JP2001276228A - Catheter with balloon - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter with a balloon which enables reduction in the number of necessary parts and higher operability by lessening the tube diameter of the catheter. SOLUTION: This catheter with a balloon has a double type tube comprising inner and outer tubes which are arranged concentrically and slidable mutually in the axial direction thereof and a balloon with one end thereof fastened on the inner tube and the other end thereof one the outer tube. The outer diameter of the outer tube is below 4 mm while the bending moment is in the range of 70-250 g.cm at a point 40 cm or less from the tip of the tube when the angle of bending of the outer tube is 45 deg..

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter with a balloon which is used in medical treatment for performing a treatment such as expanding a mitral valve of a stenotic heart and normalizing blood flow, and more particularly, to a catheter inserted into a blood vessel. The present invention relates to a catheter with a balloon for reducing the diameter of a tube, reducing the number of parts, and improving operability.

[0002]

2. Description of the Related Art In recent years, treatment methods using a catheter with a balloon have become widespread. With the diameter of the balloon reduced (diameter reduced), it is sneaked into a stenotic or occluded blood vessel, etc., and the fluid is injected to expand the balloon to expand the blood vessel, etc., so that the stenosis or occlusion is normal. It is being treated. In addition, non-incision-based percutaneous percutaneous fissures can be used in place of valve-opening surgery for heart valves stenotic due to aging, calcification, or sequelae of rheumatic fever, or valve replacement surgery for artificial valves. -25459
A balloon catheter as described in JP-A-81 is already widely used.

FIG. 3 is a cross-sectional view showing a general catheter when the balloon is inflated, and FIG. 4 is a cross-sectional view showing a general catheter when the balloon is deflated.

[0004] In a general balloon catheter, FIG.
As shown in (2), the balloon 52 attached to the distal end of the tube 51 is sunk into the blood vessel M along with the tube 51 along the guide wire W, and the balloon 52 is inflated to perform treatment. When the balloon 52 is sunk into the blood vessel M or when the balloon 52 is pulled out from the blood vessel M, as shown in FIG. 4, the balloon 52 is expanded and reduced in diameter.

[0005] The tube 51 is a double tube type tube comprising an inner tube 53 and an outer tube 54, and a balloon 52.
Is fixed to the inner tube 53 side and the other end is fixed to the outer tube 54 side. The outer tube 54 is stopped, and only the inner tube 53 is pushed by the extension pipe 55 to be advanced with respect to the outer tube 54. Thereby, the balloon 52 is configured to be expanded and reduced in diameter.

[0006]

However, the above-mentioned conventional catheter with a balloon has a problem that the tube 51 is thick. When the tube 51 is thick, it is difficult to insert the tube 51 into the blood vessel M, and there is still room for improvement in the operability of the operator and the burden on the patient.

However, even if the diameter of the tube is made too small, a practically usable one cannot be obtained. In order to reduce the diameter, the present inventors reviewed the structure of the catheter and arrived at the present invention. That is, the reason that the tube 51 of the conventional catheter with a balloon is thicker is that the diameter of the inner tube 53 needs to be increased so that the elongation pipe 55 for pushing the inner tube 53 can be inserted when the diameter of the balloon 52 is reduced. This is because it is necessary to increase the diameter of the outer tube 54 so that the air bleeding tube 56 for bleeding the air (air) from the balloon 52 can be inserted.

[0008] In view of the above circumstances, an object of the present invention is to provide a balloon catheter having a small tube diameter.

[0009]

In other words, the present invention provides a double tube type tube comprising an inner tube and an outer tube which are axially slidable and concentrically arranged with respect to each other; Has a balloon fixed to the outer tube, 40 cm from the tube tip when the outer diameter of the outer tube is 4 mm or less and the bending angle of the outer tube is 45 degrees.
A catheter with a balloon having a bending moment in the range of 70 to 250 g · cm in the following.

Further, the present invention provides a double tube type tube comprising an inner tube and an outer tube which are axially slidable and concentrically arranged, and one end of which is fixed to the inner tube and the other end of which is fixed to the outer tube. Having an outer diameter of 4 mm or less, the outer tube being made of a synthetic resin, and having a plasticizer content of 28 to 40 parts contained in the synthetic resin.
It is a catheter with a balloon which is a part.

