JP4524243B2 - Fistula catheter kit - Google Patents

Description

  The present invention relates to a fistula catheter kit excellent in operability for use in percutaneous endoscopic gastrostomy performed for the purpose of supplementing nutrients or drugs.

  As a method of administering nutrition to a patient who cannot take nutrients orally, in general, intravenous nutrition administration, gavage nutrition by inserting a feeding tube into the stomach or intestine nasally, and gastrostomy There are three methods of administration for enteral nutrition. In recent years, with the development of enteral nutrition and its administration method, enteral nutrition management by percutaneous endoscopic gastrostomy (PEG) has been frequently performed. Compared with surgical open gastrostomy, PEG is small invasion and can reduce the medical cost by overwhelmingly, so it has become the standard method for gastrostomy in Europe and America. Yes. The fistula catheter kit is for carrying out this PEG. Specifically, the fistula catheter kit is for transdermally supplying nutrients or drug solutions from the outside of the body into the stomach.

  Conventionally, various fistula catheter kits have been proposed. In general, a fistula catheter kit is located in the body in the installed state attached to the distal end portion of a catheter having a lumen for replenishing nutrients or chemicals from outside the body into the stomach, and the catheter is inserted from the stomach. It consists of an indwelling part that prevents it from being removed. If necessary, a flat extracorporeal fixing part is also provided at the rear end of the tube so that the tube is not buried in the stomach.

  Conventionally, this indwelling portion is usually formed by a thin shell balloon, and is configured so that expansion and contraction of the indwelling portion can be selected by supplying and discharging fluid to the balloon. However, if the indwelling part is a balloon type, it may be deformed unscheduled due to damage such as rupture, the catheter cannot be maintained embedded in the stomach, and may be removed from the stomach. .

  US Pat. No. 4,863,438 of Patent Document 1 discloses a fistula catheter kit that solves these problems. This fistula catheter kit is elastically deformed by an external force, and in a free state, it protrudes radially outward from the catheter. When an external force is applied, the indwelling part is projected coaxially with the catheter. And a non-balloon in-vivo indwelling portion in which the projected area is smaller than the overhanging state.

  According to this fistula catheter kit, when inserting a catheter from outside the body into the stomach, a rod-shaped obturator is inserted inside or outside the catheter to the tip of the catheter, and further the obturator is pushed in. As a result, the indwelling portion is elastically extended. In this state, the catheter is inserted into the stomach together with the obturator. After insertion, only the obturator is removed from the catheter, so that the indwelling portion is restored to the overhanging state. As described above, since the indwelling portion is a non-balloon type, unlike the balloon type after the catheter is embedded in the stomach, there is little possibility that the catheter is deformed unscheduled. Removal from is prevented.

  However, this fistula catheter kit is disclosed to insert a catheter into the stomach from outside the body through a fistula already built in a patient, but does not disclose the specific method. When constructing a fistula, a through hole is formed in the patient's abdominal wall and stomach wall with a needle or the like, and a catheter or the like is inserted into the through hole. At the time of this insertion, the stomach wall is fixed with a suture thread or the like so that it does not move with respect to the abdominal wall, but in reality it is difficult to fix completely, and the gastrostoma is not properly constructed, and acute May cause peritonitis.

  Japanese Patent No. 3347315 of Patent Document 2 solves this problem in constructing a fistula and is attached below the catheter 100 and the tube 101 as shown in FIGS. In this engaged state, an external force is transmitted from the outside of the body to the indwelling portion 102, and an in-rod passage 202 through which the guide wire 400 is inserted is provided. There is disclosed a gastrostomy catheter kit 500 comprising a hollow rod 200 and having a communication passage 105 in the indwelling portion 102 that connects the intra-rod passage 202 to a space in the stomach in an engaged state. The hollow rod 200 has a function as an obturator while inserting the guide wire 400.

Specifically, since the central axes of the through holes 303 of the stomach wall 302 and the abdominal wall 301 are not aligned and the catheter 100 cannot be inserted properly, the guide wire 400 is inserted through the through hole 303 and the abdominal wall along the guide wire 400 is inserted. 301 and the through-hole 303 of the stomach wall 302 are arranged in a row, so that the insertion path of the catheter 100 is optimized, and there is a passage in the rod 202 in the assembly of the hollow rod 200 and the extended indwelling portion 102. The guide wire 400 is passed through the communication passage 105, and the catheter 100 is inserted into the stomach from outside the body.
U.S. Pat. No. 4,863,438 Japanese Patent No. 3347315 (Claims 1-3, FIGS. 5-7)

  However, in the catheter kit described in Japanese Patent No. 3347315, when the indwelling portion 102 of the catheter 100 is elastically deformed from the free state to the external force acting state, the guide wire passage 202 passes through the operation portion 201 of the hollow rod 200. Therefore, when the operation part 201 of the hollow rod 200 is pushed with a finger, the guide wire 400 becomes an obstacle and makes the operator aware of avoiding the guide wire 400 (FIG. 22). It is also conceivable that the operation part 201 has a shape that extends largely outward in the radial direction of the hollow rod 200 so that the guide wire 400 does not become an obstacle. However, in this case, since the direction in which the operation part 201 of the hollow rod 200 is pushed with the finger is deviated from the central axis of the hollow rod 200, the force is not efficiently transmitted from the hollow rod 200 to the indwelling part 102 of the catheter 100. There's a problem.

On the other hand, since the catheter used in the conventional fistula catheter kit is entirely made of an elastic material, when an external force is applied by an obturator or a hollow rod, not only an indwelling portion but also a tube that does not need to be stretched is eliminated. It stretches out into meaning. That is, as shown in FIG. 22, it becomes a length _l 2 (> _{l 1)} length _{l 1} of the free state of the tube 101 in the external force acting state. In this case, since the external force is not concentrated on the indwelling portion, an operation for further increasing the external force may be performed, and the insertion operation into the body becomes more difficult. Further, in the conventional fistula catheter kit, when the indwelling portion is pushed and extended by the obturator or the hollow rod, the obturator or the hollow rod breaks through the tip of the indwelling portion at the contact portion, and the indwelling portion There was a problem that could not be inserted into the body. Furthermore, in the conventional fistula catheter kit, the operation of pushing and extending the indwelling portion 102 of the catheter 100 and the operation of inserting the catheter 100 into the stomach must be performed simultaneously, compared to the method of performing individual operations sequentially. There was a problem of requiring operation force and operation technology.

