Patent Description:
Priority is claimed on <CIT>, <CIT>, and <CIT>.

In the related art, as gastrostomy catheters, a gastrostomy catheter is known, which is configured to administer a nutrient into a stomach and to place a tip portion of the catheter in the stomach by a gastrointestinal fixing portion (gastrointestinal indwelling device) such as an expandable bumper or balloon in order to maintain a state in which the nutrient can be administered into the stomach.

Specifically, there is a gastrostomy catheter having a bumper of which a diameter is reduced by a rod, as disclosed in PTL <NUM>, or a gastrostomy catheter having a balloon which is inflated or deflated by a fluid such as an aqueous salt solution, as disclosed in Patent Document <NUM>.

When a gastrostomy catheter is attached to a body, it is important to avoid or suppress the gastrointestinal fixing portion from compressing or damaging a wall surface of a fistula, thereby reducing a burden on a subject.

For example, PTL <NUM> discloses a gastrostomy catheter insertion jig set (described as a gastrostomy instrument in PTL <NUM>) including a cap (described as a capsule in PTL <NUM>) which covers an gastrointestinal fixing portion (described as an internal bolster in PTL <NUM>) and can maintain a state in which the gastrointestinal fixing portion is folded.

In the insertion jig set described in PTL <NUM>, the gastrointestinal fixing portion can be inserted into a stomach through a fistula in a state in which the gastrointestinal fixing portion is folded by a cap, and thus, a burden on a subject is reduced. A hole through which a lip cord (tear string) can pass is formed in this cap. The cap is torn by pulling the lip cord which has passed through the hole, and the state is shifted from a state in which the gastrointestinal fixing portion is restrained to a state in which the gastrointestinal fixing portion is expandable. Accordingly, the gastrointestinal fixing portion is placed into the stomach.

Further prior art related to catheter anchoring systems can be found in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

In the gastrostomy catheter of PTL <NUM>, since it is necessary to stably place the bumper in the stomach, it is difficult to use a highly flexible bumper. Therefore, when the gastrostomy catheter is inserted into the fistula or removed from the fistula, a large resistance may be applied to a wall surface portion of the fistula from the bumper. In order to reduce the burden on the body, it is desirable that the resistance is smaller.

In the balloon catheter of PTL <NUM>, since it is necessary to replace a fluid which fills the balloon, it takes time and effort required for management, and it is difficult to place the balloon catheter for a long time.

In the insertion jig set described in PTL <NUM>, the cap is torn by the lip cord. Accordingly, since there is no mechanism for separating the cap from the gastrointestinal fixing portion, there is a concern that the torn cap is left in a state of being attached to the gastrointestinal fixing portion. In this case, there is a concern that the shifting of the gastrointestinal fixing portion from the folded state to the expanded state may be hindered.

In addition, it is necessary to provide the hole for the lip cord to pass through in the cap, and it is necessary that the cap has a thickness and a material that can be torn by the lip cord. Accordingly, a holding force for maintaining the state in which the gastrointestinal fixing portion is folded may be restricted. For this reason, in a case where this cap is used for a gastrointestinal fixing portion having high elasticity, elastic restoration of the gastrointestinal fixing portion cannot be suppressed. Accordingly, it is possible that the cap is unexpectedly detached from the gastrointestinal fixing portion.

Furthermore, it is difficult for a surgeon to obtain confirmation that the cap is detached from the gastrointestinal fixing portion only by pulling the lip cord.

The present invention is made in consideration of the above-described problems, and object thereof is to provide a gastrostomy catheter capable of reducing time and effort required for management while keeping a resistance applied to a body low and capable of being placed for a relatively long time.

In addition, another object of the present invention is to provide an insertion jig set, an insertion jig, and a gastrostomy catheter set capable of preventing the cap from being unexpectedly detached from the gastrostomy catheter and capable of suitably removing the cap.

Dependent claims <NUM>-<NUM> define further embodiments.

According to an aspect of the present invention, there is provided a gastrostomy catheter including: a shaft in which a lumen is provided; a flexible bumper which is provided at a tip of the shaft; and a wire which has elasticity and biases the bumper in a diameter-increasing direction.

According to another aspect not according to the present invention, there is provided an insertion jig set for inserting a gastrostomy catheter having a foldable gastrointestinal fixing portion at a tip into a body, the insertion jig set including: an insertion jig configured to include a tubular mantle portion and an inner insertion portion which is movable forward and rearward through the mantle portion; the gastrostomy catheter which is attached around the mantle portion; and a cap which is disposed on a tip side of the mantle portion and covers at least a portion of the folded gastrointestinal fixing portion, in which one of the gastrostomy catheter or the mantle portion and the cap has a locking portion which is locked to the other, and the inner insertion portion releases locking by the locking portion when the inner insertion portion moves forward through the mantle portion.

According to still another aspect not according to the present invention, there is provided an insertion jig for inserting a gastrostomy catheter having a foldable gastrointestinal fixing portion at a tip and a cap covering at least a portion of the folded gastrointestinal fixing portion into a body, the insertion jig including: a tubular mantle portion around which the gastrostomy catheter is attachable; and an inner insertion portion which passes through the mantle portion, in which the mantle portion has a locking portion which is locked to the cap, and the inner insertion portion releases locking by the locking portion when the inner insertion portion moves forward through the mantle portion.

According to still another aspect not according to the present invention, there is provided a gastrostomy catheter set including: a gastrostomy catheter which has a foldable gastrointestinal fixing portion at a tip; and a cap which covers at least a portion of the folded gastrointestinal fixing portion, in which the gastrostomy catheter is formed so that a portion of an insertion jig for inserting the gastrostomy catheter into the stomach is inserted, and the cap has a locked portion which is locked to the insertion jig.

According to the gastrostomy catheter of the present invention, the linear member is provided, which can bias the bumper in a diameter-increasing direction.

Accordingly, it is possible to use the bumper made of a material which is more flexible than the gastrostomy catheter of the related art. Accordingly, it is possible to suppress a resistance applied to a body when the catheter is inserted or removed to a low level. Moreover, unlike a gastrostomy catheter having a balloon, a fluid is not used. Accordingly, there is no need to replace the fluid. Therefore, compared with the gastrostomy catheter provided with the balloon, time and effort required for management can be reduced, and the gastrostomy catheter can be placed for a relatively long time.

According to the insertion jig set, the insertion jig, and the gastrostomy catheter set of the present disclosure, it is possible to suitably remove the cap while preventing the cap from being unexpectedly removed from the gastrostomy catheter.

The embodiment described below is merely an example for facilitating the understanding of the present invention, and does not limit the present invention which is defined by the appended claims.

Moreover, in all the drawings, the same reference numerals are assigned to the same components, and repeated descriptions thereof will be appropriately omitted.

First, an overview of a gastrostomy catheter <NUM> according to the present embodiment will be described mainly with reference to <FIG> and <FIG>. <FIG> is a front view of the gastrostomy catheter <NUM> according to the present embodiment, and <FIG> is a front cross-sectional view of the gastrostomy catheter <NUM>.

In the present specification, a "distal side" refers to a side of the gastrostomy catheter <NUM> far from an operator of the gastrostomy catheter <NUM> unless otherwise specified, and specifically, refers to a side on which a bumper <NUM> is provided. Further, the distal side may be referred to as a tip side.

Moreover, a "proximal side" refers to a side of the gastrostomy catheter <NUM> close to the operator unless otherwise specified. In addition, the proximal side may be referred to as a base end side.

The gastrostomy catheter <NUM> includes a shaft <NUM> in which a lumen is provided, a flexible bumper <NUM> which is provided at a tip of the shaft <NUM>, and a linear member (wire <NUM>) which has elasticity and can bias the bumper <NUM> in a diameter-increasing direction or can restrict deformation of the bumper <NUM> in a diameter-decreasing direction.

Here, "the bumper <NUM> can be biased in the diameter-increasing direction" means that the wire <NUM> is elastically deformed and comes into contact with the bumper <NUM> in a radial direction, and thus, it is possible to apply a restoring force in the diameter-increasing direction of the bumper <NUM>.

Further, "the deformation of the bumper <NUM> in the diameter-decreasing direction can be restricted" means that when the bumper <NUM> abuts on an edge surface of a stomach wall and a diameter of the bumper <NUM> decreases, the wire <NUM> abuts on the bumper <NUM>, and thus, the deformation of the bumper <NUM> in the diameter-decreasing direction can be restricted. That is, the wire <NUM> is not limited to a wire which constantly biases the bumper <NUM> in the diameter-increasing direction, and the wire <NUM> may be biased in the diameter-increasing direction for the first time when an external force is applied to the bumper <NUM>.

Moreover, in the present embodiment, the restoring force of the wire <NUM> is applied to the bumper <NUM> from the inside in the diameter-increasing direction. However, in an example not according to the present invention, the restoring force in the diameter-increasing direction may be applied from a linear member (no illustrated) disposed outside the bumper <NUM>.

The gastrostomy catheter <NUM> includes the wire <NUM> which can bias the bumper <NUM> in the diameter-increasing direction or restrict the deformation of the bumper <NUM> in the diameter-decreasing direction. Accordingly, as compared with a gastrostomy catheter <NUM> which does not have the wire <NUM>, it is possible to employ a material having flexibility for the bumper <NUM>.

Accordingly, a resistance applied to a body when the gastrostomy catheter <NUM> is inserted or removed can be suppressed low. In addition, the gastrostomy catheter <NUM> including the bumper <NUM> and the wire <NUM> does not use a fluid unlike the gastrostomy catheter including a balloon. Accordingly, there is no need to replace the fluid. Therefore, as compared with a case where a balloon is used, time and effort required for management can be reduced, and the gastrostomy catheter <NUM> can be placed for a relatively long time.

Next, details of a structure of the gastrostomy catheter <NUM> will be described mainly with reference to <FIG> in addition to <FIG> and <FIG> is a bottom view of the bumper <NUM> when viewed in a direction of an arrow 1III in <FIG>, <FIG> is an explanatory view for explaining an angle of each site of a wire <NUM> with respect to an inner peripheral surface of the bumper <NUM>. <FIG> is a schematic explanatory view illustrating a state of the gastrostomy catheter <NUM> in which the bumper <NUM> is placed in a stomach <NUM>.

The gastrostomy catheter <NUM> mainly includes the shaft <NUM>, a fixing portion (extracorporeal fixing unit <NUM>) which is provided in a base end portion of the shaft <NUM>, the bumper <NUM> which is provided on a tip side of the gastrostomy catheter <NUM>, and the wire <NUM> which is disposed over the inside of each of the extracorporeal fixing unit <NUM>,the shaft <NUM>, and the bumper <NUM>.

