JP6708615B2 - Balloon catheter - Google Patents

Description

TECHNICAL FIELD The present invention relates to a balloon catheter used for an operation of expanding a stenosis portion in a body cavity.

BACKGROUND ART Conventionally, a balloon catheter has been widely used for an operation of expanding a stenosis portion generated in a body cavity. The balloon catheter has a double balloon structure, and is configured to be fixed and expanded. As shown in FIG. 7, the balloon catheter 1 for dilatation of the esophagus is provided with an inner balloon 3 that bulges in a spherical shape for fixing on the outer peripheral surface of a tube body 2, and bulges in a long bale shape that surrounds the outer side thereof in the front and rear directions. The outer balloon 4 was provided for expansion.

In the swallowing training procedure for a patient with dysphagia using the balloon catheter 1, first, as shown in FIG. 7A, the catheter 1 is inserted from the oral cavity into the esophagus under fluoroscopy. At this time, since the catheter 1 has the contrast ring 5, it can be confirmed whether the inner balloon 3 has passed through the narrowed portion of the esophagus. Then, when the inner balloon 3 passes through the narrowed portion of the esophagus, the inner balloon 3 is expanded and fixed to the narrowed portion.

As shown in FIG. 7B, the outer balloon 4 is expanded while the tube body 2 is slightly pulled upward (oral cavity side) so that the inner balloon 3 fixed to the stenosis does not shift downward (gastric side). .. The outer balloon 4 is in the shape of a bale, and its expansion expands the entire balloon to give a pressure stimulus to the stenosis. In this state, since the tube body 2 is pulled upward, the contents (air) of the outer balloon 4 are moved downward as shown in FIG. 7C, and the position of the outer balloon 4 as a whole is displaced. There was a problem.

As a conventional technique capable of solving the above-mentioned problem, for example, one disclosed in Patent Document 1 is known. That is, on the outer peripheral surface of the tube main body, a plurality of inner balloons are provided at intervals in the axial direction, each inner balloon is covered, and one outer balloon portion that can be easily expanded from each inner balloon is provided. Is. According to such a balloon catheter, the stenosis portion is settled in the valley portion of both inner balloons, and the positional displacement can be prevented even when the outer balloon is expanded.

Japanese Patent No. 4705715

However, in the above-mentioned conventional balloon catheter described in Patent Document 1, the number of inner balloons for fixation is large, which is two or more, and moreover, the tube body is provided with a plurality of lumens that communicate with each balloon individually. Was also needed. Therefore, there is a problem that it becomes a factor of increasing the cost of the balloon catheter.

Further, in the balloon catheter described in Patent Document 1, the operation of expanding and contracting the contents (air) by feeding the contents (air) through the lumens is performed for each of the large number of balloons. Therefore, there is also a problem that it takes time and labor to use the balloon catheter.

The present invention has been made by paying attention to the problems of the above-described conventional technology, and the number of balloons is only two, ie, the inner side and the outer side, and the simple configuration does not increase the cost. Another object of the present invention is to provide a balloon catheter which is easy to operate, requires no effort and time, and can surely prevent positional displacement when performing expansion of a stenotic portion in a body cavity and can perform an operation easily.

The gist of the present invention for achieving the above-mentioned object lies in the inventions of the following items.
[1] In a balloon catheter (10) used for an operation of expanding a stricture in a body cavity,
A flexible tube body (11) extending in the longitudinal direction is provided, and an inner balloon (20) that is expandable in the entire circumferential direction is provided on the outer peripheral surface of the tube body (11) in the middle thereof. 20) is provided with an outer balloon (30) which is expandable in the entire circumferential direction in a state of surrounding the
The outer balloon (30) has a distal end, which is the front in the approach direction of the tube body (11), close to the distal end side of the inner balloon (20), and is rearward in the approach direction of the tube body (11). The base end side that becomes is extending rearward from the same base end side of the inner balloon (20),
The outer balloon (30) is in contact with the inner balloon (20) which is also expanded at the time of expansion in a range of about a half from the front end to the rear end, and is outward toward the base end side rearward from the end of the contacted portion. A balloon catheter (10) which is inflated into a tapered shape whose diameter gradually increases .