Further, the present invention provides a double tube type tube comprising an inner tube and an outer tube which are concentrically arranged so as to be slidable in the axial direction, and one end of which is fixed to the inner tube and the other end of which is fixed to the outer tube. Having a balloon, without an air bleed tube between the inner tube and the outer tube, before inserting into the subject, introduce liquid into the balloon with the balloon tip side substantially downward, A balloon-equipped catheter that is used by inflating and deflating the balloon at least once to eliminate the gas in the balloon.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A catheter with a balloon (hereinafter abbreviated as "catheter" as appropriate) of the present invention and the operation of expanding and reducing the diameter of the balloon and inserting the balloon into a blood vessel will be described.

When the balloon of the catheter of the present invention is inserted into or taken out of a tube (blood vessel or the like) to be treated, the inner tube is advanced relatively to the outer tube (to advance). Operation) to extend the balloon in the axial direction of the tube to reduce the diameter.

In the present invention, the outer diameter of the outer tube is 4 mm.
It is important to: By doing so, it is expected that the operability is improved even when the catheter is inserted into the blood vessel of the subject, and the burden on the subject is reduced. The outer diameter of the outer tube is preferably 3.8 mm or less.

In the present invention, it is necessary that the bending moment of the outer tube within a range of 40 cm or less from the tip of the tube when the bending angle is 45 degrees is in the range of 70 to 250 g · cm. Preferably, it is in the range of 90 to 200 g · cm.

The bending moment is TINIUS OLS
It can be measured using EN STIFFNES TESTER. Span length 12mm, weight 95g
Then, outer tube samples of 50 mm each were taken from both ends and the center between 40 cm from a position 3 mm away from the connection pipe binding part toward the hand side, and each was fixed to a rotary sample vise about 20 mm, and the load scale After zero-adjustment of the angle pointer, turn on the motor meshing lever and visually check the angle pointer every 5 degrees during automatic operation. At almost the same time, the load scale is continuously measured and recorded to 45 degrees.
At the time of 5 degrees, it is calculated by the following equation. The average of n = 3 at both ends and the center is defined as the bending moment of the outer tube defined in the present invention. Further, n number 3 may be collected from another catheter of the same type. Bending moment = 95 x load scale indicated value (%) ÷ 1
00 (g-cm).

In the present invention, the outer diameter of the outer tube is smaller than that of the conventional tube, but since the bending moment at a bending angle of 45 degrees is in the range of 70 to 250 g · cm, the same rigidity and catheter as those of the conventional tube are used. The required flexibility is maintained, and the operability can be improved because the tube can be smoothly moved in the blood vessel by the small outer diameter while maintaining the conventional feeling of use.

As described above, the catheter according to the present invention can be operated with the same feeling as before even though the outer diameter of the catheter is reduced. Pain can be reduced.

The outer tube having the diameter and the bending moment in the above ranges can be achieved by making the outer tube of a synthetic resin and setting the content of the plasticizer contained in the synthetic resin to 28 to 40 parts. The content of the plasticizer is preferably 31
Parts to 40 parts.

When polyvinyl chloride is used as the synthetic resin forming the outer tube, examples of the plasticizer include diheptyl phthalate, dioctyl phthalate, dibutyl phthalate, octyldecyl phthalate, diisodecyl phthalate, and butyl phthalate. Benzyl and the like.

Further, a catheter having a diameter in the above range while maintaining the function usable for the therapeutic use of the present invention can be achieved by omitting the conventionally required air vent tube.

The air release tube is required to introduce a liquid into the balloon on the distal end side and replace the gas (air) in the balloon before inserting the balloon catheter into the subject. However, the idea is that replacement can be easily performed by introducing a liquid into the balloon with the balloon tip side substantially downward, and inflating and deflating the balloon at least once (only about once to three times). As a result, the air vent tube is omitted, and the space can be saved.

In the catheter of the present invention, the length between the binding portions in a state where the balloon is expanded when the blood vessel is inserted is 57 to 6 mm.
It is preferably 5 mm. By doing so, the applied sheath 12Fr can be maintained without changing the balloon diameter after expansion.
(4.0 mm) and can be made thinner at the time of insertion without changing the expansion effect of the valve, so that the passage through the blood vessel is smooth.

The length of the balloon in a stretched state can be defined, for example, by fixing the depth at which the balloon stretching pipe is pushed in at hand.

Further, the balloon-equipped catheter of the present invention
At the tip of the inner tube is provided a balloon expansion pipe stop that is inserted into the inner tube and abuts a balloon expansion pipe for expanding and reducing the diameter of the balloon. Thick portion, a relatively narrow portion on the tip side, and a constricted portion between them.The inner diameter on the tip side extends over the longitudinal direction without increasing the inner diameter from the constricted portion toward the tip side. It is preferably substantially uniform.

