JPH0691006A - Balloon catheter for expansion - Google Patents

Abstract

PURPOSE:To provide a balloon catheter for expansion in which formation is made without thickening the outer diameter of a connection portion that connects a connection due to the connection end portion of a balloon formed in a two-axis orientation. CONSTITUTION:A flexible tube 3 or a core member is positioned at the balloon portion of a balloon 2 formed by means of two-axis orientation prepared by blow forming, and a connection place is heated by means of a heating device, and at the same time, a close contact portion is formed by pulling fingers holding a balloon end portion from the balloon side to the near-at-hand side and bringing the balloon end portion into close contact with, for example, the flexible tube 3. Next, an FEP heat contraction tube 9 whose material quality fusion point is higher than those of the material qualities of the other members, is put over the close contact portion, and this close contact portion is welded by carrying out sufficient melting by conducting re-heating using the heating device. At this time, the outer diameter of the heat contraction tube thus heated is regulated by means of an outer diameter regulating jig. In addition, after the cooling of the welded portion, the heat contraction tube 9 is removed, and at the same time, a core metal 6 inserted into the cavity of the flexible tube 3 beforehand is pulled out, and a connection portion 10 connecting the balloon end portion to the flexible tube 3 is formed.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is endoscopically inserted into a stenosis in a body cavity to supply air, or liquid is supplied to expand a balloon provided at the distal end to expand the stenosis. A dilatation balloon catheter.

[0002]

2. Description of the Related Art Recently, a treatment has been performed in which a dilatation balloon catheter is inserted into a narrowed portion in a body cavity and the balloon portion of the balloon catheter is inflated to dilate the narrowed portion. The manufacturing method of the dilatation balloon catheter is described in US Pat.
P4411055 and Japanese Examined Patent Publication No. 4-670, and in the method for manufacturing a dilatation balloon catheter of the above-mentioned USP 4411055, the heat shrinkability of the end of the connecting portion of the balloon is utilized to cover the aluminum foil. It is covered and heated to heat-weld.

In the method of manufacturing a dilatation balloon catheter disclosed in Japanese Patent Publication No. 4-670, a balloon made by biaxial orientation blow molding is covered with a glass mold and heat-welded.

[0004]

However, the connecting end portion of the balloon and the connecting tube as shown in FIGS. 7 and 8 of the above Japanese Patent Publication No. 4-670 are heated and welded to orient the two axes. With a balloon formed in this way, when heat-welding this balloon connection end, it is necessary to form the outer diameter of the balloon end to be thicker than the original tube outer diameter. Since it may occur, it is difficult to surely seal and fix it.

Further, when the balloon connecting end portion of a balloon formed by biaxial orientation is heated and contracted to be welded to a connecting tube or the like, the balloon extending axially outward is a balloon connecting end. The heated part will shrink inward in the axial direction to increase the wall thickness of the balloon, increase the outer diameter of the welded part, and length of the welded part between the balloon connecting end and the connecting tube. However, there is a problem in that the reliability of the welding is reduced due to the shortened length.

Furthermore, when fixing the connection end of the balloon and the connection tube, etc., the balloon connection end is covered with a glass tube for heating, so that the outside diameter of the connection section is regulated from the outside of the glass tube. In addition to this, there is a problem in that the portion that expands by heating adheres to the glass tube so as to fill the gap with the glass tube, and it becomes difficult to remove the glass tube from the connection portion after cooling.

On the other hand, a balloon formed as described in US Pat. No. 4,411,055 does not have a problem caused by shrinkage due to heating, but since it is not formed by being biaxially oriented, the strength as a balloon is weak and the stenosis is expanded. I am worried about the strength of doing.

Further, there is a drawback in that it is impossible to confirm the welding state between the balloon connecting end portion and the connecting tube because the cover is made of aluminum foil or the like and heat welding is performed.

The present invention has been made in view of the above circumstances, and the outer diameter of the connecting portion between the balloon connecting end portion formed by being biaxially oriented and the connecting tube is larger than the outer diameter of the original connecting end portion. There is provided a dilatation balloon catheter formed by welding without being formed.