[2] The balloon catheter (10) according to the above [1], wherein the outer balloon (30) is formed such that the thickness of the proximal side is smaller than that of the distal side.

[3] The inner balloon (20) adheres to the outer peripheral surface of the tube body (11) when contracted,
When the outer balloon (30) contracts, the portion covering the inner balloon (20) including the distal end side is in close contact with the inner balloon (20), and the portion not covering the inner balloon (20) including the proximal end side is The balloon catheter (10) according to the above [1] or [2], which is provided so as to be in close contact with the outer peripheral surface of the tube body (11).

[4] The balloon catheter (10) according to the above [1], [2] or [3], characterized in that a contrast marker (16) is provided on the proximal side of the inner balloon (20).

[5] The tube body (11) is provided with depth marks (17) starting from the contrast marker (16) along the axial direction thereof, [1], [2], [ 3] or the balloon catheter (10) according to [4].

[6] In the above-mentioned [1], [2], [3], [4] or [5], the tube body (11) is provided with a contrast line (15) extending in the axial direction thereof. The described balloon catheter (10).

[7] The body cavity is an esophagus and is used for dilatation of the esophageal entrance of a patient with dysphagia, [1], [2], [3], [4], [5] ] Or [6] the balloon catheter (10).

Next, the operation based on the above-mentioned solving means will be described.
In the balloon catheter (10) described in the above [1], the tube body (11) is provided with two balloons, an inner balloon (20) and an outer balloon (30) surrounding the inner balloon (20). Here, the outer balloon (30) has a distal end close to the distal end of the inner balloon (20) and a proximal end extending rearward from the proximal end of the inner balloon (20). Therefore, the distal side of the outer balloon (30) overlaps the distal side of the inner balloon (20), but the proximal side of the outer balloon (30) does not overlap the inner balloon (20).

When the outer balloon (30) is expanded, the tip side of the outer balloon (30) is contacted with the same expanded inner balloon (20) in a range from the front end to the rear end . Therefore, the content (fluid) of the outer balloon (30) does not move forward from the tip side of the inner balloon (20). Moreover, when the outer balloon (30) is expanded, the taper is such that the outer diameter gradually expands toward the base end side rearward from the end of the contact point in the range of about half toward the rear end from the front end of the inner balloon (20). It becomes a shape. Therefore, even if the proximal side of the outer balloon (30), which does not overlap with the inner balloon (20) in the inflated range, comes into pressure contact with the stenosis in the body cavity, the content of the outer balloon (30) remains the outer balloon (30) itself. It is difficult for the outer balloon (30) to move from the proximal side to the distal side, and the outer balloon (30) is not deformed and displaced from the narrowed portion.

According to the balloon catheter (10) of [2], the outer balloon (30) is formed such that the thickness of the outer balloon (30) on the proximal side is smaller than that on the distal side. As a result, the outer balloon (30) is more likely to be inflated on the proximal side than on the distal side at the time of expansion for filling with the fluid. Therefore, even if the outer balloon (30) is not formed in the tapered shape in advance, the outer balloon (30) can be formed in the tapered shape depending on the difference in the bulge due to the internal pressure.

According to the balloon catheter (10) of [3], the inner balloon (20) is in close contact with the outer peripheral surface of the tube body (11) during contraction. Further, when the outer balloon (30) contracts, the portion covering the inner balloon (20) including the distal end side is in close contact with the inner balloon (20), and the portion not covering the inner balloon (20) including the proximal end side is the tube. It adheres closely to the outer peripheral surface of the body (11).

As a result, when the balloons (20, 30) are deflated, a part of each balloon (20, 30) does not come into close contact with the tube body (11) and a large slack does not occur, and the balloon (20, 30) is inserted into the patient's esophagus. There is no danger of causing pain. Here, the term "close contact" means not only a state in which the balloons (20, 30) are in close contact with each other around the entire circumference without any gaps, but the entire outer circumference of the balloons (20, 30) is in close contact even if some wrinkles are generated due to the large outer diameter. It also includes various states.

According to the balloon catheter (10) of the above [4], since the contrast marker (16) is provided on the proximal end side of the inner balloon (20), the tube body (11) is inserted toward the narrowed part in the body cavity. In doing so, the position of the inner balloon (20) can be easily confirmed under fluoroscopy or the like.