The gastrostomy catheter <NUM> according to the present embodiment, except for the wire <NUM>, is integrally formed of silicone rubber or urethane rubber. However, the present invention is not limited to this configuration and a separate component may be joined to constitute the gastrostomy catheter <NUM>. In particular, even in a configuration in which a separate component is joined to constitute the gastrostomy catheter <NUM>, the same kind of material is preferable in terms of quality.

The extracorporeal fixing unit <NUM> and the shaft <NUM> include the lumen. The lumen includes a main lumen <NUM> for injecting a nutrient and a sub-lumen <NUM> which accommodates at least a portion (base end side) of the wire <NUM>.

The main lumen <NUM> communicates with a hollow space of the bumper <NUM> and a communication hole 13a to be described later which is formed in the bumper <NUM> and forms a flow path which penetrates from the base end portion to the tip portion in the gastrostomy catheter <NUM>. Accordingly, the nutrient can be injected into the stomach <NUM> from outside the body. The main lumen <NUM> is formed in a D-shaped cross section in the present embodiment, and linearly extends along an axial direction of the shaft <NUM> at centers of the shaft <NUM> and the extracorporeal fixing unit <NUM>.

In the hollow bumper <NUM>, a communication hole 13a which is a circular hole is formed at an end to which the main lumen <NUM> extends. The communication hole 13a is formed to have a large diameter so as to expose the main lumen <NUM> and the sub-lumen <NUM> and include the main lumen <NUM> and the sub-lumen <NUM> inside when viewed from a bottom of the bumper <NUM>.

The nutrient supplied into the stomach <NUM> (refer to <FIG>) via the gastrostomy catheter <NUM> passes through the extracorporeal fixing unit <NUM> and the main lumen <NUM> of the shaft <NUM> and is supplied into the stomach <NUM> through the communication hole 13a of the bumper <NUM>. A check valve for preventing backflow of a content such as gastric juice from the inside of the stomach <NUM> to the outside of the body is provided in the main lumen <NUM>. However, in a state in which the check valve is omitted, <FIG> or the like is illustrated.

The sub-lumen <NUM> is formed on an outer peripheral side of the main lumen <NUM>. The main lumen <NUM> is formed in a D-shaped cross section in a site passing through the shaft <NUM>. Accordingly, the sub-lumen <NUM> is formed through a site formed thicker than other sites. The sub-lumen <NUM> is formed in a circular cross section and is bent in an L shape along the shaft <NUM> and the extracorporeal fixing unit <NUM>. Specifically, the sub-lumen <NUM> linearly extends along the axial direction in the shaft <NUM>, is bent at a right angle at a site reaching the extracorporeal fixing unit <NUM>, and linearly extends along the extension direction of the extracorporeal fixing unit <NUM>. Since a portion of the wire <NUM> is accommodated in the sub-lumen <NUM>, the injection of the nutrient through the main lumen <NUM> side is not hindered. Further, the wire <NUM> can be protected in the sub-lumen <NUM>.

In the sub-lumen <NUM>, a tip opening portion 19b, which is a distal end portion having a certain length, extends linearly from the proximal side to the distal side and is continuous with the inside of the bumper <NUM>. Here, that the tip opening portion 19b of the sub-lumen <NUM> is continuous with the inside of the bumper <NUM> means that the tip opening portion 19b of the sub-lumen <NUM> is provided in a space continuous with a space inside the bumper <NUM>. In this way, the sub-lumen <NUM> is formed and a base end side of the wire <NUM> is disposed in the sub-lumen <NUM>. Accordingly, a tip side of the wire <NUM> can be guided into the bumper <NUM>.

The extracorporeal fixing unit <NUM> abuts on an abdominal wall <NUM>, and thus, fixes (restricts a movement to a predetermined position) the gastrostomy catheter <NUM> outside the body so that the gastrostomy catheter <NUM> is not embedded in a fistula <NUM>. The extracorporeal fixing unit <NUM> is formed larger than the shaft <NUM> in at least one direction perpendicular to the axial direction of the shaft <NUM> passing through the fistula <NUM>. The extracorporeal fixing unit <NUM> in the present embodiment has a small piece shape which extends linearly perpendicular to an axis of the shaft <NUM>. As illustrated in <FIG>, the fistula <NUM> is formed to penetrate the abdominal wall <NUM> and the stomach wall <NUM>.

The extracorporeal fixing unit <NUM> according to the present embodiment is formed integrally with the shaft <NUM> and the bumper <NUM>. In the extracorporeal fixing unit <NUM>, an opening 18a, which is a central portion of the shaft <NUM> in a radial direction and is a proximal opening of the main lumen <NUM> formed in the axial direction, is formed. Moreover, a strap <NUM> extends integrally from a side surface of the extracorporeal fixing unit <NUM>, and a cap <NUM> capable of sealing the opening 18a is formed at a tip portion of the strap <NUM>.

The extracorporeal fixing unit <NUM> includes a base end holding portion 15c described later which holds a base end portion 14a of the wire <NUM>.

The base end portion 14a of the wire <NUM> is embedded in the base end holding portion 15c, and thus, the base end holding portion 15c holds the base end portion 14a. In order to easily pull out the wire <NUM> from other sites in the gastrostomy catheter <NUM>, the base end holding portion 15c is provided in the extracorporeal fixing unit <NUM> so as to be cuttable. A configuration of the base end holding portion 15c which holds the base end portion 14a of the wire <NUM> is not limited to the configuration in which the base end portion 14a is embedded to hold the wire <NUM>. For example, in order to hold the wire <NUM>, a stopper or the like may be provided at the base end of the wire <NUM> so that a portion of the extracorporeal fixing unit <NUM> is locked to the stopper, or the base end portion 14a of the wire <NUM> may be interposed therebetween by a portion of the extracorporeal fixing unit <NUM>.

In particular, a linear marker 15b serving as a guide for a cutout portion is provided on a side surface of the extracorporeal fixing unit <NUM> according to the present embodiment. The marker 15b is attached to a position included in an imaginary plane (vertical surface in the present embodiment) intersecting a base end portion 19a of the sub-lumen <NUM>, which is a position where the base end holding portion 15c can be reliably cut off. Here, the base end portion 19a does not mean a base end surface, but means a site having a certain length at the base end.

The position at which the marker 15b is attached may be an upper surface (proximal end surface) of the extracorporeal fixing unit <NUM>. Moreover, the marker 15b may be formed of a paint, or may be simply a groove-shaped cut. Further, as long as the positions of the wire <NUM> and the sub-lumen <NUM> can be visually recognized, the marker 15b is not necessarily an essential component.

The base end holding portion 15c is provided in this manner, and thus, the wire <NUM> can be placed at a predetermined position at which the tip portion of the wire <NUM> is located in the bumper <NUM>.

For example, in the gastrostomy catheter <NUM> according to the present embodiment, a site disposed outside the body may be a so-called button type or a tube type. If there are other sites disposed outside the body, such as in a case of the tube type, the configuration of the gastrostomy catheter is not limited to a configuration in which the base end holding portion 15c is provided in the extracorporeal fixing unit <NUM>, and it is sufficient if there is a site which holds the base end portion 14a of the wire <NUM> on a proximal side from the distal end 15a of the extracorporeal fixing unit <NUM>.

If the base end holding portion 15c is not cut off, as in the base end holding portion 15c according to the above-described configuration, the wire <NUM> is prevented from coming off from the extracorporeal fixing unit <NUM> or the like. Accordingly, it is possible to prevent a patient from unexpectedly removing the wire <NUM>.

The bumper <NUM> is formed integrally with the shaft <NUM> and is formed in a hollow disk shape. The shape of the bumper <NUM> in the present embodiment is the same (including substantially the same) disk shape in appearance in a natural state and a state in which the tip side of the wire <NUM> is accommodated. However, the bumper <NUM> is not limited to this shape, and may have flexibility such that the bumper <NUM> expands radially outward only when the tip side of the wire <NUM> is accommodated.

Moreover, the bumper <NUM> is formed to have a thickness thinner than a thickness (strictly speaking, a distance between a wall surface of the main lumen <NUM> and an outer surface of the shaft <NUM> at a site where the sub-lumen <NUM> is not formed) of the shaft <NUM> so as to have a predetermined flexibility. In this way, since the bumper <NUM> is thinner than the shaft <NUM>, the bumper <NUM> can be easily expanded and shrunk.

As described above, the communication hole 13a which allows the inside and the outside of the bumper <NUM> to communicate with each other is formed on an extension side of the main lumen <NUM> on the distal side of the bumper <NUM>.

In the bumper <NUM>, the tip side of the wire <NUM> formed of a super-elastic alloy is disposed so as to be coiled. Accordingly, the bumper <NUM> is biased radially outward and a disk-shaped shape (including a shape of which a diameter is slightly reduced in the radial direction) is maintained in the stomach <NUM>. The present invention is not limited to the configuration in which the wire <NUM> constantly biases the bumper <NUM> radially outward. That is, a configuration may be adopted in which the bumper <NUM> is biased radially outward when an external force is applied to the bumper <NUM> so that the bumper <NUM> is deformed in the diameter-decreasing direction and the bumper <NUM> abuts on the wire <NUM>, and the deformation of the bumper <NUM> is restricted.

Furthermore, the present invention is not limited to the configuration in which the bumper <NUM> is formed in a disk shape in a natural state, and a configuration may be adopted in which the bumper <NUM> is formed in a disk shape for the first time when the tip side of the wire <NUM> is disposed in the bumper <NUM>.

A portion on at least the tip side of the linear member (wire <NUM>) is disposed in the bumper <NUM>, and the linear member <NUM> is configured to be changed to a first state in which the linear member can bias the bumper <NUM> radially outward or can restrict the deformation of the bumper <NUM> in the diameter-decreasing direction, and a second state in which the linear member biases the bumper <NUM> radially outward lower than when the linear member is in the first state or does not bias the bumper <NUM>, or the linear member allows the deformation of the bumper <NUM> in the diameter-decreasing direction more than when the linear member is in the first state. The second state is a state in which the wire <NUM> is disposed closer to the base end side of the bumper <NUM> or the wire <NUM> is pulled out closer to a proximal side from the bumper <NUM> than when the wire <NUM> is in the first state.

Specifically, when the wire <NUM> is completely pulled out from the bumper <NUM> (pulled out closer to the proximal side from the bumper <NUM>), the wire <NUM> naturally does not bias the bumper <NUM> at all. Meanwhile, when the wire <NUM> is partially pulled out from the bumper <NUM>, the bumper <NUM> is biased by a lower force than before the bumper <NUM> is pulled out, or the restricted deformation of the bumper <NUM> in the diameter-decreasing direction is allowed. The state of the bumper <NUM> relating to both of these is referred to as a "second state".