[0010]

A dilatation balloon catheter according to the present invention is a dilatation balloon catheter which is formed by connecting a flexible tube or a shaft to a biaxially oriented balloon end portion made of a thermoplastic resin. The flexible tube or the shaft is arranged at a predetermined position of the balloon end, and the balloon end provided with the flexible tube or the balloon end provided with the shaft is heated to form a close contact portion. On the other hand, the contact portion is covered with a heat-shrinkable tube and heated to be melted, and after the contact portion is cooled, the heat-shrinkable tube is removed to form a connection portion.

[0011]

According to this structure, first, the flexible tube or the shaft is arranged at a predetermined position of the biaxially oriented balloon end.

Next, the balloon end provided with the flexible tube or the balloon end provided with the shaft is heated to form a close contact portion.

Then, a heat-shrinkable tube is put on the contact portion and heated again to melt and weld the contact portion, and at the same time, the heat-shrinkable tube is heated and shrunk.

After cooling the final contact portion, the heat-shrinkable tube is removed to form a connecting portion between the flexible tube and the balloon end or the shaft and the balloon end.

[0015]

Embodiments of the present invention will be described below with reference to the drawings. 1 to 12 relate to a first embodiment of the present invention,
FIG. 1 is an explanatory view showing a schematic configuration of a dilatation balloon catheter, FIG. 2 is a perspective view showing a state in which a flexible tube having a cored bar inserted in a distal end portion is covered with a balloon, and FIG. 3 is a flexible tube having a balloon proximal end. FIG. 4 is a perspective view showing a state in which the heat-sealing portion is heat-shrinked, FIG. 4 is a perspective view showing a state where the heat-sealing portion is covered with a heat-shrinkable tube, and FIG. 6 is an explanatory view showing a state in which the heat-shrinkable tube and the cored bar have been removed after cooling the heating portion, and FIG. 7 is a perspective view showing a wire assembly in which a core member having a tip fixed to the tip is covered with the heat-shrinkable tube. Is an explanatory view showing a state in which the wire assembly is inserted and positioned from the distal end side of the balloon, FIG. 9 is an explanatory view showing a state in which the wire assembly is heat-adhered to the balloon distal end, and FIG. 10 is a balloon distal end. Cover the heat shrink tube and heat shrink. FIG. 11 is a perspective view showing a state in which a balloon tip portion is formed by means of a balloon, FIG. 11 is an explanatory view showing the formed balloon tip portion, and FIG. 12 is an explanatory view showing a schematic configuration of a balloon dilator using the dilatation balloon catheter of the present invention. is there.

As shown in FIG. 1, a dilatation balloon catheter 1 is formed by extruding a balloon 2 formed by biaxially oriented blow molding of a thermoplastic resin tube and polyethylene or the like connected to a rear end portion 2a of the balloon 2. A flexible tube 3 having an inner cavity 3a formed therein, a core member 4 inserted through the inner cavity 3a of the flexible tube 3 and connected to the distal end portion 2b of the balloon 2, and a base of the flexible tube 3. It is composed of a base 5 and the like provided at the end.

Here, the balloon catheter for dilation 1
The connection between the balloon rear end 2a and the distal end of the flexible tube 3 will be described. As shown in FIG. 2, the flexible tube 3 is positioned and disposed at the balloon rear end portion 2a of the balloon 2 formed by biaxial orientation blow molding. It is to be noted that the inner cavity 3a provided in the flexible tube 3 is prevented from being blocked during the connecting step, and a slender cored bar 6 which can be easily removed at the end of the connecting step is provided on the distal end portion of the flexible tube 3. It is inserted.

Then, as shown in FIG. 3, the connecting portion is heated by the heating device 7, and the finger holding the balloon rear end 2a is pulled from the balloon side toward the hand side to pull the balloon rear end 2a and the flexible tube 3 together. And are brought into close contact with each other to form a close contact portion 8. At this time, the balloon is sequentially brought into close contact with the rear end side from the balloon side so that no air remains between the balloon rear end 2a and the flexible tube 3. Further, since the balloon rear end portion 2a is pulled and pulled close to the hand side, the outer diameter of the close contact portion 8 does not become large.

