JPH10146389A - Expansion balloon catheter capable of being guided under endoscope - Google Patents

Abstract

PROBLEM TO BE SOLVED: To simplify various operations related to an EPBD and to enable manual techniques with which even a single operator can employ the EPBD by providing a balloon catheter that can be directly guided to a Vater's papilla and inserted therein. SOLUTION: This expansion balloon catheter, which can be guided under an endoscope, comprises a balloon having a pressure resistance of at least 0.8Mpa and a catheter shaft in which a flexible tube 1 having a first, longitudinally penetrating lumen and a second lumen open to the inside of the balloon has an end chip joined to its end, the end chip comprising another flexible tube 2. In this case, the catheter has ahead of the balloon a guide part made of a tube 2 which is 20 to 60mm long, and the tube 2 is made from a material with a modulus of elasticity of 20O to 1000MPa. The balloon can easily and safely be inserted into a Vater's papilla, various operations related to the insertion are simplified, and the catheter is very effective as a medical instrument ensuring manual techniques that can be done by an operator alone.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dilatation balloon catheter which is inserted endoscopically to treat common bile duct stones and the like.

[0002]

2. Description of the Related Art Gallstone disease is a disease in which gallstones develop in the liver, gallbladder, common bile duct, and the like, causing symptoms such as inflammation. Intrahepatic stones, common bile duct stones, and gallbladder stones depend on the site where the gallstones occur. With the name. Common bile duct stones are gallstones that form in the common bile duct, which is the passage of bile secreted from the liver.If the common bile duct blocks the common bile duct, jaundice may occur, or drainage may occur as quickly as possible. It causes purulent cholangitis due to infection and can be fatal.

[0003] Traditionally, the treatment of common bile duct stones is mainly laparotomy, which has been a great burden for patients with gallstones. However, in recent years, with the development of technology, a minimally invasive treatment means that does not perform laparotomy using an endoscope has been developed. Endoscopic papillectomy (EST), which is one of the endoscopic treatments for common bile duct stones, is performed by using a high-frequency scalpel (a scalpel) that can remove stones from the Vater's papilla, which has an opening into the duodenum of the common bile duct. Papillotomes) are used to remove stones in the common bile duct into the duodenum and are now widely used.

However, in this method, since a scalpel is inserted into the Vater's papilla, an incision is made. If the incision position, direction, and degree of incision are incorrect, complications such as arterial hemorrhage and duodenal perforation occur. Have. In addition, these complications require an emergency laparotomy, so that the burden on the patient is no different from laparotomy. Endoscopic papillary balloon dilatation (hereinafter abbreviated as EPBD) may be said to have been devised to overcome the shortcomings of ESTs. In this method, a Vater's papilla is dilated using a balloon catheter. In other words, instead of incising the Vater's papilla, the balloon is placed endoscopically on the Vater's papilla, and then the balloon is inflated with high pressure to expand the opening of the Vater's papilla to the extent that the calculus can be removed. It is. Since this method does not involve an incision, there is no complication which was a drawback of EST, and there is an advantage that the function of Vater's papilla can be preserved.

[0005] Furthermore, in cases other than stone removal, such as examination using a cholangioscope or the like, the above-mentioned EST involves a large amount of invasion of the patient and poses a risk of complications.
D has begun to be applied as a safe and effective method.
However, on the other hand, the EPBD has a drawback that the insertion operation method is complicated due to a structural defect of the balloon catheter, and a plurality of assistants are required in addition to the surgeon. Here, the method of inserting the balloon catheter will be described in detail with reference to the drawings to clarify the problem to be solved by the present invention. FIG. 1 is a diagram showing a positional relationship between a balloon catheter, an endoscope and a Vater's papilla when a balloon is inserted, and FIG.
FIGS. 4D to 4D are diagrams showing a procedure for inserting a balloon catheter into the papilla of Vater.

