JPH0733797Y2 - Compression hemostatic balloon catheter - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial field of application] The present invention relates to a balloon catheter used for emergency hemostasis at the time of gastrointestinal rupture hemorrhage in the fields of gastroenterological surgery and gastroenterology.

[Conventional technology]

As a first aid for bleeding due to a ruptured gastric varices, an emergency hemostasis with a compression hemostasis balloon is performed. When hemorrhage occurs due to the rupture of gastric varices, this hemostatic method inserts a balloon catheter equipped with a hemostatic balloon into the stomach through the esophagus through the esophagus, and when the hemostatic balloon reaches the stomach, Air is sent to the intestine to inflate the balloon and place it in the stomach, and the balloon wall presses the gastric varices to stop the bleeding.

In general, the inflated shape of this compression hemostatic balloon is often close to a spherical shape, and the adhesive portion with the tube has a depressed shape. The site of occurrence of gastric varices is often the gastric cardia, which is the connection between the esophagus and the stomach, or the fundus that expands upward beyond the height of the cardia. Therefore, when the balloon is inflated in a spherical shape, in the varicose vein of the gastric cardia, the balloon catheter is inflated, and then the balloon catheter is pulled toward the esophagus to force the balloon shape to match the shape of the gastric cardia. You must hold down and stop bleeding. At this time,
The stomach is lifted up and the patient's pain is great,
Further, due to excessive pressure on the gastric mucosa, necrosis of gastric mucosal tissue occurs when the balloon is left in place for a long time.

On the other hand, in varicose veins that occur in the fundus, the fundus is located at a position that exceeds the height of the cardia on the greater curvature side, so in a balloon that expands to the stadium, the balloon wall reaches this fundus. It's difficult to get it done. If air is supplied to the balloon excessively and the balloon is inflated completely in the stomach, the balloon wall can reach the fundus to some extent, but at this time, the small bowel region is excessively compressed. By
It causes necrosis of the gastric mucosa. Also, the balloon must have a fairly large volume to be inflated throughout the stomach. The balloon is made of a material with a large elongation, such as rubber, but there is a limit to the expansion, and it is necessary to attach a somewhat large balloon to the catheter, and this large balloon becomes an obstacle when inserting it into the stomach. .

In order to efficiently stop hemostasis of varicose veins in the gastric cardia, the balloon that can be placed in the stomach has a thin shape on the esophagus side, and after inflation, the catheter can be pulled lightly toward the esophagus side to reach the gastric cardia. Although there is a catheter, it is still difficult to stop varicose veins in the fundus.

[Problems to be solved by the device]

The present invention solves these problems in pressure hemostasis in the stomach, and its purpose is to effectively stop hemostasis of varicose veins occurring in the gastric cardia and fundus and to prevent gastric mucosa. It is an object of the present invention to provide a compression hemostatic balloon catheter that does not cause tissue necrosis and can reduce patient distress.

[Means for Solving the Problems]

That is, the present invention is a catheter tube having three lumens, a radiopaque tip at the tip, and a balloon attached near the tip, wherein the first lumen is distal to the balloon. In addition to having a plurality of side holes on the side, the proximal portion is connected to a branch pipe I provided with a connector, the second lumen has a plurality of lateral holes near the proximal side of the balloon, and the proximal portion is A balloon catheter that is connected to a branch pipe II with a connector, and the third lumen has a side hole at a position inside the balloon, and the proximal end is connected to a branch pipe III with a check valve. In the above, the outer shape of the balloon is composed of a body parallel to the central axis of the balloon and a tapered portion forming an angle of 15 to 30 °, and the film forming the balloon sandwiches the central axis of the balloon. The thickness of the balloon on one side is adjusted to be 10% to 25% larger, and when the radius of the body portion in the thick portion of the film of the balloon is doubled or more, the body portion of the balloon has a thick portion and a thin portion. A hemostatic balloon catheter of the compression type, which is eccentrically expanded in a ratio of maximum radii of 1: 1.5 to 1: 3.

Hereinafter, the present invention will be described in detail with reference to the drawings. FIG. 1 is a schematic view showing an entire compression hemostatic balloon catheter according to an embodiment of the present invention, FIG. 2 is an axial sectional view of the balloon before inflation, and FIG. 3 shows the shape of the balloon during inflation. FIG.

