JPH11192305A - Balloon catheter and its production - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter which dilates a balloon without eccentricity, is capable of exactly measuring cardiac output and blood pressure, is easily insertable and withdrawable into and from an introducer sheath and is particularly adequately usable for cardiac catheter inspection. SOLUTION: This balloon catheter has a catheter tube 12 which is formed with at least one of lumens 32, and 34 along a longitudinal direction and the balloon 30 which is adhered to the distal end of the catheter tube 12 in such a manner that the balloon 30 is dilated by the introduction of the fluid sent through these lumens 32 and 34 to the inner side of the balloon 30. Block grooves 24 and 26 for receiving the excess adhesives applied on adhesive parts 20 and 22 are formed adjacently to the adhesive parts 20 and 22 on the outer periphery at the distal end of the catheter tube 12 adhered with the balloon 30 in such a manner that the axial length of the adhesive parts is limited.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter and a method of manufacturing the same, and more particularly, to a balloon catheter which is inflated without eccentricity and easily manufactured, and a method of manufacturing the same.

[0002]

2. Description of the Related Art A catheter is inserted from a peripheral blood vessel into a heart, an aorta, a pulmonary artery, a coronary artery, etc., for the purpose of confirming the abnormality in the heart and grasping the severity of the abnormality in a patient having a heart disease. Content measurement, cardiovascular imaging, thermodilution method,
Indicator dilution, electrophysiology, myocardial biopsy, etc. are performed. Balloon catheters with a balloon at the distal end of the catheter tube have less risk of damaging the heart,
It is widely used because it can be relatively easily advanced from the right atrium to the right ventricle and the pulmonary artery in the bloodstream. Cardiovascular balloon catheters, such as thermodilution catheters and temporary pacing catheters, are clinically inserted from the thigh, etc., into the right atrium, right ventricle, and the pulmonary artery bifurcation from the vena cava. Place the distal end.

[0003] The balloon catheter of this type measures the blood pressure by inflating the balloon to carry the distal end to a target site along with the flow of blood flow, or closing the blood vessel by the balloon. You can do things.

FIG. 5A shows a conventional balloon catheter.
As shown in the figure, a balloon mounting portion 3 having a smaller outer diameter than the catheter tube main body is provided at a distal end portion of the catheter tube 1, a balloon 4 is fitted to the balloon mounting portion 3, and both ends of the balloon 4 are bonded using an adhesive. It is manufactured by bonding to the balloon mounting part. Usually, the bonding of the balloon is performed by turning up the end of the balloon fitted to the balloon mounting portion 3, applying the adhesive to the bonding portion 5, and then returning the end of the balloon 4 to its original position.

[0005]

However, according to such a method, the adhesive does not adhere to a uniform width at both ends of the balloon 4, and as shown in FIG. Wide and narrow parts are likely to occur. Therefore, as shown in FIG. 5 (A), if the width of the adhesive applied is wide and narrow, the width of the inflated portion of the balloon 4 becomes narrow in the portion where the adhesive is wide, and the portion where the adhesive width of the adhesive is narrow Then balloon 4
The width of the inflated portion becomes wider. When the balloon 4 fixed to the balloon mounting section 3 is inflated in such a state, FIG.
As shown in (B), when the width of the inflated portion is small, the balloon 4 is inflated small, and where the width of the inflated portion is wide, the balloon 4 is largely inflated. With the center of the visible balloon 4
A so-called eccentricity occurs in which the positions of the centers of the catheter tubes 1 do not match.

When the balloon 4 is eccentric in the inflated state, when the cardiac output is measured by a thermodilution method using a balloon catheter, an intravascular connection is made through a hole formed in a catheter tube proximal to the balloon 4. The flow of cold water discharged to the air becomes uneven, making it difficult to perform accurate measurement. In addition, if the inflated state of the balloon 4 is eccentric, when pressure measurement is performed using a balloon catheter, occlusion of a blood vessel becomes incomplete, and it becomes difficult to perform accurate measurement.

