JPH10127770A - Baloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a baloon catheter in which a baloon can be swollen without becoming largely eccentric, in a pulse rate or pressure can be correctly measured and in which it can be easily inserted into and pulled out from an introducer sheath, and which can be favorably used for catheter inspection of a heart. SOLUTION: In a baloon catheter having a baloon 4 at a baloon installation part 3 at a farther end part of a catheter tube 1, the baloon installation part 3 comprises a baloon binding part 7 on the farther end 2 side, a baloon swollen part 6 in the middle, and the baloon binding part 7 on the closer end side, where an outer diameter of the catheter tube 1 at the baloon swollen part 6 is smaller than an outer diameter of the catheter tube 1 at the baloon binding part 7 on both sides to provide a step between the baloon swollen part 6 and the baloon binding part 7.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a balloon catheter. More specifically, the present invention relates to a balloon catheter which can be suitably used for a cardiac catheterization test, in which the balloon expands without large eccentricity and has a low resistance when pulled out from the introducer sheath.

[0002]

2. Description of the Related Art A catheter is inserted from a peripheral blood vessel into the heart, aorta, pulmonary artery, coronary artery, etc., for the purpose of definitive diagnosis of intracardiac abnormalities and grasping the severity of the disease in a patient having a heart disease. Measurement, cardiovascular imaging, thermodilution,
Indicator dilution, electrophysiology, myocardial biopsy, etc. are performed. Balloon catheters having a balloon at the distal end have become widely used because they have a lower risk of damaging the heart and can be relatively easily advanced from the right atrium to the right ventricle and the pulmonary artery in the bloodstream. Was. Circulatory balloon catheters such as thermodilution catheters and temporary pacing catheters are inserted clinically from the thigh, etc., and from the vena cava to the right atrium, right ventricle, and further to the distal end of the pulmonary artery bifurcation. Detain. Balloon catheters are generally equipped with a small balloon at its distal end, which can be inflated to carry the blood flow and carry the distal end to a target site,
It is used for purposes such as measuring blood pressure by closing a blood vessel with a balloon. In a conventional balloon catheter, a balloon mounting portion having a smaller outer diameter than the catheter tube main body is provided at the distal end of the catheter tube, the balloon is fitted to the balloon mounting portion, and both ends of the balloon are bonded using an adhesive or the like. It was manufactured by bonding to the mounting part. FIG. 5A is a side view of a distal end of a conventional balloon catheter. A balloon 4 is fitted to a balloon mounting section 3 provided near the distal end 2 of the catheter tube 1 with a smaller outer diameter than the catheter tube, and both ends of the balloon are fixed to the balloon mounting section by an adhesive 5. I have. The bonding of the balloon is usually performed by turning up the end of the balloon fitted to the balloon mounting portion, applying the adhesive, and then returning the end of the balloon to its original position. According to such a method, the adhesive does not adhere to a uniform width at both ends of the balloon, and FIG.
As shown in (a), a portion where the adhesive is applied has a wide portion and a narrow portion easily. FIG. 5B is a side view showing a state where the balloon of the balloon catheter of FIG. 5A is inflated. As shown in FIG. 5 (a), if the width of the adhesive is wide or narrow,
The width of the inflated portion of the balloon becomes narrower in the portion where the adhesive is applied wider, and the width of the inflated portion of the balloon becomes wider in the portion where the adhesive width is smaller. When the balloon fixed to the balloon mounting portion is inflated in such a state, as shown in FIG. 5B, the balloon is inflated small where the width of the inflated portion is small, and is inflated where the width of the inflated portion is wide. When the balloon is greatly inflated and the inflated balloon is observed from the front, a so-called eccentricity occurs in which the center of the balloon that looks circular and the center of the catheter tube do not match.
If the balloon is eccentric in the inflated state, when measuring cardiac output by the thermodilution method using a balloon catheter, the flow of cold water injected from the proximal hole will be uneven and accurate measurement will be performed. It will be difficult. In addition, if the balloon is eccentric in the inflated state, when performing pressure measurement using a balloon catheter, the occlusion of the blood vessel becomes incomplete and it becomes difficult to perform accurate measurement. Furthermore, when the balloon is eccentrically inflated, when the pressure inside the balloon is released and deflated, the portion of the balloon having a large expansion ratio does not completely return to its original state, causing a slack, and when the balloon catheter is pulled out of the introducer sheath. Easily become an obstacle. As means for reducing the resistance during insertion into the introducer sheath and withdrawal from the introducer sheath, the outer diameter of the balloon at the time of deflation is made smaller than the outer diameter of the catheter tube. However, according to this method. It is difficult to increase the outer diameter of the balloon when inflated, and there is a problem that a step is generated between the catheter tube and the balloon mounting portion, and a thrombus is easily generated when the balloon catheter is placed in a blood vessel. Was. For this reason, the balloon expands without eccentricity, so that the cardiac output and the pressure can be measured accurately, and furthermore, the operability is easy to insert into and pull out from the introducer sheath. Development of an excellent balloon catheter is required.