In this way, a state in which the wire <NUM> restricts the deformation of the bumper <NUM> can be changed depending on the position of the wire <NUM> with respect to the bumper <NUM>.

The term "radially outward" means a direction having a radially outward component, and means all directions except a radially inward direction (in other words, a direction toward a center of the bumper <NUM>). The same applies to the following.

As described above, the base end portion 14a of the wire <NUM> is embedded in the base end holding portion 15c. At least the tip portion 14b of the wire <NUM> is movably disposed in the bumper <NUM> without being supported by other members, and can be inserted into or drawn from the inside and outside (more specifically, the inside of the bumper <NUM> and a distal side outer portion of the bumper <NUM>) of the bumper <NUM> via the communication hole 13a.

According to this configuration, it is possible to easily manufacture the gastrostomy catheter <NUM> which is disposed so that the tip portion 14b of the wire <NUM> is coiled in the bumper <NUM>. Specifically, first, a manufacturer once puts out the tip portion 14b of the wire <NUM> passing through the sub-lumen <NUM> from the communication hole 13a to the outside of the bumper <NUM>. Thereafter, a base end side rather than a tip side in the tip portion 14b of the wire <NUM> coming out from the bumper <NUM> is accommodated in the bumper <NUM> so as to be gradually coiled in the bumper <NUM>, and thus, the wire <NUM> is disposed in the bumper <NUM> until the tip thereof is in the bumper <NUM>. Accordingly, it possible to easily manufacture the gastrostomy catheter <NUM> having the wire <NUM> which is accommodated so that the tip side is coiled.

The above-described wire <NUM> is changed from the first state to be disposed on a proximal side in a direction pulled out from the bumper <NUM> to the second state, it is possible to weaken a biasing force to the bumper <NUM> or to allow the deformation of the bumper <NUM> in the diameter-decreasing direction. In this way, the wire <NUM> is set to the second state, and thus, a resistance applied to the body when the gastrostomy catheter <NUM> is removed can be suppressed low.

Moreover, in the present embodiment, as will be described later, the gastrostomy catheter <NUM> is inserted in a state in which the tip side of the wire <NUM> is accommodated in the bumper <NUM> and in a state in which the bumper <NUM> is folded by a capsule cover <NUM>. For example, when inserting the gastrostomy catheter <NUM> without using the capsule cover <NUM>, the wire <NUM> is pulled out from the bumper <NUM>, and after the bumper <NUM> is in the second state, the gastrostomy catheter <NUM> may be inserted. In this case as well, the resistance applied to the body can be suppressed low.

The present invention is not limited to the configuration in which the tip side of the coiled wire <NUM> has a curvature to constantly bias an inner surface of the bumper <NUM>. That is, the tip side of the coiled wire <NUM> may have a radius of curvature larger than an outer diameter of the shaft <NUM>, and may be disposed to be separated from the inner surface of the bumper <NUM> as long as the deformation of the bumper <NUM> is suppressed so that the bumper <NUM> can be locked to an edge of the fistula <NUM> in the stomach <NUM>.

In the above embodiment, the configuration in which the wire <NUM> is completely pulled out from the gastrostomy catheter <NUM> is described. However, the present invention is not limited to the configuration. For example, only a portion of the wire <NUM> may be pulled out from the bumper <NUM> to reduce an amount of a site of the wire <NUM> in the bumper <NUM>. Even in this case, the radially outward biasing force of the bumper <NUM> is weakened or the force for restricting the deformation of the bumper <NUM> in the diameter-decreasing direction is weakened by an amount corresponding to the reduction in the amount of the wire <NUM>. Accordingly, it is possible to suppress the resistance when the gastrostomy catheter <NUM> is inserted into or removed from the inside of the stomach <NUM>. The configuration is preferable in that a load of the wire <NUM> acting on the bumper <NUM> can be easily adjusted.

However, the present invention is not limited to this configuration, and is not limited to a configuration in which the wire <NUM> is pulled out to the proximal side of the gastrostomy catheter <NUM> as long as the load of the wire <NUM> on the bumper <NUM> can be adjusted. For example, a rod for hooking the wire <NUM> may be inserted from the main lumen <NUM>, and the wire <NUM> may be wound in the bumper <NUM> to reduce the diameter so that the radially outward load on the bumper <NUM> is reduced.

Further, at least the tip portion 14b of the wire <NUM> is covered with a coating portion 14c having a lower hardness than the wire <NUM>, or is formed into a blunt (substantially spherical shape) shape by electric discharge machining.

At least the tip portion 14b of the wire <NUM> is covered with a coating portion 14c, or is formed into a blunt (substantially spherical shape) shape by electric discharge machining. According to this configuration, it is possible to prevent the tip portion 14b from damaging the bumper <NUM> when the tip portion 14b of the wire <NUM> is accommodated in the bumper <NUM>.

In a state in which the wire <NUM> is disposed over the sub-lumen <NUM> and the bumper <NUM>, as illustrated in <FIG>, a first site 14x of the wire <NUM> disposed in the sub-lumen <NUM> and a second site 14y disposed in the bumper <NUM> are bent at the bending point 14j and are formed continuously. In other words, the wire <NUM> is bent in the bumper <NUM> outward at the bending point 14j in the radial direction of the bumper <NUM>.

As described above, since the wire <NUM> is bent, it is easy to smoothly bias the bumper <NUM> in the diameter-increasing direction or to uniformly restrict the deformation of the bumper <NUM> in the diameter-decreasing direction at the end of the wire <NUM> inserted into the sub-lumen <NUM>. Accordingly, it is possible to suitably maintain a state in which the bumper <NUM> is biased in the diameter-increasing direction and a state in which the deformation of the bumper <NUM> in the diameter-decreasing direction is restricted. <NUM>, and it is possible to prevent the bumper <NUM> and the gastrostomy catheter <NUM> from being unexpectedly pulled out from the fistula <NUM>.

Further, in the state in which the wire <NUM> is disposed over the sub-lumen <NUM> and the bumper <NUM>, at least a portion of the site of the wire <NUM> disposed in the bumper <NUM> is formed so as to be bent at a bending point <NUM> to extend in a direction along an inner peripheral surface of the bumper <NUM>.

Here, as illustrated in <FIG>, when an angle between an extension line of a certain portion of the wire <NUM> and a normal line to the inner peripheral surface of the bumper <NUM> is represented by an incident angle 1α, the angle of incidence with respect to an extension line from the bending point 14j toward the inner peripheral surface of the bumper <NUM> is defined 1α1, and the angle of incidence with respect to the extension line from the bending point <NUM> toward the inner peripheral surface of the bumper <NUM> is defined as 1α2. In this case, that the wire <NUM> is bent so as to extend in the direction along the inner peripheral surface of the bumper <NUM> means that the wire <NUM> is bent so that the incident angle 1α2 is larger than the incident angle 1α1.

Since the wire <NUM> is formed to be bent in the direction along the inner peripheral surface of the bumper <NUM>, the wire <NUM> can be led along the inner peripheral surface of the bumper <NUM>, and at each position in a circumferential direction of the bumper <NUM>, it is easy to uniformly apply a load which biases the bumper <NUM> in the diameter-increasing direction or a load which restricts the deformation of the bumper <NUM>.

Next, a method of attaching the gastrostomy catheter <NUM> will be described with reference to <FIG> and <FIG> in addition to <FIG>. <FIG> is a schematic explanatory view illustrating a state in which the gastrostomy catheter <NUM> is inserted into the stomach <NUM> through the fistula <NUM>, and <FIG> is a schematic explanatory view illustrating a state in which the capsule cover <NUM> is removed from the gastrostomy catheter <NUM> by an insertion jig <NUM> and the bumper <NUM> is expanded.

The gastrostomy catheter <NUM> includes the cover (capsule cover <NUM>) which holds and accommodates the bumper <NUM> in a state in which the tip side of the wire <NUM> is disposed in the bumper <NUM> and is folded. Here, the capsule cover <NUM> can be directly or indirectly attached to the shaft <NUM> and may be any one as long as it holds the folded state of the bumper <NUM> and accommodates the bumper <NUM>. In other words, the term "accommodation" includes accommodation of the entirety of the bumper <NUM> and accommodation of at least a portion of the bumper <NUM>.

When the bumper <NUM> is disposed in the stomach <NUM> via the fistula <NUM>, the capsule cover <NUM> suppresses the resistance applied to the wall surface of the fistula <NUM> while maintaining the folded state of the bumper <NUM> and facilitates insertion of the bumper <NUM> into the body.

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

The surgeon removes the capsule cover <NUM> in the body, and thus, can increases the diameter of the bumper <NUM> by biasing of the wire <NUM> in the diameter-increasing direction. The insertion jig <NUM> is used to attach the gastrostomy catheter <NUM> to the fistula <NUM> and remove the capsule cover <NUM>.

The insertion jig <NUM> includes a main body tube 111a, a pair of claws 111b which is attached to the main body tube 111a, an operation unit 111c, a piston 111d which is reciprocally movable with respect to the main body tube 111a, and an extrusion rod 111e which is connected to the piston 111d and protrudes/retreats in an axial direction.

When the gastrostomy catheter <NUM> is inserted into the fistula <NUM>, the surgeon folds the bumper <NUM> and covers the folded bumper <NUM> with the capsule cover <NUM>, and thus, maintains the folded state of the bumper <NUM>.

Further, the surgeon grasps the insertion jig <NUM>, supports a lower surface (distal surface) of the extracorporeal fixing unit <NUM> of the gastrostomy catheter <NUM> so that the shaft <NUM> is interposed between the pair of claws 111b, and maintains the insertion jig <NUM> as illustrated in <FIG>.

Next, the surgeon causes the bumper <NUM> covered with the capsule cover <NUM> to pass through the fistula <NUM> together with the capsule cover <NUM>, and pushes the gastrostomy catheter <NUM> in the stomach <NUM> by the insertion jig <NUM> to a position (a position where the claw 111b abuts on a surface of the abdominal wall <NUM>) at which the bumper <NUM> reaches the inside of the stomach <NUM>.

Thereafter, as illustrated in <FIG>, the surgeon operates to push the operation unit 111c to the distal side and pushes the piston 111d into the main body tube 111a so that the extrusion rod 111e protrudes. In this case, the extrusion rod 111e pushes out only the capsule cover <NUM> through the communication hole 13a of the bumper <NUM>, and the capsule cover <NUM> falls out of the bumper <NUM>, as illustrated in <FIG>.

The diameter of the bumper <NUM> released from the holding from the capsule cover <NUM> increases to have a diameter larger than a diameter of the fistula <NUM> by the biasing force of the wire <NUM>, and the bumper <NUM> is placed in the stomach <NUM>.

