JP5762017B2 - Fistula catheter - Google Patents

Description

  The present invention relates to a fistula catheter used for supplying fluids such as liquid foods and nutrients into the digestive tract of a patient.

  Conventionally, enteral nutritional administration that supplies liquid foods, nutrients, etc. using a fistula catheter to people who have the ability to ingest food by mouth due to aging or illness (hereinafter referred to as patients) has been Has been done. In enteral nutrition administration, a fistula (gastric fistula) is constructed in the patient's abdomen, a fistula catheter is attached to the fistula, and liquid food or the like is supplied to the patient through the fistula catheter.

Such a fistula catheter used for enteral nutrition administration can be roughly classified into a so-called balloon type and a bumper type depending on the shape of the in-vivo fixing portion installed inside the body.
As a bumper-type in-vivo fixing portion, a wing portion is formed by a plurality of slits formed on the outer periphery of the tube, and the in-vivo fixing portion is formed by extending / collapsing the wing portion ( For example, see Patent Document 1).

JP 2008-541842 A (page 6, FIG. 4)

  The in-vivo fixed part described in Patent Document 1 forms a part (bumper) having a diameter larger than the diameter of the tube by bending the wing part and expanding radially like a petal when crushed. . And it is comprised by this bumper so that a fistula catheter may be fixed in digestive tract walls, such as a stomach wall.

  However, the fistula catheter described in Patent Document 1 has a large gap between its wings. For this reason, when the fistula catheter is pulled from the surface of the body, the long sides of each wing may bite into the digestive tract wall, causing ulcers in the digestive tract wall and so-called bumper buried syndrome. It was.

  The gap between the wings can be reduced by reducing the width of the wings (that is, increasing the number of slits formed in the tube). In this case, it is also assumed that the wing part is less likely to bite into the digestive tract wall than when the gap between the wing part is large. However, since the width of the wing portion is small, the resistance to the digestive tract wall is reduced. For example, when the wing portion is pulled from the body surface side, the wing portion easily expands and the fistula catheter may come out of the fistula.

  The present invention has been made in order to solve the above-described problems, and provides a fistula catheter provided with an in-vivo fixing portion that is less invasive to the digestive tract wall. In addition, the present invention provides a fistula catheter provided with an in-vivo fixing part that is difficult to be released even when pulled from the body surface side.

The fistula catheter according to the present invention is a fistula catheter having a catheter part and a body fixing part formed on the distal end side of the catheter part and placed in the digestive tract wall, the body fixing part includes an inner tube, An outer tube provided on the outer side of the inner tube, and the inner tube and the outer tube are configured by a belt formed by dividing the tube wall into a plurality of portions in the circumferential direction, and have a portion extending outward in the radial direction. has wings, wing portion of the blade portion and the outer tube of the inner tube, with provided from the distal end of the catheter portion to position the same distance, are staggered along the circumferential direction It is what.

  The wing portion of the outer tube and the inner tube of the fistula catheter according to the present invention is configured such that at least a part of the belt is bent or curved by bringing the distal end side and the proximal end side of the belt closer to each other in the axial direction. It is what.

  The outer tube and the inner tube of the fistula catheter according to the present invention are almost straightened by extending the proximal end and the distal end apart from each other, and when the extended state is released, the distal end and the proximal end Is formed so as to be deformable so that a portion extending toward the outside in the radial direction is formed.

  The wing portions of the outer tube and the inner tube of the fistula catheter according to the present invention have a curved portion that is curved in the axial direction toward the distal end side or the proximal end side.

  The inner tube of the fistula catheter according to the present invention is configured to have a length that is longer on the proximal end side than the outer tube and that the proximal end of the inner tube protrudes to the body surface side in a state of being placed in the fistula. Is.

  The outer tube of the fistula catheter according to the present invention is configured to have a length that is longer to the proximal end side than the inner tube and that the proximal end of the outer tube protrudes to the body surface side in a state of being placed in the fistula. Is.

  The fistula catheter according to the present invention is inserted into the inner tube and fixed to the inner peripheral surface of the inner tube at a position proximal to the wing portion of the inner tube so as to be axially movable, and the inner tube An inner cylinder having a fixing portion fixed to the inner peripheral surface of the inner tube at a position closer to the distal end side than the distal end side end portion of the slit or cut.

  The fistula catheter according to the present invention includes a wing part of the inner tube and a wing part of the outer tube such that at least a part of the other wing part is located in a gap between the wing part and the wing part of the inner tube or the outer tube. Arranged alternately along the circumferential direction. For this reason, the area of the gap in contact with the digestive tract wall is reduced, the wings are less likely to bite into the digestive tract wall, and the invasion to the patient can be suppressed. Further, even when the fistula catheter is pulled from the body surface side, the wing portion of the inner tube is prevented from closing the wing portion of the outer tube, and the fistula catheter is not easily removed from the fistula.

  The wing portion of the outer tube and the inner tube of the fistula catheter according to the present invention is configured such that at least a part of the belt is bent or curved by bringing the distal end side and the proximal end side of the belt closer to each other in the axial direction. Yes. Since the tube has a relatively simple structure in which a part of the tube is bent or curved, and the number of parts is small, a fistula catheter with low manufacturing cost can be obtained.

