JP2012176118A - Fistula catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a fistula catheter including an internal fixing part which has high fixing force and prevents unintended removal such as self extraction.SOLUTION: The fistula catheter 100 includes a catheter part A formed on a part of a tube 1 and an internal fixing part B formed by deforming the distal end side of the tube 1, and retained in a digestive tract wall 82. The internal fixing part B has blade parts 10, 20 and 30 in which deformed belts 6 are formed by dividing a peripheral wall in an area at a predetermined distance from the distal end and proximal end of the tube 1 in a circumferential direction. The blade parts 10, 20 and 30 include first curve parts 13, 23 and 33 and second curve parts 15, 25 and 35, which are curved by bringing the distal end side and proximal end side of the belt 6 closer to each other. On the radially inside of the first curve parts 13, 23 and 33 of the blade parts, the second curve parts 15, 25 and 35 of one of the blades parts on both sides are arranged.

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 body fixing part, “consisting of a plurality of wall strips (strips) formed in the tube wall region at a distance from the tip of the distal end of the tube, these strips were provided on the wall of the tube. Although separated by a plurality of slits, it remains connected to this wall at both ends of the strip, the strip is curved outward to form a corm, and the distal end of the tube retracts into the corm Has been proposed (see, for example, Patent Document 1). The in-vivo fixed part (corm) described in Patent Document 1 is formed by heat-forming a tube such as polyurethane.

JP 2009-542270 A (6th page, FIG. 4)

  The inside of the digestive tract wall such as the stomach wall where the in-vivo fixed part is indwelled is an environment where the movement is intense and the contents and body fluids are exposed. In addition, an unreasonable force may be applied to the internal fixation part when the patient tries to pull out the fistula catheter. Since the in-vivo fixing part is placed in such an environment, further enhancement of the fixing force has been desired.

  The present invention has been made to solve the above-described problems, and provides a fistula catheter provided with an in-vivo fixing portion that has a high fixing force and can suppress unintentional extraction such as self-extraction.

  The fistula catheter according to the present invention is a fistula catheter having a catheter part formed of a part of a tube and a body fixing part formed by deforming the distal end side of the tube and placed in the digestive tract wall. The section has a plurality of wings formed by deforming a belt formed by dividing a peripheral wall in a region at a predetermined distance from the distal end and the proximal end of the tube in the circumferential direction. A first curved portion and a second curved portion that are curved by bringing the distal end side and the proximal end side of the belt closer to each other, and other wing portions are arranged radially inside the first curved portion of each wing portion. The second curved portion is arranged.

  The first curved portion and the second curved portion of the fistula catheter according to the present invention rotate the tube on the distal end side in the circumferential direction with respect to the tube on the proximal end side of the belt, and the distal end side of the belt And the proximal end side are made closer to each other.

  The belt of the fistula catheter according to the present invention is formed parallel to the axial direction of the tube.

  The fistula catheter according to the present invention includes n (n is 3 or more) belts, and substantially connects the n first curved portions adjacent to each other when the body fixing portion is viewed perpendicular to the axial direction. Thus, a regular n-corner shape is formed.

  The tube of the fistula catheter according to the present invention is provided with an extender locking portion to which the extender of the wing portion is detachably locked at a position distal to the belt.

  A fistula catheter according to the present invention includes an inner cylinder to be inserted into a tube, and the inner cylinder includes a distal end side holding portion that holds the inner peripheral surface of the tube on the distal end side of the wing portion, and a wing portion. And a proximal end holding portion for holding the inner peripheral surface of the tube on the proximal end side.

  The proximal end side holding portion of the inner tube of the fistula catheter according to the present invention holds the inner peripheral surface of the tube in a detachable manner, and releases the holding on the inner peripheral surface of the tube when the wing portion is extended. Is.

  The plurality of wing portions of the fistula catheter according to the present invention include a first bending portion and a second bending portion that are bent by bringing the distal end side and the proximal end side of the belt closer to each other, and the first bending of each wing portion A second curved portion of one wing portion of the wing portions adjacent to each other is disposed on the radially inner side of the portion. For this reason, even when a force that reduces the diameter of the first bending portion is applied, such as when the fistula catheter is pulled from the body surface side, the second bending portion suppresses the diameter reduction of the first bending portion. Thereby, the shape of the wing | blade part of a body fixing | fixed part is hold | maintained, and unintentional extraction, such as self extraction, can be suppressed.

  The first curved portion and the second curved portion of the fistula catheter according to the present invention rotate the tube on the distal end side of the belt and the tube on the proximal end side in different directions in the circumferential direction, and It is formed by bringing the end side and the proximal end side closer. For this reason, a body fixing | fixed part can be formed with a simple procedure, and a body fixing | fixed part can be made into an extended state.

  Since the belt of the fistula catheter according to the present invention is formed parallel to the axial direction of the tube, the tube can be easily processed when forming the belt.

  The fistula catheter according to the present invention includes n (n is 3 or more) belts, and substantially connects the n first curved portions adjacent to each other when the body fixing portion is viewed perpendicular to the axial direction. Since the regular n-corner shape is formed, the shape of the wing part of the in-vivo fixed part is maintained, and unintentional extraction such as self-extraction can be suppressed.

  Since the tube of the fistula catheter according to the present invention includes the extension tool locking portion to which the extension tool of the wing portion is detachably locked at a position on the distal end side from the belt, Formation and release are possible.

  In the fistula catheter according to the present invention, the inner tube holds the tube inner peripheral surface on the distal end side of the wing portion and the tube inner peripheral surface on the proximal end side of the wing portion. For this reason, the maintenance of the curved state of the wing portion is strengthened, and a fistula catheter that is difficult to be removed from the fistula can be obtained.

  The proximal end side holding portion of the inner tube of the fistula catheter according to the present invention holds the inner peripheral surface of the tube in a detachable manner, and releases the holding on the inner peripheral surface of the tube when the wing portion is extended. . For this reason, insertion / extraction of a fistula catheter can be performed in the state which extended the wing | blade part.