[0003]

SUMMARY OF THE INVENTION According to the present invention, the balloon is inflated without large eccentricity, the cardiac output and the pressure can be accurately measured, and the balloon can be easily inserted into and pulled out of the introducer sheath. An object of the present invention is to provide a balloon catheter which can be suitably used for a cardiac catheter test.

[0004]

The inventor of the present invention has conducted intensive studies to solve the above-mentioned problems. As a result, the outer diameter of the catheter tube of the balloon inflation portion at the balloon mounting portion is reduced by the outer diameter of the balloon bonding portion on both sides thereof. A balloon catheter smaller than the outer diameter of the catheter tube and having a step between the balloon inflation portion and the balloon bonding portion, the balloon expands without being eccentric, and inserted into the introducer sheath,
The inventor has found that it is easy to pull out, and completed the present invention based on this finding. That is, the present invention
(1) In a balloon catheter in which a balloon is mounted on a balloon mounting portion at a distal end portion of a catheter tube, the balloon mounting portion has a balloon bonding portion on the distal end side, an intermediate balloon inflation portion, and a balloon bonding portion on the proximal end side. A balloon catheter, wherein the outer diameter of the catheter tube of the balloon inflation portion is smaller than the outer diameter of the catheter tube of the balloon bonding portion on both sides thereof, and a balloon catheter having a step between the balloon inflation portion and the balloon bonding portion, and , (2)
The outer diameter of the catheter tube is A, the outer diameter of the balloon before inflation is a, the outer diameter of the catheter tube at the balloon bonding portion is b, and the outer diameter of the catheter tube at the balloon inflation portion is c,
The length of the balloon mounting part is d, and the length of the balloon inflation part is e.
(1) where a / A is 0.8 to 1.2, c / b is 0.2 to 0.95, and e / d is 0.65 to 0.95. The balloon catheter according to any one of the preceding claims.

[0005]

