JP2004329314A - Drainage catheter for bile duct - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a drainage catheter for bile duct that can be inserted easily into a bile duct without expanding the bile duct by means of a dilator even when the bile duct is strongly strangulated. <P>SOLUTION: This drainage catheter for bile duct is provided with a catheter tube the distal end side of which is inserted into the bile duct. The catheter tube comprises a main body section having a substantially equal outside diameter along its longitudinal direction, a first tapered section which communicates with the distal end side of the main body section and the outside diameter of which becomes smaller as going toward the distal end, and a narrow-diameter straight shell section which communicates with the distal end side of the first tapered section and has a substantially equal diameter along its longitudinal direction. The catheter tube also comprises a second tapered section which communicates with the distal end side of the narrow-diameter straight shell section and the outside diameter of which becomes smaller as going toward the distal end. The outside diameter of the narrow-diameter straight shell section is adjusted to 20-80% of that of the main body section and the length of the section is adjusted to 20-250 mm. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a drainage catheter for bile ducts.
[0002]
[Prior art]
For patients whose bile is no longer excreted from the bile duct due to stenosis or obstruction of the bile duct, a technique such as Percutaneous Transhepatic Biliary Drainage (hereinafter abbreviated as "PTCD") is used. It is necessary to take measures to remove bile from the bile duct. In PTCD, bile is discharged from the bile duct to the outside of the body via a drainage catheter inserted into the bile duct transdermally and hepaticly.
[0003]
In such a PTCD, the drainage catheter needs to have a certain thickness in order to sufficiently discharge bile out of the body. On the other hand, since the bile duct of a patient to whom PTCD is applied is narrowed, the drainage catheter needs to be used. It is often difficult to insert. In order to insert a drainage catheter into such a narrowed bile duct, a technique of inserting a dilator in advance to expand the narrowed bile duct is generally known (for example, see Patent Document 1).
[0004]
In particular, when the degree of bile duct stenosis is severe, it is difficult to sufficiently dilate with a single dilator. A technique of inserting a thicker dilator is adopted.
[0005]
However, since the operation of inserting and removing the dilator is complicated and hinders smooth treatment, even when the degree of stenosis of the bile duct is severe, the dilator can be inserted into the bile duct without dilation. There is a need for a drainage catheter that can be inserted.
[0006]
[Patent Document 1]
JP-A-2-274266
[Problems to be solved by the invention]
In view of the circumstances of the prior art as described above, an object of the present invention is to provide a bile duct that can be easily inserted into the bile duct without dilator dilation even when the degree of bile duct stenosis is severe. It is to provide a drainage catheter.
[0008]
[Means for Solving the Problems]
The inventor of the present invention has conducted extensive studies on the structure of the drainage catheter for bile ducts. It has been found that the above-mentioned object can be achieved by adopting a structure having a small-diameter straight body and a predetermined length, and the present invention has been completed.
[0009]
Thus, according to the present invention, there is provided a drainage catheter for a bile duct including a catheter tube whose distal end side is inserted into a bile duct, wherein the catheter tube has an outer diameter substantially the same along a longitudinal direction. Part, a first tapered part connected to the distal end side of the main body part, and having an outer diameter narrowing toward the distal end side; and a continuous part connected to the distal end side of the first tapered part, and the outer diameter is in the longitudinal direction. And a second taper portion that is substantially the same along the small diameter straight body portion, and is connected to the distal end side of the small diameter straight body portion, and the outer diameter decreases toward the distal end side. There is provided a drainage catheter for a bile duct, wherein the outer diameter of the small-diameter straight body is 20 to 80% of the outer diameter of the main body, and the length of the small-diameter straight body is 30 to 250 mm.
[0010]
In the drainage catheter for bile duct of the present invention, it is preferable that the small-diameter straight body has a curved shape when the inner core is not inserted, and has a substantially straight shape when the inner core is inserted.
[0011]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
[0012]
FIG. 1 is a plan view showing the overall shape of the drainage catheter for bile duct of the present invention. FIG. 1 (A) shows a state where the inner core is inserted, and FIG. 1 (B) shows a state where the inner core is not inserted. .
[0013]
The bile duct drainage catheter 1 shown in FIG. 1 has a catheter tube 2 whose distal end is inserted into a bile duct, and a hub 9 connected to a proximal end of the catheter tube. In FIG. 1A, an inner core 10 that is more rigid than the catheter tube 2 is inserted from the proximal end side of the hub 9 through the inside of the catheter tube 2 in the longitudinal direction.