By this, when the extended balloon tip is inserted into the incision of the blood vessel along the guide wire,
The gap between the guide wire and the inner wall of the extension pipe stopper is reduced, and the extension pipe stopper serves as a guide, so that the tip of the balloon does not shift from the direction indicated by the guide wire, making it easier to insert the blood vessel into the incision, Operability can be improved. Of course, on the edge of the tip of the pipe stop,
Applying the taper processing and the R processing does not hinder this effect, so they are not excluded, but the point of removing burrs on the processing of the pipe stopper,
It is rather preferable from the viewpoint of preventing the guide wire from being caught. In addition, although a step is inevitably generated in the throttle portion of the pipe stop, the step in this portion does not affect the effect of the present invention and does not exclude such an aspect.

The balloon used in the present invention has a double bag type structure in which an inner balloon which is inflated by the introduction of a fluid is received by an outer balloon, so that the balloon is easily inflated and hardly torn, and has sufficient elasticity and pressure resistance. Is preferred because it can be applied to

The balloon used in the present invention is preferably reinforced by a fabric containing a core-sheath yarn comprising a core elastic yarn and a sheath inelastic yarn having a longer free length than the core elastic yarn. This is preferable in that the balloon is provided with elasticity, sufficient pressure resistance, and uniformity of inflation.

Further, the catheter of the present invention has a tip at the tip of the balloon for smoothly inserting the tip of the balloon into the blood vessel without damaging the blood vessel. Three to eight ribs are provided inside the tip. And the inner diameter formed by the arrangement of the ribs is the maximum outer diameter of the extension pipe stopper +
It is preferable to make it within 0.3 mm. By doing so, the rib serves as a guide when the distal tip is bonded, and the distal tip is less likely to be inclined with respect to the extension pipe stop, thereby facilitating the bonding operation.

In the catheter of the present invention, it is preferable that the length of the operating portion hub of the needle tube of the sliding portion is increased to 3.6 to 10 mm. By doing so, the operability is improved because it is easy to grasp by hand and becomes less slippery.

Next, an embodiment of the balloon catheter according to the present invention will be described more specifically with reference to the drawings. FIG. 1 is a cross-sectional view showing a detailed configuration near the distal end of a catheter according to one embodiment of the present invention, and FIG. 2A is a plan view showing a schematic configuration of the entire catheter according to one embodiment of the present invention. FIG. 2B is a plan view showing the balloon shape when the balloon is inflated.

The catheter of the embodiment shown in FIG. 2A has an elongated tube 1 having a round cross section and a smooth surface.
In addition to a balloon 2 attached to the distal end of the tube 1, a fluid inlet or the like is provided at the rear end of the tube 1 as necessary.

As shown in FIG. 1, the tube 1 is a double tube type tube comprising an inner tube 3 and an outer tube 4 which are slidable in the axial direction and are inserted concentrically. . The balloon 2 is an example of a double-bag type balloon including an inner balloon 5 that expands by introducing a fluid and an outer balloon 6 that receives the inner balloon 5 that expands with the introduction of the fluid from the front side.

The inner balloon 5 is formed of a cylindrical elastic film, and silicone grease is applied to both the front and back surfaces of the inner balloon 5. The outer balloon 6 includes an outer cylindrical elastic film 6a and an inner balloon reinforcing cylindrical core-sheath thread 6a.
b, the core-sheath thread 6b for reinforcing the balloon is attached to the inner surface of the elastic film 6a with rubber glue or the like, and is not displaced by the expansion and contraction of the balloon while preventing the scattering of the elastic film 6a. It is configured to provide uniform expansion. Balloon 2 can be of any length,
A range of -70 mm is often appropriate.

As described above, the overall layer structure of the balloon 2 is desirably a three-layer structure of the above-mentioned elastic film / tubular core-sheath thread / elastic film. The elastic film of the inner balloon 5 is formed of the outer balloon 6 having a two-layer structure.
In particular, it has sufficient elasticity and pressure resistance due to the reinforcing effect of the core-sheath thread 6b, and is capable of achieving a large balloon internal pressure (about 2 to 5 atmospheres at which the valve is mechanically cleaved). Has become. Further, the elastic film 6a having a smooth surface has a function of deflating the expanded balloon and a function of improving the permeability in the blood vessel.