FIG. 6 is a diagram for explaining an indwelling state of the fistula catheter according to Embodiment 1. 3 is a schematic side view of the fistula catheter according to Embodiment 1 in an extended state. FIG. FIG. 3 is a side sectional view of the fistula catheter according to the first embodiment in an extended state. FIG. 3 is a schematic cross-sectional view taken along the line AA in FIG. 2. 1 is a side view of a fistula catheter according to Embodiment 1. FIG. 1 is a perspective 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. It is a figure explaining the principal part of the in-vivo fixing | fixed part which concerns on Embodiment 1. FIG. FIG. 10 is a diagram for explaining a manufacturing process of the fistula catheter according to the first embodiment. FIG. 10 is a diagram for explaining the insertion / extraction operation of the fistula catheter according to the first embodiment. It is a figure explaining the fistula catheter which concerns on Embodiment 2. FIG. It is a figure explaining the extension state of the fistula catheter concerning Embodiment 2. FIG. It is a figure explaining the fistula catheter which concerns on Embodiment 3. FIG. It is a figure explaining the extension state of the fistula catheter concerning Embodiment 3. FIG. 6 is a development view of a tube according to Embodiment 4. FIG. 6 is a side view of a fistula catheter according to Embodiment 4. FIG. FIG. 10 is a side view of a fistula catheter according to a fifth embodiment. 6 is a schematic cross-sectional view of a fistula catheter according to Embodiment 5. FIG. It is a cross-sectional schematic diagram of the extended state of the fistula catheter according to Embodiment 5.

Embodiment 1 FIG.
FIG. 1 is a diagram illustrating an indwelling state of a fistula catheter according to Embodiment 1. FIG.
The fistula catheter 100 is attached to a fistula 83 formed so as to penetrate the patient's abdominal wall 81 and digestive tract wall 82.
As shown in FIG. 1, the fistula catheter 100 includes a catheter part A and a body fixing part B. The catheter part A is inserted into the fistula 83 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 82 such as the stomach wall when the fistula catheter 100 is placed in the patient's fistula 83, and has a function of suppressing the fistula catheter 100 from coming out of the fistula 83 of the patient. The fistula catheter 100 includes the tube 1 as a main component, and a part of the tube 1 is bent to form an in-vivo fixed portion B. Further, the in-body fixing part B can be extended by releasing the curved state.
In the following description, “distal end” or “tip” refers to the lower end of the fistula catheter 100 shown in FIG. 1, and “proximal end” or “proximal end” refers to the figure. The upper end of the fistula catheter 100 shown in FIG.

First, the fistula catheter 100 in a state where the internal fixation part B is extended will be described.
2 is a schematic side view showing the stretched state of the fistula catheter 100 according to the first embodiment, FIG. 3 is a side sectional view showing the stretched state of the fistula catheter 100 according to the first embodiment, and FIG. It is an AA cross-sectional schematic diagram.
As shown in FIGS. 2 and 3, the tube 1 is divided into a catheter portion 2, a fixing portion forming portion 3, and a distal end region 4. The catheter part 2 corresponds to the catheter part A shown in FIGS. The fixing part forming part 3 forms the in-vivo fixing part B by being deformed (described later). The distal end region 4 is a region on the distal end side of the fixed portion forming portion 3 in the tube 1 and has an axial length of, for example, about 2 mm to 10 mm.

  As shown in FIGS. 2 to 4, on the wall surface of the fixed portion forming portion 3, three slits 5 communicating with the inside and outside of the tube 1 are provided in parallel to the axial direction. In the first embodiment, three slits 5 are provided at positions that divide the peripheral wall of the tube 1 into approximately three equal parts. Since the slit 5 is parallel to the axial direction, processing (slit formation) on the tube 1 is easy.

  The peripheral wall of the tube 1 is divided into three by the slits 5 formed in the fixed part forming part 3, and three belts 6 are formed by the division. Since the slit 5 is provided only in the fixing portion forming portion 3 which is a region spaced a predetermined distance from the distal end and the proximal end of the tube 1, the belt 6 has the upper end portion and the lower end portion thereof. It is in a state of being connected as a peripheral wall.

  In addition, in the lumen of the distal end region 4 of the tube 1, an extender locking part 7 is provided as a functional part for locking the extender 60 described later. In the first embodiment, the extender locking portion 7 is configured by an annular member that is inserted and fixed in the lumen of the distal end region 4. This annular member is made of a material such as stainless steel or titanium. A female screw 7 a is formed on the inner peripheral surface of the annular member constituting the extender locking portion 7.

  The tube 1 is made of, for example, a resin material such as polyurethane resin, polyvinyl chloride resin, or silicone resin, and has a lumen for allowing a fluid to pass therethrough. Although the material of the tube 1 is not limited to the above material, it is possible to perform heat shaping, and it is preferable to use a material having flexibility even after heat shaping.

  Next, the fistula catheter 100 in a state in which the body fixing part B is formed will be described. 5 is a side view of the fistula catheter 100 according to the first embodiment, FIG. 6 is a perspective view of the fistula catheter 100, FIG. 7 is a plan view of the fistula catheter 100, and FIG. . FIG. 9 is a diagram for explaining a main part of the in-vivo fixing part B. In FIG. 9, for ease of viewing the drawing, the wing part 10 of the body fixing part B shown in FIG. ing.

  As shown in FIGS. 5 to 8, the body fixing part B according to the first embodiment includes a wing part 10, a wing part 20, and a wing part 30. The wing parts 10, 20, 30 have a shape projecting radially outward with respect to the tube 1.

  As shown in FIGS. 5 to 9, the wing portion 10 includes a first belt portion 12 extending radially outward from the proximal end 11, and a radially inner side and a proximal end side from the end portion of the first belt portion 12. A first bending portion 13 that bends in the direction, a second band portion 14 that extends radially inward and in the proximal direction from the first bending portion 13, and a distal end from the end of the second band portion 14 A second bending portion 15 that is bent toward the region 4 side and a third belt portion 16 that continues from the second bending portion 15 to the distal end 17 are provided.