DETAILED DESCRIPTION OF THE INVENTION The balloon catheter of the present invention
The balloon mounting part comprises a balloon bonding part on the distal end side, an intermediate balloon inflation part and a balloon bonding part on the proximal end side,
The outer diameter of the catheter tube at the balloon inflation portion is smaller than the outer diameter of the catheter tube at the balloon bonding portion on both sides thereof, and there is a step between the balloon inflation portion and the balloon bonding portion. FIG. 1A is a side view of the distal end of one embodiment of the balloon catheter of the present invention. The distal end 2 of the catheter tube 1 is formed into a curved surface, and a balloon mounting portion 3 is provided near the distal end. The balloon mounting portion includes an intermediate balloon inflation portion 6 and a balloon bonding portion 7 on both sides thereof. The outer diameter of the catheter tube in the balloon inflation portion is smaller than the outer diameter of the catheter tube in the balloon bonding portion. In the balloon catheter of the present invention, when the balloon 4 is fitted to the balloon mounting portion, the balloon comes into contact with the balloon mounting portion only at the balloon bonding portion, and a gap 11 exists between the balloon and the balloon inflation portion. Therefore, when applying the adhesive to the balloon bonding part and bonding the balloon,
The adhesive is adhered on a circumferential surface of exactly equal width and, as in the conventional balloon catheter shown in FIG.
There is no irregular displacement of the edge of the portion where the adhesive is applied. There is no particular limitation on the method of applying the adhesive to the balloon bonding portion, but usually, after fitting the balloon to the balloon mounting portion, rolling up the end of the balloon and applying the adhesive to the exposed balloon bonding portion. Then, by returning the balloon to the original state, it is possible to perform bonding without protruding the adhesive. The adhesive to be used is not particularly limited. However, since a high pressure is not usually applied to the balloon, a cyanoacrylate adhesive having a short adhesive time and good workability can be suitably used. FIG. 1 (b) is a cross-sectional view of the distal end of the balloon catheter of FIG. 1 (a). The catheter tube can include a lumen for inflating the balloon, a lumen for injecting a drug solution, a lumen for pressure measurement, a lumen for an electrode, and the like, depending on the purpose of use. In this cross-sectional view, a lumen 8 for gas for inflating the balloon and a lumen 9 for pressure measurement are shown, the lumen for gas has an opening in the balloon inflation portion, and the lumen for pressure measurement is It has an aperture at the distal end. FIG. 1C is a side view showing a state where the balloon of the balloon catheter of FIG. 1A is inflated. In the balloon catheter of the present invention, since there is a step between the balloon bonding portion and the balloon inflation portion, the balloon is bonded to the balloon mounting portion exactly at the balloon bonding portion, and the balloon in the balloon inflation portion is not disturbed at the end. Due to the complete circumferential surface, when the balloon is inflated by injecting gas into the balloon, the balloon expands symmetrically with respect to the central axis of the catheter tube without being eccentric.

FIG. 2 is an explanatory view of the dimensions of the balloon catheter of the present invention. In the balloon catheter of the present invention, the outer diameter of the catheter tube is A, the outer diameter of the balloon before inflation is a, the outer diameter of the catheter tube at the balloon bonding portion is b,
When the outside diameter of the catheter tube of the balloon inflation portion is c, the length of the balloon mounting portion is d, and the length of the balloon inflation portion is e, the ratio of the outside diameter A of the catheter tube to the outside diameter a of the balloon before inflation. a / A is 0.8 to 1.2, and the ratio c / b of the outer diameter c of the catheter tube at the balloon inflation portion to the outer diameter b of the catheter tube at the balloon bonding portion is 0.2 to 0.2.
95, and the ratio e / d of the length e of the balloon inflatable portion to the length d of the balloon mounting portion is preferably 0.65 to 0.95. If the ratio a / A of the outer diameter A of the catheter tube to the outer diameter a of the balloon before inflation is less than 0.8, a step may be formed at the distal end of the balloon catheter, and thrombus may be easily generated. . If a / A exceeds 1.2, a step may occur at the distal end of the balloon catheter, which may easily cause a thrombus, and is easy to insert into and pull out from the introducer sheath. It may disappear. If the ratio c / b of the outer diameter c of the catheter tube at the balloon inflation portion to the outer diameter b of the catheter tube at the balloon bonding portion is less than 0.2, the balloon inflation portion is too thin and the strength of the catheter tube is insufficient. It may be easily damaged, and the space for providing the lumen therein may be insufficient. c /
If b exceeds 0.95, the step between the balloon inflation portion and the balloon bonding portion is too small, and the adhesive may protrude into the balloon inflation portion, and the bonding end may have an irregular shape.
Usually, the outer diameter b of the catheter tube at the balloon bonding portion
The difference (bc) between the outer diameter c of the catheter tube and the balloon inflation portion is preferably about 0.2 mm. The ratio e of the length e of the balloon inflation portion to the length d of the balloon mounting portion
If / d is less than 0.65, it may be difficult to inflate the balloon significantly. e / d is 0.95
When it exceeds, the area of the balloon bonding portion becomes too small, and the bonding strength may be insufficient.