  Since the fistula catheter according to the present invention is almost straightened only by being extended, insertion / removal into the fistula can be performed in this state. Since it is almost straight, the resistance during insertion / extraction is lowered, and the risk of damaging the fistula can be reduced. In addition, since the extension / cancellation is canceled, the fistula catheter can be inserted / removed and placed, so that the procedure is simple and the burden on the operator can be reduced.

  The wing portions of the outer tube and the inner tube of the fistula catheter according to the present invention have a curved portion that curves in the axial direction toward the distal end side or the proximal end side. For this reason, in a state where the fistula catheter is placed in the fistula, the gastrointestinal wall is softly contacted with the curved portion of the wing portion as the center, so that the invasion to the gastrointestinal wall can be further reduced.

  The inner tube of the fistula catheter according to the present invention is configured to have a length that is longer on the proximal end side than the outer tube and that the proximal end of the inner tube protrudes to the body surface side in a state of being placed in the fistula. . For this reason, even if the inner tube protruding toward the body surface is pulled, the wing portion of the outer tube having a diameter larger than that in the digestive tract wall is prevented from coming off, and the fistula catheter is difficult to come out from the fistula.

  The outer tube of the fistula catheter according to the present invention is configured to have a length that is longer to the proximal end side than the inner tube and that the proximal end of the outer tube protrudes to the body surface side in a state of being placed in the fistula. . For this reason, there is no level | step difference by the outer diameter difference of an inner tube on the outer surface of a fistula catheter, resistance at the time of insertion / extraction to a fistula can be reduced, and the invasion risk to a fistula can be reduced.

  In the fistula catheter according to the present invention, since the inner tube is fixed to the inner peripheral surface of the inner tube at the proximal end side and the distal end side of the wing portion, the bent state of the wing portion of the inner tube is strengthened. A fistula catheter that is difficult to come out of the fistula can be obtained.

1 is a perspective view of a fistula catheter according to Embodiment 1. FIG. 1 is a side view of a fistula catheter according to Embodiment 1. FIG. 1 is a plan view of a fistula catheter according to Embodiment 1. FIG. 3 is a bottom view of the fistula catheter according to Embodiment 1. FIG. 3 is a schematic side view of an inner tube of a fistula catheter according to Embodiment 1. FIG. FIG. 3 is a schematic side view showing an extended state of the fistula catheter according to Embodiment 1. FIG. 3 is a schematic cross-sectional view of the main part in the extended state of the fistula catheter according to Embodiment 1. It is an AA arrow cross-sectional schematic diagram of FIG. FIG. 10 is a diagram for explaining the insertion / extraction operation of the fistula catheter according to the first embodiment. FIG. 6 is a diagram for explaining an indwelling state of the fistula catheter according to the first embodiment. FIG. 6 is a schematic diagram of a main part of a fistula catheter according to a second embodiment. 10 is a schematic cross-sectional view illustrating the operation of a fistula catheter according to Embodiment 2. FIG. FIG. 10 is a perspective view of a fistula catheter according to Embodiment 3. It is a figure explaining the modification of the fistula catheter concerning Embodiment 1-3. It is a figure explaining the modification of the fistula catheter concerning Embodiment 1-3.

Embodiment 1 FIG.
1 is a perspective view of a fistula catheter 1 according to Embodiment 1, FIG. 2 is a side view of the fistula catheter 1, FIG. 3 is a plan view of the fistula catheter 1, and FIG. 4 is a bottom view of the fistula catheter 1. . FIG. 5 is a side view of the inner tube 10 of the fistula catheter 1 according to the first embodiment. 6 is a schematic side view showing the stretched state of the fistula catheter 1 according to Embodiment 1, FIG. 7 is a schematic cross-sectional view of the main part of the fistula catheter 1 in the stretched state, and FIG. It is an arrow cross-sectional schematic diagram. In each figure, the magnitude relationship of each member may be different from the actual thing.

The fistula catheter 1 is attached to a fistula 73 formed so as to penetrate the patient's abdominal wall 71 and digestive tract wall 72 (see FIG. 10).
As shown in FIG. 1, the fistula catheter 1 includes a catheter part A and a body fixing part B. The catheter part A is inserted into the fistula and has a function of allowing fluid such as nutrients to pass through. The internal fixation part B is located in the digestive tract wall 72 such as the stomach wall when the fistula catheter 1 is placed in the patient's fistula 73, and has a function of suppressing the fistula catheter 1 from coming out of the patient's fistula 73.

  In the following description, “proximal” refers to the end side of the catheter portion A of the fistula catheter 1 in a state where it is installed in the fistula 73, and indicates the upper side of the drawing in FIG. Further, “distal” refers to the opposite side of the proximal side, and shows the lower side of the drawing in FIG.

As shown in FIG. 6, the fistula catheter 1 includes an inner tube 10 and an outer tube 20 provided outside the inner tube 10.
The inner tube 10 and the outer tube 20 are made of, for example, a resin material such as polyurethane resin, polyvinyl chloride resin, or silicone resin, and have a lumen for allowing a fluid to pass therethrough. Although the material of the inner tube 10 is not limited to the above-mentioned material, heat shaping is possible, and a material having flexibility even after heat shaping is used.