According to the balloon catheter (10) of the above [5], the tube body (11) is provided with the depth mark (17) starting from the contrast marker (16) in the axial direction thereof. When inserting 11) toward the narrowed part in the body cavity, the length of the tube body 11 inserted in the body cavity can be easily confirmed.

According to the balloon catheter (10) of [6], since the tube body (11) includes the contrast line (15) extending in the axial direction, the tube body (11) is directed toward the narrowed part in the body cavity. It is possible to easily confirm the position of the entire tube body (11) in the body cavity under fluoroscopy or the like when inserting the tube body (11).

The balloon catheter (10) described above can be optimally used for dilatation of the esophageal entrance of a patient with dysphagia, as described in [7] above, for expanding a stenosis occurring in the esophagus.

ADVANTAGE OF THE INVENTION According to the balloon catheter which concerns on this invention, a simple structure does not lead to cost increase, it is also easy to operate and requires no effort or time, and when the stricture part in a body cavity is expanded, the positional displacement is surely performed. It can be prevented and the operation can be performed easily.

It is a partial longitudinal cross-sectional view of the expanded state which cuts and shows the principal part of the whole balloon catheter which concerns on embodiment of this invention in an axial direction. It is a longitudinal cross-sectional view which expands and shows the expansion state of the inner side balloon and outer side balloon of the balloon catheter which concerns on embodiment of this invention. FIG. 3 is a side view of the entire balloon catheter according to the embodiment of the present invention in a contracted state. It is a perspective view of the expanded state which shows the principal part of the balloon catheter concerning an embodiment of the invention. FIG. 4 is a vertical cross-sectional view showing an expanded or contracted state of the inner balloon and the outer balloon of the balloon catheter according to the embodiment of the present invention. It is explanatory drawing which shows the usage procedure of the balloon catheter which concerns on embodiment of this invention. It is explanatory drawing which shows the usage procedure of the conventional balloon catheter.

Hereinafter, embodiments representative of the present invention will be described with reference to the drawings.
1 to 6 show an embodiment of the present invention.
The balloon catheter 10 according to the present embodiment is a medical device used for an operation of expanding a narrowed portion in a body cavity. Hereinafter, the case where the balloon catheter 10 is used for dilating a stenosis generated in the esophagus for dilatation of the esophageal entrance of a patient with dysphagia will be described as an example.

As shown in FIG. 1, a balloon catheter 10 is provided with a flexible tube body 11 extending in the longitudinal direction, and an inner balloon 20 that is expandable in the entire circumferential direction is provided on the outer peripheral surface in the middle of the tube body 11. At the same time, an outer balloon 30 is provided which is expandable in the entire circumferential direction while surrounding the inner balloon 20. Each of the balloons 20 and 30 is arranged on the front end side (left side in FIG. 1) that is the front side in the entry direction of the tube body 11, and the base end side (right side in FIG. 1) that is the rear side in the entry direction of the tube body 11. A catheter head 40 is arranged in the.

The tube main body 11 is a long tubular shape that is elongated and can be freely curved. A suitable material for the tube body 11 is a flexible synthetic resin such as silicone rubber or soft polyvinyl chloride. Inside the tube body 11, a main lumen 12 of a main conduit and two sub-lumens 13 and 14 for supplying a fluid for expanding the balloons 20 and 30 are axially provided as independent conduits. It is formed to extend.

The main lumen 12 is for introducing a medicinal solution such as a contrast medium or a nutrient, or for sucking saliva, and is formed as a penetrating passage extending around the axial center of the tube body 11. The tip of the main lumen 12 is open to the outside from the tip of the tube body 11. On the other hand, the proximal end of the main lumen 12 communicates with the inside of a catheter head 40 described later.

One sub-lumen 13 is for passing a fluid (for example, air or sterile distilled water) for expanding an inner balloon 20 described later, and is a thin tube extending in the axial direction at a position eccentric from the axial center of the tube body 11. It is formed as a road. The tip of the sub-lumen 13 is sealed, and the middle of the tip is opened from the outer peripheral surface of the tube body 11 and communicates with the inside of the inner balloon 20 (see FIG. 2 ). The base end of the sub-lumen 13 communicates with the inside of a catheter head 40 described below.