Further, when the balloon is eccentrically inflated,
When the balloon is depressurized and deflated, the portion of the balloon having a large expansion ratio does not completely return to its original state, causing a slack, and tends to be an obstacle when the balloon catheter is pulled out of the introducer sheath. As a means for reducing the resistance during insertion into the introducer sheath and withdrawal from the introducer sheath, the outer diameter of the balloon during 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 in addition, a step is generated between the catheter tube and the balloon mounting portion, and the balloon catheter is left in the blood vessel. Sometimes there is a problem that thrombus is easily formed.

For this reason, the balloon expands without eccentricity, so that the cardiac output and the pressure can be accurately measured.
Further, there is a need for the development of a balloon catheter that is easy to insert into and withdraw from the introducer sheath and has excellent operability. There is also a need for a method that can easily manufacture such a balloon catheter.

The present invention has been made in view of such a situation, and the balloon is inflated without eccentricity, the cardiac output and the pressure can be accurately measured, and the balloon can be inserted into and pulled out of the introducer sheath. An object of the present invention is to provide a balloon catheter which is easy and can be suitably used particularly for cardiac catheter examination. Another object of the present invention is to provide a method for manufacturing a balloon catheter that can manufacture such a balloon catheter relatively easily and at low cost.

[0011]

To achieve the above object, a balloon catheter according to the present invention comprises at least one balloon catheter.
A lumen is formed along the longitudinal direction of the catheter tube, and the catheter is bonded to the distal end of the catheter tube so that the fluid sent through the lumen is introduced into the balloon so that the balloon is inflated. The balloon is applied to the bonding portion so as to limit the axial length of the bonding portion next to the bonding portion on the outer periphery of the distal end of the catheter tube to which the balloon is bonded. A partition groove for receiving extra adhesive is formed.

In the balloon catheter according to the present invention, a relatively short distal end portion is left at the distal end of the catheter tube, and has a length substantially corresponding to the axial length of the balloon. It is preferable to form a balloon mounting portion having an outer diameter smaller than that of the balloon body.

[0013] In this case, both ends of the balloon mounting portion serve as bonding portions, and both ends of the balloon are bonded to the outer periphery of the bonding portion so that the inside of the balloon is sealed. Fluid sent from the lumen is introduced into a portion where the balloon is not bonded to the balloon mounting portion, and the balloon is inflated.

In this case, the partition groove is formed on the outer periphery of the balloon mounting portion located inside the balloon in the axial direction of each bonding portion. The radius of the balloon mounting portion is preferably substantially equal to a value obtained by subtracting the thickness of the balloon after bonding from the radius of the balloon body. This is because it is preferable not to form a step between the outer periphery of the balloon after bonding and the outer periphery of the balloon body. Further, it is preferable not to form a step between the outer periphery of the distal tip portion and the balloon.

In the method for manufacturing a balloon catheter according to the present invention, a bonding portion to which a balloon is bonded is formed at an outer peripheral position of a distal end portion of a catheter tube in which at least one lumen is formed along a longitudinal direction. Forming a partition groove next to the adhesive portion to receive an extra adhesive applied to the adhesive portion so as to limit an axial length of the adhesive portion; and Applying an adhesive to the adhesive portion at the distal end to adhere the balloon.

The balloon preferably has a wavelength of 200 to
It is preferable that the material is formed of a material having a transmittance of preferably 5 to 100%, more preferably 50 to 100%, for ultraviolet rays in a region of 500 nm. In that case, the adhesive for bonding the balloon is preferably an ultraviolet-curable adhesive. The UV-curable adhesive is preferable because this type of adhesive does not cure immediately after application, and therefore can be easily bonded in a uniform width.

The ultraviolet-curable adhesive has a wavelength of 200 to 5
Radical polymerization is initiated by UV irradiation of 00 nm, and the adhesive cures in seconds. The composition of this adhesive is one-part adhesive consisting of acrylic oligomer, acrylic reaction diluent, photopolymerization initiator, and polymerization inhibitor. Agent.
Examples of the oligomer include polyester-based, polyether-based, epoxy-based, polyurethane-based, amine-based, hydroxylalkyl-based, alkyl-based, and silicone-based acrylic esters, depending on the molecular structure of the skeleton.
Examples of the reaction diluent include low-viscosity monofunctional or polyfunctional acrylates. As the photopolymerization initiator,
Benzophenone, benzoin ether and the like.

