JP5896641B2 - catheter - Google Patents

Description

  The present invention relates to a catheter used for injecting a contrast medium or the like into a tubular organ such as a blood vessel, a ureter, a bile duct, or a trachea, or placing a stent or the like.

  Conventionally, a tubular catheter is inserted into a tubular organ such as a blood vessel, ureter, bile duct, trachea, etc., and a medical solution such as a contrast agent, an anticancer agent, or a nutrient is injected through this catheter, or a guide wire is used in combination. A stent, a blood vessel obturator, or the like is placed.

  A catheter having a plurality of lumens may be used as this type of catheter. For example, such a catheter passes a guide wire through one lumen, moves the catheter through the guide wire, and injects a contrast medium from the other lumen, or from one lumen during dialysis. It is used for various purposes such as removing blood and returning purified blood from the other lumen, or simultaneously injecting a non-mixable drug solution with two lumens.

  For example, Patent Document 1 below discloses a vascular access catheter in which a blood removal lumen and a blood return lumen are formed in one catheter. This vascular access catheter (1) has a blood return lumen (22) and a blood removal lumen (21) formed by dividing the catheter lumen into two semicircular shapes. The distal end portion of the catheter (1) forms a semi-cylindrical narrow-diameter portion (11) formed by cutting the blood removal lumen (21) while leaving the blood return lumen (22). The opening (12) on the distal end side of the blood removal lumen (21) is cut obliquely so that the height gradually decreases toward the dividing surface of the narrow diameter portion (11).

JP 2008-132256 A

  However, in the above-mentioned vascular access catheter (1), the wall of the narrow-diameter portion (11) is thin, and the rigidity of the narrow-diameter portion (11) is lowered and easily deformed. When trying to insert into a stenosis, etc., sufficient pushability could not be obtained and insertion could be difficult.

  Accordingly, an object of the present invention is to provide a catheter having two lumens, having a reduced diameter tip, and maintaining rigidity that can be inserted into a narrow part of a tubular organ.

  In order to achieve the above object, the catheter of the present invention has a first lumen and a second lumen, and the first lumen forms a passage from the proximal end to the distal end of the catheter to form the passage at the distal end of the catheter. A portion having a predetermined length from the distal end of the catheter is reduced in diameter through a tapered step portion, leaving a cylindrical portion including the first lumen, and the second lumen is a base of the catheter. A passage extending from an end to the step portion is formed and opened at the step portion, and the second lumen is formed from the opening of the step portion on the outer periphery of the portion reduced in diameter by a predetermined length from the distal end of the catheter. A groove portion having a shape in which a part of the inner periphery of the opening is extended is formed along the axial direction of the opening, and the inner periphery of the groove portion has an arc shape.

  In the catheter of the present invention, it is preferable that the portion reduced in diameter by a predetermined length from the distal end of the catheter has a shape further reduced in diameter toward the distal end, including the inner periphery of the first lumen. .

  In the catheter of the present invention, radiopaque markers are provided on the inner periphery of the first lumen at a position close to the distal end opening of the first lumen and a position close to the distal end opening of the two lumen. It is preferable that

  According to the present invention, the portion having a predetermined length from the distal end of the catheter has a reduced diameter while leaving a part of the wall portion forming the second lumen (the wall portion on the first lumen side). Is sufficiently secured, and rigidity (pushability) that can be inserted into a narrow portion such as a narrowed portion of a tubular organ can be imparted.

  Further, when the guide wire is inserted into the second lumen, the guide wire inserted from the opening of the step portion advances along the groove portion extended from the opening of the step portion. Can guide the direction. Furthermore, even when a chemical solution such as a contrast medium is flowed through the second lumen, the chemical solution flowing out from the opening of the step portion flows along the groove portion, so that the outflow direction of the chemical solution can be easily controlled.

1 is a perspective view showing an embodiment of a catheter according to the present invention. The catheter is shown, (a) is sectional drawing (longitudinal sectional view) when it cuts along the axial direction, (b) is sectional drawing in the BB arrow line of (a), (c) (A) is sectional drawing in the CC arrow line of (a). An example of how to use the catheter is shown, and is an explanatory view showing the first step. It is explanatory drawing which shows the 2nd process of the usage method. It is explanatory drawing which shows the 3rd process of the usage method. It is explanatory drawing which shows the 4th process of the usage method. It is explanatory drawing which shows the 5th process of the usage method. It is explanatory drawing which shows the other example of the usage method of the catheter which concerns on this invention.

