WO2009133614A1

WO2009133614A1 - Balloon catheter

Info

Publication number: WO2009133614A1
Application number: PCT/JP2008/058327
Authority: WO
Inventors: 川尻健司; 金澤哲也; 中丸俊一; 神茂雄
Original assignee: 東レ・メディカル株式会社
Priority date: 2008-05-01
Filing date: 2008-05-01
Publication date: 2009-11-05

Abstract

A balloon catheter characterized in that two guide wire lumens, into which guide wires are to be inserted, are provided in a balloon inflation lumen having an uninflated balloon attached to the outer periphery at the tip thereof. By feeding the two guide wire lumens and balloon inflation lumen as described above toward the branching of tube along the two guide wires that have been preliminarily passed from the branching of tube into the respective branches, the lumen tip can be highly accurately placed at the position immediately before the branching of tube. Thus, the stent at the outer periphery of the balloon can be placed at the optimum target position.

Description

Balloon catheter

The present invention relates to a medical balloon catheter, and more particularly, to a medical balloon catheter suitable for dilatation treatment of a stenosis part formed in a branch pipe part such as a blood vessel, an esophagus, a trachea, a urethra, and a bile duct.

The catheter system using a balloon catheter, the stent delivery system and related stents are widely used for the treatment of stenosis, aneurysms, lesions and other abnormalities in blood vessels and other body lumens. In the treatment using a balloon catheter, generally, a medical device called a stent is sent to a predetermined stenosis or occlusion, and then the balloon is expanded, and the stent is plastically deformed by the expansion force of the balloon to form an inner surface of the stenosis. The affected area is expanded by close contact. In order to place a stent in a desired stenosis, first pass a guide wire through the affected blood vessel in advance, and then follow the guide wire to the balloon catheter with the stent attached to the distal end to the desired position. The sending method is generally implemented.

However, in the above method, it is difficult to appropriately place the stent at the target position in the branch pipe portion. In the treatment of the branch tube portion by the balloon catheter, it is necessary to accurately place the stent at an appropriate position of the branch tube portion. However, in the above method, as shown in FIG. It is difficult to prevent entering into a branch or being placed in front of a target branch site. In order to prevent this with the conventional method, first pass one guide wire through each branch of the branch tube, place the balloon catheter along one guide wire, and then between the stent and the inner wall of the blood vessel. The other guide wire sandwiched between the two is removed once, and the guide wire is passed through the catheter again to extend into the extracted branch, and the operation procedure is complicated in the treatment. It has become a thing.

Therefore, an object of the present invention is to provide a balloon catheter suitable for indwelling a stent accurately and accurately according to a target position of a branch pipe part, thereby forming a branch pipe part such as a blood vessel, an esophagus, a trachea, a urethra, and a bile duct. The purpose of this invention is to make it possible to perform dilation treatment more easily and appropriately.

In order to solve the above problems, the balloon catheter according to the present invention is provided with two guide wire lumens into which a guide wire is inserted in a balloon inflation lumen in which an uninflated balloon is attached to the outer periphery of the distal end portion. It consists of what is characterized by.

That is, in the balloon catheter of the present invention, when performing the operation of sending and placing the stent in the branch tube portion, the two guide wires branched and inserted into each branch of the branch tube are separated into separate guide wire lumens. Since the distal end portion of the balloon catheter is sent to the branch tube portion while being inserted into the branch tube portion, the balloon mounting portion of the balloon inflation lumen is branched by two guide wires that are branched and inserted into the branches. The balloon is in a state of being locked by the shape portion, and the balloon inflation lumen and the distal end portion of the balloon are stopped at the branch pipe portion or a target position immediately before the branch tube portion. As a result, the stent mounted on the outer periphery of the balloon is also positioned at the most desirable target position, and can be accurately and accurately placed at the target position after balloon inflation.

Further, the balloon catheter may have a structure in which the balloon tip side portion of the balloon inflated lumen is substantially composed only of a margin portion for joining the balloon for balloon sealing. The length in the lumen extending direction of the adhesive margin portion for balloon bonding is not particularly limited, but is preferably in the range of 1 mm to 5 mm, for example. This makes it possible to send the balloon tip to the back of the branch pipe part, that is, to the position where it hits the branch part of the branch pipe part or to the position immediately before that while securing the minimum glue margin for balloon sealing. It can prevent being detained at a position in front of the branch pipe part.

The two guide wire lumens of the balloon catheter may be extended in the balloon inflation lumen from the tip of the balloon inflation lumen to the connector joint portion at the rear end of the balloon inflation lumen (this structure is an over-the-wire ( Sometimes called OTW) type). Alternatively, the two guide wire lumens extend from the tip of the balloon inflated lumen to the inside of the balloon inflated lumen, and in the middle of the section to the connector joint at the rear end of the balloon inflated lumen, It may be led out of the lumen (this structure is sometimes referred to as a rapid exchange (RX) type). Furthermore, a structure combining the above two forms, that is, one of the two guide wire lumens extends from the tip of the balloon inflated lumen to the connector joint at the rear end of the balloon inflated lumen. The other side extends from the tip of the balloon inflated lumen to the inside of the balloon inflated lumen, and goes out of the balloon inflated lumen in the middle of the section to the connector joint at the rear end of the balloon inflated lumen. It is also possible to have a derived structure.