  As shown in FIGS. 6 and 7, the inner tube 10 is inserted into the outer tube 20 so that the distal end 15 thereof is positioned at the same height as the distal end 25 of the outer tube 20. The lumen of the inner tube 10 can circulate fluids such as nutrients. In addition, a protrusion 18 that protrudes radially inward is formed on the inner peripheral surface of the inner tube 10 near the distal end 15. The protrusion 18 has a function of locking a distal end portion of the extender 50 described later.

  The inner diameter of the outer tube 20 is substantially the same as or slightly larger than the outer diameter of the inner tube 10. The outer peripheral surface of the inner tube 10 inserted into the outer tube 20 is in contact with the inner peripheral surface of the outer tube 20. In the first embodiment, the inner tube 10 is longer than the outer tube 20, and the proximal end 14 of the inner tube 10 is configured to protrude to the body surface side in a state where the inner tube 10 is placed in the fistula 73 ( (See FIG. 10).

  As shown in FIG. 7, the inner peripheral surface of the outer tube 20 and the outer peripheral surface of the inner tube 10 are a fixing means such as an adhesive at two locations of the proximal end side fixing portion 31 and the distal end side fixing portion 32. It is fixed by. In addition, in FIG. 7, the proximal end side fixing | fixed part 31 and the distal end side fixing | fixed part 32 are marked with the thick line for description. The proximal end side fixing portion 31 and the distal end side fixing portion 32 are separated from each other by a predetermined distance in the axial direction. Here, a portion between the proximal end side fixing portion 31 and the distal end side fixing portion 32 is referred to as an intermediate portion 33 for convenience. In the intermediate portion 33, the inner peripheral surface of the outer tube 20 and the outer peripheral surface of the inner tube 10 are not fixed.

  As shown in FIGS. 6 to 8, the intermediate portion 33 of the inner tube 10 is provided with a plurality of slits 11 communicating with the inside and outside of the tube along the axial direction. A plurality of slits 21 that communicate between the inside and the outside of the tube are also provided in the intermediate portion 33 of the outer tube 20 along the axial direction. In the first embodiment, the number of slits 11 and slits 21 is three each. The lengths of the slit 11 and the slit 21 may be equal to or shorter than the length of the intermediate portion 33. The slit 11 and the slit 21 can be provided parallel to the axial direction of the tube, but may be provided obliquely with respect to the axial direction. In the first embodiment, each of the three slits 11 is provided at a position that divides the peripheral wall of the inner tube 10 into approximately three equal parts. Similarly, the three slits 21 are provided at positions that divide the peripheral wall of the outer tube 20 into approximately three equal parts.

  And as shown in FIG. 8, the slit 11 of the inner tube 10 and the slit 21 of the outer tube 20 are provided alternately so that it may become a different position in the circumferential direction.

  The slits 11 and 21 divide the peripheral walls of the inner tube 10 and the outer tube 20 into a plurality of parts, and three belts 12 and 22 are formed by the division. Since the slit 11 and the slit 21 are provided only in the intermediate portion 33, the belts 12 and 22 are connected together as a peripheral wall of the tube at the upper end portion and the lower end portion thereof. Further, the belt 22 is located on the outer side in the radial direction of the belt 12, and the belt 12 and the belt 22 are in a positional relationship corresponding to the axial direction. Then, the distal end side and the proximal end side of the belt 12 and the belt 22 are close to each other in the axial direction, and the distal end of the inner tube 10 and the distal end of the outer tube 20 are directed toward the proximal end side. When pushed, the belt 12 and the belt 22 are bent by their elasticity, and the wing part 13 and the wing part 23 as shown in FIGS. 1 and 2 are formed.

  As shown in FIGS. 1 to 4, the outer tube 20 includes three wing parts 23. The wing portion 23 has a bent portion 26 that extends from the proximal end side of the outer tube 20 toward the radially outer side and bends in the opposite direction, and continues to the bent portion 26 toward the radially inner side. The shape extends. In other words, each belt 22 is bent at the bent portion 26 so that each belt 22 is folded in two and overlapped vertically. In the first embodiment, the bent portion 26 is bent so as to draw an arc so that the cross section is U-shaped, but may be bent at an acute angle.

  Further, the wing portion 23 includes a curved portion 27 that is curved toward the distal end side in the axial direction at a position closer to the outer wall of the outer tube 20 than the bent portion 26.

  The inner tube 10 also includes three wing parts 13. The wing portion 13 has the same shape as the wing portion 23 of the outer tube, and has a bent portion 16 that extends radially outward from the proximal end side of the inner tube 10 and bends in the opposite direction. The bent portion 16 has a shape extending continuously inward in the radial direction. Since the inner tube 10 has an outer diameter smaller than that of the outer tube 20, the width of the belt 12 is also smaller than the belt 22 of the outer tube 20, and therefore the width of the wing portion 13 is also the width of the wing portion 23 of the outer tube 20. Smaller than.