In the balloon catheter of the present invention, when the balloon is inflated, the eccentricity of the balloon is small. The eccentricity of the inflated balloon can be evaluated by the eccentricity of the balloon. FIG. 3 is an explanatory diagram of the eccentricity of the balloon. When observed from the front of the balloon catheter with the balloon inflated, the balloon looks circular even if the inflated balloon is eccentric. Assuming that the radius from the center O of the circle to the circumference is r and the distance from the center of the circle to the center of the distal end of the balloon catheter is f, the eccentricity is represented by f / r. When the eccentricity f / r of the balloon is less than 0.1, the balloon catheter is easy to handle and excellent in operability, and the balloon catheter can be used for normal purposes even when the f / r is 0.1 to 0.2. It can be used, but if f / r exceeds 0.2, there may be a problem in use. The balloon catheter of the present invention usually has an f / r of less than 0.2 and an extremely rare case where the f / r exceeds 0.2, so that the cardiac output and the pressure can be accurately measured. . Since the balloon of the balloon catheter of the present invention does not largely decenter when inflated, the balloon does not partially inflate excessively, and contracts uniformly when the internal pressure is released. Therefore, even when the balloon is pulled out from the introducer sheath, there is no possibility that the balloon is caught by the introducer sheath and the pull-out resistance increases. Furthermore, since the balloon catheter of the present invention has a gap 11 between the balloon and the balloon inflation portion, when the balloon catheter is pulled out of the introducer sheath, the balloon escapes to the gap even if the introducer sheath contacts the balloon, and the balloon escapes. Does not get caught in the introducer sheath. FIG. 4 is an explanatory view showing a state where the balloon catheter is pulled out from the introducer sheath, and FIG.
4 shows a conventional balloon catheter, and FIG. 4B shows a balloon catheter of the present invention. In the conventional balloon catheter, when the balloon 4 is eccentrically inflated, the excessively inflated portion does not return to its original shape, causing a slack, easily catching on the introducer sheath 10, and even if the balloon comes into contact with the introducer sheath, The balloon had no room to escape. The balloon catheter of the present invention,
When the balloon 4 contracts to its original shape without sagging and is pulled out from the introducer sheath 10, even if the balloon comes into contact with the introducer sheath, the balloon escapes to the space 11 between the balloon inflating portion, and the pull-out resistance is reduced. It is small, easy to handle and has good operability.

In the balloon catheter of the present invention, it is preferable that the inner diameter of the balloon is equal to the outer diameter b of the catheter tube at the bonding portion of the balloon. Further, the length of the balloon is preferably equal to the length d of the balloon mounting portion. In the balloon catheter of the present invention, the material of the balloon is not particularly limited as long as it is an elastomer having appropriate elasticity, but an antithrombotic material can be particularly preferably used. Examples of such an antithrombotic material include polyurethane, silicone rubber, and polyamide. Examples of polyurethane having antithrombotic properties include polyisocyanate such as 4,4'-diphenylmethane diisocyanate (MDI), 4,4'-dicyclohexylmethane diisocyanate (hydrogenated MDI), and hexamethylene diisocyanate. Examples of the component include a polyurethane having a polyol component such as polyether polyol or polyester polyol. Examples of silicone rubber having antithrombotic properties include, for example, methyl silicone rubber having a vinyl group in a side chain,
Materials containing a peroxide as a crosslinking agent can be exemplified. Examples of the polyamide having antithrombotic properties include a polyamide elastomer which is a block copolymer of nylon 12 and polytetramethylene glycol. The method for forming the balloon is not particularly limited, and the balloon can be formed by a known elastomer forming method. Since the balloon used in the balloon catheter of the present invention has a tubular shape or a simple shape close thereto, it can be formed very easily.