Since the capsule cover <NUM> which has fallen into the stomach <NUM> is a material which is edible or decomposed in the body as described above, the capsule cover <NUM> is excreted or dissolved together with the content of the stomach and has no effect on the body.

The surgeon needs to replace the gastrostomy catheter <NUM> every predetermined period in order to suitably maintain a sanitary condition when the surgeon uses the gastrostomy catheter <NUM>. A method of removing the existing gastrostomy catheter <NUM> required when the gastrostomy catheter <NUM> is replaced will be described with reference to <FIG> is a schematic explanatory view illustrating a state of the gastrostomy catheter <NUM> in a state in which the base end holding portion 15c is removed from the extracorporeal fixing unit <NUM>. <FIG> is a schematic explanatory view illustrating a state in which the gastrostomy catheter <NUM> is removed from the inside of the stomach <NUM>.

First, the surgeon removes the base end holding portion 15c of the extracorporeal fixing unit <NUM> from other sites of the extracorporeal fixing unit <NUM> using scissors or the like so that the base end holding portion 15c is cut along the marker 15b. In this case, the surgeon separates the base end holding portion 15c from other sites of the extracorporeal fixing unit <NUM> so as not to cut the wire <NUM>. As described above, since the marker 15b is attached at the position included in the imaginary plane intersecting the base end portion 19a of the sub-lumen <NUM>, by separating the base end holding portion 15c along the marker 15b, the embedded portion of the base end portion 14a of the wire <NUM> in the extracorporeal fixing unit <NUM> is eliminated.

The surgeon grasps the base end portion 14a and pulls out the wire <NUM> from the bumper <NUM>, the shaft <NUM>, and the extracorporeal fixing unit <NUM>.

Finally, the surgeon grasps the extracorporeal fixing unit <NUM> and pulls the gastrostomy catheter <NUM> out of the body through the fistula <NUM>. In this case, as illustrated in <FIG>, the bumper <NUM> is in the second state due to the wire <NUM> being pulled out and the diameter of the bumper <NUM> decreases when the bumper <NUM> comes into contact with the wall surface of the fistula <NUM>. Accordingly, the resistance to the body is suppressed low.

In the above embodiment, as illustrated in <FIG>, the base end holding portion 15c for holding the base end portion 14a of the wire <NUM> is formed integrally with the extracorporeal fixing unit <NUM>, the wire <NUM> is embedded to be held and is cut to release the holding of the wire <NUM>. However, the present invention is not limited to this configuration.

Next, an extracorporeal fixing unit <NUM> according to Modification Example <NUM>-<NUM> will be described with reference to <FIG> is a front cross-sectional view illustrating an extracorporeal fixing unit <NUM> according to Modification Example <NUM>-<NUM>.

The base end holding portion 115a which holds the base end portion 14a of the wire <NUM> is separate from the fixing portion (extracorporeal fixing unit <NUM>) and is detachably attached to the fixing portion (extracorporeal fixing unit <NUM>).

Specifically, the base end holding portion 115a is disposed on an extension of the base end portion 19a of the sub-lumen <NUM>, has a small-diameter neck portion and a large-diameter head portion, and has a locking protrusion 115b protruding downward (distal side) at a lower portion thereof. A concave groove 115c having a shape relative to the locking protrusion 115b is formed in a site of the extracorporeal fixing unit <NUM> facing the locking protrusion 115b.

The locking protrusion 115b is accommodated in the groove 115c to be locked by an opening forming the concave groove 115c being expanded so as to be elastically deformed.

According to this configuration, a state in which the tip portion of the wire <NUM> is disposed in the bumper <NUM> can be maintained by attaching the base end holding portion 115a to the extracorporeal fixing unit <NUM>. In addition, by releasing the locking of the locking protrusion 115b into the concave groove 115c and removing the base end holding portion 115a from the extracorporeal fixing unit <NUM>, the wire <NUM> together with the base end holding portion 115a can be removed from the shaft <NUM>, the bumper <NUM>, and the extracorporeal fixing unit <NUM>.

The locking protrusion 115b may be made of a resin rubber harder than the concave groove 115c. According to this configuration, the locking protrusion 115b is easily fitted into the relatively soft concave groove 115c. A configuration in which a concave groove is provided on the base end holding portion 115a side and a locking protrusion is provided on the extracorporeal fixing unit <NUM> side may be adopted.

In order to prevent the patient from accidentally detaching the base end holding portion 115a from the extracorporeal fixing unit <NUM>, a clip (not illustrated) or the like which is interposed between the base end holding portion 115a and the extracorporeal fixing unit <NUM> may be further provided.

In the above embodiment, as illustrated in <FIG>, the configuration is described, in which the communication hole 13a is formed in the bumper <NUM> to have a large diameter so as to expose the main lumen <NUM> and the sub-lumen <NUM>. However, the present invention is not limited to this configuration.

Next, a bumper <NUM> according to Modification Example <NUM>-<NUM> will be described with reference to <FIG> is a bottom view illustrating a communication hole 113a of the bumper <NUM> according to Modification Example <NUM>-<NUM>.

A portion of an inner wall of the bumper <NUM> according to the Modification Example <NUM>-<NUM> is located on the extension of the sub-lumen <NUM>. 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 <NUM> while exposing the main lumen <NUM> with an edge when viewed from the bottom.

According to this configuration, when the wire <NUM> is inserted into the sub-lumen <NUM> and the tip portion 14b is disposed in the bumper <NUM>, the tip portion 14b abuts on a portion of the inner wall of the bumper <NUM>. Therefore, the tip side of the wire <NUM> is naturally disposed in the radial direction of the bumper <NUM>.

In particular, in a second state in which the tip side of the wire <NUM> is not disposed in the bumper <NUM>, the bumper <NUM> can be disposed in the stomach <NUM> through the fistula <NUM> while suppressing the resistance applied to the body.

Thereafter, the tip side of the wire <NUM> having the base end portion 14a embedded in the base end holding portion 115a illustrated in <FIG> is fed through the sub-lumen <NUM> so as to be coiled in the bumper <NUM>. Accordingly, the state in which the bumper <NUM> can be biased in the diameter-increasing direction or the state in which the deformation of the bumper <NUM> in the diameter-decreasing direction can be restricted can be easily achieved. Therefore, the bumper <NUM> can be brought into the first state by a simple method of inserting the wire <NUM> into the sub-lumen <NUM>, instead of a method of expanding the diameter of the bumper <NUM> by removing the capsule cover <NUM> by the insertion jig <NUM>.

The configuration is described in which the main lumen <NUM> in the above embodiment and the present example has a D-shaped cross section. However, as long as a thickness for forming the sub-lumen <NUM> can be secured in the shaft <NUM>, the main lumen <NUM> may have a circular cross-section or a rectangular cross and is not limited to such a shape. Accordingly, as long as a portion of the inner wall of the bumper <NUM> can be located on the extension of the sub-lumen <NUM>, the shape of the communication hole 113a may be a circular cross section or rectangular cross section and is not limited to such a shape.

In the above embodiment, as illustrated in <FIG>, the configuration is described in which the tip opening portion 19b of the sub-lumen <NUM> extends linearly from the proximal side to the distal side and is continuous into the bumper <NUM>. However, the present invention is not limited to this configuration.

Next, a sub-lumen <NUM> according to Modification Example <NUM>-<NUM> will be described with reference to <FIG> is a front cross-sectional view illustrating a tip opening portion 129b of the sub-lumen <NUM> according to Modification Example <NUM>-<NUM>.

A tip portion (the tip opening portion 129b) of the sub-lumen <NUM> passing through a shaft <NUM> according to Modification Example <NUM>-<NUM> is formed to be bent radially outward of the bumper <NUM>. Specifically, the tip opening portion 129b extends to the inside of the bumper <NUM>, and a wall portion defining the tip opening portion 129b is bent and extends radially outward of the bumper <NUM> in the bumper <NUM>.

According to this configuration, when the wire <NUM> is inserted into the sub-lumen <NUM> and the tip portion 14b is disposed in the bumper <NUM>, the tip portion 14b is guided radially outward of the bumper <NUM> by the tip opening portion 129b of the sub-lumen <NUM>. Therefore, the tip side of the wire <NUM> is naturally disposed radially outward of the bumper <NUM>.

In particular, similar to the Modification Example <NUM>-<NUM>, the tip side of the wire <NUM> is brought into the second state in which the tip side is not disposed in the bumper <NUM>, and thus, the bumper <NUM> can be disposed in the stomach <NUM> through the fistula <NUM> and the stomach <NUM> is inserted while the resistance applied to the body is suppressed.

Thereafter, the tip side of the wire <NUM> having the base end portion 14a embedded in the base end holding portion 115a illustrated in <FIG> is fed through the sub-lumen <NUM> so as to be coiled in the bumper <NUM>. Accordingly, the first state (that is, the state in which the bumper <NUM> can be biased in the diameter-increasing direction or the state in which the deformation of the bumper <NUM> in the diameter-decreasing direction can be suppressed) can be easily achieved. Therefore, the bumper <NUM> can be brought into the first state by a simple method of inserting the wire <NUM> into the sub-lumen <NUM>, instead of expanding the bumper <NUM> by removing the capsule cover <NUM> by the insertion jig <NUM>.

The configuration is described in which each of the bumpers <NUM> and <NUM> according to the above embodiment is formed in a hollow disk shape. However, the present invention is not limited to this configuration.

Next, a bumper <NUM> and a shaft <NUM> to which the bumper <NUM> is attached according to Modification Example <NUM>-<NUM> will be described mainly with reference to <FIG>. <FIG> is a perspective view illustrating the bumper <NUM> and the shaft <NUM> to which the bumper <NUM> is attached according to Modification Example <NUM>-<NUM>, <FIG> is a perspective view illustrating an inner layer <NUM> of the bumper <NUM> by removing an outer layer <NUM> of the bumper <NUM> and corresponds to <FIG>. <FIG> is a cross-sectional view illustrating a 1XV-1XV cross section of the bumper <NUM> and the shaft <NUM> of <FIG>.

The bumper <NUM> according to the present embodiment is formed in a star shape when viewed from an axial direction of the bumper <NUM> and is connected to a tip portion of the shaft <NUM>.

The shaft <NUM> has a shaft main body 132a and a tip portion (a first tip portion 132b and a second tip portion 132c illustrated in <FIG>) which is formed to have a diameter smaller than those of other sites (the shaft main body 132a). The bumper <NUM>, which will be described in detail later, extends from the tip portion of the shaft <NUM>.

The first tip portion 132b is formed continuously from the shaft main body 132a to the tip side and has a diameter smaller than that of the shaft main body 132a. The second tip portion 132c is formed continuously from the first tip portion 132b to the tip side and has a diameter smaller than that of the first tip portion 132b.