  Accordingly, an object of the present invention is to provide a fistula catheter kit with improved operability when inserted into a fistula of a catheter kit used in percutaneous endoscopic gastrostomy.

That is, the present invention relates to a fistula catheter kit including a catheter, an obturator, and an outer cylinder for percutaneously replenishing a patient with a nutrient or a drug solution from the outside of the body into the stomach. A tube extending along the wall surface of the fistula having a nutrient passage to be introduced into the tube, and a projecting shape that is expanded to the outside in the radial direction of the tube attached to the distal end portion of the tube, and an action of an external force by the obturator And a non-balloon in-vivo indwelling portion that is indwelled in the stomach in a living body-embedded state, and an in-vivo fixed portion that projects in the radial direction of the tube attached to the rear end of the tube. And a communication hole for connecting the guide wire passage of the obturator attached to the distal end portion of the indwelling portion from outside the body to the stomach And than, the outer cylinder is engaged removal can engaged with the tube of the catheter, which has a obturator passage obturator is slidably engaged, said obturator, abuts on the indwelling unit are those to be engaged removal can engaged in said barrel, as it has a guide wire passage for inserting the guide wire, an operation portion for transmitting an external force to said body indwelling section which is attached to the rear end there are, further have a locking means for locking the push stretched state of the indwelling portion of the catheter caused by applying an external force to the operating portion of the obturator, said locking means of the sheet to be branched from the rod body of the obturator A protrusion formed at the tip and spring-biased outward, and two lock holes provided in the vertical direction of the outer cylinder. By the engagement of the click hole, there is provided a fistula catheter kit for locking the push stretched state of the indwelling portion of the catheter.

  The present invention also provides the fistula catheter kit, wherein the obturator has a hollow guide wire passage.

  In addition, the present invention is used by being inserted through the communication hole and the guide wire passage, and in the inserted state, the assembled body of the indwelling portion, the tube and the obturator is passed from the outside of the body to the stomach through the fistula. The fistula catheter kit is further provided with a guide wire for guiding insertion into the fistula.

  The present invention also provides the fistula catheter kit having a flat shape in which the expanded diameter (diameter) in the free state of the indwelling portion is longer than the length in the axial direction of the tube.

  The present invention also provides the fistula catheter kit in which a protrusion is further attached to the distal end of the indwelling portion.

  The present invention also provides the fistula catheter kit in which a portion of the indwelling portion with which the tip of the obturator abuts is reinforced by a reinforcing member.

  According to the present invention, when the center (axial core) of the operation portion of the obturator is pushed with a finger, the force is efficiently transmitted to the indwelling portion of the catheter. In addition, the catheter can be inserted into the stomach while the extended state of the catheter indwelling portion is locked, and the operation becomes easier.

  Further, according to the present invention, it is possible to concentrate the acting force by the obturator on the indwelling portion without unnecessarily stretching the tube. For this reason, it is easy to insert the catheter into the body.

  Further, according to the present invention, the guide wire can be reliably inserted into the obturator.

  In addition, according to the present invention, the assembly of the catheter and obturator can be reliably inserted into the stomach from outside the fistula by guiding the guide wire.

  In addition, according to the present invention, when the catheter is inserted into the stomach, the projection area obtained by projecting coaxially with the indwelling portion can be reduced from the free state with a smaller force than before, so that the patient can This burden can be reduced, the operator's operability is improved, and the working time can be expected to be shortened. In addition, the fistula catheter can be stabilized in the abdomen of the patient.

  Further, according to the present invention, when the catheter is inserted into the fistula, the positioning of the indwelling portion with respect to the fistula is easy, and the operator's workability can be improved.

  Further, according to the present invention, even if an external force is applied to the indwelling portion by the obturator, the obturator does not break through the tip of the indwelling portion, and the indwelling portion can be easily and reliably inserted into the body in a reduced diameter state. Can be inserted into.

  Next, a fistula catheter kit according to the first embodiment of the present invention will be described with reference to FIGS. FIG. 1 is a schematic view of the catheter and obturator constituting the fistula catheter kit in the free state of this example, FIG. 2 is a perspective view of the catheter of FIG. 1, and FIG. 3 is a longitudinal sectional view of the catheter of FIG. 4A is an enlarged end view taken along line AA in FIG. 1, FIG. 4B is an enlarged end view seen along line BB in FIG. 1, and FIG. Fig. 5 is an enlarged end view taken along line C-C in Fig. 1, Fig. 5 is a schematic view of the fistula catheter kit in the external force acting state of this example, and Fig. 6 is an enlarged view of the distal end portion of the catheter in Fig. 1. FIG. 7 and FIG. 7 are explanatory views showing an example of a one-way valve. In the present specification, “tip” refers to the inside of the body, and “rear end” refers to the outside of the body.

  The fistula catheter kit 50 according to the first embodiment is composed of a catheter 10 and an obturator 20, and replenishes a patient with a nutrient or a chemical solution from the outside of the body into the stomach.

  The catheter 10 is made of an elastic material, has a nutrient passage 13 for introducing nutrients or chemicals into the stomach from outside the body, and extends along the wall surface 34 of the fistula 33, and is attached to the distal end portion of the tube 11. A non-balloon in-vivo indwelling portion 12 and an extracorporeal fixing portion 14 attached to the rear end of the tube so that the in-vivo indwelling portion 12 and the tube 11 are not buried in the stomach.

  The indwelling part 12 is provided in a portion located in the stomach of the patient with the catheter 10 embedded in the body, so that the catheter 10 is not removed from the patient. In other words, the indwelling portion 12 is made of an elastically deformable material, and has a protruding shape that is expanded outward in the radial direction of the tube 11 in a free state, and is contracted from the protruding state by the action of an external force by the obturator 20. In addition, it is placed in the stomach in a living body embedded state (FIG. 5).