In addition to the UV-curable adhesive, other adhesives can be used as appropriate. For example, a one-pack, room-temperature, rapid-curing adhesive containing 2-cyanoacrylate monomer as a main component can be used. A non-mixed A / B two-pack acrylic adhesive obtained by dissolving an elastomer in methyl methacrylate and polymerizing with a redox initiator,
Furthermore, an epoxy adhesive, a polyurethane adhesive, a nylon adhesive, a chloroprene rubber adhesive and the like can be mentioned. Among them, a cyanoacrylate-based adhesive having a short bonding time and good workability is preferably used.

[0019]

In the balloon catheter manufactured by the manufacturing method according to the present invention, the length of the bonding portion formed on the catheter tube in the axial direction is limited by the partition groove. The excess adhesive gets into the compartment grooves. Therefore, the excess adhesive does not flow into the non-adhesion portion of the catheter tube with the balloon.
Therefore, the end of the balloon is firmly and hermetically bonded to the catheter tube with an adhesive portion having a predetermined length in the axial direction.

As a result, when the fluid is sent through the lumen to the inside of the balloon of the balloon catheter according to the present invention, the balloon expands almost without eccentricity,
Measurement of cardiac output and blood pressure can be performed accurately. In addition, since the balloon expands without being largely eccentric, the balloon is less likely to be loosened in a contracted state, and can be easily inserted into and pulled out of the introducer sheath. Therefore, the balloon catheter according to the present invention can be suitably used particularly for cardiac catheter examination.

Further, in the method for manufacturing a balloon catheter according to the present invention, since only a partition groove is formed on the outer periphery of the distal end of the catheter tube, uneven application of the adhesive can be prevented. However, it is possible to easily manufacture a balloon catheter with less eccentricity and slackness of the balloon.

[0022]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below based on embodiments shown in the drawings. 1 is a schematic cross-sectional view of a main part of a balloon catheter according to an embodiment of the present invention, FIG. 2 is a cross-sectional view of a main part showing one manufacturing process of the balloon catheter according to the embodiment, and FIG. FIG. 4 is a sectional view of a main part showing a process, and FIG. 4 is an explanatory diagram of the eccentricity of the balloon.

As shown in FIG. 1, the balloon catheter 10 of the present embodiment has a catheter tube 12 inserted into a body cavity such as a blood vessel of a patient. At the distal end of the catheter tube 12, a balloon 30 that can be inflated to a position indicated by a two-dot chain line in FIG.

In the present embodiment, the balloon 30 has a tubular shape in a contracted state, and both ends of the balloon 30 are adhered to the distal end of the catheter tube 12. In order to adhere the balloon 30 to the distal end of the catheter tube 12, in this embodiment, as shown in FIG. A balloon mounting portion 16 having a length L1 substantially corresponding to the axial length of 30 and having a smaller outer diameter than other portions (balloon body 14) is formed.
The balloon mounting portion 16 has balloon bonding portions 20 and 22 formed at both ends thereof, a balloon inflating portion 15 formed at the center portion, and a partition groove 24 for separating and partitioning the balloon expanding portion 16 and the bonding portion 22. , 26.

As shown in FIG. 1, the balloon 30 has only two end portions, the bonding portions 20 and 2 of the balloon mounting portion 16.
The inside is sealably adhered to 2, and the balloon 30 is not adhered to the balloon inflation portion 15.

The catheter tube 12 has a lumen for inflating the balloon, a lumen for injecting a chemical solution, a lumen for injecting a test solution, a lumen for measuring pressure, and a lumen for electrodes depending on the purpose of use. Can be provided. FIG. 1 shows a lumen 32 for inflating the balloon 30 and a lumen 34 for pressure measurement. The lumen 32 is the balloon inflation portion 1
5 has an opening, and gas or liquid is fed into the balloon 30 through the lumen 32 to inflate the balloon 30 (two-dot chain line in the drawing). Further, the lumen 34 for pressure measurement has an opening at the distal end of the distal end tip 18, through which blood pressure can be measured. In addition, the distal end of the distal end tip 18 is formed into a curved surface shape to reduce the insertion resistance into the body cavity.

The proximal end of the catheter tube 12 is connected to a branch 40 located outside the patient's body. The branch portion 40 is formed with ports 42 and 44 that communicate with the lumens 32 and 34, respectively.