Since the Vater's papilla (5) is located on the posterior wall of the descending leg of the duodenum, the approach to this point requires a forceps hole exit (10), an objective lens (11) or a CCD camera (electronic scope) on the distal side. ) Is used. The operator passes the balloon catheter (6) through the forceps channel (12), observes an endoscopic image obtained through the objective lens (11), and checks the forceps hole exit (1).
An attempt is made to guide the tip (9) of the balloon catheter (6) coming out of 0) to the Vater's papilla (5). The balloon (7) is completely deflated and held in a state of being wrapped around the shaft (21) (hereinafter referred to as wrapping) and inserted into the forceps channel (12). Due to the structure, the balloon portion becomes bulky due to the return of the wrapping.

As is clear from FIG. 1, the balloon (7)
The bulkiness reduces the field of view obtained from the objective lens (11), causing a problem that the tip (9) and the Vater's papilla (5) cannot be sufficiently confirmed. The gap between the forceps hole exit (10) and the Vater's papilla (5) is set to 10 mm, which is the minimum visible distance of this type of endoscope, while the length of the balloon (7) is 25 to 30 mm. Therefore, the balloon (7) is hung on the forceps hole exit (10),
A defect that the insertion operability is significantly impaired occurs at the same time. For this reason, it is difficult to insert the balloon catheter (6) directly into the Vater's papilla, and the operator must perform the complicated procedure described below.

First, the operator inserts an ERCP catheter (endoscopic retrograde cholangiopancreatography catheter) (2) into the Vater's papilla (5) (FIG. 2A). The total length of the ERCP catheter (2) is the effective length of the endoscope (1.0 to 1.4).
m), and generally has a length of at least 1.8 m in order to allow a margin at a distal end portion for performing a treatment or the like and a proximal end portion for performing a treatment operation. This is not limited to the ERCP catheter, but is common to all medical devices inserted endoscopically, including the balloon catheter (6). next,
The operator inserts a guide wire (4) having a length at least twice as long as the guide wire (4) into the lumen of the ERCP catheter (2) so that the tip reaches the Vater's papilla (5) (FIG. 2).
b). At this time, the rear portion of the guide wire (4) is held without being inserted through the endoscope (1) and the ERCP catheter (2).

Thereafter, the ERCP catheter (2) is removed (FIG. 2C), and the balloon catheter (6) is inserted along the indwelled guide wire (4). The insertion operation is completed by placing the balloon (7) on the Vater's papilla (5) (FIG. 2-d). In order to remove the ERCP catheter (2) and insert the balloon catheter (6) under the guidance of the guide wire (4), the guide wire (4) must be removed or guided in the use state of c and d. The length of the posterior part must be large enough to be inserted into the lumen of the catheter. That is, the guide wire needs to be at least twice as long as the catheter to be used, specifically, at least 3.6 m.

For this reason, when performing the operations from b to d in the figure, the guide wire (4) and the balloon catheter (6) are held in the air to prevent contamination due to contact with the non-clean area, and to prevent the catheter from being contaminated. , And a plurality of assistants are required to perform the operation of inserting the guide wire into the catheter lumen. As described above, the EPBD has a disadvantage that the operation method is complicated and a plurality of assistants are required in addition to the surgeon. However, the features of this procedure that there are no complications and high safety and efficacy are expected by many physicians and patients, and from the viewpoint of improving QOL, a means that can be more easily performed is desired. I was

[0011]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a balloon catheter which can be directly guided and inserted into a Vater's papilla, to simplify various operations related to EPBD, and to provide an EPBD for an operator. It is intended to be a technique that can be performed alone, and to further spread this technique.