  The indwelling portion 12 has a shape that prevents the removal of the catheter 10 in the free state, and is not particularly limited as long as it is a shape that can be easily inserted into the fistula 33 in the external force acting state. For example, FIG. As shown in FIG. 3, the arm is formed into a malecot shape with two or more arms 124, and further includes notches 121 and 122 inside the joint (crotch) portion between the arms on the distal end side and the rear end side of the indwelling portion. Things. The notches 121 and 122 may be provided only on one side. Since the notches 121 and 122 are attached, the bulk of the joint portion between the arms 124 can be reduced in the external force acting state of the indwelling portion 12, and the insertion and removal of the catheter 10 into the fistula can be performed. The burden on the patient can be reduced, and the operator's workability can be improved.

  In addition, the gradual change R processing of the outer corner (edge) 127 of the arm 124 of the indwelling portion 12 makes the shape of the indwelling portion 12 in the external force acting state the same as that of the tube 11, that is, a bulky shape. This is preferable in that it can be approximated to a linear shape. While normal R machining is R machining for all corners with the same dimensions, the thickness of the arm as a whole is the same, whereas gradual change R machining is a corner of the portion 126 that becomes bulky in the external force acting state. By taking a larger R only, the thickness of that portion is reduced, and the thickness of the entire arm becomes non-uniform.

  Moreover, it is desirable that the indwelling portion 12 has a flat shape in which the diameter “a” expanded outward in the radial direction of the tube 11 is larger than the length “b” in the axial direction of the tube. Thereby, in a state where the catheter is placed inside the patient's stomach, stimulation to the stomach bottom of the patient can be reduced.

  The distal end portion of the indwelling portion 12 further has a contact portion 18 on which an external force acts. The abutting portion 18 is a portion where the distal end 24 of the obturator 20 abuts and is pushed into the body. In addition, the contact portion 18 is provided with a communication hole 15 for performing a communication function between the outside of the body and the stomach in cooperation with the guide wire passage 22 of the obturator 20. As a result, if a guide wire 40 to be described later is passed through the communication hole 15 and the guide wire passage 22, the assembly of the tube 11 and obturator 20 is reliably inserted into the stomach from outside the body through the fistula by the guide wire 40. Can do.

  The abutment portion 18 is reinforced by a reinforcing member 19, and even when an external force is applied to the indwelling portion 12 by the obturator 20, the obturator 20 does not break through the distal end of the indwelling portion 12 and penetrates the indwelling portion 18. This is preferable in that the portion 12 can be easily and reliably inserted into the body in a reduced diameter state. The reinforcing member 19 is not particularly limited in shape, material, or the like unless it interferes with the function of communicating between the body and the stomach through the joint of the communication hole 15 provided in the indwelling portion 12 and the guide wire passage 22 of the obturator 20. Although not limited, what was formed with materials, such as a metal or a thermosetting resin, is mentioned, for example, It is especially preferable that it is a metal mesh. Thereby, the contact part 18 will be in the state by which the reinforcement member 19 was embed | buried in resin, the contact area of a metal mesh and an elastic deformation material can expand, and it can improve intensity | strength.

  The extracorporeal fixation unit 14 is provided in a portion located outside the patient's body in the catheter embedded state, and prevents the catheter 10 from being embedded in the patient's body. The shape of the extracorporeal fixing part 14 is an overhanging shape in the radial direction of the tube 11 attached to the rear end of the tube 11, for example, a flat object attached around the opening of the rear end of the nutrient passage 13. . Since the extracorporeal fixation part 14 is the only part of the catheter 10 that can be seen by the patient, a flat object is preferable in that it is less bulky and does not hinder the patient's life. Further, a plug 17 that fits into the opening at the rear end of the nutrient passage 13 is attached to the extracorporeal fixing portion 14 of this example via a connecting member 171. When the plug 17 is not implanted with nutrients or a drug solution from the outside of the body into the stomach in a catheter-embedded state, the plug 17 is fitted into the opening of the nutrition passage 13 to keep the stomach tight.

  Further, the catheter 10 includes a one-way valve 16 attached to the distal end portion of the tube 11, that is, the outlet of the nutrient passage 13, so that nutrition or drug solution can be percutaneously supplied to the patient from the outside of the body into the stomach. This is preferable in that the liquid can be prevented from flowing back from the stomach to the outside of the body. On the other hand, as the valve 16, a known valve can be used. For example, the valve 16 includes a pair of valve members 16a and 16b extending from the tip of the tube 11 as shown in FIG. For this reason, a pair of valve members 16a and 16b are closed to form an airtight state, and in a replenishment state such as nutrition, the pair of valve members 16a and 16b are open.

  A protrusion 191 is attached to the outer wall surface at the tip of the indwelling portion 12. This protrusion 191 has a substantially semicircular cross-sectional shape, and its maximum diameter is substantially the same as the diameter of the tube 11. Thus, when the catheter 10 is inserted into the fistula, the positional relationship of the indwelling portion 12 with respect to the fistula can be easily seen, and the operator's workability can be improved. The size of the protrusion is not particularly limited, and the maximum diameter may be smaller than the diameter of the tube 11.

  The indwelling portion 12, the tube 11, the external fixation portion 14, the one-way valve 16, and the reinforcing member 19 that form the catheter 10 are usually manufactured by compression molding, and preferably by integral molding.

  The obturator 20 is detachably engaged with the tube 11 of the catheter, and the one having an outer diameter slightly smaller than the inner diameter of the tube 11 does not stretch the tube in a meaningless manner, and the action by the obturator. This is preferable in that the force can be concentrated on the indwelling portion. Further, the obturator 20 is detachably engaged with the catheter 10 until it comes into contact with the indwelling portion 12, and a guide wire passage 22 for inserting a guide wire 40 attached halfway from the tip of the rod-like portion 25. The operation part 21 for transmitting an external force to the indwelling part 12 attached to the rear end thereof is provided, and the rear end part 23 of the guide wire passage 22 and the operation part 21 are arranged in a separated state. Obturator 20 is usually produced by injection molding. By arranging the rear end portion 23 of the guide wire passage 22 and the operation portion 21 in a separated state, the guide wire 40 does not become an obstacle when the operation portion 21 of the obturator 20 is pushed with a finger. Moreover, the center (axial center) of the operation part 21 of the obturator 20 can be pushed with a finger, and the force is efficiently transmitted to the indwelling part 12 of the catheter 10.