In the balloon catheter 10 of the present embodiment, the material of the balloon 30 is not particularly limited as long as it is an elastomer having appropriate elasticity, but an antithrombotic material can be particularly suitably used. Such antithrombotic materials include, for example, polyurethane, silicone rubber,
Polyamide and the like can be mentioned. Examples of polyurethane having antithrombotic properties include 4,4'-diphenylmethane diisocyanate (MDI) and 4,4'-dicyclohexylmethane diisocyanate (hydrogenated MD).
I), polyurethanes having a polyisocyanate component such as hexamethylene diisocyanate and a polyol component such as polyether polyol and polyester polyol. Examples of the silicone rubber having antithrombotic properties include a material obtained by mixing a peroxide as a crosslinking agent with methyl silicone rubber or phenyl vinyl silicone rubber having a vinyl group in a side chain. Examples of the polyamide having antithrombotic properties include 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 for the balloon catheter of the present embodiment has a tubular shape or a simple shape close thereto, it can be formed very easily.

In this embodiment, the balloon 30
When an ultraviolet-curable adhesive is used for bonding, the wavelength of the balloon 30 is preferably 200 to 5 mm.
The transmittance for ultraviolet rays in the region of 00 nm is preferably 5
-100%, more preferably 50-100% of the material. From this perspective,
As the balloon 30, a polyether-based polyurethane,
Polyester-based polyurethane, silicone-based elastomer and the like are preferably used.

In the balloon catheter 10 of the present embodiment, the catheter tube 12 is preferably made of a material having a certain degree of flexibility, for example, polyethylene, polyethylene terephthalate, polypropylene, ethylene-propylene copolymer, ethylene-propylene copolymer. Vinyl acetate copolymer, polyvinyl chloride (PVC), cross-linked ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyamide elastomer, polyimide, polyimide elastomer, silicone rubber, natural rubber, and the like can be used. It is composed of polyethylene, polyamide and polyimide.

As shown in FIG. 2, in this embodiment,
The outer diameter D1 of the catheter tube body 14 in the catheter tube 12 is not particularly limited, but is preferably 1 to 5 mm, particularly preferably 1.5 to 3 mm. Further, the outer diameter D2 of the balloon bonding portions 20 and 22 of the balloon mounting portion 16 formed at the distal end of the catheter tube 12 is smaller than the outer diameter D1 of the main body 14 by two times the thickness of the balloon 30 after mounting. It is preferably about twice as small. As shown in FIG. 1, when the balloon 30 is mounted on the balloon mounting portion 16, the step between the outer circumference of the balloon 30 and the outer circumference of the main body 14 is made as small as possible. The outer diameter of the tip 18 is substantially the same as the outer diameter D1 of the main body 14.

As shown in FIG. 2, the outer diameter D3 of the balloon inflating portion 15 in the balloon mounting portion 16 is preferably substantially the same as the outer diameter D2 of the balloon bonding portions 20, 22 from the viewpoint of ease of manufacture. However, in the present invention, they are not necessarily the same.

The outer diameter D4 at the bottom of the partitioning grooves 24, 26 must be smaller than the outer diameter D2 of the bonding portions 20, 22, and is preferably 5 to 70%, more preferably 20%, relative to D2. It is preferably a value of ４０40%. If the groove depth of the partition grooves 24 and 26 is too small, it is not preferable because the excess adhesive cannot be received and the adhesive may be applied to the outer periphery of the expanded portion 15. Compartment groove 2
Preferably, 4 and 26 are grooves continuous along the circumferential direction.

The axial length L1 of the balloon mounting portion 16 is
The length is substantially the same as or longer than the axial length of the balloon 30 to be mounted, and varies depending on the use of the balloon catheter 10.
Range. The axial length L2 of the bonding portions 20, 22
L3 is preferably the same, but is not necessarily the same, and is preferably 5 to 40%, more preferably 10 to 20%, based on the length L1 of the mounting portion.
If the lengths L2 and L3 are too short, the adhesion tends to be insufficient. If the lengths L2 and L3 are too long, it is uneconomical.