  The first bending portion 13 will be further described. The bending angle of the other end side 13b is larger than the one end side 13a in the width direction of the belt 6 (that is, the other end side 13b is larger than the one end side 13a. Gently) curved. Further, the second bending portion 15 has a larger bending angle on the other end side 15a than the one end side 15b in the width direction of the belt 6 (that is, the other end side 15a is looser than the one end side 15b). To) is curved. For this reason, as shown in FIGS. 7 and 8, when viewed perpendicular to the axial direction, the first belt portion 12, the first bending portion 13, and the second belt portion 14 form a triangle, The band 14, the second curved part 15, and the third band 16 appear to form a triangle.

  The wing part 20 and the wing part 30 have the same shape as the wing part 10. That is, as with the proximal end 11, the first belt portion 12, the first bending portion 13, the second bending portion 14, the second bending portion 15, the third belt portion 16, and the distal end 17 of the wing portion 10, The section 20 includes a proximal end 21, a first strip 22, a first curved section 23, a second strip 24, a second curved section 25, a third strip 26, and a distal end 27, and the wing section 30 is near. A distal end 31, a first band portion 32, a first bending portion 33, a second band portion 34, a second bending portion 35, a third band portion 36, and a distal end 37 are provided.

  Next, the mutual relationship between the wing part 10, the wing part 20, and the wing part 30 will be described. The second curved portion 35 of the wing portion 30 enters the radially inner side of the first curved portion 13 of the wing portion 10, and the second curved portion of the wing portion 10 enters the radially inner side of the first curved portion 23 of the wing portion 20. 15 enters, and the second curved portion 25 of the wing portion 20 enters the radially inner side of the first curved portion 33 of the wing portion 30. Therefore, as shown in FIGS. 7 and 8, when the in-vivo fixing part B is viewed perpendicular to the axial direction, the first bending part 13 and the first and second belt parts 12 and 14 sandwiching the first bending part 13 are formed. A triangular shape formed by the second curved portion 15 and the second belt portion 14 and the third belt portion 16 sandwiching the second curved portion 15 is sandwiched inside the triangular shape. The same applies to the wing parts 20 and 30. Further, when the body fixing part B is viewed perpendicularly to the axial direction, connecting the three adjacent first bending parts 13, 23, 33 substantially forms an equilateral triangle. In addition, a substantially equilateral triangle means what appears to be an equilateral triangle at a glance including what is not a strict equilateral triangle.

Next, the manufacturing process of the fistula catheter 100 using the tube 1 will be described.
FIG. 10 is a diagram for explaining a process for producing the fistula catheter 100 according to the first embodiment. Here, it is assumed that the tube 1 is in an extended state as shown in FIGS.
(1) As shown in FIG. 10A, while the distal end side and the proximal end side of the belt 6 are made closer to each other in the axial direction, the distal end region 4 is viewed from the distal end side perpendicular to the axial direction. The distal end side of the belt 6 is rotated from the position P1 to the position P2. FIG. 10B shows the positional relationship between the proximal ends 11, 21, and 31 and the distal ends 17, 27, and 37 when the distal end side of the belt 6 is rotated. When the distal end side of the belt 6 is rotated from the position P1 to the position P2, as shown in FIG. 10B, the distal end portion and the proximal end portion of one belt 6 are different in the circumferential direction. Placed in position. FIG. 10B shows an example in which the distal end region 4 is rotated by 120 ° with respect to the catheter part 2.

(2) FIG. 10C is a diagram for explaining the formation process of the wing part 10. In FIG. 10C, for the sake of explanation, only the wing part 10 is shown, and the wing parts 20 and 30 are not shown. 10C, the distal end side and the proximal end side of the belt 6 are made closer to each other in the axial direction, the belt 6 is bent outward, and the first bending portions 13, 23, 33, the second bending portion Portions 15, 25 and 35 are formed. Since the belt 6 is formed by dividing the outer wall of the tube, the belt 6 can be easily deformed and projected outward. In the process shown in FIG. 10C, the belt 6 has a shape that is obtained by horizontally inverting “Z”.

(3) Subsequently, the second bending portion 35 is inserted inside the first bending portion 13, the second bending portion 15 is inserted inside the first bending portion 23, and the second bending portion 15 is inserted inside the first bending portion 33. The bending portion 25 is inserted. Thereby, the wing | blade part 10, the wing | blade part 20, and the wing | blade part 30 which are shown in FIGS. 5-8 are formed.

  The wing part 10, the wing part 20, and the wing part 30 formed in the above processes (1) to (3) are heat-shaped to fix the shape of the body fixing part B.

  The tube 1 is made of a material having flexibility even after heat forming. Therefore, when the distal end region 4 of the tube 1 is separated from the catheter portion 2 in the axial direction, the tube 1 is stretched almost straight (see FIG. 3). When the extended state is released, the wing part 10, the wing part 20, and the wing part 30 are formed again as shown in FIGS.

Next, the operation of placing the fistula catheter 100 configured as described above in the fistula 83 will be described.
First, with reference to FIG. 11, the extension tool 60 used for extending the body fixing part B of the fistula catheter 100 and inserting the body fixing part B into the digestive tract wall 82 such as the stomach wall or the intestinal wall will be described. . The extender 60 includes an engagement portion 61 provided on the distal end side, an operation portion 62 provided on the end opposite to the engagement portion 61, and between the operation portion 62 and the engagement portion 61. And a shaft portion 63 provided on the head. The engaging portion 61 and the shaft portion 63 are configured to be insertable into the lumen of the tube 1. On the outer periphery of the engaging portion 61, a male screw 61 a that can be screwed with the female screw 7 a provided in the extender locking portion 7 of the fistula catheter 100 is provided. The operation unit 62 is made of, for example, synthetic resin or metal, and has a shape that allows the operator to place a finger.