The other sub-lumen 14 is for passing a fluid (for example, air or sterilized distilled water) that expands an outer balloon 30 described later, and is a shaft opposite to the sub-lumen 13 with the main lumen 12 interposed therebetween. It is formed as a thin duct extending in the axial direction at a position eccentric from the center. The tip of the sub-lumen 14 is also sealed, and the middle of the tip is opened from the outer peripheral surface of the tube body 11 and communicates with the inside of the outer balloon 30 (see FIG. 2 ). The base end of the sub-lumen 14 communicates with the inside of a catheter head 40 described below.

As shown in FIG. 3, in the cross-sectional area of the tube body 11, a contrast line 15 is provided so as to extend in the axial direction in an empty space other than the main lumen 12 and the sub-lumens 13 and 14. The contrast line 15 is used to confirm the position of the entire tube body 11 from outside the body under the fluoroscopy (for example, X-ray), and is formed so as to include a material that does not transmit the radiation, such as barium sulfate. There is. Although the contrast line 15 in FIG. 3 is partially illustrated only on the proximal end side of the tube body 11, it actually extends to the distal end of the tube body 11.

As shown in FIG. 2, a contrast marker 16 is provided on the distal end side of the tube body 11 and on the proximal end side of the inner balloon 20. The contrast marker 16 can also be confirmed its position from outside the body under fluoroscopy (for example, X-ray), and is formed so as to include a material that does not transmit radiation, such as barium sulfate. In FIG. 2, the contrast marker 16 is provided in a ring shape that circulates around the outer peripheral surface of the tube body 11 at a position continuous with the base end of the inner balloon 20. The contrast marker 16 may be formed as a part of the inner balloon 20 on the proximal end side.

As shown in FIG. 3, the tube body 11 is provided with a depth mark 17 starting from the contrast marker 16 in the axial direction thereof. The depth mark 17 is a scale for confirming the length of the tube body 11 inserted into the body cavity, and is printed or marked. Although only a part of the depth mark 17 is shown in FIG. 3, it is preferable to mark the scale in the range of 5 to 35 mm, for example. The depth mark 17 is not limited to the outer peripheral surface of the tube body 11, but may be marked on the inner peripheral surface, or may be provided inside the peripheral wall.

As shown in FIG. 1, the inner balloon 20 is arranged on the distal end side of the tube body 11 and is provided so as to be expandable while covering the entire circumference of the tube body 11 in the middle thereof. As shown in FIG. 2, there are flange-shaped bonding margins 21 and 22 fixed to the outer peripheral surface of the tube body 11 on the distal end side and the proximal end side of the inner balloon 20, respectively, and between the bonding margins 21 and 22. An opening 13a of the sub-lumen 13 is provided inside the. The material of the inner balloon 20 may be any material that is flexible and elastically deformable, and for example, silicone rubber or the like is suitable.

The inner balloon 20 is expanded or contracted around the tube body 11 by pressurizing or depressurizing a fluid through the sub-lumen 13. When the inner balloon 20 is subjected to a pressurizing operation in which the fluid is introduced from the sub-lumen 13, it is expanded into a spherical shape which is slightly crushed in the front and rear around the tube body 11 (see FIG. 2), and the fluid is discharged from the sub-lumen 13. When the pressure reducing operation is performed, the tube body 11 contracts so as to come into close contact with the outer peripheral surface of the tube body 11 (see FIG. 3 ).

As shown in FIG. 1, the outer balloon 30 is provided on the distal end side of the tube body 11 so as to be expandable in the entire circumferential direction while surrounding the inner balloon 20. As shown in FIG. 2, flange-shaped adhesive margins 31 and 32 are provided on the distal end side and the proximal end side of the outer balloon 30, respectively, and inside the space between the adhesive margins 31 and 32, the sub-lumen 14 is provided. The opening 14a is provided. The material of the outer balloon 30 may be any material that is flexible and elastically deformable, and for example, silicone rubber or the like is suitable.

