JP2001037882A - Dilatable balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To securely relocate a balloon to the Vater's papilla without using a guide wire in the EPBD. SOLUTION: This balloon catheter comprises a balloon 1 attached at the front and a catheter tube 2 with a main lumen piercing through the balloon in the longitudinal direction and a sub-lumen opening into the balloon. The balloon 1 has a guide part 11 consisting of a flexible tube of 20-60 mm in length in front of the balloon 1. A metal wire is inserted into the main lumen, with the top reaching the boarder between the distal end of the balloon and the guide part 11 without projecting from the top of the catheter.

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 for dilating a stenosis or occlusion of a body lumen.

[0002]

2. Description of the Related Art Dilatation balloon catheters are used in a variety of medical procedures, and are used to dilate occlusions and stenosis in body lumens. For example, dilatation balloon catheters have been used in angioplasty to dilate the lumen of blood vessels narrowed or stenotic due to arteriosclerosis, and more recently in endoscopic treatment of common bile duct stones. It is also used for endoscopic papillary balloon dilatation (hereinafter abbreviated as EPBD). EPBD is intended to expand the Vater's papilla, which has an opening into the duodenum of the common bile duct, to the extent that a calculus can be removed with a balloon. Compared to endoscopic papillostomy, which is an endoscopic treatment, its application is spreading as a safe and effective treatment.

[0003] In the conventional dilatation balloon catheter used for EPBD, due to its structure, the tip of the catheter cannot be directly guided to the Vater's papilla, and the balloon cannot be placed on the Vater's papilla. This is because in the conventional dilatation balloon catheter, the length of the tube from the distal end of the balloon to the tip of the catheter is set to be shorter than 10 mm, and the distance between the endoscope and the Vater's papilla is limited by this type of endoscope. 10 which is the minimum visible distance of the mirror objective lens
This is because, when the balloon catheter tip is guided to the Vater's papilla, the balloon is always applied to the forceps outlet, causing a problem that the insertion operability is significantly impaired.

Therefore, in order to guide the distal end of a conventional balloon catheter to the Vater's papilla, and to place the balloon on the Vater's papilla, a method of guiding the balloon catheter along a guide wire which is first placed deeper than the Vater's papilla has been used. Have been done. That is, in EPBD,
When using a conventional dilatation balloon catheter, the following pretreatment is required. First, an ERCP catheter (endoscopic retrograde cholangiopancreatography catheter) is inserted into the Vater's papilla, and then a guide wire is inserted through the ERCP catheter, so that the distal end is deeper than the Vater's papilla. Then, the ERCP catheter is removed, and a guide wire is left. Because such pretreatment is necessary,
EPBD has the problem that the procedure is extremely complicated.

[0005] As a method of solving the above-mentioned problem, a tube (hereinafter referred to as a guiding portion) from the distal end of the balloon to the distal end of the catheter is set to have a length of at least 20 mm or more. Without using, direct the dilatation balloon catheter to Vater's papilla,
Since the balloon can be arranged on the Vater's papilla and the above-mentioned pretreatment is not required, the procedure for EPBD can be simplified.

[0006] In the EPBD, when the Vater's papilla is expanded by the balloon, it is not uncommon for the balloon to come off the Vater's papilla. In such a case, the balloon must be once again deflated and then placed again on the Vater's papilla. If the balloon comes off distal to the Vater's papilla, the balloon can be relatively easily relocated to the Vater's papilla by pulling the catheter proximally. However, if the balloon has come off proximally, the balloon must be repositioned on the Vater's papilla by a pushing operation, which can be difficult to perform. Because the balloon generally used for dilatation is a shaped balloon, and at the time of the first insertion, the foldable portion of the balloon (hereinafter, referred to as a wing) is tightly wound around the catheter tube,
Once this type of balloon is inflated and then deflated, the wings of the balloon extend radially and must be crushed in order to relocate to the Vater's papilla, so the balloon must first be This is because a larger force is applied to the balloon than when the balloon is placed, and the balloon may kink. A guide wire is used for a balloon catheter for the purpose of simplifying the procedure of EPBD as compared to a state in which a balloon catheter is extended along a guide wire as in the conventional method, in other words, compared to a state in which the guide wire is inserted through the balloon catheter. In a state where the balloon is not inserted, that is, in a state where the guide wire is not inserted, there is a problem that the balloon is more likely to be kinked at the time of rearrangement after the balloon has been pulled out to the proximal side from the Vater papilla.

[0007]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a dilatation balloon catheter which solves the above-mentioned problems and which can reliably relocate a balloon to a Vater's papilla without using a guide wire in an EPBD. Is to do.