[0014]
The catheter tube 2 has a main body 3 having an outer diameter that is substantially the same along the longitudinal direction, and a first taper connected to the distal end side of the main body 3 and having an outer diameter that decreases toward the distal end side. A small-diameter straight body 5 having an outer diameter substantially the same along the longitudinal direction, and a small-diameter straight body 5 continuous with the distal end of the first tapered part 4; , And a second tapered portion 6 whose outer diameter decreases toward the distal end side. A lumen 7 is formed inside the catheter tube 2 over the entire length in the longitudinal direction.
[0015]
The outer diameter of the main body 3 of the catheter tube 2 is substantially the same along the longitudinal direction, and the outer diameter D1 is usually 1.0 to 20 mm, preferably 1.5 to 15 mm, and more preferably. Is 2.0 to 4.0 mm. When the main body 3 of the catheter tube 2 has such an outer diameter D1, the lumen 7 formed inside the main body 3 can be sufficiently inserted to allow bile to flow while allowing the main body 3 to be inserted into the bile duct. It can be a large diameter. The thickness of the main body 3 of the catheter tube 2 is usually 0.1 to 5.0 mm. The length of the main body 3 is preferably 80 to 500 mm.
[0016]
The outer diameter of the small-diameter straight body portion 5 of the catheter tube 2 is substantially the same along the longitudinal direction, and the outer diameter D2 is 20 to 80% of the outer diameter D1 of the main body portion 3, preferably 30%. ~ 80%, more preferably 40 ~ 75%. By providing the catheter tube 2 with the small-diameter straight body portion 5 having such an outer diameter D2 with respect to the outer diameter D1 of the main body portion 3, inserting the small-diameter straight body portion 5 into the narrowed bile duct and placing it therein. The dilation of the narrowed bile duct can be performed, so that the main body 3 can be easily inserted into the bile duct without performing dilation with a dilator. The thickness of the small-diameter straight body portion 5 of the catheter tube 2 is usually 0.1 to 4.0 mm.
[0017]
The length of the small-diameter straight body portion 5 of the catheter tube 2 is 30 to 250 mm, preferably 40 to 200 mm, and more preferably 50 to 150 mm. If the length of the small-diameter straight trunk 5 is less than 30 mm, the length of the bile duct may be insufficient for stenosis in the bile duct, and the stenotic bile duct may not be sufficiently dilated. When the is inserted into the stenosis in the bile duct, the small-diameter straight body 5 may hinder the operability of the drainage catheter 1 for bile duct.
[0018]
It is preferable that the small-diameter straight body portion 5 of the catheter tube 2 be configured to be curved when the inner core 10 is not inserted, and to be substantially linear when the inner core 10 is inserted. It is more preferable that the small-diameter straight body portion 5 in a state where the inner core 10 is not inserted has a spiral shape as shown in FIG. When inserting the small-diameter straight body 5 of the catheter tube 2 into the bile duct, it is preferable that the small-diameter straight body 5 is linear, but when inserting the main body 3 into the bile duct, the small-diameter straight body 5 is inserted. If the remains straight, the distal end of the catheter tube 2 may reach the outlet of the pancreatic duct and induce pancreatitis. On the other hand, if the shape of the small-diameter straight body portion 5 is changed according to insertion or non-insertion of the inner core 10, the small-diameter straight body portion is gradually inserted while the body portion 3 is inserted into the bile duct. By pulling out the inner core 10 from the lumen 7 inside the part 5, the narrow-diameter straight body part 5 curls in the bile duct, and prevents the distal end of the catheter tube 2 from reaching the outlet of the pancreatic duct, thereby preventing pancreatitis. Can be. The number of turns of the spiral shape is preferably 1.5 to 3.0 times, and more preferably 1.5 to 2.0 times. If the number of turns is less than 1.5 times, the radius of the outermost circle of the spiral shape becomes large, and there is a risk that the outermost circle becomes bulky in the bile duct, and if it exceeds 3.0 times, the insertion and removal of the inner core 10 becomes difficult. There is. The radius of the outermost circle of the spiral shape is preferably 5 to 20 mm. Note that it is not always necessary to make the entire small-diameter straight body portion 5 curved, and a portion thereof can be made curved as long as the distal end of the catheter tube 2 can be prevented from reaching the outlet of the pancreatic duct. Further, the curved portion of the catheter tube 2 may extend to the first tapered portion 4, the second tapered portion 6, and the main body portion 3.
[0019]
Between the main body 3 and the small-diameter straight body 5 of the catheter tube 2, there is provided a first tapered part 4 whose outer diameter becomes smaller toward the distal end side. By providing such a first taper portion 4, the bile duct is expanded by placing the small-diameter straight body 5, and then the catheter tube 2 is further pushed, so that the main body portion 3 is relatively easily inserted into the bile duct. be able to. The angle of the tapered surface of the first tapered portion 4 is preferably 3 ° to 45 ° with respect to the longitudinal axis of the catheter tube 2, and the length of the first tapered portion 4 is preferably 5 to 80 mm.