The front end side of the outer balloon 30 is close to the same front end side of the inner balloon 20, and the rear end of the outer balloon 30 extends rearward from the same base end side of the inner balloon 20. More specifically, the tip end side adhesion margin 31 of the outer balloon 30 is fixed in a state of being overlapped with the tip end side adhesion margin 21 of the inner balloon 20, and the tips of the balloons 20 and 30 are aligned with each other. On the other hand, the adhesive margin 32 on the base end side of the outer balloon 30 is located rearward beyond the adhesive margin 21 on the base end side of the inner balloon 20, and the tube body is fitted via the attachment ring 18 fitted externally at that position. It is fixed to the outer peripheral surface of 11.

The attachment ring 18 has an inner diameter of the adhesive margin 32 on the proximal end side of the outer balloon 30 that is the same as the inner diameter of the adhesive margin 31 on the distal end side, but should not be overlapped with the adhesive margin 22 of the inner balloon 20. This is to eliminate the step caused by. Instead of interposing the attachment ring 18, the adhesive margin 32 on the proximal end side of the outer balloon 30 is made thicker and the inner diameter is narrowed so that the adhesive margin 32 is directly fixed to the outer peripheral surface of the tube body 11. good.

The outer balloon 30 expands or contracts while surrounding the inner balloon 20 by pressurizing or depressurizing a fluid through the sub-lumen 14. Here, as shown in FIG. 2, the outer balloon 30 is provided in a tapered shape in which the outer diameter on the proximal end side gradually increases as compared with the distal end side that contacts the distal end side of the inner balloon 20 that is also expanded during expansion. There is. In the example shown in FIG. 2, when the outer balloon 30 is expanded, the proximal end side is in contact with about half of the distal end of the similarly expanded inner balloon 20, and it is difficult for the fluid to enter these contacting points.

The outer balloon 30 bulges in a taper shape in which the outer diameter gradually increases toward the rear from the terminal end of a portion that is in contact with about halfway from the tip of the inner balloon 20. The outer balloon 30 has a maximum diameter on the proximal end side, and the diameter is reduced from the maximum diameter portion toward the rear bonding margin 32. Here, the shape from the maximum diameter portion of the outer balloon 30 to the bonding margin 32 is not particularly limited, but as shown in FIG. 2, the inner balloon 20 does not have to be suddenly narrowed so as to be substantially orthogonal to the axis of the tube body 11. It is sufficient if the tapered shape of a predetermined length can be maintained from the terminal end of the portion in contact with the base end side.

The outer balloon 30 expands to the above-described tapered shape when the pressurizing operation for introducing the fluid from the sub-lumen 14 is performed (see FIG. 5C), and the depressurizing operation for discharging the fluid from the sub-lumen 14 is performed. When done, the inner balloon 20 and the tube body 11 are contracted so as to come into close contact with the outer peripheral surface of the tube body 11 (see FIGS. 5A and 5B). That is, when the outer balloon 30 is deflated, the portion covering the inner balloon 20 including the distal end side is in close contact with the inner balloon 20, and the portion not covering the inner balloon 20 including the proximal end side is in close contact with the outer peripheral surface of the tube body 11. ..

Such a shape of the outer balloon 30 when inflated may be preliminarily formed as an original shape in a normal state without pressurization and depressurization. Further, the outer balloon 30 has a wall thickness smaller on the proximal end side than on the distal end side so that the outer balloon 30 is in close contact with the outer peripheral surface of the tube body 11 so that wrinkles and slacks do not occur as much as possible. You may form like. Since the outer balloon 30 expands to a greater extent in a portion having a smaller wall thickness, if the outer balloon 30 is formed so that the wall thickness at the base end side becomes gradually thinner than that at the tip end side in accordance with the above-mentioned taper shape, the base balloon from the tip end is normally used. It is also possible to form a tubular shape having almost the same diameter from the end.

Further, coat portions 33 and 34 are provided before and after both the bonding margins 31 and 32 of the outer balloon 30 so as to eliminate a step from the outer peripheral surface of the tube body 11. The front coat portion 33 has a thickness corresponding to the thickness of the adhesion margin 21 of the inner balloon 20 and the adhesion margin 31 of the outer balloon 30 overlapped with each other in order to eliminate a step corresponding to the thickness. It is provided in a taper shape in which the diameter is gradually reduced.

The rear coat portion 34 is gradually reduced in diameter from the outer diameter of the tube main body 11 to the outer diameter of the thickness of the attachment ring 18 in order to eliminate the step difference of the thickness overlapped with the bonding margin 32 of the outer balloon 30. It has a tapered shape. Each coat part 33, 34 may be molded with, for example, a silicon-based coating agent or the like.