  Although it does not restrict | limit especially as the guide wire channel | path 22, it is a hollow part of the circular cross section which has an internal diameter larger than the diameter of a guide wire in this example. The guide wire passage 22 forming portion, that is, the minimum length from the tip to the middle of the rod-like portion 25 is not particularly limited, but it may be larger than the maximum length of the catheter in the external force acting state. It is preferable in terms of ease of handling and the like. The rear end of the guide wire passage 22 is connected to the opening window 26 of the rod-like portion 25 and communicates with the outside. Thereby, the guide wire 40 is used by being inserted into the communication hole 15, the guide wire passage 22 and the opening window 26 of the catheter 11, and the assembled body of the indwelling portion 12, the tube 11 and the obturator 20 in the inserted state is used. Insertion into the stomach from outside the body through the fistula 33 can be induced.

  Next, a method for using the fistula catheter kit of the first embodiment will be described. The method for using the fistula catheter kit of this example sequentially performs a patient-side pretreatment step, a catheter kit pre-gastric insertion step, and a catheter kit intragastric insertion construction step. The patient-side pretreatment process is a process until the stomach wall and abdominal wall of the patient are fixed. That is, first, an endoscope is inserted into the stomach of a patient to sufficiently supply air, and the abdominal wall 31 and the stomach wall 32 are brought into close contact with each other. Next, the position of the stomach is confirmed by transmitted light from the endoscope, the abdominal skin is disinfected, and local anesthesia is performed. Subsequently, in order to prevent the relative position of the abdominal wall 31 and the stomach wall 32 from being shifted at that portion, gastric wall abdominal wall fixation is performed. A small incision is made with a scalpel in the vicinity of the stomach wall and abdominal wall fixation. This site is a site where the catheter 10 is to be inserted.

  In the pre-gastric insertion step of the catheter kit, first, a hollow needle or a sheathed needle is passed through the small incision site in the order of the abdominal wall 31 and the stomach wall 32 to form an insertion hole. The guide wire 40 is inserted into the stomach through the hollow hole or the lumen of the sheath into the insertion hole. After the insertion is completed, the hollow needle or the sheathed needle is removed from the patient while the guide wire 40 remains. Prior to insertion of the catheter 10 into the stomach, a sufficiently long length of the guide wire 40 is inserted into the stomach so that the guide wire 40 is not pulled out unexpectedly during the subsequent operation.

  Next, an operation for expanding the diameter of the insertion hole 33 is performed. For example, the dilator is inserted into the insertion hole 33 along the guide wire 40. After the expansion operation, the dilator is removed from the patient with the guide wire 40 left. Next, the obturator 20 is inserted from the rear end opening of the tube 11. The connecting wire 15 of the indwelling portion 12, the guide wire passage 22 of the obturator 20, and the opening window 26 are passed through the guide wire 40 coming out of the body from the insertion hole 33 in this order, and the catheter 10 is directed toward the stomach. Insert. At this time, the distal end 24 of the obturator 20 is in a free state where it abuts against the abutment portion 18 of the indwelling portion 12, and the indwelling portion 12 is in an overhanging state in which the diameter is expanded outward in the radial direction of the tube 11.

  Next, when the operating portion 21 of the obturator 20 is further pushed in, the indwelling portion 12 is reduced in diameter from the overhanging state and deformed to the external force acting state by the action of the external force by the obturator 20 (FIG. 5). In this state, the guide wire passage 22 of the obturator 20 used by inserting the guide wire 40 and the communication hole 15 attached to the contact portion 18 are in the inserted state. As described above, the operation of pushing the operation portion 21 of the obturator 20 with a finger is performed without worrying about the guide wire 40 because the opening window 26 that is the rear end portion of the guide wire 40 and the operation portion 21 are in the separated state. The center part (axial core) of the operation part 21 can be pushed in. Note that the timing for inserting the guide wire 40 into the communication hole 15, the guide wire passage 22 and the opening window 26 of the indwelling portion 12 is not limited to the above-described timing, and is performed after the indwelling portion 12 is brought into an external force acting state. May be.

  Next, the intragastric insertion construction process of the catheter kit is performed. The intragastric insertion construction step is a step of inserting an assembly of the catheter 10 and obturator 20 including the indwelling portion 12 that is elastically deformed and reduced in diameter from the overhanging state along the guide wire 40 into the stomach. The indwelling portion 12 is inserted into the stomach by the guide wire 40, and the insertion is stopped when the extracorporeal fixing portion 14 at the rear end of the tube 11 comes into contact with the abdominal wall 31 of the patient. In the insertion of the catheter kit into the stomach, the guide wire 40 can be inserted without worrying about the guide wire 40 outside since the guide wire 40 is removed from the obturator 20 away from the operation unit 21. Next, the operating force applied to the operating portion 21 of the obturator 20 is weakened, and the indwelling portion 12 in the external force acting state is restored to the free state. Thereby, the removal prevention function from the patient of the catheter 10 is also restored.

  When the catheter 10 inserted and constructed in the stomach by such a method does not percutaneously supply nutrients or chemicals from outside the body to the stomach, the plug 17 attached to the extracorporeal fixing portion 14 is attached to the tube 11. By fitting it into the opening at the rear end of the stomach, airtightness in the stomach can be maintained. Moreover, when supplying nutrition or a chemical | medical solution to a patient percutaneously from the inside of a body to the stomach, the fitting of the stopper 17 and the nutrient passage 13 can be removed, and the treatment of nutrition supplementation can be performed.

  According to the fistula catheter kit in the first embodiment, since the rear end portion of the guide wire passage in the obturator and the operation portion are arranged in a separated state, when the operation portion of the obturator is pushed with a finger, the guide wire is Since it does not become an obstacle, the operator does not have to worry about the guide wire. Further, the force can be efficiently transmitted to the in-vivo indwelling portion of the catheter by pushing the center of the operation portion of the obturator with a finger. Further, by guiding the guide wire, the assembly body of the catheter and obturator can be reliably inserted from the outside of the body into the stomach through the fistula.