[0009]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, which should not be construed as limiting the present invention. Example 1 A natural rubber balloon having a length of 10.0 mm was cut from a natural rubber tube having an outer diameter of 2.30 mm and an inner diameter of 1.90 mm. As shown in FIG. 1A, the distal end of a polyurethane catheter tube having an outer diameter of 2.30 mm is processed into a curved surface as shown in FIG.
The outer diameter of two places from the point 4 mm away and from the point 10.4 mm away from the distal end to the point 11.4 mm away.
Processed to 90 mm to form a balloon adhesive, 2.
8.0 from 4mm to 10.4mm away
The outer diameter was processed to be 1.70 mm over mm to form a balloon inflating portion to form a balloon mounting portion. The above-mentioned natural rubber balloon was fitted to the balloon mounting portion of the catheter tube, and was bonded to the catheter tube using a cyanoacrylate adhesive at the balloon bonding portion, and the distal end portion having the shape shown in FIG. Were prepared. After passing this balloon catheter through a 7 Fr introducer sheath, 1.7 ml of air was injected using a syringe to inflate the balloon, and the eccentricity was evaluated. Of the 10 balloon catheters, 7 have an eccentricity of less than 0.1 and 7 have an eccentricity of 0.1.
There were three pieces with 1 to 0.2, and none of them had an eccentricity exceeding 0.2. After leaving the balloon inflated for 10 minutes, the air was evacuated. After 5 minutes, the balloon catheter was pulled out of the introducer sheath, and the withdrawal resistance was measured. The average value of the 10 catheters was 0.29 kgf. Example 2 In the same manner as in Example 1, the outer diameter was 2.42 mm, and the inner diameter was 1.90 mm.
Was cut into a length of 10.0 mm to produce a natural rubber balloon. The same procedure as in Example 1 except that the same polyurethane catheter tube as in Example 1 was processed to have an outer diameter of 1.33 mm over 8.0 mm from 2.4 mm to 10.4 mm away from the distal end. Similarly, a balloon mounting portion was formed. The above natural rubber balloon was fitted to the balloon mounting portion, and bonded to the catheter tube using a cyanoacrylate-based adhesive at the balloon bonding portion, to produce 10 balloon catheters. In the same manner as in Example 1, the eccentricity was evaluated, and the pull-out resistance was measured. Of the 10 balloon catheters, 7 have an eccentricity of less than 0.1,
Three of them had an eccentricity of 0.1 to 0.2, and none had an eccentricity exceeding 0.2. The average value of the ten pullout resistances was 0.30 kgf. Example 3 Liquid silicone rubber [Shin-Etsu Silicone Co., Ltd., KE520
-U] in 100 g of 2,5-dimethyl-2,5-bis (t
2 g of -butylperoxy) hexane is kneaded and injected into a mold, and molded at 170 ° C. for 10 minutes by pressing at 50 kg / cm ² to obtain a silicone rubber having an outer diameter of 2.19 mm and an inner diameter of 1.90 mm. A tube was obtained. This silicone rubber tube was cut into a length of 10.0 mm to produce a silicone rubber balloon. The distal end of the same polyurethane catheter tube as in Example 1 was processed into a curved surface, and from 1.4 mm to 1.9 mm away from the distal end, and from 10.9 mm away from the distal end. The two portions were processed to an outer diameter of 1.90 mm to a distance of 11.4 mm to form a balloon bonding portion, and the outer diameter was reduced to 0 mm over 9.0 mm from 1.9 mm to 10.9 mm from the distal end. Processed to .38mm as balloon inflation part,
A balloon mounting part was formed. The above silicone rubber balloon was fitted to the balloon mounting portion, and bonded to a catheter tube using a cyanoacrylate-based adhesive at the balloon bonding portion, to produce 10 balloon catheters. In the same manner as in Example 1, the eccentricity was evaluated, and the pull-out resistance was measured. Of the ten balloon catheters, eight had an eccentricity of less than 0.1, and an eccentricity of 0.1 to 0.1
Two of the two had a eccentricity of more than 0.2. The average value of the ten pull-out resistors is equal to 0.1.
It was 28 kgf. Example 4 In the same manner as in Example 1, the outer diameter was 1.96 mm and the inner diameter was 1.60 mm.
Was cut into a length of 10.0 mm to produce a natural rubber balloon. The distal end of the same polyurethane catheter tube as in Example 1 was processed into a curved surface,
From 1.4 mm to 1.9 mm away from the distal end, and 11.10 mm from 10.9 mm away from the distal end.