According to the balloon catheter of the present invention, two guide wire lumens are simultaneously provided in the balloon inflation lumen, and one guide wire is inserted into each branch of the branch pipe portion in advance, and the balloon inflation lumen is inserted. And the balloon, and further, the distal end of the stent on the outer periphery of the balloon can be stopped at the optimum target position with respect to the branch pipe, thereby preventing the catheter or stent from entering one of the branches. Finally, it becomes possible to place the stent at the optimum target position immediately before the branch pipe portion. In addition, by making the balloon tip side part of the balloon inflation lumen substantially consist only of the glue margin part that joins the balloon for balloon sealing, the balloon tip is moved to the position just before the branch pipe part. Therefore, the stent can be prevented from being placed in front of the branch pipe portion.

In addition, when the balloon catheter according to the present invention is used, since any guide wire inserted into each branch of the branch tube is not sandwiched between the stent and the inner wall of the blood vessel, preparation for treatment can be performed without recrossing the guide wire. As a result, the work procedure can be simplified and the work time can be shortened.

It is a schematic block diagram of the balloon catheter which concerns on one embodiment of this invention. It is the schematic block diagram which showed the example of arrangement | positioning of the guide wire lumen in the balloon catheter which concerns on this invention. 1 is an overall schematic configuration diagram of a balloon catheter according to an embodiment of the present invention. It is comparison explanatory drawing of the conventional method and this invention in the stent arrangement | positioning method by a balloon catheter. It is a schematic block diagram for demonstrating an example of the stent arrangement | positioning procedure in the branch pipe part in this invention.

Explanation of symbols

1: Balloon catheter 2: Balloon inflation lumen 3: Guide wire lumen 4: Balloon 5: Balloon joint glue margin 6: Guide wire 7: Connector 8: Connector joint portion 10: Stent 11: Branch 12: Branch stent

Hereinafter, preferred embodiments of a balloon catheter according to the present invention will be described with reference to the drawings.
FIG. 1 shows a balloon catheter according to an embodiment of the present invention. In particular, a balloon distal end portion of a balloon inflation lumen is substantially composed only of a margin portion for joining the balloon for balloon sealing. The structure is shown. In FIG. 1, a balloon catheter 1 has a balloon inflation lumen 2, and two guide wire lumens 3 are provided in the balloon inflation lumen 2. The balloon catheter 1 has a balloon bonding paste margin 5 at the distal end portion, and the balloon 4 is bonded to the outer periphery of the distal end portion of the balloon catheter 1 via the balloon bonding paste margin 5 so as to be inflatable. The two guide wires 6 are relatively inserted into the respective guide wire lumens 3. In this embodiment, the tip of the balloon inflation lumen 2 has a sealing structure, and only the installation portion of the guide wire lumen 3 has the inside of the guide wire lumen 3 opened to the sealing end. The guide wire 6 can be inserted into the guide wire lumen 3.

The balloon joining structure in the balloon catheter according to the present invention is not particularly limited, but the balloon tip side portion of the balloon inflation lumen is substantially only a glue margin portion for joining the balloon for balloon sealing. Preferably, the margin portion 5 for joining the balloon is in the range of 1 mm to 5 mm. Since the balloon tip side portion is substantially composed only of the glue margin portion, it becomes easier to place the stent attached to the balloon tip at a position immediately before the branch pipe portion.

Further, in the present invention, the extending form of the guide wire lumen in the balloon inflation lumen can take various forms. In particular, in the overall configuration shown in FIG. 3, various configurations can be adopted for the extension configuration of the guide wire lumen 3 with respect to the connector 7 connected to the rear end of the balloon inflation lumen 2 and its joint portion 8. For example, as shown in FIG. 2 (A), two guide wire lumens 3 are both connected from the front end of the balloon inflated lumen 2 to the connector connecting portion 8 (shown in FIG. 3) at the rear end of the balloon inflated lumen 2. It can be set as the form extended in a fret lumen. Alternatively, as shown in FIGS. 2B and 3, two guide wire lumens 3 both extend from the tip of the balloon inflation lumen 2 in the balloon inflation lumen 2, and the balloon inflation It can also be set as the form led out of the balloon inflation lumen 2 in the middle of the section to the connector joint portion 8 at the rear end of the lumen 2. Furthermore, the structure in which both the above-described forms are combined, that is, one of the two guide wire lumens 3 is connected to the balloon inflation lumen 2 from the tip of the balloon inflation lumen 2 to the connector joint portion at the rear end of the balloon inflation lumen 2. The other is extended in the balloon inflated lumen 2 from the tip of the balloon inflated lumen 2 and in the middle of the section to the connector joint portion at the rear end of the balloon inflated lumen 2. It is also possible to adopt a form that is led out of the balloon inflation lumen 2.