  When placing the fistula catheter 100 in the fistula 83, the operator enters the lumen of the catheter part A of the fistula catheter 100 in which the internal fixation part B is formed as shown in FIGS. 5 to 8 from the proximal end side. The engaging part 61 of the extension tool 60 is inserted, and the male screw 61a of the engaging part 61 and the female screw 7a of the extension tool locking part 7 are screwed together. In this way, the fistula catheter and the extension device 60 are fixed at the distal end portion of the fistula catheter 100. Then, the surgeon pulls the proximal end side of the tube 1 toward the near side while pushing the extension tool 60 toward the distal end side of the tube 1. In this process, the tube 1 and the extender 60 are rotated in the direction opposite to the rotation direction (see FIG. 10) when forming the wing part 10, the wing part 20, and the wing part 30. If it does in this way, the engagement state of the adjacent 1st bending part 13,23,33 and the 2nd bending part 15,25,35 will be cancelled | released, and the fixing | fixed part formation part 3 will be substantially straight as shown in FIG. It becomes a state. The direction in which the male screw 61a is tightened is made to coincide with the rotation direction when releasing the wing portion 10, the wing portion 20, and the wing portion 30 (in the example of the first embodiment, the male screw 61a is a forward screw). ) Is preferred.

  Next, as shown in FIG. 11, the fistula catheter 100 that has been extended by the extension tool 60 is inserted into a fistula 83 formed in the abdominal wall 81 and the digestive tract wall 82. The diameter of the fistula catheter 100 is the same as the diameter of the tube 1, and the resistance when passing through the fistula 83 is low. For this reason, there is little risk of damaging the fistula 83.

  Then, when the insertion depth is appropriate, the operator rotates the wing portion 10, the wing portion 20, and the wing portion 30 while holding the catheter portion A against the abdominal wall 81 so that the catheter portion A does not come out (see FIG. 10), the extension tool 60 is pulled toward the front side while rotating the extension tool 60. By pulling the extender 60 to the near side, the extender locking part 7 fixed to the engaging part 61 is drawn, and the extended state of the tube 1 is released. If it does in this way, the shape of the wing | blade part 10, the wing | blade part 20, and the wing | blade part 30 currently formed by heat shaping will be decompress | restored, and the body fixing | fixed part B will be in a state as shown in FIG. By simply pulling the extension tool 60 to the front side while rotating, the stretched fistula catheter 100 can be brought into a state in which the body fixing part B is formed, and the procedure is simple. Then, the screwing of the female screw 7a and the male screw 61a is released, and the extender 60 is pulled out from the fistula catheter 100.

  The proximal end of the catheter part A of the fistula catheter 100 placed in the fistula 83 is located outside the body, and an extracorporeal 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. 1, the fistula catheter 100 placed in the digestive tract wall in a state where the in-vivo fixation part B is formed contacts the digestive tract wall 82 at the first belt portions 12, 22, and 32. The first strips 12, 22, and 32 extend radially outwardly from the proximal ends 11, 21, and 31 while being inclined in the direction of the distal end region 4 (see FIGS. 1 and 2). . Thus, since the 1st belt | band | zone part 12,22,32 inclines in the distal end area | region 4 direction, the contact | abutting with respect to the digestive tract wall 82 is soft, and the invasion to the digestive tract wall 82 can be reduced.

  When a force to pull out from the outside of the body is applied to the fistula catheter 100 placed in the fistula 83, a force that presses the wing parts 10, 20, and 30 from above by the digestive tract wall 82 works, 20 and 30 try to reduce the diameter. However, since the second bending portions 15, 25, and 35 are inside the first bending portions 13, 23, and 33, the diameter reduction of the wing portions 10, 20, and 30 is hindered, and the wing portions 10, 20, 30 are blocked. Can be suppressed. Thereby, the fixed state by the in-vivo fixing part B is maintained, and unintentional removal of the fistula catheter 100 such as self-extraction can be suppressed.

  When the indwelling fistula catheter 100 is removed from the fistula 83, the in-vivo fixation part B of the fistula catheter 100 is extended and pulled out by the same procedure as that for insertion.

  In the first embodiment, an example in which the distal end region 4 is rotated by 120 ° with respect to the catheter portion 2 is shown. However, the rotation angle is not limited to this, and the first curved portion of the adjacent wing portion is not limited thereto. Any angle that allows at least a part of the second bending portion to enter the inside may be used. For example, when three belts 6 are provided as in the first embodiment, the rotation angle can be set to 45 ° or more, preferably 60 ° to 240 °. By setting the rotation angle to about 60 ° to 240 °, the distance between the first bending portion and the second bending portion becomes closer, and the engagement state between both becomes deeper. For this reason, the fixed state of the in-vivo fixed part B becomes stronger.

In the first embodiment, the distal end region 4 of the fistula catheter 100 and the extender 60 are fixed by screwing the female screw 7a and the male screw 61a. The fixing means is not limited to the above, and any fixing means can be used as long as the distal end region 4 can be pushed and pulled.
Moreover, in this Embodiment 1, the example which provides the cyclic | annular member which is a member different from the tube 1 as the extension tool latching | locking part 7 for latching the extension tool 60 to the distal end area | region 4 of the tube 1 is shown. It was. However, the specific configuration of the extender locking portion 7 is not limited to this, and for example, the distal end of the tube 1 can be melted to form a shape corresponding to an annular member.

  As described above, the body fixing portion B of the fistula catheter 100 according to the first embodiment is formed by dividing the peripheral wall of the tube 1 in the circumferential direction at a predetermined distance from the distal end and the proximal end. The belt 6 has a plurality of deformed wing portions 10, 20, and 30. The wing portions 10, 20, and 30 are bent by bringing the distal end side and the proximal end side of the belt 6 close to each other. One bending portion 13, 23, 33 and second bending portion 15, 25, 35 are provided. And the 2nd curved part 15, 25, 35 of one wing | blade part is arrange | positioned in the radial inside of the 1st curved parts 13, 23, 33. For this reason, even when a force that reduces the diameter of the first bending portions 13, 23, 33 is applied, such as when the fistula catheter is pulled from the body surface side, the diameter of the first bending portions 13, 23, 33 is reduced. The second bending portions 15, 25, and 35 are suppressed. Thereby, the shape of the wing | blade part 10,20,30 of the body fixing | fixed part B is hold | maintained, and unintentional extraction, such as self extraction, can be suppressed.