  Hereinafter, an embodiment of the catheter of the present invention will be described with reference to the drawings.

  As shown in FIGS. 1 and 2, the catheter 10 in this embodiment has a first lumen 11 and a second lumen 12. The first lumen 11 forms a passage from the proximal end to the distal end of the catheter 10 and opens at the distal end of the catheter 10 with an opening 11a (see FIG. 2A).

  In addition, a portion having a predetermined length from the distal end of the catheter 10 is reduced in diameter while leaving a cylindrical portion including the first lumen 11 through a tapered step portion 15 whose height gradually decreases toward the distal end portion. A diameter portion 17 is formed. The distal end portion of the reduced diameter portion 17 has a shape that is further reduced in diameter toward the catheter distal end, including the inner periphery of the first lumen 11, and the inner diameter R3 of the opening 11a at the distal end of the first lumen 11 (FIG. 2). (See (a)) is narrower than the inner diameter of the other portion of the first lumen 11.

  In this embodiment, the second lumen 12 has an inner diameter larger than the inner diameter of the first lumen 11 and is formed substantially parallel to the first lumen 11, and is a passage from the proximal end of the catheter 10 to the step portion 15. In addition, the step 15 forms an opening 15a.

  As shown in FIGS. 1, 2 (a) and 2 (c), the outer periphery of the reduced diameter portion 17 extends from the opening 15 a of the step portion 15 along the axis F direction of the second lumen 12. A groove 20 having a shape in which a part of the inner periphery of the opening 15a is extended is formed. That is, the groove portion 20 has a shape that is cut in the axial direction while leaving a part of the peripheral wall of the second lumen 12 on the first lumen 11 side, and the inner periphery thereof has an arc shape. Flat surfaces 22 higher than the arc-shaped groove bottom of the groove portion 20 are formed on both sides of the groove portion 20.

  Further, as shown in FIG. 2 (a), the inner circumference of the first lumen 11, a position close to the opening 11a at the tip of the first lumen 11, and a position close to the opening 15a of the second lumen 12. Are provided with radiopaque X-ray markers 24 and 25, respectively. The X-ray markers 24 and 25 in this embodiment have a ring shape and are embedded in the inner periphery of the first lumen 11 so that no step is formed between the inner periphery of the first lumen 11.

The X-ray markers 24 and 25 are made of synthetic resin containing powders such as Pt, Ti, Pd, Rh, Au, W, Ag, Bi, Ta and alloys thereof, and BaSO ₄ , Bi, and W. Stainless steel or the like can be used. In addition to the ring shape, the X-ray markers 24 and 25 may have various shapes such as a plate shape, a coil shape, a mesh shape, and a tube shape. The X-ray markers 24 and 25 constitute “markers” in the present invention.

  Furthermore, a visual marker for facilitating visual recognition with a fiberscope (not shown) disposed at the distal end of the endoscope (see FIG. 3) is attached to the outer periphery of the distal end portion of the catheter 10. In this embodiment, an annular visual marker 26 is attached to the outer periphery of the reduced diameter portion 17 at a position close to the opening 11 a at the tip of the first lumen 11 and aligned with the X-ray marker 24. An annular visual marker 27 is also provided on the outer periphery of the catheter 10 including the first lumen 11 and the second lumen 12, adjacent to the distal end opening of the second lumen 12 and aligned with the X-ray marker 25. It is attached. Further, an annular visual marker 28 is also attached to the outer periphery of the reduced diameter portion 17 at a position away from the X-ray marker 24 and the visual marker 26 by a predetermined length. Each visual marker 26, 27, 28 preferably has a width of 1 to 15 mm, for example, and the distance between the visual markers 26 and 28 is preferably 1 to 15 mm apart.

  As shown in FIG. 1, a first inserter 29 is attached to the proximal end of the first lumen 11 of the catheter 10, and a second inserter 30 is attached to the proximal end of the second lumen 12. Each inserter 29, 30 has a cylindrical shape as a whole, its base end portion forms a gripping portion 29a, 30a, and tubes 29b, 30b are attached to its tip, and these tubes 29b, 30b are connected to each lumen 11, The inserters 29 and 30 and the lumens 11 and 12 are communicated with each other by being inserted into the base end opening 12 and connected by an adhesive or the like.