Next, as shown in FIG. 4, the heat-shrinkable tube 9 made of ethylene tetrafluoride ethylene hexafluoride (hereinafter abbreviated as FEP), which is a material having a higher melting point than that of the flexible tube 3 and the balloon 2, is used. The contact portion 8 and the tip of the flexible tube 3 are covered.

Then, as shown in FIG. 5, the contact portion 8 covered with the heat shrinkable tube 9 and the flexible tube 3 are heated by the heating device 7.
The heat-shrinkable tube 8 is heated to be sufficiently melted and welded, and the outer diameter of the heated heat-shrinkable tube 8 is regulated by an unillustrated outer-diameter regulating jig or the like to weld without increasing the outer diameter.

Further, as shown in FIG. 6, the heat-shrinkable tube 9 is removed after cooling the welded portion, and the core metal 6 inserted into the inner cavity of the flexible tube 3 is pulled out to pull out the balloon rear end portion 2a.
And a connecting portion 10 between the end portion of the flexible tube 3 and the flexible tube 3 is formed.

Next, the connection between the balloon tip portion 2b of the dilatation balloon catheter 1 and the core member 4 will be described. First, the wire assembly portion 11 serving as a connection portion for connecting the core member 4 to the balloon tip portion 2b is formed.

As shown in FIG. 7, the wire assembly portion 11 covers the tip end portion of the core member 4 with the tip member 12 fixed by spot welding or the like, while the tip end portion covered with the tip member 12 has an elongated heat-shrinkable tube. 13 is covered, and the heat-shrinkable tube 13 is heat-shrinked to form a predetermined shape.

Then, as shown in FIG. 8, the rear end portion of the core member 4 extending from the wire assembly portion 11 is inserted from the balloon tip portion side to place the wire assembly portion 11 at a predetermined position of the balloon tip portion 2b. Set up.

Further, as shown in FIG. 9, as in the case where the flexible tube 3 is closely attached to the balloon rear end portion 2a of FIG.
The balloon tip portion 2b and the heat-shrinkable tube 13 are heated by the heating device 7 to pull the finger gripping the balloon tip portion 2b toward the hand side so that the contact portion 14 does not become thick.
To form.

Subsequently, as shown in FIG. 10, as in the case of heating and welding the close contact portion 8 between the balloon rear end portion 2a and the flexible tube 3 of FIGS. 4 and 5, heat contraction of FEP. The tube 9 is attached to the balloon tip 2b and the heat shrinkable tube 13.
The heat-shrinkable tube 9 by covering the contact portion 14 with
While sufficiently melting the contact portion 14 covered with the
The tip portion is formed by thinly constricting the hollow portion from the tip 12 to the tip side so as to be crushed.

After cooling, the heat-shrinkable tube 9 is removed to form a connecting portion 15 between the balloon tip portion 2b of the dilatation balloon catheter 1 and the core member 4 as shown in FIG.

The operation of the dilatation balloon catheter 1 configured as described above will be described. First, as shown in FIG. 12, the dilatation balloon catheter 1 disposed in the balloon dilator 21 is inserted into a treatment tool insertion channel of an endoscope (not shown) to allow a narrowed portion such as an esophagus in a body cavity. To place. And balloon dilator 2
1 to the inner wall 3 of the flexible tube 3
A liquid is sent into the balloon through a to expand the balloon 2 and expand the stenosis.

In this way, the dilatation balloon catheter 1
In the balloon 2 of FIG. 1, the connection portion 15 between the balloon tip portion 2b and the core member 4 and the connection portion 10 between the balloon rear end portion 2a and the flexible tube tip portion are heated and adhered to each other, and the melting point By covering the high heat shrinkable tube 9 and melting and adhering the close contact portion again, the balloon 2 formed in a biaxial orientation is not contracted, and the connection portion is sealed while confirming the welded state of the connection portion. Can be formed.