Next, with respect to the use example of the balloon catheter 1 as described above, in particular, as an example of a method of placing a stent in a branch stenosis portion of a coronary artery of the heart as an example of a stent placement method in a branch vessel portion, This will be described in a form including various methods.
First, an introduction tube called a sheath introducer (not shown) is inserted into a blood vessel connected to a branching tube stenosis. For example, the upper arm or thigh is often selected as the insertion site. Next, a guiding catheter (not shown) is inserted into the blood vessel via the introduction tube, and the distal end of the guiding catheter is disposed up to the vicinity of the branch tube stenosis. Subsequently, two guide wires 6 are inserted through the guiding catheter to the branch stenosis, and arranged so that one guide wire 6 passes through each branch from the guiding catheter via the branch stenosis. To do. Thereafter, an unexpanded stent is attached to the balloon 4 of the balloon catheter 1, and the two guide wires 6 are passed through the respective guide wire lumens 3 from the balloon tip side portion of the balloon catheter 1. Then, the balloon catheter 1 is sent along the guide wire 6 to the branch stenosis, and the balloon inflation lumen is sent so that the tip of the balloon inflation lumen 2 is locked by the branch shape of the two guide wires 6. As a result, the distal end of the balloon inflation lumen 2 is positioned at a desired position immediately before the branch tube portion, and thereby the unexpanded stent attached to the balloon 4 is disposed at a desired position of the branch tube stenosis portion. After the stent is placed at a desired position, a liquid (for example, a diluted contrast medium) is injected into the balloon inflation lumen 2 and pressure is applied to inject the balloon into the balloon 4 to inflate the balloon 4, and the branch tube The stent disposed at a desired position of the stenosis is plastically deformed and brought into close contact with the inside of the tube. Finally, after the balloon 4 is deflated by reducing the pressure of the liquid injected into the balloon inflation lumen 2, the balloon catheter 1 is removed from the branch stenosis along the guide wire 6 so that the stent adheres to the inside of the tube. In this state, it is left at a desired position.

FIG. 4 shows an outline of the stent placement method using the balloon catheter as described above in comparison with the conventional method. FIG. 4 (A) illustrates a stent placement method according to a conventional technique. A balloon catheter 1 having a stent 10 attached to the tip of a balloon is placed along a guide wire 6 at a target position of a branch pipe. It shows how to do. As can be seen from FIG. 4A, it is difficult to prevent the stent 10 from entering the branch 11 with the conventional technique. On the other hand, when stent placement is performed using the balloon catheter according to the present invention, as shown in FIG. 4B, the balloon catheter 1 with the stent 10 attached to the tip of the balloon is branched and inserted into each branch. Since the two guide wires 6 are locked to the branched shape, the balloon tip is not inserted into the branch 11, and the stent 10 attached to the balloon is placed at the target position immediately before the branch pipe portion. It becomes possible.

FIG. 5 (A) shows a state in which the stent 10 is plastically deformed from the state of FIG. 4 (B) and brought into close contact with the inside of the tube, and after the balloon 4 is deflated, the balloon catheter 1 is removed from the branch tube portion. is there. In FIG. 5 (A), since two guide wires 6 are both arranged through the lumen of the stent 10 to the respective branches 11, as shown in FIG. By using the branching stent 12 having a size capable of passing through the ten lumens, the branching stent 12 can be easily arranged on each branch 11.

The balloon catheter according to the present invention can be applied to all fields of application involving stent placement in a branch vessel, and is particularly suitable for appropriately placing a stent in a branch stenosis of a coronary artery.

Claims

A balloon catheter characterized in that two guide wire lumens into which guide wires are inserted are provided in a balloon inflation lumen in which an uninflated balloon is attached to the outer periphery of the distal end portion.
The balloon catheter according to claim 1, wherein a balloon tip side portion of the balloon inflation lumen is substantially composed only of a margin portion for joining the balloon for balloon sealing.
The balloon catheter according to claim 1 or 2, wherein the two guide wire lumens are extended in the balloon inflation lumen from the tip of the balloon inflation lumen to the connector joint portion at the rear end of the balloon inflation lumen.
The two guide wire lumens extend from the tip of the balloon inflated lumen to the inside of the balloon inflated lumen, and in the middle of the section to the connector connecting portion at the rear end of the balloon inflated lumen, The balloon catheter according to claim 1 or 2, wherein the balloon catheter is led out.
One of the two guide wire lumens extends into the balloon inflation lumen from the balloon inflation lumen tip to the connector joint at the rear end of the balloon inflation lumen, and the other is the balloon inflation lumen tip. The balloon inflated lumen is extended from the inside of the balloon inflated lumen, and is led out of the balloon inflated lumen in the middle of a section from the balloon inflated lumen rear end to the connector connecting portion. Balloon catheter.
The balloon catheter according to any one of claims 2 to 5, wherein the length in the lumen extending direction of the adhesive margin portion for balloon bonding at the tip side portion of the balloon inflation lumen is in the range of 1 mm to 5 mm.