  The catheter 10 has a total length (length from the distal end to the proximal end) of preferably 0.3 to 2.5 m, and more preferably 1.8 to 2.0 m. Furthermore, as shown in FIG. 2 (b), the outer diameter D of the portion of the catheter 10 where the first lumen 11 and the second lumen 12 are formed is preferably 1.6 to 2.5 mm. It is more preferable that it is 7-2.2 mm.

  The inner diameters of the lumens 11 and 12 are not particularly limited, but as shown in FIG. 2 (b), the inner diameter R1 of the first lumen 11 other than the reduced distal end portion is 0.70 to 0. It is preferably 85 mm, and more preferably 0.75 to 0.80 mm. Furthermore, as shown to Fig.2 (a), it is preferable that the internal diameter R3 of the opening 11a of the 1st lumen 11 is 0.65-0.75mm, and it is more preferable that it is 0.68-0.71mm. . On the other hand, as shown in FIG. 2B, the inner diameter R2 of the second lumen 12 is preferably 0.85 to 1.1 mm, and more preferably 0.95 to 1.00 mm.

  That is, when a contrast medium or the like is administered through the second lumen 12 with the guide wire inserted through the first lumen 11, and then another guide wire is inserted through the second lumen 12, the contrast medium It is preferable to increase the inner diameter of the second lumen 12 because the slipperiness in the second lumen 12 is reduced and it may be difficult to insert the guide wire.

  Further, as shown in FIG. 2C, when the length from the inner peripheral upper end of the second lumen 12 to the flat surfaces 22 on both sides of the groove portion 20 is H1, the length H1 is the inner diameter of the second lumen 12. R2 is preferably 0.5 to 0.99 times, and more preferably 0.8 to 0.9 times. When the length H1 is less than 0.5 times the inner diameter R2, the wall portion 22 forming the groove portion 20 becomes thicker, the flexibility of the distal end portion of the catheter becomes poor, and the length H1 becomes the inner diameter R2. If it exceeds 0.99 times, the thickness of the wall part 22 on both sides of the groove part 20 becomes thin, and the rigidity of the reduced diameter part 17 decreases.

  Moreover, as shown to Fig.2 (a), it is preferable that the length L from the front-end | tip of the 1st lumen 11 to the upper end part of the step part 15 of the 2nd lumen 12 is 5-150 mm, and is 10-100 mm. More preferably, it is most preferably 20-50 mm. When the length L is less than 5 mm, it becomes difficult to ensure the flexibility of the distal end portion of the catheter 10, and when the length L exceeds 150 mm, the reduced diameter portion 17 is likely to kink.

  Examples of the material of the catheter 10 include thermoplastic elastomers such as polyurethane, nylon elastomer, and styrene elastomer, polyethylene, polypropylene, silicone, polyether block amide, polyvinyl chloride, vinyl acetate, and polytetrafluoroethylene. Synthetic resins such as fluororesins such as (PTFE), perfluoroalkoxy resin (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE) Can be used.

  Further, maleic anhydride is provided on the outer periphery of the catheter 10 and the inner periphery of the first lumen 11 and the second lumen 12 in order to improve the slipperiness with respect to the inner periphery of the endoscope, the inner wall of the tubular organ, the guide wire, and the like. It is also possible to coat a base resin, a hydrophilic resin such as polyvinyl pyrrolidone, or a silicone resin.

  Next, an example of a method for using the catheter 10 having the above structure will be described.

  As shown in FIG. 3, a nipple N is provided at the lower part of the duodenum V1, and the bile duct V2 and pancreatic duct V3 branch and extend through the nipple N. Here, a procedure for inserting the catheter 10 into the bile duct V2 through the nipple N and performing various treatments will be described.

  First, the guide wire W1 is inserted into the first lumen 11 via the first inserter 29, and is accommodated and held in the first lumen 11 so that the guide wire W1 does not protrude from the opening 11a at the tip of the first lumen 11. To do.