Further, when forming the contact portion, the balloon tip portion 2b or the balloon rear end portion 2a is pulled and brought into close contact, and when the close contact portion is heated again and welded, the outer diameter is controlled by the outer diameter controlling jig. Since it is possible to form the connecting portions 10 and 15 without increasing the diameter thereof, it is possible to reliably improve the insertability of the endoscope into the treatment instrument insertion channel.

Since the pressure gauge 22 is provided between the liquid delivery mouthpiece 5 and the liquid delivery means 21, the pressure inside the balloon can be confirmed.

FIGS. 13 to 17 relate to a second embodiment of the present invention, and FIG. 13 is a schematic view showing the configuration of a dilatation balloon catheter having a first lumen and a second lumen,
14 is an explanatory view showing a connecting portion between the balloon rear end portion and the outer tube distal end portion, FIG. 15 is an explanatory view showing a connection between the balloon distal end portion and the inner tube, and FIG. 16 is a heat-shrinkable tube inside the balloon distal end portion. FIG. 17 is an explanatory view showing a state in which the tube is closely attached to the tube and welded, and FIG. 17 is an explanatory view showing the balloon tip portion, the inner tube, and the connecting portion.

The construction of the dilatation balloon catheter of this embodiment will be described. As shown in FIG. 13, the dilatation balloon catheter 31 of this embodiment has an inner tube 32 instead of the flexible tube 3.
The outer tube 33, which is installed inside, is connected to the balloon rear end 2a, while the inner tube 32 is connected to the balloon front end 2b. In addition, a first lumen 34 communicating with the balloon 2 is formed between the outer tube 33 and the inner tube 32. Further, the inner tube 32 is formed with a second lumen 35. The first lumen 34 is the first
The second lumen 35 is inserted into the second base 37. The other structure is similar to that of the first embodiment.

The distal end portion of the outer tube 33 and the balloon rear end portion 2 of the dilatation balloon catheter 31 constructed as described above.
In the same manner as in the first embodiment, “a” is heated by a heating device to form a contact portion at one end, and the contact portion is heated and melted again to form a connection portion.

Next, as shown in FIG. 14, the inner tube 32 having the cored bar 6 inserted at its tip is inserted through the outer tube to form the inner tube 32.
The tip of the balloon is placed at a predetermined position on the balloon tip 2b.
Then, as shown in FIG. 15, the balloon tip portion 2b is heated while being pulled toward the hand side as in the first embodiment to form a close contact portion 38 between the balloon tip portion 2b and the inner tube 32. Further, the contact portion 38 is covered with the FEP heat shrinkable tube 9 and heated again to melt and weld the contact portion 38 and regulate the outer diameter. Finally, after cooling, the heat-shrinkable tube 9 covering the contact portion 38 is removed,
The core metal 6 is pulled out to form a connecting portion between the balloon tip portion 2b and the inner tube 32.

A guide wire can be inserted into the second lumen 35 provided in the inner tube 32. Other functions and effects are similar to those of the first embodiment.

FIGS. 18 to 23 relate to a first modification of the second embodiment. FIG. 18 shows that the outer tube is connected to the distal end of the balloon and an opening is formed on the outer circumference of the outer tube located inside the balloon. FIG. 19 is a schematic configuration diagram showing the configuration of the dilatation balloon catheter provided, FIG. 19 is an explanatory view showing a connecting process between the outer tube middle part and the balloon rear end part, and FIG. 20 is formed by the outer tube middle part and the balloon rear end part. 22 is an explanatory view showing a state in which the heat-shrinkable tube is covered on the adhered portion, FIG. 21 is an explanatory view showing a state in which the outer tube distal end portion and the balloon distal end portion are in close contact with each other, FIG.
FIG. 23 is an explanatory view showing a state in which a heat-shrinkable tube is covered on the contact portion formed by the outer tube tip and the balloon tip, and FIG. 23 shows a connecting portion formed by welding the outer tube tip and the balloon tip. It is an explanatory view shown.

As shown in FIG. 18, the balloon catheter 31 'of this embodiment has an outer tube 3 having an inner tube (not shown).
3 is connected to the balloon tip 2b, and an opening 38 is provided in the outer peripheral portion of the outer tube 33 located inside the balloon. The other structure is the same as that of the second embodiment.