As shown in FIGS. 1 to 4, the wing parts 23 of the outer tube 20 and the wing parts 13 of the inner tube 10 are alternately arranged in the circumferential direction. That is, each wing part 23 of the outer tube 20 is disposed in a gap between the adjacent wing part 13 and the wing part 13 of the inner tube 10, and each wing part 13 of the inner tube 10 is adjacent to the wing part of the outer tube 20. It arrange | positions in the clearance gap between 23 and the wing | blade part 23. FIG. Note that “alternately arranged in the circumferential direction” means that at least a part of the other wing portion overlaps a gap between adjacent wing portions of the outer tube 20 or the inner tube 10. This means that the other wing portion does not necessarily have to be located between the adjacent wing portions.
The wing part 13 and the wing part 23 are provided at positions corresponding to each other in the axial direction of the fistula catheter 1. Here, “provided at a position corresponding to the axial direction” means that the wing part 13 and the wing part 23 are arranged at substantially the same position in the axial direction of the fistula catheter 1.

  The distal end of the inner tube 10 and the distal end of the outer tube 20 in the state shown in FIGS. 6 to 8 are pushed so as to approach the proximal end side, and the belts 12 and 22 are bent outward in the radial direction. By doing so, the wing part 13 and the wing part 23 are formed, and the bending part 17 and the bending part 27 are provided. Then, since the in-vivo fixation part B having a shape as shown in FIGS. 1 to 4 is formed, the fistula catheter 1 is produced by heat shaping in this state.

  The inner tube 10 and the outer tube 20 are made of a material having flexibility even after heat forming. Therefore, by separating the distal end 15 of the inner tube 10 and the distal end 25 of the outer tube 20 from the proximal end 14 and the proximal end 24 side in the axial direction, the inner tube 10 and the outer tube 20 are substantially straight. (See FIG. 6). When this extended state is canceled, the wing part 13 and the wing part 23 are formed again as shown in FIG.

  Next, the operation of placing the fistula catheter 1 configured in this manner into the fistula 73 will be described. FIG. 9 is a diagram for explaining the insertion / extraction operation of the fistula catheter 1 according to Embodiment 1, and FIG. 10 is a diagram for explaining the indwelling state of the fistula catheter 1 in the same manner.

Here, the extension tool 50 used for extending the internal fixation part B of the fistula catheter 1 and inserting the internal fixation part B into the digestive tract wall 72 such as the stomach wall or the intestinal wall will be described.
As shown in FIG. 9, the extender 50 includes a tube engagement portion 51 provided on the distal end side, an operation portion 52 provided on an end opposite to the tube engagement portion 51, and an operation portion 52. And a shaft portion 53 provided between the tube engaging portion 51. The tube engaging portion 51 and the shaft portion 53 are configured to be insertable into the lumen of the inner tube 10. The operation unit 52 is made of, for example, synthetic resin or metal, and has a shape that allows the operator to place a finger.

  The tube engaging portion 51 is configured to have the same diameter as the inner tube 10 or slightly larger than the inner diameter of the inner tube 10. The axial length of the tube engaging portion 51 is configured to be longer than the combined length of the proximal end side fixing portion 31, the distal end side fixing portion 32, and the intermediate portion 33 in the inner tube 10. Yes.

The tube engaging portion 51 configured as described above is positioned in the lumen extending over the proximal end side fixing portion 31, the distal end side fixing portion 32, and the intermediate portion 33 of the extended inner tube 10. . Since the protrusion 18 is provided in the vicinity of the distal end 15 of the inner tube 10, the distal end of the extension tool 50 is locked to the protrusion 18. If it does in this way, the outer surface of the tube engaging part 51 and the inner peripheral surface of the inner tube 10 will closely_contact | adhere, and the inner tube 10 is generated by the frictional force which arises on the outer surface of the tube engaging part 51 and the inner peripheral surface of the inner tube 10. The stretched state is maintained.
Since the outer tube 20 is fixed to the inner tube 10 at the proximal end side fixing portion 31 and the distal end side fixing portion 32, the outer tube 20 is also extended with the extension of the inner tube 10, and the fistula catheter 1 is The state shown in FIG. 9 is obtained.

In addition, the structure of the extension tool 50 demonstrated here is an example, and the structure for extending the fistula catheter 1 is not limited.
For example, a rod-shaped member that can be inserted into the lumen of the inner tube 10 is used as an extension tool, and the protrusion 18 of the inner tube 10 is pushed by the tip of the rod-shaped member inserted into the lumen of the inner tube 10. May be extended.
In addition, as an example of the structure for engaging the distal end portion of the extender, an example in which the protrusion 18 is provided on the inner tube 10 has been shown. Instead of the protrusion 18, a lumen on the distal end side of the inner tube 10 is provided. A ring-shaped member may be attached to the ring-shaped member, and the distal end portion of the extender may be locked to the ring-shaped member.

  As shown in FIG. 9, the fistula catheter 1 that has been extended by the extender 50 is inserted into a fistula 73 formed in the abdominal wall 71 and the digestive tract wall 72. The diameter of the fistula catheter 1 is the same as the diameter of the outer tube 20 at the maximum, and the resistance when passing through the fistula 73 is low. For this reason, there is little risk of damaging the fistula 73.

  When the insertion depth is appropriate, the surgeon pulls the extension device 50 toward the front side while pressing the abdominal wall 71 so that the catheter part A does not come out. By pulling with a force exceeding the frictional force between the tube engaging portion 51 and the inner tube 10, the close contact state between the tube engaging portion 51 and the inner peripheral surface of the inner tube 10 is released, and the extender 50 is removed from the inner tube 10. Pulled out. Since the fistula catheter 1 is heat-shaped, when the extension device 50 is pulled out and the extended state is released, the in-vivo fixing part B is formed as shown in FIG. By simply pulling out the extender 50, the stretched fistula catheter 1 can be brought into a state where the in-vivo fixing part B is formed, and the procedure is simple.