As shown in FIG. 1, a catheter head 40 to which the main lumen 12 and the sub-lumens 13 and 14 are connected in communication is provided at the proximal end of the tube body 11. The catheter head 40 is formed in a three-pronged funnel shape that communicates with the main lumen 12 and the sub-lumens 13 and 14, respectively.

A main portion of the catheter head 40 that extends in the coaxial direction with the tube body 11 is a main-lumen connection connector 41 that communicates with the main lumen 12 and injects a contrast agent or the like. Are connection connectors 42 and 43 for the sub-lumens that communicate with the sub-lumens 13 and 14 and allow the fluid for balloon expansion to pass therethrough.

The opening of the connection connector 41 for the main lumen is provided with a plug (not shown) that can be opened and closed. Further, check valves are provided inside the openings of the sub-lumen connecting connectors 42 and 43, and only when a fluid injection syringe (not shown) is inserted into each of the openings. The sub-lumens 13, 14 are configured to communicate with the outside. The material of the catheter head 40 is also preferably silicone rubber or the like.

Further, as shown in FIG. 1, it is preferable that the tip end 19 of the tube body 11 is provided at the tip end. The distal tip 19 is formed into a tubular shape that communicates with the main lumen 12 of the tube body 11, and is tapered to improve the insertability into the stenosis in the body cavity. The tip chip 19 is also preferably made of silicone rubber or the like. When the tip end 19 is not provided, the sub-lumens 13 and 14 may be sealed with liquid silicone rubber or the like, and then the tip end of the tube body 11 may be tapered.

Next, the operation of the balloon catheter 10 according to this embodiment will be described.
The balloon catheter 10 can be optimally used for dilatation of the esophageal entrance of patients with dysphagia, as it dilates a stenosis occurring in the esophagus. First, the distal end side of the balloon catheter 10 is inserted into the esophagus through the patient's oral cavity. At this time, the inner balloon 20 and the outer balloon 30 on the distal end side of the tube body 11 are both deflated.

That is, as shown in FIG. 5( a ), the inner balloon 20 is in close contact with the outer peripheral surface of the tube body 11, and the outer balloon 30 covers the inner balloon 20 in a portion that covers the inner balloon 20 and the outer peripheral surface of the tube body 11. The extended portion that is in close contact with the inner balloon 20 and is not in contact with the inner balloon 20 is in direct contact with the outer peripheral surface of the tube body 11. When the balloons 20 and 30 are deflated in this manner, some of the balloons 20 and 30 do not come into close contact with the tube body 11 and do not cause large slack or wrinkles and can be swallowed smoothly by the patient. ..

Since the contrast marker 16 is provided on the proximal end side of the inner balloon 20, it is possible to easily confirm whether or not the inner balloon 20 has passed through the narrowed part of the esophagus under fluoroscopy (for example, X-ray). Then, when the inner balloon 20 passes through the narrowed portion of the esophagus, as shown in FIG. 6A, the inner balloon 20 is expanded and fixed to the narrowed portion. Here, the tube body 11 is slightly pulled upward (oral cavity side) so that the inner balloon 20 fixed to the stenosis is not displaced downward (gastric side). As shown in FIG. 5B, the tip side of the outer balloon 30 that overlaps the inner balloon 20 when inflated is inflated together with the inner balloon 20.

Then, as shown in FIG. 6B, the outer balloon 30 is expanded while the tube body 11 is slightly pulled, so that the narrowed part of the esophagus can be expanded. As shown in FIG. 6C, when the outer balloon 30 is inflated, its tip side is in contact with the tip side of the inflated inner balloon 20. Therefore, even if the tube body 11 is pulled upward, the content (fluid) of the outer balloon 30 does not move forward from the tip side of the inner balloon 20.

Moreover, as shown in FIG. 5C, when the outer balloon 30 is expanded, the outer balloon 30 has a taper shape in which the outer diameter on the base end side gradually expands from the front end side. Therefore, even if the proximal side of the outer balloon 30 that does not overlap the inner balloon 20 in the inflated range is pressed against the narrowed portion in the body cavity, the content of the outer balloon 30 moves from the proximal side of the outer balloon 30 itself to the distal side. It is even more difficult to move, and the outer balloon 30 is not deformed and displaced from the narrowed portion. As a result, when expanding the narrowed portion of the esophagus, it is possible to surely prevent the positional displacement and easily perform the operation.