  Then, by a known method, the endoscope 3 is moved to the duodenum V1 through the oral cavity, stomach or the like, the catheter 10 containing the guide wire W1 is inserted into the endoscope 3, and the catheter is inserted through the distal end opening 3a. 10 is protruded. Next, the catheter 10 is moved while visually recognizing the visual markers 26, 27, and 28 of the catheter 10 with a fiberscope (not shown) of the endoscope 3. At this time, in this embodiment, the catheter 10 is operated while appropriately grasping the positions of the opening 11a of the first lumen 11 and the opening 15a of the second lumen 12 by the visual markers 26, 27, and 28 provided on the catheter 10. Therefore, the catheter 10 can be accurately operated.

  3, the distal end portion 17a of the reduced diameter portion 17 of the catheter 10 is inserted into the nipple N. At this time, in this catheter 10, the second lumen 12 is provided on the outer periphery of the reduced diameter portion 17 along the axis F direction of the second lumen 12 (see FIG. 2A) from the opening 15 a of the step portion 15. An arc-shaped groove 20 having a shape cut by leaving the wall portion on the first lumen 11 side is formed, and both sides thereof form a thick wall portion 22. Therefore, the reduced diameter portion 17 of the catheter 10 can be provided with rigidity (pushability) that can be inserted even in a narrow portion such as the nipple N, and the catheter 10 can be smoothly inserted into the nipple N.

  Further, in this embodiment, since the distal end portion 17a of the reduced diameter portion 17 is further reduced in diameter toward the distal end of the catheter, it is easier to insert the catheter 10 into the nipple N. be able to.

  As shown in FIG. 4, when the reduced diameter portion 17 of the catheter 10 is inserted into the bile duct V2 through the nipple N, the guide wire W1 is inserted through the opening 11a of the first lumen 11, and the guide wire W1 is inserted into the bile duct. It is inserted into the back of V2, and the catheter 10 is moved while being guided along the outer periphery of the guide wire W1, so that the opening 15a of the second lumen 12 is positioned at a predetermined position of the bile duct V2. At this time, in this embodiment, the distal end portion 17a of the reduced diameter portion 17 has a shape gradually reduced in diameter toward the catheter distal end including the inner periphery of the first lumen 11, and the opening at the distal end of the first lumen 11 is formed. Since the inner diameter R3 of 11a is narrowed (see FIG. 2A), the guide wire W1 inserted through the opening 11a can be prevented from wobbling, and the traveling direction of the guide wire W1 can be easily controlled.

  In advance of the guide wire W1, a contrast medium is injected from the second inserter 30 into the second lumen 12, and the contrast medium flows out of the opening 15a into the bile duct V2, so that the shape of the bile duct V2 is fluoroscopically seen. You can grasp below. At this time, in the catheter 10, since the arcuate groove 20 continuous from the inner periphery of the bottom of the opening 15 a of the second lumen 12 is formed in the reduced diameter portion 17 along the axial direction, the second lumen The contrast medium that has flowed out of the 12 openings 15a can be made to flow along the groove portion 20, and the flow direction of the contrast medium can be easily controlled.

  Next, under X-ray fluoroscopy, the catheter 10 is moved while confirming the position of the catheter 10 with the X-ray markers 24 and 25. Then, as shown in FIG. 5, the guide wire W1 is inserted into the branch tube V4 so that the distal end portion 17a of the reduced diameter portion 17 of the catheter 10 is positioned in the vicinity of the inlet of the branch tube V4 and the opening of the second lumen 12 15a is positioned near the entrance of the branch pipe V5. At this time, in this embodiment, the position of the opening 11a at the tip of the first lumen 11 can be confirmed by the X-ray marker 24 provided in the vicinity of the tip opening of the first lumen 11, and the second lumen can be confirmed. The position of the opening 15a of the second lumen 12 can be confirmed by the X-ray marker 25 provided in line with the opening 15a at the tip of the twelve. Therefore, it is possible to accurately perform operations that require fine alignment such as positioning the opening 15a of the second lumen 12 in the vicinity of the entrance of the branch pipe V5, and improve the operability of the catheter 10 under fluoroscopy. Can be made. In this state, another guide wire W2 can be inserted from the second inserter 30 into the second lumen 12, inserted through the opening 15a, and the guide wire W2 can be inserted to a predetermined position of the branch pipe V5. it can.