A connection tubular portion 134a of the inner layer <NUM> of the bumper <NUM>, which will be described later, is connected to the tip portion (second tip portion 132c) of the shaft <NUM>, and the inner layer <NUM> extends. In addition, a connection tubular portion 135a of the outer layer <NUM> of the bumper <NUM>, which will be described later, is connected to the tip portion (first tip portion 132b) of the shaft <NUM>, and the outer layer <NUM> extends.

According to the above configuration, a maximum deformation amount of the bumper <NUM> in the diameter-increasing direction connected to the first tip portion 132b of the shaft <NUM> can be made larger than a case where the tip portion (first tip portion 132b) of the shaft <NUM> is formed in the same diameter as that of the shaft main body 132a. That is, as described later, the inclination of the bumper <NUM> (an inclined portion 135c thereof) after the deformation in the axial direction can be increased by the wire <NUM> (refer to <FIG>) partially provided in the bumper <NUM>. Therefore, a contact area between the deformed bumper <NUM> and the inner surface of the stomach wall <NUM> (refer to <FIG>) can increase, and the bumper <NUM> can be easily placed in the stomach <NUM>.

As illustrated in <FIG>, the bumper <NUM> includes the inner layer <NUM> and the outer layer <NUM>, a space <NUM> is provided between the inner layer <NUM> and the outer layer <NUM>, and a portion on the tip side of the linear member (wire <NUM>) is disposed in the space <NUM>.

In addition, as illustrated in <FIG>, the shaft <NUM> includes one sub-lumen 132d described later through which the wire <NUM> passes and which extends in parallel with the axial direction. The sub-lumen 132d penetrates a tip surface of the first tip portion132b and communicates with the space <NUM> between the inner layer <NUM> and the outer layer <NUM> of the bumper <NUM> attached to the tip portion of the shaft <NUM>.

According to this configuration, the space <NUM> accommodating a portion of the wire <NUM> can be formed between the inner layer <NUM> and the outer layer <NUM>. Further, since the space <NUM> is formed and a rigidity is reduced, when the wire <NUM> is pulled out from the bumper <NUM>, the bumper <NUM> can be smoothly deformed into a folded state.

On a surface of the outer layer <NUM> of the bumper <NUM>, a plurality of concave portions 135f which are depressed in the radial direction of the bumper <NUM> and extend along the axial direction of the bumper <NUM> are formed in a circumferential direction of the bumper <NUM>.

As described above, since the concave portions 135f are formed on the surface of (the outer layer <NUM> of) the bumper <NUM>, the bumper <NUM> can be smoothly deformed into a folded state. Specifically, when the bumper <NUM> is folded, a load applied from the wall of the fistula <NUM> (refer to <FIG>) is locally applied to a portion other than the concave portions 135f of the bumper <NUM>, and a starting point of the folding occurs in the concave portions 135f. Since the concave portions 135f are a space for the folding, the bumper <NUM> can be smoothly deformed into a folded state.

The outer layer <NUM> of the bumper <NUM> includes, from a base end side to a tip side thereof, the connection tubular portion 135a which is connected to the shaft <NUM>, a large diameter portion 135b which has a maximum diameter portion 135e, and a small diameter portion <NUM> which is provided on a tip side from the large diameter portion 135b.

The inner layer <NUM> of the bumper <NUM> includes, from a base end side to a tip side thereof, the connection tubular portion 134a which is connected to the shaft <NUM>, an inclined portion 134b which extends to be inclined in a diameter-increasing direction from a tip of the connection tubular portion 134a to a base end of a tip portion 134d, and the tip portion 134d which is provided on a tip side from the inclined portion 134b.

The connection tubular portion 135a is connected to the first tip portion 132b of the shaft <NUM>, and an inner diameter of the connection tubular portion 135a is substantially equal to an outer diameter of the first tip portion 132b.

The large diameter portion 135b has the inclined portion 135c which is inclined so as to increase in diameter toward the tip in a direction parallel to a axial direction of the shaft <NUM> including the maximum diameter portion 135e, the maximum diameter portion 135e, and an inclined portion 135d which is inclined so as to decrease in diameter toward the tip.

As illustrated in <FIG>, the tip portion 14b of the wire <NUM> is accommodated in a plane space perpendicular to the axial direction of the bumper <NUM> including the maximum diameter portion 135e. As described above, since the inclined portion 135c and the inclined portion 135d are formed on both sides of the maximum diameter portion 135e, when the tip portion 14b of the wire <NUM> inserted into the space <NUM> is elastically restored in the radial direction, the tip portion 14b is suitably guided in the above plane space including the maximum diameter portion 135e.

The maximum diameter portion 135e of the outer layer <NUM> of the bumper <NUM> is formed at a position separated from the tip of the shaft <NUM> toward the tip side.

As described above, since the maximum diameter portion 135e is formed at the position separated from the tip of the shaft <NUM> toward the tip side, the bumper <NUM> is prevented from covering and overlapping the shaft <NUM> when the maximum diameter portion 135e is contracted, and thus, the folded shape of the bumper <NUM> can be made compact.

The plurality of concave portions 135f are formed in the large diameter portion 135b of the outer layer <NUM> in the circumferential direction, and a plurality of concave portions <NUM> are formed in the small diameter portion <NUM> in the circumferential direction. The concave portions 135f and <NUM> in the large diameter portion 135b and the small diameter portion <NUM> are formed at corresponding positions in the circumferential direction of the bumper <NUM>.

Since the plurality of concave portions 135f and <NUM> formed in the large diameter portion 135b and the small diameter portion <NUM> are formed at the corresponding positions in the circumferential direction, sites of starting points at which the large diameter portion 135b and the small diameter portion <NUM> are folded become linear over the large diameter portion 135b and the small diameter portion <NUM>. Therefore, the outer layer <NUM> of the bumper <NUM> can be smoothly deformed into a folded state.

The "corresponding position in the circumferential direction" specifically means that the positions are located at the same angle about the axis of the bumper <NUM> when the bumper <NUM> is viewed from the axial direction.

Similarly, a plurality of concave portions 134c are formed in the inclined portion 134b of the inner layer <NUM> in the circumferential direction, and a plurality of concave portions 134e are formed in the tip portion 134d in the circumferential direction. The concave portions 134c and 134e in the inclined portion 134b and the tip portion 134d are formed at corresponding positions in the circumferential direction of the bumper <NUM>.

Since the plurality of concave portions 134c and 134e formed in the inclined portion 134b and the tip portion 134d are formed at corresponding positions in the circumferential direction, sites of starting points at which the inclined portion 134b and the tip portion 134d are folded become linear over the inclined portion 134b and the tip portion 134d. Therefore, the inner layer <NUM> of the bumper <NUM> can be smoothly deformed into the folded state.

Further, in the present embodiment, the concave portions 135f of the outer layer <NUM> and the concave portions 134c of the inner layer <NUM>, and the concave portions <NUM> of the outer layer <NUM> and the concave portions 134e of the inner layer <NUM> are provided at positions overlapping in the radial direction of the bumper <NUM>. In other words, a straight line which connects the most depressed sites of the concave portions 135f and 134c and the concave portions <NUM> and 134e and extends in the radial direction of the bumper <NUM> has a positional relationship intersecting with the axis of the bumper <NUM>.

According to this configuration, an interference between the inner layer <NUM> and the outer layer <NUM> is suppressed, and the bumper <NUM> can be smoothly deformed into the folded state.

In the large diameter portion 135b, the inner layer <NUM> and the outer layer <NUM> are separated from each other, and in the small diameter portion <NUM>, the inner layer <NUM> (strictly, the tip portion 134d) is in contact with the outer layer <NUM>.

According to the above configuration, since the inner layer <NUM> and the outer layer <NUM> are separated from each other in the large diameter portion 135b, rigidity is reduced, and thus, the contraction is easily performed. Further, since the inner layer <NUM> and the outer layer <NUM> are in contact with each other at the small diameter portion <NUM>, the rigidity can increase, and thus, excellent shape retention can be obtained.

In the embodiment illustrated in <FIG>, when the wire <NUM> is removed from the bumper <NUM> in the case where the bumper <NUM> of the gastrostomy catheter <NUM> is removed from inside the stomach, the base end holding portion <NUM> c is cut off from the extracorporeal fixing unit <NUM>. Further, in the embodiment illustrated in <FIG>, the base end holding portion 115a is removed from the extracorporeal fixing unit <NUM> by releasing the locking of the locking protrusion 115b to the concave groove 115c. However, the present invention is not limited to this configuration.

Next, an extracorporeal fixing unit <NUM> according to Modification Example <NUM>-<NUM> will be described mainly with reference to <FIG> and <FIG>. <FIG> is a perspective view illustrating an extracorporeal fixing unit <NUM> including a base end holding portion <NUM> and a support portion <NUM> for supporting the base end holding portion <NUM> according to Modification Example <NUM>-<NUM>. <FIG> is a plan view illustrating the extracorporeal fixing unit <NUM> in an initial state, <FIG> is a plan view illustrating a state in which a restriction piece <NUM> is removed from the extracorporeal fixing unit <NUM>, and <FIG> is a plan view illustrating a state in which the support portion <NUM> is pushed in from both sides and the base end holding portion <NUM> is pushed out from the extracorporeal fixing unit <NUM>. In <FIG> and <FIG>, the cap <NUM> and the strap <NUM> illustrated in <FIG> is not illustrated.

A fixing portion (extracorporeal fixing unit <NUM>) according to Modification Example <NUM>-<NUM> has the support portion <NUM> which movably supports the base end holding portion <NUM>, and the restriction unit (restriction unit <NUM>) which restricts a movement of the base end holding portion <NUM> and detachment thereof from the support portion <NUM>.

The base end holding portion <NUM> according to the present embodiment is a plate piece having a trapezoidal thickness in a plan view, and the base end portion of the wire <NUM> is embedded inside the base end holding portion <NUM>. The base end holding portion <NUM> has an inverted tapered portion 148a formed so as to expand toward the outside of the fixing portion (extracorporeal fixing unit <NUM>).

The support portion <NUM> includes a bottom wall 146c which supports the base end holding portion <NUM> from below, and connection walls 146b which are provided on both sides of the bottom wall 146c and stand uprightly. The bottom wall 146c and the connection wall 146b protrude outward from the other sites of the support portion <NUM> in an extension direction of the extracorporeal fixing unit <NUM>.