Further, the in-body fixing part B of the fistula catheter 100 is configured by processing the tube 1, and the outer diameter of the fistula catheter 100 is the outer diameter of the tube 1 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, the resistance to the fistula at the time of insertion / extraction is small, and the risk of damaging the fistula 83 can be reduced.
Further, the fistula catheter 100 has the tube 1 as a main component and has a small number of parts. For this reason, the increase in manufacturing cost can be suppressed.

  Further, the fistula catheter 100 is easily extended by separating the distal end side and the proximal end side, so that the procedure at the time of insertion / extraction is easy and the burden on the operator can be reduced.

Embodiment 2. FIG.
In the first embodiment described above, an example in which the three wing portions 10, 20, and 30 are provided by forming the three slits 5 in the fixed portion forming portion 3 has been described. An example in which two wing parts 10, 20, 30, 40 are provided is shown. In the second embodiment, differences from the first embodiment will be mainly described, and the same components as those in the first embodiment are denoted by the same reference numerals.

  12A and 12B are diagrams illustrating a fistula catheter 100A according to Embodiment 2, in which FIG. 12A is a plan view and FIG. 12B is a bottom view. FIGS. 13A and 13B are diagrams for explaining the stretched state of the fistula catheter 100A according to the second embodiment. FIG. 13A is a side view, and FIG. 13B is a schematic horizontal cross-sectional view of the fixing portion forming unit 3.

  As shown in FIG. 13, four slits 5 communicating with the inside and the outside of the tube 1 are provided on the wall surface of the fixed portion forming portion 3 in parallel to the axial direction. In the second embodiment, four slits 5 are provided at positions that divide the peripheral wall of the tube 1 into four equal parts. And the peripheral wall of the tube 1 is divided | segmented into four by the slit 5 formed in the fixing | fixed part formation part 3, and the four belts 6 are formed by having been divided | segmented.

Then, through the same manufacturing process as in the first embodiment, the in-vivo fixing part B of the fistula catheter 100A as shown in FIG. 12 is formed.
As shown in FIG. 12, the body fixing part B according to the second embodiment includes a wing part 10, a wing part 20, a wing part 30, and a wing part 40.
The second curved portion 45 of the wing portion 40 enters inside the first curved portion 13 of the wing portion 10, and the second curved portion 15 of the wing portion 10 enters inside the first curved portion 23 of the wing portion 20. The second bending portion 25 of the wing portion 20 enters inside the first bending portion 33 of the wing portion 30, and the second bending portion 35 of the wing portion 30 is inside the first bending portion 43 of the wing portion 40. It has entered. Therefore, as shown in FIG. 12, when the in-vivo fixing part B is viewed perpendicular to the axial direction, a triangular shape formed by the first bending part 13 and the first and second belt parts 12 and 14 sandwiching the first bending part 13. A triangular shape formed by the second bending portion 15 and the second and third belt portions 14 and 16 sandwiching the second bending portion 15 is located inside the inner portion. The same applies to the wing parts 20, 30, and 40.

  When the body fixing part B configured in this way is viewed perpendicularly to the axial direction, when the four adjacent first bending parts 13, 23, 33, 43 are connected, a substantially rectangular shape is formed. (See FIG. 12).

  Thus, even if the four slits 5 are provided in the fixing part forming part 3 of the tube 1 and the in-vivo fixing part B is configured by the wing parts 10, 20, 30, 40, the same effect as in the first embodiment is obtained. Obtainable.

Embodiment 3 FIG.
In the first embodiment described above, an example in which the three wing portions 10, 20, and 30 are provided by forming the three slits 5 in the fixed portion forming portion 3 has been described. An example in which two wing parts 10, 20, 30, 40, 50 are provided is shown. In the second embodiment, differences from the first embodiment will be mainly described, and the same components as those in the first embodiment are denoted by the same reference numerals.

  14A and 14B are diagrams for explaining a fistula catheter 100B according to Embodiment 3, FIG. 14A is a plan view, and FIG. 14B is a bottom view. 15A and 15B are diagrams for explaining the stretched state of the fistula catheter 100A according to Embodiment 3, FIG. 15A is a side view, and FIG. 15B is a schematic cross-sectional view of the fixing portion forming portion 3.

  As shown in FIG. 15, five slits 5 that communicate between the inside and the outside of the tube 1 are provided on the wall surface of the fixed portion forming portion 3 in parallel to the axial direction. In the present third embodiment, five slits 5 are provided at positions that divide the peripheral wall of the tube 1 into approximately five equal parts. Then, the peripheral wall of the tube 1 is divided into five by the slits 5 formed in the fixed portion forming portion 3, and five belts 6 are formed by the division.

Then, through the same manufacturing process as in the first embodiment, the in-vivo fixing part B of the fistula catheter 100B as shown in FIG. 15 is formed.
As shown in FIG. 14, the body fixing part B according to Embodiment 3 includes a wing part 10, a wing part 20, a wing part 30, a wing part 40, and a wing part 50.
The second curved portion 55 of the wing portion 50 enters inside the first curved portion 13 of the wing portion 10, and the second curved portion 15 of the wing portion 10 enters inside the first curved portion 23 of the wing portion 20. The second bending portion 25 of the wing portion 20 enters inside the first bending portion 33 of the wing portion 30, and the second bending portion 35 of the wing portion 30 is inside the first bending portion 43 of the wing portion 40. The second curved portion 45 of the wing portion 40 enters the first curved portion 53 of the wing portion 50. Therefore, as shown in FIGS. 14B and 14C, when the in-vivo fixing part B is viewed perpendicular to the axial direction, the first bending part 13 and the first and second belt parts 12 and 14 sandwiching the first bending part 13 are formed. A triangular shape formed by the second curved portion 15 and the second belt portion 14 and the third belt portion 16 sandwiching the second curved portion 15 is located inside the triangular shape. The same applies to the wing parts 20, 30, 40, 50.