The balloon (1) is a thin molded product made of silicone rubber, latex rubber, etc., and the thickness of the film is 0.1 to
0.5mm thick, but part of it, for example 1/3 in the circumferential direction
The thickness is adjusted to 10-25%. The tube (2) is made of a flexible material such as silicone rubber, soft vinyl chloride resin, urethane resin, etc., and its total length is 600 to 1
The length is 000 mm and reaches the stomach from the nose or mouth.
The tube (2) has a circular cross-sectional shape and an outer diameter of 5 to 5.
7 mm, the balloon (1) covers the tube (2) at the position where the tube (2) reaches the stomach, and the attachment portions (13a) at both ends.
The balloon (1) is attached so that (13b) is closely attached.

As shown in FIG. 3 (C), the tube (2) has a lumen I (14) for intragastric suction and a lumen for intraesophageal suction.
Lumen for air supply to II (15) and balloon (1)
Three lumens of III (16) are provided. The lumen I (14) has a distal end side mounting portion (13) of the balloon (1).
From b) to the tip side, from the position of about 10 to 30 mm, a plurality of side holes (5) for intragastric suction are provided at intervals of 10 to 15 mm. These side holes (5) are located in the stomach. Lumen I for suction
Via (14), it leads to a branch pipe I (6a) for intragastric suction and a connector I (6b) attached to the proximal portion of the catheter. At the lumen II (15), the proximal side attachment portion (13a) of the balloon (1) attached to the tube (2)
From the position of about 10 to 30 mm from the side to the proximal side, a plurality of side holes (4) for esophageal suction are provided at intervals of 10 to 15 mm, and these side holes (4) are lumen II for esophageal suction. Through (15), it leads to a branch pipe II (7a) for esophageal suction and a connector II (7b) attached to the proximal portion of the catheter. The lumen III (16) is provided with a side hole (3) for air supply at a position inside the balloon (1) of the tube (2), and the side hole (3) is the lumen III for air supply. After going through (16),
A branch pipe for air supply attached to the proximal portion of the catheter III
(8), leading to the stop pipe (9). Tube (2)
An X-ray impermeable tip (10) is adhered to the tip of the tube, and the tip (10) has contrast properties, so that the position of the tube tip can be confirmed under X-ray transmission. It is like this. Further, the tube (2) may be provided with an X-ray contrast line.

The shape of the balloon (1) before inflation is, as shown in FIG. 2, a body (1) parallel to the central axis of the balloon.
1), the tube attachment parts (13a) and (13b), and the taper part (12) between them, the taper part (1
The angle A formed by 2) with respect to the central axis of the balloon is 15 to 30.
°. When this angle A is smaller than 15 °, the tapered portion becomes long and thin, and it becomes difficult to make the balloon wall reach the fundus of the stomach no matter how much air is injected. Further, when the angle A is larger than 30 °, the expanded shape of the balloon (1) is spherical from the initial stage of expansion, and when trying to reach the balloon wall to the gastric cardia, it is necessary to pull the balloon toward the esophagus side excessively. Become.

The diameter (B) of the body (11) is 25 to 50 mm, and if it is 25 mm or less, it is smaller than the size of the stomach, and the shape of the taper part is retained when the expansion diameter is such that it can be placed in the stomach. Instead, the expanded shape becomes spherical. If it is 50 mm or more, the entire size of the balloon (1) becomes large, which hinders the insertion of the present catheter into the stomach.

The inflation shape of the balloon (1) is such that when the radius of the body (11) when the thick wall of the balloon is inflated is less than twice that before inflation, the proximal side of the tube becomes thin and the balloon wall is pulled by light pulling. Can reach the gastric cardia. on the other hand,
When the radius of the body (11) when inflated is more than double,
The body (11) of the balloon is eccentrically expanded when the ratio of the maximum radii of the thick part and the thin part is 1: 1.5 to 1: 3. The degree of eccentricity matches the degree of eccentricity of the small curvature and the large curvature of the stomach, and the balloon wall of the stomach balloon (1) can easily reach the fundus of the stomach. At this time, the taper part (12) is
The balloon (1) is inflated to the same size as that of 1), and the overall shape of the balloon (1) is close to a sphere.

As a method of eccentricly expanding the balloon (1), a method of adjusting the wall thickness of the balloon is convenient. That is,
Decrease the wall thickness on the side to be expanded greatly or increase the wall thickness on the side to be expanded small. In the present invention, a balloon (1)
From the body (11) to the taper (12) of the balloon, sandwich the center axis of the balloon and increase the thickness of the coating in the range of about 1/3 in the circumferential direction on one side by 10 to 25% When the radius of the body part in the thick part expands more than twice, it is eccentrically expanded when the ratio of the maximum radius of the thick part and the thin part is 1: 1.5 to 1: 3. .