Further, as shown in FIG. 2 (b), the outer balloon 6
An elastic band 7 is bonded with rubber glue or the like in the middle. That is, the band 7 is fitted and adhered between the elastic film 6a and the core-sheath thread 6b, and the band 7 has a gourd shape because expansion is suppressed more than the other. The valve port to be expanded is aligned with the position of the band 7, so that the balloon does not slide down from the valve port. Of course, if the balloon is not a gourd, the elastic band 7 is unnecessary.

Incidentally, even if the liquid is introduced and the inner balloon 5 being inflated is torn, and the liquid cannot be sucked in the syringe, the balloon 2 is deflated without a liquid outlet. In order to avoid such a situation, some escape holes 8 are provided in the outer balloon 6. With the balloon 2 inflated, the catheter cannot be pulled out of the body. When the inner balloon 5 is torn, the liquid is released and is released from the pores 8 so that the balloon 2 is automatically deflated (contracted).

The elastic film used for the balloons 5 and 6 is a thin film having a large elasticity and a smooth surface, and is often made thinner at the front end than at the rear end. If the thickness at the front end side is smaller than the rear end side, the front end side expands (expands) first. Examples of the material of the elastic film include rubber such as polyurethane and latex, and rubber is particularly suitable for balloons because of its low initial elastic modulus.

The thickness of the elastic film is 0.1 to 0.4 mm
Is preferable. The elastic films used for both balloons 5, 6 need not be the same thickness. The difference in thickness between the front end side and the rear end side may be about 5 to 25%. For example, the thickness may be reduced when a tubular elastic film is manufactured. Is obtained by expanding the corresponding portion, fixing the residual elongation and reducing the film thickness.

On the other hand, the tubular core-sheath thread 6b is made of a core-sheath thread (composite thread) composed of a core elastic thread and a sheath non-elastic thread having a longer free length than the core elastic thread. Knitting, knitting,
Fabrics such as woven fabrics, nonwoven fabrics, braids, and fabrics wound in a cylindrical shape with a large twill angle are preferred, and a tubular knitted structure having elasticity is preferred.

The ratio of the free length of the core elastic yarn to the sheath inelastic yarn is preferably 0.15 to 0.5. More preferably, it is 0.2 to 0.35. If this value is too large, the balloon will not be sufficiently inflated. On the other hand, if the value is too small, the reinforcing effect of the inelastic yarn is not sufficiently exerted, and the balloon is likely to be damaged when inflated. However, if the manufacturing is performed with great care to avoid breakage, the effects of the present invention can be used even when the above ratio is larger.

The ratio of the free length is determined by the S-S of the core-sheath yarn.
This can be determined by measuring the point at which the curve bends toward the high tension side. If there is a variation in the free length of the inelastic yarn and the above-mentioned point of refraction is unclear, it can be known by searching the front and rear straight portions.

The core-sheath yarn has a structure in which an elastic yarn is used as a core and an inelastic yarn is used as a sheath. In other words, in order to facilitate expansion due to internal pressure, or to set a partial order of expansion and a final expansion shape, there is a case where a habit is formed by expanding and contracting in advance. In this case, separation of both constituent yarns may have an adverse effect.

As a method of producing the core-sheath yarn, a method of twisting or fluid entanglement while overfeeding the inelastic yarn, particularly twisting a synthetic fiber with a urethane yarn (elastic yarn) (inelastic yarn)
The core-sheath yarn obtained by spirally winding is preferred in that it is compact. It is preferable that the non-elastic yarn is a processed yarn because it is excellent in stretchability and adhesiveness with an elastic film. Among the processed yarns, false twisted yarns having excellent elasticity are preferred. If it is not a processed yarn, there is a disadvantage that it is likely to separate from the elastic yarn. However, it is possible to avoid a defect that is easily separated by taking measures such as sufficiently increasing the number of twists.

The elastic yarn for the core is not particularly limited as long as it is an elastic fiber. For example, natural yarn or synthetic rubber or the like and polyurethane single yarn or twisted yarn are suitable, and the synthetic fiber (inelastic yarn) to be wound is nylon,
In addition to high-strength yarns such as polyester and polytetrafluoroethylene (“Teflon (registered trademark)”), single yarns of high-strength yarns such as polyimide and polyethylene may be used, but twisted yarns are preferred because they are more flexible. The thickness of these yarns is not particularly limited because the required pressure resistance varies according to the action site and purpose, but the elastic yarn for the core is 11 to 56 dtex, and the strong elastic yarn to be wound or the non-elastic yarn of the high-strength yarn is 33. ~ 167dte
It is often selected in the range of x.