As shown in the AA sectional view of FIG. 19, the outer tube 33 of the dilatation balloon catheter 31 'is provided with a first lumen 34 and a second lumen 35 which are substantially concentric and axially inserted. The first mandrel 41 is inserted into the first lumen 34, the tip portion of the outer tube 33 and the balloon tip portion 2b are positioned, and heated in the same manner as in the first embodiment, and the middle portion of the outer tube 33 is heated. And the balloon rear end portion 2a are brought into close contact with each other to form a close contact portion. Then, as shown in FIG. 20, the contact portion is covered with the FEP heat-shrinkable tube 9 and heated and melted again to form a connecting portion between the middle portion of the outer tube and the balloon rear end portion 2a.

Then, as shown in FIG. 21, the inner tube 32 having the cored bar 62 inserted at its tip is inserted into the outer tube. At this time, the tip of the inner tube 32 is arranged so as to be slightly protruded or flush with the tip of the outer tube 33.
Then, as in the case of the first embodiment, the balloon tip portion 2b and the inner tube 32 are brought into close contact with each other while being heated and pulled toward the hand side to form the close contact portion 38. Further, as shown in FIG. 22, the contact portion 38 is covered with the FEP heat shrinkable tube 9 and heated again to melt and weld the contact portion 38 and regulate the outer diameter. Finally, after cooling, the heat-shrinkable tube 9 covering the contact portion 38 is removed, and the cored bar 6 is pulled out to form a connection portion between the balloon tip portion 2b and the inner tube 32 as shown in FIG. Other functions and effects are similar to those of the above-mentioned embodiment.

24 to 26 relate to a second modification of the fourth embodiment of the present invention, and FIG. 24 is a schematic configuration diagram showing an outline of a dilatation balloon catheter using a perforated tube as an outer tube,
FIG. 25 is an explanatory view showing the connection between the porous tube and the balloon rear end portion, and FIG. 26 is an explanatory view showing the connection between the porous tube and the balloon front end portion.

As shown in the sectional view of FIG. 24, in this embodiment, a perforated tube 33 'having a first lumen 34 and a second lumen 35 provided in the axial direction is used instead of the outer tube 33. An opening 38 'connected to the first lumen 34 is provided on the outer peripheral portion of the perforated tube 33' located inside the balloon. The other structure is similar to that of the second embodiment.

As shown in FIG. 25, when connecting the above-mentioned porous tube 33 'and the balloon rear end portion 2a, the porous tube 33' is used.
Insert the third cored bar 63 into the first lumen 34 of the
The fourth cored bar 64 is inserted into the lumen 35 of the above, and heating is performed in the same manner as in the above-described embodiment to form a close contact portion, while the FEP heat shrinkable tube 9 is covered to melt and weld the close contact portion again, and cooling is performed. Post-heat shrink tube 9 and the third core metal 63
Is removed to form the connection part.

Then, as shown in FIG.
When connecting 3'and the balloon tip 2b, the tip of the perforated tube 33 'and the balloon tip 2 are connected as in the previous embodiment.
b with one end to form a close contact portion, and the FEP heat shrink tube 9 is covered on the close contact portion to melt and weld the close contact portion, and after cooling, the heat shrink tube 9 and the fourth cored bar 64 are attached. Pry out to form a connection. Other functions and effects are similar to those of the above-mentioned embodiment.

[0045]

As described above, according to the present invention, the outer diameter of the connecting portion between the balloon connecting end formed by being biaxially oriented and the connecting tube is larger than the outer diameter of the original connecting end. It is possible to provide a dilatation balloon catheter which is formed by welding without being formed.

[Brief description of drawings]

1 to 12 relate to a first embodiment of the present invention, and FIG. 1 is an explanatory view showing a schematic configuration of a dilatation balloon catheter.

FIG. 2 is a perspective view showing a state in which a flexible tube having a cored bar inserted at its tip is covered with a balloon.

FIG. 3 is a perspective view showing a state in which a flexible tube is heated and brought into close contact with a balloon base end portion.