The axial lengths L4, L5 of the partition grooves 24, 26
Are preferably the same, but are not necessarily the same, and are preferably 20 to 200%, more preferably 50 to 100% with respect to the lengths L2 and L3 of the bonded portions.
It is. If the lengths L4 and L5 are too short, the effect of the section tends to be small. In the present embodiment, the axial length L6 of the distal tip 18 is not particularly limited, and is preferably about 0.5 to 1.5 mm.

Next, a method for manufacturing the balloon catheter according to this embodiment will be described.

In the present embodiment, first, the catheter tube 12 having at least the lumens 32 and 34 is prepared. The catheter tube 12 is formed by, for example, extrusion.

Next, at the distal end of the catheter tube 12, the balloon inflatable portion 15, the adhesive portions 20 and 22, and the partition groove 2 of the balloon mounting portion 16 are dimensioned as shown in FIG.
4 and 26 are formed by heat and pressure molding using a mold. Alternatively, it may be formed by cutting. Alternatively, it may be formed at the same time as the catheter tube 12 is formed.

Next, a tubular balloon 30 is prepared. In the present embodiment, the balloon 30 is preferably made of a material having a transmittance of preferably 50 to 100% for ultraviolet rays in a wavelength region of 200 to 500 nm. The axial length of the balloon 30 is preferably substantially the same as or less than the axial length L1 of the balloon mounting portion 16 (see FIG. 2). It is preferable that the outer diameter of the balloon 30 be substantially equal to the outer diameter D1 of the tube main body 14 (see FIG. 2) in the state after the mounting as shown in FIG. The thickness of the balloon 30 in the state after mounting shown in FIG.
It is preferable that the calculated value is approximately equal to (D1−D2) / 2 calculated by using D1 and D2.

When mounting the balloon 30, care should be taken not to apply too much force to the balloon 30. Excessive force is not preferred because the balloon may be deformed such as twisting or distortion.

After the balloon 30 is mounted, the balloon 30
Is dried by means of natural drying, hot air drying, vacuum drying, or the like, so that the balloon 30 contracts and adheres to the outer periphery of the balloon mounting portion 16. The drying temperature is not particularly limited, but is preferably about 40 to 100 ° C. The drying time is not particularly limited, but is preferably about 0.3 to 12 hours.

Thereafter, as shown in FIG.
Are turned up to expose the bonding portions 20, 22 and the partitioning grooves 24, 26. Then, the bonding parts 20, 22
UV curable adhesive is applied to the outer peripheral surface of the substrate. The application method is not particularly limited, and means such as brush coating can be employed.

At this time, in the present embodiment, the partition grooves 24,
26, the excess adhesive is applied to the partition groove 2
4 and 26 and does not reach the outer peripheral surface of the inflated portion 15. Therefore, the bonding portions 20, 22
Can be uniformly applied to the outer peripheral surface of the substrate. In addition, the use of an ultraviolet-curable adhesive does not cause immediate curing, so that the application operation can be performed carefully and uniform application can be achieved without causing spots or the like.

Thereafter, the balloon 30 which has been rolled up is returned to its original state, and both ends of the balloon 30 are brought into contact with the outer peripheral surfaces of the bonding portions 20 and 22, and ultraviolet rays are irradiated from the outside to cure the bonding agent. As shown in (1), both ends of the balloon 30 are bonded to the outer peripheral surfaces of the bonding portions 20 and 22.

As described above, in the balloon catheter 10 manufactured by the manufacturing method according to the present embodiment, the axial length of the bonding portions 20 and 22 formed on the catheter tube 12 is limited by the partition grooves 24 and 26. Yes, bonded part 2
When the adhesive is applied to 0 and 22, excess adhesive enters the partition grooves 24 and 26. Therefore, the excess adhesive does not flow into the non-adhesion portion (the inflatable portion 15) of the catheter tube 12 with the balloon 30. Therefore, the end of the balloon 30 is firmly and hermetically bonded to the catheter tube 12 by the bonding portions 20 and 22 having a predetermined length in the axial direction.