  Next, a fistula catheter kit according to the second embodiment will be described with reference to FIGS. FIG. 8 (A) is a front view of the obturator used in the catheter kit of this example, FIG. 8 (B) is a right side view of FIG. 8 (A), and FIG. 9 (A) is D in FIG. FIG. 9B is a view taken along the line EE of FIG. 8, and FIG. 10A is a view of the outer tube used in the catheter kit of this example. FIG. 10 (B) is a right side view of FIG. 10 (A), FIG. 11 (A) is a view taken along line FF of FIG. 10, and FIG. 11 (B) is a front view. FIG. 12 is a view taken along line GG of FIG. 10, FIG. 12 is a schematic view of the assembly of the catheter kit of this example in a free state, FIG. 13 is an enlarged longitudinal sectional view of FIG. Fig. 15 is an enlarged schematic view of the assembly in the external force acting state of the catheter kit of this example, Fig. 15 is a diagram for explaining the tube deformation regulating action in the catheter kit of this example, Is a diagram illustrating a deformation of the tube in a conventional catheter kit.

  In the fistula catheter kit in the second embodiment shown in FIGS. 8 to 15, the same components as those in FIGS. 1 to 7 are denoted by the same reference numerals, and the description thereof is omitted. Mainly explained. That is, the catheter kit according to the second embodiment differs from the catheter kit according to the first embodiment in that the guide wire passage of the obturator is used as a groove, and the outer tube of the obturator is used as a new component. The point provided is that the obturator and the outer cylinder are provided with a lock mechanism.

  The guide wire passage of the obturator 20a used in the catheter kit of this example is the groove 22a. Since this obturator 20a uses an outer cylinder 60 described later when engaging the catheter, a hollow portion is formed by the groove 22a and the inner wall of the outer cylinder 60. For this reason, the insertion and guidance of the guide wire 40 are not hindered. Moreover, the obturator 20a provided with the groove 22a can reduce the manufacturing cost by injection molding as compared with the obturator 20 provided with a hollow portion in a circular cross section.

  The obturator 20a has a protrusion 29 that constitutes a lock mechanism above the groove 22a and below the operation unit 21. The protrusion 29 is at a position moved 90 degrees in the circumferential direction with respect to the guide wire passage 22a, is formed at the tip of the thin plate 28 branched from the rod body 25, and is biased outward by a spring. The projection 29 is engaged with two lock holes 62a and 62b provided in the outer cylinder 60, which will be described later, so that the tip position of the obturator is determined at any two positions with respect to the tip position of the outer cylinder. It is. The position of the protrusion 29 is not limited to the position moved 90 degrees in the circumferential direction with respect to the guide wire passage 22a, and may be in any position.

  The outer cylinder 60 is normally manufactured by injection molding, is engaged with the tube 11 of the catheter so as to be removable, and restricts deformation of the tube 11 having an outer diameter slightly smaller than the inner diameter of the tube 11. 64, an obturator passage 61 in which the obturator 20a is slidably engaged, a lateral hole 63 for taking out the guide wire 40 to the outside, and a 90 degree movement in the circumferential direction above the lateral hole 63 and relative to the lateral hole 63 The lock holes 62a and 62b are provided at two positions above and below the predetermined position. The outer cylinder 60 of this example uses a cylindrical object that is fitted into the tube 1 with almost no gap. The circular outer peripheral surface of the outer cylinder 60 is a restriction part 64, and the hollow part of the cylindrical object is an obturator passage 61.

That is, the restricting portion 64 has an outer peripheral surface shape on the distal end side of the outer cylinder 60, and restricts deformation of the tube 11 in the longitudinal direction when an external force is applied to the indwelling portion 12. In the conventional catheter kit shown in FIG. 16, there is a gap 112 between the tube 11 and obturator 20a. For this reason, when the abutment portion 18 of the indwelling portion 12 is pushed and extended by the obturator 20a, not only the indwelling portion 12 but also the tube 11 is stretched while being reduced in diameter, as shown by a two-dot chain line in FIG. The entire result is stretched to a length of l ₃ + l ₄ + l ₅ . On the other hand, in the catheter kit 50a of this example, since the cylindrical outer cylinder 60 is fitted into the tube 11 with almost no gap, the outer cylinder regulates the diameter of the tube 11 even when an external force is applied. To do. For this reason, the acting force hardly acts on the tube 11, the acting force concentrates only on the indwelling portion 12, and the deformation of the tube 11 in the longitudinal direction is restricted. In FIG. 15, the total length is l ₃ + l ₅ . Thus, the shape of the restricting portion 64 is not limited to a shape that acts on the entire inner peripheral surface of the tube 11 without a gap, and it is sufficient that a part thereof is in contact, for example, a substantially I-shaped cross section, a substantially T-shaped cross section, Examples include a substantially inverted T-shaped cross section, a substantially cross-shaped cross section, and a substantially rectangular cross section.

  The obturator passage 61 is usually a circular hollow portion, and the obturator 20a is slidably engaged therewith. It is preferable that the inner diameter of the obturator passage 61 is slightly larger than the outer diameter of the obturator 20a in that the obturator 20a can slide without being subjected to frictional resistance in the obturator passage 61 and can be easily operated.

  When the outer tube 60 and the catheter 10 are engaged, the lateral hole 63 is located above the catheter 10 and is disposed so as to overlap the groove 22a of the obturator 20a. Thereby, the insertion hole of the guide wire 40 formed by the groove portion 22a of the obturator 20a and the lateral hole 63 communicates with the outside. Accordingly, the guide wire 40 is used by being inserted into the communication hole 15, the groove 22a and the lateral hole 63 of the catheter 11, and the assembled body of the indwelling portion 12, the tube 11, the obturator 20a, and the outer cylinder 60 in the inserted state. The insertion from the outside of the body into the stomach through the fistula 33 can be induced.

  When the two lock holes 62a and 62b are engaged with the protrusion 29 of the obturator 20a, the tip position of the obturator 20a can be determined at any two positions with respect to the tip position 111 of the outer cylinder 60. That is, in the free state shown in FIG. 13, the protrusion 29 of the obturator 20a and the lock hole 62a above the outer cylinder 60 are engaged. Thereby, the distal end position of the obturator 20a is in the contact portion 18 of the indwelling body 12 in a free state with respect to the distal end position 111 of the outer cylinder 60 at the connection position of the tube 11 and the indwelling body 12. On the other hand, in the external force acting state shown in FIG. 14, the protrusion 29 of the obturator 20a and the lock hole 62b below the outer cylinder 60 are engaged. Thereby, the distal end position of the obturator 20a is further away from the distal end position 111 of the outer cylinder 60, and the contact portion 18 of the indwelling portion 12 is pushed and extended. Since the catheter 10 is made of an elastically deformable material, the lock function can be easily switched by the reaction force of the indwelling portion 12. Since the indwelling portion 12 can be maintained in the free state and the external force acting state by the lock function, the operation of pushing and extending the indwelling portion 12 by the obturator 20a and the operation of inserting the catheter 10 into the body are performed simultaneously. This eliminates the need to do so, improving work efficiency. Further, the locking function may be constituted by a spring spring and a protrusion fitted to the spring spring, instead of the protrusion 29 of the leaf spring of the obturator 20a as shown in FIGS. The lock function is achieved by sliding the protrusion 29 only in the longitudinal direction without moving between the two lock holes 62a and 62b in the circumferential direction. It does not affect the system.