  When the body fixing part B configured in this way is viewed perpendicularly to the axial direction, when the five adjacent first curved parts 13, 23, 33, 43, 53 are connected, a substantially pentagonal shape is obtained. (See FIG. 14).

  Thus, even if the five fixing portions 5 are provided in the fixing portion forming portion 3 of the tube 1 and the in-vivo fixing portion B is configured by the wing portions 10, 20, 30, 40, 50, the same as in the first embodiment An effect can be obtained.

Embodiment 4 FIG.
In the above-described first to third embodiments, an example in which the slit 5 parallel to the axial direction is provided has been described. In the fourth embodiment, an example in which a slit 5A oblique to the axial direction is provided will be described. In the fourth embodiment, differences from the first embodiment will be mainly described, and the same components as those in the first embodiment are denoted by the same reference numerals.

  FIG. 16 is a development view of the tube 1 according to the fourth embodiment. FIG. 17 is a side view of a fistula catheter 100C according to the fourth embodiment.

  As shown in FIG. 16, the tube 1 is provided with slits 5A that are inclined with respect to the axial direction. A straight line Q indicated by a two-dot chain line in FIG. 16 is a virtual straight line having the same length provided in a position that is parallel to the axial direction of the tube 1 and that divides the peripheral wall of the tube 1 into three equal parts. Assuming such a straight line Q, the slit 5A is formed along a straight line connecting one end of a certain straight line Q and the other end of the straight line Q adjacent thereto, and the cutting angle X of the slit 5A is determined in this embodiment. In form 4, the angle is 60 °. In the fourth embodiment, there are three slits 5A. Three slits 5A form three belts 6A having an oblique angle with respect to the axial direction. The distal end of the belt 6A is axially parallel to the proximal end of the adjacent belt 6A.

A process for producing a fistula catheter 100C using the tube 1 in which such a slit 5A is formed will be described.
(1) First, unlike Embodiment 1, the distal end side and the proximal end side of the belt 6A are brought closer to the axial direction without rotating the catheter portion 2 and the distal end region 4 in the circumferential direction.
(2) In the process of (1), the belt 6A is bent outward to form the first bending portions 13, 23, 33 and the second bending portions 15, 25, 35. Then, the second bending portion 35 is inserted inside the first bending portion 13, the second bending portion 15 is inserted inside the first bending portion 23, and the second bending portion 25 is inserted inside the first bending portion 33. (See FIG. 17). Thereby, the wing part 10, the wing part 20, and the wing part 30 are formed.

  The wing part 10, the wing part 20, and the wing part 30 formed in the processes of (1) and (2) are heat-shaped to fix the shape of the in-vivo fixing part B.

  As described above, even if the in-vivo fixing portion B is configured by providing the fixing portion forming portion 3 of the tube 1 with the slit 5A having an oblique angle with respect to the axial direction, the same effect as in the first embodiment can be obtained. .

  In addition, since the slit 5A is provided at an angle such that the distal end of the belt 6A is positioned parallel to the proximal end of the adjacent belt 6A in the axial direction, in the manufacturing process of forming the wings 10, 20, 30 There is no need to rotate the catheter part 2 and the distal end region 4 in the opposite directions in the circumferential direction. That is, at the time of attachment / extraction to / from the fistula 83, the embodiment 2 is performed without rotating the catheter part 2 and the distal end region 4 using the extension tool 60 when extending the wing parts 10, 20, and 30. A configuration similar to the engagement relationship of one wing portion 10, 20, 30 can be obtained.

  In the fourth embodiment, the example in which the slit 5A is provided at an angle such that the distal end of the belt 6A is positioned parallel to the proximal end of the adjacent belt 6A in the axial direction has been described. Is not limited to this. Although depending on the outer diameter of the tube 1 and the number of slits 5A, the cutting angle X shown in FIG. 16 can be 1 ° to 180 °, preferably 30 ° to 150 °. In the case of providing three slits 5A, if the cutting angle X is other than 60 °, the distal end region 4 with respect to the catheter portion 2 is formed in the manufacturing process of forming the wing portions 10, 20, and 30. It can be rotated clockwise or counterclockwise by a predetermined angle.

Embodiment 5 FIG.
In the fifth embodiment, an example in which the inner cylinder 70 is provided as a member for increasing the shape maintaining force of the in-vivo fixed portion B will be described. In the fifth embodiment, differences from the first embodiment are mainly described, and the same components as those in the first embodiment are denoted by the same reference numerals.

  18 is a side view of a fistula catheter according to the fifth embodiment, FIG. 19 is a schematic sectional view of the fistula catheter according to the fifth embodiment, and FIG. 20 is a schematic sectional view of the fistula catheter according to the fifth embodiment in an extended state. is there. In FIG. 19, for convenience of explanation, a part of the wing is omitted.

As shown in FIGS. 18 to 20, the fistula catheter 100 </ b> D according to the fifth embodiment includes an inner cylinder 70 inserted into the tube 1. The inner cylinder 70 maintains the shape of the wings 10, 20, 30 formed by the belt 6 by maintaining the state in which the distal end side and the proximal end side of the belt 6 are close to each other in the axial direction. Have
The inner cylinder 70 is made of a material such as stainless steel or titanium and has a lumen for allowing a fluid to pass therethrough.

A distal end locking portion 71, a distal end side fixing portion 72, and a proximal end side fixing portion 73 are provided on the outer wall of the inner cylinder 70, and an extension tool is attached to the inner peripheral surface on the distal end side of the inner cylinder 70. A stop 74 is provided. The distal end locking portion 71 is disposed at a position protruding from the distal end region 4 of the tube 1 and locks the distal end surface of the distal end region 4.
The distal end locking part 71 has a shape that gradually decreases in diameter toward the distal end, and the fistula 83, the digestive tract wall 82, and the abdominal wall 81 are inserted by the distal end locking part 71 during insertion / removal or indwelling. It is configured to prevent damage.