As a result, when the fluid is sent through the lumen 32 to the inside of the balloon 30 of the balloon catheter according to the present embodiment, the balloon 30 is inflated almost without eccentricity, and the measurement of cardiac output and blood pressure can be accurately performed. Can be done. The eccentricity of the inflated balloon can be evaluated from the eccentricity of the balloon. FIG. 4 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 30 looks circular even if the inflated balloon is eccentric. Assuming a radius r from the center O of the circle to the circumference and a distance f from the center of the circle to the center of the distal end of the balloon catheter, 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 f / r is not more than 0.1.
Even if the ratio is 1 to 0.35, the balloon catheter can be used without hindrance to normal purposes, but the f / r is 0.3
If it exceeds 5, there may be a problem in use. The balloon catheter of the present embodiment usually has an f / r of 0.35
When f / r exceeds 0.35, it is extremely rare that the cardiac output and the pressure can be accurately measured.

Further, since the balloon 30 of the balloon catheter of the present embodiment does not become largely eccentric when inflated, the balloon 30 does not partially inflate excessively,
When the internal pressure is released, it contracts uniformly. Therefore, even when the balloon catheter is withdrawn from the introducer sheath, the balloon 30 does not get caught on the introducer sheath, and there is no possibility that the withdrawal resistance increases.

Therefore, the balloon catheter 10 according to the present embodiment can be suitably used particularly for cardiac catheter examination.

Further, in the method of manufacturing the balloon catheter 10 according to the present embodiment, it is possible to prevent uneven application of the adhesive only by forming the partition grooves 24 and 26 on the outer periphery of the distal end of the catheter tube 12. Therefore, even an unskilled worker can easily manufacture the balloon catheter 10 in which the eccentricity and the slack of the balloon 30 do not occur.

The present invention is not limited to the above-described embodiment, but can be variously modified within the scope of the present invention.

For example, in the above-described embodiment, the partitioning grooves 24 and 26 are formed at positions where both the bonding portions 20 and 24 formed at both ends of the balloon mounting portion 16 and the inflatable portion 15 are partitioned. However, in the present invention, one of the partition grooves 24 and 26 may be omitted. Alternatively, a partition groove may be formed between the bonding portion 20 and the main body 14,
A partition groove may be formed between the bonding portion 22 and the tip 18. Further, a spiral groove, a large number of minute projections, and the like are formed on the outer peripheral surface of the inflating portion 15 (or roughened) separately from the partitioning groove, and a fluid passage or the like when the balloon 30 starts to expand is secured. You may.

In the present invention, the partition grooves 24 and 26 are
Each of them need not be single, and a plurality of each may be formed.

[0053]

EXAMPLES Hereinafter, the present invention will be described based on more detailed examples, but the present invention is not limited to these examples.

Example 1 As shown in FIG. 2, a distal end portion of a catheter tube 12 made of polyurethane was molded under heat and pressure using a mold. D1 = 2.3 mm, D2 = D3 = 1.9 mm, D4
= 1.5 mm, L1 = 9.0 mm, L2 = L3 = 0.8
mm, L4 = L5 = 0.3 mm, and L6 = 1 mm.

Next, an inner diameter of 1.9 mm and a thickness of 0.18 m
m, a tubular balloon made of polyether polyurethane having a length of 9.0 mm was prepared. Wavelength 200-500n
The transmittance of the balloon to ultraviolet rays in the region of m is 80%
Met.

The balloon was mounted on the balloon mounting portion of the catheter tube. At that time, care was taken not to apply too much force to the balloon.

Thereafter, as shown in FIG.
Were rolled up, and an ultraviolet-curing adhesive mainly composed of a polyester-based acrylate was applied to the outer peripheral surfaces of the bonding portions 20 and 22. Thereafter, the turn-up of both ends of the balloon 30 was returned to its original position, and ultraviolet light was irradiated from the outside to bond the balloon 30 airtightly at the bonding portions 20 and 22, thereby obtaining the balloon catheter 10 shown in FIG. Thus, ten balloon catheters 10 were produced.

After passing each balloon catheter 10 through a 7 Fr introducer sheath, 1.5 ml of air was injected using a syringe to inflate the balloon, and the eccentricity was evaluated. The eccentricity was evaluated by the method shown in FIG.

Out of the ten balloon catheters, ten had an eccentricity of less than 0.2, and none had an eccentricity of more than 0.2. After leaving the balloon inflated for 10 minutes, 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 tubes was 0.29 k.
gf.