  The method of using the fistula catheter kit of the second embodiment is a method of using the fistula catheter kit for constructing a living body gastrostomy, and the fistula formed so as to penetrate the abdominal wall and stomach wall of the living body. A step of inserting the guide wire to be inserted into the communication hole, the groove and the lateral hole while being locked in a free state or an external force acting state by a lock mechanism, and an assembly of the catheter, obturator and outer cylinder in the guide wire in the external force acting state. Inserting the assembled body into the stomach from outside the body through the fistula while guiding the body, embedding the indwelling portion in the stomach, releasing the lock, removing the obturator and the outer tube from the catheter, The step of elastically restoring the indwelling portion to a free state and removing the guide wire from the body is performed in this order. The method of using the fistula catheter kit of the second embodiment will be described mainly with respect to differences from the first embodiment. That is, the second embodiment is different from the first embodiment in the step before inserting the catheter kit 50a into the stomach. That is, in the pre-gastric insertion step of the catheter kit 50a, the outer tube 60 and obturator 20a are engaged with the catheter 10 and assembled (FIGS. 12 and 13). That is, the outer cylinder 60 is fitted into the tube 11 of the catheter 10, and the obturator 20 a is fitted into the obturator passage 61 of the outer cylinder 60. At this time, the operation portion 21 of the obturator 20a is pushed in a little to bring the tip 24 of the obturator 20a into contact with the contact portion 18 of the indwelling portion 12. At this time, the indwelling part 12 is expanded in the radially outer side of the tube 11 and is in a protruding free state. Next, the connecting hole 15 of the indwelling portion 12, the groove portion 22a of the obturator 20a, and the lateral hole 63 of the outer tube 60 are passed through the guide wire 40 that has come out of the body from the insertion hole 33 in this order, and the catheter assembly is placed in the stomach direction. Let each pass through.

  Next, when the operating portion 21 is pushed in, the indwelling portion 12 is reduced in diameter from the protruding state and deformed to the external force acting state by the action of the external force by the obturator 20a (FIG. 14). In this state, the catheter assembly is locked, and the communication hole 15 attached to the contact portion 18 and the groove portion 22a of the obturator 20a through which the guide wire 40 is inserted are inserted. The timing for inserting the guide wire 40 into the communication hole 15, the groove 22 a and the lateral hole 63 of the indwelling portion 12 is not limited to the above-mentioned timing, and may be performed after the indwelling portion 12 is in an external force acting state. Good.

  In the intragastric insertion construction process of the catheter kit 50a, the assembly of the catheter 10, the obturator 20a, and the outer tube 60 including the indwelling portion 12 that is elastically deformed and has a diameter reduced from the protruding state is the same as that of the first embodiment. What is necessary is just to insert in the stomach along the guide wire 40 by the same method. According to the assembly of the catheter 10, obturator 20a, and outer cylinder 60 of this example, the indwelling portion 12 can be maintained in an external force acting state by the locking function, and therefore the indwelling operation of the indwelling portion 12 by the obturator 20a is performed. And it is not necessary to perform the operation of inserting the catheter 10 into the body at the same time, and the working efficiency is improved.

  After the indwelling portion 12 is inserted into the body by the assembly of the catheter 10, obturator 20a, and outer cylinder 60, the locking mechanism in the external force acting state is released to restore the indwelling portion 12 to a free state. Thereby, the removal prevention function from the patient of the catheter 10 is also restored. Thereafter, the guide wire 40, obturator 20a, and outer cylinder 60 are removed from the patient. Thereby, embedding the catheter 10 in the patient is completed.

  According to the method of using the fistula catheter kit of the second embodiment, the catheter kit 50a has an outer cylinder with almost no gap in the tube 11 in addition to the same effects as the method of using the first embodiment. Since 60 is fitted, even if an external force is applied, the acting force hardly acts on the tube 11, and the acting force can be concentrated only on the indwelling portion 12. For this reason, compared with the case where the outer cylinder 60 is not used, a small acting force may be sufficient, and the lifetime of the contact part 18 will become long. Further, since the guide wire 40 passes through the passage formed by the groove 22a and the outer cylinder 60 in the obturator 20a, the passage functions as a hollow portion. Further, since the indwelling portion 12 is maintained in the external force acting state by the lock function, it is not necessary to simultaneously perform the operation of pushing and extending the indwelling portion 12 of the catheter 10 and the operation of inserting the catheter 10 into the body by the obturator 20a. , Work efficiency is improved.

  Next, a fistula catheter kit according to a third embodiment will be described with reference to FIGS. FIG. 17 is a perspective view of the outer cylinder used in this example, FIG. 18 (A) is a front view of the outer cylinder of FIG. 17, FIG. 18 (B) is the left side of FIG. FIG. 20 is a longitudinal sectional view of the assembled body in the free state of the catheter kit of this example, and FIG. 20 is a longitudinal sectional view of the assembled body in the external force acting state of the catheter kit of this example.

  In the fistula catheter kit in the third embodiment shown in FIGS. 17 to 20, the same components as those in FIGS. Mainly explained. That is, the catheter kit of the third embodiment is mainly different from the catheter kit of the second embodiment in that a finger hook and a stopper are provided on the outer cylinder, and an obturator is fitted to the outer cylinder. At this time, a spring spring is interposed. In other words, the outer cylinder 60 a of this example has an outer cylinder on the first base end portion 86 to which the stopper 80 positioned above the restricting portion 64 is attached and the second base end portion 87 positioned above the first base end portion 86. And a finger hook 70 attached in a projecting manner in a direction perpendicular to the radial direction of the. The lateral hole 63 is formed in the axial direction with a length from the first base end portion 86 to the finger hook 70, and the upper lock hole 621 is axially formed with a predetermined length in the cylindrical member on the upper side of the outer cylinder. Is formed. Further, a step 623 to which one end of the spring spring is fixed is formed in the obturator passage 61 of the outer cylinder 60a.