[0012]

SUMMARY OF THE INVENTION The present invention is directed to a flexible tube 1 having a balloon at a front portion and having a first lumen penetrating in a longitudinal direction and a second lumen opening inside the balloon. A balloon catheter comprising a catheter shaft to which a distal tip made of a flexible tube 2 is joined, having a guide portion made of a flexible tube 2 having a length of 20 to 60 mm in front of the balloon, and The material constituting the tube 2 is 200 to 1000MP
(a) An endoscope-guided dilatation balloon catheter characterized by being formed from a material having a flexural modulus of a.

[0013]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to embodiments. 3 is a view schematically showing a balloon catheter according to one embodiment of the present invention, FIG. 4 is a view showing a cross-sectional shape along AA ′ of FIG. 3, and FIG. 5 is a balloon catheter according to another embodiment of the present invention. FIG. 6 is a schematic view of a balloon catheter according to the present invention inserted into a Vater's papilla.

In FIGS. 3 and 4, the shaft (21) leads from the first lumen (25) penetrating in the longitudinal direction and the inflation connector (23) into the balloon (7) through the balloon branch tube (24). A double lumen tube having a second lumen (26). A tip (30) is attached to the tip of the shaft (21).
The lumen (33) communicates with the first lumen (25), and a guide wire can be inserted from a connector of the main lumen branch pipe (22) or a contrast agent can be injected. The balloon (7) is hermetically joined at two points on the shaft (21) in front of the balloon catheter (6) and the distal tip (30).

Although the embodiment of FIG. 3 uses a double lumen tube having two lumens in the shaft (21), the present invention does not limit the structure of the shaft (21) to only this. As shown in FIG. 5, a coaxial type shaft composed of an inner pipe (31) and an outer pipe (32) may be used. The material for forming the shaft (21) is not particularly limited, and for example, any flexible material such as soft polyvinyl chloride, polyolefin, polyamide, polyester, polyurethane, and Teflon can be used. However, since the shaft (21) is inserted into the forceps channel (12), the shaft made of a material having a high coefficient of friction cannot smoothly pass through the forceps channel (12) of the endoscope, and the operation of the balloon catheter is not performed. It is not preferable because the property is lowered.

The forceps channel (1) of the endoscope (1)
In many cases, the surface of 2) is unnecessary because it is formed of Teflon. However, in order to further improve the operability of inserting the balloon catheter, the surface of the shaft (21) has lubricity such as Teflon coat or polyparaxylylene coat. Processing may be performed. When flexibility is given to the shaft (21), the shaft (21) is formed from a soft material. In this case, when the balloon catheter (6) is inserted into the forceps channel (12), the shaft (21) is broken at the forceps inlet (14), so that a stainless wire is inserted into the first lumen (25). Equipped with a stylet consisting of etc.

The balloon (7) is at least 0.8MP
a. If the pressure resistance is less than 0.8 MPa, the Vater nipple (5) cannot be expanded sufficiently, which is not preferable. Examples of the balloon that can be used in the present invention include a balloon made of polyolefin, and Japanese Patent Publication No. Sho 63-2.
No. 6655, a balloon composed of polyethylene terephthalate, a balloon composed of a polyamide elastomer or nylon disclosed in JP-A-63-212373 and JP-A-3-57462, A balloon made of the polyurethane disclosed in 213848 is suitable. However, the present invention does not limit the balloon to be used.

According to the present invention, the distal tip (31) is provided at the front portion of the balloon (7) with a guide portion (34) having a length L.
Is configured. The guiding portion (34) projects from the forceps hole exit (10) to reach the Vater's papilla (5) prior to the balloon (7), and serves as a guide for inserting the balloon (7) into the Vater's papilla (5). As is clear from FIG. 6, the balloon (7) is completely housed in the forceps channel (12) and does not enter the field of view of the endoscope. 9) and Vater's papilla (5) can be easily confirmed. In addition, the balloon (7) hangs on the forceps hole outlet (10), so that the insertion operability of the catheter is not reduced.