The balloon 2 is attached to the tube 1 by fixing one end to the inner tube 3 and the other end to the outer tube 4 as shown in FIG. That is, the metal distal pipe 9 is fixed by inserting the metal distal pipe 9 into the distal end of the inner tube 3 so as to fit about half of the entire length, and then binding and stopping the thread 15. One end of the outer balloon 6 is tied and fixed to the insertion area of the tip pipe 9 with the thread 15, and one end of the outer balloon 6 is also tied and fixed to the insertion area of the tip pipe 9 with the thread 15. Also, at the very tip of the tube 1,
The tapered tip chip 10 is adhesively fixed by an adhesive 11 of an epoxy resin or the like, and the balloon end or the connection portion is smoothly finished by the adhesive 11 of an epoxy resin or the like. Tip 10 is 3 inside
８8 ribs 18 (see FIG. 5 in cross section) are attached, and the inner diameter of the ribs 18 is within +0.3 mm of the maximum diameter on the tip end side of the tip pipe, so that the adhesive is soft when the tip tip 10 is bonded. When the direction of the tip 10 is easily changed, the tip pipe 9 serves as a guide, so that the direction of the tip 10 is stable and the bonding operation is easy to perform.

Further, the metal connection pipe 12 is fixed by inserting a metal connection pipe 12 into the end of the outer tube 4 so as to fit into about 1/3 of the total length, and then binding and stopping the thread. The other end of the inner balloon 5 is tied and fixed to the tip of the connection pipe 12 with a thread, and the other end of the outer balloon 6 is connected to the connection pipe 12.
It is tied with a thread in the middle and is fixed. Further, the balloon end and the connection portion are smoothly finished with an adhesive 13 such as an epoxy resin.

At the time of insertion or withdrawal into a blood vessel or a heart cavity, the inner tube 3 is slid forward (in the axial direction) with respect to the outer tube 4 to move the inner and outer balloons 5 and 6 in the axial direction. In the present invention, the operation of extending and reducing the diameter (reducing the diameter) is performed. In the case of the present invention, it is necessary to increase the balloon extension length to reduce the diameter of the balloon. Can be easily inserted.

Also, as shown in FIG. 6, the balloon extension pipe stopper is composed of a relatively large diameter portion on the proximal side, a relatively small diameter portion on the distal side, and a constricted portion therebetween. The diameter of the tip side is substantially uniform over the longitudinal direction without increasing the inner diameter from the squeezed portion toward the tip side, and the inner diameter at the tip side of the pipe stop and the balloon extension pipe are used. In particular, when the difference in inner diameter is ± 0.2 mm or less, there is no step, so there is no catch when inserting the guide wire, and the gap between the inner diameter of the tip pipe and the guide wire is small, and the tip is displaced from the guide wire. Since there is no blood vessel, it is easy to insert the blood vessel into the incision.

After the balloon extension pipe 55 is inserted into the inner tube sliding needle tube in preparation for extending the balloon, the inner tube sliding needle tube hub and the balloon extension pipe 55 hub are locked. If the length d1 of the operating portion hub 16 of the inner tube sliding needle tube is set to 3.6 to 10 mm during the locking and unlocking work, the fingertip can be grasped firmly without slipping even in the state of being coated with blood or the like, and the operation is easy. Becomes

By performing the operation of inflating and deflating the balloon 2 with the expanding liquid once or three times with the balloon 2 down, the air in the balloon can be evacuated without using the air bleeding tube. As a result, the diameter of the outer tube can be reduced by saving space due to the need for an air release tube.

As described above, the inner and outer tubes 3 and 4 can be reduced in diameter, so that the outer diameter of the tube 1 (that is, the outer diameter of the outer tube 4) can be made much smaller than before. The outer diameter d2 of the outer tube 4 is usually 14
Fr (4.7 mm) or less.
r (4.0 mm) or less is more desirable. Even if the outer tube is made thinner, the flexural rigidity of the outer tube can be made equal to the conventional one by setting the amount of the plasticizer to 28 to 40 parts, and the operation at the time of surgery is not affected.

The length of the tube 1 is not limited to a specific length because it varies depending on the age and physique of the patient and the distance from the insertion site to the place to be treated, but is preferably in the range of 20 to 120 cm. Things are used.

Examples of the rigid inner tube 3 include tubes made of a synthetic resin such as polyethylene, polytetrafluoroethylene (“Teflon”), polypropylene, or nylon. In addition to these tubes, tubes made of polyvinyl chloride resin that have been made rigid by extracting the plasticizer with a solvent, tubes made of synthetic resin that has been made rigid by being cross-linked and cured by irradiation with radiation, It is also possible to use a synthetic resin tube or the like having a reduced rigidity.