  The proximal end of the catheter part A of the catheter placed in the fistula 73 is located outside the body, and an external body fixing part is attached to the proximal end side of the catheter part A. For example, in a so-called button type, an extracorporeal fixing part is attached to the proximal end of the catheter part A formed to a length that is hardly exposed on the body surface side. In the so-called tube type, the extracorporeal fixing portion is detachably attached to a portion located near the body surface of the catheter portion A formed so as to protrude a predetermined length on the body surface side.

As shown in FIG. 10, the fistula catheter 1 placed in the digestive tract wall in the state where the in-vivo fixation part B is formed has the upper surface (proximal end side surface) of the wing part 13 and the wing part 23. Touch the wall.
Since the wing portions 13 of the inner tube 10 and the wing portions 23 of the outer tube 20 are alternately arranged in the circumferential direction, a gap between the wing portions is reduced. In particular, as shown in FIG. 3, the wings 13 of the inner tube 10 and the wings of the outer tube 20 are provided at the center of the wings 13 and 23 (that is, near the outer peripheral surfaces of the outer tube 20 and the inner tube 10). A substantially circular surface S is formed with the portion 23. This surface S abuts around the fistula 73 of the digestive tract wall 72. Since the surface S contacts the digestive tract wall 72, there is little invasion to the digestive tract wall 72.

  Further, since the wing portion 13 and the wing portion 23 are provided with the bending portion 17 and the bending portion 27, the wing portion 13 and the wing portion 23 are rounded with respect to the digestive tract wall 72. For this reason, the hit with respect to the digestive tract wall is soft, and the invasion to the digestive tract wall 72 can be reduced.

Further, for example, when the fistula catheter 1 is pulled from the abdominal wall 71 side, the upper surface of the wing part 23 is pressed against the digestive tract wall 72 and the wing part 23 of the outer tube 20 in a radially expanded state is intended to be closed. The force works in the direction to do. That is, in the wing portion 23 of the outer tube 20, the bent portion 26 moves radially inward and the outer diameter of the wing portion 23 tends to be reduced.
However, since the wing part 13 of the inner tube 10 enters between the adjacent wing parts 23 of the outer tube 20, even if the wing part 23 of the outer tube 20 is closed, the wing part of the inner tube 10 is closed. 13 becomes resistance and it can suppress that the wing | blade part 23 of the outer tube 20 tends to close. That is, the fixed state by the body fixing part B is maintained, and unintentional removal of the fistula catheter 1 such as self-extraction can be suppressed.

  When the indwelling fistula catheter 1 is removed from the fistula 73, the in-vivo fixed part of the fistula catheter 1 is extended and pulled out by the same procedure as that for insertion.

  Thus, according to the first embodiment, the wing portions 13 of the inner tube 10 and the wing portions 23 of the outer tube 20 are alternately arranged along the circumferential direction. And the contact area of the in-vivo fixed part with the gastrointestinal tract wall increases, so that invasion of the gastrointestinal tract wall can be reduced. Therefore, the risk of digestive tract wall ulcers and bumper buried syndrome can be reduced.

  Further, since the wing portions 13 of the inner tube 10 and the wing portions 23 of the outer tube 20 are alternately arranged along the circumferential direction, the wing portion 13 when the fistula catheter 1 is pulled from the outside of the body at the time of indwelling. The diameter reduction of the wing part 23 can be suppressed. For this reason, the fixed state of the in-vivo fixing part B in the digestive tract wall 72 is difficult to be released, and unintentional removal such as self-extraction can be suppressed.

The fistula catheter 1 is configured by inserting the inner tube 10 into the outer tube 20, and the outer diameter of the fistula catheter 1 is the outer diameter of the outer tube 20 in the extended state. For this reason, the outer diameter at the time of extension is small compared with the bumper comprised so that it may expand in the digestive tract wall made from a general synthetic resin. Therefore, there is little resistance to the fistula at the time of insertion / extraction, and the risk of damaging the fistula 73 can be reduced.
The fistula catheter 1 is composed of two tubes, an inner tube 10 and an outer tube 20, and has a small number of parts. For this reason, the increase in manufacturing cost can be suppressed.

  Moreover, since the fistula catheter 1 is easily extended by pulling the distal end side and the proximal end side apart, the procedure at the time of insertion / extraction is easy, and the burden on the operator can be reduced.

  The inner tube 10 is longer than the outer tube 20 on the proximal end side, and is configured to have a length such that the proximal end 14 of the inner tube 10 protrudes to the body surface side in a state where the inner tube 10 is placed in the fistula 73. . For this reason, even if the inner tube 10 projecting to the body surface side is pulled, the wing portion 23 of the outer tube 20 having a larger diameter in the digestive tract wall is prevented from coming off, and the fistula catheter 1 is removed from the fistula 73. It is hard to come off.

