion which can be advanced and retracted through the outer collar portion;
    The gastrostomy catheter attached around the mantle;
    A cap disposed on the distal end side of the mantle and covering at least a part of the intragastric fixation part in a folded state;
    One of the gastrostomy catheter or the mantle and the cap has a locking portion for locking to the other,
    The insertion jig set which the said insertion part cancels | releases the latching by the said latching | locking part, when it passes and advances to the inside of the said mantle part.
23. The locking portion is provided on an inner wall surface of the outer collar portion and configured to be lockable to the cap,
    The insertion jig set according to claim 22, wherein the insertion portion releases the locking by the locking portion by coming into contact with a part of the inner wall surface of the outer collar portion to expand the outer collar portion.
24. A protrusion projecting radially inward is formed on the inner wall surface of the outer collar portion,
    The protrusion is disposed proximal to the locking portion,
    The insertion jig set according to claim 23, wherein the insertion portion abuts on the projecting portion when the insertion portion is advanced into the outer collar portion to expand the outer collar portion.
25. A slit is formed at the tip of the outer collar,
    The insertion jig set according to claim 23 or 24, wherein the slit extends in the axial direction of the outer collar portion up to the tip of the outer collar portion.
26. 26. The apparatus according to claim 22, wherein the insertion portion is configured to be advanceable to a position capable of coming into contact with the proximal end of the cap to release the cap from the gastrostomy catheter and the mantle. The insertion jig set according to any one of the above.
27. 27. The at least one portion of the intragastric fixed portion is accommodated in a portion of the space excluding the locking portion in the cap or a portion locked to the locking portion. Insertion jig set described in.
28. An insertion jig for inserting into a body a gastrostomy catheter having a foldable intragastric fixation part at its tip and a cap covering at least a part of the intragastric fixation part in a folded state,
    A tubular mantle through which the gastrostomy catheter can be attached and an insertion section which is inserted into the mantle;
    The outer collar portion has a locking portion for locking to the cap,
    The insertion part releases the locking by the locking part when the insertion part is advanced through the inside of the outer collar part.
29. A gastric fistula catheter having a foldable intragastric fixation at its tip;
    A cap covering at least a part of the intragastric fixation part in a folded state;
    The gastrostomy catheter is configured to be insertable with a part of an insertion jig for insertion into the stomach,
    The said cap is a gastrostomy catheter set which has a to-be-locked part latched by the said insertion jig.
30. A gastric fistula catheter having a foldable intragastric fixation at its tip;
    A cap covering at least a part of the intragastric fixation part in a folded state;
    The gastrostomy catheter is configured to be insertable with a part of an insertion jig for insertion into the stomach,
    A gastrostomy catheter set having a locking portion for locking one of the gastrostomy catheter and the cap to the other.

Images