In the support portion <NUM>, a trapezoidal opening 146d in a plan view, which exposes at least a portion of the base end holding portion <NUM>, is formed on a proximal side of the support portion <NUM>. Since the opening 146d is formed in this manner, the surgeon can touch the base end holding portion <NUM> with a finger and separate the base end holding portion <NUM> from the extracorporeal fixing unit <NUM>, in addition to picking the support portion <NUM> from both sides as described later.

The restriction piece <NUM> is connected to the connection walls 146b and the bottom wall 146c of the support portion <NUM>, and is provided in a size and a position overlapping in a thickness direction with respect to the base end holding portion <NUM> in a direction in which the base end holding portion <NUM> is detached from the support portion <NUM>.

As illustrated in <FIG>, the base end holding portion <NUM> is configured to be separable from the support portion <NUM> by separating the restriction piece <NUM> from the support portion <NUM>.

The extracorporeal fixing unit <NUM> has the support portion <NUM> and the restriction piece <NUM>. Accordingly, as compared with a case where the entire base end holding portion <NUM> is connected to the extracorporeal fixing unit <NUM>, the base end holding portion <NUM> can be easily separated from the support portion <NUM> only by separating the restriction piece <NUM> from the support portion <NUM>.

In the present embodiment, as the configuration in which the base end holding portion <NUM> can be separated, the support portion <NUM> is not provided on a path where the base end holding portion <NUM> is projected on the restriction piece <NUM>, and a through hole 146e illustrated in <FIG> is formed. According to this configuration, the movement of the base end holding portion <NUM> in the direction toward the restriction piece <NUM> is not restricted by the support portion <NUM>, and the movement is restricted only by the restriction piece <NUM>.

The support portion <NUM> has a facing portion 146a which extends along the inverted tapered portion 148a of the base end holding portion <NUM> in a state in which the support portion <NUM> is attached to the extracorporeal fixing unit <NUM>. The support portion <NUM> is configured to be deformable so that the facing portion 146a abuts on the inverted tapered portion 148a and the base end holding portion <NUM> can be pushed into the outside of the fixing portion (extracorporeal fixing unit <NUM>) after the restriction piece <NUM> is separated from the support portion <NUM>.

According to this configuration, as illustrated in <FIG>, the surgeon grasps the support portion <NUM> from both sides in a direction (in directions of thick arrows) sandwiching the base end holding portion <NUM>, and deforms the facing portion 146a of the support portion <NUM>. Then, a component force (in directions of thin arrows) of the load applied to the inverted tapered portion 148a from the facing portion 146a toward the outside in the extension direction of the extracorporeal fixing unit <NUM> is generated, and thus, the base end holding portion <NUM> is easily removed from the support portion <NUM> to the outside of the extracorporeal fixing unit <NUM>.

The "outside of the extracorporeal fixing unit <NUM>" is not limited to a direction away from the shaft <NUM> (refer to <FIG>) in the extension direction of the extracorporeal fixing unit <NUM>, but may be a direction outward from a center of a thickness of the extracorporeal fixing unit <NUM> in direction intersecting the extension direction of the extracorporeal fixing unit <NUM>. The term "deformable" is a concept including elastic deformation and plastic deformation.

The shape of the base end holding portion <NUM> is not limited to a trapezoidal shape including the inverted tapered portion 148a in a plan view, and for example, may be formed in a pair of arcs instead of the linear inverted tapered portion 148a. That is, the shape of the base end holding portion <NUM> may be a shape which is enlarged (in the direction in which the base end holding portion <NUM> is taken out) toward the outside of the extracorporeal fixing unit <NUM>.

First, an outline of each of an insertion jig set <NUM> and an insertion jig (obturator <NUM>) according to the present embodiment will be described with reference to <FIG>. <FIG> is a perspective view illustrating the insertion jig set <NUM> according to an embodiment not forming part of the present invention and illustrates a state in which a cap <NUM> restrains a bumper 24a so that the bumper 24a is folded, and <FIG> is a partial cross-sectional view illustrating a portion of the insertion jig set <NUM> and is a view illustrating a 2II-2II cross section of <FIG>. <FIG> is a partial cross-sectional perspective view illustrating a cross section of a distal end portion of a mantle portion <NUM> and is a view illustrating a 2III-2III cross section of <FIG>. <FIG> is a perspective view illustrating the insertion jig set <NUM> and illustrates a state in which the cap <NUM> releases the bumper 24a to expand the bumper. <FIG> is a partial cross-sectional view illustrating a portion of the insertion jig set <NUM> and is a view illustrating a 2V-2V cross section in <FIG>.

In the present specification, a "distal side" refers to a side of the insertion jig set <NUM> and the obturator <NUM> far from an operator of the insertion jig set <NUM> and the obturator <NUM>, unless otherwise specified, and specifically, refers to a side attached to the cap <NUM> or covered with the cap <NUM>. Further, the distal side may be referred to as a tip side.

Moreover, a "proximal side" refers to a side of the insertion jig set <NUM> and the obturator <NUM> closer to the operator unless otherwise specified. In addition, the proximal side may be referred to as a base end side.

Moreover, components of the insertion jig set <NUM> moving to the distal side may be referred to moving forward, and the components moving to the proximal side may be referred to moving rearward.

The insertion jig set <NUM> according to the embodiment not forming part of the present invention is an insertion jig set <NUM> for inserting a gastrostomy catheter <NUM> having a foldable gastrointestinal fixing portion (bumper 24a) at a tip into a body (into the stomach).

The insertion jig set <NUM> includes the insertion jig (obturator <NUM>) configured to include the tubular mantle portion <NUM> and an inner insertion portion <NUM> which is movable forward and rearward through the mantle portion <NUM>, the gastrostomy catheter <NUM> which is attached around the mantle portion <NUM>, and the cap <NUM> which is disposed on a tip side of the mantle portion <NUM> and covers at least a portion of the folded gastrointestinal fixing portion (bumper 24a).

One of the gastrostomy catheter <NUM> or the mantle portion <NUM> and the cap <NUM> has a locking portion (locking claw 22b) which is locked to the other, and when the inner insertion portion <NUM> moves forward through the mantle portion <NUM>, the locking by the locking claw 22b is released.

According to the above configuration, the gastrostomy catheter <NUM> or the mantle portion <NUM> and the cap <NUM> are locked to each other, and the locking can be released by the inner insertion portion <NUM>. Accordingly, the cap <NUM> can be prevented from being unexpectedly detached from the gastrostomy catheter <NUM> and the mantle portion <NUM>.

In the present invention, the term "lock" refers to a state in which movement is restricted by being temporarily held and fixed, and in addition to a structurally locked state described below, includes a state of being physically adhered with an adhesive or the like so as to be detachable.

As a configuration for releasing the locking by the locking portion when the inner insertion portion <NUM> moves forward through the mantle portion <NUM>, there is a configuration in which the inner insertion portion <NUM> moving forward directly or indirectly abuts on a member including the locking portion, a locking force of the locking portion is weakened by deforming the member, and the locking is released.

In addition, there is a configuration in which the inner insertion portion <NUM> moving forward directly or indirectly abuts on the member including the locking portion or a member to be locked and presses the member, and the locking by the locking portion is released by applying a load stronger than the locking force by the locking portion between the locking portion and the member having the locking or the member to be locked. Details of these will be described later.

The insertion jig (obturator <NUM>) according to the embodiment not forming part of the present invention inserts the gastrostomy catheter <NUM> having a foldable gastrointestinal fixing portion (bumper 24a) at the tip and the cap <NUM> covering at least a portion of the folded gastrointestinal fixing portion into the body.

The insertion jig (obturator <NUM>) is configured to include the tubular mantle portion <NUM> around which the gastrostomy catheter <NUM> can be attached, and an inner insertion portion <NUM> which passes through the mantle portion <NUM>. The mantle portion <NUM> has the locking portion (locking claw 22b) which is locked to the cap <NUM>.

The inner insertion portion <NUM> releases the locking by the locking claw 22b when the inner insertion portion <NUM> moves forward through the mantle portion <NUM>.

According to the above configuration, the mantle portion <NUM> and the cap <NUM> are locked to each other and the locking can be released by the inner insertion portion <NUM>. Accordingly, the cap <NUM> is prevented from being unexpectedly detached from the mantle portion <NUM>.

The gastrostomy catheter set 2S1 according to the embodiment not forming part of the present invention is configured to include the gastrostomy catheter <NUM> having the foldable gastrointestinal fixing portion (bumper 24a) at the tip and the cap <NUM> covering at least a portion of the folded bumper 24a.

The gastrostomy catheter <NUM> is formed so that a portion of the insertion jig (obturator <NUM>) for inserting the gastrostomy catheter <NUM> into the stomach can be inserted, and the cap <NUM> has a locked portion (locked block 25c) which is locked to the locking claw 22b of the obturator <NUM>.

Since the cap <NUM> has the locked portion which is locked to the obturator <NUM>, the cap <NUM> can be prevented from being unexpectedly detached from the gastrostomy catheter <NUM>.

Next, the configurations of the insertion jig set <NUM> and the insertion jig (obturator <NUM>) will be described with reference to <FIG>. As described above, the insertion jig set <NUM> includes the obturator <NUM> for inserting the gastrostomy catheter <NUM> into the body, the gastrostomy catheter <NUM> attached around the mantle portion <NUM>, and the cap <NUM> which is disposed on the tip side of the mantle portion <NUM> and covers at least a portion of the folded gastrointestinal fixing portion.

As described above, the obturator <NUM> is configured to include the mantle portion <NUM> and the inner insertion portion <NUM>.

A holding portion 22d for holding an extracorporeal fixing portion 24b located on a proximal side of the gastrostomy catheter <NUM> is provided at a central portion of the mantle portion <NUM>. The holding portion 22d has a forked portion extending in a direction intersecting an axial direction of the obturator <NUM>, and holds the extracorporeal fixing portion 24b of the gastrostomy catheter <NUM> by the forked portion.

The gastrostomy catheter <NUM> which has passed through a distal end of the mantle portion <NUM> is attached to an outer periphery of a distal end portion of the mantle portion <NUM>.

At a proximal end of the obturator <NUM>, an operation unit 23b continuous to the inner insertion portion <NUM> is provided at a proximal end of the obturator <NUM>, and the surgeon reciprocates the operation unit 23b in the axial direction with respect to the mantle portion <NUM> so that the inner insertion portion <NUM> can reciprocate.

As illustrated in <FIG>, four slits 22c are formed at a tip portion of the mantle portion <NUM>, and the slits 22c extend in the axial direction of the mantle portion <NUM> until the slits <NUM> reach the tip of the mantle portion <NUM>. The tip portion of the mantle portion <NUM> is divided into four pieces by the four slits 22c. The term "extension in the axial direction" means extension including an axial component, and includes not only extension in a direction parallel to the axial direction but also extension in a direction oblique with respect to the axial direction.