[0020]
On the distal end side of the small-diameter straight body portion 5 of the catheter tube 2, a second taper portion 6 whose outer diameter decreases toward the distal end side is provided. In the present embodiment, the second taper portion 6 is provided. Is located at the most distal end of the catheter tube 2. By providing such a second tapered portion 6, even when the degree of stenosis is severe, the small-diameter straight body 5 can be inserted into the bile duct relatively easily. The outer diameter of the distal end of the second tapered portion 6 is preferably 0.3 to 10 mm. Further, the angle of the tapered surface of the second tapered portion 6 is preferably 3 ° to 45 ° with respect to the longitudinal axis of the catheter tube 2, and the length of the second tapered portion 6 is preferably 1 to 30 mm. preferable.
[0021]
As described above, the catheter tube 2 can be formed using a profile extrusion molding method, and a tube having the same outer diameter along the longitudinal direction is obtained by an extrusion molding method or the like, and then subjected to hot melt processing. Or by cutting.
As a method of shaping the small-diameter straight body portion 5 so as to be curved without the inner core 10 being inserted, a core rod shaped into a curved shape is inserted into the small-diameter straight body portion 5. A method of heating the small-diameter straight body portion 5 is exemplified.
[0022]
The catheter tube 2 is preferably formed with a side hole 8 penetrating from the outer peripheral surface to the inner lumen 7. From the side hole 8, bile in the bile duct can be taken into the lumen 7 of the catheter tube 2 and discharged out of the body. The side hole 8 formed in the catheter tube 2 is positioned at a distance of 60 mm from the distal end to the proximal end of the main body 3 to a position of 50 mm from the proximal end to the distal end of the small-diameter straight body 5. It is preferable to be provided between them.
[0023]
The shape of the side hole 8 is not particularly limited, and can be various shapes such as a circular shape, an elliptical shape, and a polygonal shape. The number of side holes 8 is not particularly limited, but is preferably about 2 to 12. The opening area per side hole 8 is not particularly limited, but is preferably about 0.1 to 80 mm ² .
[0024]
Examples of the material constituting the catheter tube 2 include polyolefin such as polyethylene and polypropylene, polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyester such as polyethylene terephthalate and polybutylene terephthalate, polyamide, polyether polyamide, and polyester. Various resin materials such as polyamide, ABS resin, AS resin, fluorine resin such as polytetrafluoroethylene, and various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, and polybutadiene. . Further, a contrast agent such as barium sulfate or bismuth oxide may be added to these materials so that the indwelling of the catheter tube 2 in the bile duct can be confirmed by X-ray fluoroscopy.
[0025]
The catheter tube 2 may be formed of a laminate in which two or more different materials are laminated. Examples of a method for forming the catheter tube 2 from a laminate include a method of bonding using an adhesive resin such as a modified polyolefin and a two-color extrusion molding method. Further, the catheter tube 2 may be provided with a reinforcing material. As the reinforcing material, for example, a reinforcing material formed of a metal linear body or a net-like body may be used.
[0026]
The material constituting the catheter tube 2 may be different along the longitudinal direction. For example, the constituent materials can be different so that the rigidity of the small-diameter straight body portion 5 is higher than that of the main body portion 3. By configuring the catheter tube 2 in such a manner, the small-diameter straight body 5 has sufficient rigidity, so that it can be easily inserted into a bile duct with severe stenosis, and since the main body 3 has sufficient flexibility, it can be inserted into the bile duct. The burden on the patient at the time of insertion of the patient can be reduced.
[0027]
The hub 9 of the drainage catheter 1 for a bile duct is a tubular body having a lumen, and is connected to the proximal end of the catheter tube 2 by means such as caulking, screwing, or bonding. The lumen of the hub 9 communicates with the lumen 7 of the catheter tube 2, and through this hub 9, the insertion of the inner core 10 or the like into the lumen 7, the injection of a drug solution or the like into the body, the bile outside the body, or the like. Can be discharged. The hub 9 is configured to be able to connect another medical device to the proximal end side. The material for forming the hub 9 is not particularly limited, but includes polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polyamides, polyether polyamides, and polyesters. It is preferable to use various resin materials such as polyamide, polycarbonate, ABS resin, AS resin, and fluorine resin such as polytetrafluoroethylene.