Balloon (1) of the hemostatic balloon catheter of the present invention
Expands as follows by pressurizing air.
First, when the air volume of 70 to 100 ml is injected under atmospheric pressure, the maximum diameter of the body (11) is 40 to 50 mm, and as shown in FIG. It expands while maintaining the taper. Then, when 400 to 700 ml of air is injected under atmospheric pressure, the maximum diameter becomes 80 to 100 mm, as shown in FIGS. 3 (b) and 3 (c).
As shown in Fig. 3, the eccentricity is caused and one side expands more greatly.

Next, a method of using the compression hemostatic balloon catheter of the present invention will be described. When bleeding occurs from a gastric varices, the tip of the tube (2) is inserted from the oral cavity or nasal cavity of the patient, and the balloon (1) reaches the stomach through the esophagus. 70 to 100 m in case of bleeding due to varicose vein disruption in the gastric cardia
The air (1) is pressed in to inflate the balloon (1), lightly pull it to the esophagus side, and place it. On the other hand, in the case of bleeding due to the rupture of a varicose vein in the fundus, 400 to 700 ml of air is pressed into the balloon (1) to greatly inflate it, and the balloon (1) is gently pulled to the esophagus side and placed. If you do not know whether it is bleeding from the gastric cardia or fundus, first, 70 to 100 ml
After trying to stop the gastric cardia by injecting the air of 400 to 7
Attempt to stop the bleeding of the fundus by injecting 00 ml of air.

The status of hemostasis can be grasped from the status of blood clots in the contents sucked through the gastric suction side hole (5) and the esophageal suction side hole (4). These suction side holes are used not only for grasping the status of hemostasis, but also for discharging gastric contents, degassing the stomach, and discharging saliva stored in the esophagus.

[Effect of device]

According to the present invention, it is possible to effectively and surely perform emergency hemostasis in case of bleeding at the time of rupture of varicose veins occurring in the gastric cardia and fundus, and in addition, the vein in which the bleeding occurred in the gastric cardia. Even if it is not possible to determine whether it is due to the rupture of a varicose vein or the rupture of a varicose vein that has developed in the fundus of the stomach, one compression hemostasis balloon catheter is placed and the inflation degree of the balloon is adjusted. Hemorrhage can be reliably achieved even with bleeding at the site, and the patient's pain is reduced because the catheter can be pulled to the esophagus side when the varicose vein is ruptured in the gastric cardia, and the patient's pain is also minimized. Therefore, insertion from the nasal cavity or mouth can be facilitated, the patient's pain at the time of catheter insertion can be reduced, and it is suitable as a compression hemostatic balloon catheter for emergency hemostasis at the time of gastric varices bleeding.

[Brief description of drawings]

FIG. 1 is a schematic view showing an entire compression hemostatic balloon catheter according to an embodiment of the present invention, FIG. 2 is an axial sectional view of a gastric balloon before inflation, and FIG. 3 is a shape of the balloon during inflation. In the figure, (a) shows the case where the radius of the balloon body is not more than twice that before expansion, (b) shows the case where it is more than twice, and (c) shows the XX ′ cross section of (b). It is a figure.

Claims (1)

[Scope of utility model registration request] 1. A catheter tube having three lumens, a radiopaque tip at the tip, and a balloon attached near the tip, wherein the first lumen is distal to the balloon. In addition to having a plurality of side holes on the side, the proximal portion is connected to a branch pipe I provided with a connector, the second lumen has a plurality of lateral holes near the proximal side of the balloon, and the proximal portion is A balloon catheter that is connected to a branch pipe II with a connector, and the third lumen has a side hole at a position inside the balloon, and the proximal end is connected to a branch pipe III with a check valve. In, the outer shape of the balloon is composed of a body parallel to the central axis of the balloon and a tapered portion forming an angle of 15 to 30 °, and the film forming the balloon sandwiches the central axis of the balloon. The thickness of one side of the balloon is adjusted to be 10 to 25% larger, and when the radius of the body part in the thick part of the film of the balloon is expanded to twice or more, the body part of the balloon has a thick part and a thin part. A hemostatic balloon catheter of the compression type, which is eccentrically expanded in a ratio of maximum radii of 1: 1.5 to 1: 3.