FIG. 4 is a perspective view showing a state in which a heat-shrinkable tube is covered on the heating contact portion.

FIG. 5 is a perspective view showing a state where the heat-shrinkable tube is heat-shrinked.

FIG. 6 is an explanatory view showing a state in which the heat-shrinkable tube and the cored bar are removed after cooling the heating portion.

FIG. 7 is a perspective view showing a wire assembly section in which a core member having a tip fixed to a tip is covered with a heat-shrinkable tube.

FIG. 8 is an explanatory view showing a state in which the wire assembly is inserted and positioned from the distal end side of the balloon.

FIG. 9 is an explanatory view showing a state in which the wire assembly is heated and closely attached to the balloon tip.

FIG. 10 is a perspective view showing a state in which the balloon tip is covered with a heat-shrinkable tube and heat-shrinked to form the balloon tip.

FIG. 11 is an explanatory view showing the formed balloon tip.

FIG. 12 is an explanatory diagram showing a schematic configuration of a balloon dilator using the dilatation balloon catheter of the present invention.

13 to 17 relate to a second embodiment of the present invention, and FIG. 13 is a schematic diagram showing a dilatation balloon catheter having a first lumen and a second lumen.

FIG. 14 is an explanatory view showing a connecting portion between a balloon rear end portion and an outer tube distal end portion.

FIG. 15 is an explanatory diagram showing the connection between the balloon tip and the inner tube.

FIG. 16 is an explanatory view showing a state in which a heat-shrinkable tube is covered and welded on the contact portion between the balloon tip and the inner tube.

FIG. 17 is an explanatory diagram showing a balloon tip portion, an inner tube, and a connection portion.

FIGS. 18 to 23 relate to a first modification of the second embodiment, and FIG. 18 shows an outer peripheral portion of the outer tube located inside the balloon while connecting the outer tube to the distal end of the balloon. Schematic diagram showing the configuration of the balloon balloon catheter for dilation

FIG. 19 is an explanatory view showing a step of connecting the middle part of the outer tube and the rear end part of the balloon.

FIG. 20 is an explanatory view showing a state in which a heat-shrinkable tube is covered on the close contact portion formed by the middle portion of the outer tube and the rear end portion of the balloon.

FIG. 21 is an explanatory view showing a state in which the outer tube distal end portion and the balloon distal end portion are in close contact with each other.

FIG. 22 is an explanatory view showing a state in which a heat-shrinkable tube is covered on the close contact portion formed by the outer tube distal end portion and the balloon distal end portion.

FIG. 23 is an explanatory view showing a connecting portion formed by welding the outer tube distal end and the balloon distal end.

FIGS. 24 to 26 relate to a second modification of the fourth embodiment of the present invention, and FIG. 24 is a schematic configuration diagram showing an outline of an expansion balloon catheter using a perforated tube as an outer tube.

FIG. 25 is an explanatory view showing a connection between a porous tube and a balloon rear end portion.

FIG. 26 is an explanatory view showing the connection between the porous tube and the balloon tip.

[Explanation of symbols]

 1 ... Dilatation balloon catheter 2 ... Balloon 3 ... Flexible tube 4 ... Core member

 ─────────────────────────────────────────────────── ─── Continuation of front page (72) Inventor Yasushi Machida 2-43-2 Hatagaya, Shibuya-ku, Tokyo Olympus Optical Co., Ltd. (72) Inventor Jun Matsumoto 2-43-2 Hatagaya, Shibuya-ku, Tokyo Olympus Optical Co., Ltd.

Claims (1)

[Claims] 1. A dilatation balloon catheter which is formed by connecting a flexible tube or a shaft to a biaxially oriented balloon end made of a thermoplastic resin, wherein the flexible tube or the shaft is a balloon end. The balloon end, which is arranged at a predetermined position in which a flexible tube is arranged, or
While heating the end portion of the balloon provided with the shaft to form a close contact portion, the close contact portion is covered with a heat shrinkable tube and melted by heating, and the heat shrinkable tube is removed after the close contact portion is cooled and connected. A balloon catheter for dilation, characterized by forming a portion.