As described above, if the outer balloon 30 is formed so that the thickness at the proximal end side is thinner than that at the distal end side, the outer balloon 30 does not have to have a tapered shape in advance, but has a tapered shape due to the difference in the bulge due to the internal pressure. It is also possible to Further, the base end side may be molded with silicone rubber having higher flexibility and elasticity than the tip end side. In addition, it is possible to prevent the balloons 20 and 30 from slackening and wrinkling at the time of deflation, and to bring the balloons 20 and 30 into closer contact with the tube body 11. Here, the term "close contact" includes not only a state in which the balloons are in close contact with each other around the entire circumference but also a state in which even if some wrinkles are generated due to the large outer diameter of the base end side, the entire balloons are in close contact. ..

Further, according to the balloon catheter 10, since the tube body 11 is provided with the depth mark 17 starting from the contrast marker 16 along the axial direction thereof, when the tube body 11 is inserted toward the stricture part of the esophagus, The length of the tube body 11 inserted into the esophagus can be easily confirmed. Further, since the tube body 11 is provided with the contrast line 15 extending in the axial direction thereof, when the tube body 11 is inserted toward the narrowed part of the esophagus, it is easy to position the entire tube body 11 in the esophagus under fluoroscopy or the like. You can also check with.

Although the embodiment of the present invention has been described above with reference to the drawings, the specific configuration is not limited to the above-described embodiment, and even if there are changes and additions within the scope not departing from the gist of the present invention, the present invention Included in the invention. For example, the specific shapes and relative sizes of the tube body 11, the inner balloon 20, the outer balloon 30, and the catheter head 40 are not limited to those illustrated.

The balloon catheter according to the present invention is not limited to the one used for the dilatation of the esophageal entrance of a patient with dysphagia, and as a body cavity, a narrowed portion that occurs in the digestive tract such as the trachea or the bile duct or a blood vessel. It can be applied to balloon catheters for various purposes such as those used for dilatation treatment.

10... Balloon catheter 11... Tube body 12... Main lumen 13, 14... Sub-lumen 20... Inner balloon 30... Outer balloon 40... Catheter head

Claims (7)

In a balloon catheter used for the operation of expanding the stenosis in the body cavity,
Equipped with a flexible tube body extending in the longitudinal direction, an inner balloon that is expandable in the entire circumferential direction is provided on the outer peripheral surface in the middle of the tube body, and it can be expanded in the entire circumferential direction while surrounding the inner balloon. With an outer balloon,
The outer balloon has a distal end that is forward of the tube body in the advancing direction close to the distal end of the inner balloon, and a proximal end that is rearward of the tube main body in the same direction is the proximal end of the inner balloon. It extends from the side to the rear,
When the outer balloon is inflated, the outer balloon is in contact with the inflated inner balloon in a range of about half from the front end to the rear end, and the outer diameter is gradually increased toward the base end side rearward from the end of the contacted portion. A balloon catheter which is inflated in a tapered shape. The balloon catheter according to claim 1, wherein the outer balloon is formed such that the thickness of the proximal side is smaller than that of the distal side. The inner balloon adheres to the outer peripheral surface of the tube body when contracted,
When the outer balloon is deflated, the portion covering the inner balloon including the distal end side is closely attached to the inner balloon, and the portion not covering the inner balloon including the proximal end side is closely attached to the outer peripheral surface of the tube body. The balloon catheter according to claim 1, wherein the balloon catheter is provided. The balloon catheter according to claim 1, wherein a contrast marker is provided on the proximal end side of the inner balloon. The balloon catheter according to claim 1, 2, 3 or 4, wherein the tube body is provided with depth marks starting from the contrast marker along the axial direction thereof. The balloon catheter according to claim 1, 2, 3, 4, or 5, wherein the tube body is provided with a contrast line extending in an axial direction thereof. The balloon catheter according to claim 1, 2, 3, 4, 5 or 6, wherein the body cavity is an esophagus and is used for dilatation of an esophageal entrance of a patient with dysphagia.