  The distal end side fixing portion 72 is a portion having a function of fixing the tube 1 and the inner cylinder 70 on the proximal end side with respect to the distal end locking portion 71. The distal end side fixing portion 72 according to the fifth embodiment has a collar shape having an outer diameter that is slightly larger than the inner diameter of the tube 1, and the distal end side fixing portion 72 is fixed in the distal end region 4 of the tube 1. The tube 1 is pushed outward by pushing the portion 72, and both are fixed by friction between the distal end side fixing portion 72 and the inner periphery of the tube 1. Note that the method of fixing the tube 1 in the distal end side fixing portion 72 is not limited to this. For example, a protrusion provided on the inner cylinder 70 that winds an annular member from the outside of the tube 1 and fastens the tube 1 to the inner cylinder 70 is provided. Arbitrary methods, such as making it fit in the fitting hole formed in the tube 1, are employable.

  The proximal end side fixing portion 73 has a function of detachably holding the tube 1 and the inner cylinder 70 on the proximal end side of the inner cylinder 70. The proximal end side fixing portion 73 according to the fifth embodiment has a tapered structure in which the outer wall of the tube 1 is reduced in diameter toward the proximal end side, and fixes the tube 1 and the inner cylinder 70 by fitting friction. By inserting the proximal end side fixing portion 73 into the lumen of the tube 1 to an appropriate depth, a frictional force is generated between the inner peripheral surface of the tube 1 and the outer peripheral surface of the proximal end side fixing portion 73. Is fixed, and by pulling out the proximal end side fixing portion 73, the fixation of both is released. In addition, the fixing method of the tube 1 in the proximal end side fixing | fixed part 73 is not restricted to this, What is necessary is just what can be hold | maintained so that attachment or detachment is possible, and it is more preferable if it can attach or detach by operation by the extension tool 60.

Further, the extension tool locking portion 74 is a functional portion for locking the extension tool 60 to the inner cylinder 70. In the fifth embodiment, the extender locking portion 74 includes a female screw 74 a formed on the inner peripheral surface of the inner end of the inner cylinder 70. The inner cylinder 70 and the extension tool 60 are fixed by screwing the female screw 74 a and the male screw 61 a of the extension tool 60.
The fistula catheter 100D according to the fifth embodiment does not include the extender locking portion 7 provided as a functional portion for locking the extender 60 in the first embodiment.

Next, the fistula catheter 100D in a state where the wing portions 10, 20, and 30 are formed will be described focusing on the relationship between the inner cylinder 70 and the tube 1.
As shown in FIGS. 18 and 19, the distal end surface of the distal end region 4 of the tube 1 is locked to the distal end locking portion 71. Further, the distal end region 4 of the tube 1 is fixed to the distal end side fixing portion 72. Further, the proximal end side fixing portion 73 of the inner cylinder 70 is fixed to the inner peripheral surface of the catheter portion 2 on the proximal end side with respect to the proximal ends 11, 21, 31 of the wing portions 10, 20, 30. Thus, the inner peripheral surface of the tube 1 on the distal end side and the proximal end side of the wing parts 10, 20, 30 is fixed to the inner cylinder 70, so that the shape of the wing parts 10, 20, 30 is obtained. Maintenance is strengthened. The wings 10, 20, 30 are basically maintained in shape by the elasticity of the heat-formed tube 1, but the inner cylinder 70 is connected to the distal end side of the wings 10, 20, 30 and By holding the proximal end side, it is possible to suppress the wings 10, 20, and 30 from extending (that is, the state of the belt 6).

Next, the fistula catheter 100D in a state where the wing parts 10, 20, and 30 are not formed will be described focusing on the relationship between the inner cylinder 70 and the tube 1.
As shown in FIG. 20, the distal end region 4 of the tube 1 is fixed to the inner cylinder 70 by a distal end locking portion 71 and a distal end side fixing portion 72 as in FIGS. 18 and 19. .
And the fixation of the tube 1 and the inner cylinder 70 in the proximal end side fixing | fixed part 73 is cancelled | released, and the proximal end side fixing | fixed part 73 is located in the location corresponding to the belt 6. FIG.

Next, the extending operation of the fistula catheter 100D will be described.
First, as shown in FIGS. 18 and 19, the fistula catheter 100 </ b> D is assumed to have wings 10, 20, and 30 formed thereon. In such a state, the surgeon inserts the extender 60 into the lumens of the tube 1 and the inner cylinder 70. Then, the engaging portion 61 of the extender 60 is advanced to a position corresponding to the extender locking portion 74 of the inner cylinder 70, and the male screw 61a of the engaging portion 61 and the female screw 74a of the extender locking portion 74 are moved. Screw together. In this way, the inner tube 70 of the fistula catheter 100D and the extension tool 60 are fixed. Then, the surgeon pulls the proximal end side of the tube 1 toward the near side while pushing the extension tool 60 toward the distal end side of the tube 1. In this process, the tube 1 and the extender 60 are rotated in the direction opposite to the rotation direction (see FIG. 10) when forming the wing part 10, the wing part 20, and the wing part 30. If it does in this way, the engagement state of the adjacent 1st bending part 13,23,33 and the 2nd bending part 15,25,35 will be cancelled | released, and as shown in FIG. 20, the fixing | fixed part formation part 3 will be substantially straight. It becomes a state. Further, the fixation between the tube 1 and the inner cylinder 70 at the proximal end side fixing portion 73 is released.

  By doing so, the fistula catheter 100D is in the extended state, and can be inserted / removed into / from the fistula 83.