On the other hand, a tube made of the same material as the inner tube 3 can also be used for the hard outer tube 4 having torque.

Further, it is preferable to mix a compound of barium sulfate or bismuth or a contrast agent of a metal powder such as tungsten into these tubes, because it helps to know the position in the blood vessel by radiography.

In FIG. 1, a lead yarn (for example, an aramid fiber yarn “Kevlar”) is attached with its tip sandwiched between the inner surface of the outer tube 4 and the surface of the metal connection pipe 12 and led to the hand side. The “thread” 14 slides and advances the inner tube 3 (in the axial direction) with respect to the outer tube 4 to expand and contract both the inner and outer balloons 5 and 6 in the axial direction. This is to stop the elongation. The yarn for suppressing the elongation of the outer tube 4 is not limited to a specific material, but a fiber having a high elastic modulus, for example, a polyamide yarn is suitable. Furthermore, a knitted material may be used instead of a thread to reduce the elongation of the outer tube 4. Further, a yarn or a knitted material for suppressing the extension of the outer tube 4 may be embedded in the outer tube 4.

The fluid for inflating the balloon 2 is sent to the inner balloon 5 through the gap between the inner tube 3 and the outer tube 4, as indicated by the arrow RA in FIG. Balloon 2
As a fluid for expanding the liquid, for example, a liquid such as a physiological saline solution or a contrast solution, or a gas such as carbon dioxide is used. These fluids are used in such a manner that a certain amount thereof is press-fitted with a syringe or the like. When the fluid is sufficiently sent to the inner balloon 5, the balloon 2 expands in a gourd shape as shown in FIG.

The balloon 2 of the catheter according to the above-described embodiment has a large elasticity so that the outer diameter of the balloon 2 can be made small, and the diameter of the tube 1 can be made very small. It can be inserted by the Sertinga method. Therefore, the wound for treatment can be small, post-operative treatment and management are easy, the time until healing is much faster, and the burden on patients and caregivers is reduced. Also,
Even when the balloon 2 is pushed into the heart lumen, the insertion operation such as placing it on a guide wire or blood flow becomes easy, and in addition, the tip of the balloon 2 is soft and there is no fear of damaging the blood vessel inner wall, so operability is improved. Is done. In addition, it is easy to manufacture and assemble a cylindrical elastic film for a balloon and a cylindrical core-sheath thread for reinforcing a balloon, and it can be manufactured at a good yield and at low cost.

Next, an example having a specific configuration conforming to the catheter of the above-described embodiment will be described.

[0061]

[Example 1] A false twisted yarn (non-elastic yarn for sheath) composed of a polyester yarn of 78 dtex-24f is used as a polyurethane yarn of 33 dtex (elastic yarn for core) and 370% overfeed of the polyurethane yarn. 412T /
m to produce a core-sheath yarn (composite yarn). When the ratio of the free length of both yarns was read from the SS curve, it was 0.26 (free length of polyester: free length of polyurethane = 1: 0.2
6).

The core-sheath yarn produced in this manner was used for a 20 m diameter.
The knitting machine in which 50 knitting needles were arranged on the circumference of m was knitted into a tube to obtain a tubular core-sheath thread material 6 b used for the outer balloon 6.

On the other hand, as the outer tube 4, a 222 dtex polyimide twisted yarn as the lead yarn 14 is provided along the hollow side of a 690 mm long vinyl chloride tube of 11 Fr containing 40 parts of DOP (dioctyl phthalate) and 50% of a contrast agent. At the same time, a stainless steel pipe was attached to the tip as a metal connection pipe 12, and a Y connector 19 was attached to the rear end in the same manner. The bending moment of the outer tube was 10 g · cm.

On the other hand, as the inner tube 3, the outer diameter of the tip portion containing 24 parts of DOP (dioctyl phthalate) is 1.7 m.
m, a stainless steel pipe 9 with an outer diameter of 1.5 mm and an inner diameter of 0.9 mm at the center drawing portion is attached to the end of the tube as an extension pipe stop, and an outer diameter of 2.5 mm at the rear end. A 30 mm-thick stainless steel pipe with a needle base was inserted. Each stainless steel pipe is 70 μm and 11
The inner tube and the outer tube were tightly fixed with a 0 μm nylon thread. The bending moment of the inner tube 3 was 20 g · cm. Then, the inner tube 3 was first passed through the Y connector 19, and then further inserted into the outer tube 4, and then the outer tube 4 was fixed to the Y connector 19, thereby producing a portion to be the tube 1 of the catheter.