Since the slit 22c is formed at the tip portion of the mantle portion <NUM>, the tip side of the mantle portion <NUM> can be easily expanded. For this reason, when the surgeon moves the inner insertion portion <NUM> forward to release the locking by the locking claws 22b as described later, the cap <NUM> can be smoothly detached from the mantle portion <NUM>.

When the number of the slits 22c is four, the distal end portion of the mantle portion <NUM> can be divided into four pieces, and facing two pieces can be bent and deformed in a well-balanced manner. Therefore, it is preferable because the locking of the locked block 25c of the cap <NUM> and the release of the locking by the locking claw 22b described later can be stably performed. However, the example is not limited to this configuration, and the number of slits 22c is arbitrary as long as a diameter of the distal end portion of the mantle portion <NUM> can increase to release the locking of the cap <NUM>. Further, for example, in a case where the mantle portion <NUM> is formed of a material which can be elastically deformed, the slit 22c need not be provided.

The mantle portion <NUM> include the locking portion (locking claw 22b) for locking a portion of the cap <NUM>.

The locking claw 22b is provided on an inner wall surface of the mantle portion <NUM>, and is configured to be locked to a constricted portion of the locked block 25c of the cap <NUM> described later. More specifically, the locking claws 22b are provided in the facing two pieces of the four pieces divided at the tip portion of the mantle portion <NUM>.

The example is not limited to the configuration in which the locking claws 22b are provided in the facing two pieces divided at the tip portion of the mantle portion <NUM>. That is, the number of the locking claws 22b is arbitrary, and the locking claws 22b may be provided in all of the four pieces divided at the tip portion of the mantle portion <NUM>. If the locking claws 22b are provided in all of the four pieces, each of the locking claws 22b disposed at four locations at every <NUM>° in a circumferential direction of the mantle portion <NUM> is locked to the constricted portion of the locked block 25c of the cap <NUM>. Therefore, it is possible to more suitably maintain the locked state with respect to the cap <NUM>.

Further, as described above, since the plurality of slits 22c are further formed, when the tip portion of the mantle portion <NUM> is further formed of a plurality of pieces, the locking claws 22b may be provided in an arbitrary plurality of pieces.

The cross section of the locking claw 22b according to the present embodiment in the radial direction with respect to the axis of the mantle portion <NUM> is formed in a trapezoidal shape with the axis side as an upper side. This trapezoid is formed such that an angle on an acute side between a side on a distal side and the other nearby inner wall surface is smaller than an angle on an acute side between a side on a proximal side and the other nearby inner wall surface. That is, a surface formed to include the side on the distal side of the trapezoid is an inclined surface which is more inclined than a surface formed to include the side on the proximal side of the trapezoid.

In the present embodiment, the side on the proximal side is formed at a right angle with respect to the other nearby inner wall surface. That is, the surface on the proximal side of the locking claw 22b is a surface orthogonal to the axial direction of the mantle portion <NUM>. The surface on the distal side of the locked block 25c provided in the cap <NUM>, which is the object to be locked by the locking claw 22b, is also formed in the direction orthogonal to the axial direction of the mantle portion <NUM> in a state of being inserted into the distal end portion of the mantle portion <NUM>.

When the locked block 25c of the cap <NUM> is inserted into the locking claw 22b, which is formed as described above, from the distal side, a proximal end surface 25a abuts on the inclined surface. Accordingly, a force is naturally applied in the diameter-increasing direction, and the distal end portion of the mantle portion <NUM> can be easily expanded.

Meanwhile, as described above, the surface on the proximal side of the locking claw 22b and the surface on the distal side of the locked block 25c are surfaces orthogonal to the axial direction of the mantle portion <NUM>. Therefore, when the locked block 25c of the cap <NUM> is inserted up to the proximal side beyond the locking claw 22b, even if the cap <NUM> moves in the axial direction of the mantle portion <NUM>, It is difficult for a force to be applied in a direction of expanding the distal end portion of the mantle portion <NUM>, and it is difficult for the locking by the locking claw 22b to be released.

A protrusion 22a which protrudes radially inward is formed in each of the two inner wall surfaces of the mantle portion <NUM> where the locking claws 22b are provided. As will be described later, when the inner insertion portion <NUM> moves forward through the mantle portion <NUM> (when the inner insertion portion <NUM> is inserted from the proximal side to the distal side of the mantle portion <NUM>), an outer peripheral surface of the inner insertion portion <NUM> abuts on the protrusions 22a. Accordingly, the distal sides of the two pieces of the mantle portion <NUM> are expanded (bent and deformed radially outward). The protrusion 22a is formed in an arc shape in cross section, extends in the circumferential direction, and is disposed on the proximal side from the locking portion (locking claw 22b). The inner insertion portion <NUM> abuts on the protrusions 22a and the mantle portion <NUM> is expanded. Accordingly, the locking between the cap <NUM> and the mantle portion <NUM> can be suitably released.

In addition, since the protrusion 22a is formed in an arc shape in cross section, the distal sides of the two pieces of the mantle portion <NUM> can be smoothly deformed to the outside in an external direction without obstructing the movement of the inner insertion portion <NUM> in the axial direction of the mantle portion <NUM>. However, the shape of the protrusion is not limited to the arc shape in cross section. That is, a triangular cross section or a trapezoidal cross section may be used as long as the surface on the proximal side abutting on the outer surface of the inner insertion portion <NUM> is an inclined surface which is gently inclined with respect to the axial direction.

The gastrostomy catheter <NUM> allows the outside of the body and the inside of the stomach to communicate with each other through the fistula, is attached to the outer periphery of the mantle portion <NUM>, and is fixed by holding the extracorporeal fixing portion 24b by the holding portion 22d of the obturator <NUM>. The gastrostomy catheter <NUM> is configured to include the radially expandable and contractible bumper 24a placed in the stomach, the extracorporeal fixing portion 24b disposed outside a body surface, and a shaft 24c communicating with the bumper 24a and the extracorporeal fixing portion 24b.

The bumper 24a according to the present embodiment is formed in an umbrella shape, expands in the radial direction perpendicular to the axial direction in a natural state, and can be accommodated in the space <NUM> of the cap <NUM> described later in a folded and elastically deformed state. The bumper 24a is not limited to an umbrella-shaped member as long as it can expand and contract in the radial direction, and may be formed of only a plurality of bendable rod-shaped members.

When the bumper 24a is disposed in the stomach through a fistula (not illustrated), the cap <NUM> suppresses the resistance applied to the wall surface of the fistula while maintaining the folded state of the bumper 24a, and thus, the bumper 24a is easily inserted into the body. The cap <NUM> is formed of a hard capsule cover used for food made of a cellulose-based material or a gelatin-based material, or a material decomposed in the body such as polylactic acid, and a distal end side of the cap <NUM> is formed in a blunt cap shape.

More specifically, the cap <NUM> is integrally formed by the locked block 25c, a shaft center portion 25b which is provided at a radially center portion continuously from the locked block 25c and extends in the axial direction, and a peripheral wall 25d which is provided on the radially outer side in a continuous manner with a distal side of the shaft center portion 25b. An outer peripheral portion of the shaft center portion 25b and an inner peripheral portion of the peripheral wall 25d form a circular deep moat-shaped space <NUM> which can accommodate the folded bumper 24a.

At least a portion of the gastrointestinal fixing portion (bumper 24a) is accommodated a portion of the space <NUM> in the cap <NUM> except for the site (locked block 25c) locked to the locking portion (locking claw 22b) in a state illustrated in <FIG> in which the inner insertion portion <NUM> is not inserted into the distal side of the mantle portion <NUM>.

According to this configuration, the cap <NUM> can accommodate at least a portion of the bumper 24a in a state in which the cap <NUM> is locked to the mantle portion <NUM>.

The space <NUM> is formed in a size which can accommodate the bumper 24a. Specifically, an outer diameter of the shaft center portion 25b is smaller than an inner diameter of the shaft 24c of the gastrostomy catheter <NUM>, and an inner diameter of a proximal end surface of the peripheral wall 25d is larger than an outer diameter of the shaft 24c.

A through hole 25e extends in the axial direction from the shaft center portion 25b to the locked block 25c. The through hole 25e allows a guide wire (not illustrated) to pass therethrough.

Next, an operation of inserting the gastrostomy catheter <NUM> into the body by the insertion jig set <NUM> will be described with reference to <FIG>.

The surgeon causes the gastrostomy catheter <NUM> with the extracorporeal fixing portion 24b oriented to be located on the proximal side to pass through the distal end portion of the mantle portion <NUM>, hangs the holding portion 22d on the extracorporeal fixing portion 24b, and attaches the gastrostomy catheter <NUM> to the mantle portion <NUM>. The surgeon inserts the cap <NUM> into the mantle portion <NUM> while attaching the cap <NUM> to the gastrostomy catheter <NUM> so that the bumper 24a of the gastrostomy catheter <NUM> is accommodated in the space <NUM> of the cap <NUM>, and locks the cap <NUM> to the locking claw 22b. Here, a locking position of the cap <NUM> by the locking claw 22b is a position where the locked block 25c exceeds the locking claw 22b of the mantle portion <NUM>.

Next, the surgeon causes the bumper 24a covered with the cap <NUM> together with the cap <NUM> to pass through the fistula, and pushes the gastrostomy catheter <NUM> by the obturator <NUM> up to a position (a position at which the holding portion 22d abuts on the surface of the abdominal wall) at which the bumper 24a reaches the inside of the stomach.

As illustrated in <FIG>, the surgeon operates to push the operation unit 23b to the distal side, and pushes the inner insertion portion <NUM> to the distal side of the mantle portion <NUM>. The inner insertion portion <NUM> abuts on the protrusion 22a when the inner insertion portion <NUM> moves forward through the mantle portion <NUM> and applies a bending load to the two pieces having the protrusion 22a at the distal end portion of the mantle portion <NUM> to expand the two pieces of the distal end portion of the mantle portion <NUM>.

Therefore, the locking to the locked block 25c by the locking claws 22b provided at the two distal ends of the mantle portion <NUM> is released, and the cap <NUM> can fall into the stomach by its own weight. Since the cap <NUM> which has fallen into the stomach is a material which is edible or decomposed in the body as described above, the cap <NUM> is excreted or dissolved together with the content of the stomach and has no effect on the body.

In this way, the bumper 24a released from the restraint by the cap <NUM> can be expanded in the radial direction, and the bumper 24a of the gastrostomy catheter <NUM> can be placed in the stomach.