  The finger hook 70 attached to the second base end portion 87 of the outer tube 60a is used to assist the operation of pushing the operation portion 21 of the obturator 20a and transmitting an external force to the indwelling portion 12 of the catheter 10, and is one hand of the operator. This makes it easier to operate. That is, when the obturator 20a is used as a power point, the finger hook 70 of the outer tube 60a serves as a fulcrum, so that the operability of transmitting the external force by the obturator 20a to the indwelling portion 12 of the catheter 10 can be significantly improved.

  The stopper 80 is a member that restricts the movement of the catheter 10 in the distal direction relative to the outer tube 60 a when the indwelling portion contracts due to the action of an external force, and is a fitting formed on the first proximal end portion 86. An arm-like slide part 83 slidable on the part 65, a fixing part 85 having a pair of clamping parts 851 spaced apart by substantially the same length as the outer diameter of the tube 11 attached to one end of the slide part 83, and a fixing part A spring-like first pushing portion 81 extending in a direction bent by 180 degrees from one end of 85 and a second pushing portion 84 attached to the other end of the slide portion 83 are provided. The shape of the fitting portion 65 formed on the first base end portion 86 is not particularly limited. For example, a hole shape such as a round hole or a square hole; a groove shape such as an I-shaped groove, a T-shaped groove, or a curved groove Is mentioned. In this case, the cross-sectional shape of the slide portion 83 is also appropriately determined according to the shape of the fitting portion 65. The fitting portion 65 is preferably a groove shape in that the slide portion 83 of the stopper 80 can be detachably attached to the fitting portion 65. Further, it is preferable that a plurality of fitting portions 65 formed on the first base end portion 86 are provided at an appropriate pitch with respect to the axial direction. Thus, by attaching the stopper 80 to an appropriate position of the fitting portion 65 of the outer cylinder 60a and changing the position of the clamping portion 851, it is possible to cope with various catheters 10 having different tube 11 lengths.

  In order to assemble the catheter 10 and the outer cylinder 60a using the stopper 80, the positions of the catheter 10 and the outer cylinder 60a are determined and engaged in advance (the solid line portion in FIG. 18 (A)), and then the first pushing portion 81 Is pushed into the outer cylinder 60a side, and the catheter 10 is sandwiched so that the sandwiching portion 851 is located directly below the extracorporeal fixation portion 14 (the two-dot chain line portion in FIG. 18B). As a result, the displacement of the positional relationship between the catheter 10 and the outer cylinder 60a associated with the pushing and extending operation of the catheter 10 can be eliminated, and the acting force can be concentrated only on the indwelling portion 12; It doesn't stretch out meaninglessly.

  The method of using the fistula catheter kit of the third embodiment will be described mainly with respect to differences from the second embodiment. That is, the third embodiment is different from the second embodiment mainly in the pre-gastric insertion step of the catheter kit 50b. That is, in the pre-gastric insertion step of the catheter kit 50b, the outer tube 60a and the obturator 20a are engaged with the catheter 10 and assembled. That is, the outer cylinder 60a in which the obturator 20a is fitted in the obturator passage 61 is fitted into the tube 11 of the catheter 10, and then the first pushing portion 81 of the stopper 80 is pushed toward the outer cylinder 60a, so that the holding portion of the stopper 80 is held. At 851, the tube 11 immediately below the external fixation part 14 is clamped to obtain a catheter assembly. At this time, the operation portion 21 of the obturator 20a is pushed in a little to bring the tip 24 of the obturator 20a into contact with the contact portion 18 of the indwelling portion 12. At this time, the indwelling portion 12 is expanded in the radially outer side of the tube 11 and is in an overhanging free state (FIG. 19). When the obturator 20a is fitted into the obturator passage 61, a spring spring 98 is interposed in advance. Next, the connecting hole 15 of the indwelling portion 12, the groove portion 22a of the obturator 20a, and the lateral hole 63 of the outer tube 60a are passed through the guide wire 40 that has come out of the body from the insertion hole 33 in this order, and the catheter assembly is moved in the stomach direction. Let each pass through.

  Next, for example, when the index finger and the middle finger are hung on the finger hook 70, the thumb is hung on the operation portion 21 of the obturator 20a, the finger hook 70 of the outer tube 60a is used as a fulcrum, and the operation portion 21 of the obturator 20a is pushed in, the indwelling portion 12 is moved to the obturator 20a. Due to the action of the external force, the diameter is reduced from the overhanging state and is transformed into the external force acting state (FIG. 20). In this state, the catheter assembly is locked, and the communication hole 15 attached to the contact portion 18 and the groove portion 22a of the obturator 20a through which the guide wire 40 is inserted are inserted.

  After the indwelling portion 12 is inserted into the body by the assembly of the catheter 10, obturator 20a, and outer cylinder 60a, the protrusion 29 is pushed in, the locking mechanism in the external force acting state is released, and the stopper 80 is pushed in the second time. The part 84 is pushed into the outer cylinder 60a side, the nipping of the tube 11 is released, and the indwelling part 12 is restored to a free state. By this. The function of preventing removal of the catheter 10 from the patient is also restored. Thereafter, the guide wire 40, obturator 20a, and outer cylinder 60a are removed from the patient. Thereby, embedding the catheter 10 in the patient is completed. The unlocking of the assembly of the catheter 10, obturator 20a, and outer cylinder 60a and the release of the clamping action by the stopper 80 are not limited to the above order, and either may be performed first.

  According to the method of using the fistula catheter kit of the third embodiment, the catheter kit 50b has an outer cylinder with almost no gap in the tube 11 in addition to the same effects as the method of using the second embodiment. Since 60a is fitted, almost no acting force is applied to the tube 11 even if an external force is applied, and the catheter 11 and the outer cylinder 60a associated with the pushing and extending operation of the catheter 11 by the action of the stopper 80 The positional relationship is eliminated, and the acting force can be more concentrated on the indwelling portion 12 only.