Next, a rubber tube having a thickness of 0.3 mm and a length of 25 mm is used as an elastic film of the inner balloon 5, and one end and the other end thereof are tied to the tips of the inner tube 3 and the outer tube 4 with 70 μm nylon thread, respectively. After fixing, a small amount of silicone grease was applied to the surface of the rubber tube.

The thickness of the core-sheath thread 6b is 0.2
After attaching a rubber band having a length of 7 mm and a length of 7 mm as an elastic band 7 with rubber glue, a rubber tube having a thickness of 0.2 mm at the front end and 0.3 mm at the rear end is further provided on the outside thereof. It was stuck as an elastic film 6a on the outer balloon 6. Put this on the inner balloon 5 and the total length is 25mm
The inner tube 3 and the outer tube 4 were tied and fixed with 70 μm and 110 μm nylon threads. Then, the extra knitted portion and the rubber portion were cut off, and the balloon 2 including the inner balloon 5 and the outer balloon 6 was produced.

Then, a two-way cock was attached to the Y connector 19, and both ends, the tip and the joint of the balloon 2 were finished smoothly with an epoxy resin adhesive.
Was completed.

After the syringe was attached to the completed catheter, the air was replaced with water while bleeding air, and about 5 ml of water was injected. Only the tip of balloon 2 is about 20m
m. Further, when the injection amount was further set to 18 ml, the balloon 2 was inflated to about 26 mm. Next, when water was drained from the balloon 2, the surface shrunk (wilted) in a smooth state without wrinkles.

After passing through the guide wire W, the stainless steel pipe with the needle base of the inner tube 3 is pushed to push the inner tube 3
When the balloon 2 was extended from 25 mm to 60 mm, the diameter of the balloon 2 was reduced from about 7 mm to about 5 mm, and when the stainless steel pipe with the needle base was pulled back, the diameter of the balloon 2 was also reduced to about 7 mm. I returned.

Further, the balloon 2 is turned down.
By performing the operation of inflating and deflating water with water about once to three times, it was also confirmed that the air bleeding of the balloon 2 could be completely performed without using the air bleeding tube.

Next, a clinical application example of the catheter with a balloon according to the first embodiment will be described. In the following clinical application example, the catheter of Example 1 is applied to mitral valvuloplasty.

First, the right hip vein is percutaneously punctured, and a catheter for puncturing the atrial septum is inserted into the left atrium by the transatrial septum method. The atrial septum puncture catheter is replaced with a guidewire, through which a dilator is introduced into the left atrium to dilate the hip vein and the atrial septum puncture. After removing the dilator, the balloon 2 of the catheter of Example 1 was similarly introduced into the left atrium, passed through the mitral orifice using a stylet, and the distal side of the balloon 2 was further diluted with a contrast medium. It was inflated and lightly pulled against the orifice to be split. When the balloon 2 was inflated at that position, the balloon 2 expanded the valve port without slipping off. The dehiscence procedure including 5 seconds of balloon inflation and deflation requires less operability and smoothness in a shorter time than before, shortens postoperative hemostasis time without side effects, and shortens the post-operative course. Very good.

[Example 2] As shown in FIG. 6, a pipe with an outer diameter of 1.53 mm on the proximal side, an inner diameter of 1.13 mm, an outer diameter on the distal side of 1.2 mm, and an inner diameter of 0.8 mm were used as the extension pipe stopper.
Example 1 was repeated except that the stainless steel pipe of Example 1 was used.

Two doctors performed a total of 10 cases, all of which were easier to insert than conventional products.

The present invention is not limited to the above embodiment, but can be modified as follows. (1) Although the catheter of FIG. 1 is a double-bag type balloon, a catheter having a configuration in which the balloon is a single-bag type balloon can also be mentioned as a modification.

More specifically, in FIG. 1, an elastic film as the inner balloon 5 and a multilayer single-bag type balloon bonded to the core-sheath thread 6b, or a single-layer single-balloon without the core-sheath thread 6b Examples include a bag-type balloon catheter. (2) The catheter of FIG. 1 has a configuration in which the balloon is inflated in a gourd shape. However, a catheter in which the balloon is not inflated in a non-gourd shape in which the elastic band 7 is not attached to the balloon,
It can be mentioned as a modification.