Embodiment 2. FIG.
FIG. 11 is a schematic diagram of a main part of a fistula catheter 1 according to the second embodiment. FIG. 12 is a schematic cross-sectional view of an essential part of the fistula catheter 1 according to the second embodiment, and shows the operation of extending the in-vivo fixing part B of the fistula catheter 1. In FIG. 12, for convenience of explanation, the outer tube is not shown. In the second embodiment and the subsequent embodiments, differences from the first embodiment will be mainly described, and the same or corresponding components as those in the first embodiment are denoted by the same reference numerals.

As shown in FIGS. 11 and 12, the fistula catheter 1 according to the second embodiment includes an inner tube 60 inserted into the inner tube 10.
The inner cylinder 60 is made of stainless steel, titanium, or the like, and has a lumen for allowing a fluid to pass therethrough.

  As shown in FIG. 11 and FIG. 12A, the inner cylinder 60 has a function of maintaining the shape of the wing part 13 of the inner tube 10. That is, the fixing portion 63 of the inner cylinder 60 is fixed to the inner peripheral surface on the distal end side of the inner tube 10, and the fixing portion 64 of the inner cylinder 60 is located on the inner side closer to the proximal end than the start end P of the wing portion 13. Fixed to the peripheral surface. Thereby, the adhering part 63 and the fixing | fixed part 64 maintain the state of the wing | blade part 13 formed when the proximal end and distal end of the inner tube 10 approach. In addition, the outer tube 20 fixed to the inner tube 10 also maintains the shape of the wing portion 23 in the same manner as the inner tube 10.

  Near the tip on the distal end side of the inner cylinder 60, a brim-shaped tip enlarged-diameter portion 62 whose diameter is increased outward in the radial direction is formed. The distal diameter expanding portion 62 has a shape that gradually decreases in diameter toward the distal end, and is configured so that the distal diameter expanding portion 62 does not easily damage the fistula or the digestive tract wall during insertion / extraction or indwelling. The tip enlarged diameter portion 62 is disposed at a position protruding from the distal end 15 of the inner tube 10.

  The axial length of the inner cylinder 60 is configured to be longer than the combined length of the proximal end side fixing portion 31, the distal end side fixing portion 32, and the intermediate portion 33 in the extended state. .

A fixing portion 63 is provided in a region closer to the proximal end side than the tip enlarged diameter portion 62 on the outer peripheral surface of the inner cylinder 60, and a fixing portion 64 is provided in a region on the proximal end side of the outer peripheral surface of the inner cylinder 60 distal end. Is provided. In FIGS. 11 and 12, the fixing portion 63 and the fixing portion 64 are indicated by bold lines for the sake of explanation.
The fixing portion 63 is fixed to the inner peripheral surface of the inner tube 10. The fixing portion 63 is fixed to the inner peripheral surface of the inner tube 10 on the distal end side of the distal end of the slit 11. In the second embodiment, an adhesive is used as means for fixing the inner tube 10 in the fixing portion 63. Note that any means can be used as the means for fixing the fixing portion 63 to the inner tube 10. For example, the protrusion formed on the outer peripheral surface of the inner cylinder 60 and the protrusion formed on the inner peripheral surface of the inner tube 10 are engaged. The protrusions formed on the outer peripheral surface of the inner cylinder 60 and the frictional force between the inner peripheral surfaces of the inner tube 10 may be fixed.

The fixing portion 64 is fixed to the inner peripheral surface of the inner tube 10 so as to be movable in the axial direction. Here, “fixed so as to be movable in the axial direction” means that the fixing portion 64 is in the state of the inner tube 10, that is, in a state where the extended state or the extended state is released (the state where the wing portion 13 is formed). This means that the inner peripheral surface of the inner tube 10 is fixed at a different position. In the second embodiment, the outer diameter of the fixing portion 64 is configured to be the same as or slightly larger than the inner diameter of the inner tube 10, and is fixed by the frictional force generated between the fixing portion 64 and the inner peripheral surface of the inner tube 10. The part 64 is fixed to the inner peripheral surface of the inner tube 10.
A tapered portion 66 is formed on the outer periphery from the proximal end 61 of the inner cylinder 60 to the fixed portion 64.

On the inner peripheral surface of the inner cylinder 60, an inner protrusion 65 that protrudes radially inward is provided. The internal protrusion 65 has a function of engaging with a distal end portion of the extender 50 described later.
Since the inner protrusion 65 has the same function as the protrusion 18 of the inner tube 10 in the first embodiment, the inner tube 10 according to the second embodiment does not include the protrusion 18.

Next, the extension operation of the fistula catheter 1 will be described with reference to FIGS. 12 (a) to 12 (c).
First, as shown in FIG. 12 (a), it is assumed that the inner tube 10 of the fistula catheter 1 has a wing 13 formed thereon. In such a state, the extender 50 is inserted into the inner lumen of the inner tube 10 and the inner cylinder 60. Here, the extender 50 according to the second embodiment has an inner cylinder engaging portion 54 that is detachably fixed to the inner peripheral surface of the inner cylinder 60, and the tube engaging portion shown in the first embodiment. 51 is not provided. In the second embodiment, both are fixed by the frictional force generated between the inner peripheral surface of the inner protrusion 65 provided on the inner tube 60 and the outer peripheral surface of the inner tube engaging portion 54. Yes. That is, when the extender 50 is inserted to an appropriate position in the inner cylinder 60, a frictional force acts between the inner cylinder engaging portion 54 and the inner protrusion 65 of the inner cylinder 60, and the extension tool 50 in the inner cylinder 60 is moved. Progress is stopped.