[0008]

That is, the present invention provides a balloon catheter comprising a balloon attached to a front portion, and a catheter tube having a main lumen penetrating in a longitudinal direction and a sub lumen opening inside the balloon. In addition, the front portion of the balloon has a guiding portion made of a flexible tube having a length of 20 to 60 mm, and a linear body made of metal passes through the main lumen,
The dilatation balloon catheter is characterized in that its distal end reaches at least the boundary between the distal end of the balloon and the guiding portion and does not protrude from the distal end of the catheter.

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to embodiments. FIG. 1 is a view schematically showing a dilatation balloon catheter according to one embodiment of the present invention, and FIG. 2 is a cross-sectional view of a front portion of the dilatation balloon catheter according to one embodiment of the present invention.

Referring to FIGS. 1 and 2, a balloon (1)
Are hermetically joined at two points on the catheter tube (2). The catheter tube (2) is formed from a shaft (3) having two lumens penetrating in the axial direction and a distal tube (4) having one lumen penetrating in the axial direction. The joint between the shaft (3) and the tip tube (4) is in the balloon (1) and allows inflation fluid to be delivered into the balloon through one sub-lumen (5) of the shaft (3). The other main lumen (6) of the shaft (3) communicates with the lumen of the distal tube (4). The structure of the catheter tube according to the present invention is not limited to the above, and may have, for example, a coaxial type structure including an inner tube and an outer tube.

The balloon (1) or the catheter tube (2) in the balloon (1) has a graduation line indicating an optimal insertion level so that the balloon (1) can be securely placed on the papilla of Vater. 8) is preferably provided. Furthermore, an X-ray opaque marker (9) such as a metal ring is provided on the distal end of the catheter tube (2) so that the distal end position of the catheter tube (2) can be confirmed under fluoroscopy from the viewpoint of safety. Is preferably attached.

According to the present invention, the main body lumen (6) and the lumen communicating with the distal end tube (4) of the catheter tube (2) have a linear body (10) (hereinafter referred to as a metal body) made of metal.
The distal end of the stylet (10) at least reaches the boundary between the distal end of the balloon and the guiding portion (11), and does not protrude from the distal end of the catheter. . That is, since the stylet (10) is inserted through the entire area of the balloon (1), the balloon (1) does not kink during the pushing operation for repositioning the balloon (1) to the Vater's papilla. The rearrangement can be performed reliably. In addition, since the stylet (10) does not protrude from the distal end of the catheter, there is no fear of damaging the papilla of Vater and the inner lumen wall by the stylet, and is safe.

The material of the stylet (10) is preferably stainless steel and more preferably high-tensile stainless steel for springs in terms of kink resistance and cost, but the present invention is not limited to these materials. For the purpose of improving kink resistance, for example, a superelastic alloy such as nitinol (a nickel-titanium alloy) can be used.

A cap (12) is joined to the base end of the stylet (10) to form a main lumen (6).
Connector (1) of the main lumen branch pipe (13)
4) can be joined. Since the connector (7) of the main lumen branch pipe (13) is a two-way connector, it is possible to inject a contrast agent even when the stylet (10) is equipped. The outer diameter of the stylet (10) is preferably about 40 to 60% of the inner diameter of the main lumen (6) or the inner lumen communicating with the distal tube (4), and is designed to be 45 to 55%. Is more preferred. If the outer diameter of the stylet (10) is greater than 60% of the inner diameter of the main lumen (6) or the lumen communicating with the distal tube (4), there is a high possibility that significant resistance will occur during the injection of the contrast medium. If it is less than 40%, the kink resistance of the stylet (10) is reduced, and the effect of preventing balloon kink during rearrangement of the balloon (1) to the Vater's papilla is not preferable.

[0015]

As is clear from the above, the dilatation balloon catheter according to the present invention is extremely useful as a medical device in EPBD, which can reliably reposition the balloon to the papilla of Vater without using a guide wire. .

[Brief description of the drawings]

FIG. 1 is a view showing a dilatation balloon catheter according to one embodiment of the present invention.

FIG. 2 is a sectional view of a front portion of a dilatation balloon catheter according to an embodiment of the present invention.

[Explanation of symbols]

 1. Balloon 2. 2. catheter tube Shaft 4. Tip tube 5. Minor lumen 6. Main lumen 7. Connector 8. Scale line 9. X-ray opaque marker 10. Stylet 11． Guidance part 12. Cap 13. Main lumen branch

Claims (1)

[Claims] 1. A balloon catheter comprising a balloon attached to a front portion, a catheter tube having a main lumen penetrating in a longitudinal direction and a sub-lumen opening inside the balloon, wherein a balloon tube is provided in front of the balloon. A guide portion made of a flexible tube having a length of 20 to 60 mm, a linear body made of metal passes through the main lumen, and the tip reaches at least the boundary between the distal end of the balloon and the guide portion. A dilatation balloon catheter, which does not protrude from the catheter tip.