[0077]

According to the catheter with a balloon of the present invention, the operability of the operator is improved while the conventional feeling of use is maintained, the burden on the subject is reduced, and the postoperative course is improved. Can be expected. Furthermore, the cost can be reduced as compared with the conventional product by omitting parts.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing a detailed configuration near the distal end of a catheter according to an embodiment of the present invention.

FIG. 2 is a plan view showing a schematic configuration of the entire catheter according to one embodiment of the present invention.

FIG. 3 is a cross-sectional view showing a state of a general catheter when a balloon is inflated.

FIG. 4 is a cross-sectional view showing a state of a general catheter when a balloon is deflated.

FIG. 5 is a cross-sectional view illustrating a state of a rib attached to the inside of the tip chip.

FIG. 6 is a cross-sectional view showing a detailed configuration near the distal end of a catheter according to another embodiment of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Tube 2 ... Balloon 3 ... Inner tube 4 ... Outer tube 5 ... Inner balloon 6 ... Outer balloon 6a ... Elastic film 6b ... Cylindrical core-sheath thread 7 ... Band 8 ... Relief pore 9 ... Tip pipe 10 ... Tip Tip 11 ... Adhesive 12 ... Connecting pipe 13 ... Adhesive 14 ... Lead thread 15 ... Binding thread 16 ... Operation hub of needle tube for inner tube operation 17 ... Pipe hub for balloon extension 18 ... Rib 19 ... Y connector 51 ... Tube 52 ... Balloon 53 ... inner tube 54 ... outer tube 55 ... balloon expansion pipe 56 ... air release tube W ... guide wire M ... blood vessel d1 ... length of operation section hub 16 d2 ... outer diameter of outer tube

Claims (9)

[Claims] 1. A double tube type tube comprising an inner tube and an outer tube, which are concentrically slidable with each other in an axial direction, and a balloon having one end fixed to the inner tube and the other end fixed to the outer tube. The outer tube has an outer diameter of 4 mm or less and a bending angle of the outer tube of 45 degrees, the bending moment at 40 cm or less from the tube tip is 70 to
A catheter with a balloon in the range of 250 g · cm. 2. A double tube type tube comprising an inner tube and an outer tube which are concentrically slidable with each other in an axial direction, and a balloon having one end fixed to the inner tube and the other end fixed to the outer tube. A catheter having a balloon, wherein the outer diameter of the outer tube is 4 mm or less, the outer tube is made of a synthetic resin, and the content of the plasticizer contained in the synthetic resin is 28 to 40 parts. 3. A double-tube type tube comprising an inner tube and an outer tube which are arranged concentrically so as to be slidable in the axial direction, and a balloon having one end fixed to the inner tube and the other end fixed to the outer tube. Having, without an air release tube between the inner tube and the outer tube, before inserting it into the subject,
A catheter with a balloon, wherein a liquid is introduced into the balloon with the balloon tip side substantially downward, and the balloon is inflated and deflated at least once to eliminate the gas in the balloon and to be used. 4. The catheter with a balloon according to claim 1, wherein a length between the binding portions in a state where the balloon is extended is 57 to 65 mm. 5. A balloon expansion pipe stop which is inserted into the inner tube and abuts a balloon expansion pipe for expanding and reducing the diameter of the balloon is provided at the distal end of the inner tube.
The pipe stop for balloon expansion is composed of a relatively thick part of the diameter on the proximal side, a relatively thin part on the distal side, and a constricted part between them. The catheter with a balloon according to any one of claims 1 to 4, wherein the inner diameter on the distal end side is substantially uniform in the longitudinal direction without expansion. 6. The balloon has a tip at the tip of the balloon,
The catheter with a balloon according to any one of claims 1 to 5, wherein three to eight ribs are provided therein, and an inner diameter formed by the arrangement of the ribs is set to be within +0.3 mm of a maximum outer diameter of a balloon extension pipe stop. . 7. The double-bag type balloon according to claim 1, wherein the balloon is an inner balloon that is inflated by the introduction of a fluid, and an outer balloon that receives the inner balloon that is inflated with the introduction of the fluid on the front side. Or a balloon catheter. 8. The balloon according to claim 1, wherein the balloon is reinforced with a core-sheath yarn comprising a core elastic yarn and a sheath inelastic yarn having a longer free length than the core elastic yarn. Catheter with balloon. 9. The balloon-equipped catheter according to claim 1, wherein the length of the operation portion hub of the inner tube sliding needle tube is 3.6 mm to 10 mm.