  When the extension tool 50 is further pushed in this state and a force exceeding the frictional force with the inner peripheral surface of the inner tube 10 in the fixing portion 64 is applied, the fixation of both is once released. Then, as shown in FIG. 12B, the inner cylinder 60 engaged with the inner cylinder engaging portion 54 of the extender 50 advances to the distal end side along with the extender 50. And the front-end | tip part of the inner tube 10 fixed by this inner cylinder 60 and the fixing | fixed part 63 will also advance to a distal end side. Thus, by pushing in the extension tool 50, the wing | blade part 13 of the inner tube 10 is extended, and it will be in a state like FIG.12 (c). In order to realize such an operation, the frictional force generated between the inner cylinder engaging portion 54 and the inner protrusion 65 of the inner cylinder 60 is greater than the frictional force generated between the fixed portion 64 and the inner peripheral surface of the inner tube 10. Is also configured to be larger. Although not shown in FIG. 12, the wing portion 23 of the outer tube 20 is also extended in the same manner as the wing portion 13 of the inner tube 10 extends.

  By doing so, the fistula catheter 1 is in an extended state, and can be inserted / removed into / from the fistula 73.

  As described above, according to the second embodiment, the inner cylinder 60 to be inserted into the inner tube 10 is provided. And this inner cylinder 60 is provided with the fixing | fixed part 64 fixed to the inner peripheral surface of the inner tube 10 in the proximal end side rather than the proximal end side edge part of the slit 11 of the inner tube 10 so that it can move to an axial direction, The fixing part 63 fixed to the inner peripheral surface of the inner tube 10 on the distal end side than the distal end side end part of the slit 11 of the inner tube 10 was provided. In the state where the wing part 13 and the wing part 23 are formed, the fixing part 64 and the fixing part 63 are fixed to the inner peripheral surface of the inner tube 10 so that the shapes of the wing part 13 and the wing part 23 can be maintained. . For this reason, the shape of the in-vivo fixed part B can be more easily maintained even in the digestive tract wall 72 exposed to contents and body fluids that are intensely moved. Therefore, the indwelling state of the fistula catheter 1 can be kept good, and unintentional removal such as self-extraction can be suppressed.

  The detachable fixing structure between the inner tube 60 and the extender 50 is not limited to the one using the friction force generated by the inner tube engaging portion 54 and the inner protrusion 65 described above, and the wing portion 13 of the fistula catheter 1, If the extension tool 50 and the inner cylinder 60 can be fixed when the extension tool 50 is pushed in to extend the wing 23 and the extension tool 50 is removed to release the extension state, the two parts are separated from each other. Good. For example, you may provide the screw screwed together in the inner peripheral surface of the inner cylinder 60, and the outer peripheral surface of the extension tool 50 near the front-end | tip.

Embodiment 3 FIG.
In the first embodiment described above, the inner tube is longer than the outer tube. In the third embodiment, a fistula catheter in which the outer tube is longer than the inner tube will be described.

FIG. 13 is a perspective view of a fistula catheter 1A according to the third embodiment.
As shown in FIG. 13, the outer tube 20A is longer on the proximal end side than the inner tube 10A, and the proximal end 24 of the outer tube 20A protrudes more on the body surface side than the fistula in a state where it is placed in the fistula. It is configured to length. The inner tube 10A configured shorter than the outer tube 20A is in a state of being inserted into the outer tube 20A. Other configurations are the same as those of the first embodiment.

Thus, according to the third embodiment, even if the outer tube 20A is longer than the inner tube 10A, the same effect as in the first embodiment can be obtained.
Further, the outer tube 20A is configured to have a length that is longer to the proximal end side than the inner tube 10A and that the proximal end 24 of the outer tube 20A protrudes to the body surface side from the fistula in a state where it is placed in the fistula. As a result, only the outer tube 20A is exposed above the in-vivo fixing portion B of the fistula catheter 1. For this reason, since the level | step difference by the outer diameter difference of the inner tube 10A and the outer tube 20A cannot be performed, the resistance with respect to the fistula at the time of insertion / extraction can be reduced. Therefore, the risk of damaging the fistula during insertion / removal can be reduced.

  In addition to the configurations described in the first to third embodiments, the following applications are possible.

In the first embodiment, the wing portion 13 and the wing portion 23 are provided with the bending portion 17 and the bending portion 27, respectively. However, as shown in FIG. 14, for example, the bending portion may not be provided.
Moreover, in Embodiment 1, although the curved part 17 and the curved part 27 which curve toward the distal end side in the axial direction were shown, you may provide the curved part of another shape. That is, for example, as shown in FIG. 15, the wing part 13 (the wing part 23) is bent toward the proximal end side in the axial direction, and the bent part 16 (bent part 26) is further bent into the inner tube 10 (outer tube). 20) It curves so that it may approach the outer wall. The wing portion 13 (wing portion 23) is formed by bending the wing portion 13 (wing portion 23) so as to have a “U” shape when viewed from the side as described above, thereby forming the wing portion 13 (wing portion 23). Since the abutting portion of the gastrointestinal tract is in contact with the curved portion, the contact with the gastrointestinal tract wall is softened and the invasion to the gastrointestinal tract wall can be reduced.