The length L of the guiding portion (34) is 20 to 60 m.
m. When L <20 mm, the balloon (7) is applied to the forceps hole exit (10) when the tip (9) is inserted into the Vater's papilla (5), which narrows the field of view of the endoscope and decreases the insertion operability, which is not preferable. , L> 60m
m is not preferable because the common bile duct or the pancreatic duct deep in the Vater's papilla (5) may be damaged by the tip (9) of the catheter when the balloon (7) is inserted. More preferably, the length L of the tip portion (34) is 30 to 50 mm,
Operability and safety can be further improved.

The tip (3) constituting the guiding portion (34)
0) is 200 to obtain good insertion operability.
It is formed from a material having a flexural modulus of 1000 MPa. Since the guiding portion (34) is pushed into the opening of the Vater's papilla (5) with the forceps hole outlet (10) as a fulcrum, a large pushing force is obtained with the tip (30) made of a material having a bending elastic modulus of more than 1000 MPa. On the other hand, since the hardness increases, the guiding portion (34) is not preferable because the guiding portion (34) is broken when the guide portion (34) is turned about 90 ° with respect to the forceps channel (12) at the forceps hole outlet (10). When the flexural modulus is less than 200 MPa, the flexibility of the guide portion (34) increases, and the guide portion (34) is provided between the forceps hole outlet (10) and the Vater's papilla (5).
Is undesirably deformed and insertion becomes difficult.
A more preferable bending elastic modulus is 300 to 850 MPa, and by using a material having a bending elastic modulus in this range, it is possible to obtain a high-dimensional tip that combines excellent indentation force transmission and bending resistance. Becomes

The material of the tip (30) which can be used in the present invention is not particularly limited as long as it satisfies the above conditions. For example, a polyamide alloy disclosed in Japanese Patent Application No. 8-135563 is disclosed. A tube made of one of the most preferred materials. Further, a material in which a filler such as a contrast-enhancing material is kneaded can be used. The filler to be kneaded is not particularly limited, but when imparting contrast to the guiding portion (34), a barium compound, a bismuth compound,
Fillers such as tungsten compounds are preferred. The balloon catheter according to the present invention is provided with a marker (29) for indicating the optimal insertion level of the balloon (7), which enables the insertion operation to be simplified. When inserting the balloon (7), the surgeon can easily place the balloon (7) at the optimum position simply by aligning the marker (29) and the Vater's papilla (5) under the endoscope. is there. Marker (2
9) is provided by printing or fitting a metal ring or the like on the tip chip (30) in the balloon (7).

[0022]

As is clear from the above, the balloon catheter according to the present invention can insert a balloon into a Vater's papilla easily, quickly and safely without using an ERCP catheter or a guide wire.
In addition to simplifying the various operations related to, it is extremely useful as a medical device as a procedure that can be performed by the operator alone.

[Brief description of the drawings]

FIG. 1 is a diagram showing a balloon catheter, and a positional relationship between an endoscope and a Vater's papilla when a balloon is inserted.

FIG. 2 is a view showing a procedure for inserting a balloon catheter into a papilla of Vater.

FIG. 3 is a diagram of a balloon catheter according to one embodiment of the present invention.

FIG. 4 is a diagram showing a cross-sectional shape along AA ′ in FIG. 3;

FIG. 5 is a sectional view of a front portion of a balloon catheter according to another embodiment of the present invention.

FIG. 6 is a schematic diagram when a balloon catheter according to the present invention is inserted into a papilla of Vater.

Claims (1)

[Claims] 1. A flexible tube 1 having a balloon at a front portion thereof and having a first lumen penetrating in a length direction and a second lumen opening inside the balloon comprises another flexible tube 2 at a distal end. A balloon catheter comprising a catheter shaft to which a distal tip is joined, which has a guiding portion formed of a flexible tube 2 having a length of 20 to 60 mm in front of the balloon, and the flexible tube 2 has a length of 200 to 60 mm.
An endoscope-guided dilatation balloon catheter made of a material having a flexural modulus of 1000 MPa.