In the above description, the configuration is described in which the mantle portion <NUM> is expanded to release the locking of the locking claw 22b and the cap <NUM> is detached from the mantle portion <NUM> by the weight of the cap <NUM>. Further, as illustrated in <FIG> and <FIG>, it is preferable that the inner insertion portion <NUM> is configured to be movable forward up to the position at which the inner insertion portion <NUM> abuts on the proximal end portion (proximal end surface 25a) of the cap <NUM> and the cap <NUM> can be detached from the gastrostomy catheter <NUM> and the mantle portion <NUM>.

According to the above configuration, even if the cap <NUM> is not detached from the gastrostomy catheter <NUM> and the mantle portion <NUM> only by releasing the locking between the locking claw 22b and the cap <NUM>, the inner insertion portion <NUM> abuts on the proximal end surface 25a of the cap <NUM> such that the cap <NUM> can be reliably detached.

When the inner insertion portion <NUM> abuts on the proximal end surface 25a of the cap <NUM> and is pushed in to remove the cap <NUM>, the extracorporeal fixing portion 24b is held by the holding portion 22d of the obturator <NUM> and the gastrostomy catheter <NUM> does not move. Accordingly, the cap <NUM> can be relatively moved.

In the obturator <NUM> according to the above embodiment, the configuration is described in which the inner insertion portion <NUM> abuts on the protrusion 22a of the mantle portion <NUM> to expand the distal end portion of the mantle portion <NUM>. However, the example provided is not limited to this configuration.

Next, a locking structure according to Modification Example <NUM>-<NUM> will be described mainly with reference to <FIG> is a cross-sectional view illustrating a locking structure between a mantle portion <NUM> and a cap <NUM> according to Modification Example <NUM>-<NUM> and illustrates a bent end portion 212a in a closed arm state, and <FIG> is a cross-sectional view illustrating the locking structure between the mantle portion <NUM> and the cap <NUM> and is a view illustrating the bent end portion 212a in an open arm state.

A gastrostomy catheter set 2S2 according to the present modification example is configured to include the gastrostomy catheter <NUM> having the foldable gastrointestinal fixing portion (bumper 24a) at the tip, and the cap <NUM> covering at least a portion of the folded bumper 24a.

The gastrostomy catheter <NUM> is formed so that a portion (the mantle portion <NUM>) of the insertion jig (obturator <NUM>) for inserting the gastrostomy catheter <NUM> into the stomach can be inserted, and the cap <NUM> has the locked portion (locked block 25c) which is locked to the locking claw 212b of the obturator <NUM>.

Since the cap <NUM> has the locked block 25c which is locked by the locking claw 212b of the obturator <NUM>, the cap <NUM> can be prevented from being unexpectedly detached from the gastrostomy catheter <NUM>.

In particular, facing two pieces of a distal end portion of the mantle portion <NUM> form a bent end portion 212a which is bent so as to approach an axis toward a distal end in a natural state. A distal end of the bent end portion 212a is formed so as to be located on the axis side with respect to a size between the outer surfaces of the inner insertion portion <NUM>, and the locking claw 212b locked to a distal end portion of the locked block 25c is formed so as to protrude in the axial direction from the distal end of the bent end portion 212a.

As illustrated in <FIG>, the inner insertion portion <NUM> pushed in to the distal side with respect to the mantle portion <NUM> abuts on the bent end portion 212a, which is a portion of the inner wall surface of the mantle portion <NUM>, to expand the bent end portion 212a of the mantle portion <NUM>. Accordingly, the locking by the locking portion (the locking claw 212b) can be released.

Particularly, unlike the mantle portion <NUM> according to the above embodiment, the facing two pieces of the distal end portion of the mantle portion <NUM> do not protrude radially outward from other sites of the mantle portion <NUM>. Accordingly, the inner wall of the gastrostomy catheter <NUM> does not hinder the deformation. Therefore, compared with the mantle portion, the locked state between the mantle portion <NUM> and the cap <NUM> can be released more smoothly than in the mantle portion <NUM>.

The example is not limited to the configuration in which the bent end portions 212a are provided on the facing two pieces of the distal end portion of the mantle portion <NUM>. That is, the number of the bent end portions 212a is arbitrary, and the bent end portions 212a may be provided in all of the four divided pieces in the distal end portion of the mantle portion <NUM>. If the bent end portions 212a are provided in all of the four pieces, each of the bent end portions 212a disposed at four positions at every <NUM>° in a circumferential direction of the mantle portion <NUM> is locked to a constricted portion of the locked block 25c of the cap <NUM>. Therefore, it is possible to more suitably maintain the locked state with respect to the cap <NUM>.

Further, as described above, since the plurality of bent end portions 212a are further formed, when the tip portion of the mantle portion <NUM> is further formed of a plurality of pieces, the bent end portions 212a may be provided in an arbitrary plurality of pieces.

In the above embodiment, the example is described in which the locking claws 22b and 212b of the mantle portions <NUM> and <NUM> are locked to the locked block 25c of the cap <NUM>. However, the example provided is not limited to this configuration.

Next, a locking structure according to Modification Example <NUM>-<NUM> will be described mainly with reference to <FIG> is a cross-sectional view illustrating a locking structure between the gastrostomy catheter <NUM> and a cap <NUM> according to Modification Example <NUM>-<NUM>.

A gastrostomy catheter set 2S3 according to the present modification example is configured to include the gastrostomy catheter <NUM> having the foldable gastrointestinal fixing portion (bumper 24a) at the tip, and the cap <NUM> covering at least a portion of the folded bumper 24a. The gastrostomy catheter <NUM> is formed so that a portion (the mantle portion <NUM>) of the insertion jig (obturator <NUM>) for inserting the gastrostomy catheter <NUM> into the stomach can be inserted.

The cap <NUM> according to the present modification example has a locking portion (locking protrusion 225b) which is locked to the bumper 24a of the gastrostomy catheter <NUM>.

For example, the locking protrusion 225b is made of an elastic material, and is configured so that the bumper 24a is accommodated in a space <NUM> of the cap <NUM> and is compressed and deformed by a load radially outward from the outer peripheral surface of the bumper 24a. The cap <NUM> is locked to the bumper 24a by a frictional force due to an elastic restoring force of the locking protrusion 225b.

According to this locking structure, since the cap <NUM> is locked to the gastrostomy catheter <NUM>, the cap <NUM> can be prevented from being unexpectedly detached from the gastrostomy catheter <NUM>.

When the locking by the locking protrusion 225b is released, as in the above embodiment, a distal end surface 23a of the inner insertion portion <NUM> abuts on a proximal end surface 225a of the cap <NUM>, and the inner insertion portion <NUM> may be pushed to the distal side up to the position at which the locking protrusion 225b is detached from the bumper 24a.

In addition, a locking portion (not illustrated) which is locked to the inner surface of the peripheral wall 225d of the cap <NUM> may be provided on the bumper 24a of the gastrostomy catheter <NUM> without providing the locking protrusion 225b on the inner surface of the peripheral wall 225d of the cap <NUM>.

In Modification Example <NUM>-<NUM>, the cap <NUM> having the locking protrusion 225b for locking the umbrella-shaped bumper 24a is described. However, the example provided is not limited to this configuration.

Next, a locking structure according to Modification Example <NUM>-<NUM> will be described mainly with reference to <FIG> and <FIG>. <FIG> is a cross-sectional view illustrating a locking structure between a gastrostomy catheter <NUM> and a cap <NUM> according to the Modification Example <NUM>-<NUM> and is a view illustrating a locked state. <FIG> is a cross-sectional view illustrating the locking structure between the gastrostomy catheter <NUM> and the cap <NUM> and is a view illustrating an unlocked state.

The gastrostomy catheter set 2S4 according to the present modification example is configured to include the gastrostomy catheter <NUM> having a foldable gastrointestinal fixing portion (bumper 234a) at the tip, and the cap <NUM> covering at least a portion of the folded bumper 234a.

The gastrostomy catheter <NUM> is formed so that a portion (mantle portion <NUM>) of the insertion jig for inserting the gastrostomy catheter <NUM> into the stomach can be inserted, and the cap <NUM> has the locking portion (locking protrusion 235b) which is locked to the gastrostomy catheter <NUM>.

In particular, the bumper 234a includes a wire 234b which is coiled inside the bumper 234a. The bumper 234a is accommodated in the space <NUM> of the cap <NUM> in a state in which the wire 234b is contracted toward an axis of the bumper 234a from the natural state.

When the locking protrusion 235b of the cap <NUM> abuts on the wire 234b inside the bumper 234a via the bumper 234a, the cap <NUM> is locked to the gastrostomy catheter <NUM>.

The inner insertion portion <NUM> is configured to be movable forward through the mantle portion <NUM> up to a position at which the inner insertion portion <NUM> abuts on a proximal end portion (proximal end surface 235a) of the cap <NUM> and the cap <NUM> can be detached from the gastrostomy catheter <NUM> and the mantle portion <NUM>. Specifically, the distal end surface 23a of the inner insertion portion <NUM> abuts on a proximal end surface 235a of the cap <NUM>, and the cap <NUM> is pushed in a distal direction by the inner insertion portion <NUM> up to a position at which the locking protrusion 235b crosses the wire 234b. By pushing the cap <NUM> in this manner, the cap <NUM> can be detached from the gastrostomy catheter <NUM> as illustrated in <FIG>.

The surgeon removes the cap <NUM> in the body, and thus, the surgeon can increase a diameter of the bumper 234a by biasing when the wire 234b is restored in a diameter-increasing direction. A diameter of the bumper 234a increases to be larger than a diameter of a fistula (not illustrated), and thus, a distal end of the gastrostomy catheter <NUM> is placed in the stomach.

The configuration is described in which the locking protrusions 225b and 235b of the caps <NUM> and <NUM> according to the above modification example are locked to the portions of the bumpers 24a and 234a of the gastrostomy catheters <NUM> and <NUM>. However,
the locking protrusions 225b and the 235b may be locked to the shaft portion.

Further, in the above embodiment, the configuration is described in which the inner insertion portion <NUM> directly abuts on the member including the locking portion or a member to be locked and presses the member and the locking by the locking portion is released. However, the inner insertion portion <NUM> may indirectly press the member via a third member to release the locking.

Claim 1:
A gastrostomy catheter (<NUM>) comprising:
a shaft (<NUM>) in which a lumen (<NUM>, <NUM>) is provided;
a flexible bumper (<NUM>) which is provided at a tip of the shaft (<NUM>); and
a wire (<NUM>) which has elasticity and biases the bumper (<NUM>) in a diameter-increasing direction,
characterized in that at least a portion of the wire (<NUM>) is disposed in the bumper (<NUM>), and in that said portion is elastically deformed and comes into contact with the bumper (<NUM>) in a radial direction, thereby applying a restoring force and biasing the bumper (<NUM>) from the inside in the diameter-increasing direction of the bumper (<NUM>).