Further, in the first embodiment, the inner peripheral surface of the outer tube 20 and the outer peripheral surface of the inner tube 10 are fixed with adhesive or the like at two locations of the proximal end side fixing portion 31 and the distal end side fixing portion 32. Although the example fixed by a means was shown, a fixing means is not restricted to an adhesive agent. For example, a protrusion is provided on the outer peripheral surface of the inner tube 10, an engagement hole that engages with the protrusion is provided on the inner peripheral surface or wall portion of the outer tube 20, and the protrusion of the inner tube 10 is an engagement hole of the outer tube 20. Insert into. Even in this way, the inner tube 10 and the outer tube 20 can be fixed.
In the above description, an example in which the inner peripheral surface of the outer tube 20 and the outer peripheral surface of the inner tube 10 are fixed at the proximal end side fixing portion 31 and the distal end side fixing portion 32 has been shown. However, the inner peripheral surface of the outer tube 20 and the outer peripheral surface of the inner tube 10 do not necessarily have to be fixed at two locations across the wing portion 13 and the wing portion 23. That is, by providing the wing part 13 and the wing part 23 at positions corresponding to the axial direction, these wing parts regulate the movement of the outer tube 20 and the inner tube 10 in the axial direction. An effect equivalent to that of

The number of the slits 11 and the slits 21 is three for each of the inner tube 10 and the outer tube 20 in the above description, but can be any number of two or more.
Moreover, although the example which provided the slit 11 and the slit 21 in the position which each divides the surrounding wall of the inner tube 10 or the outer tube 20 into the radial direction was shown, you may provide in the position which is not divided into three.
Further, the slit 11 and the slit 21 may have different axial lengths.

  In the above description, the example in which the slit 11 and the slit 21 are provided in order to form the belt 12 and the belt 22 in the inner tube 10 and the outer tube 20 is shown. The slit forms a narrow gap in the inner tube 10 and the outer tube 20, but a slit may be provided instead of such a slit.

  Further, the same material may be used for the inner tube 10 and the outer tube 20, or different materials may be used.

  Further, the thickness of the inner tube 10 and the thickness of the outer tube 20 may be the same or different.

  1, 1A fistula catheter, 10, 10A inner tube, 11 slit, 12 belt, 13 wings, 14 proximal end, 15 distal end, 16 bent portion, 17 bent portion, 18 protruding portion, 20, 20A outer tube, 21 Slit, 22 Belt, 23 Wings, 24 Proximal end, 25 Distal end, 26 Bending part, 27 Bending part, 31 Proximal end side fixing part, 32 Distal end side fixing part, 33 Intermediate part, 50 Extension Tool, 51 Tube engaging part, 52 Operation part, 53 Shaft part, 54 Inner cylinder engaging part, 60 Inner cylinder, 61 Proximal end, 62 Tip diameter increasing part, 63 Adhering part, 64 Fixing part, 65 Internal protrusion, 66 Tapered part, 71 Abdominal wall, 72 Gastrointestinal tract wall, 73 Fistula, A Catheter part, B body fixing part, P Starting point of wing part, S surface.

Claims (7)

A catheter part;
A fistula catheter formed on the distal end side of the catheter part and having an in-vivo fixing part placed in the digestive tract wall,
The body fixing portion includes an inner tube and an outer tube provided outside the inner tube,
The inner tube and the outer tube are constituted by a belt formed by dividing a tube wall into a plurality of portions in the circumferential direction, and have a wing portion having a portion extending outward in the radial direction.
Wings of the outer tube and the wing portion of the inner tube, and characterized in that with is provided in the position of the same distance from the distal end of the catheter portion are arranged alternately along the circumferential direction To fistula catheter.
The wings of the outer tube and the inner tube are
The fistula catheter according to claim 1, wherein at least a part of the belt is bent or curved by bringing the distal end side and the proximal end side of the belt closer to each other in the axial direction. The outer tube and the inner tube are
By extending the proximal end and the distal end apart, it becomes almost straight,
The deformed shape is formed so that the distal end and the proximal end approach each other when the extended state is released and a portion extending outward in the radial direction is formed. Item 3. The fistula catheter according to Item 2. The said wing | blade part of the said outer tube and an inner tube has a curved part which curves toward a distal end side or a proximal end side in an axial direction. Any one of Claims 1-3 characterized by the above-mentioned. A fistula catheter according to 1. The inner tube is longer than the outer tube on the proximal end side, and is configured to have such a length that the proximal end of the inner tube protrudes to the body surface side in a state of being placed in the fistula. The fistula catheter according to any one of claims 1 to 4. The outer tube is longer than the inner tube on the proximal end side, and is configured to have such a length that the proximal end of the outer tube protrudes to the body surface side in a state of being placed in the fistula. The fistula catheter according to any one of claims 1 to 4. Inserted into the inner tube,
A fixing portion fixed to the inner peripheral surface of the inner tube at a position proximal to the wing portion of the inner tube so as to be movable in the axial direction;
A fixing portion that is fixed to the inner peripheral surface of the inner tube at a position on the distal end side relative to the distal end side end portion of the slit or cut of the inner tube;
The fistula catheter according to any one of claims 1 to 6, wherein the fistula catheter is provided.

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