Two places were processed to an outer diameter of 1.60 mm to a distance of 4 mm to form a balloon bonding portion, and an outer diameter of 1.40 mm over a distance of 9.0 mm from a distance of 1.9 mm to a distance of 10.9 mm from the distal end. To form a balloon mounting portion as a balloon inflatable portion. The above natural rubber balloon was fitted to the balloon mounting portion, and bonded to the catheter tube using a cyanoacrylate-based adhesive at the balloon bonding portion, to produce 10 balloon catheters. In the same manner as in Example 1, the eccentricity was evaluated, and the pull-out resistance was measured. Of the 10 balloon catheters, 6 have an eccentricity of less than 0.1 and 6 have an eccentricity of 0.1 to 0.1.
Two were four and none had an eccentricity of more than 0.2. The average value of the ten pullout resistors is 0.2.
It was 5 kgf. Example 54 30.0 g (119.9 mmol) of 4,4'-diphenylmethane diisocyanate (MDI)
l), 104.4 g (104.4 mmol) of polytetramethylene glycol (PTMG, number average molecular weight 1,000) and 0.92 g (10.2 mmol) of 1.4-butanediol were mixed, and heated to 80 ° C. Stir for a minute to dissolve uniformly,
A polyurethane tube having an outer diameter of 2.65 mm and an inner diameter of 1.90 mm was molded by quickly pouring the inner surface into a mold coated with a silicone-based polymer and heating and molding at 100 ° C. for 24 hours. This polyurethane tube was cut into a length of 10.0 mm to produce a polyurethane balloon. The distal end of the same polyurethane catheter tube as in Example 1 was processed into a curved surface, and from 1.4 mm to 1.9 mm away from the distal end, and from 10.9 mm away from the distal end. The two parts were processed to an outer diameter of 1.90 mm to a distance of 11.4 mm to form a balloon bonding portion, and the outer diameter was adjusted to 9.0 mm from a distance of 1.9 mm to a distance of 10.9 mm from the distal end. It was processed to have a diameter of .52 mm to form a balloon mounting portion as a balloon inflatable portion. The above-mentioned polyurethane balloon was fitted to the balloon mounting portion, and was bonded to a catheter tube using a cyanoacrylate-based adhesive at the balloon bonding portion, thereby producing 10 balloon catheters. Example 1
In the same manner as in the above, the eccentricity was evaluated, and the pull-out resistance was measured. Eccentricity of 0.1 out of 10 balloon catheters
The number of eccentricities was less than 6 and the number of eccentricities was 0.1 to 0.2, and the number of eccentricities was not more than 0.2. The average value of the ten pull-out resistances was 0.35 kgf. Comparative Example 1 A natural rubber balloon was manufactured by cutting a natural rubber tube having an outer diameter of 2.30 mm and an inner diameter of 1.90 mm to a length of 10.0 mm. The distal end of a polyurethane catheter tube having an outer diameter of 2.30 mm was processed into a curved surface at the distal end, so that the outer diameter was 1.90 mm from 1.4 mm to 11.4 mm away from the distal end. Processing was performed to form a balloon mounting portion having no step. The above-mentioned natural rubber balloon was fitted to the balloon mounting portion of the catheter tube, and both ends thereof were bonded to the catheter tube with a width of 1.0 mm using a cyanoacrylate-based adhesive. Ten balloon catheters having a distal end were made. In the same manner as in Example 1, the eccentricity was evaluated, and the pull-out resistance was measured. Of the 10 balloon catheters,
Four had an eccentricity of less than 0.1, three had an eccentricity of 0.1 to 0.2, and three had an eccentricity of more than 0.2. The average value of the ten pull-out resistors is 0.4.
It was 5 kgf. Comparative Example 2 An outer diameter of 2.30 mm was prepared in the same manner as in Example 5 on the balloon mounting portion of the same catheter tube as in Comparative Example 1.
A polyurethane balloon having an inner diameter of 1.90 mm and a length of 10.0 mm was fitted, and both ends were bonded to a catheter tube with a width of 1.0 mm using a cyanoacrylate-based adhesive. Ten balloon catheters having a distal end were made. In the same manner as in Example 1, the eccentricity was evaluated, and the pullout resistance was measured. Of the ten balloon catheters, five had an eccentricity of less than 0.1, two had an eccentricity of 0.1 to 0.2, and three had an eccentricity of more than 0.2. Was. The average value of the ten pullout resistances was 0.48 kgf. Example 1
Table 1 shows the results of Comparative Examples 1 to 5 and Comparative Examples 1 and 2.