  Further, the fistula catheter kit of the present invention can be used when a catheter already constructed in a patient (a catheter in use) is replaced with a new catheter. An example of this replacement work is shown below. First, the obturator 20 or obturator 20a and the outer cylinder 60 (60a) are inserted into the catheter 10 already built in the patient from the rear end opening of the tube 11. Next, the guide wire 40 is inserted into the opening window 26 of the obturator 20, the guide wire passage 22 and the communication hole 15 of the indwelling portion 12 in this order, or the lateral hole 63 of the outer tube 60 (60a), the groove portion 22a of the obturator 20a and the body. The guide wire 40 is inserted from the outside of the body into the stomach through the communication hole 15 of the indwelling portion 12 in this order. Subsequently, the operation part 21 of the obturator 20 or the obturator 20a is pushed in, and the indwelling part 12 is deformed into an external force acting state. And the catheter 10 is extracted from a patient with this state. At this time, only the catheter 10 and the obturator 20 or the obturator 20a and the outer tube 60 (60a) are removed from the patient, and the guide wire 40 is left in a state of being inserted through the abdominal wall 31 and the stomach wall 32 of the patient. This completes the extraction operation of the catheter 10 in use. Subsequently, using the new catheter 10, the catheter replacement operation is performed by sequentially performing the pre-gastric insertion step of the catheter kit of the first to third embodiments described above and the intragastric insertion construction step of the catheter kit. Ends.

  According to the present invention, if the center of the operation part of the obturator is pushed with a finger, the force is efficiently transmitted to the indwelling part of the catheter. In addition, the catheter can be inserted into the stomach while the extended state of the catheter indwelling portion is locked, and the operation becomes easier. Further, the assembly of the catheter and obturator or the assembly of the catheter, obturator and outer tube can be reliably inserted from the outside of the body into the stomach through the fistula by the guide wire. Further, according to the present invention, in percutaneous endoscopic gastrostomy, only the indwelling portion of the catheter can be pushed and extended, the operability is improved, and there is no need to worry about the guide wire. Can be expected to reduce stress and shorten operation time.

It is the schematic of the catheter and obturator which comprise the catheter kit for fistulas in the free state of this example. FIG. 2 is a perspective view of the catheter of FIG. 1. It is a longitudinal cross-sectional view of the catheter of FIG. (A) is an enlarged end view seen along the line AA in FIG. 1, (B) is an enlarged end view seen along the line BB in FIG. 1, and (C) is FIG. It is the expanded end view seen along the CC line. It is the schematic of the catheter kit for fistula in the external force action state of this example. It is an enlarged view of the front-end | tip part of the catheter of FIG. It is explanatory drawing which shows an example of a one-way valve. (A) is a front view of an obturator used in the catheter kit of the second embodiment, and (B) is a right side view of FIG. 8 (A). (A) is the figure seen along the DD line of FIG. 6, (B) is the figure seen along the EE line of FIG. (A) is a front view of the outer cylinder used with the catheter kit of this example, (B) is a right view of (A). (A) is the figure seen along the FF line | wire of FIG. 10, (B) is the figure seen along the GG line | wire of FIG. It is the schematic of the assembly body in the free state of the catheter kit of this example. It is a longitudinal cross-sectional view of FIG. It is the schematic of the assembly body in the external force action state of the catheter kit of this example. It is a figure explaining the tube deformation | transformation suppression effect in the catheter kit of this example. It is a figure explaining the tube deformation | transformation in the conventional catheter kit. It is a perspective view of the outer cylinder used with the catheter kit of the example of 3rd Embodiment. (A) is a front view of the outer cylinder of FIG. 17, and (B) is a left side of (A). It is a longitudinal cross-sectional view of the assembly in the free state of the catheter kit of this example. It is a longitudinal cross-sectional view of the assembly body in the external force action state of the catheter kit of this example. It is the schematic in the free state of the conventional catheter kit. It is the schematic in the external force action state of the conventional catheter kit.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Catheter 11 Tube 12 Non-balloon type indwelling part 13 Nutrition passage 14 Extracorporeal fixation part 20 Obturator 50 Fistula catheter kit 33 Fistula 34 Wall 124 Arm 121, 122 Notch

Claims (6)

In a catheter kit for fistula comprising a catheter, obturator, and outer tube for percutaneously replenishing a patient with nutrients or chemicals from outside the body into the stomach,
The catheter has a tube extending along the wall of a fistula having a nutrient passage for introducing nutrient or drug solution from outside the body into the stomach, and the diameter of the catheter is increased radially outward of the tube attached to the distal end of the tube. A non-balloon indwelling portion that is placed in the stomach and attached to the rear end of the tube in a living body embedded state. The tube has an externally fixed part protruding in the radial direction of the tube, and a communication hole for connecting the guide wire passage of the obturator attached to the distal end of the indwelling part from outside the body to the stomach,
The outer cylinder is detachably engaged with the tube of the catheter, and has an obturator passage in which the obturator is slidably engaged.
The obturator is detachably engaged with the outer cylinder until it comes into contact with the indwelling portion, and is connected to a guidewire passage for inserting a guidewire, and the indwelling portion attached to the rear end. be one having an operation section for transmitting an external force, further have a locking means for locking the push stretched state of the indwelling portion of the catheter caused by applying an external force to the operating portion of the obturator,
The locking means comprises a protrusion formed at the tip of a thin plate branched from the rod body of the obturator and spring-biased outward, and two lock holes provided in the vertical direction of the outer cylinder, A fistula catheter kit characterized by locking a stretched state of an indwelling portion of the catheter by engagement between a protrusion and the lock hole below. Guide wire passage of the obturator, fistula catheter kit according to claim 1, wherein the hollow portion. It is used by being inserted through the communication hole and the guide wire passage, and in the inserted state, the insertion of the indwelling portion of the body, the tube, and the obturator into the stomach from outside the body through the fistula is guided. the guide wire, fistula catheter kit according to claim 1 or 2, further comprising. The fistula according to any one of claims 1 to 3 , wherein an expanded diameter (diameter) of the indwelling portion in a free state is a flat shape longer than a length in the axial direction of the tube. Catheter kit. The fistula catheter kit according to any one of claims 1 to 4 , further comprising a protrusion attached to a tip of the indwelling portion. The fistula catheter kit according to any one of claims 1 to 5 , wherein a portion of the indwelling portion with which the tip of the obturator abuts is reinforced by a reinforcing member.

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