  After inserting the expanded fistula catheter 100D into the fistula 83 at an appropriate depth, the operator holds the wing part 10, the wing part 20, and the wing part 30 while pressing the abdominal wall 81 side so that the catheter part A does not come out. The extension tool 60 is pulled toward the front side while rotating the extension tool 60 in the rotation direction (see FIG. 10) when forming. By pulling the extension tool 60 to the near side, the inner cylinder 70 fixed to the engaging portion 61 is also drawn to the near side of the operator. By pulling the inner cylinder 70, the distal end region 4 of the tube 1 fixed to the distal end side fixing portion 72 of the inner cylinder 70 is also drawn, and accordingly, the proximal end side fixing portion of the inner cylinder 70 is also pulled. 73 advances to the lumen of the catheter part 2. At the same time, the shapes of the wing part 10, the wing part 20, and the wing part 30 formed by heat shaping are restored, and the in-vivo fixed part B is in a state as shown in FIGS. By simply pulling the extension tool 60 to the front side while rotating it, the stretched fistula catheter 100D can be brought into a state in which the in-vivo fixation part B is formed, and the procedure is simple. Then, the screwing of the female screw 74a and the male screw 61a is released, and the extender 60 is pulled out from the fistula catheter 100D.

  Thus, according to the fifth embodiment, the inner cylinder 70 inserted into the tube 1 is provided. And this inner cylinder 70 is the proximal end side fixing | fixed part 73 which fixes the inner peripheral surface of the catheter part 2 so that attachment or detachment is possible on the base end side rather than the proximal ends 11, 21, and 31 of the wing | blade part 10,20,30. And a distal end side fixing portion 72 fixed to the inner peripheral surface of the tube 1 on the distal end side of the distal ends 17, 27, 37 of the wing portions 10, 20, 30. In a state where the wing parts 10, 20, 30 are formed, the distal end side fixing part 72 and the proximal end side fixing part 73 are fixed to the inner peripheral surface of the tube 1. The shape 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 82 exposed to contents and body fluids that are intensely moved. Therefore, the indwelling state of the fistula catheter 100 can be kept good, and unintentional removal such as self-extraction can be suppressed.

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

  In the said embodiment, it comprised so that the 2nd curved part of one wing | blade part might be arrange | positioned in the radial inside of a 1st curved part. That is, in the example of the first embodiment, the second curved portion 35 of the wing portion 30 is arranged inside the first curved portion 13 of the wing portion 10 in the radial direction. However, instead of the adjacent wing part, the second bending part of one or more wing parts may be arranged on the radially inner side of the first bending part of a certain wing part. In order to do this, when the wing portion is formed by rotating the catheter portion 2 and the distal end region 4 in the opposite directions in the circumferential direction, the wing portion is further rotated than that described in the first to third embodiments. I will let you.

  Moreover, although the slit 5 was shown in the example each provided in the position which divides the surrounding wall of the tube 1 into radial direction, it does not need to be strictly divided equally. Moreover, in the said embodiment, although the number of the slits 5 was 3-5, the number of slits is not limited to this, It can also be made into 6 or more.

  In the above description, an example in which a slit is provided in order to form a belt in the tube has been shown. This slit forms a narrow gap in the tube, but instead of such a slit, a slit may be provided, and the belt may be formed by this slit.

  1 tube, 2 catheter part, 3 fixing part forming part, 4 distal end region, 5 slit, 5A slit, 6 belt, 6A belt, 7 extender locking part, 7a female screw, 10 wing part, 11 proximal end , 12 First belt portion, 13 First bending portion, 13a One end side, 13b Other end side, 14 Second belt portion, 15 Second bending portion, 15a One end side, 15b Other end side, 16 Third belt portion, 17 Distal End, 20 Wings, 21 Proximal End, 22 First Band, 23 First Curve, 24 Second Band, 25 Second Curve, 26 Third Band, 27 Distal End, 30 Wings 31, proximal end, 32 first belt portion, 33 first bending portion, 34 second belt portion, 35 second bending portion, 36 third belt portion, 37 distal end, 40 wing portion, 43 first bending portion Part, 45 second bending part, 50 wing part, 53 first bending part, 55 second bending part, 60 extension , 61 Engagement part, 61a Male screw, 62 Operation part, 63 Shaft part, 70 Inner tube, 71 Distal end locking part, 72 Distal end side fixing part, 73 Proximal end side fixing part, 74 Extender Stop part, 74a female screw, 81 abdominal wall, 82 digestive tract wall, 83 fistula, 100 fistula catheter, 100A fistula catheter, 100B fistula catheter, 100C fistula catheter, 100D fistula catheter, A catheter part, B body fixing part.

Claims (7)

A catheter portion comprising a portion of a tube;
In a fistula catheter formed by deforming the distal end side of the tube and having an in-vivo fixing part placed in the digestive tract wall,
The body fixing portion has a plurality of wing portions in which a belt formed by dividing a peripheral wall in a region spaced a predetermined distance from a distal end and a proximal end of the tube in a circumferential direction is deformed,
The plurality of wing parts include a first curved part and a second curved part that are curved by bringing the distal end side and the proximal end side of the belt closer to each other,
The fistula catheter, wherein the second curved portion of the other wing portion is arranged on the radially inner side of the first curved portion of each wing portion. The first bending portion and the second bending portion rotate the tube on the distal end side in the circumferential direction with respect to the tube on the proximal end side of the belt, and are close to the distal end side of the belt. The fistula catheter according to claim 1, wherein the fistula catheter is formed by bringing the distal end side closer. The fistula catheter according to claim 1 or 2, wherein the belt is formed in parallel to the axial direction of the tube. n belts (n is 3 or more),
When the said body fixing | fixed part is looked at perpendicular | vertical with respect to an axial direction, if n adjacent said 1st curved part is tied, a regular n-corner shape will be formed substantially. The fistula catheter according to any one of Items 3. The said tube was provided with the extension tool latching | locking part in which the extension tool of the said wing | blade part is detachably latched in the position of the distal end side rather than the said belt. The fistula catheter according to any one of the above. An inner cylinder inserted into the tube,
The inner cylinder is
A distal end side holding portion that holds the inner peripheral surface of the tube on the distal end side of the wing portion;
The fistula catheter according to any one of claims 1 to 5, further comprising a proximal end side holding portion that holds the inner peripheral surface of the tube on a proximal end side of the wing portion. The proximal end side holding portion of the inner cylinder detachably holds the inner peripheral surface of the tube, and releases the holding on the inner peripheral surface of the tube in a state where the wing portion is extended. The fistula catheter according to claim 6.

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