  Thereafter, the guide wire W1 and the guide wire W2 are fixed at the proximal side and held at a predetermined position, and the catheter 10 is pulled toward the proximal side, thereby leaving the guide wires W1 and W2 as shown in FIG. The catheter 10 can be extracted from the mirror 3 and the body.

  In this state, a medical tube (not shown) containing the stent S2 (see FIG. 7) is moved while being guided along the outer periphery of the guide wire W2, and the distal end of the medical tube reaches the branch tube V5. After that, the stent S2 is pushed out from the distal end portion of the medical tube via a pusher or the like, and the stent S2 is placed in the branch pipe V5 as shown in FIG. Similarly, the stent S1 is placed in the branch pipe V4 while guiding the medical tube containing the stent S1 with the guide wire W1. Since the two guide wires W1 and W2 can be arranged in the branch pipes V4 and V5 by one catheter insertion operation using the catheter 10 having the two lumens 11 and 12 in this way, the branch pipe Stents S1 and S2 can be efficiently placed in V4 and V5 (see FIG. 7). Further, after the placement of the stents S1 and S2, the guide wires W1 and W2 are removed from the outside of the body, respectively.

  In this embodiment, the inner circumference of the first lumen 11, the position close to the opening 11 a of the first lumen 11, and the position close to the opening 15 a of the second lumen 12 are not radiopaque. X-ray markers 24 and 25 are provided, and the X-ray markers 24 and 25 are provided only on the inner periphery of the first lumen 11. Therefore, it is only necessary to prepare markers with the same diameter, and markers with different diameters are not required. Thus, productivity can be improved and costs can be reduced. Furthermore, since the distal end portion 17 a of the reduced diameter portion 17 has a shape that gradually decreases in diameter toward the distal end of the catheter, including the inner periphery of the first lumen 11, the X-ray marker 24 is placed inside the first lumen 11. It can be made difficult to move around, and it can be reliably prevented from coming off the first lumen 11.

  FIG. 8 shows another method of using the catheter 10. This method of use is used when the guide wire W1 is inserted into one of the branch tubes V4 and V5 branched from the bile duct V2. Here, the case where the guide wire W1 is inserted into the branch pipe V5 will be described.

  That is, the distal end portion 17a of the reduced diameter portion 17 is brought into contact with the inner wall in the vicinity of the outlet of the bile duct V2 and locked, and the catheter 10 is operated to bend the reduced diameter portion 17. Then, the direction of the distal end portion of the catheter 10 is changed or rotated through the curved diameter-reduced portion 17 so that the opening 15a of the second lumen 12 is aligned with the branch pipe V5. After that, the guide wire W1 is inserted into the branch pipe V5 from the opening 15a.

  Thus, in this catheter 10, since the diameter-reduced portion 17 is reduced in diameter and is relatively flexible, the diameter-reduced portion 17 can be curved as described above. Utilizing this, the opening 15a of the second lumen 12 can be aligned so as to be aligned with the branch pipe V5, so that the guide wire W1 can be accurately inserted into the predetermined branch pipe V5.

DESCRIPTION OF SYMBOLS 10 Catheter 11 1st lumen 11a Opening 12 2nd lumen 15 Step part 15a Opening 17 Reduced diameter part 17a Tip part 20 Groove part 22 Wall parts 24 and 25 X-ray marker

Claims (3)

In a catheter having a first lumen and a second lumen,
The first lumen forms a passage from the proximal end to the distal end of the catheter and opens at the distal end of the catheter;
A predetermined length portion from the distal end of the catheter is reduced in diameter through a tapered step portion, leaving a cylindrical portion including the first lumen,
The second lumen forms a passage from the proximal end of the catheter to the stepped portion and opens at the stepped portion,
A part of the inner periphery of the opening extends from the opening of the step portion along the axial direction of the second lumen on the outer periphery of the portion reduced in diameter by a predetermined length from the distal end of the catheter. A catheter having a shape-shaped groove portion and an inner periphery of the groove portion having an arc shape.   The catheter according to claim 1, wherein a portion reduced in diameter by a predetermined length from the distal end of the catheter has a shape further reduced in diameter toward the distal end including the inner periphery of the first lumen.   The radiopaque marker is provided in the inner periphery of the first lumen at a position close to the distal end opening of the first lumen and a position close to the distal end opening of the two lumen. Catheter.