Example 2 Example 1 was repeated except that a silicone rubber tube having a transmittance to ultraviolet rays of 60% was used as a balloon, a cyanoacrylate adhesive was used as an adhesive, and no ultraviolet irradiation was performed. In the same manner as described above, ten balloon catheters were manufactured. Example 1 Eccentric Balloon
When evaluated in the same manner as in the above, eight pieces had an eccentricity of less than 0.2, and two pieces had an eccentricity of 0.2 to 0.35.
None exceeded 0.35. When the pullout resistance was measured in the same manner as in Example 1, the average value of the ten wires was 0.32 kgf.

Example 3 Example 1 was repeated except that a natural rubber tube having a transmittance of 30% to ultraviolet rays was used as a balloon, a cyanoacrylate adhesive was used as an adhesive, and no ultraviolet irradiation was performed. In the same manner as described above, ten balloon catheters were manufactured. The eccentricity of the balloon was evaluated in the same manner as in Example 1.
Of the books, those with an eccentricity of 0.2 to 0.35 are 0 and 0.3
Nothing exceeded five. When the pull-out resistance was measured in the same manner as in Example 1, the average value of the ten wires was 0.31 kgf.

COMPARATIVE EXAMPLE 1 A dividing groove 2 shown in FIG.
Without forming 4,26, a natural rubber tube having a transmittance of 30% to ultraviolet rays was used as a balloon, a cyanoacrylate adhesive was used as an adhesive, and no ultraviolet irradiation was performed. In the same manner as in Example 1, ten balloon catheters were manufactured. When the eccentricity of the balloon was evaluated in the same manner as in Example 1, the number of the eccentricities less than 0.2 was four, and the eccentricity was 0.2 to 0.2.
There were two pieces with 0.35 and one piece with an eccentricity exceeding 0.35. When the pull-out resistance was measured in the same manner as in Example 1, the average value of the ten wires was 0.3 kg.
f.

[0063]

As described above, according to the present invention, when a fluid is fed through the lumen into the balloon of a balloon catheter, the balloon expands almost without eccentricity, and the cardiac output and blood pressure are increased. Can be measured accurately. Further, since the balloon expands without being excessively eccentric, there is little possibility that the balloon may be loosened in a state where the balloon is deflated, and insertion and withdrawal from the introducer sheath are easy. Therefore, the balloon catheter according to the present invention can be suitably used particularly for cardiac catheter examination.

Further, in the method for manufacturing a balloon catheter according to the present invention, since only the partition groove is formed on the outer periphery of the distal end of the catheter tube, uneven application of the adhesive can be prevented. However, it is possible to easily manufacture a balloon catheter with less eccentricity and slackness of the balloon.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view of a main part of a balloon catheter according to one embodiment of the present invention.

FIG. 2 is a fragmentary cross-sectional view showing one manufacturing step of the balloon catheter according to the embodiment.

FIG. 3 is a fragmentary cross-sectional view showing another manufacturing step of the balloon catheter.

FIG. 4 is an explanatory diagram of an eccentricity of a balloon.

FIGS. 5A and 5B are cross-sectional views of main parts of a balloon catheter according to a conventional example.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 ... Balloon catheter 12 ... Catheter tube 14 ... Catheter tube main body 15 ... Balloon inflatable part 16 ... Balloon mounting part 18 ... Tip tip 20, 22 ... Adhesive part 24, 26 ... Partition groove 30 ... Balloon 32, 34 ... Lumen 40 ... Branch Part 42, 44 ... Port

Claims (2)

[Claims] 1. A catheter tube having at least one lumen formed along a longitudinal direction thereof, wherein a fluid introduced through the lumen is introduced into the balloon so that the balloon is inflated.
A balloon adhered to the distal end of the catheter tube, and limiting the axial length of the adhesive portion next to the adhesive portion on the outer periphery of the distal end of the catheter tube to which the balloon is adhered. As described above, the balloon catheter is formed with a partition groove for receiving an extra adhesive applied to the adhesive portion. 2. forming an adhesive portion to which a balloon is attached at an outer peripheral position of a distal end portion of the catheter tube having at least one lumen formed along a longitudinal direction; Forming a partition groove for receiving excess adhesive applied to the adhesive portion so as to limit the axial length of the adhesive portion; and bonding to the adhesive portion at the distal end of the catheter tube. Applying the agent and adhering the balloon.