[0028]
The inner core 10 is a linear body inserted from the hub 9 of the drainage catheter 1 for bile duct into the lumen 7 of the catheter tube 2. The inner core 10 has a greater rigidity than the catheter tube 2, and is inserted into the lumen 7 of the catheter tube 2 in which the small-diameter straight body 5 is formed into a curved shape, whereby the small-diameter straight body 5 is substantially straightened. Shape. The length of the inner core 10 is preferably set so as to protrude from the distal end of the catheter tube 2 by 1 to 30 mm when inserted into the catheter tube 2. The outer diameter of the inner core 10 is usually 0.5 to 10 mm, and is preferably substantially the same as the diameter of the lumen 7 of the catheter tube 2. Further, it is preferable that the inner core 10 be provided with a lumen penetrating along the longitudinal direction so that a guide wire can be inserted therein. The diameter of the lumen provided in the inner core 10 is usually 0.3 to 9 mm. As a material constituting the inner core 10, a metal material such as stainless steel, brass, a Ni—Ti alloy, or a high flexural modulus such as polyetheretherketone or polyimide is used so that the inner core 10 has sufficient rigidity. A resin material can be used. The distal end of the inner core 10 is preferably provided with a tapered portion so that it can be easily inserted into a narrowed bile duct. Further, it is preferable to provide a connector 11 that can be fitted to the hub 9 of the drainage catheter 1 for bile duct on the proximal end side of the inner core 10.
[0029]
Next, an example of a method of using the drainage catheter for bile duct of the present invention will be described.
[0030]
First, a perforation that penetrates the liver from the abdominal wall of the patient into the bile duct using a puncture needle or the like is provided, a guide wire is inserted from the perforation, and the distal end is placed in the bile duct.
[0031]
Next, the catheter tube of the drainage catheter for the bile duct into which the inner core has been inserted is inserted into the bile duct along the guide wire, and the small-diameter straight body is positioned at the stenosis in the bile duct. In this state, the stenosis is expanded by leaving it for a while. At this time, since the small-diameter straight body has substantially the same outer diameter in the longitudinal direction, it can be stably placed in the narrowed portion.
[0032]
When the stenosis in the bile duct is sufficiently expanded by the small-diameter straight body, the catheter tube is further pushed into the bile duct while the inner core is being pulled out little by little, and the main body is placed in the stenosis in the bile duct. If the small-diameter straight body is preformed into a curved shape, for example, a spiral shape, the small-diameter straight body is rounded in the bile duct by extracting the inner core, so that the distal end of the catheter tube reaches the outlet of the pancreatic duct Can be prevented.
[0033]
When the main body is placed in the stenosis in the bile duct, the side hole provided in the vicinity of the first taper reaches the bile retention part in the bile duct, and the bile flows from the side hole into the lumen of the catheter tube, It is discharged out of the body through the hub. Since the pressure inside the bile duct is usually higher than the external pressure, the bile is discharged without performing suction or the like. After the bile discharge is completed, the inner tube is gradually inserted into the lumen inside the small-diameter straight body, and the catheter tube is pulled out of the body while gradually returning the small-diameter straight body straight from the proximal end side.
[0034]
Note that the present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention. For example, the second tapered portion 6 does not necessarily need to be located at the most distal end of the catheter tube 2, and if necessary, a straight body portion may be further provided on the distal end side of the second tapered portion 6. The stenosis in the bile duct can be expanded in multiple stages.
[0035]
【The invention's effect】
As described above, according to the present invention, even when the degree of stenosis of the bile duct is severe, it can be easily inserted into the bile duct without performing dilation by a dilator, and a smooth treatment can be performed. A drainage catheter for bile ducts is provided.
[Brief description of the drawings]
FIG. 1 is a plan view showing the entire shape of a drainage catheter for bile duct of the present invention. FIG. 1 (A) shows a state where an inner core is inserted, and FIG. 1 (B) shows an inner core inserted. Indicates a state that is not performed.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Drainage catheter for bile ducts 2 Catheter tube 3 Main part 4 1st taper part 5 Small diameter straight body part 6 Second taper part 7 Lumen 8 Side hole 9 Hub 10 Inner core 11 Connector

Claims (2)

A drainage catheter for a bile duct having a catheter tube whose distal end side is inserted into the bile duct,
The catheter tube has a main body having an outer diameter that is substantially the same along the longitudinal direction, and a first tapered portion that continues to a distal end side of the main body and has an outer diameter that decreases toward the distal end. A small-diameter straight body having an outer diameter that is substantially the same along the longitudinal direction, and a small-diameter straight body connected to the distal end side of the first tapered portion; A second tapered portion whose outer diameter becomes smaller toward the end side,
An outer diameter of the small-diameter straight body portion is 20 to 80% of an outer diameter of the main body portion;
The drainage catheter for a bile duct, wherein the length of the small-diameter straight body is 30 to 250 mm. The drainage catheter for a bile duct according to claim 1, wherein the small-diameter straight body has a curved shape when the inner core is not inserted, and has a substantially straight shape when the inner core is inserted.

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