[0010]

[Table 1]

[0011] The balloon catheter of the present invention having steps in the balloon bonding portion and the balloon inflation portion in Examples 1 to 5,
The balloon was inflated without eccentricity, and none of them had an eccentricity exceeding 0.2. In addition, the resistance to pulling out of the introducer sheath in the contracted state after expansion was as small as 0.25 to 0.35 kgf, and the pulling out was easy. On the other hand, in the balloon catheters of Comparative Examples 1 and 2 in which there is no step between the balloon bonding portion and the balloon inflation portion, the eccentricity which causes trouble in use during inflation exceeds 0.2 and 3 out of 10 balloons are eccentric. Each one has a pull-out resistance of 0.45 to 0.48 kgf from the introducer sheath.
And it was difficult to handle and inferior in operability.

[0012]

According to the balloon catheter of the present invention, since the balloon is inflated without large eccentricity, the cardiac output and the pressure can be measured accurately, and the balloon can be easily inserted into and pulled out of the introducer sheath. It can be suitably used for cardiac catheter examination.

[Brief description of the drawings]

FIG. 1 is a side view and a cross-sectional view of the distal end of one embodiment of the balloon catheter of the present invention.

FIG. 2 is an explanatory diagram of dimensions of the balloon catheter of the present invention.

FIG. 3 is an explanatory diagram of an eccentricity of a balloon.

FIG. 4 is an explanatory view showing a state in which the balloon catheter is pulled out from the introducer sheath.

FIG. 5 is a side view of the distal end of a conventional balloon catheter.

[Explanation of Signs] 1 catheter tube 2 distal end 3 balloon mounting part 4 balloon 5 adhesive 6 balloon inflation part 7 balloon bonding part 8 lumen for gas 9 lumen for pressure measurement 10 introducer sheath 11 gap

Claims (2)

[Claims] 1. A balloon catheter having a balloon mounted on a balloon mounting portion at a distal end portion of a catheter tube, wherein the balloon mounting portion has a balloon bonding portion on a distal end side, an intermediate balloon inflation portion, and a balloon on a proximal end side. A balloon catheter comprising an adhesive portion, wherein the outer diameter of the catheter tube of the balloon inflation portion is smaller than the outer diameter of the catheter tube of the balloon adhesive portion on both sides thereof, and a step between the balloon inflation portion and the balloon adhesion portion. . 2. The outer diameter of the catheter tube is A, the outer diameter of the balloon before inflation is a, the outer diameter of the catheter tube at the balloon bonding portion is b, the outer diameter of the catheter tube at the balloon inflation portion is c, and the balloon mounting portion is When the length of d is d and the length of the balloon inflated portion is e, a / A is 0.8 to 1.2, c / b is 0.2 to 0.95, and e / d is 0.65
The balloon catheter according to claim 1, which has a diameter of from 0.95 to 0.95.